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<p>Agilia SP,</p><p>Agilia SP MC, Agilia SP MC WiFi,</p><p>Agilia SP TIVA, Agilia SP TIVA WiFi</p><p>Syringe Infusion Pumps</p><p>Applicable to software version 2.2</p><p>Technical Manual</p><p>2 11378-7_TM_Agilia_SP_V2.2_ASU_Eng</p><p>Symbol Descriptions</p><p>Symbols Used in this Document</p><p>_____________________________________________________________________________________</p><p>Labeling Symbols</p><p>WARNING</p><p>Warning of a potential hazard that could result in serious personal injury and/or product damage if the written instructions are not</p><p>followed.</p><p>INFORMATION</p><p>Recommendations to be followed.</p><p>Warning</p><p>(Refer to the Instructions for Use)</p><p>Name and address of the manufacturer / Date of</p><p>manufacture</p><p>Refer to the Instructions for Use Name and address of the manufacturing facility</p><p>Product reference / part number Protection against electric shock: class II</p><p>Product serial number Non-ionizing electromagnetic radiation</p><p>Input terminal - connector CE mark</p><p>Output terminal - connector Fragile, handle with care</p><p>Electrical fuses This way up</p><p>Alternating Current (AC) Keep away from rain</p><p>Direct Current (DC) Temperature limitation</p><p>IP22 Index of protection against solid foreign objects</p><p>(> 12.5 mm) and driping liquids Humidity limitation</p><p>Not for use in residential areas Atmospheric pressure limitation</p><p>Part included in a recycling process General symbol for recyclable material</p><p>Protection against leakage current; defibrillation-</p><p>proof type CF applied part Eco packaging symbol</p><p>0 1 2 3</p><p>3</p><p>Table of Contents</p><p>1 INTRODUCTION 6</p><p>1.1 SCOPE ................................................................................................................................................... 6</p><p>1.2 INTENDED USE ....................................................................................................................................... 6</p><p>1.3 PRINCIPLES OF OPERATION..................................................................................................................... 6</p><p>1.4 INTENDED USERS.................................................................................................................................... 7</p><p>1.5 CONTRAINDICATIONS............................................................................................................................... 7</p><p>1.6 USE ENVIRONMENT................................................................................................................................. 7</p><p>2 DESCRIPTION 8</p><p>2.1 PHYSICAL DESCRIPTION.......................................................................................................................... 8</p><p>2.1.1 Housing ...................................................................................................................................................... 8</p><p>2.1.2 Keypad ....................................................................................................................................................... 9</p><p>2.1.3 Display Board........................................................................................................................................... 13</p><p>2.1.4 CPU Board ............................................................................................................................................... 16</p><p>2.1.5 Power Supply Board................................................................................................................................. 20</p><p>2.1.6 AC Power Board....................................................................................................................................... 23</p><p>2.1.7 Wi-Fi Board .............................................................................................................................................. 24</p><p>2.1.8 Back View................................................................................................................................................. 25</p><p>2.1.9 Mechanical Framework Assembly............................................................................................................ 25</p><p>2.1.10 Mechanical Plunger Driver Assembly....................................................................................................... 25</p><p>2.2 PRINCIPLES OF OPERATION................................................................................................................... 26</p><p>2.3 OPERATION DIAGRAM ........................................................................................................................... 27</p><p>3 FUNDAMENTALS 28</p><p>3.1 TRAINING.............................................................................................................................................. 28</p><p>3.2 MAINTENANCE SCHEDULE ..................................................................................................................... 28</p><p>3.3 ACCESSING / EXITING THE OPERATING FUNCTIONS................................................................................ 29</p><p>4 PROFILE MENU 30</p><p>4.1 ACCESSING THE PROFILE MENU............................................................................................................ 30</p><p>4.2 PROFILE MENU FUNCTIONS................................................................................................................... 30</p><p>5 BASIC PROFILE CONFIGURATION 32</p><p>5.1 ACCESSING THE BASIC PROFILE CONFIGURATION .................................................................................. 32</p><p>5.2 BASIC PROFILE CONFIGURATION FUNCTIONS ......................................................................................... 32</p><p>6 MAINTENANCE OPERATIONS 37</p><p>6.1 MAINTENANCE OPTIONS........................................................................................................................ 37</p><p>6.2 RUNNING TESTS ................................................................................................................................... 39</p><p>6.2.1 Accessing the Tests Menu ....................................................................................................................... 39</p><p>6.2.2 Test 1: Identification ................................................................................................................................. 40</p><p>6.2.3 Test 2: Maintenance................................................................................................................................. 41</p><p>6.2.4 Test 3: Maintenance Messages ............................................................................................................... 41</p><p>6.2.5 Test 4: Events .......................................................................................................................................... 41</p><p>6.2.6 Test 5: Force ............................................................................................................................................ 42</p><p>6.2.7 Test 6: Displacement................................................................................................................................ 44</p><p>6.2.8 Test 7: Syringe Barrel Clasp .................................................................................................................... 46</p><p>6.2.9 Test 8: Battery Info ................................................................................................................................... 49</p><p>6.2.10 Test 9: Indication...................................................................................................................................... 50</p><p>6.2.11 Test 10: Keypad ....................................................................................................................................... 50</p><p>4</p><p>6.2.12 Test 11: Ageing Test ................................................................................................................................ 51</p><p>6.2.13 Test 12: Battery Life ................................................................................................................................. 52</p><p>6.2.14 Test 13: Battery Test ................................................................................................................................</p><p>power supply indicator, infusion</p><p>indicator lights are lit.</p><p> OK is blinking in the bottom-right corner of the screen.</p><p>5. Press OK.</p><p>6. Check that:</p><p> A blue Indication screen is displayed.</p><p> The battery charge status indicator, power supply indicator, infusion</p><p>indicator lights are flashing.</p><p> Exit is displayed in the bottom-right corner.</p><p> The microphone and buzzer sound.</p><p>7. Press exit to return to the Tests menu.</p><p>If you do not press exit in the next 10 seconds, the pump returns automatically to Tests menu.</p><p>Test Description</p><p>Run this test to check the correct functioning of all pump keys.</p><p>The keypad works properly.</p><p>If this test fails, replace the upper case that supports the keypad.</p><p>See section 8.2, page 84.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 10: Keypad.</p><p>3. Press enter.</p><p>4. Press all keys one by one, and check that the corresponding circle on the</p><p>screen is highlighted.</p><p>5. Press for at least 5 seconds to exit and return to the Tests menu.</p><p>51</p><p>6.2.12 Test 11: Ageing Test</p><p>Test Description</p><p>The Ageing test checks that the motor unit is functioning correctly by carrying out</p><p>displacements between the 115 mm (4.52 in) and 20 mm (0.79 in) positions.</p><p>The motor unit is functioning correctly.</p><p>If the test fails, replace the motor unit. See section 8.9, page 105.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 11: Ageing test.</p><p>3. Press enter.</p><p>4. Press the arrow keys to enter the flow rate to be applied in mL/h.</p><p>Available range: 0.1 to 1500 mL/h.</p><p>5. Press OK.</p><p>6. Press the arrow keys to enter the motor command mode (Current).</p><p>Available options: Low, High, Maximum or Auto.</p><p>7. Press OK.</p><p>8. Press the arrow keys to select the displacement type Advance or Go/return.</p><p>9. Press OK to start the test.</p><p>If a battery alarm is present, the test cannot be launched (the OK button is not</p><p>available).</p><p>The pump starts moving the plunger forward.</p><p>While an ageing test is in progress, the pump displays the following information:</p><p> Flow rate in mL/h</p><p> Motor command mode (Current = Low, High, Maximum or Auto)</p><p> Animation representing the plunger displacement</p><p>The test ends when:</p><p> The plunger reaches the 20 mm (0.79 in) position (Displacement = Advance).</p><p> The plunger reaches the 115 mm (4.52 in) position (Displacement = Go/return). The plunger</p><p>starts moving backwards when it reaches the 20 mm position.</p><p> The user presses the exit key.</p><p>INFORMATION</p><p>During the test, the motor rotation is tested and the pump triggers an error if a problem is detected.</p><p>At end of test, the pump displays the following information:</p><p> Flow rate in mL/h</p><p> Motor command mode (Low, High, Maximum or Auto)</p><p> The test status (Finish)</p><p>10.Press exit at end of test to return to the Test screen.</p><p>52</p><p>6.2.13 Test 12: Battery Life</p><p>Test Description</p><p>This test provides information on the current battery charge percentage, and displays results of</p><p>the last battery discharge test (last run of "Test 13: Battery test").</p><p>The battery capacity is acceptable.</p><p>If the charge is low, connect the pump to an AC power supply to charge the battery.</p><p>If the displayed "Alarm" is less than 01h30 (01:30), replace the battery.</p><p>See section 8.1, page 82.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>Prerequisites</p><p>Run test 13: "Battery test" on the pump before launching this test.</p><p>See section 6.2.14, page 53.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 12: Battery life.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Charge: Battery charge current rate (in %)</p><p> Auto Off: Date of last automatic cut off (value saved during last battery</p><p>test)</p><p> Pre alarm: Duration between transition to battery and pre alarm (value</p><p>saved during last battery test)</p><p> Alarm: Duration between transition to battery and alarm (value saved</p><p>during last battery test)</p><p> Cut off: Duration from alarm to automatic pump power off (value saved</p><p>during last battery test)</p><p>5. Press exit to return to the Tests menu.</p><p>53</p><p>6.2.14 Test 13: Battery Test</p><p>Test Description</p><p>During this test, a battery discharge is performed. Pre alarm, alarm and cut off times are</p><p>determined and registered so that it is possible to evaluate if the battery works correctly.</p><p>At the end of a battery test, the results are recorded and can be checked by running</p><p>"Test 12: Battery life". Then the pump powers off.</p><p>The battery capacity is acceptable.</p><p>Replace the battery.</p><p>See section 8.1, page 82.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>Prerequisites</p><p> The pump is disconnected from the AC power supply.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 13: Battery test.</p><p>3. Press enter.</p><p>INFORMATION</p><p>If the pump is connected to an AC power supply, the test does not start and the</p><p>following screen is displayed.</p><p>Disconnect the pump from the AC power supply. The test is automatically initiated.</p><p>While a battery test is in progress, the pump displays the following information:</p><p> Pre alarm: Duration from transition to battery until pre alarm in hours and</p><p>minutes (hh:mm).</p><p>This duration increases up to the pre alarm triggering time, then stops.</p><p> Alarm: Duration from transition to battery until alarm in hours and minutes</p><p>(hh:mm).</p><p>This duration:</p><p>- is equal to ’--:--’ as long as the pre alarm is not triggered,</p><p>- starts from the pre alarm triggering time, then increases up to the alarm</p><p>triggering time, and finally stops.</p><p> Cut off: Duration from alarm to automatic pump power off.</p><p>This duration:</p><p>- is equal to ’--:--’ as long as the alarm is not triggered,</p><p>- is reset to ’00:00’ when the alarm is triggered,</p><p>- increases up to the pump cut off.</p><p>INFORMATION</p><p>If the pump is connected to an AC power supply while a battery test is running,</p><p>the test stops and the following screen is displayed.</p><p>Press exit to return to the Tests menu.</p><p>54</p><p>4. At end of test, display the "Pre alarm", "Alarm" and "Cut off" stored in memory:</p><p> Connect the pump to an AC power supply</p><p> Power on the pump</p><p> Run test 12 (Battery life)</p><p> Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).</p><p>If not, replace the battery. See section 8.1, page 82.</p><p>5. Press exit to return to the Tests menu.</p><p>55</p><p>6.2.15 Test 20: Pump Code</p><p>6.2.16 Test 21: Power Info</p><p>Test Description</p><p>Run this test to display and modify the code which gives access to the Pump Settings from the</p><p>Options menu. See section 3.3, page 29.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 20: Pump code.</p><p>3. Press enter.</p><p>The current Pump Settings access code is displayed.</p><p>4. Enter the code.</p><p>5. Press OK to confirm.</p><p>6. Press exit to return to the Tests menu.</p><p>INFORMATION</p><p>If you do not want to protect access to the Pump settings by a code, enter "0000".</p><p>Test Description</p><p>Run this test to display power source information on the following parts:</p><p> DC voltage</p><p> Battery DC voltage charging value</p><p> Backup capacitor voltage and temperature</p><p> 5 V booster voltage.</p><p>INFORMATION</p><p>The backup capacitor voltage and temperature must be systematically checked during the maintenance</p><p>protocol.</p><p>The AC power board and power supply boards work properly.</p><p>DC voltage out of limits:</p><p> Check the connections between power supply board (J5 connector) and AC power</p><p>board.</p><p> Check the fuse on AC power board.</p><p> Replace the power supply board.</p><p>See section 8.5, page 91.</p><p> Replace the angle bracket supporting the AC power board.</p><p>See section 8.5, page 91.</p><p>Backup capacitor voltage and/or 5 V booster voltage out of limits:</p><p> Connect the pump to an AC power supply and wait for 30 minutes.</p><p> Check the backup capacitor voltage.</p><p> Replace the power supply board if the voltage</p><p>is outside the limits.</p><p>See section 8.5, page 91.</p><p>A too high voltage may result in damage to the equipment.</p><p>56</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 21: Power info.</p><p>3. Press enter.</p><p>The DC voltage is displayed:</p><p> Conversion: DC voltage conversion value (in mV)</p><p> DC voltage: DC voltage charging value (in V)</p><p>4. Connect and disconnect the pump from the power source, and check that the DC voltage value</p><p>changes:</p><p> With a pump connected to an AC power supply:</p><p> With a pump running on battery:</p><p>5. Press the arrow keys to scroll through the other information screens:</p><p> Conversion: Backup capacitor conversion value in mV</p><p> Backup capacitor: Backup capacitor voltage in V</p><p> Conversion: Backup capacitor temperature conversion value in mV</p><p> Backup temperature: Backup capacitor temperature in °C</p><p> Conversion: 5 V booster conversion value in mV</p><p> 5 V booster: 5 V booster voltage in V</p><p>6. Check that the displayed values are within the limits shown in the table below.</p><p>Value Limits</p><p>DC Voltage - Pump connected to an AC power supply 9.5 V to 10.5 V</p><p>DC Voltage - Pump running on battery -0.5 V to 0.5 V</p><p>Backup capacitor 2.3 V to 2.7 V</p><p>Backup temperature -20 °C to +110 °C (-4 °F to +230 °F)</p><p>5 V booster 4600 mV to 5920 mV</p><p>7. Press exit to return to the Tests menu.</p><p>57</p><p>6.2.17 Test 22: LCD Voltage</p><p>6.2.18 Test 23: Temperature</p><p>Test Description</p><p>Run this test to display the charge voltage of the pump’s LCD screen (for information only).</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 22: Lcd Voltage.</p><p>3. Press enter.</p><p>The following data is displayed:</p><p> Conversion: This conversion voltage value is the LCD charge pump</p><p>voltage measured at the CPU board input terminals.</p><p> Voltage: This voltage value is the measured LCD charge pump voltage.</p><p>4. Press exit to return to the Tests menu.</p><p>Test Description</p><p>Run this test to display the temperature measured by the NTC thermistor (for information only).</p><p>The CPU board works properly.</p><p>If this test fails, replace the CPU board. See section 8.4, page 88.</p><p>If the problem persists, contact the Fresenius Kabi Technical Service.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 23: Temperature.</p><p>3. Press enter.</p><p>The following data is displayed:</p><p> Conversion: The temperature conversion value measured in mV by the</p><p>NTC thermistor on the CPU board.</p><p> Temperature: The temperature measured in °C by the NTC thermistor on</p><p>the CPU board.</p><p>4. Check that the displayed value is within the limits shown in the table below.</p><p>Values Limit</p><p>Temperature -20 °C to +80 °C (-4 °F to +176 °F)</p><p>58</p><p>6.2.19 Test 24: Watchdog</p><p>Test Description</p><p>This test checks the status of the pump’s microprocessor (free or busy) every 2 seconds.</p><p>The pump’s microprocessor is not too busy to carry out infusions correctly.</p><p>If the test fails, it means that the pump’s microprocessor is too busy.</p><p>An infusion is likely not to be carried out correctly.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>Prerequisites</p><p> The pump must be used on battery with the AC power cord disconnected.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 24: Watchdog.</p><p>3. Press enter.</p><p>If the pump is connected to the AC power supply:</p><p> Disconnect the AC power cable.</p><p>The OK button becomes available.</p><p> Press OK.</p><p>4. Press OK to confirm.</p><p>The pump starts checking the fault mode.</p><p>5. Check that all red LEDs light up and that the buzzer sounds between 1.0 second and 2.25 seconds.</p><p>If the test fails, a message "Watchdog not functional return to After Sales Service" is displayed.</p><p>6. Press key for 5 seconds to stop the alarm and return to Tests screen.</p><p>INFORMATION</p><p>The Watchdog test must be systematically carried out after each maintenance procedure.</p><p>59</p><p>6.2.20 Test 25: Wi-Fi Module Information</p><p>Test Description</p><p>This test displays for information the Wi-Fi parameters saved on the pump. Run this test to</p><p>check that all parameters are correct.</p><p>If they are not, upload the Wi-Fi configuration to the pump using Agilia Partner maintenance</p><p>software.</p><p>Prerequisites</p><p> The pump must be equipped with Wi-Fi.</p><p>INFORMATION</p><p>When powering on a pump, it may take a few minutes for the Wi-Fi module information to refresh.</p><p>If some data are not displayed when performing this test, wait a few minutes for the pump to refresh Wi-Fi</p><p>module information (without powering off the pump), then run the test again.</p><p>If after a prolonged period where no information is displayed, contact your Biomed or IT service</p><p>department.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 25: Wi-Fi module information.</p><p>3. Press enter.</p><p>The following data is displayed for information:</p><p> Network SSID (Service Set IDentifier)</p><p> MAC address</p><p> IP address</p><p> Subnet mask address</p><p> Gateway address</p><p> RSSI: value in dBm</p><p> SNR: value in dBm</p><p> Data rate: value in Mbps.</p><p> Date and time of last connection to server</p><p> Version of Wi-Fi module application firmware</p><p> Version of Wi-Fi module Bootloader firmware</p><p> Version of Wi-Fi module Radio firmware</p><p>4. Press exit to return to the Tests screen.</p><p>60</p><p>6.2.21 Checking the Pressure Limit Alarm</p><p>Figure 6.6: Installation of dynamometer</p><p>Test Description</p><p>Run this test to check the triggering of an occlusion alarm when the pressure downstream the</p><p>pump exceeds the pressure limit stated in the Pressure management menu.</p><p>Required Tools and Equipment</p><p> 1 Dynamometer</p><p>Prerequisites</p><p> The dynamometer’s calibration certificate is valid.</p><p>1. Access the Basic Profile configuration. See section 5.1, page 32.</p><p>2. Press the arrow keys to select User.</p><p>3. Press enter.</p><p>4. Press the arrow keys to select User 4: Pressure.</p><p>5. Press enter.</p><p>6. Select:</p><p> Mode = 3 levels</p><p> High = 900 mmHg (17.4 PSI or 1.20 bar)</p><p> Medium = 500 mmHg (9.67 PSI or 0.67 bar)</p><p> Low = 200 mmHg (3.87 PSI or 0.27 bar)</p><p>7. Power the pump off and on again to exit the Options menu and return to standard operation.</p><p>8. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to</p><p>the right.</p><p>9. Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.</p><p>10.Secure the dynamometer with the syringe barrel clasp.</p><p>11.Slide the arms spacer to the left.</p><p>12.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with</p><p>the plunger head of the dynamometer.</p><p>13.Release the disengagement lever.</p><p>The arms must not be in contact with the arms spacer.</p><p>61</p><p>6.2.22 Checking the End of Infusion Alarm</p><p>14.Press C to change the syringe.</p><p>15.Press the arrow keys to select "BD Precise 50 mL".</p><p>16.Press OK.</p><p>17.Press or .</p><p>18.Press the arrow keys to select .</p><p>19.Select a Medium limit of 500 mmHg. (9.67 PSI or 0.67 bar).</p><p>20.Select a flow rate of 120 mL/h.</p><p>21.Start the infusion at 120 mL/h.</p><p>22.Check for the absence of an occlusion alarm.</p><p>23.Check that the infusion LEDs are flashing.</p><p>24.Check that the occlusion alarm is triggered at an "x" pressure value of:</p><p>430 mmHg (8.31 PSI or 0.6 bar) < x < 570 mmHg (11.02 PSI or 0.8 bar).</p><p>25.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to</p><p>the right.</p><p>26.Remove the dynamometer.</p><p>1. Power the pump off and on again to exit the Options menu and return to standard operation.</p><p>2. Push the disengagement lever down and move the plunger to the right.</p><p>3. Install a BD Plastipak 50 mL syringe.</p><p>4. Secure the syringe with the syringe barrel clasp.</p><p>5. Position the syringe piston at a remaining VTBI value of at least 10 mL.</p><p>6. Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact</p><p>with the syringe, with the antisiphon arms positioned on the syringe piston.</p><p>7. Release the disengagement lever.</p><p>8. Select a flow rate of 200 mL/h.</p><p>9. Start the infusion and check that the end of infusion pre alarm is triggered.</p><p>10.Wait for the End of infusion alarm.</p><p>11.Run Test 6 Displacement.</p><p>12.Note the Position value and check that Position = 17.7 mm ± 0.5 mm</p><p>(0.7 in ±0.02 in).</p><p>62</p><p>6.2.23 Control the plunger head detection finger and anti-siphon arms movement</p><p>1. Press the disengagement lever.</p><p>2. Check that the anti-siphon arms move towards</p><p>the syringe.</p><p>3. Release the disengagement lever.</p><p>4. Check that the anti-siphon arms move partially</p><p>back.</p><p>5. Check that the arms are symmetrical and in</p><p>contact.</p><p>6. Press the plunger head detection finger.</p><p>A "click" is to be heard.</p><p>7. Check that the anti-siphon arms move back</p><p>towards the plunger driver (the finger detects the</p><p>presence of the syringe and the arms lock it against</p><p>the plunger driver).</p><p>CONFORM</p><p>8. If the anti-siphon arms do not move back or if the</p><p>plunger head detection finger remains depressed,</p><p>the control is not conform.</p><p>NOT CONFORM</p><p>63</p><p>6.2.24 Control the disengagement and plunger head alarms</p><p>9. If this test is not conform, either:</p><p> replace the plunger kit for Agilia SP (see section 8.14, page 124.),</p><p>or</p><p> disassemble the plunger driver and remove the upper and lower anti-siphon arms,</p><p> clean and grease their axes with "Polylub GLI151" ref. Z171423,</p><p> grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,</p><p> reassemble the parts paying attention to the correct positioning of the (white) left helico gear,</p><p>(black) right helico gear and left helico lever.</p><p>10.Perform the following calibrations using Agilia Partner maintenance software.</p><p> Force sensor</p><p> Displacement</p><p>11.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 66.</p><p>1. If needed, exit the Maintenance mode</p><p>pressing "OFF" .</p><p>2. Install a 50mL syringe and secure it with</p><p>the syringe barrel clasp.</p><p>3. Move the plunger driver and position it in</p><p>contact with the syringe plunger head.</p><p>4. Close the anti-siphon arms on the</p><p>syringe plunger.</p><p>5. Press "ON" .</p><p>6. Select a profile.</p><p>7. Check that a "50mL" syringe is</p><p>displayed with no alarm being triggered.</p><p>8. Confirm selection of syringe.</p><p>9. Program an infusion (refer to the IFU for</p><p>detailed procedure according to profile).</p><p>10.Start the infusion.</p><p>64</p><p>11.Press the disengagement lever.</p><p>12.Check that the "Disengagement</p><p>mechanism !!!" message is displayed.</p><p>13.Move back the plunger driver and</p><p>release the disengagement lever.</p><p>14.Check that the "Plunger head alarm !!!"</p><p>message is displayed.</p><p>15.Press "Alarm silence" key.</p><p>16.Press and hold the plunger head</p><p>detection finger.</p><p>17.Check that the "Plunger head alarm !!!"</p><p>message disappears and is replaced by</p><p>the "Disengagement mechanism !!!"</p><p>message.</p><p>18.Release the plunger head detection</p><p>finger.</p><p>19.Check that the "Plunger head alarm !!!"</p><p>message reappears.</p><p>20.If this test is not conform, either:</p><p> replace the plunger kit for Agilia SP (see section 8.14, page 124.),</p><p>or</p><p> disassemble the plunger driver and remove the upper and lower anti-siphon arms,</p><p> clean and grease their axes with "Polylub GLI151" ref. Z171423,</p><p> grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,</p><p> reassemble the parts paying attention to the correct positioning of the (white) left helico gear,</p><p>(black) right helico gear and left helico lever.</p><p>21.Perform the following calibrations using Agilia Partner maintenance software.</p><p> Force sensor</p><p> Displacement</p><p>22.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 66.</p><p>65</p><p>6.2.25 Checking the AC Power Supply / Battery Operation</p><p>6.2.26 Electrical Test</p><p>Test Description</p><p>Run this test to check the power supply indicator state while switching from AC power supply</p><p>to battery.</p><p>The power supply indicator works properly.</p><p>If this test fails, replace the upper case that supports the keypad.</p><p>See section 8.2, page 84.</p><p>1. Disconnect the pump’s AC power cord.</p><p>2. Check that the plug-shaped power supply indicator is off.</p><p>3. Connect the pump to an AC power supply.</p><p>4. Check that the plug-shaped power supply indicator lights up green.</p><p>Test Description</p><p>This test checks the electrical safety of the pump according to the IEC 60601-1 medical</p><p>electrical equipment standard.</p><p>The pump is compliant with the IEC 60601-1 medical electrical equipment standard.</p><p>Contact your biomedical department or your Fresenius Kabi sales representative.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>Run the electrical safety test according to the IEC 60601-1 medical electrical equipment standard.</p><p>66</p><p>6.3 Quality Control Procedure</p><p>6.3.1 Running a Quality Control</p><p>Print the form provided. See section 6.3.2, page 69.</p><p>Run Test 2: Maintenance. See section 6.2.3, page 41.</p><p> Enter the following maintenance data in the form:</p><p>- Running time in hours since last preventive maintenance date</p><p>- Last preventive maintenance date</p><p> Fix the next preventive maintenance date. Add a maximum of 3 years to the date of last preventive</p><p>maintenance.</p><p> Fill the Next maintenance date in the form.</p><p>1. Run Test 1: Identification. Identification and general appearance check. See section 6.2.2, page 40.</p><p> Check housing.</p><p> Check AC power cord.</p><p> Check the product code REF and serial number SN on the pump</p><p>identification label.</p><p> Fill the pump identification data in the form:</p><p>- Pump type</p><p>- Product code</p><p>- Serial number</p><p>2. Check the attachment lock knob and rotating pole clamp (locking system test).</p><p>67</p><p>3. Check the LCD contrast and adjust if necessary:</p><p> Access the Pump Settings menu in the Options menu.</p><p> Select User 3: Contrast.</p><p>4. Run Test 9: Indication. See section 6.2.10, page 50.</p><p>Check backlight, all pump LEDs, power supply indicator, battery charge indicator. Check that the</p><p>speaker and buzzer are functioning correctly.</p><p>5. Run Test 10: Keypad. See section 6.2.11, page 50.</p><p>Check the keypad.</p><p>6. Run Test 24: Watchdog. See section 6.2.19, page 58.</p><p> Check that all red LEDs light up and that the buzzer sounds between 1.0 second and</p><p>2.25 seconds.</p><p> Press for 5 seconds to stop the alarm and power off the pump.</p><p>7. Run Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.</p><p>See section 6.2.8, page 46.</p><p> Position the V1 diameter verification gauge.</p><p> Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm</p><p>(0.35 in to 0.47 in).</p><p> Position the V2 diameter verification gauge.</p><p> Check the value displayed for Diameter. The value must be equal to 15.5 mm ± 1.5 mm</p><p>(0.55 in to 0.70 in).</p><p> Position the V4 diameter verification gauge.</p><p> Check the value displayed for Diameter. The value must be equal to 28.0 mm ± 1.5 mm</p><p>(1.04 in to 1.16 in).</p><p> If one of these values is outside the tolerance zone, run a calibration of the syringe barrel clasp</p><p>sensor using Agilia Partner maintenance software.</p><p>8. Run Test 5: Force (occlusion alarm test). See section 6.2.6, page 42.</p><p> Install a dynamometer.</p><p> Start an infusion at 1000 mL/h.</p><p> Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than</p><p>60 seconds when 8.0 PSI (0.55 bar) < Pressure < 10.9 PSI (0.75 bar).</p><p>If not, calibrate the force sensor using Agilia Partner maintenance software.</p><p> Press to silence the alarm.</p><p> Press to stop the infusion.</p><p>9. Run Test 6: Displacement. Check the displacement sensor. See section 6.2.7, page 44.</p><p> Move the plunger driver to the right stop.</p><p> Check the value displayed for Position. The value must be between 118.5 mm and 137.5 mm</p><p>(4.67 in and 5.41 in).</p><p> Install the 65 mm (2.56 in) displacement gauge.</p><p> Check the value displayed for Position. The value must be equal to 65 mm ± 1.5 mm</p><p>(2.56 in ± 0.06 in).</p><p> Move the plunger driver to the left stop.</p><p> Check the value displayed for Position. The value must be between 10 mm and 15.2 mm (0.39 in</p><p>and 0.60 in).</p><p> If one of these values is outside the tolerance zone, run a calibration of the displacement sensor</p><p>using Agilia Partner maintenance software.</p><p>10.Control the plunger head detection finger and anti-siphon arms movement (see section 6.2.23,</p><p>page 62).</p><p>68</p><p>11.Control the disengagement and plunger head alarms (see section 6.2.24, page 63).</p><p>12. Check the AC power disconnection:</p><p> Disconnect the pump’s AC power cord.</p><p> Check that the plug-shaped power supply indicator is off.</p><p> Connect the pump to an AC power supply.</p><p> Check that the plug-shaped power supply indicator lights up green.</p><p>13. Check the battery life:</p><p> Connect the pump to an AC power supply.</p><p> Recharge the battery for 8 hours (pump switched off).</p><p> Run Test 13: Battery test. See section 6.2.14, page 53.</p><p> At end of test:</p><p>- Connect the pump to an AC power supply</p><p>- Power on the pump</p><p>- Run Test 12: Battery life. See section 6.2.13, page 52.</p><p>- Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).</p><p>If not, replace the battery. See section 8.1, page 82.</p><p>14. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.26, page 65.</p><p>15. Enter the following identification data in the form:</p><p> Result (Pass/Fail) for each test</p><p> Global result for Quality control (Pass/Fail)</p><p> Biomedical name</p><p> Ward name</p><p> Name</p><p> Technical department</p><p> Date and signature</p><p>69</p><p>6.3.2 Quality Control Certificate</p><p>Pump type: Product code: Serial number:</p><p>Hospital name:</p><p>Ward name:</p><p>Running time since last</p><p>preventive maintenance date:</p><p>Date of last preventive maintenance:</p><p>Date of next preventive maintenance:</p><p>No. Procedure Pass Fail</p><p>1 Test 1: Identification and general appearance check.</p><p>Pump housing, AC power cord, product code, serial number.</p><p>2 Locking system test. Check the attachment lock knob and rotating pole clamp.</p><p>3 LCD display test. Check/adjust the LCD contrast (Pump settings > User 3).</p><p>4 Test 9: Indication. Backlight, LEDs, indicators and buzzer test.</p><p>5 Test 10: Keypad. Keypad test.</p><p>6 Test 24: Watchdog.Watchdog.</p><p>Default mode triggered in seconds (between 1.0 second and 2.25 seconds).</p><p>7 Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.</p><p>Tool V1 - Diameter: mm (between 9.0 mm and 12.0 mm (0.35 in and 0.47 in)).</p><p>Tool V2 - Diameter: mm (between 14 0 mm and 17.0 mm (0.55 in and 0.70 in)).</p><p>Tool V4 - Diameter: mm (between 26.5 mm and 29.5 mm (1.04 in and 1.16 in)).</p><p>8 Test 5: Force. Occlusion alarm test</p><p>Triggering of an occlusion alarm in less than 60 seconds at PSI</p><p>(between 8.0 PSI (0.55 bar) and 10.9 PSI (0.75 bar)).</p><p>9 Test 6: Displacement calibration test. Checking the displacement sensor</p><p>Right stop - Position: mm (between 4.67 in and 5.41 in (118.5 mm and 137.5 mm)).</p><p>65 mm gauge - Position: mm (between 2.50 in and 2.62 in (63.5 mm and 66.5 mm)).</p><p>Left stop - Position: mm (between 0.39 in and 0.60 in (10.0 mm and 15.2 mm)).</p><p>10 Check the plunger head detection finger and anti-siphon arms movement.</p><p>11 Check the disengagement and plunger head alarms.</p><p>12 Power indicator test. AC power disconnection.</p><p>13 Electrical tests</p><p>Pass</p><p>Fail</p><p>Name:</p><p>Technical department:</p><p>Date: Signature:</p><p>Observations:</p><p>70</p><p>6.4 Testing the Flow Rate</p><p>Test Description</p><p>During this flow rate test an infusion is carried out at a certain flow rate, and the delivered</p><p>volume is reported.</p><p>The volume reported is compared to the theoretical volume, and the flow rate test is stated as</p><p>passed if the calculated flow rate error is between -3 % and +3 %.</p><p>The flow rate is correctly calibrated.</p><p>If the test fails, calibrate the displacement using Agilia Partner maintenance software.</p><p>Required Tools and Equipment</p><p> 1 Scale with a sensitivity of 0.01 g and a beaker</p><p> 1 Catheter extension with a Luer lock end: length 40 in (100 cm), interior diameter 0.1 in (2.5 mm)</p><p> 1 Needle: type G18 or G21 (flow rate > 30 mL/h), or G26 (flow rate < 30 mL/h)</p><p> 1 Luer Lock syringe (brand new)</p><p> 1 Chronometer</p><p>Distilled water, oil.</p><p>Prerequisites</p><p> The scale’s calibration certificate is valid.</p><p>Recommended temperatures for flow rate accuracy:</p><p>Room temperature: 10 °C to 30 °C (50 °F to 86 °F)</p><p> Temperature of the water in the syringe: 10 °C to 30 °C (50 °F to 86 °F)</p><p>INFORMATION</p><p> Do not recycle distilled water.</p><p> The test procedure below can be performed with all syringe sizes (minimum of 5 mL and maximum</p><p>of 60 mL).</p><p>1. Setup the equipment:</p><p> Fill the syringe with distilled water at the maximum of its volume.</p><p> Prime the syringe to eliminate air bubbles.</p><p> Connect the catheter extension to the syringe.</p><p> Connect the cannula to the other end of the catheter extension.</p><p> Install the syringe on the pump.</p><p> Place the beaker at the center of the scale platform.</p><p> Place the cannula inside the beaker.</p><p> Fill the beaker with some water, making sure the cannula is dipped in the water (> 1 cm (0.4 in)).</p><p> Add several drops of oil to create a greasy film on the surface of the water. This way the user will</p><p>avoid any measurement error due to evaporation of the water.</p><p> Power on the pump.</p><p>71</p><p>Figure 6.7: Flow rate test using a scale</p><p>Legend</p><p>Catheter extension bracket support Anti-vibration measuring table</p><p>Scale</p><p>INFORMATION</p><p>Check that the installation surface is level.</p><p>2. Prime the syringe and the extension set using the key.</p><p>Refer to the Instructions for Use of the relevant pump.</p><p>3. Check for the absence of air bubbles.</p><p>4. On the pump, select a flow rate and start a first infusion to stabilize it.</p><p>For a flow rate of less than 5 mL/h, wait at least one hour.</p><p>For higher rates, wait between 10 and 30 minutes.</p><p>5. Stop the infusion when the stabilization time is elapsed.</p><p>6. Zero the scale or write down the initial weight.</p><p>7. Simultaneously re-start the infusion with the same flow rate and start the chronometer.</p><p>8. After the infusion time (e.g. 10 minutes, 15 minutes, 1 hour), stop the infusion.</p><p>9. At the end of infusion, weigh the beaker with water and write down this new value.</p><p>If the scale was not zeroed at start of infusion, calculate the difference with the initial weight.</p><p>10.Divide the infused volume in mL (for water: 1 mL for 1 g) by the infusion time in hours: this gives the</p><p>measured value for the flow rate in mL/h.</p><p>11.Calculate the difference between the theoretical value and the measured value according to the</p><p>following formula:</p><p>(Measured value - Theoretical value)</p><p>x100 = Error percentage</p><p>Theoretical value</p><p>The flow rate test is stated as passed if the calculated flow rate error is between -3 % and +3 %.</p><p>10 20 30 40 50</p><p>60</p><p>m</p><p>l</p><p>3</p><p>1</p><p>2</p><p>0.4 in</p><p>(1 cm)</p><p>1 3</p><p>2</p><p>72</p><p>7 Troubleshooting and Messages</p><p>7.1 Alarm Messages and Information Signals</p><p>Displayed Message Priority Problem / Resolution</p><p>ERxx(yyyy) !!! High (!!!) Technical alarm. See section 7.3, page 77.</p><p>Battery alarm !!!</p><p>High (!!!)</p><p>The battery is discharged.</p><p>The pump will power OFF automatically within 5 minutes.</p><p>Connect the pump to a power supply immediately.</p><p>Very low battery !!!</p><p>High (!!!)</p><p>Very low battery.</p><p>Connect the pump to a power supply and allow time to</p><p>charge.</p><p>End of infusion !!! High (!!!) The infusion is completed (simple rate).</p><p>Occlusion alarm !!!</p><p>High (!!!)</p><p>The pressure in the infusion line has reached the threshold</p><p>level.</p><p>Check whether the infusion line is occluded. If necessary,</p><p>readjust the pressure threshold.</p><p>Syringe installation !!!</p><p>High (!!!)</p><p>The syringe is not installed correctly (plunger driver, syringe</p><p>barrel clasp or flange detection).</p><p>Check the syringe installation.</p><p>End of volume limit !!! High (!!!) The volume limit is reached.</p><p>End of volume/time !!! High (!!!)</p><p>The VTBI is completed.</p><p>End of dose/time !!! High (!!!)</p><p>Plunger head alarm !!! High (!!!) The plunger head is missing or incorrectly inserted.</p><p>Check the syringe installation.</p><p>Disengagement mechanism !!!</p><p>High (!!!)</p><p>The Disengagement mechanism is open after selection of a</p><p>syringe.</p><p>Check the syringe installation.</p><p>Battery pre-alarm !! Medium (!!) Low battery.</p><p>Connect the pump to a power supply.</p><p>Occlusion pre-alarm !!</p><p>Medium (!!)</p><p>In-line pressure has reached the following value:</p><p> 25 mmHg / 2.5 kPa / 0.5 PSI below the programmed</p><p>threshold (from 50 to 250 mmHg).</p><p> 50 mmHg / 5 kPa / 1 PSI below the</p><p>programmed threshold</p><p>(over 250 mmHg).</p><p>Check the infusion line.</p><p> Set the correct pressure threshold.</p><p>Near end of infusion !!</p><p>Medium (!!)</p><p>The time remaining is less than the defined time duration</p><p>(adjustable between 1 and 30 minutes), and the remaining</p><p>volume of fluid in the syringe has dropped to less than 10% of</p><p>the syringe capacity.</p><p>Near end of volume limit !!</p><p>Medium (!!)</p><p>The time remaining is less than the defined time duration</p><p>(adjustable between 1 minute and 30 minutes), and the</p><p>remaining VTBI until the volume limit has dropped to less than</p><p>10% of the syringe capacity.</p><p>Near end of volume/time !! Medium (!!) The time remaining is less than the defined time duration</p><p>(adjustable between 1 and 30 minutes), and the remaining</p><p>VTBI has dropped to less than 10% of the syringe capacity.</p><p>Near end of dose/time !! Medium (!!)</p><p>Check settings !!</p><p>Medium (!!)</p><p>The flow rate (or dose) has been modified using the keys, but</p><p>has not been confirmed.</p><p>Check the flow rate (or dose) and press OK to confirm.</p><p>Waiting settings !! Medium (!!) A value must be entered.</p><p> Enter a value and press OK to confirm.</p><p>Waiting start !!</p><p>Medium (!!)</p><p>The infusion settings have been entered, but have not been</p><p>confirmed with start.</p><p>Check the infusion settings, and press start to start the</p><p>infusion.</p><p>73</p><p>End of volume limit ! Low (!) The volume limit is reached and the end of infusion setting is</p><p>set as "KVO" or "continuous".</p><p>End of volume/time ! Low (!) The VTBI is completed and the end of infusion setting is set as</p><p>"KVO" or "continuous".End of dose/time ! Low (!)</p><p>Pressure increase ! Low (!) The pressure is increasing in the infusion line.</p><p>Check for occlusions in the infusion line.</p><p>Drop in pressure !</p><p>Low (!)</p><p>The pressure is decreasing in the infusion line.</p><p>Check the downstream Luer lock connection and the</p><p>integrity of the entire line.</p><p>High internal temperature !</p><p>Low (!)</p><p>Temperature increase.</p><p>Check device environment.</p><p> Send the pump for maintenance.</p><p>AC power failure ! Low (!) The power supply is inconsistent.</p><p>Contact your Fresenius Kabi Technical Service.</p><p>Low (!) If the pump is not used during an extended period, connect to a</p><p>power supply and wait until the battery is charged.</p><p>Alarm reporting not available</p><p>on the Link ! Low (!)</p><p>The pump is mounted on a Link+ Agilia rack that has not been</p><p>upgraded.</p><p>Contact your qualified technician or your Fresenius Kabi</p><p>Technical Service.</p><p>Remove completely syringe ! Low (!) Preventive auto-test on potential failure of plunger head.</p><p>Remove and reinstall syringe.</p><p>Upper soft max Information signal The upper soft limit is exceeded, according to the drug settings</p><p>defined in the drug library.</p><p>Lower soft min Information signal The lower soft limit is exceeded, according to the drug settings</p><p>defined in the drug library.</p><p>Reached hard limit Information signal The upper or lower hard limit is reached.</p><p>Power disconnection</p><p>Information signal</p><p>The pump is disconnected from the AC power. A single beep is</p><p>emitted.</p><p> Press to acknowledge.</p><p>Check that the battery life is sufficient for the expected</p><p>infusion duration.</p><p> If the disconnection was unintentional, check the power</p><p>connection.</p><p>Keypad lock status Information signal The keypad is locked.</p><p>Unlock the keypad.</p><p>Keypad locked</p><p>Information signal</p><p>The keypad is locked and the syringe barrel clasp was opened</p><p>and closed.</p><p>Unlock the keypad.</p><p>Unlock keypad to continue</p><p>Insufficient Dose Information signal In TCI mode, the remaining volume/dose in the syringe is</p><p>insufficient to reach the target (for Agilia SP TIVA).</p><p>High concentration</p><p>Information signal</p><p>The upper soft limit for concentration is exceeded, according to</p><p>the drug settings defined in the drug library (for Agilia SP</p><p>TIVA).</p><p>Low concentration</p><p>Information signal</p><p>The lower soft limit for concentration is exceeded, according to</p><p>the drug settings defined in the drug library (for Agilia SP</p><p>TIVA).</p><p>Reached hard limit Information signal The upper of lower hard limit for concentration is reached (for</p><p>Agilia SP TIVA).</p><p>Displayed Message Priority Problem / Resolution</p><p>74</p><p>In the case of a system malfunction, the alarm sounds and an error message Erxx(yyyy) !!! is</p><p>displayed.</p><p>1. Record the error message Erxx(yyyy) !!!.</p><p>2. Disconnect the pump from the power supply.</p><p>3. Reset the device by pressing the key for 10-15 seconds, and release it when the device powers</p><p>off.</p><p>WARNING</p><p>If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact</p><p>qualified biomedical engineering staff in your healthcare facility, or your Fresenius Kabi sales</p><p>representative.</p><p>Alarm Priority Required Operator Response Description</p><p>High (!!!) Immediate response</p><p> The infusion stops.</p><p> An alarm description is displayed on the</p><p>pump screen.</p><p>Medium (!!) Prompt response</p><p> The infusion continues.</p><p>Low (!) Awareness</p><p>Information</p><p>Signals Awareness</p><p> The infusion continues.</p><p> An information message is displayed on the</p><p>pump screen.</p><p>75</p><p>7.2 Troubleshooting Guide</p><p>Description Cause Recommended Action</p><p>End of infusion detected too early (at</p><p>approximately 10 mL).</p><p>No end of infusion pre-alarm and alarm</p><p>The installed syringe doesn't</p><p>correspond to the selected</p><p>syringe.</p><p>Replace or confirm the right syringe brand.</p><p>Calibrate the displacement sensor using</p><p>Agilia Partner maintenance software.</p><p>Flow rate or displacement drift. The installed syringe doesn't</p><p>correspond with the selected</p><p>syringe.</p><p>The position sensor calibration</p><p>values have drifted.</p><p>Replace or confirm the right syringe brand.</p><p>Check the displacement calibration.</p><p> If necessary, recalibrate the displacement</p><p>sensor using Agilia Partner maintenance</p><p>software.</p><p>Replace the displacement sensor.</p><p>See section 8.12, page 118.</p><p>Occlusion alarm after the pump has been</p><p>turned on.</p><p>Wrong calibration of the force</p><p>sensor.</p><p>Force sensor is out of order.</p><p>Flexible circuit is cut.</p><p>Recalibrate the force sensor using</p><p>Agilia Partner maintenance software.</p><p>Replace the force sensor and ribbon cable kit.</p><p>See section 8.11, page 113.</p><p>Occlusion alarm during the infusion. The pressure limit selected is too</p><p>low.</p><p>Wrong calibration of the force</p><p>sensor.</p><p>Flexible circuit is cut.</p><p> Select a higher pressure limit (Pressure</p><p>management menu ).</p><p>Recalibrate the force sensor using</p><p>Agilia Partner maintenance software.</p><p>Replace the force sensor and ribbon cable kit.</p><p>See section 8.11, page 113.</p><p>Disengagement alarm after the pump has</p><p>been turned on or during the infusion.</p><p>The disengagement micro-switch</p><p>is defective.</p><p>Carriage flexible circuit is cut.</p><p>Replace the disengagement flexible circuit.</p><p>See section 8.10, page 108.</p><p>Unjustified alarm involving plunger head</p><p>position.</p><p>Optical switch and/or anti-siphon</p><p>arm finger detection are defective.</p><p>Flexible circuit is cut.</p><p>Check the anti-siphon system.</p><p>Check the plunger driver internal mechanism.</p><p>Replace the force sensor.</p><p>See section 8.11, page 113.</p><p>Unjustified alarm involving syringe barrel</p><p>clasp and/or syringe body.</p><p>Defective syringe barrel clasp</p><p>potentiometer.</p><p>Flat ribbon cable is defective.</p><p>Switch or flat ribbon cable flange</p><p>detection is defective.</p><p>Check the syringe barrel clasp.</p><p>Run test 7. See section 6.2.8, page 46.</p><p> If the error remains, replace the syringe barrel</p><p>clasp. See section 8.7, page 97.</p><p>Calibrate the syringe barrel clasp using</p><p>Agilia Partner maintenance software and</p><p>check the pump functionality.</p><p>Display defect: LED, LCD display. Control transistors, LED and/or</p><p>connections are defective.</p><p>Check the display board.</p><p>Check the connectIons between CPU board</p><p>and display board.</p><p>Replace the display board/LCD display.</p><p>See section 8.3, page 86.</p><p>The power supply indicator doesn't light</p><p>up.</p><p>Battery is totally discharged.</p><p>Power supply board is defective.</p><p>Connect the pump to the AC power supply.</p><p>Replace the battery.</p><p>See section 8.1, page 82.</p><p>Check the power cord and AC power supply.</p><p>Replace the power supply board.</p><p>See section 8.5, page 91.</p><p>Battery alarm even though it has been</p><p>completely charged.</p><p>The power supply board is</p><p>damaged.</p><p>Replace the power supply board.</p><p>See section 8.5, page 91.</p><p>The pump turns ON or OFF by itself. Defective keypad.</p><p>Power supply board is damaged.</p><p>Replace the upper case. See section 8.2,</p><p>page 84.</p><p>Check the keypad by running test 10.</p><p>See section 6.2.11, page 50.</p><p>Replace the power supply board if necessary.</p><p>See section 8.5, page 91.</p><p>Some keys of the keypad do not work. Defective keypad. Replace the upper case.</p><p>See section 8.2, page 84.</p><p>Check the keypad by running test 10.</p><p>See section 6.2.11, page 50.</p><p>76</p><p>At start-up, the pump displays: "Software</p><p>is upgrading...".</p><p>Pump ugrade from V1.x to V2.x  - Connect the pump to the AC power supply.</p><p>Then, wait few minutes without touching the</p><p>keypad until the message disappears and the</p><p>pump starts as usual.</p><p> - Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>Mechanical elements are damaged. After a fall. Check the status of the casings and the</p><p>mechanical system.</p><p> The pump must not be used.</p><p>Description Cause Recommended Action</p><p>77</p><p>7.3 Error Codes</p><p>Error Code Description Recommended Actions</p><p>01 Motor rotation Check correct functioning of the motor.</p><p>Check the ribbon cable connection between the optical switch</p><p>and the CPU board (J5 connector). See figure 2.7, page 16.</p><p>Check the correct functioning of the motor rotation optical switch.</p><p>Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>02 Displacement Check the displacement sensor calibration.</p><p>Run test 6 Displacement. See section 6.2.7, page 44.</p><p>Check the displacement sensor connection to CPU board</p><p>(J2 connector). See figure 2.7, page 16.</p><p>Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>10 RAM Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>11 Flash memory (deleting or</p><p>programming problem)</p><p>Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>12 Resources Carry out a complete configuration for the pump using the</p><p>Agilia Partner maintenance software.</p><p>If the problem cannot be resolved:</p><p> Replace the CPU board. See section 8.4, page 88.</p><p> Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>13 Secondary Crc16</p><p>microcontroller - version is</p><p>incorrect</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>14 Secondary microcontroller</p><p>restarting - Watchdog</p><p>problem</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>15 Secondary microcontroller</p><p>communication</p><p>Check the ribbon cable connection between Power supply board</p><p>(J1 connector) and CPU board (J6 connector).</p><p>See figure 2.7, page 16.</p><p>See figure 2.9, page 20.</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>16 Disconnected battery Check the battery connection to power supply board</p><p>(J3 connector). See section 2.1.5, page 20.</p><p>Check the battery charging voltage. Run test 12.</p><p>See section 6.2.13, page 52.</p><p>Replace the battery. See section 8.1, page 82.</p><p>17 Battery charge Check the battery charging voltage. Run test 12.</p><p>See section 6.2.13, page 52.</p><p>Replace the battery. See section 8.1, page 82.</p><p>18 AC power presence Remove the battery door. See section 8.1, page 82.</p><p>Check the status of the AC power fuse.</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>19 Battery temperature Check the battery status. Run test 8.</p><p>See section 6.2.9, page 49.</p><p>Replace the battery. See section 8.1, page 82.</p><p>78</p><p>20 Syringe barrel clasp</p><p>potentiometer</p><p>Check the syringe barrel clasp calibration. Run test 7.</p><p>See section 6.2.8, page 46.</p><p>Calibrate the syringe barrel clasp using Agilia Partner</p><p>maintenance software.</p><p> If the error remains, check the cable connection to CPU board</p><p>(J1 connector). See figure 2.7, page 16.</p><p> If the error remains, replace the syringe barrel clasp.</p><p>See section 8.7, page 97.</p><p>Calibrate the syringe barrel clasp using Agilia Partner</p><p>maintenance software and check the pump functionality.</p><p>21 Displacement linear</p><p>potentiometer</p><p>Check the displacement calibration. Run test 6.</p><p>See section 6.2.7, page 44.</p><p>Calibrate the displacement using Agilia Partner maintenance</p><p>software.</p><p> If the error remains, check the cable connection to CPU board</p><p>(J2 connector). See figure 2.7, page 16.</p><p> If the error remains, replace the displacement sensor.</p><p>See section 8.12, page 118.</p><p>Calibrate the displacement using Agilia Partner maintenance</p><p>software and check the pump functionality.</p><p>22 Force sensor Check the force sensor calibration. Run test 5.</p><p>See section 6.2.6, page 42.</p><p>Calibrate the force sensor using Agilia Partner maintenance</p><p>software.</p><p> If the error remains, check the cable connection to CPU board</p><p>(J9 connector). See figure 2.7, page 16.</p><p> If the error remains, replace the force sensor and ribbon cable kit.</p><p>See section 8.11, page 113.</p><p>Calibrate the force sensor using Agilia Partner maintenance</p><p>software and check the pump functionality.</p><p>23 Syringe flanges switch Check the syringe flanges switch is functioning correctly by</p><p>running test 7. See section 6.2.8, page 46.</p><p>Check the cable connection to CPU board (J1 connector).</p><p>See figure 2.7, page 16.</p><p>Replace the syringe barrel clasp flexible circuit.</p><p>See section 8.7, page 97.</p><p>24 Disengagement switch Check the functionality of the disengagement switch.</p><p>Check the cable connection to CPU board (J9 connector).</p><p>See figure 2.7, page 16.</p><p>Replace the disengagement flexible circuit.</p><p>See section 8.10, page 108.</p><p>25 Syringe head detection</p><p>optical switch</p><p>Check the functionality of the syringe head optical switch by</p><p>running test 7. See section 6.2.8, page 46.</p><p>Check the cable connection to CPU board (J9 connector).</p><p>See figure 2.7, page 16.</p><p>Replace the plunger kit.See section 8.14, page 124.</p><p>26 Board missing Check the connection between Display board and CPU board.</p><p>See section 2.1.3, page 13.</p><p>See section 2.1.4, page 16.</p><p>Check the connection between Power supply board and CPU</p><p>board.</p><p>See section 2.1.4, page 16.</p><p>See section 2.1.5, page 20.</p><p>Replace the faulty part(s).</p><p>27 LCD backlight missing Check the connection between Display board (J3 connector) and</p><p>LCD display. See section 2.1.3, page 13.</p><p>Replace the LCD display. See section 8.3, page 86.</p><p> If the problem cannot be resolved, replace the Display board.</p><p>Error Code Description Recommended Actions</p><p>79</p><p>28 Keypad Run test 10 to check the keypad. See section 6.2.11, page 50.</p><p>Replace the upper case. See section 8.2, page 84.</p><p>Run test 10 to check the keypad.</p><p> If the problem cannot be resolved, replace the Display board.</p><p>See section 8.3, page 86.</p><p>29 Analog/digital converter Replace the CPU board.See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>30 Time keeper Replace the Power supply board supporting the secondary</p><p>microcontroller. See section 8.5, page 91.</p><p>Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>31 Syringe parameters Carry out a complete configuration using Agilia Partner</p><p>maintenance software.</p><p>33 Disengagement optical</p><p>switch</p><p>Check the functionality of the disengagement switch.</p><p>Check the cable connection to CPU board (J9 connector).</p><p>See figure 2.7, page 16.</p><p>Replace the disengagement flexible circuit.</p><p>See section 8.10, page 108.</p><p>34 Infusion flow rate Carry out a complete configuration using Agilia Partner</p><p>maintenance software.</p><p>35 Motor period Carry out a complete configuration using Agilia Partner</p><p>maintenance software.</p><p>36 Motor rotation</p><p>direction Carry out a complete configuration using Agilia Partner</p><p>maintenance software.</p><p>37 OFF key.</p><p>Reading status problem or</p><p>key pressed too repeatedly</p><p>Check that you have not pressed the OFF key too repeatedly.</p><p>Replace the Power supply board to check the functionality of the</p><p>secondary microcontroller. See section 8.5, page 91.</p><p>Replace the Display board. See section 8.3, page 86.</p><p>Replace the CPU board to check the functionality of the main</p><p>microcontroller.See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>38 Locked OFF key Run test 10 to check the functionality of the keypad, and</p><p>especially the OFF key. See section 6.2.11, page 50.</p><p>Replace the upper case. See section 8.2, page 84.</p><p>Replace the Power supply board to check the secondary</p><p>microcontroller functionality. See section 8.5, page 91.</p><p>39 Impossible to power off Replace the Power supply board.See section 8.5, page 91.</p><p>40 TCI calculation error</p><p>(for Agilia SP TIVA)</p><p>Restart the pump.</p><p> Program and start an infusion with a TCI profile.</p><p>Please refer to the Agilia SP TIVA Instructions for Use.</p><p>43 LCD communication failure Replace the Display board. See section 8.3, page 86.</p><p>44 LCD driver failure Replace the Display board. See section 8.3, page 86.</p><p>45 Defective LCD voltage Replace the Display board.See section 8.3, page 86.</p><p>46 Backup capacitor</p><p>temperature too high</p><p>Contact the Fresenius Kabi Technical Service.</p><p>47 Backup capacitor</p><p>temperature out of range</p><p>Contact the Fresenius Kabi Technical Service.</p><p>48 Pump temperature out of</p><p>range</p><p> Place the pump in normal operating temperature.</p><p>Please refer to the Instructions for Use of the relevant pump.</p><p>49 Backup capacitor and safety</p><p>5 V booster charging circuit</p><p>defective</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>50 Power supply board voltage</p><p>out of range</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>Error Code Description Recommended Actions</p><p>80</p><p>51 Defective speaker Check the connection to Power supply board (J2 connector).</p><p>See section 2.1.5, page 20.</p><p>Replace the speaker and flexible circuit.</p><p>52 Defective buzzer Buzzer sound level too low or defective speaker (see error code 51).</p><p>Replace the Power supply board supporting the buzzer.</p><p>See section 8.5, page 91.</p><p>53 Battery parameter in</p><p>coulometer EPROM</p><p>Contact the Fresenius Kabi Technical Service.</p><p>54 Secondary microcontroller /</p><p>coulometer power supply</p><p>board communication</p><p>Contact the Fresenius Kabi Technical Service.</p><p>55 Defective profile Carry out a complete configuration check using Agilia Partner</p><p>maintenance software.</p><p>56 CMDFAIL</p><p>Autotest failure on starting</p><p>up the pump.</p><p>Replace the Power supply board. See section 8.5, page 91.</p><p>Replace the Display board. See section 8.3, page 86.</p><p>Replace the CPU board.See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>97 Defective oscillator Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>98 Defective reset circuit Replace the CPU board. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>99 Activation of the watchdog Replace the Power supply board to check the functionality of the</p><p>secondary microcontroller. See section 8.5, page 91.</p><p>Replace the CPU board to check the functionality of the main</p><p>microcontroller. See section 8.4, page 88.</p><p>Carry out a complete configuration/calibration/control cycle using</p><p>Agilia Partner maintenance software.</p><p>Error Code Description Recommended Actions</p><p>81</p><p>8 Intervention Procedures</p><p>This section details all dismantling and re-assembling procedures.</p><p>WARNING</p><p> ONLY use the recommended accessories and spare parts delivered with the pump. NO PART IS</p><p>REPAIRABLE. When replacing components, only use Fresenius Kabi spare parts. Refer to the</p><p>"Spare Parts Catalog" for ordering information.</p><p> Any instruments or devices used for maintenance must be regularly checked or re-calibrated</p><p>according to their specifications and local regulations.</p><p> Disconnect the battery, and discharge the boost capacitor before opening the pump (see</p><p>procedure no.1). A risk of electric shock exists when touching a charged boost capacitor.</p><p> For safety reasons, the technician should not intervene when the pump is connected to an AC power</p><p>supply:</p><p>- Unplug the power supply cord from the AC power supply.</p><p>- Power off the pump.</p><p> When working with electronic components, we recommend wearing an anti-static bracelet</p><p>connected to earth and working on an anti-static mat.</p><p> Do not touch the electronic boards with your hands.</p><p>82</p><p>8.1 Procedure #1: Battery and Battery Door - Boost Capacitor Discharge</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>The battery must be only replaced by a qualified person.</p><p>See section 3.1, page 28.</p><p>Dismantling</p><p>1. Unscrew the 2 screws [1] that hold the battery door in place.</p><p>2. Remove the battery door [2].</p><p>3. Power on the pump.</p><p>2</p><p>1 1</p><p>83</p><p>4. Power on the pump.</p><p>5. Disconnect the [J3] connector and remove the battery [3].</p><p>The boost capacitor starts to discharge.</p><p>The buzzer sounds and red LEDs light during this discharge (approximately 20 minutes).</p><p>INFORMATION</p><p>If the identification labels of the fuse [5] and the battery [4] are damaged, they must be replaced.</p><p>Contact Fresenius Kabi to get new labels.</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>2. Insert the battery in the correct direction.</p><p>3. Perform a charge/discharge cycle.</p><p>4. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>3</p><p>J3</p><p>4</p><p>5</p><p>84</p><p>8.2 Procedure #2: Upper Case</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>85</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the display board / keypad cable (connection at [J1]).</p><p>9. Remove the 4 screws [6] that fasten the board unit to the upper case.</p><p>10.Remove the display board unit from the upper case [7].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>6 J2 6</p><p>6 6</p><p>J1</p><p>7</p><p>86</p><p>8.3 Procedure #3: Display Board/LCD Display</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>87</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the display</p><p>board / keypad cable (connection at [J1]).</p><p>9. Remove the 4 screws [6] that fasten the board unit to the upper case.</p><p>10.Remove the display board unit from the upper case.</p><p>11.Disconnect the display board / LCD display connection at [J3].</p><p>12.Unclip and separate the LCD display [8] from the display board [7].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> LCD contrast</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>6 J2 J3 6</p><p>6 6</p><p>J1</p><p>J3</p><p>7</p><p>8</p><p>88</p><p>8.4 Procedure #4: CPU Board</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>89</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>90</p><p>9. Remove the CPU board [7].</p><p>While doing this, take care not to pull out the flat cable on the inside.</p><p>10.Disconnect the flat cable [J9].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibrations using Agilia Partner maintenance software:</p><p> Force sensor</p><p> Syringe barrel clasp</p><p> Displacement</p><p> Date</p><p> LCD contrast</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>INFORMATION</p><p>When replacing the CPU board, carry out a complete configuration of the pump (calibrations and tests).</p><p>Each pump has its own CPU board model. Be careful not to mix up the different pump references.</p><p>J9</p><p>7</p><p>91</p><p>8.5 Procedure #5: Power Supply Board and AC Power Board</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>92</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect flat cable [J2].</p><p>9. Unscrew and remove screw [4].</p><p>10.Remove the power supply board:</p><p> Pull the board out by its corner edge to dislodge it from securing clip [5].</p><p> Dislodge the board from slot [6].</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>4</p><p>5 6</p><p>93</p><p>Re-assembling</p><p>1. Place the black insulator part [7] on the AC supply board.</p><p>2. Insert the power supply board in slot [6].</p><p>3. Locate securing clip [5] then press the power supply board down, locking the board into</p><p>position with the securing clip.</p><p>4. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>5. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>7</p><p>5</p><p>6</p><p>94</p><p>8.6 Procedure #6: Wi-Fi Board</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> This procedure is only applicable to pumps equipped with a Wi-Fi module.</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>95</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cable connected to the CPU board at [J4] (Wi-Fi board connection).</p><p>9. Unscrew and remove the screw [7] that holds the Wi-Fi board holder [8] to the CPU board.</p><p>10.Dislodge the Wi-Fi board holder from the right flange slot [9].</p><p>J2</p><p>6</p><p>J1</p><p>8</p><p>7</p><p>J4</p><p>9</p><p>96</p><p>11.Dislodge the Wi-Fi board [10] from the holder [8].</p><p>12.Disconnect flat cable [11] from Wi-Fi board [10] (connection at [J1]).</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>10 108</p><p>11</p><p>J1</p><p>97</p><p>8.7 Procedure #7: Syringe Barrel Clasp</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>98</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Unscrew and remove the 2 screws [6] that hold the syringe guard.</p><p>9. Remove the syringe guard [7].</p><p>10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at</p><p>[J2].</p><p>J2</p><p>6</p><p>J1</p><p>6</p><p>6</p><p>7</p><p>J2</p><p>99</p><p>11.Push the disengagement lever [8] down and move the plunger driver to its maximum.</p><p>12.Remove the 2 plastic caps [9] using a flat screwdriver.</p><p>13.Unscrew and remove the 2 screws.</p><p>14.Unclip and remove the syringe flange cradle [10].</p><p>15.Unscrew and remove the 2 screws [11] that hold the base.</p><p>16.Remove the base [12].</p><p>While removing the base [12], pay attention to the position of angle bracket clip kit [13]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>17.Unscrew and remove the 2 screws [14].</p><p>18.Remove the syringe barrel clasp bridle [15].</p><p>9</p><p>8</p><p>9</p><p>12</p><p>9</p><p>1111 13</p><p>13</p><p>12</p><p>14 14</p><p>15</p><p>15</p><p>100</p><p>19.Unclip and remove clip [18].</p><p>20.Pull syringe barrel clasp kit [16] out of its base location.</p><p>21.Disconnect the syringe detector [17] from the syringe barrel clasp kit [16].</p><p>22.Remove syringe barrel clasp kit [16]</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Do not forget to clip part [18] into the groove of syinge barrel clasp before attaching bridle</p><p>[15].</p><p>Pay attention to the</p><p>direction of the flat cable connections when assembling.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> Syringe barrel clasp</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>18 1816 1617</p><p>101</p><p>8.8 Procedure #8: Syringe Detection System</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>102</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Unscrew and remove the 2 screws [6] that hold the syringe guard.</p><p>9. Remove the syringe guard [7].</p><p>J2</p><p>6</p><p>J1</p><p>6</p><p>6</p><p>7</p><p>103</p><p>10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at</p><p>[J2].</p><p>11.Push the disengagement lever [8] down and move the plunger driver to its maximum.</p><p>12.Remove the 2 plastic caps [9] using a flat screwdriver.</p><p>13.Unscrew and remove the 2 screws.</p><p>14.Unclip and remove the syringe flange cradle [10].</p><p>15.Unscrew and remove the 2 screws [11] that hold the base.</p><p>16.Remove the base [12].</p><p>While removing the base [12], pay attention to the position of angle bracket clip kit [13]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>17.Unscrew and remove the 2 screws [14].</p><p>18.Remove the syringe barrel clasp bridle [15].</p><p>19.Unscrew and remove the 2 screws [16].</p><p>J2</p><p>9</p><p>8</p><p>9</p><p>12</p><p>9</p><p>1111 13</p><p>13</p><p>12</p><p>104</p><p>20.Unclip and remove clip [18].</p><p>21.Pull syringe barrel clasp kit [17] out of its base location.</p><p>22.Disconnect the syringe detector [19] from the syringe barrel clasp kit [17].</p><p>23.Remove the syringe detector [19].</p><p>24.Remove membrane [20].</p><p>The syringe detection system [21] comprises syringe detector [19] and membrane [20].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Do not forget to clip part [18] into the groove of syinge barrel clasp before attaching bridle</p><p>[15]. Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> Syringe barrel clasp</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>1416 14</p><p>1516</p><p>15</p><p>18 19 21</p><p>20</p><p>17</p><p>2019</p><p>18</p><p>105</p><p>8.9 Procedure #9: Motor</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>106</p><p>7. Disconnect the cable that connects the motor to the CPU board at [J7].</p><p>8. Unscrew and remove the 4 screws [7] that hold the motor [8] to the mechanical framework.</p><p>9. Remove the motor [8].</p><p>J7</p><p>8</p><p>7</p><p>7 7</p><p>7</p><p>8</p><p>107</p><p>Re-assembling</p><p>1. Place the motor in position being careful not to damage the gear wheel teeth. While doing</p><p>this, pay attention to reconnect the opto motor ground loop [9] on the inside at screw [7b]</p><p>level (see the sketch below).</p><p>2. Engage the 2 gear wheels together without forcing, and turn them slightly.</p><p>3. Tighten the 4 motor fixing screws, following the order [7a], [7b], [7c], [7d] given in the</p><p>sketch below.</p><p>4. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>5. Perform the following calibration using Agilia Partner maintenance software:</p><p> Displacement</p><p>6. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>9</p><p>7a</p><p>7d</p><p>7c</p><p>7b 7a</p><p>7d</p><p>7c</p><p>7b</p><p>108</p><p>8.10Procedure #10: Disengagement Flexible Circuit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>109</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>6</p><p>7</p><p>110</p><p>10.Remove the CPU board.</p><p>While doing this, be careful not to pull out the flat cable on the inside.</p><p>11.Disconnect the flat cable [J9].</p><p>12.Unscrew the upper screw [9] that holds the board disengagement flexible circuit to the</p><p>carriage kit [10].</p><p>J9</p><p>9</p><p>10</p><p>111</p><p>13.Remove self-locking ring [11] using a flat screwdriver. This self-locking ring holds the board</p><p>disengagement flexible circuit to the carriage kit.</p><p>14.Disconnect the plunger driver flat cable [12] from the board [13].</p><p>15.Unscrew and remove the screw [14] that holds the upper 1/2 band to the lower 1/2 band.</p><p>16.Dislodge the disengagement flexible circuit [15].</p><p>111111</p><p>12</p><p>14</p><p>1314</p><p>15</p><p>112</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>Insert aperture [16] in spur [17].</p><p>Replace self-locking ring [11] with a new one when assembling the board disengagement</p><p>flexible circuit to the carriage kit.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> Displacement</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>1617</p><p>113</p><p>8.11Procedure #11: Force Sensor + Ribbon Cable Kit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>114</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat</p><p>cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>6</p><p>7</p><p>115</p><p>10.Remove the CPU board.</p><p>While doing this, take care not to pull out the flat cable on the inside.</p><p>11.Disconnect the flat cable [J9].</p><p>12.Push the disengagement lever down [9] and move the plunger driver to its maximum.</p><p>13.Remove the 2 plastic caps [10] using a flat screwdriver.</p><p>14.Unscrew and remove the 2 screws.</p><p>15.Unclip and remove the syringe flange cradle [11].</p><p>16.Unscrew and remove the 2 screws [12] that hold the base.</p><p>17.Remove the base [13].</p><p>While removing the base [13], pay attention to the position of angle bracket clip kit [14]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>18.Unscrew and remove the 3 screws [15] that hold the right flange assembly to the aluminum</p><p>profile.</p><p>19.Take the unit apart.</p><p>J9</p><p>10</p><p>11</p><p>9</p><p>10</p><p>13</p><p>15</p><p>1212 14</p><p>14</p><p>13</p><p>15 15</p><p>116</p><p>20.Remove the self-locking ring [16].</p><p>21.Unscrew and remove the linking band that holds screw [17].</p><p>22.Disconnect the flat cable [18].</p><p>23.Remove the carriage kit [19].</p><p>24.Remove the 2 plastic caps [20] using a flat screwdriver.</p><p>25.Unscrew then remove the 2 screws that hold the plunger cover in place.</p><p>26.Remove the plunger cover and lever kit [21].</p><p>27.Unscrew and remove the 2 screws [22] that hold the pressure sensor support [23].</p><p>28.Remove the pressure sensor support [23].</p><p>While removing the pressure sensor support [23], pay attention to the position of</p><p>spring [24]. Do not forget to position this spring as it was before re-fixng the support.</p><p>29.Rotate part [25] in the direction shown in the sketch.</p><p>30.At the same time, dislodge boards [26] and [27] and pull out the force sensor and ribbon</p><p>cable kit [28].</p><p>While pulling out the force sensor and ribbon cable kit, pay attention to the position of the</p><p>boards [26] and [27]. Also pay attention to the springs that maintain part [25]. Do not forget</p><p>to position all these elements as they were before re-assembling the unit.</p><p>17</p><p>20</p><p>20</p><p>21</p><p>19</p><p>16</p><p>18</p><p>21</p><p>24 25</p><p>22</p><p>22</p><p>23</p><p>26 27</p><p>117</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> Force sensor</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>28</p><p>26</p><p>27</p><p>118</p><p>8.12Procedure #12: Linear Sensor Kit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>119</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>6</p><p>7</p><p>120</p><p>10.Remove the CPU board.</p><p>While doing this, take care not to pull out the flat cable on the inside.</p><p>11.Disconnect the flat cable [J9].</p><p>12.Push the disengagement lever down [9] and move the plunger driver to its maximum.</p><p>13.Remove the 2 plastic caps [10] using a flat screwdriver.</p><p>14.Unscrew and remove the 2 screws.</p><p>15.Unclip and remove the syringe flange cradle [11].</p><p>16.Unscrew and remove the 2 screws [12] that hold the base.</p><p>17.Remove the base [13].</p><p>While removing the base [13], pay attention to the position of angle bracket clip kit [14]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>18.Unscrew and remove the 3 screws [15] that hold the right flange assembly to the aluminum</p><p>profile.</p><p>19.Take the unit apart.</p><p>J9</p><p>10</p><p>11</p><p>9</p><p>10</p><p>13</p><p>15</p><p>1212 14</p><p>14</p><p>13</p><p>15 15</p><p>121</p><p>20.Remove the self-locking ring [16].</p><p>21.Remove gear wheel [17].</p><p>22.Unscrew and remove the 3 screws [18] that hold the linearity sensor kit in place.</p><p>23.Remove the linearity sensor kit [20] being careful not to pull out the flat cable [19].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections and to reconnect the opto motor</p><p>ground loop when assembling.</p><p>2. Perform the following calibration using Agilia Partner maintenance software:</p><p> Displacement</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>16 17</p><p>16</p><p>18 18</p><p>18</p><p>19</p><p>20</p><p>122</p><p>8.13Procedure #13: Plunger Cover and Lever Kit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 flat screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 2 screws [1] that hold the syringe guard.</p><p>3. Remove the syringe guard [2].</p><p>4. Remove the 2 plastic caps [3] using a flat screwdriver.</p><p>5. Unscrew then remove the 2 screws that hold the plunger cover in place.</p><p>6. Remove the plunger cover [4] and lever kit [5].</p><p>1</p><p>1</p><p>2</p><p>3</p><p>3 5</p><p>4</p><p>123</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>2. Perform the following calibrations using Agilia Partner maintenance software:</p><p> Force sensor</p><p> Displacement</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>124</p><p>8.14Procedure #14: Plunger Kit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 flat screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>125</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>6</p><p>7</p><p>126</p><p>10.Remove the CPU board.</p><p>While doing this, take care not to pull out the flat cable on the inside.</p><p>11.Disconnect the flat cable [J9].</p><p>12.Push the disengagement lever down [9] and move the plunger driver to its maximum.</p><p>13.Remove the 2 plastic caps [10] using a flat screwdriver.</p><p>14.Unscrew and remove the 2 screws.</p><p>15.Unclip and remove the syringe flange cradle [11].</p><p>16.Unscrew and remove the 2 screws [12] that hold the base.</p><p>17.Remove the base [13].</p><p>53</p><p>6.2.15 Test 20: Pump Code ................................................................................................................................ 55</p><p>6.2.16 Test 21: Power Info .................................................................................................................................. 55</p><p>6.2.17 Test 22: LCD Voltage............................................................................................................................... 57</p><p>6.2.18 Test 23: Temperature............................................................................................................................... 57</p><p>6.2.19 Test 24: Watchdog ................................................................................................................................... 58</p><p>6.2.20 Test 25: Wi-Fi Module Information ........................................................................................................... 59</p><p>6.2.21 Checking the Pressure Limit Alarm.......................................................................................................... 60</p><p>6.2.22 Checking the End of Infusion Alarm......................................................................................................... 61</p><p>6.2.23 Control the plunger head detection finger and anti-siphon arms movement............................................ 62</p><p>6.2.24 Control the disengagement and plunger head alarms ............................................................................. 63</p><p>6.2.25 Checking the AC Power Supply / Battery Operation ................................................................................ 65</p><p>6.2.26 Electrical Test........................................................................................................................................... 65</p><p>6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 66</p><p>6.3.1 Running a Quality Control ........................................................................................................................ 66</p><p>6.3.2 Quality Control Certificate ........................................................................................................................ 69</p><p>6.4 TESTING THE FLOW RATE ..................................................................................................................... 70</p><p>7 TROUBLESHOOTING AND MESSAGES 72</p><p>7.1 ALARM MESSAGES AND INFORMATION SIGNALS ..................................................................................... 72</p><p>7.2 TROUBLESHOOTING GUIDE.................................................................................................................... 75</p><p>7.3 ERROR CODES ..................................................................................................................................... 77</p><p>8 INTERVENTION PROCEDURES 81</p><p>8.1 PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 82</p><p>8.2 PROCEDURE #2: UPPER CASE .............................................................................................................. 84</p><p>8.3 PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY.................................................................................... 86</p><p>8.4 PROCEDURE #4: CPU BOARD............................................................................................................... 88</p><p>8.5 PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD......................................................... 91</p><p>8.6 PROCEDURE #6: WI-FI BOARD.............................................................................................................. 94</p><p>8.7 PROCEDURE #7: SYRINGE BARREL CLASP............................................................................................. 97</p><p>8.8 PROCEDURE #8: SYRINGE DETECTION SYSTEM ................................................................................... 101</p><p>8.9 PROCEDURE #9: MOTOR..................................................................................................................... 105</p><p>8.10 PROCEDURE #10: DISENGAGEMENT FLEXIBLE CIRCUIT ........................................................................ 108</p><p>8.11 PROCEDURE #11: FORCE SENSOR + RIBBON CABLE KIT ..................................................................... 113</p><p>8.12 PROCEDURE #12: LINEAR SENSOR KIT................................................................................................ 118</p><p>8.13 PROCEDURE #13: PLUNGER COVER AND LEVER KIT ............................................................................ 122</p><p>8.14 PROCEDURE #14: PLUNGER KIT.......................................................................................................... 124</p><p>8.15 PROCEDURE #15: CARRIAGE KIT ........................................................................................................ 128</p><p>9 CLEANING AND DISINFECTING 132</p><p>10 DEVICE STORAGE 133</p><p>11 POWER MANAGEMENT 134</p><p>5</p><p>12 TECHNICAL CHARACTERISTICS 135</p><p>12.1 POWER SUPPLY.................................................................................................................................. 135</p><p>12.2 BATTERY ............................................................................................................................................ 135</p><p>12.3 POWER CONSUMPTION ....................................................................................................................... 135</p><p>12.4 COMMUNICATION PORT....................................................................................................................... 136</p><p>12.5 INFRARED COMMUNICATION ................................................................................................................ 136</p><p>12.6 AGILIA USB CABLE............................................................................................................................. 136</p><p>12.7 COMPLIANCE ...................................................................................................................................... 136</p><p>12.8 DIMENSIONS - WEIGHT........................................................................................................................ 137</p><p>12.9 ELECTRONIC BOARDS ......................................................................................................................... 137</p><p>12.10 MATERIAL CHARACTERISTICS ............................................................................................................. 137</p><p>13 SPECIFICATIONS 138</p><p>14 RECYCLING 139</p><p>15 WARRANTY 140</p><p>16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 141</p><p>17 SPARE PARTS CATALOG 142</p><p>18 ORDERING INFORMATION 143</p><p>18.1 DATA MANAGEMENT CABLES............................................................................................................... 143</p><p>18.2 ASSOCIATED SOFTWARE ..................................................................................................................... 143</p><p>18.3 DISPOSABLES ..................................................................................................................................... 143</p><p>19 GLOSSARY OF TERMS 144</p><p>INDEX 147</p><p>6</p><p>1 Introduction</p><p>1.1 Scope</p><p>1.2 Intended Use</p><p>1.3 Principles of Operation</p><p>This technical manual is applicable to the Agilia SP range:</p><p> Agilia SP</p><p> Agilia SP MC</p><p> Agilia SP MC WiFi</p><p> Agilia SP TIVA</p><p> Agilia SP TIVA WiFi</p><p>The user must adhere to the instructions specified in this technical manual. Failure to adhere to these</p><p>instructions may result in damage to the equipment, injury to patients or injury to users.</p><p>Certain functions and options described in this technical manual differ from one infusion pump version to</p><p>another (Agilia SP, Agilia SP MC, Agilia SP MC WiFi, Agilia SP TIVA, Agilia SP TIVA WiFi), and according</p><p>to the destination country.</p><p>WARNING</p><p>Check that this technical manual is applicable to the current software version of the device.</p><p> The software version of the device is displayed on the startup screen.</p><p> The software</p><p>While removing the base [13], pay attention to the position of angle bracket clip kit [14]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>18.Unscrew and remove the 3 screws [15] that hold the right flange assembly to the aluminum</p><p>profile.</p><p>19.Take the unit apart.</p><p>J9</p><p>10</p><p>11</p><p>9</p><p>10</p><p>13</p><p>15</p><p>1212 14</p><p>14</p><p>13</p><p>15 15</p><p>127</p><p>20.Remove theself-locking ring [16].</p><p>21.Unscrew and remove the linking band that holds screw [17].</p><p>22.Disconnect the flat cable [18].</p><p>23.Remove the carriage kit [19].</p><p>24.Take apart the plunger kit [20] using a rotating movement to remove the pin from the</p><p>plunger cover.</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibrations using Agilia Partner maintenance software:</p><p> Force sensor</p><p> Displacement</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>17</p><p>19</p><p>16</p><p>18</p><p>20</p><p>128</p><p>8.15Procedure #15: Carriage Kit</p><p>Required Tools and Equipment</p><p> 1 Torx T-10 screwdriver</p><p> 1 Torx T-8 screwdriver</p><p> 1 flat screwdriver</p><p> 1 anti-static bracelet</p><p>Maintenance level</p><p>Level 3 specialist technician.</p><p>See section 3.1, page 28.</p><p>Prerequisites</p><p> The battery is disconnected and the boost capacitor discharged.</p><p>See section 8.1, page 82.</p><p>Dismantling</p><p>If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described</p><p>later in this procedure.</p><p>To remove the Wi-Fi board: See section 8.6, page 94.</p><p>1. Turn the pump upside down.</p><p>2. Unscrew and remove the 3 screws [1].</p><p>3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].</p><p>4. Disconnect CPU board flat cable [5] at [J1].</p><p>5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.</p><p>6. Remove the upper case [4], being careful not to pull out the display board flat cable.</p><p>1 1</p><p>1</p><p>2</p><p>J1</p><p>3</p><p>4</p><p>3</p><p>5</p><p>129</p><p>7. Disconnect the display board flat cable at [J2].</p><p>8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].</p><p>9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.</p><p>J2</p><p>6</p><p>J1</p><p>J2</p><p>J7</p><p>J5</p><p>J1</p><p>J3</p><p>J6</p><p>J1</p><p>6</p><p>7</p><p>130</p><p>10.Remove the CPU board.</p><p>While doing this, take care not to pull out the flat cable on the inside.</p><p>11.Disconnect the flat cable [J9].</p><p>12.Push the disengagement lever down [9] and move the plunger driver to its maximum.</p><p>13.Remove the 2 plastic caps [10] using a flat screwdriver.</p><p>14.Unscrew and remove the 2 screws.</p><p>15.Unclip and remove the syringe flange cradle [11].</p><p>16.Unscrew and remove the 2 screws [12] that hold the base.</p><p>17.Remove the base [13].</p><p>While removing the base [13], pay attention to the position of angle bracket clip kit [14]</p><p>between the base and the aluminum profile. When re-assembling the base, make sure to</p><p>position this part as it was originally.</p><p>18.Unscrew and remove the 3 screws [15] that hold the right flange assembly to the aluminum</p><p>profile.</p><p>19.Take the unit apart.</p><p>J9</p><p>10</p><p>11</p><p>9</p><p>10</p><p>13</p><p>15</p><p>1212 14</p><p>14</p><p>13</p><p>15 15</p><p>131</p><p>20.Remove the self-locking ring [16].</p><p>21.Unscrew and remove the linking band that holds screw [17].</p><p>22.Disconnect the flat cable [18].</p><p>23.Remove the carriage kit [19].</p><p>Re-assembling</p><p>1. Perform the dismantling procedure in reverse order to re-assemble the unit.</p><p>Pay attention to the direction of the flat cable connections when assembling.</p><p>2. Perform the following calibrations using Agilia Partner maintenance software:</p><p> Force sensor</p><p> Displacement</p><p>3. Perform the regular servicing tests. See Quality Control Procedure, page 66.</p><p>17</p><p>19</p><p>16</p><p>18</p><p>19</p><p>132</p><p>9 Cleaning and Disinfecting</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> When to clean and disinfect the pump</p><p> Recommended and prohibited agents</p><p> Instructions for cleaning and disinfecting</p><p>WARNING</p><p> The disinfecting procedure must be done immediately after cleaning. Disinfecting the pump without</p><p>prior cleaning is not effective.</p><p> The pump is not intended to be sterilized; sterilization may result in damage to the pump.</p><p>133</p><p>10 Device Storage</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> Precautions for storage</p><p> Storage and transport conditions</p><p> Preparing the device for storage</p><p> Using the device after storage</p><p>134</p><p>11 Power Management</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> AC power supply precautions</p><p> Battery precautions</p><p> Battery operating mode</p><p>135</p><p>12 Technical Characteristics</p><p>12.1Power Supply</p><p>12.2Battery</p><p> = Wi-Fi enabled</p><p> = Wi-Fi disabled or not used</p><p>12.3Power Consumption</p><p>Use the power supply cord supplied with the pump.</p><p>For use in the US, it is mandatory to use an Agilia power cord compliant with USA standards and with the</p><p>IEC 60227 standard.</p><p>Maximum admissible apparent electrical cable network impedance: 50 Ω.</p><p>The power cord conductor must have a cross section of at least 0.75 mm2.</p><p>AC Power</p><p>Power supply 100 V - 240 V ~ / 50 / 60 Hz with functional earth</p><p>Maximum consumption 10-15 VA</p><p>Protective fuse 1 X T1.6AH 250V accessible in the battery</p><p>compartment</p><p>External</p><p>Power Supply</p><p>(Available in a</p><p>Future Release)</p><p>9 VDC / Power > 15 W</p><p>Cord</p><p>Length: 3.00 m</p><p>Maximum length: 3.00 m</p><p>Type: SJT3x18AWG</p><p>Technical data: 3x18AWG (Green, black, white), dielectric strength: 2 kVac, 1 min</p><p>Standard: UL62 CSA 22.2 No. 49</p><p>Plug</p><p>Type: HG/TR</p><p>Technical data: 15A - 12.5V AC.</p><p>Standard: NEMA 5-15 Hospital Grade</p><p>Connector</p><p>Type: C13</p><p>Technical data: 10A - 250V UL CSA</p><p>Standard: EN 60320-1 C22.2 N°21 UL 817</p><p>Disconnect the battery before opening the device. Avoid short circuits and extreme temperatures.</p><p>If the device is not used for more than 3 months, the date is erased (all other settings are stored</p><p>permanently). When you power on the pump, you must set the date again.</p><p>Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery</p><p>Weight Approximately 100 g</p><p>Battery Life</p><p>Flow Rate Wi-Fi Battery Life</p><p>5 mL/h</p><p>5 mL/h</p><p></p><p></p><p>> 6 h</p><p>> 11 h</p><p>Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h</p><p>The infusion pump typically consumes about 3.5 W in standard operating conditions.</p><p>136</p><p>12.4Communication Port</p><p>12.5 Infrared Communication</p><p>12.6Agilia USB Cable</p><p>12.7Compliance</p><p>* After a defibrillation, the pump recovery time is around 2 seconds.</p><p>** The functional earth is directly connected to the power suply cord. It reduces residual current that may disturb ECG or EEG devices.</p><p>The connector located at the back of the device allows data communication with a PC.</p><p>Serial Cable TTL output</p><p>Power Input 10 V / 15 W to power supply the product</p><p>Power Output 5 VDC / 150 mA to power Agilia USB cable</p><p>The pump is equipped with an infrared cell located at the back of the device.</p><p>Mode Wireless optical communication using infrared light</p><p>Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no carrier</p><p>Transport</p><p>Protocol Proprietary</p><p>Speed 115.2 kb/s max</p><p>Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth</p><p>Eye Safety Class 0 of IEC 62471</p><p>Function Allows communication between a pump and a computer on the USB port</p><p>Connector 8-pin proprietary connector / Male A USB connector</p><p>Input / Output</p><p>power (pump) 250 mW</p><p>Input / Output</p><p>Power (PC) 100 mW</p><p>Compatibility USB 2.0 compliant.</p><p>Insulation 1500 V, compliant with UL standard</p><p>Speed 19.2 kb/s max</p><p>Length 85 in (2.15 m)</p><p>Maximum Length 110 in (2.8 m)</p><p>ElectroMedical</p><p>Equipment Safety</p><p>Compliant with the following standards:</p><p> IEC 60601-1</p><p> IEC 60601-1-8</p><p>IP22 Index of protection against solid foreign objects</p><p>(> 12.5 mm) and driping liquids</p><p>EMC</p><p>(ElectroMagnetic</p><p>Compatibility)</p><p>Compliant with the following standards:</p><p> IEC 60601-1-2</p><p>Protection against leakage current: Defibrillation-proof</p><p>type CF applied part*</p><p>Particular</p><p>Standards</p><p> IEC 60601-2-24</p><p> ANSI/AAMI ID26</p><p>Protection against electric shocks: class II</p><p>Functional</p><p>earth**</p><p>137</p><p>12.8Dimensions - Weight</p><p>12.9Electronic Boards</p><p>12.10 Material Characteristics</p><p>H / W / D 135 x 345 x 170 mm (5.3 x 13.6 x 6.7 in)</p><p>Weight Approximately 2.1 kg (4.6 lbs)</p><p>Screen Size 70 x 35 mm (2.7 x 1.4 in)</p><p>The pumps from the Agilia SP range are equipped with 4 electronic boards:</p><p> Power supply board</p><p> AC Power board</p><p> CPU board</p><p> Display board</p><p>For the WiFi pumps from the Agilia SP range, an additional electronic board is present:</p><p> Wi-Fi board</p><p>Component Material</p><p>1 Screw cap (2) Polyamide</p><p>2 Nut bolt button Polyamide</p><p>3 M8 molded screws Polyamide</p><p>4 Angle bracket ABS</p><p>5 Battery door ABS</p><p>6 Light guide Polycarbonate</p><p>7 Window Polycarbonate</p><p>8 Molded base ABS</p><p>9 Cover hook Polyamide 6</p><p>10 Infrared window Polycarbonate</p><p>11 Eccentric bolt POM</p><p>12 Bolt front case POM</p><p>13 Bolt rear case POM</p><p>14 Bolt button POM</p><p>15 Bolt button pen POM</p><p>16 Molded lever + hooks Polyarylamide</p><p>17 Motor silent blocks Elastomere</p><p>18 Back foot LSR</p><p>19 Front foot LSR</p><p>20 Syringe barrel clasp stop Polyamide</p><p>21 Connector stopper TPE EPTR</p><p>22 Right and left flange Polycarbonate</p><p>23 Wi-Fi board support Polycarbonate</p><p>24 Plunger driver body Polycarbonate</p><p>25 Plunger driver flange Polycarbonate</p><p>26 Plunger driver flange stop Polycarbonate</p><p>27 Wing switch support Polycarbonate</p><p>28 Syringe barrel clasp bridle Polycarbonate</p><p>29 Molded syringe barrel clasp Polycarbonate</p><p>30 Dual syringe wings holder Polycarbonate</p><p>138</p><p>13 Specifications</p><p>Essential Features</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> Infusion Rate</p><p> Volume To Be Infused (VTBI)</p><p> Infusion Tme</p><p> Flow Rate Accuracy</p><p> Occlusion Alarm Response Time</p><p> Occlusion Alarm Threshold</p><p> Pressure Management</p><p> Trumpet and Start-up Curves</p><p>Feature Refer to</p><p>Flow rate accuracy IFU</p><p>Time to Detect Occlusion IFU</p><p>Bolus Volume After Occlusion Release IFU</p><p>Management of High-priority Alarms IFU</p><p>139</p><p>14 Recycling</p><p>Before disposal, remove the battery from the device. Batteries and devices with this label must</p><p>not be disposed of with the general waste. They must be collected separately and disposed of</p><p>according to local regulations.</p><p>INFORMATION</p><p> For more information on waste processing regulations, contact your local Fresenius Kabi</p><p>organization or the local distributor.</p><p> For more information on dismantling the device, refer to the chapter "Intervention Procedures" in this</p><p>document.</p><p> Follow healthcare facility policy regarding proper disposal after use.</p><p>140</p><p>15 Warranty</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> General conditions of warranty</p><p> Limited warranty</p><p> Warranty conditions for accessories</p><p>141</p><p>16 Guidance and Manufacturer's Declaration on EMC</p><p>Refer to the Instructions for Use of the relevant pump for the following information:</p><p> Electromagnetic compatibility</p><p> Electrostatic discharge (ESD) information</p><p> ESD precautions to be taken</p><p> Electromagnetic compatibility and interference guidance</p><p> Table 1 - Guidance and manufacturer's declaration - Electromagnetic Emissions</p><p> Table 2 - Guidance and manufacturer's declaration - Electromagnetic Immunity</p><p> Table 4 - Guidance and manufacturer's declaration - Electromagnetic Immunity</p><p> Table 6 - Recommended separation distances between portable and mobile RF communication</p><p>equipment and Agilia infusion pumps.</p><p>Wi-Fi compatibility</p><p>The Agilia infusion pumps include RF transmitters whose effective radiated power (EIRP power) is defined</p><p>below:</p><p> Frequency band 2.4 GHz: 20 dBm.</p><p> Frequency band 5 GHz: 17 dBm.</p><p>142</p><p>17 Spare Parts Catalog</p><p>Refer to the spare parts catalog of the relevant pump.</p><p>143</p><p>18 Ordering Information</p><p>18.1Data Management Cables</p><p>18.2Associated Software</p><p>18.3Disposables</p><p>For more information, contact your Fresenius Kabi sales representative.</p><p>Refer to the Instructions for Use of the relevant pump</p><p>Refer to the Instructions for Use of the relevant pump</p><p>Refer to the Instructions for Use of the relevant pump</p><p>144</p><p>19 Glossary of Terms</p><p>Term Description</p><p>A Amperes</p><p>AC Alternating Current</p><p>Ah Ampere-hours</p><p>AM Amplitude Modulation</p><p>BSA Body Surface Area</p><p>CCU Critical Care Unit</p><p>CDC Centers for Disease Control</p><p>CIS Clinical Information System</p><p>CISPR Special International Committee on Radio Interference</p><p>CT Scan Computed Tomography</p><p>dBA Decibels</p><p>DC Direct Current</p><p>DECT Digital Enhanced Cordless Telecommunications</p><p>DEHP Di(2-ethylhexyl) phthalate</p><p>DERS Dose Error Reduction Software</p><p>DI Dose Infused</p><p>DPS Dynamic Pressure System</p><p>DUR Duration</p><p>ECG Electrocardiogram</p><p>ECMO ExtraCorporeal Membrane Oxygenation</p><p>ED Emergency Department</p><p>EEG Electroencephalogram</p><p>EMC ElectroMagnetic compatibility</p><p>ErXX Error message</p><p>ESD ElectroStatic Discharge</p><p>FM Frequency Modulation</p><p>ft Feet</p><p>GPL General Public License</p><p>H/W/D Height / Width / Depth</p><p>HF High Frequency</p><p>hPa Hectopascals</p><p>Hz Hertz</p><p>IEC International Electrotechnical Commission</p><p>IFU Instructions for Use</p><p>in Inches</p><p>IT Information Technology</p><p>145</p><p>IV Intravenous</p><p>kg Kilograms</p><p>KVO Keep Vein Open</p><p>lb Pounds</p><p>LED Light Emitting Diode</p><p>LSB Least Significant Bit</p><p>mA Milliamperes</p><p>mEq Milliequivalents</p><p>mL/h Milliliters per hour</p><p>mmHg Millimeters of Mercury</p><p>MOS Metal Oxyde Semiconductor</p><p>MRI Magnetic Resonance Imaging</p><p>mW/sr Milliwatts per steradian</p><p>NAM North America</p><p>NICU, PICU Neonatal and Pediatric Intensive Care Units</p><p>NMR Nuclear Magnetic Resonance</p><p>OCS Occlusivity Check System</p><p>OR Operating Room</p><p>PACU Post-Anesthesia Care Unit</p><p>PC Personal Computer</p><p>PE Protective Earth</p><p>PSI Pounds per Square Inch</p><p>RAM Random Access Memory</p><p>REF Product reference / part number</p><p>RF Radio Frequency</p><p>RFID Radio Frequency IDentification</p><p>ROW Rest Of the World (other countries than US and Canada)</p><p>RS232 Serial interface connector</p><p>S/N Serial Number</p><p>SELV Safety Extra Low Voltage</p><p>SIR Asynchronous Serial Infrared</p><p>UPS Uninterruptable Power Supply</p><p>USB Universal Serial Bus</p><p>USB 2.0 OTG USB On-The-Go</p><p>Ut Test specification level</p><p>V Volt</p><p>VA Volt-Amperes</p><p>VDC Volts Direct Current</p><p>VI Volume Infused</p><p>Term Description</p><p>146</p><p>VTBI Volume to Be Infused</p><p>W Watts</p><p>Term Description</p><p>147</p><p>A</p><p>AC Power Board</p><p>Description 23</p><p>Dismantle/Re-assemble 91</p><p>Ageing Test 51</p><p>Alarms 72</p><p>B</p><p>Basic Profile Configuration 32</p><p>Battery</p><p>Dismantle/Re-assemble 82</p><p>Test 49, 52</p><p>C</p><p>Carriage Kit 128</p><p>CPU Board</p><p>Description 16</p><p>Dismantle/Re-assemble 88</p><p>D</p><p>Disengagement Flexible Circuit 108</p><p>Displacement Sensor Test 44</p><p>Display Board</p><p>Description 13</p><p>Dismantle/Re-assemble 86</p><p>E</p><p>Error Codes 77</p><p>Events</p><p>Data Log 38</p><p>Test 41</p><p>F</p><p>Force Sensor</p><p>Dismantle/Re-assemble 113</p><p>Test 42</p><p>I</p><p>Indication Test 50</p><p>K</p><p>Keypad</p><p>Description 9</p><p>Test 50</p><p>L</p><p>LCD Display</p><p>Dismantle/Re-assemble 86</p><p>Voltage 57</p><p>Lever Kit 122</p><p>Linear Sensor Kit 118</p><p>M</p><p>Maintenance</p><p>Date 37</p><p>Display Startup Screen 38</p><p>Schedule 28</p><p>Maintenance Options Menu 37</p><p>Maintenance Test 41</p><p>Material Characteristics 137</p><p>Motor 105</p><p>O</p><p>Operation Diagram 27</p><p>Options Menu 30</p><p>P</p><p>Plunger Cover 122</p><p>Plunger Kit 124</p><p>Power Information 55</p><p>Power Supply Board</p><p>Description 20</p><p>Dismantle/Re-assemble 91</p><p>Pressure Limit Alarm Test 60</p><p>Pump Code 55</p><p>Pump Identification 40</p><p>Q</p><p>Quality Control</p><p>Certificate 69</p><p>Maintenance 28</p><p>R</p><p>Release Notes 149</p><p>Ribbon Cable Kit 113</p><p>S</p><p>Symbol Descriptions 2</p><p>Syringe Barrel Clasp</p><p>Dismantle/Re-assemble 97</p><p>Test 46</p><p>Syringe Detection System 101</p><p>T</p><p>Table of Contents 3</p><p>Technical Characteristics 135</p><p>Temperature Test 57</p><p>Tests</p><p>Access Menu 39</p><p>List 39</p><p>Training 28</p><p>Troubleshooting 75</p><p>U</p><p>Upper Case 84</p><p>Index</p><p>148</p><p>W</p><p>Watchdog 58</p><p>Wi-Fi Board</p><p>Description 24</p><p>Dismantle/Re-assemble 94</p><p>Wi-Fi Module Information 59</p><p>149</p><p>Release Notes</p><p>This document may contain inaccuracies or typographical errors.</p><p>Modifications may thus be made, and included in later editions.</p><p>Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the text and images of this document are</p><p>applicable only to the device with which it is included.</p><p>The screenshots in this document are for illustrative purposes only. Screen contents may vary based on individual configurations and minor</p><p>software modifications;</p><p>therefore, some screenshots may appear slightly different from what you see on the product.</p><p>This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant® and Agilia® are registered</p><p>trademarks in the name of Fresenius Kabi in selected countries.</p><p>Made in France</p><p>Revision date: May 2020</p><p>Date Software Version Revision Description</p><p>November 2016</p><p>2.2</p><p>0 Creation</p><p>January 2017 1  Intended use modification</p><p> New IFU revision</p><p>January 2017 2 New IFU revision</p><p>March 2017 3</p><p>Update of intervention procedures No 4, 6, 7, 8, 9, 10, 11,</p><p>12, 14 and 15 to remove the motor ground wire. This spare</p><p>part has been removed in devices whose serial number is</p><p>from 23407157.</p><p>November 2017 4 Battery life values are updated.</p><p>March 2018 5</p><p> Section 6.2 - Running tests: An information is added to</p><p>ask the user to work with a pump configured with Basic</p><p>Profile and Factory settings.</p><p> Section 6.2.22 - Checking the End of Infusion Alarm: BD</p><p>Plastipak syringe replaces BD Precise for this test.</p><p> Section 6.3.1 - Quality control procedure and Section</p><p>6.3.2 - Quality Control Certificate: Control of the plunger</p><p>head detection finger and anti-siphon arms movement as</p><p>well as control of the disengagement and plunger head</p><p>alarms are added. Battery life test is removed since it is</p><p>not requested by a Quality Control.</p><p> Intervention procedure no 9 - Motor: The reassembling</p><p>procedure is improved to avoid damages to the opto</p><p>motor ground loop.</p><p>Feb. 2020 6 New IFU revision</p><p>May 2020 7 New IFU revision</p><p>Fresenius Kabi AG</p><p>61346 Bad Homburg</p><p>Germany</p><p>Fresenius Vial S.A.S</p><p>Le Grand Chemin</p><p>38590 Brézins</p><p>France</p><p>www.fresenius-kabi.com</p><p>0 1 2 3</p><p>http://www.fresenius-kabi.com/</p><p>Fresenius Vial S.A.S</p><p>Le Grand Chemin</p><p>38590 Brézins - France</p><p>Fresenius Kabi AG</p><p>61346 Bad Homburg</p><p>Germany</p><p>11378-7_TM_Agilia_SP_V2.2_ASU_Eng</p><p>Local Contacts for Servicing</p><p>Agilia SP MC</p><p>Agilia SP MC WiFi</p><p>Syringe Infusion Pumps</p><p>Applicable to software version 2.2</p><p>Instructions For Use</p><p>For Use in Healthcare Facilities</p><p>11103-5_Master_IFU_Agilia_SP_MC_Eng</p><p>Symbol Descriptions</p><p>Warning</p><p>(Refer to the Instructions for Use)</p><p>Name and address of the</p><p>manufacturer / Date of manufacture</p><p>Refer to the Instructions for Use Name and address of the</p><p>manufacturing facility</p><p>Product reference / part number Protection against electric shock:</p><p>class II</p><p>Product serial number Non-ionizing electromagnetic</p><p>radiation</p><p>Input terminal - connector Fragile, handle with care</p><p>Output terminal - connector This way up</p><p>Electrical fuses Keep away from rain</p><p>Alternating Current (AC) Temperature limitation</p><p>Direct Current (DC) Humidity limitation</p><p>IP22</p><p>Index of protection against solid</p><p>foreign objects (> 12.5 mm) and</p><p>dripping liquids</p><p>Atmospheric pressure limitation</p><p>Not for use in residential areas General symbol for recyclable</p><p>material</p><p>Part included in a recycling process Eco packaging symbol</p><p>Protection against leakage current;</p><p>defibrillation-proof type CF applied</p><p>part</p><p>CE mark</p><p>Warning of a potential hazard that</p><p>could result in serious personal</p><p>injury and/or product damage if the</p><p>written instructions are not followed.</p><p>Recommendations to be followed.</p><p>0 1 2 3</p><p>2</p><p>3</p><p>Table of Contents</p><p>1 INTRODUCTION 9</p><p>1.1 SCOPE ...................................................................................................9</p><p>1.2 INTENDED USE........................................................................................9</p><p>1.3 PRINCIPLES OF OPERATION.....................................................................9</p><p>1.4 INTENDED PRODUCTS TO BE INFUSED....................................................10</p><p>1.5 INTENDED USERS..................................................................................10</p><p>1.6 INTENDED PATIENTS .............................................................................11</p><p>1.7 CONTRAINDICATIONS.............................................................................12</p><p>1.8 USE ENVIRONMENT...............................................................................12</p><p>2 AGILIA CONNECT INFUSION SYSTEM 13</p><p>3 DESCRIPTION 15</p><p>3.1 FRONT VIEW.........................................................................................15</p><p>3.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................15</p><p>3.3 BACK VIEW...........................................................................................16</p><p>3.4 KEYPAD................................................................................................17</p><p>3.5 DISPLAY AND SYMBOLS.........................................................................19</p><p>3.5.1 Infusion Status.................................................................................... 19</p><p>3.5.2 Screen Options................................................................................... 19</p><p>3.5.3 Navigation Buttons ............................................................................. 20</p><p>3.5.4 Alarms and Safety Features............................................................... 20</p><p>3.5.5 Infusion Features................................................................................ 20</p><p>3.5.6 Data Communication.......................................................................... 20</p><p>3.6 PACKAGING ..........................................................................................21</p><p>4 FUNDAMENTALS 22</p><p>4.1 PROFILES .............................................................................................22</p><p>4.2 DRUG LIBRARIES...................................................................................23</p><p>4.3 DRUG LISTS..........................................................................................23</p><p>4.4 DRUGS .................................................................................................24</p><p>4.4.1 Infusion Rates .................................................................................... 24</p><p>4.4.2 Drug X (mL/h)..................................................................................... 24</p><p>4.4.3 Hard Limits and Soft Limits ................................................................ 24</p><p>4.4.4 Infusion Modes ................................................................................... 24</p><p>4.5 DATA SET.............................................................................................25</p><p>4</p><p>5 INSTALLATION 26</p><p>5.1 TYPES OF INSTALLATIONS .....................................................................26</p><p>5.2 USING THE ROTATING POLE CLAMP.......................................................27</p><p>5.3 ATTACHING THE PUMP(S) ......................................................................28</p><p>5.3.1 Attaching to a Pole ............................................................................. 28</p><p>5.3.2 Attaching to a Rail .............................................................................. 29</p><p>5.3.3 Using on a Flat Table ......................................................................... 29</p><p>5.3.4 Attaching Two Pumps Together ......................................................... 30</p><p>6 GETTING STARTED 31</p><p>6.1 FLOWCHART .........................................................................................31</p><p>6.2 USING THE PUMP FOR THE FIRST TIME..................................................32</p><p>6.3 POWERING ON ......................................................................................32</p><p>6.4 INSTALLING A SYRINGE..........................................................................34</p><p>6.5 PUMP HEIGHT.......................................................................................34</p><p>7 OPERATION 35</p><p>7.1 FLOWCHART .........................................................................................35</p><p>7.2 SELECTING A PROFILE ..........................................................................36</p><p>7.3 SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ........................37</p><p>7.4 SELECTING A SYRINGE..........................................................................38</p><p>7.5 SELECTING A DRUG ..............................................................................39</p><p>7.6 PROGRAMMING AN INFUSION .................................................................39</p><p>7.6.1 Programming an Infusion by Flow Rate ............................................. 40</p><p>7.6.2 Programming an Infusion by Dose ..................................................... 40</p><p>7.6.3 Programming Beyond Soft Limits....................................................... 45</p><p>7.7 STARTING AN INFUSION .........................................................................47</p><p>7.8 MONITORING AN INFUSION.....................................................................48</p><p>7.8.1 Monitoring an Infusion when Programmed by Flow Rate................... 48</p><p>7.8.2 Monitoring an Infusion when Programmed by Dose .......................... 49</p><p>7.9 FUNCTIONS DURING INFUSION...............................................................50</p><p>7.9.1 Stop .................................................................................................... 50</p><p>7.9.2 Rate Titration...................................................................................... 50</p><p>7.9.3 Administering a Bolus......................................................................... 50</p><p>7.10 COMPLETING AN INFUSION ....................................................................53</p><p>7.10.1 Near End of Infusion Alert .................................................................. 53</p><p>7.10.2 End of Infusion ................................................................................... 54</p><p>7.10.3 Powering off ....................................................................................... 55</p><p>7.11 INFUSION MODES..................................................................................55</p><p>5</p><p>7.11.1 Simple Rate........................................................................................ 55</p><p>7.11.2 Volume/Time & Dose/Time ................................................................ 55</p><p>7.11.3 Volume Limit....................................................................................... 56</p><p>7.12 OTHER FUNCTIONS ...............................................................................57</p><p>7.12.1 Priming the Syringe and the Extension Set........................................ 57</p><p>7.12.2 Pre-programming the Pump ............................................................... 59</p><p>8 MENUS 60</p><p>8.1 OVERVIEW............................................................................................60</p><p>8.2 PROFILE ...............................................................................................61</p><p>8.3 PRESSURE............................................................................................62</p><p>8.4 KEYPAD LOCK STATUS..........................................................................65</p><p>8.5 BATTERY LIFE.......................................................................................67</p><p>8.6 VOLUME INFUSED / DOSE INFUSED ........................................................68</p><p>8.7 PAUSE..................................................................................................69</p><p>8.8 PROGRAMMED BOLUS ...........................................................................70</p><p>8.9 PATIENT ...............................................................................................70</p><p>8.10 DAY/NIGHT MODE.................................................................................71</p><p>8.11 VOLUME/TIME & DOSE/TIME..................................................................73</p><p>8.12 VOLUME LIMIT.......................................................................................73</p><p>8.13 ALARM VOLUME....................................................................................74</p><p>8.14 VOLUME-DOSE HISTORY .......................................................................75</p><p>8.15 VIEW FLOW RATE HISTORY...................................................................76</p><p>8.16 VIEW PRESSURE HISTORY ....................................................................77</p><p>8.17 SYRINGE...............................................................................................78</p><p>8.18 VIEW EVENT LOG .................................................................................79</p><p>8.19 DATE / TIME .........................................................................................80</p><p>8.20 MAINTENANCE ......................................................................................81</p><p>8.21 LIBRARY INFORMATION..........................................................................82</p><p>8.22 CLINICAL INFORMATION .........................................................................83</p><p>8.23 DATA SET.............................................................................................84</p><p>9 OPTIONS 85</p><p>9.1 COMMANDS ..........................................................................................85</p><p>9.2 OPTION DESCRIPTIONS .........................................................................85</p><p>9.3 PUMP SETTINGS ...................................................................................86</p><p>6</p><p>10 DATA COMMUNICATION 87</p><p>10.1 OVERVIEW............................................................................................87</p><p>10.2 COMMUNICATION VIA AGILIA CABLES .....................................................87</p><p>10.3 COMMUNICATION VIA WI-FI ...................................................................88</p><p>10.4 DATA SET UPLOAD ..............................................................................88</p><p>11 USER TEST 89</p><p>12 ALARMS AND SAFETY FEATURES 90</p><p>12.1 INTRODUCTION......................................................................................90</p><p>12.2 ALARM DESCRIPTIONS ..........................................................................90</p><p>12.3 GENERAL REMARKS..............................................................................91</p><p>12.4 LIST OF ALARMS ...................................................................................91</p><p>12.5 AUDIO-ONLY INFORMATION SIGNALS ......................................................97</p><p>13 SYRINGES 98</p><p>13.1 SYRINGE LIST .......................................................................................98</p><p>13.2 PREPARING A SYRINGE .........................................................................98</p><p>13.3 OPERATIONS FOR SYRINGES ...............................................................100</p><p>13.4 GRAVITY INFUSION IN PARALLEL WITH A PUMP.....................................101</p><p>14 DEVICE STORAGE 102</p><p>14.1 PRECAUTIONS FOR STORAGE ..............................................................102</p><p>14.2 STORAGE AND TRANSPORT CONDITIONS..............................................102</p><p>14.3 PREPARING THE DEVICE FOR STORAGE...............................................102</p><p>14.4 USING THE DEVICE AFTER STORAGE...................................................103</p><p>15 SPECIFICATIONS 104</p><p>15.1 ESSENTIAL FEATURES.........................................................................104</p><p>15.2 FLOW RATE ........................................................................................104</p><p>15.3 VOLUME TO BE INFUSED (VTBI) .........................................................105</p><p>15.4 DOSE TO BE INFUSED (DTBI) .............................................................105</p><p>15.5 INFUSION TIME....................................................................................105</p><p>15.6 CONCENTRATION ................................................................................106</p><p>15.7 PATIENT DATA ....................................................................................106</p><p>15.8 PRESSURE MANAGEMENT ...................................................................106</p><p>15.9 ACCURACY .........................................................................................107</p><p>7</p><p>15.10 UNITS AND CONVERSION RULES..........................................................109</p><p>16 CLEANING AND DISINFECTING 111</p><p>16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................111</p><p>16.2 RECOMMENDED AND PROHIBITED AGENTS...........................................111</p><p>16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................112</p><p>17 POWER MANAGEMENT 115</p><p>17.1 AC POWER SUPPLY PRECAUTIONS......................................................115</p><p>17.2 BATTERY PRECAUTIONS......................................................................115</p><p>17.3 BATTERY OPERATING MODE ...............................................................116</p><p>18 TECHNICAL CHARACTERISTICS 117</p><p>18.1 POWER SUPPLY..................................................................................117</p><p>18.2 BATTERY ............................................................................................117</p><p>18.3 POWER CONSUMPTION........................................................................117</p><p>18.4 COMMUNICATION PORT .......................................................................118</p><p>18.5 INFRARED COMMUNICATION.................................................................118</p><p>18.6 SOUND LEVELS...................................................................................118</p><p>18.7 COMPLIANCE ......................................................................................119</p><p>18.8 DIMENSIONS AND WEIGHT ...................................................................119</p><p>18.9 TRUMPET AND START-UP CURVES.......................................................120</p><p>19 WI-FI 122</p><p>19.1 GENERAL INFORMATION ......................................................................122</p><p>19.2 SPECIFICATIONS .................................................................................123</p><p>20 TROUBLESHOOTING 125</p><p>21 RECYCLING 127</p><p>22 WARRANTY 128</p><p>22.1 GENERAL WARRANTY CONDITIONS......................................................128</p><p>22.2 LIMITED WARRANTY ............................................................................128</p><p>22.3 WARRANTY CONDITIONS FOR ACCESSORIES........................................128</p><p>23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 129</p><p>23.1 ELECTROMAGNETIC COMPATIBILITY ..................................................129</p><p>8</p><p>23.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................129</p><p>23.3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE .130</p><p>23.4 EMC AND ESSENTIAL PERFORMANCES ................................................132</p><p>24 SERVICING 138</p><p>24.1 INFORMATION ON DEVICE SERVICING...................................................138</p><p>24.2 MAINTENANCE REQUIREMENTS............................................................138</p><p>24.3 QUALITY CONTROL .............................................................................139</p><p>25 GLOSSARY OF TERMS 140</p><p>APPENDIX: FACTORY CONFIGURATION 144</p><p>INDEX 145</p><p>9</p><p>1 Introduction</p><p>1.1 Scope</p><p>1.2 Intended Use</p><p>1.3 Principles of Operation</p><p>These Instructions for Use (IFU) are applicable to the Agilia SP MC and</p><p>Agilia SP MC WiFi pumps. These devices are referred to throughout this</p><p>manual as the "Agilia SP MC".</p><p>The user must adhere to the instructions specified in this IFU. Failure to</p><p>adhere to these instructions may result in damage to the equipment,</p><p>injury to patients or injury to users.</p><p>Warning</p><p>Check that this IFU is applicable to the current software version of the</p><p>device.</p><p> The software version of the device is displayed on the start-up</p><p>screen.</p><p> The software version described in this IFU is displayed in the</p><p>Release Notes, page 147.</p><p>The Agilia SP MC Syringe Pump is intended for use on adults,</p><p>pediatrics, and neonatal patients for the intermittent or continuous</p><p>delivery of parenteral fluids (such as solutions, colloids, parenteral</p><p>nutrition), medications (such as diluted drugs, chemotherapy,</p><p>anesthesia drugs), blood and blood derivatives, and medications</p><p>through clinically accepted routes of administration. It is intended for use</p><p>by trained healthcare professionals in clinical healthcare facilities and in</p><p>pre-hospital medical ground transportation.</p><p>Agilia SP MC is a programmable electronic medical system dedicated to</p><p>administering a pre-determined volume of a syringe at a programmed</p><p>rate. This syringe pump ensures a fluid delivery, by pushing the syringe</p><p>plunger and advancing the liquid to the patient through an extension set</p><p>(applied part).</p><p>Agilia SP MC is a transportable and reusable device that can be used</p><p>everyday.</p><p>The size of a syringe can be 5, 10, 20, 30 or 50-60 mL.</p><p>Agilia SP MC can be used for intermittent or continuous infusions.</p><p>Agilia SP MC is intended for use on only one patient at a time. It can be</p><p>reused indefinitely on multiple patients throughout its lifetime.</p><p>10</p><p>1.4 Intended Products to be Infused</p><p>1.5 Intended Users</p><p>The pump administers products through clinically accepted routes.</p><p>These products include but are not limited to the following:</p><p>Intended Products</p><p>Parenteral Fluids</p><p> Standard solutions</p><p> Colloids</p><p> Parenteral nutrition</p><p>Medication</p><p> Diluted drugs</p><p> Antibiotics</p><p> Chemotherapy</p><p> Catecholamines</p><p> Short acting drugs</p><p> Anesthesia drugs</p><p>Transfusion</p><p> Blood</p><p> Red blood cells</p><p> Platelets</p><p> Plasma</p><p> Albumin</p><p>When using Agilia SP MC to infuse critical medications, ensure that</p><p>adequate monitoring is provided, and that backup pumps and syringes</p><p>are available for immediate use.</p><p>Only use Agilia SP MC for the infusion of fluids that are intended for</p><p>infusion pumps.</p><p>Administration Routes</p><p>The system allows infusion via the following access routes:</p><p> IV access with any device that administers a medical fluid to a vein</p><p>and is equipped with a female Luer lock,</p><p> Subcutaneous access.</p><p>The pump must only be used by qualified and trained healthcare</p><p>professionals including but not limited to: nurses (primary users),</p><p>physicians, nurse practitioners and physician assistants.</p><p>Typical initial training duration: 1 hour.</p><p>It is recommended that users attend a refresher training session of about</p><p>20 minutes every year.</p><p>For training, contact your Fresenius Kabi sales representative.</p><p>11</p><p>1.6 Intended Patients</p><p>Agilia SP MC is intended to be used according to healthcare facilities</p><p>protocols on patients with the following characteristics:</p><p>Patient Characteristics</p><p>Sex Male</p><p>Female</p><p>Age</p><p>Neonates</p><p>Pediatrics</p><p>Adults</p><p>Elderly</p><p>Weight 0.25 kg to 350 kg</p><p>Body Surface Area 0.05 m² to 4.5 m²</p><p>When using the pump with a very sensitive population such as the</p><p>neonates, make sure to:</p><p> Switch to night mode</p><p> Set the alarm volume to the minimum level</p><p>Warning</p><p>Specific attention for infusing high risk and life sustaining medication</p><p>therapies : use the smallest compatible syringe size necessary to deliver</p><p>the fluid or medication; this is especially important when infusing high</p><p>risk or life-sustaining medications at low infusion rates (e.g., less than 5</p><p>mL per hour, and especially flow rates less than 0.5 mL per hour). Using</p><p>a larger syringe when infusing at low rates can lead to inadequate</p><p>syringe pump performance including delivery inaccuracies, delay of</p><p>therapy, and delayed generation of occlusion alarms. This is due to the</p><p>increased friction and compliance of the syringe plunger head with larger</p><p>syringes.</p><p>12</p><p>1.7 Contraindications</p><p>1.8 Use Environment</p><p> Do not modify the pump (except in the case of operations</p><p>recommended by Fresenius Kabi).</p><p> Do not use the pump with the following fluids:</p><p>- Flammable liquids</p><p>- Fluids not suitable for infusion</p><p> Do not use the pump in the following environments:</p><p>- Explosive or flammable environments</p><p>- High humidity environments (shower, bath, etc.)</p><p>- Ultrasonic environments</p><p>- Magnetic Resonance Imaging (MRI)</p><p>- Hyperbaric chamber</p><p> Do not use the pump for the following purposes:</p><p>- Infusion in association with a dialyser or ECMO</p><p>- Enteral nutrition</p><p>- Epidural use</p><p> Do not allow the pump to come in direct contact with the patient's</p><p>body.</p><p> While the pump is infusing a patient, do not connect a computer</p><p>installed with Agilia Partner software to perform technical</p><p>operations.</p><p>Agilia SP MC is intended for use in healthcare facilities, under the</p><p>supervision of trained healthcare personnel.</p><p>The pump must be used in the following operational conditions to ensure</p><p>proper performance:</p><p> Operating temperature range: 5 °C to 40 °C</p><p> Operating pressure range: 700 hPa (525 mmHg / 10.15 PSI) to</p><p>1060 hPa (795 mmHg / 15.37 PSI)</p><p> Operating humidity range: 20 % to 90 % with no condensation</p><p> Altitude: Up to 3000 m above sea-level</p><p>Warning</p><p>The functionality of the pump can be affected by pressure variations,</p><p>mechanical shocks, heat ignition sources, and so on.</p><p>Information</p><p> The pump can be used in ambulances exclusively with the Agilia</p><p>Holder Ambulance accessory. Due to use in road ambulances,</p><p>performances of the device can be modified. For more information,</p><p>refer to Agilia Holder Ambulance IFU.</p><p> For more information on using the device in specific conditions,</p><p>contact your Fresenius Kabi representative.</p><p>13</p><p>2 Agilia Connect Infusion System</p><p>Agilia range Description</p><p>Pump</p><p>Agilia VP range</p><p>Volumetric Infusion Pump</p><p>Pumps designed to deliver the contents of parenteral</p><p>infusion container (bag or bottle) through a line connected</p><p>to a patient.</p><p>Agilia SP range</p><p>Syringe Infusion Pump</p><p>Pumps designed to deliver the contents of a syringe through</p><p>a line connected to a patient.</p><p>Agilia SP PCA</p><p>Patient Controlled Analgesia (PCA) syringe pump</p><p>Pumps intended for PCA therapy and for the administration</p><p>of analgesic drugs under the patient’s or the clinician’s</p><p>control.</p><p>Agilia ProNeo</p><p>Enteral Nutrition Syringe Pump for Neonates</p><p>Pumps designed to deliver enteral nutrition to neonates,</p><p>preterm babies and children via clinically accepted routes of</p><p>administration.</p><p>Software</p><p>Vigilant Master Med</p><p>Medication Safety Solution</p><p>DERS (Dose Error Reduction Software) designed to create,</p><p>customise and manage data sets to be uploaded to the</p><p>Agilia VP and SP infusion pumps.</p><p>Agilia Vigilant</p><p>Drug’Lib</p><p>Medication Safety Software</p><p>Software designed to create, customize and manage data</p><p>sets to be uploaded to the Agilia VP and SP infusion pumps.</p><p>Agilia Partner</p><p>Maintenance Software</p><p>Software designed to maintain, configure, test and calibrate</p><p>the Agilia VP and SP infusion pumps.</p><p>Centerium</p><p>Distribution Server</p><p>Software intended to distribute data sets to Agilia infusion</p><p>pumps and centralize information coming from infusion</p><p>pumps for post analysis and reporting.</p><p>Vigilant Insight</p><p>Infusion Data Reporting Software</p><p>Software designed to improve the accuracy of clinical</p><p>settings included into a data set. It provides reports about</p><p>the use of infusion pumps.</p><p>Rack Link Agilia</p><p>Link+ Agilia</p><p>Stacking Rack Systems</p><p>Rack systems designed to stack 4, 6 or 8 Agilia infusion</p><p>pumps. Link Agilia is designed to centralize the power</p><p>supply. Link+ Agilia is designed to centralize the power</p><p>supply and to centrally replicate infusion pump signalling.</p><p>Accessories Agilia Holder</p><p>Ambulance</p><p>Medical device intended to be used in road ambulances</p><p>equipped with AC power source and a horizontal rail in</p><p>order to fix an infusion pump.</p><p>Disposables Syringes</p><p>(applied part) See section 13, page 98.</p><p>14</p><p>Information</p><p>For a list of compatible accessories, disposables and software, and for</p><p>ordering information, refer to the System Components booklet.</p><p>15</p><p>3 Description</p><p>3.1 Front View</p><p>Figure 3.1: Front View</p><p>3.2 Bottom View (Device Identification Label)</p><p>Legend</p><p>Handle Plunger Driver</p><p>Syringe Barrel Clasp Disengagement Lever</p><p>Syringe Flange Cradle Syringe Guard</p><p>For more information on device identification label symbols, see Symbol</p><p>Descriptions, page 2.</p><p>3 5</p><p>6</p><p>2</p><p>1</p><p>4</p><p>1 14</p><p>12 35</p><p>3 36</p><p>16</p><p>3.3 Back View</p><p>Figure 3.2: Back View</p><p>Legend</p><p>Release Button Power Cord Inlet</p><p>Rotating Pole Clamp Infrared Cell</p><p>RS232 Communication Port Attachment Lock Knob</p><p>Symbol Location Description</p><p>Near Power Cord Inlet</p><p>Warning</p><p>See section 18, page 117.</p><p>Near RS232</p><p>Communication Port</p><p>Warning</p><p>See section 10, page 87.</p><p>6</p><p>4</p><p>3</p><p>5</p><p>21</p><p>1 14</p><p>12 35</p><p>3 36</p><p>17</p><p>3.4 Keypad</p><p>3.4.1 Keypad Description</p><p>Figure 3.3: Keypad</p><p>Legend</p><p>Screen Decrement</p><p>Battery Charge Status Indicator Fast Decrement</p><p>Power Supply Indicator Confirm Value / Move to Next Field</p><p>Wi-Fi Symbol Stop</p><p>On / Off Cancel Value / Move Back to Previous</p><p>FieldBolus / Prime</p><p>Fast Increment Menu</p><p>Increment Pressure Menu</p><p>Infusion Indicator Lights Alarm Silence</p><p>9</p><p>15</p><p>14</p><p>17</p><p>16</p><p>1312118 10765</p><p>1</p><p>2</p><p>3</p><p>4</p><p>1 3710</p><p>12 311</p><p>3 312</p><p>4 313</p><p>5</p><p>314</p><p>36</p><p>37 315</p><p>38 316</p><p>379 317</p><p>18</p><p>3.4.2 Keypad Details</p><p>3.4.2.1 Selection Keys</p><p>3.4.2.2 Infusion Indicator Lights</p><p>3.4.2.3 Status Indicators</p><p>Key Description</p><p>Arrow Keys</p><p>Keys for selecting volume, time, flow rate and other values.</p><p>+ Fast Access to Maximum Value or Top of a List</p><p>+ Fast Access to Minimum Value or Bottom of a List</p><p>Note:</p><p> Pressing and holding any of the arrow keys results in faster increment or decrement.</p><p>Indicator Description</p><p>Infusion in Progress (flashing green)</p><p>Low-Priority Alarm (constant yellow)</p><p>Medium-Priority Alarm (flashing yellow)</p><p>High-Priority Alarm (flashing red)</p><p>Note:</p><p> Infusion indicator lights provide information about the infusion: in progress, or with a low, medium</p><p>or high-priority alarm.</p><p> Green indicator lights will continuously flash from right to left while the infusion is running.</p><p> The frequency of flashing varies according to flow rate.</p><p>Indicator Description</p><p>Power Supply Indicator</p><p>When the device is attached to an active power supply, the indicator light is</p><p>a constant green. If the pump is not connected to the AC power, it does not</p><p>light up.</p><p>Battery Charge Status Indicator</p><p>When the device is attached to an active power supply, the indicator light</p><p>provides information about battery charge status:</p><p> If the indicator is blinking, the battery is being charged.</p><p> If the indicator is lit permanently, the battery is fully charged.</p><p>If the pump is not connected to the AC power, it does not light up.</p><p>19</p><p>3.5 Display and Symbols</p><p>3.5.1 Infusion Status</p><p>3.5.2 Screen Options</p><p>Symbol Description</p><p>Infusion in Progress (Basic Profile + Custom Profiles with a drug list)</p><p>Symbols for infusion in progress.</p><p>Infusion in Progress (Custom Profiles with a drug library)</p><p>This symbol is displayed when the pump is infusing a drug customized with</p><p>Agilia Vigilant Drug’Lib software.</p><p>Infusion Stopped</p><p>STOP remains in the center of the screen until the user starts the infusion</p><p>again.</p><p>Symbol Description</p><p>Battery Logo</p><p> This symbol shows three different charge levels.</p><p>< 30 % battery charge</p><p>30 % - 70 % battery charge</p><p>> 70 % battery charge</p><p> If the ‘Battery logo’ option is enabled, this symbol is displayed constantly.</p><p> If the ‘Battery logo’ option is disabled, this symbol is only displayed when</p><p>the pump is operating on battery.</p><p>Pressure Logo</p><p>This symbol gives information about pump pressure settings and measured</p><p>pressure levels.</p><p>Keypad locked symbol</p><p>This symbol informs the user that the keypad is locked.</p><p>Wi-Fi module status</p><p> The Wi-Fi signal strength is high.</p><p> The Wi-Fi signal strength is medium.</p><p> The Wi-Fi signal strength is low.</p><p> No Wi-Fi signal (the Wi-Fi module is activated).</p><p> The Wi-Fi module is not activated.</p><p>20</p><p>3.5.3 Navigation Buttons</p><p>3.5.4 Alarms and Safety Features</p><p>3.5.5 Infusion Features</p><p>3.5.6 Data Communication</p><p>Symbol Description</p><p>Start</p><p>Confirm</p><p>Access Function</p><p>Access Function and Clear Settings</p><p>Exit Function</p><p>Change Selection</p><p>Program Function</p><p>Select / Unselect</p><p>See More Information</p><p>/ Zoom in / Zoom out</p><p>/ Move the Event Marker to the Left / Right</p><p>Symbol Description</p><p>Power Disconnection</p><p>Alarm Silenced</p><p>Pressure Increase</p><p>Drop in Pressure</p><p>Note: For more information on alarms, see section 12, page 90.</p><p>Symbol Description</p><p>Loading Dose</p><p>This symbol is displayed when programming a loading dose.</p><p>Symbol Description</p><p>Data Set Loaded</p><p>A new data set has been loaded to the pump.</p><p>start</p><p>OK</p><p>enter</p><p>New ?</p><p>exit</p><p>C</p><p>prog</p><p>21</p><p>3.6 Packaging</p><p>The Agilia SP MC packaging contains the following:</p><p> 1 Agilia SP MC pump</p><p> 1 Instructions for Use manual</p><p>(this document + System Components booklet)</p><p> 1 Power cord</p><p>Packaging weight: Approximately 530 g.</p><p>Packaging consists of: Recycled cardboard.</p><p>Information</p><p> It is the healthcare facility’s responsibility to check the pump integrity</p><p>upon</p><p>reception.</p><p> If the packaging contents are incomplete or damaged, contact your</p><p>Fresenius Kabi sales representative.</p><p>22</p><p>4 Fundamentals</p><p>4.1 Profiles</p><p>4.1.1 Basic Profile</p><p>A profile defines the device configuration and drug library used for a</p><p>group of patients in a given health care environment.</p><p>By default, factory settings include only 1 profile (Basic Profile).</p><p>Custom profiles can be created and loaded to the pump with Agilia</p><p>Vigilant Drug’Lib software. Custom profiles feature a specific pump</p><p>configuration and a drug library.</p><p>A pump can manage up to 20 profiles:</p><p> 1 Basic Profile</p><p> Up to 19 custom profiles</p><p>Information</p><p>For pumps used on only one group of patients, we recommend disabling</p><p>the ability to select the profile, thus locking the pumps to the selected</p><p>profile.</p><p>Basic Profile allows programming of an infusion whose settings have not</p><p>been pre-defined with Agilia Vigilant Drug’Lib software.</p><p>To program an infusion with Basic Profile, choose "Basic Profile" when</p><p>selecting a profile.</p><p>Basic Profile has the following characteristics:</p><p> All infusion settings are to be defined.</p><p> The Agilia Vigilant Drug’Lib software's safeguards are unavailable:</p><p>- The infusion is programmed without drug names.</p><p>- Limits on drug infusion rates are not included.</p><p>Configurations and settings accessible in Basic Profile may not be</p><p>suitable for all patient groups and protocols.</p><p>23</p><p>4.1.2 Custom Profiles</p><p>4.2 Drug Libraries</p><p>4.3 Drug Lists</p><p>Custom profiles can be configured and loaded to the pump with Agilia</p><p>Vigilant Drug’Lib software.</p><p>A custom profile contains the following:</p><p> a specific device configuration (pump settings that control the</p><p>mechanical functions of the pump such as alarm volume, and so on)</p><p> a comprehensive list of medications and fluids to be infused</p><p>(optional):</p><p>- a drug library: a list with limits on drug infusion rates,</p><p>see section 4.2, page 23.</p><p>- a drug list: a list without limits on drug infusion rates.</p><p>Depending on the way it is pre-configured with Agilia Vigilant Drug’Lib</p><p>software, a custom profile may or may not include all of the</p><p>functionalities described in this IFU.</p><p>Information</p><p> We recommend using a custom profile when infusing critical drugs.</p><p> We recommend that you create and upload profiles in order to limit</p><p>usage errors, and to better adapt the use of the pump to the local</p><p>practices of the different care units. For example, make sure to limit</p><p>flow rates for sensitive populations.</p><p> We recommend creating a specific profile per patient population</p><p>and/or care unit, therapy, protocol, and so on.</p><p>A drug library is a comprehensive list of drugs that includes limits on drug</p><p>infusion rates.</p><p>Information</p><p> Each drug library can support up to 150 drug entries that are defined</p><p>and validated by healthcare professionals according to the drug</p><p>protocols used at the healthcare facility and/or ward level.</p><p> Drug settings may be adjusted on the pump according to pre-defined</p><p>programming limits, such as dose limits.</p><p> Infusion modes are not adjustable on the pump for drugs pre-</p><p>configured with Agilia Vigilant Drug’Lib software.</p><p>A drug list is a list of drugs that does not include limits on drug infusion</p><p>rates.</p><p>24</p><p>4.4 Drugs</p><p>4.4.1 Infusion Rates</p><p>4.4.2 Drug X (mL/h)</p><p>4.4.3 Hard Limits and Soft Limits</p><p>4.4.4 Infusion Modes</p><p>A drug can be pre-configured with Agilia Vigilant Drug’Lib software</p><p>according to one of the following rates:</p><p> Flow rate: Infusion of a volume over a period of time</p><p> Dose: Infusion of a specific amount of a drug corresponding to a</p><p>dose rate</p><p>Drug X (mL/h) is an open entry that can be selected if the intended drug</p><p>is not found in the drug library. It has the following characteristics:</p><p> Fewer limits than the other drugs in the library.</p><p> A full compliment of the Agilia Vigilant Drug’Lib software’s</p><p>safeguards are unavailable.</p><p>It is strongly recommended to use Drug X (mL/h) in a limited number of</p><p>clinical cases and under close patient monitoring by the clinical staff.</p><p>For each custom profile, the healthcare facility can enable or disable</p><p>Drug X (mL/h) using the Agilia Vigilant Drug’Lib software.</p><p>Programming limits can be set for each drug with Agilia Vigilant Drug’Lib</p><p>software. Two types of limits can be set:</p><p> Hard limits: limits that cannot be overridden when programming an</p><p>infusion.</p><p> Soft limits: limits that can be overridden within an authorized range</p><p>when programming an infusion. An additional confirmation will be</p><p>required.</p><p>An infusion can be started according to the following modes:</p><p>Infusion Mode Description</p><p>Infusion Rate</p><p>Flow Rate Dose</p><p>Simple Rate Infusion with a programmed rate  </p><p>Volume/Time</p><p>Dose/Time</p><p>Infusion of a programmed volume or dose over a</p><p>programmed period of time  </p><p>Volume Limit Infusion with a limitation on the volume or dose to</p><p>be infused  </p><p>25</p><p>4.5 Data Set</p><p>A data set is a combination of custom profiles (up to a maximum of 19)</p><p>that can be uploaded to Agilia pumps with Agilia Vigilant Drug’Lib</p><p>software.</p><p>If there is no data set uploaded to the pump, the pump can be used with</p><p>the Basic Profile, without the protections of the Agilia Vigilant Drug’Lib</p><p>software.</p><p>. . .</p><p>Device</p><p>Configuration</p><p>(factory)</p><p>Device</p><p>Configuration</p><p>2</p><p>Device</p><p>Configuration</p><p>3</p><p>Device</p><p>Configuration</p><p>4</p><p>Device</p><p>Configuration</p><p>20</p><p>Drug List</p><p>B</p><p>Drug Library</p><p>A</p><p>Drug Library</p><p>C</p><p>Drug Library</p><p>S</p><p>Data Set configured with Agilia Vigilant Drug’Lib software</p><p>Profile 1</p><p>(Basic)</p><p>Profile 2</p><p>(Custom)</p><p>Profile 3</p><p>(Custom)</p><p>Profile 4</p><p>(Custom)</p><p>Profile 20</p><p>(Custom)</p><p>26</p><p>5 Installation</p><p>5.1 Types of Installations</p><p>A pump can be installed on any of the following:</p><p>Location Comments</p><p>On a Pole</p><p> See section 5.3.1, page 28.</p><p>Pole specifications:</p><p> Diameter: from 15 to 40 mm</p><p>On a Rail</p><p> See section 5.3.2, page 29.</p><p>Rail specifications:</p><p> Height: from 25 to 35 mm</p><p> Depth: from 8 to 10 mm</p><p>On the</p><p>Agilia Link</p><p>Rack</p><p> Refer to the Agilia Link accompanying</p><p>documents.</p><p>On a Table</p><p> See section 5.3.3, page 29.</p><p>Only install a pump on a table if it is not</p><p>possible to attach it to a pole, a rail or</p><p>recommended Agilia accessory.</p><p>On Another</p><p>Pump</p><p> See section 5.3.4, page 30.</p><p>On an Agilia</p><p>Duo</p><p> Refer to the Agilia Duo accompanying</p><p>documents.</p><p>27</p><p>5.2 Using the Rotating Pole Clamp</p><p>5.2.1 Rotating Pole Clamp Description</p><p>Figure 5.1: Rotating Pole Clamp System</p><p>5.2.2 Using the Rotating Pole Clamp</p><p>In an Agilia</p><p>Holder</p><p>Ambulance</p><p> Refer to the Agilia Holder Ambulance</p><p>accompanying documents.</p><p>Do not use accessories that appear to be damaged. For more</p><p>information on accessories, refer to their respective accompanying</p><p>documents.</p><p>Warning</p><p> The pump must be used in a horizontal and stable position to function</p><p>properly.</p><p> Use recommended Agilia accessories to ensure stability and prevent</p><p>the pump from falling. Do not stack the pump with equipment other</p><p>than those recommended.</p><p>The rotating pole clamp is located at the back of the pump.</p><p>When installing the pump on a pole or a rail, fasten the rotating pole</p><p>clamp firmly to avoid any movement of the pump.</p><p>Legend</p><p>Screw Clamp</p><p>Release Button</p><p>Rotating Pole Clamp</p><p>You can secure the rotating pole clamp vertically or horizontally by</p><p>folding it outward until the release button clicks into the locked position.</p><p>Location Comments</p><p>3</p><p>2</p><p>1</p><p>1</p><p>12</p><p>3</p><p>28</p><p>5.2.2.1 Folding the Clamp Down (outward)</p><p>5.2.2.2 Folding the Clamp Up (inward toward the pump)</p><p>5.2.2.3 Rotating the Clamp</p><p>5.3 Attaching the pump(s)</p><p>5.3.1 Attaching to a Pole</p><p>You can fold the clamp down as follows:</p><p>1. Push the release button.</p><p>2. Fold the clamp outward.</p><p>You can fold the clamp up as follows:</p><p>1. Push the release button.</p><p>2. Fold the pole clamp inward toward the</p><p>pump.</p><p>You can rotate the clamp as follows:</p><p>1. Fold the clamp up (see above).</p><p>2. Rotate the clamp to a vertical position.</p><p>3. If necessary, fold the clamp outward</p><p>(see above).</p><p>1. Fold the pole clamp down to the horizontal position:</p><p>see section 5.2.2.1, page 28.</p><p>2. Unscrew the clamp, attach to the</p><p>pole, and screw the clamp until the</p><p>pump is fully secured</p><p>to the pole.</p><p>3. Make sure that the pump is securely</p><p>attached.</p><p>For more information on installing the</p><p>pump on a pole, consult the pole’s</p><p>Instructions for Use.</p><p>Information</p><p>When installed on a rolling stand, do not tip over the system more than</p><p>5°: it may fall.</p><p>29</p><p>5.3.2 Attaching to a Rail</p><p>5.3.3 Using on a Flat Table</p><p>Only single pumps can be attached to a bed rail or gurney rail.</p><p>1. Rotate the pole clamp to the vertical position: see section 5.2.2.3,</p><p>page 28.</p><p>2. Unscrew the clamp, attach to the rail,</p><p>and screw the clamp until pump is</p><p>fully secured to the rail.</p><p>3. Make sure that the pump is securely</p><p>attached.</p><p>1. Fold the pole clamp up: see section 5.2.2.2, page 28.</p><p>2. Place the pump far enough from the</p><p>table's edges to prevent it from</p><p>accidentally being pushed off.</p><p>30</p><p>5.3.4 Attaching Two Pumps Together</p><p>You can attach two pumps together either for transport, or before fixing</p><p>them to a pole.</p><p>1. Fold both pumps’ pole clamps up: see</p><p>section 5.2.2.2, page 28.</p><p>2. Slide the slot on the bottom of the</p><p>upper pump onto the handle of the</p><p>lower pump.</p><p>3. Turn the attachment lock knob on the</p><p>lower pump handle clockwise until the</p><p>locked symbol lines up with the</p><p>marker.</p><p>4. Make sure the two pumps are</p><p>securely attached together.</p><p>5. If needed, fold the two pole clamps</p><p>down and secure them tightly to the</p><p>pole.</p><p>Symbol Location Description</p><p>Attachment Lock Knob Locked Position</p><p>Attachment Lock Knob Unlocked Position</p><p>31</p><p>6 Getting Started</p><p>6.1 Flowchart</p><p>Once the pump is installed at the bedside, you must follow the steps</p><p>below in order to install a syringe and power on the pump.</p><p>Information</p><p>In order to ensure that all the safety features of the device are activated,</p><p>make sure that the following instructions are applied:</p><p> The pump is powered on prior to being connected to the patient.</p><p> The pump is not connected to the patient during the set-up.</p><p>Preparing and priming the syringe and the extension set</p><p>Section 13.2, page 98.</p><p>Powering on</p><p>Section 6.3, page 32.</p><p>Installing the syringe</p><p>Section 6.4, page 34.</p><p>Programming an infusion</p><p>Section 7, page 35.</p><p>32</p><p>6.2 Using the Pump for the First Time</p><p>6.3 Powering on</p><p>1. Make sure the pump is correctly installed at the bedside.</p><p>See section 5, page 26.</p><p>2. Plug the pump into the AC power supply.</p><p>See section 17.1, page 115.</p><p>3. Before starting the pump for the first time, you must charge the</p><p>battery for approximately 6 hours.</p><p>Wait until the pump is fully charged.</p><p>Do not use the pump during the first charge.</p><p>4. Power on the pump.</p><p>See section 6.3, page 32.</p><p>5. Install a syringe into the pump.</p><p>See section 6.4, page 34.</p><p>Information</p><p> The pump can operate using the battery; however, we recommend</p><p>that the pump be connected to a power supply as often as possible</p><p>during use in order to ensure that the battery remains charged.</p><p> When the pump is connected to the power supply, check that the</p><p>power supply indicator lights up green, and that the power cord</p><p>and the wall plug are accessible.</p><p>1. Press .</p><p>An auto-test checks the functionality of the pump.</p><p>2. Immediately after powering on the pump, make sure that all LED</p><p>lights blink.</p><p>3. Acknowledge the different screens listed in the table below.</p><p>Screen After Powering on Description</p><p>Startup screen: the following information is</p><p>displayed:</p><p> Product name / Ward name</p><p> Wi-Fi module status (if applicable)</p><p> Date & time</p><p>33</p><p> The pump is operating on battery.</p><p>The symbol shows three different charge</p><p>levels:</p><p>< 30 % battery charge</p><p>30 % - 70 % battery charge</p><p>> 70 % battery charge</p><p> No syringe is installed on the pump.</p><p> Syringe installation !!! is displayed on</p><p>top of the screen.</p><p> Install a syringe.</p><p>See section 6.4, page 34.</p><p> Maintenance reminder message (optional).</p><p> Same infusion screen (optional).</p><p>Press Yes to keep previous infusion settings.</p><p> Profile confirmation screen (optional).</p><p>Press Ok to confirm the profile.</p><p>Note: This screen is linked to the "same infusion"</p><p>function above.</p><p> Data Set information (optional)</p><p>Screen After Powering on Description</p><p>34</p><p>6.4 Installing a Syringe</p><p>6.5 Pump Height</p><p>Precautions for pump position</p><p> If using multiple syringe pumps and it is not clinically feasible to have all pumps</p><p>level with the distal tip of the catheter (or the site of fluid delivery), place the</p><p>high risk or life-sustaining medications as close to level with the distal tip of the</p><p>catheter as possible. When infusing multiple high risk or life-sustaining</p><p>medications, consider placing the ones infusing at the lowest rates as close to</p><p>the level with the distal tip of the catheter as possible.</p><p> Minimize the height difference between the pump and the patient and avoid</p><p>changes in the height of the pump (e.g., during transport of critically ill patients)</p><p>to prevent unintended fluctuations in the flow rate.</p><p>Warning</p><p>This must only be done when the patient is not connected.</p><p>1. Open the syringe barrel clasp [A].</p><p>2. Push the disengagement lever [B]</p><p>down and move the plunger driver to</p><p>the right.</p><p>3. Place the syringe in its cradle, with</p><p>the flanges correctly inserted in the</p><p>provided slot.</p><p>4. Secure the syringe with the syringe</p><p>barrel clasp [A].</p><p>5. Push the disengagement lever [B]</p><p>and move the plunger driver gently to</p><p>the left until it is in contact with the</p><p>plunger head.</p><p>6. Check the general installation.</p><p>Warning</p><p>Ideally, the syringe pump should be level with the distal tip of the</p><p>catheter (e.g., the site of fluid delivery; if accessing a central line the</p><p>syringe pump should be at the level of the patient’s heart). If the pump</p><p>height is raised relative to the distal tip of the catheter (e.g., during</p><p>patient transport), the increase in height of the syringe pump can result</p><p>in a temporary increase in fluid delivery or bolus until the flow rate</p><p>stabilizes. Alternatively, if the pump is lowered relative to the distal tip of</p><p>the catheter, the decrease in height of the syringe pump may result in a</p><p>decrease in delivery or under-infusion until the flow rate stabilizes.</p><p>A B</p><p>35</p><p>7 Operation</p><p>7.1 Flowchart</p><p>Selecting a Profile</p><p>Section 7.2, page 36.</p><p>Basic Profile</p><p>Section 4.1.1, page 22.</p><p>Custom Profile</p><p>(with a Drug List)</p><p>Section 4.1.2, page 23.</p><p>Custom Profile</p><p>(with a Drug Library)</p><p>Section 4.1.2, page 23.</p><p>Selecting the</p><p>Infusion Rate</p><p>Section 7.3, page 37.</p><p>Selecting the</p><p>Infusion Rate</p><p>Section 7.3, page 37.</p><p>Selecting a Syringe</p><p>Section 7.4, page 38.</p><p>Selecting a Drug</p><p>Section 7.5, page 39.</p><p>Starting the Infusion</p><p>Section 7.7, page 47.</p><p>Monitoring the Infusion</p><p>Section 7.8, page 48.</p><p>Functions during Infusion</p><p>Section 7.9, page 50.</p><p>Completing the Infusion</p><p>Section 7.10, page 53.</p><p>Programming an Infusion</p><p>Section 7.6, page 39.</p><p>36</p><p>7.2 Selecting a Profile</p><p>You can only select a profile if more than one profile is loaded in the</p><p>pump.</p><p>1. Press to power on the pump.</p><p>2. Press the arrow keys to select a profile that corresponds to the</p><p>target group of patients.</p><p>The (lighthouse) symbol refers to custom profiles that contain</p><p>drug libraries and have been configured with Agilia Vigilant Drug’Lib</p><p>software.</p><p>3. Press OK to confirm.</p><p>The selected profile information is displayed.</p><p>4. Press OK to confirm the drug library version, or C to change the</p><p>profile.</p><p>The drug library is loaded for the profile selected.</p><p>37</p><p>7.3 Selecting the Infusion Rate (Flow Rate or Dose)</p><p>The programming mode step allows you to select the infusion rate. This</p><p>step occurs just after selecting Basic Profile, or a custom profile with a</p><p>drug list.</p><p>Note: The infusion rates for each drug of a drug library are pre-defined</p><p>with Agilia Vigilant Drug’Lib software.</p><p>The infusion rate that was last used is displayed.</p><p>1. Press OK to confirm the infusion rate or press C to change it.</p><p>2. Press the arrow keys to select a new infusion rate.</p><p>3. Press OK to confirm.</p><p>Flow rate Dose</p><p>Flow rate Dose</p><p>38</p><p>7.4 Selecting a Syringe</p><p>The pump automatically detects the size of the installed syringe.</p><p>1. Press OK to confirm the displayed syringe, or C to change it.</p><p>2. If you have chosen to select another syringe,</p><p>press the arrow keys</p><p>to select a new syringe.</p><p>3. Press OK to confirm the new syringe.</p><p>A clinical advisory message may appear, if one is configured for the</p><p>selected syringe.</p><p>4. Press OK to acknowledge the clinical advisory message, or C to</p><p>return to the syringe selection screen.</p><p>Warning</p><p>During programming and prior to starting an infusion, verify that the</p><p>syringe size and model on the syringe pump’s display screen matches</p><p>the syringe size and model loaded onto the syringe pump.</p><p>39</p><p>7.5 Selecting a Drug</p><p>7.6 Programming an Infusion</p><p>Note: The drug selection step is not applicable with Basic Profile.</p><p>Drugs are sorted alphabetically by the first letter of their names:</p><p> A  C</p><p> D  F</p><p> G  I</p><p> J  L</p><p> M  O</p><p> P  R</p><p> S  U</p><p> V  Z</p><p> Drug X (mL/h)</p><p>1. Press the arrow keys to scroll to the drug’s first letter, and press OK.</p><p>2. Press the arrow keys to scroll to the drug’s name, and press OK.</p><p>A clinical advisory message may appear, if one is configured for the</p><p>selected drug.</p><p>3. Press OK to acknowledge the clinical advisory message and</p><p>continue programming, or C to change the drug.</p><p> This section describes the programming of an infusion with the</p><p>Simple Rate infusion mode.</p><p> You can also program an infusion with the following modes:</p><p>- Volume/Time (or Dose/Time), see section 7.11.2, page 55.</p><p>- Volume Limit, see section 7.11.3, page 56.</p><p>40</p><p>7.6.1 Programming an Infusion by Flow Rate</p><p>7.6.2 Programming an Infusion by Dose</p><p>7.6.2.1 Selecting the Drug Concentration</p><p>1. Press the arrow keys to program the flow rate.</p><p>Profile Drug Concentration Selection Procedure</p><p>Basic Profile</p><p>A- Basic Profile and Custom Profiles (with a Drug List), page 40.Custom Profile</p><p>(with a drug list)</p><p>Custom Profile</p><p>(with a drug library) B- Custom Profiles, page 41.</p><p>A- Basic Profile and Custom Profiles (with a Drug List)</p><p>1. Press the arrow keys to select the drug concentration unit, and</p><p>press OK.</p><p>2. Press the arrow keys to select a mass value, and press OK.</p><p>3. Press the arrow keys to select a volume value, and press OK.</p><p>The concentration is automatically calculated and displayed in the</p><p>unit selected above.</p><p>4. Press OK to confirm.</p><p>41</p><p>B- Custom Profiles</p><p>The selected drug is configured in Agilia Vigilant Drug’Lib software to</p><p>allow adjustments to its concentration in one of the following ways:</p><p> Within an authorized range</p><p> At authorized finite values (up to 5)</p><p>If no adjustment of the concentration is allowed, see section 7.6.2.2,</p><p>page 42.</p><p>Authorized Concentration Range</p><p>Authorized Finite Concentrations</p><p>Legend</p><p>Unauthorized Range Hard Limits</p><p>Authorized Range Default Value</p><p>Finite Values</p><p>Selecting the Drug Concentration</p><p>1. Press the arrow keys to select the concentration.</p><p>2. Press OK to confirm.</p><p>Range Finite values</p><p>42</p><p>7.6.2.2 Selecting the Patient’s Characteristics</p><p>7.6.2.3 Selecting the Infusion Unit</p><p>Note: This step is only applicable with custom profiles that contain a drug</p><p>library.</p><p>1. Press the arrow keys to enter the patient's weight or body surface</p><p>area.</p><p>2. Press OK to confirm.</p><p>Information</p><p> The weight entry screen only appears if the selected drug uses</p><p>weight for dose rate calculations.</p><p> The body surface area entry screen only appears if the selected drug</p><p>uses body surface area for dose rate calculations.</p><p> A pre-populated default weight or body surface area will be</p><p>configured with the Agilia Vigilant Drug’Lib software.</p><p>Note: This step is only applicable with Basic Profile and custom profiles</p><p>that contain a drug list. The infusion units for each drug of a drug library</p><p>are pre-defined with Agilia Vigilant Drug’Lib software.</p><p>1. Press the arrow keys to select the infusion unit.</p><p>2. Press OK to confirm.</p><p>Weight Body Surface Area</p><p>43</p><p>7.6.2.4 Programming the Infusion</p><p>7.6.2.5 Programming a Loading Dose</p><p>1. Press the arrow keys to program the dose rate value.</p><p>2. Press OK to confirm.</p><p>Note: This feature can be activated or deactivated in Agilia</p><p>Vigilant Drug’Lib software (custom profiles).</p><p>Information</p><p>The loading dose is only available with the first start of an infusion. If no</p><p>is pressed inadvertently, power the pump off and then on to access the</p><p>loading dose again.</p><p>If enabled for the selected drug, you can program a loading dose after</p><p>programming an infusion defined by dose.</p><p>The screens below will appear prior to starting the infusion.</p><p>Selecting a Loading Dose</p><p>On the loading dose screen:</p><p> Press no to return to the programming screen.</p><p> Press Yes to program a loading dose prior to starting the infusion.</p><p>44</p><p>Programming a Loading Dose</p><p>1. Press the arrow keys to enter a value for the dose, and press OK to</p><p>confirm.</p><p>2. Press the arrow keys to program the loading dose duration</p><p>(__ h __ min __), and press OK to confirm each time segment.</p><p>The VTBI and the flow rate are automatically calculated based on</p><p>dose and duration settings.</p><p>3. Press OK to confirm the loading dose settings.</p><p>If needed, press C or to change the loading dose settings before</p><p>starting.</p><p>4. Press start to initiate the loading dose.</p><p>Once the loading dose is finished, the pump automatically starts the</p><p>programmed infusion.</p><p>45</p><p>7.6.3 Programming Beyond Soft Limits</p><p>Interrupting a Loading Dose</p><p>1. To pause the loading dose, press .</p><p>The screen displays Continue?</p><p>2. Choose one of the following options:</p><p> Press no or to stop the loading dose and proceed to the</p><p>programmed infusion.</p><p> Press start to continue with the loading dose.</p><p>Note: This step is only available with custom profiles that contain a drug</p><p>library.</p><p>You can override soft limits, and adjust flow rate and dose within the</p><p>authorized ranges. You cannot override a hard limit.</p><p>Legend</p><p>Unauthorized Range Hard Limits</p><p>Programmable Range</p><p>(warning and confirmation) Soft Limits</p><p>Authorized Range Default Value</p><p>46</p><p>Overriding a Soft Limit</p><p>1. If you reach a soft limit when programming an infusion, the pump</p><p>displays a message at the top of the screen:</p><p> Upper soft max = the upper soft limit is exceeded</p><p> Lower soft min = the lower soft limit is exceeded</p><p>2. If the displayed settings correspond to the intended flow rate or</p><p>dose, press OK.</p><p>3. Carefully review the program settings.</p><p>The original infusion settings continue until you confirm the new</p><p>settings.</p><p>4. Press OK or start to confirm the soft limit override.</p><p>During infusion, the upper or lower soft limit message will alternate with</p><p>the drug name and concentration at the top of the screen.</p><p>Flow rate Dose</p><p>Flow rate Dose</p><p>Flow rate Dose</p><p>47</p><p>7.7 Starting an Infusion</p><p>1. Check the delivery path integrity, (syringe and access device).</p><p>2. Check that there is no air in the syringe or in the extension set.</p><p>3. Confirm that the syringe is correctly installed in the pump.</p><p>4. Connect the syringe’s extension set to the patient's access device.</p><p>5. Check the infusion settings prior to starting the infusion.</p><p>6. Press start to start the infusion.</p><p>Warning</p><p> When connecting the syringe’s extension set to the patient's access</p><p>device, always use aseptic technique according to your healthcare</p><p>facility policy.</p><p> During programming and prior to starting an infusion, verify that the</p><p>syringe size and model on the syringe pump’s display screen matches</p><p>the syringe size and model loaded onto the syringe pump.</p><p>Information</p><p>If the syringe is not correctly positionned in the pump, we recommend</p><p>clamping, closing or disconnecting the extension set from the patient’s</p><p>access device.</p><p>Flow rate Dose</p><p>48</p><p>7.8 Monitoring an Infusion</p><p>7.8.1 Monitoring an Infusion when Programmed by Flow Rate</p><p>Legend</p><p>Drug Name (Custom profiles only)</p><p>Infusion Flow Rate (mL/h)</p><p>To change the flow rate during an infusion, see section 7.9.2, page 50.</p><p>The flow rate is displayed with the largest font size.</p><p>Infusion Duration</p><p>At the current rate, the remaining infusion time in hours and minutes.</p><p>Infusion duration may or may not be displayed depending on the configuration preset with</p><p>Agilia Vigilant Drug’Lib software for this drug.</p><p>Syringe Name / Ward Name (configurable)</p><p>Custom Profile Sign</p><p>When infusing a drug selected from the</p><p>Agilia Vigilant Drug’Lib software library,</p><p>this lighthouse sign is displayed on the screen continuously.</p><p>3</p><p>5</p><p>1 2</p><p>4</p><p>1</p><p>12</p><p>3</p><p>4</p><p>5</p><p>49</p><p>7.8.2 Monitoring an Infusion when Programmed by Dose</p><p>Legend</p><p>Drug Name (Custom profiles only)</p><p>Dose</p><p>To change the dose during an infusion, see section 7.9.2, page 50.</p><p>Dose is displayed with the largest font size.</p><p>Drug Concentration</p><p>Infusion Flow Rate</p><p>Syringe Name / Ward Name (configurable)</p><p>Patient Characteristics</p><p>Custom Profile Sign</p><p>When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,</p><p>this lighthouse sign is displayed on the screen continuously.</p><p>6</p><p>7</p><p>1 32</p><p>5 4</p><p>1</p><p>12</p><p>3</p><p>4</p><p>5</p><p>6</p><p>7</p><p>50</p><p>7.9 Functions During Infusion</p><p>7.9.1 Stop</p><p>7.9.2 Rate Titration</p><p>7.9.3 Administering a Bolus</p><p>To stop the infusion, press .</p><p>After 2 minutes, an alarm is generated as a reminder that the infusion is</p><p>stopped.</p><p>To restart the infusion, first confirm or modify the programming settings,</p><p>then start the infusion. See section 7.6, page 39.</p><p>You can adjust the infusion rate (flow rate or dose) during the infusion.</p><p>Depending on your pump configuration, stopping the infusion may be</p><p>required before modifying the infusion rate.</p><p>1. If required, stop the infusion, see section 7.9.1, page 50.</p><p>2. Press the arrow keys to modify the flow rate or dose.</p><p>3. Press OK to confirm.</p><p>A bolus is an extra dose that a pump can deliver during an infusion.</p><p>There are two ways to deliver a bolus dose during an infusion:</p><p> Direct bolus</p><p> Programmed bolus</p><p>Flow rate Dose</p><p>Flow rate Dose</p><p>51</p><p>7.9.3.1 Direct Bolus</p><p>Direct Bolus Programmed Bolus</p><p>Access Key or</p><p>Occlusion</p><p>Pressure Level</p><p>Set to its maximum value: 900 mmHg / 120 kPa / 17.4 PSI</p><p>Information</p><p> The bolus volume is added to the Volume Infused (VI).</p><p> The key is not active when the menu screen is displayed.</p><p>Note: This feature can be activated or deactivated in Agilia</p><p>Vigilant Drug’Lib software (custom profiles) or in the pump options</p><p>(Basic profile).</p><p>1. During the infusion, press .</p><p>2. Press bolus to confirm access to bolus function.</p><p>3. To administer a direct bolus, press and hold .</p><p>4. Monitor the volume infused on the main display until the desired</p><p>bolus is reached.</p><p>5. To stop the bolus, release the key.</p><p>The infusion resumes its previous rate after the bolus is delivered.</p><p>52</p><p>7.9.3.2 Programmed Bolus</p><p>Note: This feature can be activated or deactivated in Agilia</p><p>Vigilant Drug’Lib software (custom profiles) or in the pump options</p><p>(Basic profile).</p><p>During the infusion, you can program a bolus in one of the following two</p><p>ways:</p><p> Press , then prog.</p><p> Press , and select in the menu. Press enter to confirm.</p><p>Programming a Bolus</p><p>1. Press the arrow keys to program the bolus volume or dose, and</p><p>press OK.</p><p>2. Press the arrow keys to program the bolus duration</p><p>(__ h __ min __), and press OK.</p><p>The flow rate is calculated automatically.</p><p>3. Press start to start the bolus.</p><p>The infusion resumes its previous rate after the bolus is delivered.</p><p>Press exit or to exit the bolus function and save the programmed</p><p>bolus settings.</p><p>If you press again, this screen appears immediately and displays the</p><p>settings of the last bolus.</p><p>Flow rate Dose</p><p>Flow rate Dose</p><p>53</p><p>7.10Completing an Infusion</p><p>7.10.1 Near End of Infusion Alert</p><p>Interrupting a Programmed Bolus</p><p>1. Press to interrupt the bolus.</p><p>2. Answer the question: Continue?</p><p> Press no to return to the infusion.</p><p> Press start to continue the bolus.</p><p>Prior to the end of an infusion, a near end of infusion alert is</p><p>automatically triggered. The following happens:</p><p> An audible alarm is triggered.</p><p> An alarm message appears on the pump screen.</p><p> The infusion indicator lights flash yellow.</p><p>Near end of infusion alert is triggered when the two criteria below are</p><p>reached simultaneously.</p><p>Setting Range of Values Default Pump</p><p>Setting</p><p>Time Before the End of the Infusion From 1 to 30 minutes 5 minutes</p><p>The remaining volume of fluid in the</p><p>syringe < 10 % of the syringe capacity N/A N/A</p><p>Near end of infusion alert settings are configurable with Agilia</p><p>Vigilant Drug’Lib software (custom profiles), or in the pump options</p><p>(Basic Profile). For more information, refer to the technical manual.</p><p>Flow rate Dose</p><p>54</p><p>7.10.2 End of Infusion</p><p>Silencing Near End of Infusion Alert</p><p>1. Press to silence the alarm.</p><p>2. If required, press OK to confirm the empty syringe mode.</p><p>Depending on the pump configuration, the following happens:</p><p> The infusion continues at the programmed rate until the plunger</p><p>reaches the tip of the syringe. The syringe is not completely emptied</p><p>(regular end of infusion).</p><p> The infusion continues until the syringe is completely emptied. The</p><p>flow rate decreases when the plunger reaches the tip of the syringe</p><p>(empty syringe - only in Simple Rate mode).</p><p>When the infusion is complete, the following happens:</p><p> An audible alarm is triggered.</p><p> An alarm message appears on the pump screen.</p><p> The infusion indicator lights flash red.</p><p>End of infusion settings are configurable with Agilia Vigilant Drug’Lib</p><p>software (custom profiles), or in the pump options (Basic Profile). For</p><p>more information, refer to the technical manual.</p><p>Silencing the Alarm</p><p>1. Press to silence the alarm.</p><p>2. Prepare a new syringe, and adjust the settings for a new infusion.</p><p>55</p><p>7.10.3 Powering off</p><p>7.11 Infusion Modes</p><p>7.11.1 Simple Rate</p><p>7.11.2 Volume/Time & Dose/Time</p><p>You can power off the pump as follows:</p><p>1. Press to stop the infusion.</p><p>2. Press and hold until the pump powers off.</p><p>You can program an infusion with the different infusion modes available,</p><p>depending on the pump configuration, and on the selected drug.</p><p>1. Press the arrow keys to select the infusion rate.</p><p>2. Press OK.</p><p>For more information, see section 7.6, page 39.</p><p>You can use this infusion mode to program a volume to be infused</p><p>(VTBI) over a programmed period of time.</p><p>When the VTBI is reached, an alarm is triggered.</p><p>1. For information on how to access the Volume/Time or Dose/Time</p><p>menu, see section 8.11, page 73.</p><p>2. Press the arrow keys to set the volume or dose to be infused (VTBI /</p><p>DTBI), and press OK.</p><p>The infusion rate is automatically calculated.</p><p>Volume/Time Dose/Time</p><p>56</p><p>7.11.3 Volume Limit</p><p>Information</p><p>If you program a volume to be infused that is greater than the actual</p><p>volume in the syringe, make sure to replace the syringe when it is empty,</p><p>see section 13.3.2, page 100.</p><p>3. Press the arrow keys to set the infusion time, and press OK.</p><p>The infusion rate is automatically readjusted.</p><p>4. Press the arrow keys to configure the end of infusion settings and</p><p>press OK to confirm.</p><p> Stop: The infusion stops when the VTBI is completed.</p><p> Keep Vein Open (KVO): After the VTBI is completed, the infusion</p><p>continues at a preset flow rate to keep the access device open.</p><p> Continuous: After the VTBI is completed, the infusion continues at</p><p>the programmed flow rate.</p><p>5. Press start to start the infusion.</p><p>You can use this infusion mode to set a limit to the volume infused.</p><p>When the limit is reached, an alarm is triggered.</p><p>1. Access the Volume Limit menu, see section 8.12, page 73.</p><p>2. Press the arrow keys to set the volume limit, and press OK.</p><p>Volume/Time Dose/Time</p><p>Flow rate Dose</p><p>57</p><p>7.12Other Functions</p><p>7.12.1 Priming the Syringe and the Extension Set</p><p>Information</p><p> If you program a volume limit that exceeds the actual volume in the</p><p>syringe, make sure to replace the syringe when it is empty, see</p><p>section 13.3.2, page 100.</p><p> The volume already infused (VI) before accessing the volume limit</p><p>mode is taken into account.</p><p>3. Press the arrow keys to configure the end of infusion settings and</p><p>press OK to confirm.</p><p> Stop: The infusion stops when the volume limit is reached.</p><p> Keep Vein Open (KVO): After the volume limit is reached, the</p><p>infusion continues at a preset flow rate to keep the access device</p><p>open.</p><p> Continuous: After the volume limit is reached, the infusion continues</p><p>at the programmed flow rate.</p><p>4. Press start to start the infusion.</p><p>Note: The prime function can be configured with Agilia</p><p>version described in this document is displayed in the Release Notes at the end of this</p><p>document.</p><p>The Agilia Connect Infusion System is dedicated to the intermittent or continuous delivery of parenteral</p><p>fluids (such as solutions, colloids, parenteral nutrition) and medications (such as diluted drugs,</p><p>chemotherapy, anesthesia drugs) and transfusion of blood and blood derivative products. Infusions can</p><p>be performed on adult, pediatric and neonatal patients through clinically accepted routes of</p><p>administration (such as intravenous, intra-arterial, or subcutaneous routes) in healthcare facilities, by</p><p>trained healthcare professionals, and according to healthcare facility protocols.</p><p>The Agilia SP range is intended for use on adults, pediatrics, and neonatal patients for the intermittent or</p><p>continuous delivery of parenteral fluids (such as solutions, colloids, parenteral nutrition), medications (such</p><p>as diluted drugs, chemotherapy, anesthesia drugs), blood and blood derivatives, and medications through</p><p>clinically accepted routes of administration. It is intended for use by trained healthcare professionals in</p><p>clinical healthcare facilities and in pre-hospital medical ground transportation.</p><p>The Agilia SP range is a programmable electronic medical system dedicated to administering a pre-</p><p>determined volume of a syringe at a programmed rate. This syringe pump ensures a fluid delivery, by</p><p>pushing the syringe plunger and advancing the liquid to the patient through an extension set (applied part).</p><p>The Agilia SP TIVA focuses on anesthesia infusions.</p><p>The Agilia SP range is a transportable and reusable device that can be used everyday.</p><p>The size of a syringe can be minimum of 5 mL and maximum of 60 mL.</p><p>The Agilia SP range can be used for intermittent or continuous infusions.</p><p>The Agilia SP range is intended for use on only one patient at a time. It can be reused indefinitely on</p><p>multiple patients throughout its lifetime.</p><p>For more information, refer to the Instructions for Use of the relevant pump.</p><p>7</p><p>1.4 Intended Users</p><p>1.5 Contraindications</p><p>1.6 Use Environment</p><p>The pump must only be used by qualified and trained healthcare professionals, including but not limited</p><p>to: nurses (primary users), physicians, nurse practitioners and physician assistants.</p><p>Service and maintenance must only be performed by biomedical engineers or technicians, or by IT</p><p>specialists.</p><p>Technical maintenance tasks (including inspections and checks) are performed by trained biomedical</p><p>engineers, or by dedicated medical rental and/or service organizations who have been trained and</p><p>approved by the manufacturer.</p><p>For training, contact your Fresenius Kabi sales representative.</p><p> While being serviced, the device must not be connected to a patient.</p><p> Do not modify the pump (except in the case of operations recommended by Fresenius Kabi).</p><p>For more information, refer to the Instructions for Use of the relevant pump.</p><p>Pumps must be used in the operating conditions (temperature, pressure, humidity and altitude) specified</p><p>in their Instructions for Use. Refer to the Instructions for Use of the relevant pump.</p><p>8</p><p>2 Description</p><p>2.1 Physical Description</p><p>2.1.1 Housing</p><p>Figure 2.1: Housing</p><p>Legend</p><p>Cover Disengagement Lever</p><p>Keypad Syringe Guard</p><p>Base Syringe Flange Cradle</p><p>Syringe Barrel Clasp Angle Bracket</p><p>Plunger Driver</p><p>The Agilia SP range of pumps is made up of 3 main parts: a cover, a base and an angle bracket.</p><p> The cover contains the following:</p><p>- Display board</p><p>- Keypad</p><p> The base supports the following:</p><p>- CPU board</p><p>- Mechanical framework assembly</p><p>- Plunger driver unit</p><p>- Wi-Fi board (for Wi-Fi infusion pumps)</p><p> The angle bracket supports the following:</p><p>- Power supply board</p><p>- AC power board</p><p>- Battery</p><p>- Fixing clamp system</p><p>1</p><p>3</p><p>9</p><p>6</p><p>2</p><p>3</p><p>1</p><p>9</p><p>78</p><p>4 5</p><p>1 6</p><p>2 7</p><p>3 8</p><p>4 9</p><p>5</p><p>9</p><p>2.1.2 Keypad</p><p>Figure 2.2: Keypad for Agilia SP</p><p>There are different keypads depending on the pump's model and country of destination.</p><p>Legend</p><p>Screen Infusion Indicator Lights</p><p>Battery Charge Status Indicator Decrement</p><p>Power Supply Indicator Fast Decrement</p><p>On / Off Confirm Value / Move to Next Field</p><p>Bolus / Prime Stop</p><p>Fast Increment Menu / Cancel Value / Move Back to Previous</p><p>Field</p><p>Increment Alarm Silence</p><p>8</p><p>13</p><p>14</p><p>1211107 9654</p><p>1</p><p>2</p><p>3</p><p>4</p><p>1 8</p><p>2 9</p><p>3 10</p><p>4 11</p><p>5 12</p><p>6 13</p><p>7 314</p><p>10</p><p>Figure 2.3: Keypad for Agilia SP MC</p><p>Legend</p><p>Screen Decrement</p><p>Battery Charge Status Indicator Fast Decrement</p><p>Power Supply Indicator Confirm Value / Move to Next Field</p><p>Wi-Fi Symbol (for Wi-Fi pumps only) Stop / Pause</p><p>On / Off Cancel Value / Move Back to Previous Field</p><p>Bolus / Prime Menu</p><p>Fast Increment Pressure Menu</p><p>Increment Alarm Silence</p><p>Infusion Indicator Lights</p><p>9</p><p>15</p><p>14</p><p>17</p><p>16</p><p>1312118 10765</p><p>1</p><p>2</p><p>3</p><p>4</p><p>1 10</p><p>2 11</p><p>3 12</p><p>4 13</p><p>5 314</p><p>6 315</p><p>7 316</p><p>8 317</p><p>9</p><p>11</p><p>Figure 2.4: Keypad for Agilia SP TIVA</p><p>Legend</p><p>Screen Decrement</p><p>Battery Charge Status Indicator Fast Decrement</p><p>Power Supply Indicator Confirm Value / Move to Next Field</p><p>Wi-Fi Symbol Stop</p><p>On / Off Cancel Value / Move Back to Previous Field</p><p>MenuBolus / Prime</p><p>Fast Increment Graph</p><p>Increment Alarm Silence</p><p>Infusion Indicator Lights</p><p>SP</p><p>4</p><p>9</p><p>15</p><p>14</p><p>17</p><p>16</p><p>1312118 10765</p><p>1</p><p>2</p><p>3</p><p>1 10</p><p>2 11</p><p>3 12</p><p>4 13</p><p>5 314</p><p>6 315</p><p>7 316</p><p>8 317</p><p>9</p><p>12</p><p>Figure 2.5: Keypad for Agilia SP TIVA, Japanese market</p><p>Legend</p><p>Screen Decrement</p><p>Battery Charge Status Indicator Fast Decrement</p><p>Power Supply Indicator Confirm Value / Move to Next Field</p><p>On / Off Stop / Pause</p><p>Bolus / Prime Cancel Value / Move Back to Previous Field</p><p>Fast Increment Menu</p><p>Increment Graph</p><p>Infusion Indicator Lights Alarm Silence</p><p>SP</p><p>8</p><p>14</p><p>13</p><p>16</p><p>15</p><p>1211107 9654</p><p>1</p><p>2</p><p>3</p><p>4</p><p>1 9</p><p>2 10</p><p>3 11</p><p>4 12</p><p>5 13</p><p>6 314</p><p>7 315</p><p>8 316</p><p>13</p><p>2.1.3 Display Board</p><p>Figure 2.6: Display Board</p><p>The display board is located under the front of the command panel, and contains all essential parts for</p><p>human-machine interaction:</p><p> Keypad</p><p> Synoptics and control indicators</p><p> LCD screen</p><p>This board is connected to other parts with the connectors shown below.</p><p>Legend</p><p>J1 Connector to Keypad</p><p>J2 Connector to CPU Board</p><p>J3 Connector to LCD Display</p><p>J3</p><p>J2</p><p>J1</p><p>J1</p><p>J2</p><p>J3</p><p>14</p><p>J1 Connector to Keypad</p><p>J2 Connector to CPU Board</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 KBD_COL_0 Column 0</p><p>3 KBD_COL_1 Column 1</p><p>4 KBD_COL_2 Column 2</p><p>5 KBD_LINE_0 Line 0</p><p>6 KBD_LINE_1 Line 1</p><p>7 KBD_LINE_2 Line 2</p><p>8 TON/OFF On/Off key</p><p>9 KBD_LINE_3 Line 3</p><p>10 GND Ground</p><p>11 GND Ground</p><p>12 GND Ground</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 PRES_BOARD/ HMI board presence detection</p><p>3 +3V3 +3.3V power supply</p><p>4 +3V3 +3.3V power supply</p><p>5 ANA_VLCD LCD charge pump voltage</p><p>6 GND Ground</p><p>7 S_ANA_DOOR Door close detection</p><p>8 RESET/ Global reset</p><p>9 GND Ground</p><p>10 CS_LED-KBD/ LED or keypad selection</p><p>11 CS_LCD/ LCD selection</p><p>12 GND Ground</p><p>13 LCD_CD LCD type of the interface cycle:</p><p>Control/Data (0:control, 1:data)</p><p>14 LCD_MS LCD mode selection</p><p>15 GND Ground</p><p>16 HMI_MOSI_SDA SPI data written / I²C data for HMI board</p><p>17 GND Ground</p><p>18 HMI_MISO SPI data read for HMI board</p><p>19 GND Ground</p><p>20 HMI_SCK_SCL SPI/I²C clock for HMI board</p><p>21 GND Ground</p><p>22 KON-OFF On/Off key</p><p>23 +5V +5V power supply</p><p>24 +5V +5V power supply</p><p>25 CMD_FAIL LED command failure</p><p>26 GND Ground</p><p>15</p><p>J3 Connector to Display</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 A Anode of the backlight (+5V)</p><p>3 K Cathode of the backlight</p><p>4 GND Ground</p><p>5 SCK SPI clock (HMI_SCK_SCL signal)</p><p>6 GND Ground</p><p>7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)</p><p>8 GND Ground</p><p>9 CD Control/Data (0:control, 1:data) (LCD_CD signal)</p><p>10 GND Ground</p><p>11 /RST Reset (RESET/ signal)</p><p>12 GND Ground</p><p>13 CS0 Chip select (CSLCD/ signal)</p><p>14 GND Ground</p><p>15 BM0/DB13 Mode select (LCD_MS signal)</p><p>16 GND Ground</p><p>17 VLCD Charge pump voltage (ANA_VLCD signal)</p><p>18 GND Ground</p><p>19 +3V3 +3V3 power supply</p><p>20 GND Ground</p><p>21 GND Ground</p><p>22 GND Ground</p><p>16</p><p>2.1.4 CPU Board</p><p>Figure 2.7: CPU Board (Front View)</p><p>Figure 2.8: CPU Board (Back View)</p><p>The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or</p><p>power functions, such as:</p><p> One single-step bipolar motor command</p><p> Adjustment</p><p>Vigilant Drug’Lib</p><p>(custom profiles) or in the pump options (Basic profile):</p><p> Mandatory: A message is displayed and the user is required to</p><p>prime the line before infusion.</p><p> Advised: A message is displayed to encourage the user to prime</p><p>the line before infusion.</p><p> Not displayed: The pump does not remind the user to prime the line</p><p>before infusion.</p><p>Information</p><p>We strongly recommend to always use the prime function, especially for</p><p>life-sustaining drugs. Priming the syringe and the extension set</p><p>removes all the mechanical gaps and ensures that the programmed flow</p><p>rate is reached within the smallest delay once the start button is pressed.</p><p>Flow rate Dose</p><p>58</p><p>1. Press to power on the pump.</p><p>2. Press .</p><p>3. Make sure the extension set is not connected to the patient, as</p><p>indicated on the screen.</p><p>4. Press OK to proceed.</p><p>5. Press and hold the key to prime.</p><p>6. To end priming, release the key.</p><p>7. Make sure there is no air in the extension set.</p><p>Information</p><p> Priming is only accessible prior to starting the infusion.</p><p> The key is not active when the menu screen is displayed.</p><p> During priming, the occlusion pressure level is set to its maximum</p><p>value 900 mmHg / 120 kPa / 17.4 PSI.</p><p> Priming is limited to 5 mL maximum. Above 5 mL, you must release</p><p>and press the key again to restart priming.</p><p>Quick-Start</p><p>Quick-start is designed to decrease the delay of therapy when the</p><p>pump’s prime function is not used.</p><p>When quick-start is triggered, the infusion starts at a high flow rate</p><p>(120 mL/h) until the pump’s plunger driver starts pushing the syringe</p><p>plunger head. The flow rate then automatically switches to the</p><p>programmed value.</p><p>At the beginning of an infusion, quick-start is triggered or not triggered in</p><p>the following situations:</p><p>59</p><p>7.12.2 Pre-programming the Pump</p><p>Prime Function</p><p>Configuration Quick-start Trigger Rule</p><p>Mandatory  Not triggered</p><p>Advised  Not triggered</p><p>Not displayed</p><p> Triggered if flow rate is equal or inferior to 50 mL/h and the</p><p>automatic priming is not done.</p><p> Not triggered if the automatic priming is done by the user.</p><p>Information</p><p>Priming the line automatically ensures better pump performances than</p><p>using quick-start.</p><p>Warning</p><p>If the prime function is set as "Not displayed", and if the quick-start is</p><p>triggered, an undesired bolus may occur in some cases. Always prefer</p><p>the automatic prime function for life-sustaining drugs.</p><p>You can program the pump before installing the syringe.</p><p>1. Press to power on the pump.</p><p>Syringe installation !!! is displayed on top of the pump</p><p>screen.</p><p>2. Make sure the syringe barrel clasp is folded up against the pump.</p><p>The prog symbol is displayed.</p><p>3. Press prog.</p><p>4. Program the infusion. See section 7.6, page 39.</p><p>5. Press exit to confirm.</p><p>6. When ready, install the syringe.</p><p>7. Press start to start the infusion.</p><p>60</p><p>8 Menus</p><p>8.1 Overview</p><p>8.1.1 Commands</p><p>8.1.2 Menu Description</p><p>Operation Key</p><p>Access menu or exit menu</p><p>Select</p><p>Confirm (corresponds to enter on the screen)</p><p>Select  / Deselect </p><p>Menu Symbol</p><p>Stop</p><p>Infusion</p><p>Required</p><p>Associated Procedure</p><p>Profile NO  Displaying active profile information, page 61.</p><p>Pressure NO  Modifying the pressure limit, page 62.</p><p>Keypad lock status NO  Locking / Unlocking the keypad, page 65.</p><p>Battery life NO  Viewing the battery life, page 67.</p><p>Volume Infused</p><p>NO  Viewing and clearing the volume or dose infused,</p><p>page 68.Dose Infused</p><p>Pause YES  Programming a pause, page 69.</p><p>Programmed bolus NO  Programming a bolus, page 70.</p><p>Patient NO  Changing a patient’s weight or body surface area,</p><p>page 70.</p><p>Day/Night mode NO  Switching between day mode and night mode,</p><p>page 71.</p><p>Volume/Time YES  Programming a Volume/Time or Dose/Time infusion,</p><p>page 73.Dose/Time YES</p><p>Volume limit YES  Programming a Volume Limit infusion, page 73.</p><p>Alarm volume NO  Adjusting the alarm volume, page 74.</p><p>Volume-Dose history YES  Viewing the infusion history, page 75.</p><p>View flow rate history NO  Viewing flow rate history, page 76.</p><p>View pressure history NO  Viewing pressure history, page 77.</p><p>Syringe NO  Displaying on-pump syringe information, page 78.</p><p>Pro</p><p>mL?</p><p>V/T</p><p>D/T</p><p>VL</p><p>61</p><p>Note: The displayed menu may change depending on the pump configuration.</p><p>For more information on factory configuration, refer to Appendix: Factory Configuration, page 144.</p><p>8.2 Profile</p><p>View event log NO  Viewing the event log, page 79.</p><p>Date / Time NO  Setting the date and time, page 80.</p><p>Maintenance NO  Displaying maintenance information, page 81.</p><p>Library information NO  Displaying drug library information, page 82.</p><p>Clinical information NO  Viewing remaining time before clinical information</p><p>display, page 83.</p><p>Data Set NO  Displaying active data set information, page 84.</p><p>Symbol</p><p>Procedure Displaying active profile information</p><p>You can display the active profile name as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>The active profile information is displayed.</p><p>Menu Symbol</p><p>Stop</p><p>Infusion</p><p>Required</p><p>Associated Procedure</p><p>DS</p><p>Pro</p><p>Pro</p><p>62</p><p>8.3 Pressure</p><p>Symbol</p><p>Procedure Modifying the pressure limit</p><p>The pump pressure limit is pre-defined in the pump options in one of the</p><p>following modes:</p><p> 3 levels (low , medium , high ).</p><p>The pressure limit is adjustable according to 3 pre-set values.</p><p> Variable</p><p>The pressure limit is adjustable within a pre-defined range.</p><p>When the pressure limit is reached, an occlusion alarm is triggered.</p><p>You must silence the alarm, resolve the occlusion and start the infusion</p><p>again.</p><p>To consult the pressure settings, see section 15.8, page 106.</p><p>Warning</p><p>When addressing or clearing an occlusion:</p><p> Ensure the fluid flow to the patient is OFF to prevent administering an</p><p>unintended bolus. An occlusion may pressurize the infusion tubing</p><p>and syringe, which can result in an unintended bolus of drug when the</p><p>occlusion is cleared. In order to prevent this additional bolus,</p><p>disconnect the tubing, or relieve the excess pressure through a</p><p>stopcock, if present. The health care professional should weigh the</p><p>relative risks of disconnection with the risks of an unintended bolus of</p><p>drug.</p><p> Be aware that using larger size syringes on a high plunger force</p><p>setting may produce a larger post occlusion bolus due to excessive</p><p>syringe plunger head compliance.</p><p>You can modify the pressure limit as follows:</p><p>1. Open the pressure menu in one of the two following ways:</p><p> Press .</p><p> Through the Menu:</p><p>- Press .</p><p>- Press the arrow keys to select .</p><p>2. Press enter to access the pressure limit screen.</p><p>63</p><p>3. Press the arrow keys to increase or decrease the pressure limit.</p><p>4. Press OK to validate.</p><p>5. Press to enable or disable the DPS function (optional).</p><p>6. Press OK to confirm.</p><p>Warning</p><p>To avoid the presence of air and to minimize the amount of time it takes</p><p>the pump to recognize an occlusion and generate an alarm while</p><p>infusing at low rates (e.g., less than 5 mL per hour, and especially flow</p><p>rates less than 0.5 mL per hour):</p><p> Consider occlusion pressure threshold setting and adjust it, as</p><p>necessary. The lower the occlusion pressure threshold setting, the</p><p>shorter the occlusion detection time. However, when infusing viscous</p><p>or thick fluids (e.g., lipids), the occlusion pressure threshold setting</p><p>may need to be adjusted to reduce false alarms.</p><p> Use the smallest compatible syringe size necessary to deliver the</p><p>fluid or medication. This minimizes the amount of friction and</p><p>compliance (i.e., stiffness) of the syringe plunger head. Because</p><p>syringe pumps infuse fluids by precisely controlling the plunger,</p><p>smaller syringes provide more precise fluid delivery than larger</p><p>syringes.</p><p> Use the prime feature on the pump when changing a syringe and/or</p><p>tubing.</p><p> Use extension set which have the smallest internal volume or</p><p>deadspace (e.g., use microbore tubing when infusing at low rates,</p><p>shorter length of tubing, etc.).</p><p>64</p><p>Information</p><p> The Dynamic Pressure System (DPS) informs the user of any</p><p>sudden rise or drop in pressure before the pressure limit is reached.</p><p> If</p><p>variable pressure mode is enabled, a pre alarm is triggered when</p><p>the pressure reaches 50 mmHg below maximum pressure</p><p>(25 mmHg when maximum pressure is 50 mmHg).</p><p> If other pumps are used in parallel, it is recommended that their</p><p>pressure limits be adjusted to the same level.</p><p>65</p><p>8.4 Keypad Lock Status</p><p>Symbol</p><p>Procedure Locking / Unlocking the keypad</p><p>You can use this feature to avoid inadvertent key presses.</p><p>Note: The following features can be activated or deactivated in the pump</p><p>options:</p><p> Automatic lock: The keypad will lock automatically at infusion start,</p><p>or after a time-out.</p><p> Unlock code: The user must enter a code to unlock the keypad.</p><p>Locking the Keypad</p><p>You can lock the keypad as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Lock the keypad as follows:</p><p> Press to lock the keypad.</p><p>The keypad is locked and the screen displays .</p><p> Press to activate the automatic lock.</p><p>The keypad will lock automatically at infusion start. If the keypad is</p><p>unlocked during the infusion, it will lock again automatically after a</p><p>time-out.</p><p>5. Press OK to confirm.</p><p>66</p><p>Unlocking the Keypad</p><p>You can unlock the keypad as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Unlock the keypad as follows:</p><p> If a code is required, press the keys to enter the unlock code.</p><p>The keypad is unlocked.</p><p> If no code is required, press , and press OK to confirm.</p><p>The keypad is unlocked and the screen displays .</p><p>Information</p><p> The and keys remain functional when the keypad is locked.</p><p> During keypad lock, the key is functional when the infusion is</p><p>stopped.</p><p> During keypad lock, the key is functional when an alarm occurs,</p><p>or at the end of infusion.</p><p> The keypad locked status is memorized when the pump is powered</p><p>off.</p><p> In case of forgotten unlock code, contact your biomedical</p><p>department.</p><p>Unlock code enabled Unlock code disabled</p><p>67</p><p>8.5 Battery Life</p><p>Symbol</p><p>Procedure Viewing the battery life</p><p>You can view the battery life as follows:</p><p>1. Press .</p><p>2. Use the arrow keys to select .</p><p>The time remaining under current flow rate conditions is displayed.</p><p>The bar graph shows a visual representation of battery life.</p><p>The symbol displayed shows the following:</p><p> : The pump is plugged into the AC power supply.</p><p> : The pump is operating on battery.</p><p>68</p><p>8.6 Volume Infused / Dose Infused</p><p>Symbol</p><p>Procedure Viewing and clearing the volume or dose infused</p><p>You can view and clear the volume or dose infused as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>The total volume, or total dose, infused includes the programmed</p><p>infusion, loading doses and boluses. The length of time over which</p><p>they were infused is also displayed.</p><p>3. To clear the volume or dose infused, press enter.</p><p>4. Press OK to confirm.</p><p>Information</p><p>When the pump is powered off or a new drug is selected, the volume or</p><p>dose infused is cleared.</p><p>mL?</p><p>Flow rate Dose</p><p>mL?</p><p>69</p><p>8.7 Pause</p><p>Symbol</p><p>Procedure Programming a pause</p><p>You can program a pause as follows:</p><p>1. Press to stop the infusion.</p><p>2. Press .</p><p>3. Press the arrow keys to select .</p><p>4. Press enter.</p><p>5. Press the arrow keys to program the pause duration in hours and</p><p>minutes, and press OK.</p><p>6. Press the button to activate the "Start infusion at pause end"</p><p>feature. (optional)</p><p>7. Press OK to begin the programmed pause.</p><p>8. To restart the infusion before the end of the pause period, press</p><p>then start.</p><p>Information</p><p>If you do not activate the "Start infusion at pause end" option, an audible</p><p>alarm is generated at the end of the pause. The infusion must be started</p><p>manually to continue the infusion.</p><p>70</p><p>8.8 Programmed Bolus</p><p>8.9 Patient</p><p>Symbol</p><p>Procedure Programming a bolus</p><p>To program a bolus, see section 7.9.3.2, page 52.</p><p>Symbol</p><p>Procedure Changing a patient’s weight or body surface area</p><p>Information</p><p> If the selected dose rate unit is weight-based (kg), the screen</p><p>displays the patient’s weight.</p><p> If the selected dose rate unit is body surface area-based (m²), the</p><p>screen displays the patient’s body surface area.</p><p>You can change the patient’s weight or body surface area as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press OK to change the patient’s weight or body surface area.</p><p>5. Press OK to confirm the infusion settings.</p><p>Weight Body Surface Area</p><p>71</p><p>8.10Day/Night Mode</p><p>Symbol</p><p>Procedure Switching between day mode and night mode</p><p>This function switches between day mode and night mode .</p><p>The default night mode settings are as follows:</p><p> The key-press beep is silenced.</p><p> Infusion indicators and screen brightness are dimmed.</p><p>Depending on your pump configuration, the switch between day and</p><p>night mode may be managed either through this menu (manual mode),</p><p>or according to pre-defined settings (auto mode). For more information,</p><p>refer to the technical manual.</p><p>Switching from Day Mode to Night Mode</p><p>You can switch to night mode as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press to activate night mode.</p><p>The screen displays .</p><p>5. Press OK to confirm.</p><p>72</p><p>Switching from Night Mode to Day Mode</p><p>You can switch to day mode as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press to activate day mode.</p><p>The screen displays .</p><p>5. Press OK to confirm.</p><p>73</p><p>8.11Volume/Time & Dose/Time</p><p>8.12Volume Limit</p><p>Symbols</p><p>Procedure Programming a Volume/Time or Dose/Time infusion</p><p>1. Press .</p><p>2. Press the arrow keys to select (or ).</p><p>3. Press enter.</p><p>For more information on how to program a Volume/Time or Dose/Time</p><p>infusion, see section 7.11.2, page 55.</p><p>Symbol</p><p>Procedure Programming a Volume Limit infusion</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>For more information on how to program a Volume Limit infusion, see</p><p>section 7.11.3, page 56.</p><p>V/T</p><p>D/T</p><p>Volume/Time Dose/Time</p><p>V/T D/T</p><p>VL</p><p>Flow rate Dose</p><p>VL</p><p>74</p><p>8.13Alarm Volume</p><p>Symbol</p><p>Procedure Adjusting the alarm volume</p><p>You can adjust the alarm volume as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press the arrow keys to select the alarm volume.</p><p>The pump emits an alarm at the selected volume level.</p><p>5. Press OK.</p><p>75</p><p>8.14Volume-Dose History</p><p>Symbol</p><p>Procedure Viewing the infusion history</p><p>This function allows the user to view the infusion history on the pump.</p><p>You can view the infusion history as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press the arrow keys to select the desired infusion.</p><p>The selected infusion’s details are displayed:</p><p>- Drug name</p><p>- Drug concentration</p><p>- Volume or dose infused</p><p>- Infusion total duration</p><p>- Infusion date & time</p><p>5. Press exit to return to the menu.</p><p>76</p><p>8.15View Flow Rate History</p><p>Symbol</p><p>Procedure Viewing flow rate history</p><p>This function allows the user to check the current infusion’s history</p><p>information in order to verify the dose administered.</p><p>You can view flow rate history as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>The following information is displayed:</p><p>- An event marker (cursor)</p><p>- The event details (time and flow rate)</p><p>- The measured flow rate (solid line)</p><p>4. Press the and buttons to browse the events.</p><p>5. Press to view information about the selected event.</p><p>Information</p><p> The history is not refreshed while the history screen is displayed. To</p><p>refresh the history data, exit and select the history again.</p><p> Flow rate history is not stored after powering off.</p><p>77</p><p>8.16View Pressure History</p><p>Symbol</p><p>Procedure Viewing pressure history</p><p>This function allows the user to check the current infusion’s history</p><p>information in order to verify changes in pressure.</p><p>You can view pressure history as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>The following information is displayed:</p><p>- An event marker (cursor)</p><p>- The event details (time and pressure limit)</p><p>- The pressure limit (dotted line)</p><p>- The measured pressure (solid line)</p><p>4. Press the and buttons to browse the events.</p><p>5. Press</p><p>to view information about the selected event.</p><p>Information</p><p> The history is not refreshed while the history screen is displayed. To</p><p>refresh the history data, exit and select the history again.</p><p> Pressure history is not stored after powering off.</p><p>78</p><p>8.17Syringe</p><p>Symbol</p><p>Procedure Displaying on-pump syringe information</p><p>You can display on-pump syringe information as follows:</p><p>1. Press .</p><p>2. Use the arrow keys to select .</p><p>3. Press enter.</p><p>The following information is displayed:</p><p>- Syringe capacity</p><p>- Syringe brand / name</p><p>79</p><p>8.18View Event Log</p><p>Symbol</p><p>Procedure Viewing the event log</p><p>The event log displays details of the last events that occurred on the</p><p>pump. Events are stored in the log even after the pump is powered off</p><p>and on again. The log can store up to 1500 events. Older events are</p><p>overwritten.</p><p>Note: When the AC Power is disconnected for a period of time, or when</p><p>the batteries are not operating, the log file is kept in a non-volatile</p><p>memory for approximately 10 years.</p><p>You can view the event log as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press the arrow keys to select the desired event.</p><p>5. Press enter.</p><p>The details of the event are displayed.</p><p>6. Press exit to return to the previous screen.</p><p>80</p><p>8.19Date / Time</p><p>Symbol</p><p>Procedure Setting the date and time</p><p>You can set the date and time as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press the arrow keys to set the following:</p><p> Day</p><p> Month</p><p> Year</p><p> Hours</p><p> Minutes</p><p>5. Press OK to confirm.</p><p>81</p><p>8.20Maintenance</p><p>Symbol</p><p>Procedure Displaying maintenance information</p><p>You can display maintenance information as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the maintenance information.</p><p>The following information is displayed:</p><p> Pump serial number</p><p> Next maintenance date (dd/mm/yyyy)</p><p> Pump model</p><p> Software version</p><p> Total operating time since last maintenance</p><p>82</p><p>8.21Library Information</p><p>Symbol</p><p>Procedure Displaying drug library information</p><p>You can display drug library information as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>The number of drugs contained in the drug library is displayed.</p><p>3. Press enter.</p><p>All the drugs contained in the drug library are displayed.</p><p>4. Press the arrow keys to select a drug.</p><p>5. Press to view information on the selected drug.</p><p>83</p><p>8.22Clinical Information</p><p>Symbol</p><p>Procedure Viewing remaining time before clinical information display</p><p>If configured for the selected drug with Agilia Vigilant Drug’Lib, a</p><p>protocol message will be displayed on the pump screen after a pre-</p><p>defined period of time.</p><p>You can view the remaining time before clinical information display as</p><p>follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>The remaining time before clinical information is displayed.</p><p>3. Press enter.</p><p>The clinical information message is displayed.</p><p>84</p><p>8.23Data Set</p><p>Symbol</p><p>Procedure Displaying active data set information</p><p>You can display active data set information as follows:</p><p>1. Press .</p><p>2. Press the arrow keys to select .</p><p>3. Press enter.</p><p>The active data set information is displayed.</p><p>DS</p><p>DS</p><p>85</p><p>9 Options</p><p>9.1 Commands</p><p>9.2 Option Descriptions</p><p>Operation Key</p><p>Options access +</p><p>Option selection</p><p>Confirm (corresponds to enter on the screen)</p><p>Select  / Deselect </p><p>Selected current values are stored when the device is powered off after programming.</p><p>To return to the normal menus, power off then power on again.</p><p>Four different option groups are available on the pump. This IFU only</p><p>describes the "Pump Settings" options.</p><p>Option Access Code? Description Location</p><p>Pump Settings No Section 9.3, page 86.</p><p>Basic Profile Configuration Yes Technical Manual</p><p>Profile Yes Technical Manual</p><p>Maintenance Yes Technical Manual</p><p>Information</p><p>If the wrong access code is entered, error is displayed.</p><p>86</p><p>9.3 Pump Settings</p><p>The following options have different functions that you can select or</p><p>deselect to customize your Agilia SP MC.</p><p>Function Choice Default</p><p>Pump Setting</p><p>[User 2]:</p><p>Menu items</p><p> Maintenance: display or hide maintenance Disabled</p><p> Date / Time: display or hide date/time menu Disabled</p><p>[User 3]:</p><p>Contrast</p><p> Adjustment of screen contrast using the fast</p><p>increment and decrement keys Medium level</p><p>[User 7]:</p><p>Date/Time</p><p> Date selection: dd/mm/yyyy Production plant date</p><p>and time Time selection: __ h __</p><p>[User 8]:</p><p>Language  A scrolling list with all available languages Official language of the</p><p>target country</p><p>[User 14]:</p><p>Wi-Fi module  Enable/Disable the Wi-Fi module Enabled</p><p>[Par 5]:</p><p>Syringe selection</p><p> Enable/Disable selected syringe confirmation</p><p>screen Enabled</p><p>[Par 6]:</p><p>Syringes</p><p> Checkbox list with the names of available</p><p>syringes, and other syringes sizes Section 13.1, page 98.</p><p>[Par 13]:</p><p>AC power</p><p>disconnection alert</p><p> Enable/Disable "AC power disconnection"</p><p>message and "Device operating on battery"</p><p>message at power on</p><p>Enabled</p><p>[Par 35]:</p><p>Dose display format</p><p> Enable/Disable display of the decimal "0" after</p><p>a dose value</p><p>Remove trailing 0 /</p><p>Remove trailing 0</p><p>during programming</p><p>[Par 37]:</p><p>Alarm system</p><p> Enable/Disable preventive silence for alarm</p><p>system Enabled</p><p>[Par 38]:</p><p>Keypad unlock code</p><p> Set or disable keypad unlock code (4-digit).</p><p>Disable value: 0000 0000 (Disabled)</p><p>87</p><p>10 Data Communication</p><p>10.1Overview</p><p>10.2Communication via Agilia Cables</p><p>10.2.1 Data Communication Cables</p><p>10.2.2 Using the Communication Port</p><p>Cable Communication Wi-Fi Communication</p><p>Connection of 1 pump to a PC for the following</p><p>purposes:</p><p> Data set upload (via Agilia Vigilant Drug’Lib</p><p>software)</p><p> Maintenance (via Agilia Partner software)</p><p>Communication between a hospital information</p><p>system server and a number of identified pumps</p><p>for the following purposes:</p><p> Data set upload</p><p> Pump history retrieval</p><p>Information</p><p> Ensure that all hospital information systems have been approved by</p><p>Fresenius Kabi. For more information, contact your technical</p><p>services representative.</p><p> Before connecting the pump to a hospital information system, ask</p><p>your IT or biomedical department to configure the device.</p><p>Information</p><p> Only use recommended Agilia cables.</p><p> All connections and disconnections must be performed by qualified</p><p>and appropriately trained staff.</p><p> All IT devices (including computers, hubs and switches) inside the</p><p>patient area (< 1.5 m) must comply with IEC/EN 60601-1 (leakage</p><p>current).</p><p> IT devices connected outside the patient area (> 1.5 m) must be at</p><p>least IEC/EN 60950 compliant.</p><p>1. Remove the protective cap from the</p><p>pump’s RS232 communication port.</p><p>2. Connect the cable to the RS232</p><p>communication port by turning the</p><p>cable wheel.</p><p>Information</p><p>Do not disconnect communication cables while data is being transferred.</p><p>88</p><p>10.3Communication via Wi-Fi</p><p>10.4Data Set Upload</p><p>The Wi-Fi option allows the pump to connect to a hospital information</p><p>system without cables. To know if your pump is equipped with a Wi-Fi</p><p>module, check for the presence of the Wi-Fi logo on the pump’s keypad.</p><p>See section 3.4.1, page 17.</p><p>To activate or deactivate the Wi-Fi module, see section 9.3, page 86.</p><p>For more information on the Wi-Fi module, refer to the technical manual.</p><p>Information</p><p>Wi-Fi pumps can be configured with Wi-Fi module enabled or disabled.</p><p>A new data set may be uploaded to the pump while it is infusing. The</p><p>new data set will be installed at the next pump start-up.</p><p>When a new data set has been uploaded since the last start-up of the</p><p>pump, the symbol is displayed on the screen.</p><p>1. Power on the pump.</p><p>2. Press OK to acknowledge.</p><p>The data set information is displayed.</p><p>3. Press OK to acknowledge this information, or C to return to the</p><p>previous screen.</p><p>The data set is installed in the pump.</p><p>Information</p><p>It is the hospital's responsibility to define a data set and upload it to the</p><p>Centerium Server for distribution to the device.</p><p>Wi-Fi pump Non Wi-Fi pump</p><p>89</p><p>11 User Test</p><p>The following protocol provides the user with a quick integrity</p><p>check</p><p>guide to ensure that the pump system is functional. Perform this user</p><p>test before each use of the pump.</p><p>1. Check the external appearance of the pump for the absence of</p><p>cracks or other visible damage.</p><p>2. Check for the absence of visible damage on the power cord inlet</p><p>and the power cord.</p><p>3. When used on a pole or a rail, check that the pump is securely</p><p>attached.</p><p>4. Connect the pump to the AC power supply, and check that the</p><p>power indicator lights up and a beep is emitted.</p><p>5. Power on the pump, and wait for the auto-test to complete. Check</p><p>the display and light indicators.</p><p>6. Press any key and listen for a key beep (if key beep is activated).</p><p>90</p><p>12 Alarms and Safety Features</p><p>12.1 Introduction</p><p>12.2Alarm Descriptions</p><p>Agilia SP MC has a continuous monitoring system that begins when the</p><p>pump is started.</p><p>When an alarm is triggered, a message is displayed on the pump</p><p>screen. We recommend that the user stand in front of the pump to read</p><p>the message before acknowledgment.</p><p>Warning</p><p>Audible alarm signals from medical devices may be masked by</p><p>environmental noise. Make sure to set the alarm volume high enough so</p><p>that you can hear the alarm signal above environmental noise.</p><p>There are several different levels of alarm priorities:</p><p> High-priority alarms</p><p> Medium-priority alarms</p><p> Low-priority alarms</p><p> Information signals</p><p>Alarm Priority</p><p>Required</p><p>Operator</p><p>Response</p><p>Description</p><p>High (!!!) Immediate</p><p>response</p><p> The infusion stops.</p><p> The infusion indicator lights flash red.</p><p> The pump emits audible alarm signals.</p><p> An alarm description is displayed on the pump screen.</p><p> The key silences the alarm for two minutes. End of</p><p>infusion is acknowledged.</p><p>Medium (!!) Prompt</p><p>response</p><p> The infusion continues.</p><p> The infusion indicator lights flash yellow.</p><p> The pump emits audible alarm signals.</p><p> Depending on the alarm, the key silences the</p><p>alarm for no time limit or for a defined duration. For</p><p>detailed description of each alarm, please refer to List of</p><p>Alarms, page 91.</p><p>Low (!) Awareness</p><p>Information Signals Awareness</p><p> The infusion continues.</p><p> An information message is displayed on the pump</p><p>screen.</p><p>91</p><p>12.3General Remarks</p><p>12.4List of Alarms</p><p>12.4.1 Syringe Alarms</p><p> When two alarms occur at the same time, the higher priority alarm is</p><p>displayed.</p><p> When two alarms with the same priority level are triggered at the</p><p>same time, the pump software assigns them a priority.</p><p> When the cause of a high-priority alarm has been fixed, the red</p><p>indicators switch off. However, the message remains displayed at</p><p>the top of the screen as a reminder of the cause of the alarm.</p><p> The device guarantees the triggering of high-level priority alarms in</p><p>every use condition.</p><p> A maximum of 1 mL may be infused due to a single fault condition.</p><p> For all alarms (except occlusion alarms), the amount of time</p><p>between the alarm condition and the alarm generation is less than</p><p>5 seconds.</p><p> If the AC power is disconnected and if the battery is discharged, the</p><p>alarms settings are not modified and are stored indefinitely.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>Syringe</p><p>installation !!! High (!!!) Yes</p><p>The syringe is not installed correctly (plunger</p><p>driver, syringe barrel clasp or flange</p><p>detection).</p><p> Check the syringe installation.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Plunger head</p><p>alarm !!! High (!!!) Yes</p><p>The plunger head is missing or incorrectly</p><p>inserted.</p><p> Check the syringe installation.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Disengagement</p><p>mechanism !!! High (!!!) Yes</p><p>Disengaged mechanism.</p><p> Check the syringe installation.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>92</p><p>12.4.2 Volume Limit Alarms</p><p>12.4.3 Volume/Time & Dose/Time Alarms</p><p>Remove completely</p><p>syringe ! Low (!) No</p><p>This message displays when the pump is</p><p>switched ON and OFF more than 5 times after</p><p>the syringe type and brand have been</p><p>confirmed.</p><p> Remove and reinstall the syringe.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>End of volume</p><p>limit !!! High (!!!) Yes</p><p>The volume limit is reached.</p><p>Note: The key acknowledges the</p><p>alarm.</p><p>Near end of volume</p><p>limit !! Medium (!!) No</p><p>The time remaining is less than the defined</p><p>time duration (adjustable between 1 and</p><p>30 minutes), and the remaining VTBI is less</p><p>than 10% of the syringe capacity.</p><p>Note: The key silences the alarm for no</p><p>time limit.</p><p>End of volume</p><p>limit ! Low (!) No</p><p>The volume limit is reached and the end of</p><p>infusion setting is set as "KVO" or</p><p>"continuous".</p><p>Note: The key silences the alarm for a</p><p>duration from 1 minute to 12 hours.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>End of</p><p>volume/time !!!</p><p>High (!!!) Yes</p><p>The VTBI is completed.</p><p>Note: The key silences the alarm for no</p><p>time limit.End of dose/time !!!</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>93</p><p>12.4.4 Infusion Alarms</p><p>Near end of</p><p>volume/time !!</p><p>Medium (!!) No</p><p>The time remaining is less than the defined</p><p>time duration (adjustable between 1 and</p><p>30 minutes), and the remaining VTBI has</p><p>dropped to less than 10 % of the syringe</p><p>capacity.</p><p>Note: The key silences the alarm for no</p><p>time limit.</p><p>Near end of</p><p>dose/time !!</p><p>End of volume/time !</p><p>Low (!) No</p><p>The VTBI is completed and the end of infusion</p><p>setting is set as "KVO" or "continuous".</p><p>Note: The key silences the alarm for a</p><p>duration from 1 minute to 12 hours.</p><p>End of dose/time !</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>End of infusion !!! High (!!!) Yes</p><p>The infusion is completed (simple rate).</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Near end of</p><p>infusion !! Medium (!!) No</p><p>The time remaining is less than the defined</p><p>time duration (adjustable between 1 and</p><p>30 minutes), and the remaining volume of fluid</p><p>in the syringe has dropped to less than 10 %</p><p>of the syringe capacity.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Check settings !! Medium (!!) No</p><p>An infusion value has been modified using the</p><p>keys, but has not been confirmed.</p><p> Check this value and press OK to confirm.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Waiting settings !! Medium (!!) No</p><p>A value must be entered.</p><p> Enter a value and press OK to confirm.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>94</p><p>12.4.5 Pressure Alarms</p><p>Waiting start !! Medium (!!) No</p><p>The infusion settings have been entered, but</p><p>the infusion has not been started with start</p><p>key.</p><p> Check the infusion settings.</p><p> Press start to start the infusion.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Upper soft max</p><p>Information</p><p>signal No The upper soft limit is exceeded, according to</p><p>the drug settings defined in the drug library.</p><p>Lower soft min</p><p>Information</p><p>signal No The lower soft limit is exceeded, according to</p><p>the drug settings defined in the drug library.</p><p>Reached hard limit</p><p>Information</p><p>signal No The upper or lower hard limit is reached.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>Occlusion alarm !!! High (!!!) Yes</p><p>The pressure in the infusion line has reached</p><p>the threshold level.</p><p> Check whether the infusion line is</p><p>occluded. If necessary, readjust the</p><p>pressure threshold. See Section 8.3,</p><p>page 62.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Occlusion</p><p>pre alarm !! Medium (!!) No</p><p>In-line pressure has reached the following</p><p>value:</p><p> 25 mmHg / 2.5 kPa / 0.5 PSI below the</p><p>programmed threshold (from 50 to</p><p>250 mmHg).</p><p> 50 mmHg / 5 kPa / 1 PSI below the</p><p>programmed threshold (over 250 mmHg).</p><p> Check the infusion line.</p><p> Set the correct pressure threshold.</p><p>Note: The key silences the alarm for no</p><p>time limit.</p><p>Pressure increase ! Low (!) No</p><p>The pressure is increasing in the infusion line.</p><p> Check for occlusions in the infusion line.</p><p>Note: The key acknowledges the alarm.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>95</p><p>12.4.6 Battery Alarms</p><p>12.4.7 Power Alarms</p><p>Drop in pressure ! Low (!) No</p><p>The pressure is decreasing in the infusion line.</p><p> Check the downstream Luer lock</p><p>connection and the integrity of the entire</p><p>line.</p><p>Note: The key silences the alarm for no</p><p>time limit.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>Battery alarm !!! High (!!!) Yes</p><p>The battery is discharged.</p><p> The pump will power OFF automatically</p><p>within 5 minutes.</p><p> Connect the pump to a power supply</p><p>immediately.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Very low battery !!! High (!!!) Yes</p><p>Very low battery.</p><p> Connect the pump to a power supply.</p><p> Allow time to charge.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Battery pre alarm !! Medium (!!) No</p><p>Low battery.</p><p> Connect the pump to a power supply.</p><p>Note: The key acknowledges the alarm.</p><p>Low (!) No</p><p>If the pump is not used during an extended</p><p>period, connect to a power supply and wait</p><p>until the battery is charged.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>AC power failure ! Low (!) No</p><p>The power supply is inconsistent.</p><p> Contact your technical support.</p><p>Note: The key acknowledges the alarm.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>96</p><p>12.4.8 Keypad Alarms</p><p>12.4.9 Technical Error Alarms</p><p>Power disconnection</p><p>Information</p><p>signal No</p><p>The pump is disconnected from the AC power.</p><p>A single beep is emitted.</p><p> Press to acknowledge or reconnect</p><p>to the AC power supply.</p><p> Check that the battery life is sufficient for</p><p>the expected infusion duration.</p><p> If the disconnection was unintentional,</p><p>check the power connection.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>Keypad lock status</p><p>Information</p><p>signal No</p><p>The keypad is locked.</p><p> Unlock the keypad.</p><p>Keypad locked</p><p>Information</p><p>signal No</p><p>The keypad is locked and the syringe barrel</p><p>clasp was opened and closed.</p><p> Unlock the keypad.</p><p>Unlock keypad to</p><p>continue</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>Erxx(yyyy) !!! High (!!!) Yes</p><p>Technical alarm.</p><p> Contact your qualified technician or your</p><p>Fresenius Kabi sales representative.</p><p>Note: The key silences the alarm for a</p><p>duration of 30 seconds.</p><p>High internal</p><p>temperature ! Low (!) No</p><p>Temperature increase.</p><p> Check device environment.</p><p>Note: The key silences the alarm for a</p><p>duration of 2 minutes.</p><p>Alarm reporting not</p><p>available on the</p><p>Link !</p><p>Low (!) No</p><p>The pump is mounted on a Link+ Agilia rack</p><p>that has not been upgraded.</p><p> Contact your qualified technician or your</p><p>Fresenius Kabi sales representative.</p><p>Note: The key acknowledges the alarm.</p><p>Message Priority Stops</p><p>Infusion? Problem / Resolution</p><p>97</p><p>12.5Audio-only Information Signals</p><p>In the case of a system malfunction, the alarm sounds and an error</p><p>message Erxx(yyyy) !!! is displayed.</p><p>1. Record the error message Erxx(yyyy) !!!.</p><p>2. Disconnect the pump from the power supply.</p><p>3. Switch the pump off by pressing the key.</p><p>Warning</p><p>If the alarms persist when the pump is powered on again, do not use the</p><p>device on a patient, and contact qualified biomedical engineering staff in</p><p>your healthcare facility, or your Fresenius Kabi sales representative.</p><p>Type Comment Stops</p><p>Infusion? Activation</p><p>Switch mode Beep until key is</p><p>released No Beep starts when action is not allowed</p><p>End of loading dose 3 beeps No At the end of the loading dose</p><p>End of programmed</p><p>bolus 3 beeps No At the end of a programmed bolus</p><p>Start infusion at the end</p><p>of pause 3 beeps N/A At the end of a pause, when the infusion</p><p>automatically starts</p><p>AC power connection 1 beep No When power is connected</p><p>Forbidden key 1 beep No Repeated until key is released</p><p>Key beep 1 beep No For each key pressed</p><p>Other non validation</p><p>beep 1 beep No For each key pressed</p><p>Direct bolus 1 beep No Repeated for each mL infused</p><p>Syringe prime 1 beep N/A Repeated every 5 seconds</p><p>End of pause 4 beeps N/A At the end of pause - repeated</p><p>98</p><p>13 Syringes</p><p>13.1Syringe List</p><p>13.2Preparing a Syringe</p><p>Information</p><p> The Agilia SP pump offers a maximum 100 syringes of different</p><p>types, brands and sizes. For a list of compatible syringes, and for</p><p>ordering information, refer to the System Components booklet.</p><p> The list of available syringes on your pump is accessible from the</p><p>pump options.</p><p> For general information on syringes (expiration date, storage,</p><p>sterility, and so on), refer to the syringe manufacturer’s instructions.</p><p>Warning</p><p> Fresenius Kabi cannot accept responsibility for any flow rate errors</p><p>that are due to changes to syringe specifications introduced by the</p><p>manufacturer.</p><p> Ensure syringe sizes and models are compatible with the syringe</p><p>pump, refer to the System Components booklet. Use of incompatible</p><p>syringes can cause injury to the patient and improper pump</p><p>operation resulting in inaccurate fluid delivery, insufficient occlusion</p><p>sensing, and other potential problems.</p><p>1. Prepare the fluid to be infused</p><p>according to your healthcare facility’s</p><p>protocol.</p><p>2. Select a syringe.</p><p>3. Check the syringe and access device</p><p>integrity.</p><p>4. Connect the extension set to the</p><p>syringe according to local practices.</p><p>5. If necessary, fill the syringe and check</p><p>that it is watertight.</p><p>6. Manually prime the extension set</p><p>according to your healthcare facility’s</p><p>protocol.</p><p>7. Confirm that there is no air in the syringe or in the extension set.</p><p>99</p><p>Information</p><p> The fluid in the syringe and the syringe must be within normal</p><p>operating temperature conditions: +18 °/+30 °C.</p><p> It is recommended to prime the set immediately before starting the</p><p>infusion.</p><p> Do not use in conjunction with positive pressure infusion devices that</p><p>could generate back pressure higher than 2000 hPa (1500 mmHg):</p><p>doing so will damage the administration set and the pump.</p><p> Some extension sets may have components such as a filter that</p><p>require special instructions.</p><p> Certain drugs may require specific extension sets.</p><p> Connect the infusion line in accordance with procedures in your</p><p>healthcare facility using good medical practices. It is recommended</p><p>to use a Luer lock system to reduce the risk of disconnection,</p><p>leakage, air-in-line, or contamination.</p><p> Manually prime the syringe and extension set to remove all air,</p><p>before connecting to the pump.</p><p>Precautions for the use of extension sets</p><p> Use extension sets which have the smallest internal volume or</p><p>“deadspace” to minimize residual volumes between the syringe and</p><p>the patient when administering medications or fluids at low infusion</p><p>rates (e.g., less than 5mL per hour, and especially flow rates less</p><p>than 0.5 mL per hour). This reduces the amount of time it takes for</p><p>fluid to reach the patient, maintains delivery accuracy, and reduces</p><p>occlusion detection times.</p><p>For example:</p><p>- Tubing internal diameter: Small bore or microbore tubing is</p><p>recommended when infusing at low rates</p><p>- Tubing length: Tubing length should be minimized, when</p><p>possible</p><p>- Filters: Internal volume (deadspace) of in-line filters should be</p><p>minimized</p><p>- Connection sites: The number of connection sites such as</p><p>stopcocks and Y-sites should be limited, and high risk or life-</p><p>sustaining solutions should be connected as close to the</p><p>intravenous access site as possible.</p><p> Avoid use of extension sets with ports containing high pressure</p><p>valves. High pressure valves require additional pressure (e.g., 50-</p><p>200 mmHg) to open and allow fluid flow. These high pressure valves</p><p>may cause a significant delay in therapy followed by a sudden bolus</p><p>once the valve is opened, particularly at low infusion rates (e.g., less</p><p>than 5 mL per hour, and especially flow rates less than 0.5 mL per</p><p>hour).</p><p>100</p><p>13.3Operations for Syringes</p><p>13.3.1 Removing a Syringe</p><p>13.3.2 Changing a Syringe</p><p>13.3.3 Syringe Replacement Interval</p><p>1. Press to stop the infusion.</p><p>2. Disconnect the patient.</p><p>3. Open the syringe barrel clasp.</p><p>4. Press to silence the audible signal for 2 minutes.</p><p>5. Push the disengagement lever down and remove the syringe</p><p>from</p><p>its cradle.</p><p>6. Disconnect the syringe from its extension set.</p><p>7. Disconnect the extension set from the access device in accordance</p><p>with healthcare facility protocol.</p><p>1. Remove the syringe,</p><p>See section 13.3.1, page 100.</p><p>2. Prepare a new syringe and follow the steps described in the</p><p>flowchart.</p><p>See section 6.1, page 36.</p><p>3. After the new syringe is installed, acknowledge the "same therapy"</p><p>screen (optional screen).</p><p>Warning</p><p>Electronically prime the syringe pump system after replacing a near-</p><p>empty syringe with a replacement syringe.</p><p>Information</p><p>Properly dispose of used syringes.</p><p>Replace the syringe according to your healthcare facility’s protocol or</p><p>CDC guidelines.</p><p>101</p><p>13.4Gravity Infusion in Parallel with a Pump</p><p>Figure 13.1: Gravity Infusion (in parallel with a pump)</p><p>You can infuse the contents of a fluid container via gravity, in parallel</p><p>with the pump.</p><p>Information</p><p> Fresenius Kabi recommends the use of a back check valve or</p><p>positive pressure infusion devices when an infusion on the pump is</p><p>connected to a gravity line. This will prevent the back-up of IV fluid or</p><p>medication into the gravity line.</p><p> If there is no back check valve on a gravity infusion line during a</p><p>multi-line infusion, it will be impossible to detect patient-side</p><p>occlusions. Such an occlusion could cause the pumped drug to back</p><p>up into the gravity line, and later be infused in an uncontrolled</p><p>manner when the occlusion is released.</p><p> Be careful about drugs interactions and incompatibilites during a</p><p>multi-line infusion. Fresenius Kabi recommends infusing the critical</p><p>drugs first.</p><p>10 20 30 40 50</p><p>60</p><p>m</p><p>l</p><p>102</p><p>14 Device Storage</p><p>14.1Precautions for Storage</p><p>14.2Storage and Transport Conditions</p><p>14.3Preparing the Device for Storage</p><p> Handle the device with care during storage.</p><p> Store the device in a cool, dry place. The storage area must be</p><p>clean and organized.</p><p> Clean and disinfect the device prior to storage.</p><p>Warning</p><p>If the device is not used for an extended period (longer than 2 months),</p><p>it is recommended that the battery be removed from the device and put</p><p>in storage by authorized personnel. If the battery cannot be removed, or</p><p>the device will be used in less than 2 months, charge the battery at least</p><p>once a month by connecting the device to the AC power supply for at</p><p>least 6 hours.</p><p>Observe the following conditions for storage and transport:</p><p> Temperature: -10 °C to +60 °C</p><p> Pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg</p><p>/ 15.37 PSI)</p><p> Relative humidity: 10 % to 90 % without condensation</p><p> Altitude: Up to 3000 m</p><p>Prepare the device for storage as follows:</p><p>1. Power the pump OFF and remove the disposable.</p><p>2. If necessary (long-term storage), disconnect the pump’s power cord</p><p>and all data communication cables.</p><p>3. Remove the pump from its mounting point.</p><p>4. Clean the pump.</p><p>5. Handle the pump with care, and store it in a compliant area.</p><p>For detailed instructions, refer to the related chapters in this document.</p><p>103</p><p>14.4Using the Device After Storage</p><p>The device can be used immediately after storage without any cooling</p><p>or warm up period.</p><p>If the battery has been removed for long-term storage, contact your</p><p>biomedical department in order to reinstall the battery prior to use.</p><p>We recommend charging the battery for at least 6 hours.</p><p>We recommend that the "User test" is performed when the device is</p><p>installed after storage, and before being used on a patient, see section</p><p>11, page 78.</p><p>104</p><p>15 Specifications</p><p>15.1Essential Features</p><p>15.2Flow Rate</p><p>* Direct bolus default value = Upper flow rate value for each syringe size.</p><p>** KVO defaut value = 1 mL/h.</p><p>Information</p><p>The range of settings and default values described in this section</p><p>correspond to the factory configuration. Range of settings and default</p><p>values may be adjusted in the pump options (Basic Profile) or in Agilia</p><p>Vigilant Drug’Lib software (custom profiles). Increment rules may be</p><p>modified by Agilia Vigilant Drug’Lib software (custom profiles).</p><p>The pump’s essential features are defined in standard operating</p><p>conditions:</p><p>Feature Refer to</p><p>Flow Rate Accuracy Section 15.9.1, page 107.</p><p>Section 18.9, page 120.</p><p>Time to Detect Occlusion Section 15.9.3, page 108.</p><p>Bolus Volume After Occlusion Release Section 15.9.4, page 108.</p><p>Management of High-priority Alarms Section 12, page 90.</p><p>Format</p><p>Syringe</p><p>Minimum</p><p>Increment50 mL</p><p>/</p><p>60 mL</p><p>30 mL 20 mL 10 mL 5 mL</p><p>Infusion Rate mL/h</p><p>0.1</p><p></p><p>1200</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>350</p><p>0.1</p><p></p><p>250</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.10 9.99)</p><p>(10.0 99.9)</p><p>(100 1200)</p><p>Direct Bolus* mL/h</p><p>50</p><p></p><p>1200</p><p>50</p><p></p><p>600</p><p>50</p><p></p><p>600</p><p>50</p><p></p><p>350</p><p>50</p><p></p><p>250</p><p>50</p><p>Priming mL/h 1200 600 600 350 250 N/A</p><p>Programmed Bolus mL/h</p><p>0.1</p><p></p><p>1200</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>350</p><p>0.1</p><p></p><p>250</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.10 9.99)</p><p>(10.0 99.9)</p><p>(100 1200)</p><p>KVO** mL/h</p><p>0.1</p><p></p><p>5</p><p>0.1</p><p></p><p>5</p><p>0.1</p><p></p><p>5</p><p>0.1</p><p></p><p>5</p><p>0.1</p><p></p><p>5</p><p>0.1</p><p>Loading Dose mL/h</p><p>0.1</p><p></p><p>1200</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>600</p><p>0.1</p><p></p><p>350</p><p>0.1</p><p></p><p>250</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.10 9.99)</p><p>(10.0 99.9)</p><p>(100 1200)</p><p>105</p><p>15.3Volume To Be Infused (VTBI)</p><p>Applicable for all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL, 5 mL)</p><p>15.4Dose To Be Infused (DTBI)</p><p>Applicable for all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL, 5 mL)</p><p>15.5 Infusion Time</p><p>Applicable for all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL, 5 mL)</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>Volume Limit mL 0.1 999 0.1 0.1</p><p>1</p><p>(0.1 99.9)</p><p>(100 999)</p><p>Volume/Time mL 0.1 99.9 0.1 0.1</p><p>Direct Bolus mL 0.1  50 N/A 0.1</p><p>Programmed Bolus mL 0.1 99.9 0.1 0.1</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>Dose Unit 0.01 9999 N/A</p><p>0.001</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.010 4.999)</p><p>(5.00 9.99)</p><p>(10.0 99.9)</p><p>(100 9999)</p><p>Programmed Bolus Unit 0.01 9999 N/A</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.01 9.99)</p><p>(10 99.9)</p><p>(100 9999)</p><p>Loading Dose Unit 0.01 9999 N/A</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.01 9.99)</p><p>(10.0 99.9)</p><p>(100 9999)</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>Infusion Rate __ h __</p><p>min __</p><p>00h00min01</p><p></p><p>96h00min00</p><p>N/A 00h00min01</p><p>Programmed Bolus __ h __</p><p>min __</p><p>00h00min01</p><p></p><p>24h00min00</p><p>00h02min00 00h00min01</p><p>Loading Dose __ h __</p><p>min __</p><p>00h00min01</p><p></p><p>24h00min00</p><p>00h02min00 00h00min01</p><p>KVO Silence Alarm</p><p>Duration __ h __ 00h01 12h00 00h01 00h01</p><p>Pause __ h __ 00h01 24h00 00h01 00h01</p><p>106</p><p>15.6Concentration</p><p>Applicable for all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL, 5 mL)</p><p>15.7Patient Data</p><p>15.8Pressure Management</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>Concentration Unit 0.01 70000 0.01</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.01 9.99)</p><p>(10.0 99.9)</p><p>(100 70000)</p><p>Volume of Diluent mL 1 2000 1 1</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>Patient Weight kg 0.25 350 70</p><p>0.01</p><p>0.1</p><p>1</p><p>(0.25 9.99)</p><p>(10.0 19.9)</p><p>(20 350)</p><p>Patient Body</p><p>Surface Area m² 0.05 4.5 2 0.01</p><p>Setting Description Setting Format Default Value</p><p>Mode Infusion pressure mode. 3 levels / Variable Variable</p><p>DPS Allows DPS option activation</p><p>on the pump pressure menu. Yes / No Yes</p><p>Unit Pressure unit selection. mmHg / kPa / PSI mmHg</p><p>Limit Stored</p><p>The last pressure limit</p><p>adjustment is automatically</p><p>stored in memory for the next</p><p>startup.</p><p>Enabled / Disabled Disabled</p><p>DPS Stored</p><p>The last DPS adjustment is</p><p>automatically stored in</p><p>memory for the next startup.</p><p>Enabled / Disabled Disabled</p><p>107</p><p>Note: 1 bar = 750 mmHg = 100 kPa = 14.5 PSI.</p><p>15.9Accuracy</p><p>15.9.1 Flow Rate Accuracy</p><p>15.9.2 Effects of Pressure Variations on Accuracy</p><p>Format Range of Settings Default</p><p>Value</p><p>Minimum</p><p>Increment</p><p>3</p><p>Le</p><p>ve</p><p>ls Low mmHg 50 300 100 50</p><p>Medium mmHg 150 700 250 50</p><p>High mmHg 250 900 500 50</p><p>Va</p><p>ria</p><p>bl</p><p>e Full Range mmHg 50 900 500 25</p><p>50</p><p>(50 250)</p><p>(250 900)</p><p>Maximum</p><p>Limit mmHg 500 900 900 50</p><p>D</p><p>PS</p><p>Raise</p><p>Threshold mmHg 50 400 100 50</p><p>Drop</p><p>Threshold mmHg 100 400 100 50</p><p>Warning</p><p>Accuracy (flow rate, time, volume infused, pressure) can be influenced</p><p>by syringe model, syringe configuration, extension set configuration,</p><p>fluid viscosity, and fluid temperature.</p><p>Note: All tests below are in accordance with the IEC 60601-2-24</p><p>standard and ANSI/AAMI ID26.</p><p>Values</p><p>are representative of syringes used during internal tests and are</p><p>provided as indicators only.</p><p>Accuracy</p><p>Flow Rate ± 3%</p><p>Back Pressure Accuracy</p><p>(From Mean Values)</p><p>+ 39.9 kPa</p><p>+ 13.33 kPa</p><p>- 13.33 kPa</p><p>~ - 3%</p><p>~ - 1.5%</p><p>~ + 1.5%</p><p>108</p><p>15.9.3 Occlusion Alarm Accuracy</p><p>* Test condition: Temperature: 20 °C, Extension set length: 150 cm</p><p>** Syringe: BD Precise</p><p>15.9.4 Volume Accuracy</p><p>* Test condition: Back pressure: 0 mmHg</p><p>** Syringe: BD Precise</p><p> A back flow pumping is provided to reduce the bolus volume at occlusion release.</p><p> During pump movement from 0 to 1 m above the patient, a bolus (-0.05 ≤ X ≤ 0.35 mL) may occur.</p><p>15.9.5 Pressure Accuracy</p><p>Accuracy</p><p>Occlusion Alarm Response</p><p>Time*</p><p>Syringe** Rate</p><p>Occlusion Alarm Threshold</p><p>50 mmHg 900 mmHg</p><p>50 mL</p><p>0.1 mL/h</p><p>1 mL/h</p><p>5 mL/h</p><p>< 5 hours</p><p>< 30 minutes</p><p>< 7 minutes</p><p>< 28 hours</p><p>< 3 hours</p><p>< 30 minutes</p><p>20 mL</p><p>0.1 mL/h</p><p>1 mL/h</p><p>5 mL/h</p><p>< 4 hours</p><p>< 20 minutes</p><p>< 5 minutes</p><p>< 14 hours</p><p>< 75 minutes</p><p>< 15 minutes</p><p>Warning</p><p>Accuracy may be reduced when the infusion flow rate is below 1 mL/h.</p><p>Accuracy</p><p>Direct Bolus* ≤ 10 mL: ± 0.2 mL</p><p>> 10 mL: ± 3%Programmed Bolus*</p><p>Bolus Volume at Occlusion</p><p>Release*</p><p>Syringe** Rate</p><p>Bolus Volume at Occlusion Release</p><p>50 mmHg 900 mmHg</p><p>50 mL 5 mL/h -0.05 ≤ X ≤ 0.35 mL -0.05 ≤ X ≤ 0.35 mL</p><p>Accuracy</p><p>Pressure < 500 mmHg: ± 75 mmHg</p><p>> 500 mmHg: ± 15 %</p><p>109</p><p>15.10Units and Conversion Rules</p><p>15.10.1Concentration Units</p><p>15.10.2Dose Units</p><p>Units Suffix</p><p>Concentration</p><p>Units</p><p>nanog, microg, mg, g</p><p>/mL, /--mL</p><p>mmol</p><p>mUnit, Unit</p><p>cal, kcal</p><p>mEq</p><p>Units</p><p>Dose Units</p><p>nanog/h,</p><p>nanog/kg/min, nanog/kg/h</p><p>microg/min, microg/h,</p><p>microg/kg/min, microg/kg/h</p><p>mg/min, mg/h, mg/24h,</p><p>mg/kg/min, mg/kg/h, mg/kg/24h,</p><p>mg/m²/h, mg/m²/24h</p><p>g/h, g/kg/min, g/kg/h, g/kg/24h</p><p>mmol/h, mmol/kg/h, mmol/kg/24h</p><p>mUnit/min, mUnit/kg/min, mUnit/kg/h</p><p>Unit/min, Unit/h, Unit/kg/min, Unit/kg/h</p><p>kcal/h, kcal/24h, kcal/kg/h</p><p>mEq/min, mEq/h, mEq/kg/min, mEq/kg/h</p><p>mL/kg/min, mL/kg/h, mL/kg/24h</p><p>110</p><p>15.10.3Conversion Rules</p><p>Conversion Rules</p><p>1 micro unit = 1000 nano unit</p><p>1 m unit = 1000 micro unit</p><p>1 k unit = 1000 unit</p><p>1 unit/h = 24 unit/24 h</p><p>1 unit/min = 60 unit/h</p><p>mL/h =</p><p>unit/kg/h (dose) × kg (weight) Conversion of a dose</p><p>including the unit/kg into</p><p>volume flow rate (mL/h)unit/mL (concentration)</p><p>mL/h =</p><p>unit/m2/h (dose) × m2 (body surface area) Conversion of a dose</p><p>including the unit/m2 into</p><p>volume flow rate (mL/h)unit/mL (concentration)</p><p>mL/h =</p><p>unit/h (dose) Expression of a</p><p>volumetric flow rateunit/mL (concentration)</p><p>mL =</p><p>unit/kg (dose) × kg (weight) Conversion of a dose</p><p>including the unit/kg into</p><p>volume (mL)unit/mL (concentration)</p><p>mL =</p><p>unit/m2 (dose) × m2 (body surface area) Conversion of a dose</p><p>including the unit/m2 into</p><p>volume (mL)unit/mL (concentration)</p><p>mL =</p><p>unit (dose) Expression of a volume</p><p>(mL)unit/mL (concentration)</p><p>111</p><p>16 Cleaning and Disinfecting</p><p>16.1When to Clean and Disinfect the Pump</p><p>16.2Recommended and Prohibited Agents</p><p>16.2.1 Recommended Agents</p><p>To avoid the risks of infection and microbial transmission, make sure to</p><p>adequately clean and disinfect the equipment.</p><p>Warning</p><p> The disinfecting procedure must be done immediately after cleaning.</p><p>Disinfecting the pump without prior cleaning is not effective.</p><p> The pump is not intended to be sterilized; sterilization may result in</p><p>damage to the pump.</p><p> In case of contamination by blood or bodily fluids when the pump is</p><p>in use, and if allowed by your local practices and healthcare facility</p><p>policies, immediately perform the quick cleaning described below.</p><p>Always follow your local protection rules.</p><p>Quick Cleaning Only</p><p>Note: This quick cleaning does not replace the need for a complete</p><p>cleaning.</p><p>1. Check that the keypad is locked in order to avoid unintended</p><p>modification of the infusion parameters. Do not move the pump.</p><p>2. Use ready-to-use wipes to wipe down all exposed surfaces of the</p><p>pump.</p><p>3. At the end of the infusion, perform the complete cleaning protocol,</p><p>see section 16.3.1, page 112.</p><p>Thoroughly clean and disinfect the pump in the following cases:</p><p> After each patient use</p><p> Before any maintenance</p><p> On a routine basis when the pump is not in use</p><p> Before storage</p><p>We recommend the following cleaning and disinfecting agents:</p><p>Recommended Agent</p><p>Cleaning Didecyldimethylammonium chloride</p><p>(example: Wip’Anios Excel by Anios)</p><p>Disinfecting Didecyldimethylammonium chloride</p><p>(example: Wip’Anios Excel by Anios)</p><p>112</p><p>16.2.2 Prohibited Agents</p><p>16.3 Instructions for Cleaning and Disinfecting</p><p>16.3.1 Cleaning Instructions</p><p>The following cleaning and disinfecting agents are prohibited:</p><p> Trichloroethylene</p><p> Abrasive detergents</p><p> Undiluted alcohol</p><p>These aggressive agents may damage the plastic parts of the pump and</p><p>cause it to malfunction.</p><p>Follow the instructions provided to ensure effective cleaning and</p><p>disinfecting of the equipment.</p><p> Use the agents according to the manufacturer's instructions. This</p><p>may include wearing personal protective equipment (gloves, lab</p><p>coat, glasses, and so on), or diluting the agent according to the</p><p>manufacturer's guidelines.</p><p> For disinfectants, respect the contact time required for the</p><p>antimicrobial agents to act (the time the agent must be left on the</p><p>pump for disinfection to be effective).</p><p>The following warning is provided to protect staff against electric shock,</p><p>and to protect the pump from damage that can cause it to malfunction.</p><p>Warning</p><p> Only trained staff can clean and disinfect the pump.</p><p> Do not place the pump in an autoclave or immerse it in liquid.</p><p> Do not spray liquids directly on connectors. Instead, use a cleaning</p><p>cloth or disposable wipes.</p><p>Prerequisites</p><p> The pump is powered off.</p><p> The power cord and all other cables are unplugged.</p><p> The air is at room temperature (20 to 25 °C).</p><p> The operator is wearing suitable protective equipment.</p><p>113</p><p>16.3.2 Disinfecting Instructions</p><p>Protocol</p><p>1. Place the pump on a clean surface or disposable underlay.</p><p>2. Use a ready-to-use wipe to remove any major grime.</p><p>3. Thoroughly wipe down all exposed surfaces (housing, keyboard,</p><p>syringe barrel area, syringe guard, plunger driver, disengagement</p><p>lever, syringe barrel clasp, etc.) of the pump, from top to bottom. You</p><p>can use the silver handle to lift and move the pump.</p><p> When wiping down the sides, avoid wetting the connector sockets.</p><p> Do not allow liquids to run, leak, or drip into the pump housing.</p><p>4. Make sure the pump remains damp for at least 1 minute.</p><p>5. Set down the pump, and wipe down the silver handle, the</p><p>attachment lock knob, the screw clamp and the release button.</p><p>6. Use a fresh ready-to-use wipe to gently wipe down the back side of</p><p>the syringe barrel clasp and all exposed surfaces in the syringe</p><p>barrel area.</p><p>7. Make sure the pump remains damp for at least 1 minute to dissolve</p><p>all organic matter.</p><p>8. Use a swab to gently scrub the exposed surfaces of the pump. Be</p><p>sure to scrub along the seams and edges of the control panel, and</p><p>the narrow or hard-to-reach areas.</p><p>9. Wipe down the power cord and any pump accessories.</p><p>10. Allow the pump to dry completely at room temperature.</p><p>Prerequisites</p><p> The cleaning protocol has been performed.</p><p> The pump is powered off.</p><p> The power cord and all other cables are unplugged.</p><p> The air is at room temperature (20 to 25 °C).</p><p> The operator is wearing suitable protective equipment.</p><p>Protocol</p><p>1. Place the previously cleaned pump on a clean surface or disposable</p><p>underlay.</p><p>2. Use a ready-to-use wipe to wipe down all exposed surfaces of the</p><p>pump, making sure to cover all cracks, crevices, and hard-to-reach</p><p>areas. You can use the silver handle to lift and move the pump.</p><p> When wiping down the sides, avoid wetting the connector sockets.</p><p> Do not allow liquids to run, leak, or drip into the pump housing.</p><p>114</p><p>3. Set down the pump, and wipe down the silver handle, the</p><p>attachment lock knob, the screw clamp and the release button.</p><p>4. Use a fresh ready-to-use wipe to gently wipe down the back side of</p><p>the syringe barrel clasp and all exposed surfaces in the syringe</p><p>barrel area.</p><p>5.</p><p>Using a fresh ready-to-use wipe, repeat steps 2 to 4.</p><p>6. Leave the disinfecting agent on the pump for at least 3 minutes.</p><p>7. Wipe down the power cord and any pump accessories.</p><p>8. Allow the pump to dry completely at room temperature.</p><p>115</p><p>17 Power Management</p><p>17.1AC Power Supply Precautions</p><p>17.2Battery Precautions</p><p>Check that the AC power supply voltage corresponds to the value</p><p>indicated on the label on the bottom of the device. Do not exceed the</p><p>permitted voltage.</p><p>The power outlet must remain accessible at all times to allow emergency</p><p>power supply disconnection.</p><p>Warning</p><p> The pump and its accessories can only be connected to the AC</p><p>power supply with the power cord supplied by Fresenius Kabi, or</p><p>with a power supply accessory from the Agilia product range.</p><p> Do not use an extension cord when connecting the pump to the AC</p><p>power supply.</p><p> Pumps must be plugged into a medical grade power strip if one is</p><p>used.</p><p>The device uses a Lithium-ion rechargeable battery.</p><p>The following actions may cause leakage, overheating, smoke,</p><p>explosion or fire; which could result in deterioration of performance,</p><p>failure, damage to the equipment or injury to the user:</p><p> Incorrect handling of a Lithium-ion battery.</p><p> Replacement of the battery by inadequately trained personnel.</p><p>116</p><p>17.3Battery Operating Mode</p><p>Information</p><p> Do not replace with a battery other than the one provided by</p><p>Fresenius Kabi.</p><p> Do not use the pump without the battery connected.</p><p> Do not disconnect the battery when the device is operating on AC or</p><p>battery power. Disconnect the power cord and power off the device</p><p>before disconnecting the battery.</p><p> Do not incinerate or place near a flame.</p><p> Do not drop, crush, puncture, modify or disassemble the battery.</p><p> Do not use a battery that is severely scratched or damaged.</p><p> Do not short the terminals.</p><p> Do not expose to high temperatures or very low temperatures: refer</p><p>to the operating conditions for use, and the storage instructions.</p><p> Do not try to charge or discharge the battery outside of the device.</p><p> For more information on replacing the battery, refer to the technical</p><p>manual.</p><p>The device is provided with an internal battery that automatically</p><p>provides power to the device in case of power failure or disconnection</p><p>from the AC power supply. The battery charges when the pump is</p><p>connected to AC power supply.</p><p>Before starting for the first time, charge the battery for approximately</p><p>6 hours by plugging in the power supply cord with the pump powered off.</p><p>Information</p><p>During operation, leave the device connected to the power supply in</p><p>order to maintain the battery's charge and maximum capacity, and to</p><p>maximize battery lifetime and performance.</p><p>117</p><p>18 Technical Characteristics</p><p>18.1Power Supply</p><p>18.2Battery</p><p> = Wi-Fi enabled</p><p> = Wi-Fi disabled or not used</p><p>18.3Power Consumption</p><p>It is mandatory to use an Agilia power cord compliant with the IEC 60227</p><p>standard.</p><p>The power cord conductor must have a cross section of at least</p><p>0.75 mm2.</p><p>AC Power</p><p>Power supply 100 V - 240 V ~ / 50 / 60 Hz with functional</p><p>earth</p><p>Maximum consumption 10-15 VA</p><p>Protective fuse 1 X T1.6AH 250V accessible in the battery</p><p>compartment</p><p>Disconnect the battery before opening the device. Avoid short circuits</p><p>and extreme temperatures.</p><p>If the device is not used for more than 3 months, the date is erased (all</p><p>other settings are stored permanently). When you power on the pump,</p><p>you must set the date again.</p><p>Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery</p><p>Weight Approximately 100 g</p><p>Battery Life</p><p>Flow Rate Wi-Fi Battery Life</p><p>5 mL/h</p><p>5 mL/h</p><p></p><p></p><p>> 6 h</p><p>> 11 h</p><p>Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h</p><p>The pump typically consumes about 3.5 W in standard operating</p><p>conditions.</p><p>118</p><p>18.4Communication Port</p><p>18.5 Infrared Communication</p><p>18.6Sound Levels</p><p>18.6.1 Operating Pump Sound Levels (without alarms)</p><p>Note: These values are provided for information purposes only.</p><p>The connector located at the back of the device allows data</p><p>communication with a PC.</p><p>Serial Cable TTL output</p><p>Power Input 10 V / 15 W to power supply the product</p><p>Power Output 5 VDC / 150 mA to power Agilia USB cable</p><p>The pump is equipped with an infrared cell located at the back of the</p><p>device.</p><p>Mode Wireless optical communication using infrared light</p><p>Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no</p><p>carrier</p><p>Transport Protocol Proprietary</p><p>Speed 115.2 kb/s max</p><p>Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth</p><p>Eye Safety Class 0 of IEC 62471</p><p>Flow Rate (mL/h) Sound Level (dBA)</p><p>0 21</p><p>1 23</p><p>20 27</p><p>100 30</p><p>400 49</p><p>1200 32</p><p>119</p><p>18.6.2 Alarms Sound Levels</p><p>18.7Compliance</p><p>* After a defibrillation, the pump recovery time is around 2 seconds.</p><p>** The functional earth is directly connected to the power supply cord. It reduces residual current that</p><p>may disturb ECG or EEG devices.</p><p>18.8Dimensions and Weight</p><p>Alarm Priority</p><p>Sound Level (dBA)</p><p>min Max</p><p>High-priority 55 63</p><p>Medium-priority 50 57</p><p>Low-priority 45 52</p><p>ElectroMedical</p><p>Equipment Safety</p><p>Compliant with the following</p><p>standards:</p><p> IEC 60601-1</p><p> IEC 60601-1-8</p><p>IP22</p><p>Index of protection against</p><p>ingress of water or particulate</p><p>matter</p><p>EMC</p><p>(ElectroMagnetic</p><p>Compatibility)</p><p>Compliant with the following</p><p>standard:</p><p> IEC 60601-1-2</p><p>Protection against leakage</p><p>current: Defibrillation-proof</p><p>type CF applied part*</p><p>Particular</p><p>Standards</p><p> IEC 60601-2-24</p><p> ANSI/AAMI ID26</p><p>Protection against electric</p><p>shocks: class II</p><p>Functional earth**</p><p>H / W / D 135 x 345 x 170 mm</p><p>Weight Approximately 2.1 kg</p><p>Screen Size 70 x 35 mm</p><p>120</p><p>18.9Trumpet and Start-up Curves</p><p>18.9.1 Flow rate: 1 mL/h</p><p>Figure 18.1: Start-up and instantaneous flow rate</p><p>(1 mL/h over first 2 hours on 96 hours)</p><p>The trumpet curve shows the variation of the mean flow rate accuracy</p><p>over specific observation periods. The variations are presented only as</p><p>maximum and minimum deviations from the overall mean flow within the</p><p>observation window.</p><p>Trumpet curves are presented below for a number of representative flow</p><p>rates.</p><p>The test protocol used to obtain these results is described in ANSI/AAMI</p><p>ID26.</p><p>The curves can be helpful in determining the suitability of infusion</p><p>parameters for specific drugs and concentrations.</p><p>Syringe used: BD Precise 50 mL</p><p>Fluid used: distilled water</p><p>Recommendations to improve performances and safety when the pump</p><p>is commonly used at low flow rates (≤ 20 mL/h):</p><p> Limit the range of available flow rates in accordance with the</p><p>maximum flow rate to be used.</p><p> Lower the pressure limit in order to gain in time to detect occlusion.</p><p>Legend</p><p>Instantaneous</p><p>flow rate</p><p>Set flow rate</p><p>Sampling time: 10 s</p><p>Fl</p><p>ow</p><p>ra</p><p>te</p><p>(m</p><p>L/</p><p>h)</p><p>Time (minutes)</p><p>0</p><p>1</p><p>2</p><p>0 10 20 30 40 50 60 70 80 90 100 110 120</p><p>121</p><p>Figure 18.2: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows</p><p>(1 mL/h over first 2 hours on 96 hours)</p><p>18.9.2 Flow rate: 5 mL/h</p><p>Figure 18.3: Start-up and instantaneous flow rate</p><p>(5 mL/h over first 2 hours on 96 hours)</p><p>Figure 18.4: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows</p><p>(5 mL/h over first 2 hours on 96 hours)</p><p>Legend</p><p>Measured</p><p>variance from</p><p>flow rate</p><p>Error</p><p>Flow rate</p><p>Sampling time: 10 s</p><p>Legend</p><p>Instantaneous</p><p>flow rate</p><p>Set flow rate</p><p>Sampling time: 10 s</p><p>Legend</p><p>Measured</p><p>variance from</p><p>flow rate</p><p>Error</p><p>Flow rate</p><p>Sampling time: 10 s</p><p>Fl</p><p>ow</p><p>ra</p><p>te</p><p>(m</p><p>L/</p><p>h)</p><p>Time (minutes)</p><p>6,0</p><p>3,9</p><p>1,0 1,1</p><p>-8,6</p><p>-6,5</p><p>-4,4</p><p>-1,9 -1,6</p><p>-10</p><p>-5</p><p>0</p><p>5</p><p>10</p><p>0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30</p><p>Fl</p><p>ow</p><p>ra</p><p>te</p><p>(m</p><p>L/</p><p>h)</p><p>Time (minutes)</p><p>0</p><p>1</p><p>2</p><p>3</p><p>4</p><p>5</p><p>6</p><p>7</p><p>8</p><p>9</p><p>10</p><p>0 10 20 30 40 50 60 70 80 90 100 110 120</p><p>Fl</p><p>ow</p><p>ra</p><p>te</p><p>(m</p><p>L/</p><p>h)</p><p>Time (minutes)</p><p>1,7</p><p>1,0 0,7 0,4 0,2</p><p>-1,9 -1,0 -0,7 -0,5 -0,3</p><p>-10</p><p>-5</p><p>0</p><p>5</p><p>10</p><p>0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30</p><p>122</p><p>19 Wi-Fi</p><p>19.1General Information</p><p>The Agilia Connect Infusion System includes an IEEE 802.11 radio-</p><p>frequency transmitter incorporated in the Agilia Wi-Fi pumps. It operates</p><p>using the following standards and frequencies:</p><p> IEEE 802.11a: 5 GHz Frequency</p><p>Band</p><p> IEEE 802.11b: 2.4 GHz Frequency Band</p><p> IEEE 802.11g: 2.4 GHz Frequency Band</p><p> IEEE 802.11n: 2.4 and 5 GHz Frequency Band</p><p>Information</p><p>For more information on differentiation between Wi-Fi and non Wi-Fi</p><p>pumps, see section 10.3, page 104.</p><p>The Wi-Fi module incorporated in the Agilia Wi-Fi pumps is intended to</p><p>perform the following, via periodic communication cycles:</p><p> Transfer data sets (from Centerium server to pump)</p><p> Transfer pump history (from pump to a server)</p><p> Communicate general information on the operating status of the</p><p>pump</p><p>Agilia infusion pumps contain transmitter with the following IDs:</p><p> FCC ID: XF6-RSWC301</p><p> IC ID: 8407A-RSWC301.</p><p>Agilia Wi-Fi pumps must be installed to provide a separation distance of</p><p>at least 8 in (20 cm) from all persons and must not be co-located or</p><p>operating in conjunction with any other antenna or transmitter.</p><p>Warning</p><p>Agilia Wi-Fi pumps must be configured by qualified and appropriately</p><p>trained staff.</p><p>Information</p><p>If communication with the wireless network is interrupted, the pump can</p><p>be used as intended. For more information, contact your</p><p>Fresenius Kabi sales representative</p><p>123</p><p>19.2Specifications</p><p>19.2.1 Technical Specifications</p><p>19.2.2 Electromagnetic Compatibility</p><p>19.2.2.1 USA - FCC Notice</p><p>19.2.2.2 Europe - RED</p><p>Description</p><p>Technology IEEE 802.11 a/b/g/n</p><p>Frequency Band  2.400  2.500 GHz (2.4 GHz is ISM band)</p><p> 4.900  5.850 GHz (High Band)</p><p>Modulation OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and</p><p>DSSS</p><p>Wireless Security WPA/WPA2-Entreprise, WPA/WPA2-PSK</p><p>Network Protocols TCP, IPv4, DHCP, HTTP</p><p>Typical Transmit</p><p>Power (± 2 dBm)</p><p> 17 dBm for 802.11b DSSS</p><p> 17 dBm for 802.11b CCK</p><p> 15 dBm for 802.11g/n OFDM</p><p> 12 dBm in 802.11a mode</p><p>For information on electromagnetic compatibilty, see section 23,</p><p>page 129.</p><p>The users manual or instruction manual for an intentional or</p><p>unintentional radiator shall caution the user that changes or</p><p>modifications not expressely approved by the party responsible for</p><p>compliance could void the user's authority to operate the equipment.</p><p>This product is designated as a radio device that utilizes harmonized</p><p>frequencies and power levels for Europe.</p><p>124</p><p>19.2.3 Protocols and Standards</p><p>This wireless functionality references and uses the following protocols</p><p>and standards:</p><p> IEEE 802.11a/b/g/n standard</p><p> WPA/WPA2-Entreprise, WPA/WPA2-PSK (Wi-Fi protected access)</p><p>is a long-term security solution for wireless networks. For more</p><p>information, refer to the IEEE 802.11.</p><p> TCP (Transmission Control Protocol / Internet Protocol), IPv4</p><p>(Internet Protocol Version 4), DHCP (Dynamic Host Configuration</p><p>Protocol) and HTTP (Hypertext Transfer Protocol) are standard data</p><p>transport protocol used for the internet and other similar networks.</p><p>Agilia infusion pumps do not require an active wireless communication</p><p>to function as intended (infuse). All wireless transactions are initiated by</p><p>the device and are periodic in nature. The absence of connection (for</p><p>example, out of range) does not affect the device ability to infuse. Data</p><p>that is pending is stored and re-transmitted when the connection</p><p>becomes available. Data integrity and quality of service are inherent in</p><p>the design. The system should be ensured and maintained by a qualified</p><p>and trained technical user, or a Fresenius Kabi representative.</p><p>125</p><p>20 Troubleshooting</p><p>Issue Recommended Actions</p><p>The pump is unstable when mounted.  Check that the rotating pole clamp is fastened.</p><p>The pump is damaged, or you notice</p><p>something abnormal (unusual noise,</p><p>abnormal heat or smoke).</p><p> Remove the power cord.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative immediately.</p><p>The pump has been dropped or was</p><p>subjected to a force that may have</p><p>produced internal damage.</p><p> Do not use the pump.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The pump cannot be installed or</p><p>removed from the Link Agilia.</p><p> Check the rotating pole clamp position.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The pump does not start after</p><p>pressing .</p><p> Connect the pump to the AC power supply to see if the</p><p>battery is fully discharged.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>Data communication cables cannot be</p><p>connected or removed from the pump.</p><p> Check the cable connector.</p><p> Check the pump connector.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>Flow rate variance is higher than flow</p><p>rate accuracy.</p><p> Check the infusion line configuration.</p><p> Check the fluid viscosity.</p><p> Check that the fluid temperature is within the</p><p>recommended range.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>Keypad problem (keys, LEDs).</p><p> Check the general condition of the keypad.</p><p> Check the contrast.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The power supply indicator does not</p><p>light up.</p><p> Connect the pump to the AC power supply.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The pump powers off on its own.</p><p> Connect the pump to the AC power supply.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The battery alarm is ON even though</p><p>the pump has been correctly charged.</p><p> Check the AC power voltage.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>The pump powers off when it is</p><p>disconnected from the AC power</p><p>supply.</p><p> The battery is completely discharged: charge the battery.</p><p> Contact your biomedical department or your</p><p>Fresenius Kabi sales representative.</p><p>Wi-Fi communication error.  Contact your IT or biomedical department, or your</p><p>Fresenius Kabi sales representative.</p><p>126</p><p>At start-up, the pump displays:</p><p>"Software is upgrading...".</p><p> Connect the pump to the AC power supply. Then, wait few</p><p>minutes without touching the keypad until the message</p><p>disappears and the pump starts as usual.</p><p> Contact your biomedical department, or your</p><p>Fresenius Kabi sales representative.</p><p>Issue Recommended Actions</p><p>127</p><p>21 Recycling</p><p>Before disposal, remove the battery from the device. Batteries and</p><p>devices with this label must not be disposed of with the general waste.</p><p>They must be collected separately and disposed of according to local</p><p>regulations.</p><p>Information</p><p> For more information on waste processing regulations, contact your</p><p>Fresenius Kabi sales representative or the local distributor.</p><p> For more information on dismantling the device, refer to the technical</p><p>manual.</p><p> Follow healthcare facility policy regarding proper disposal after use.</p><p>128</p><p>22 Warranty</p><p>22.1General Warranty Conditions</p><p>22.2Limited Warranty</p><p>22.3Warranty Conditions for Accessories</p><p>Fresenius Kabi guarantees that this product is free from defects in</p><p>material and workmanship during the period defined by the accepted</p><p>sales conditions, except for the batteries and the accessories.</p><p>To benefit from the materials and workmanship guarantee from our</p><p>Fresenius Kabi sales representative or authorized agent, make sure to</p><p>observe the following conditions:</p><p> The device must have been used according to the instructions</p><p>described in this document and in other accompanying documents.</p><p> The device must not have been damaged while being stored or</p><p>repaired, and must not show signs of improper handling.</p><p> The device must not have been altered or repaired by unqualified</p><p>personnel.</p><p> The internal battery of the device must not have been replaced by a</p><p>battery other than that specified by the manufacturer.</p><p> The serial number (SN) must not have been altered, changed or</p><p>erased.</p><p>Information</p><p> If one or more of these conditions have been violated,</p><p>Fresenius Kabi will prepare a repair estimate covering all required</p><p>parts and labor.</p><p> To repair or return a device, contact your Fresenius Kabi sales</p><p>representative.</p><p>Batteries and accessories may have</p><p>specific warranty conditions.</p><p>Contact your Fresenius Kabi sales representative for more information.</p><p>129</p><p>23 Guidance and Manufacturer's Declaration on</p><p>EMC</p><p>23.1Electromagnetic Compatibility</p><p>23.2Electrostatic Discharge (ESD)</p><p>Warning</p><p> The Agilia pump and its accessories are intended to be used in the</p><p>electromagnetic environments specified below.</p><p> The customer or the user of the Agilia pump should ensure that it is</p><p>used in such environments.</p><p> The Agilia pump must not be used in the presence of intense</p><p>electromagnetic fields, such as those generated by certain</p><p>electrically powered medical devices. Do not use the pump in MRI.</p><p> Prolonged exposure to X-ray environments can damage the</p><p>electronic components of the device and influence the flow rate</p><p>accuracy. For a safe usage, we recommend to:</p><p>- always put the device at the maximum distance from the patient</p><p>and the source</p><p>- limit the presence of the device in such environments.</p><p>When mounted on the Link+ Agilia, the pump is intended to be used in</p><p>the electromagnetic environment specified in the Link+ Agilia IFU.</p><p>Excluding the cases described in this manual, pump operation must be</p><p>systematically checked by a qualified operator, if the pump is installed in</p><p>the vicinity of other electrical devices.</p><p>Points (e.g. screws) and surfaces that are only accessible for</p><p>maintenance also require precautions. Points (e.g. battery contacts for</p><p>battery replacement) and surfaces that are accessible only by</p><p>maintenance staff also require precautions.</p><p>Information</p><p> Electronic components and semiconductors can be destroyed by</p><p>electrostatic discharge (ESD). In particular, components made with</p><p>metal oxide semiconductor (MOS) can be damaged from direct or</p><p>indirect discharges. Damage caused by ESD may not be</p><p>immediately identifiable, and malfunctions can even occur after a</p><p>longer period of operation.</p><p> Exceeding and / or repeating the test level attained in guidance &</p><p>manufacturer's declaration on EMC may permanently damage the</p><p>device and / or cause serious malfunctions (for example, loss of</p><p>communication and system failures).</p><p>130</p><p>23.3Electromagnetic Compatibility and Interference Guidance</p><p>The following environmental conditions related to electrostatic sensitive</p><p>components (ESD standards) must be observed:</p><p> Floors coated with wood, tiles or concrete</p><p> Relative humidity of at least 30%</p><p>If it is not possible to guarantee this environment, the following additional</p><p>precautions must be taken:</p><p> Use of anti-static equipment</p><p> Preliminary user discharge (explained below)</p><p> Anti-static clothing</p><p>The best precaution is preliminary user discharge on a grounded metal</p><p>object such as a rail, a pole or a metal part located at the rear of the</p><p>Agilia pump.</p><p>For maintenance operations performed on the Agilia pump, place the</p><p>device on a conductive working surface, and wear a special ESD</p><p>conductive wristband.</p><p>The Agilia pump has been tested in accordance with the</p><p>electromagnetic compatibility standards applicable to medical devices.</p><p>Its immunity is designed to ensure correct operation. Limitation of the</p><p>emitted radiation avoids undesirable interference with other equipment.</p><p>The Agilia pump is classified as a Class B device according to CISPR 11</p><p>emitted radiation. The user might be required to take mitigation</p><p>measures, such as relocating or reorienting the equipment.</p><p>131</p><p>Warning</p><p> Use of the Agilia pump adjacent to or stacked with other equipment</p><p>should be avoided because it could result in improper operation. If</p><p>such use is necessary, this equipment and the other equipment</p><p>should be observed to verify that they are operating normally.</p><p> Use of accessories, transducers and cables other than those</p><p>specified or provided by the manufacturer of the Agilia pump could</p><p>result in increased electromagnetic emissions or decreased</p><p>electromagnetic immunity of this equipment and result in improper</p><p>operation.</p><p> Portable RF communications equipment (including peripherals such</p><p>as antenna cables, internal and external antennas) should be used</p><p>no closer than 10 cm for cell phones and 30 cm for other equipments,</p><p>to any part of the Agilia pump, including cables specified by the</p><p>manufacturer. Otherwise, degradation of the essential performances</p><p>of Agilia pump could result.</p><p> Electrosurgical equipment (including base unit, cables, electrodes)</p><p>should be used no closer than 30 cm, to any part of the Agilia pump,</p><p>including cables specified by the manufacturer. Otherwise,</p><p>degradation of the essential performances of Agilia pump could</p><p>result.</p><p>The user might be required to take mitigation measures, such as</p><p>relocating or re-orienting the equipment.</p><p>If the Agilia pump is placed near RF communication equipment such as</p><p>cell phones, DECT phones or wireless access points, RFID reader &</p><p>tags,... It is essential to observe a minimum distance between the Agilia</p><p>pump and this equipment specified above. If the Agilia pump causes</p><p>harmful interference or if it is itself disrupted, the user is encouraged to</p><p>try to correct the interference by one of the following actions:</p><p>- Reorient or relocate the Agilia pump, the patient or disruptive</p><p>equipment.</p><p>- Change the routing of cables.</p><p>- Connect the Agilia pump power plug to a protected / backed-up /</p><p>filtered supply or directly to the UPS circuit (uninterruptible power</p><p>supply).</p><p>- Increase the separation between the Agilia pump and disruptive</p><p>equipment.</p><p>- Plug the Agilia pump into an outlet on a different circuit from the</p><p>one to which the patient or disruptive equipment is connected.</p><p>- In any case, whatever the context, the user should conduct</p><p>interoperability testing in a real situation to find the correct setup</p><p>and location.</p><p>132</p><p>23.4EMC and essential performances</p><p>23.4.1 Table 1 - Guidance and Manufacturer's Declaration -</p><p>Electromagnetic Emissions</p><p>23.4.2 Table 2 - Guidance and Manufacturer's Declaration -</p><p>Electromagnetic Immunity</p><p>In the case of electromagnetic disturbances, if the essential</p><p>performance, Section 15.1, page 125, is lost or degraded, the</p><p>consequences for the patient are as follows: overdose, underdose,</p><p>delay of therapy, air embolism, trauma, exsanguination.</p><p>Warning</p><p> The Agilia pump and its accessories are intended to be used in the</p><p>electromagnetic environments specified below.</p><p> The customer or the user of the Agilia pump should ensure that it is</p><p>used in such environments.</p><p>Emission Test</p><p>Compliance</p><p>Obtained by</p><p>the Device</p><p>Electromagnetic Environment - Guidance</p><p>RF emissions</p><p>CISPR 11 Group 1</p><p>The Agilia pump only uses RF energy for its internal</p><p>operation. Its RF emissions are therefore very low and are</p><p>not likely to cause any interference in nearby electronic</p><p>equipment.</p><p>RF emissions</p><p>CISPR 11 Class B</p><p>The Agilia pump is suitable for use in all establishments</p><p>other than domestic and those directly connected to the</p><p>public low-voltage power supply network that supplies</p><p>buildings used for domestic purposes.</p><p>Harmonic emissions</p><p>IEC61000-3-2 Class A</p><p>Voltage fluctuations</p><p>Flicker emissions</p><p>IEC 61000-3-3</p><p>Compliant</p><p>Conducted</p><p>emissions 150 kHz -</p><p>108 Mhz CISPR25</p><p>Class 5</p><p>The Agilia pump is suitable for use in automotive</p><p>environments.Radiated emissions</p><p>150 kHz - 2.5 Ghz</p><p>CISPR25</p><p>Class 3</p><p>Warning</p><p> The Agilia pump and its accessories are intended to be used in the</p><p>electromagnetic environments specified below.</p><p> The customer or the user of the Agilia pump should ensure that it is</p><p>used in such environments.</p><p>133</p><p>Note: "Ut" is the AC Power voltage prior to applying the test level.</p><p>Immunity Test</p><p>IEC 60601-1-2</p><p>- - - - - - - - - - - - - - Compliance</p><p>Level</p><p>Obtained by</p><p>the Device</p><p>Electromagnetic Environment -</p><p>Guidance</p><p>IEC 60601-2-24</p><p>and ANSI/AAMI</p><p>ID26</p><p>Test Level</p><p>Electrostatic</p><p>Discharge (ESD)</p><p>IEC 61000-4-2</p><p>± 6 kV contact</p><p>± 8 kV air</p><p>- - - - - - - - - - - - - -</p><p>± 8 kV contact</p><p>± 15 kV air</p><p>Floor coverings made from wood, tiles and</p><p>concrete, with relative humidity level at</p><p>least 30 %, make it possible to guarantee</p><p>the necessary level</p><p>of and acquisition from different detectors</p><p> Different lines of communication (synchronous and asynchronous serial links).</p><p>The CPU Board is connected to the Display Board with the J3 connector.</p><p>A ribbon cable connects it to the Power Supply Board with the J6 connector.</p><p>Legend</p><p>J1 Connector - Connection to Syringe Barrel</p><p>Clasp (potentiometer and flange switch)</p><p>J6 Connector - Connection to Power Supply Board</p><p>J2 Connector - Connection to Linear Displacement</p><p>Potentiometer</p><p>J7 Connector - Connection to Motor</p><p>J3 Connector - Connection to Display Board J8Connector - Connection to JTAG Connector</p><p>(micro programming)</p><p>J4 Connector - Connection to Wi-Fi Board if one is</p><p>present</p><p>J9 Connector - Connection to Plunger Driver</p><p>(force sensor and disengagement opto switch)</p><p>J5 Connector - Connection to Opto Motor</p><p>J7 J8J6</p><p>J3</p><p>J4</p><p>J1 J2</p><p>J5</p><p>J9</p><p>J1 J6</p><p>J2 J7</p><p>J3 J1J8</p><p>J4 J9</p><p>J5</p><p>17</p><p>J1 Connector to Syringe Barrel Clasp</p><p>J2 Connector to Displacement Linear Potentiometer</p><p>J3 Connector to Display Board</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 SW_OUT Flange switch state</p><p>3 SW_IN Flange switch power supply</p><p>4 DIA+ +3.3 V power supply</p><p>5 DIA_OUT Syringe barrel clasp potentiometer value</p><p>6 DIA- Ground</p><p>Pin n° Signal Description</p><p>1 DISP- Ground</p><p>2 DISP_OUT Displacement potentiometer status</p><p>3 DISP+ +3.3 V power supply</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 A Anode of the backlight (+5V)</p><p>3 K Cathode of the backlight (K_BACKL signal)</p><p>4 GND Ground</p><p>5 SCK SPI clock (HMI_SCK_SCL signal)</p><p>6 GND Ground</p><p>7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)</p><p>8 GND Ground</p><p>9 CD Control/data (0:control, 1:data) (LCD_CD signal)</p><p>10 GND Ground</p><p>11 /RST Reset (RESET/ signal)</p><p>12 GND Ground</p><p>13 CS0 Chip select (CSLCD/ signal)</p><p>14 GND Ground</p><p>15 BM0/DB13 Mode select (LCD_MS signal)</p><p>16 GND Ground</p><p>17 VLCD Charge pump voltage (ANA_VLCD signal)</p><p>18 GND Ground</p><p>19 +3V3 +3V3 power supply</p><p>20 GND Ground</p><p>21 GND Ground</p><p>22 GND Ground</p><p>18</p><p>J4 Connector to Wi-Fi Board (for Wi-Fi pumps only)</p><p>J5 Connector to Opto Motor</p><p>J6 Connector to Power Supply Board</p><p>Pin n° Signal Description</p><p>1 Floating Not used on Agilia VP range. Leave floating</p><p>2 Floating Not used on Agilia VP range. Leave floating</p><p>3 GND Ground</p><p>4 Floating Not used on Agilia VP range. Leave floating</p><p>5 Floating Not used on Agilia VP range. Leave floating</p><p>6 GND Ground</p><p>7 WIFI_VCC +3V3 Wi-Fi power supply</p><p>8 WIFI_VCC +3V3 Wi-Fi power supply</p><p>9 UART-RxD Receive data</p><p>10 UART-TxD Transmit data</p><p>11 UART-RTS Hardware flow control (request to send)</p><p>12 UART-CTS Hardware flow control (clear to send)</p><p>13 GND Ground</p><p>14 GND Ground</p><p>Pin n° Type Signal Description</p><p>1 Power GND Ground</p><p>2 Input OP_OPTO Analog output signal of the photomicrosensor (photo-transistor collector)</p><p>3 Power GND Ground (photo-transistor emitter)</p><p>4 Power GND Ground (photo-diode cathode)</p><p>5 Output OP_CD_OPTO Power supply signal of the photomicrosensor (photo-diode anode)</p><p>6 Power GND Ground</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 PRES_BOARD/ HMI board presence detection</p><p>3 +3V3 +3V3 power supply</p><p>4 +3V3 +3V3 power supply</p><p>5 ANA_VLCD LCD charge pump voltage</p><p>6 GND Ground</p><p>7 S_ANA_DOOR Door close detection</p><p>8 RESET/ Global reset</p><p>9 GND Ground</p><p>10 CS_LED-KBD/ LED or keypad selection</p><p>11 CS_LCD/ LCD selection</p><p>12 GND Ground</p><p>13 LCD_CD LCD type of the interface cycle: Control/data (0:control, 1:data)</p><p>14 LCD_MS LCD mode selection</p><p>15 GND Ground</p><p>16 HMI_MOSI_SDA SPI data written/I²C data for HMI board</p><p>17 GND Ground</p><p>18 HMI_MISO SPI Data read for HMI board</p><p>19 GND Ground</p><p>20 HMI_SCK_SCL SPI/I²C clock for HMI board</p><p>21 GND Ground</p><p>22 KON-OFF On/Off key</p><p>23 +5V +5V power supply</p><p>19</p><p>J7 to Motor Connector</p><p>J8 to JTAG Connector (micro programming)</p><p>J9 Connector to Plunger Driver</p><p>24 +5V +5V power supply</p><p>25 CMD_FAIL LED command failure</p><p>26 GND Ground</p><p>Pin n° Signal Description</p><p>1 MOTP_OUT1B Output B of the coil 1</p><p>2 MOTP_OUT1A Output A of the coil 1</p><p>3 MOTP_OUT2A Output A of the coil 2</p><p>4 MOTP_OUT2B Output B of the coil 2</p><p>5 GND Ground</p><p>6 GND Ground</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 +3V3 +3.3V power supply</p><p>3 TRST/ Test reset</p><p>4 TDO Test data output</p><p>5 GND Ground</p><p>6 TDI Test data input</p><p>7 MR/ Manual reset</p><p>8 TMS Test mode select</p><p>9 TCK Test clock</p><p>10 GND Ground</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 PLGH_OPTO/ Analog output signal of the piston photomicrosensor</p><p>3 FORCE - Negative input of the force sensor</p><p>4 FORCE + Positive input of the force sensor</p><p>5 +3V3 3V3 power supply of force sensor</p><p>6 DSG_OPTO/ Analog output signal of the release photomicrosensor</p><p>7 PLGHDSG_CD_OPTO Power supply signal of the photomicrosensors</p><p>8 DSG_SW_ON/ Analog output signal of the release switch</p><p>9 DSG_SW_OFF/ Analog output signal of the release switch</p><p>10 GND Ground</p><p>Pin n° Signal Description</p><p>20</p><p>2.1.5 Power Supply Board</p><p>Figure 2.9: Power Supply Board (Front View)</p><p>Figure 2.10: Power Supply Board (Back View)</p><p>The power supply board consists of he following:</p><p> An ATtiny26L secondary microcontroller associated with the one on the CPU board.</p><p> Different analog or power functions, including:</p><p>- Power supply management for all boards</p><p>- Battery charger</p><p>- Infrared interface</p><p>- Separate lines of communication (internal and external) to the boards</p><p>- Speaker</p><p>- Buzzer</p><p>- Super-capacitor</p><p>The power supply board is located on the angle bracket. See figure 2.1, page 8. It supplies power to the</p><p>electronic unit from the 100 V - 240 V AC network, or from 9 V DC. It also charges a 2.2 Ah battery. This</p><p>board is connected to other parts with the connectors shown below.</p><p>Legend</p><p>J1 Connector - Connection to CPU Board J4 Connector - Connection to Secondary</p><p>Microcontroller</p><p>J2 Connector - Connection to microphone,</p><p>speaker and external plug (RS232 Communication</p><p>Port and DC Power Input/Output)</p><p>J5 Connector - Connection to AC Power Board</p><p>J3 Connector - Connection to Internal Battery</p><p>J2</p><p>J1</p><p>J3</p><p>J4</p><p>J5</p><p>J1 J4</p><p>J2 J5</p><p>J3</p><p>21</p><p>J1 Connector to CPU Board</p><p>J2 Connector to External plug</p><p>Pin n° Signal Description</p><p>1 GND Ground</p><p>2 +5V +5V power supply</p><p>3 +5V +5V power supply</p><p>4 GND Ground</p><p>5 +VCOMM Common power supply (main or external +10V)</p><p>6 +VCOMM Common power supply (main or external +10V)</p><p>7 GND Ground</p><p>8 SO_ANA_SPEAK Speaker analog output</p><p>9 +3V3-PERM Permanent +3.3V power supply (battery backup)</p><p>10 GND Ground</p><p>11 PWR_SCL I²C clock for POWER board</p><p>12 GND Ground</p><p>13 PWR_SDA I²C data for POWER board</p><p>14 GND Ground</p><p>15 IRDA_TX Infrared data transmission</p><p>16 PWR_CD_PRI_VCOMM Primary microcontroller common power supply switch</p><p>17 IRDA_RX Infrared data received</p><p>18 SO_CD_SHDN/ Speaker shutdown command</p><p>19 SO_ANA_MIC Analog microphone input</p><p>20 GND Ground</p><p>21 EXT_TX External transmit data</p><p>22 PRES_BOARD/ HMI and UC board presence detection</p><p>23 EXT_RX External receive data</p><p>24 CMD_FAIL LED command failure</p><p>25 KON-OFF On/Off key</p><p>26 GND Ground</p><p>Pin n° Signal Description</p><p>1 SP- Negative connection to the speaker</p><p>2 SP+ Positive connection to the speaker</p><p>3 GND Ground - Terminal 2 of the microphone</p><p>4 MIC_TERM1 Microphone terminal 1 signal</p><p>5 GND Ground</p><p>6 VEXT_IN 10 VDC input</p><p>7 GND Ground</p><p>8 RELAY Nurse call output</p><p>9 GND Ground</p><p>10 5V0_OUT 5 VDC output</p><p>11 RXD RxD communication line</p><p>12 TXD TxD communication line</p><p>13 GND Ground</p><p>14 GND Ground</p><p>22</p><p>J3 Connector to Internal Battery</p><p>J4 Connector to ATtiny 26 Secondary Microcontroller</p><p>J5 Connector to AC Power Board</p><p>Pin n° Signal Description</p><p>1 VBAT Positive output of the smart battery</p><p>2 BAT_DATA One-wire communication link between the SMP and the battery</p><p>3 GND Ground (negative output of the smart battery)</p><p>4 GND Ground</p><p>5 GND Ground</p><p>Pin n° Signal Description</p><p>1 MISO Secondary microcontroller SPI data input</p><p>2 +3V3-PERM Secondary microcontroller power supply</p><p>3 SCK Secondary microcontroller SPI clock</p><p>4 MOSI Secondary microcontroller SPI data output</p><p>5 RST/ Secondary microcontroller reset</p><p>6 GND Ground</p><p>Pin n° Signal Description</p><p>1 Neutral Neutral wire</p><p>2 Line Hot wire</p><p>3 GND Ground</p><p>23</p><p>2.1.6 AC Power Board</p><p>Figure 2.11: AC Power Board (Front View)</p><p>Figure 2.12: AC Power Board (Back View)</p><p>J1 Connector to Power Supply Board</p><p>J2 Connector to AC Power</p><p>The AC power board contains the power cord inlet, the ECM filter, and the F1 line fuse.</p><p>of conformity. If it is not</p><p>possible to guarantee this environment,</p><p>additional precautions must be taken, such</p><p>as: use of anti-static equipment,</p><p>preliminary user discharge and the</p><p>wearing of antistatic clothing.</p><p>± 8 kV contact</p><p>± 15 kV air</p><p>Electrical fast</p><p>Transient / burst</p><p>IEC 61000-4-4</p><p>± 2 kV for power</p><p>supply lines</p><p>± 1 kV for input</p><p>output lines</p><p>± 2 kV for power</p><p>supply lines</p><p>± 1 kV for input</p><p>output lines</p><p>AC power quality should be that of a</p><p>typical commercial or healthcare facility</p><p>environment.</p><p>Surge</p><p>IEC 61000-4-5</p><p>± 1 kV</p><p>differential mode</p><p>± 2 kV</p><p>common mode</p><p>± 1 kV</p><p>differential mode</p><p>± 2 kV</p><p>common mode</p><p>AC power quality should be that of a</p><p>typical commercial or healthcare facility</p><p>environment.</p><p>Voltage dips,</p><p>short</p><p>interruptions and</p><p>voltage</p><p>variations on</p><p>power supply</p><p>input lines</p><p>IEC 61000-4-11</p><p>< 5% Ut</p><p>(> 95% dip in Ut)</p><p>for 0.5 cycles</p><p>< 5% Ut</p><p>(> 95% dip in Ut)</p><p>for 0.5 cycles</p><p>AC power quality should be that of a</p><p>typical commercial or healthcare facility</p><p>environment.</p><p>For short and long interruptions (< than</p><p>battery life) of AC power, the internal</p><p>battery provides continuity of service.</p><p>40% Ut</p><p>(60% dip in Ut)</p><p>for 5 cycles</p><p>40% Ut</p><p>(60% dip in Ut)</p><p>for 5 cycles</p><p>70% Ut</p><p>(30% dip in Ut)</p><p>for 25 cycles</p><p>70% Ut</p><p>(30% dip in Ut)</p><p>for 25 cycles</p><p>< 5% Ut</p><p>(> 95% dip in Ut)</p><p>for 5 s</p><p>< 5% Ut</p><p>(> 95% dip in Ut)</p><p>for 5 s</p><p>Power frequency</p><p>(50/60 Hz)</p><p>magnetic field</p><p>IEC 61000-4-8</p><p>3 A/m</p><p>- - - - - - - - - - - - - -</p><p>400 A/m If necessary, the power of the magnetic</p><p>field should be measured in the intended</p><p>installation location to ensure that it is</p><p>lower than compliance level.</p><p>If the measured field in the location where</p><p>the Agilia pump is used exceeds the</p><p>applicable magnetic field compliance level</p><p>above, observe the Agilia pump to verify</p><p>that it is operating normally. If you notice</p><p>abnormal performance, additional</p><p>measures may be necessary, such as</p><p>reorienting or relocating the Agilia pump,</p><p>or installing magnetic shielding.</p><p>400 A/m</p><p>134</p><p>23.4.3 Table 4 - Guidance and Manufacturer's Declaration -</p><p>Electromagnetic Immunity</p><p>Notes:</p><p> At 80 MHz and 800 MHz, the highest frequency range applies.</p><p> These guidelines may not apply to all situations. Absorption and reflection from structures, objects and people may</p><p>affect the electromagnetic propagation.</p><p> (a) Field strengths from fixed transmitters, such as base stations for radio (cell / cordless) telephones and land</p><p>mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically</p><p>with accuracy. To access the electromagnetic environment due to the fixed RF transmitters, an electromagnetic</p><p>site survey should be considered. If the measured field strength in the location where the Agilia pump is used</p><p>exceeds the applicable RF compliance level above, the Agilia SP pump should be observed to verify normal</p><p>operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or</p><p>relocating the Agilia pump, or installing magnetic shielding.</p><p> (b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.</p><p>Warning</p><p> The Agilia pump and its accessories are intended to be used in the</p><p>electromagnetic environments specified below.</p><p> The customer or the user of the Agilia pump should ensure that it is</p><p>used in such environments.</p><p>Immunity Test</p><p>IEC 60601-1-2</p><p>- - - - - - - - - - - - - - Compliance</p><p>Level</p><p>Obtained by</p><p>the Device</p><p>Electromagnetic Environment -</p><p>Guidance</p><p>IEC 60601-2-24</p><p>and ANSI/AAMI</p><p>ID26</p><p>Test Level</p><p>Portable and mobile RF communication</p><p>equipment should be used no closer to</p><p>any part of the Agilia pump (including</p><p>cables), than the recommended</p><p>separation distance calculated from the</p><p>transmitter frequency equation.</p><p>Conducted RF</p><p>IEC 61000-4-6</p><p>3 Vrms</p><p>150 kHz to</p><p>80 MHz</p><p>- - - - - - - - - - - - - -</p><p>Not applicable</p><p>3 Vrms</p><p>Recommended separation distance:</p><p>D = 0.35  P,</p><p>for a frequency of 150 kHz to 80 MHz</p><p>Radiated RF</p><p>IEC 61000-4-3</p><p>3 V/m</p><p>80 MHz to</p><p>2.5 GHz</p><p>- - - - - - - - - - - - - -</p><p>10 V/m</p><p>80 MHz to</p><p>2.5 GHz</p><p>10 V/m D = 0.35  P,</p><p>for a frequency of 80 MHz to 800 MHz</p><p>D = 0.7  P,</p><p>for a frequency of 800 MHz to 2.5 GHz</p><p>P is the maximum output power rating of</p><p>the transmitter in Watts (W) according to</p><p>the transmitter manufacturer, and D is the</p><p>recommended separation distance in</p><p>meters (m).</p><p>Field strengths from fixed RF transmitters,</p><p>as determined by an electromagnetic site</p><p>survey (a), should be less than compliance</p><p>level (b).</p><p>Interference may occur in the vicinity of</p><p>equipment marked with the following</p><p>symbol:</p><p>135</p><p>23.4.4 Table 6 - Recommended Separation Distances Between Portable</p><p>and Mobile RF Communication Equipment and the Agilia Pump</p><p>Information</p><p> The Agilia pump and its accessories are intended for use in</p><p>electromagnetic environments in which radiated RF disturbances are</p><p>controlled.</p><p> Users of the Agilia pump may prevent electromagnetic interference</p><p>by maintaining a minimum distance between portable and mobile RF</p><p>communication equipment (transmitters) and the Agilia pump as</p><p>recommended below, and according to the maximum output power</p><p>of the communication equipment (transmitters).</p><p> The device should not be used next to other equipment. If adjacent</p><p>use is necessary, observe the device to verify that it operates</p><p>normally in the configuration in which it will be used (pump with a AC</p><p>power cord, an RS232 cable).</p><p>Rated Maximum</p><p>Output Power of</p><p>Transmitter (W)</p><p>Separation Distance According</p><p>to Transmitter Frequency in Meters (m)</p><p>150 kHz to 80 MHz</p><p>D = 0.35  P</p><p>80 MHz to 800 MHz</p><p>D = 0.35  P</p><p>800 MHz to 2.5 GHz</p><p>D = 0.7  P</p><p>0.01 0.04 0.04 0.07</p><p>0.1 0.11 0.11 0.22</p><p>1 0.3 0.3 0.7</p><p>10 1.1 1.1 2.2</p><p>100 3.5 3.5 7</p><p>For transmitters rated at a maximum output power not listed above, the</p><p>recommended separation distance D in meters (m) can be estimated</p><p>using the equation applicable to the transmitter frequency, where P is</p><p>the maximum output power rating of the transmitter in watts (W) as</p><p>designated by the transmitter manufacturer.</p><p>Information</p><p> At 80 MHz and 800 MHz, the separation distance for the higher</p><p>frequency range applies.</p><p> These guidelines may not apply in all situations. Electromagnetic</p><p>propagation is affected by absorption and reflection from structures,</p><p>objects and people.</p><p>136</p><p>23.4.5 EMC test deviations and suplementary tests</p><p>To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special</p><p>environments, specific, additional or deviating tests are listed below with respect to the</p><p>basic tests, in accordance to manufacturer risk analysis.</p><p>Immunity test</p><p>IEC 60601-1-2</p><p>IEC 60601-2-24</p><p>Test level</p><p>Compliance level</p><p>obtained</p><p>by the device</p><p>Electromagnetic</p><p>environment – guidance</p><p>Discharge (ESD)</p><p>IEC 61000-4-2</p><p>± 8 kV contact</p><p>± 15 kV air</p><p>± 8 kV contact</p><p>± 15 kV air</p><p>Wooden, tiled or concrete flooring, with a</p><p>relative humidity level at least 30%, makes it</p><p>possible to guarantee the level of necessary</p><p>conformity. If it is not possible to guarantee this</p><p>environment, the additional precautions must</p><p>be taken, such as: use of anti-static material,</p><p>preliminary user discharge and wearing anti-</p><p>static clothing.</p><p>Radiated RF - IEC</p><p>61000-4-3 10 V/m, 80 MHz à 2,7 GHz 10 V/m, 80 MHz à 2,7 GHz</p><p>Portable and mobile RF</p><p>communications equipment should be</p><p>used no closer to any part of the Agilia</p><p>pump, including cables, than the</p><p>recommended separation distance</p><p>calculated from the equation</p><p>applicable to the frequency and power</p><p>of transmitter</p><p>For standard communication services</p><p>and equipment, the specific</p><p>frequencies were tested for a minimum</p><p>approach distance of 30 cm and 10 cm</p><p>(see below)</p><p>Near field radiated</p><p>RF</p><p>IEC 61000-4-3</p><p>test method</p><p>385 MHz, PM 18Hz, 27 V/m</p><p>450 Mhz, 1 KHz, 28 V/m</p><p>710 MHz, PM 217 Hz, 9 V/m</p><p>745 MHz, PM 217 Hz, 9 V/m</p><p>780 MHz, PM 217 Hz, 9 V/m</p><p>810 MHz, PM 18 Hz, 28 V/m</p><p>870 MHz, PM 18 Hz, 28 V/m</p><p>930 MHz, PM217 18 Hz, 28V/m</p><p>1720 MHz, PM 217 Hz, 28 V/m</p><p>1845 MHz, PM 217 Hz, 28 V/m</p><p>1970 MHz, PM 217</p><p>Hz, 28 V/m</p><p>2450 MHz, PM 217 Hz, 28 V/m</p><p>5240 MHz, PM 217 Hz, 9 V/m</p><p>5500 MHz, PM 217 Hz, 9 V/m</p><p>5785 MHz, PM 217 Hz, 9 V/m</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>Not tested</p><p>2450 MHz, PM 217 Hz, 28 V/m</p><p>5240 MHz, PM 217 Hz, 9 V/m</p><p>5500 MHz, PM 217 Hz, 9 V/m</p><p>5785 MHz, PM 217 Hz, 9 V/m</p><p>For minimal distance approach 30 cm</p><p>(12 inches)</p><p>"Not tested" frequencies are replaced</p><p>by IEC 61000-4-39 test method and</p><p>reduced minimal distance approach</p><p>(see below)</p><p>Portable and mobile RF</p><p>communications equipment should be</p><p>used no closer to any part of the Agilia</p><p>pump, including cables, than the</p><p>recommended minimal separation</p><p>distance (30 cm) for these frequencies</p><p>Near field radiated</p><p>RF - special test</p><p>IEC 61000-4-39</p><p>test method</p><p>450 MHz, PM 217 Hz, 28 V/m</p><p>710 MHz, PM 217 Hz, 28 V/m</p><p>787 MHz, PM 217 Hz, 28 V/m</p><p>810 MHz, PM 217 Hz, 44 V/m</p><p>830 MHz, PM 217 Hz, 44 V/m</p><p>870 MHz, PM 217 Hz, 44 V/m</p><p>1750 MHz, PM 217 Hz, 28 V/m</p><p>1875 MHz, PM 217 Hz, 28 V/m</p><p>1970 MHz, PM 217 Hz, 28 V/m</p><p>2560 MHz, PM 217 Hz, 28 V/m</p><p>2655 MHz, PM 217 Hz, 28 V/m</p><p>450 MHz, PM 217 Hz, 28 V/m</p><p>710 MHz, PM 217 Hz, 28 V/m</p><p>787 MHz, PM 217 Hz, 28 V/m</p><p>810 MHz, PM 217 Hz, 44 V/m</p><p>830 MHz, PM 217 Hz, 44 V/m</p><p>870 MHz, PM 217 Hz, 44 V/m</p><p>1750 MHz, PM 217 Hz, 28 V/m</p><p>1875 MHz, PM 217 Hz, 28 V/m</p><p>1970 MHz, PM 217 Hz, 28 V/m</p><p>2560 MHz, PM 217 Hz, 28 V/m</p><p>2655 MHz, PM 217 Hz, 28 V/m</p><p>For minimal distance approach 10 cm</p><p>250 mW average power for 28 V/m</p><p>test level</p><p>600 mW average power for 44 V/m</p><p>test level</p><p>Portable and mobile RF</p><p>communications equipment should be</p><p>used no closer to any part of the Agilia</p><p>pump, including cables, than the</p><p>recommended minimal separation</p><p>distance (10 cm) for these frequencies</p><p>137</p><p>Electrical Fast</p><p>transient / Burst</p><p>IEC 61000-4-4</p><p>± 2 kV for power</p><p>supply lines</p><p>± 1 kV for input</p><p>output lines</p><p>100 KHz repetition</p><p>± 2 kV for power</p><p>supply lines</p><p>± 1 kV for input</p><p>output lines</p><p>100 KHz repetition</p><p>Electricity power quality should be that</p><p>of a typical domestic, commercial or</p><p>hospital environment</p><p>Surge</p><p>IEC 61000-4-5</p><p>± 1 kV</p><p>differential mode</p><p>± 2 kV</p><p>common mode</p><p>± 1 kV</p><p>differential mode</p><p>± 2 kV</p><p>common mode</p><p>Electricity power quality should be that</p><p>of a typical domestic, commercial or</p><p>hospital environment. For very</p><p>exposed establishments or buildings</p><p>with the lightning, a protection must be</p><p>installed on electricity power. Class II</p><p>product and no earth connexion.</p><p>Conducted RF</p><p>IEC 61000-4-6</p><p>3 Vrms</p><p>150 KHz to 80 MHz</p><p>And 6 Vrms in the ISM and</p><p>amateur radio bands</p><p>3 Vrms</p><p>150 KHz to 80 MHz</p><p>And 6 Vrms in the ISM and</p><p>amateur radio bands</p><p>Portable and mobile RF</p><p>communications equipment should be</p><p>used no closer to any part of the Agilia</p><p>pump including cables, than the</p><p>recommended separation distance</p><p>calculated from the equation</p><p>applicable to the frequency and power</p><p>of transmitter (see table 6)</p><p>Power frequency</p><p>(50 / 60 Hz)</p><p>magnetic field</p><p>IEC 61000-4-8</p><p>400 A / m 400 A / m</p><p>If necessary, the power magnetic field</p><p>should be measured in the intended</p><p>installation location to make sure it is</p><p>lower than the compliance level.</p><p>If the measured field in the location</p><p>where the Agilia pump is used exceeds</p><p>the applicable magnetic field</p><p>compliance level above, the Agilia</p><p>pump should be observed to verify</p><p>normal operation. If abnormal</p><p>performance is observed, additional</p><p>measures may be necessary, such as</p><p>reorienting or relocating the Agilia</p><p>pump, or installing magnetic shielding.</p><p>Voltage dips,</p><p>short</p><p>interruptions</p><p>and voltage</p><p>variations on</p><p>power supply</p><p>input lines</p><p>IEC 61000-4-11</p><p>0 % Ut</p><p>(100% dip in Ut)</p><p>for 0,5 cycle</p><p>at 0°, 45°, 90°, 135°,180°, 225°,</p><p>270°,and 315°</p><p>0% Ut</p><p>(100% dip in Ut)</p><p>for 1 cycle</p><p>70% Ut</p><p>(30% dip in Ut)</p><p>for 25 cycles at 50 Hz</p><p>for 30 cycles at 60 Hz</p><p>at 0°</p><p>0 % Ut</p><p>(100% dip in Ut)</p><p>for 0,5 cycle</p><p>at 0°, 45°, 90°, 135°,180°, 225°,</p><p>270°,and 315°</p><p>0% Ut</p><p>(100% dip in Ut)</p><p>for 1 cycle</p><p>70% Ut</p><p>(30% dip in Ut)</p><p>for 25 cycles at 50 Hz</p><p>for 30 cycles at 60 Hz</p><p>at 0°</p><p>Electricity power quality should be that</p><p>of a typical domestic, commercial or</p><p>hospital environment.</p><p>For short and long interruptions (< than</p><p>battery autonomy) of electricity power</p><p>supply, the internal battery provides</p><p>the continuity of service.</p><p>For very long (> than battery</p><p>autonomy) interruptions of electricity</p><p>power supply, the Agilia pump must be</p><p>powered from an external</p><p>Uninterruptible Power Supply (UPS).</p><p>Note: Ut is the a/c mains voltage prior</p><p>to application of the test level.</p><p>Immunity test</p><p>IEC 60601-1-2</p><p>IEC 60601-2-24</p><p>Test level</p><p>Compliance level</p><p>obtained</p><p>by the device</p><p>Electromagnetic</p><p>environment – guidance</p><p>138</p><p>24 Servicing</p><p>24.1 Information on Device Servicing</p><p>24.2Maintenance Requirements</p><p>If the device must be sent for servicing, proceed as follows:</p><p>1. Contact Fresenius Kabi to have packaging shipped to your facility.</p><p>2. Clean and disinfect the device.</p><p>3. Pack the device in the provided packaging.</p><p>4. Ship the device to Fresenius Kabi.</p><p>Information</p><p> Fresenius Kabi is not liable for loss or damage to the device during</p><p>transport.</p><p> For more information on servicing, contact your Fresenius Kabi</p><p>sales representative.</p><p>Warning</p><p>Perform preventive maintenance at least once every 3 years. This</p><p>includes replacing the battery.</p><p>To ensure the device continues to operate normally, follow the</p><p>instructions below:</p><p> Preventive maintenance should be performed by trained and</p><p>qualified technical personnel in compliance with the technical</p><p>manual and procedures. Only authorized service personnel should</p><p>attempt to repair the device.</p><p> The qualified personnel must be informed if the device is dropped or</p><p>if any malfunctions occur. In this case, do not use the device and</p><p>contact your biomedical department or Fresenius Kabi.</p><p> Failure to comply with these maintenance procedures could damage</p><p>the device and lead to a functional failure. Internal inspection of the</p><p>device requires compliance with special procedures to avoid</p><p>damage to the device.</p><p> When replacing components, only use spare parts from</p><p>Fresenius Kabi.</p><p>The life cycle of the pump is 10 years provided that the maintenance is</p><p>properly performed as described above.</p><p>Information</p><p>If the device needs upgrading, Fresenius Kabi or its representative will</p><p>provide relevant instructions. It is the healthcare facility's responsibility</p><p>to follow Fresenius Kabi’s instructions.</p><p>139</p><p>24.3Quality Control</p><p>Upon request by the healthcare facility, a quality control check can be</p><p>performed on the device every 12 months.</p><p>A regular quality control check (not included in the guarantee) consists</p><p>of various inspection operations listed in the technical manual.</p><p>Information</p><p> These control checks must be performed by trained technical</p><p>personnel, and are not covered by any contract or agreement</p><p>provided by Fresenius Kabi.</p><p> For more information, refer to the technical manual, or contact your</p><p>Fresenius Kabi sales representative.</p><p>140</p><p>25 Glossary of Terms</p><p>Term Description</p><p>A Amperes</p><p>AC Alternating Current</p><p>Ah Ampere-hours</p><p>AIDC Automatic Identification and Data Capture</p><p>AM Amplitude Modulation</p><p>A/m Amperes per meter</p><p>BPSK Binary Phase Shift Keying</p><p>BSA Body Surface Area</p><p>cal Calorie</p><p>CCK Complementary Code Keying</p><p>CDC Centers for Disease Control</p><p>CISPR Special International Committee on Radio Interference</p><p>CT Scan Computed Tomography</p><p>dBA Decibels</p><p>dBm Decibels-Milliwatts</p><p>DC Direct Current</p><p>DECT Digital Enhanced Cordless Telecommunications</p><p>DEHP Di(2-ethylhexyl) phthalate</p><p>DERS Dose Error Reduction Software</p><p>DHCP Dynamic Host Configuration Protocol</p><p>DTBI Dose to Be Infused</p><p>DI Dose Infused</p><p>DPS Dynamic Pressure System</p><p>DSSS Direct Sequence Spread Spectrum</p><p>DUR Duration</p><p>141</p><p>ECG Electrocardiogram</p><p>ECMO ExtraCorporeal Membrane Oxygenation</p><p>EEG Electroencephalogram</p><p>EMC Electromagnetic compatibility</p><p>ErXX Error message</p><p>ESD Electrostatic Discharge</p><p>FCC Federal Communications Commission</p><p>FM Frequency Modulation</p><p>ft Feet</p><p>GPL General Public License</p><p>GTIN Global Trade Item Number</p><p>H/W/D Height / Width / Depth</p><p>HF High Frequency</p><p>hPa Hectopascals</p><p>HTTP HyperText Transfer Protocol</p><p>Hz Hertz</p><p>IC Industry Canada</p><p>IEC International Electrotechnical Commission</p><p>IEEE Institute of Electrical and Electronics Engineers</p><p>IFU Instructions for Use</p><p>in Inches</p><p>IT Information Technology</p><p>IV Intravenous</p><p>kg Kilograms</p><p>KVO Keep Vein Open</p><p>lb(s) Pound(s)</p><p>LED Light Emitting Diode</p><p>Term Description</p><p>142</p><p>mA Milliamperes</p><p>mEq Milliequivalents</p><p>mL/h Milliliters per hour</p><p>mmHg Millimeters of Mercury</p><p>mmol Millimole</p><p>MOS Metal Oxyde Semiconductor</p><p>MRI Magnetic Resonance Imaging</p><p>mW/sr Milliwatts per steradian</p><p>N/A Not Applicable</p><p>NMR Nuclear Magnetic Resonance</p><p>OCS Occlusivity Check System</p><p>OFDM Orthogonal Frequency Division Multiplexing</p><p>OR Operating Room</p><p>PC Personal Computer</p><p>PSI Pounds per Square Inch</p><p>PSK Phase Shift Keying</p><p>QAM Quadrature Amplitude Modulation</p><p>QPSK Quadrature Phase Shift Keying</p><p>REF Product reference / part number</p><p>RF Radio Frequency</p><p>RFID Radio Frequency IDentification</p><p>RS232 Serial interface connector</p><p>SN Serial Number</p><p>SELV Safety Extra Low Voltage</p><p>SIR Asynchronous Serial Infrared</p><p>TCP Transmission Control Protocol</p><p>UDI Unique Device Identifier</p><p>Term Description</p><p>143</p><p>USB Universal Serial Bus</p><p>Ut Test specification level</p><p>V Volts</p><p>VA Volt-Amperes</p><p>VDC Volts Direct Current</p><p>VI Volume Infused</p><p>Vrms Root Mean Square Voltage</p><p>VTBI Volume to Be Infused</p><p>V/m Volts per meter</p><p>W Watts</p><p>WPA Wi-Fi Protected Access</p><p>Term Description</p><p>144</p><p>Appendix: Factory Configuration</p><p> = Activated with factory configuration (Basic Profile).</p><p> = Not activated with factory configuration. Can be activated in the pump options or with Agilia Vigilant</p><p>Drug’Lib software. Otherwise can be activated on request.</p><p>Feature Availability Feature Availability</p><p>Menus</p><p>Profile </p><p>Infusion</p><p>Modes</p><p>Simple Rate </p><p>Pressure  Volume/Time</p><p>Dose / Time </p><p>Keypad lock</p><p>status  Volume Limit </p><p>Battery life </p><p>Infusion</p><p>Features</p><p>Direct Bolus </p><p>Volume infused</p><p>/ Dose infused  Programmed</p><p>Bolus </p><p>Pause  Loading Dose </p><p>Programmed</p><p>bolus  KVO </p><p>Patient  Prime Set </p><p>Day/Night</p><p>mode </p><p>Dynamic</p><p>Pressure</p><p>System (DPS)</p><p></p><p>Volume/Time</p><p>Dose/Time </p><p>Volume Limit </p><p>Alarm volume </p><p>Volume-Dose</p><p>history </p><p>View flow rate</p><p>history </p><p>View pressure</p><p>history </p><p>Syringe </p><p>View event log </p><p>Date / Time </p><p>Maintenance </p><p>Library</p><p>information </p><p>Clinical</p><p>information </p><p>Data Set </p><p>145</p><p>Index</p><p>A</p><p>Agilia Connect Infusion System 13</p><p>Agilia USB Cable 88</p><p>Alarm</p><p>Adjust Volume 74</p><p>List 91</p><p>Priority 18, 90</p><p>Sound Level 119</p><p>Arrow Keys 18</p><p>B</p><p>Battery</p><p>Characteristics 117</p><p>Charge Level 33, 67</p><p>Full Charge Time 32</p><p>Operating Mode 116</p><p>Bolus 50</p><p>Direct 51</p><p>Programmed 52, 70</p><p>C</p><p>Cables 87</p><p>Cleaning 111</p><p>Clinical Information Message 83</p><p>Contraindications 12</p><p>D</p><p>Data Communication 87</p><p>Data Set 25</p><p>Display Information 84</p><p>Upload 20, 88</p><p>Date / Time 80, 86</p><p>Day Mode 71</p><p>Dimensions and Weight 119</p><p>Disinfecting 111</p><p>Dose 24, 40, 49</p><p>Dose/Time 55, 73</p><p>Drug 24</p><p>Concentration Selection 40</p><p>Select 39</p><p>Drug Library 23</p><p>Display Information 82</p><p>Drug X (mL/h) 24</p><p>E</p><p>Electromagnetic Guidance 129</p><p>Empty Syringe 54</p><p>Environment 12</p><p>Essential Features 104</p><p>Event Log 79</p><p>F</p><p>Factory Configuration 144</p><p>First Use 32</p><p>Flow Rate 24, 40, 48</p><p>G</p><p>Glossary 140</p><p>Graphics</p><p>Flow Rate History 76</p><p>Pressure History 77</p><p>H</p><p>Hard Limit 24</p><p>I</p><p>Infusion</p><p>Change Infusion Rate 50</p><p>End 53</p><p>Monitor 48</p><p>Pause 69</p><p>Program 39</p><p>Start 47</p><p>Stop 50</p><p>View History 75</p><p>Infusion Modes 24, 55</p><p>Infusion Status 19</p><p>Installation 26</p><p>Intended Use 9</p><p>K</p><p>Keypad</p><p>Description 17</p><p>Lock / Unlock 65</p><p>Unlock Code 86</p><p>KVO 56, 57</p><p>L</p><p>Language Selection 86</p><p>Loading Dose</p><p>Pause 45</p><p>Program 44</p><p>Select 43</p><p>Stop 45</p><p>146</p><p>M</p><p>Maintenance 138</p><p>Display Information 81</p><p>Reminder Message 33</p><p>Requirements 138</p><p>Menu</p><p>Customization 86</p><p>List 60</p><p>Monitoring</p><p>Dose 49</p><p>Flow Rate (ml/h) 48</p><p>N</p><p>Navigation Buttons 20</p><p>Near End of Infusion Alert 53</p><p>Night Mode 71</p><p>O</p><p>Options 85</p><p>P</p><p>Packaging 21</p><p>Patient Characteristics 11, 106</p><p>Change 70</p><p>Select 42</p><p>Power Cord 117</p><p>Power Supply 18, 117</p><p>Powering Off 55</p><p>Powering On 32</p><p>Pre-programming 59</p><p>Pressure</p><p>DPS 64</p><p>Management 106</p><p>Modify Limit 62</p><p>Operating Range 12</p><p>Priming</p><p>Manual Prime 98</p><p>Prime With Pump 57</p><p>Profile 22</p><p>Basic Profile 22</p><p>Custom Profile 23</p><p>Display Information 61</p><p>Select 36</p><p>Q</p><p>Quick-Start 58</p><p>R</p><p>Recycling 127</p><p>Release Notes 147</p><p>Rotating Pole Clamp 27</p><p>S</p><p>Screen</p><p>Contrast 86</p><p>Display and Symbols 19</p><p>Selection Keys 18</p><p>Servicing 138</p><p>Simple Rate 55</p><p>Soft Limit 24</p><p>Override 45</p><p>Software Version 147</p><p>Sound Levels 118</p><p>Stop function 50</p><p>Storage 102</p><p>Symbol Descriptions 2</p><p>Syringe 98</p><p>Change 100</p><p>Display Information 78</p><p>Install 32</p><p>List 98</p><p>Remove 100</p><p>Replacement Interval 100</p><p>Select 38</p><p>T</p><p>Table of Contents 3</p><p>Temperature</p><p>Operating Range 12</p><p>Titration 50</p><p>Training 10</p><p>Troubleshooting 125</p><p>Trumpet Curves 120</p><p>U</p><p>Units 109</p><p>User Test 89</p><p>V</p><p>Volume Infused 68</p><p>Volume Limit 56, 73</p><p>Volume/Time 55, 73</p><p>VTBI 55, 105</p><p>W</p><p>Warranty 128</p><p>Wi-Fi 19, 86, 88</p><p>Communication 122</p><p>Specifications 123</p><p>147</p><p>Release Notes</p><p>This document may contain inaccuracies or typographical errors.</p><p>Modifications may thus be made, and included in later editions.</p><p>Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the</p><p>text and images of this document are applicable only to the device with which it is included.</p><p>The screenshots and illustrations in this document are for illustrative purposes only. Screen contents</p><p>may vary based on individual configurations and minor software modifications; therefore, some</p><p>screenshots may appear slightly different from what you see on the product.</p><p>This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.</p><p>Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries.</p><p>Made in France</p><p>Revision date: May 2020</p><p>Date Software Version Description</p><p>January 2017</p><p>2.2</p><p>Creation</p><p>November 2019 Improvement of alarms description (documentary only</p><p>- no impact on the device itself)</p><p>May 2020</p><p>Update of the compliance to IEC 61000-3-3 and IEC</p><p>61000-4-5 standards in Section "Guidance and</p><p>Manufacturer's Declaration on EMC".</p><p>Fresenius Kabi AG</p><p>61346 Bad Homburg</p><p>Germany</p><p>Fresenius Vial S.A.S</p><p>Le Grand Chemin</p><p>38590 Brézins</p><p>France</p><p>www.fresenius-kabi.com</p><p>First CE Mark:</p><p>Agilia SP MC WiFi: December 2015</p><p>Agilia SP MC: November 2016</p><p>0 1 2 3</p><p>http://www.fresenius-kabi.com/</p><p>Local Contacts for Servicing</p><p>Fresenius Vial S.A.S</p><p>Le Grand Chemin</p><p>38590 Brézins - France</p><p>Fresenius Kabi AG</p><p>61346 Bad Homburg</p><p>Germany</p><p>11</p><p>10</p><p>3-</p><p>5</p><p>_M</p><p>as</p><p>te</p><p>r_</p><p>IF</p><p>U</p><p>_A</p><p>gi</p><p>lia</p><p>_S</p><p>P</p><p>_M</p><p>C</p><p>_E</p><p>ng</p><p>1 Introduction</p><p>1.1 Scope</p><p>1.2 Intended Use</p><p>1.3 Principles of Operation</p><p>1.4 Intended Users</p><p>1.5 Contraindications</p><p>1.6 Use Environment</p><p>2 Description</p><p>2.1 Physical Description</p><p>2.1.1 Housing</p><p>2.1.2 Keypad</p><p>2.1.3 Display Board</p><p>2.1.4 CPU Board</p><p>2.1.5 Power Supply Board</p><p>2.1.6 AC Power Board</p><p>2.1.7 Wi-Fi Board</p><p>2.1.8 Back View</p><p>2.1.9 Mechanical Framework Assembly</p><p>2.1.10 Mechanical Plunger Driver Assembly</p><p>2.2 Principles of Operation</p><p>2.2.1 Syringe Test and Maintenance Sub-assembly</p><p>2.2.2 Motor Sub-assembly</p><p>2.2.3 External Connection Sub-assembly</p><p>2.3 Operation Diagram</p><p>3 Fundamentals</p><p>3.1 Training</p><p>3.2 Maintenance Schedule</p><p>3.2.1 Preventive Maintenance</p><p>3.2.2 Quality Control</p><p>3.3 Accessing / Exiting the Operating Functions</p><p>3.3.1 Accessing the Options Menu</p><p>3.3.2 Exiting the Options Menu</p><p>4 Profile Menu</p><p>4.1 Accessing the Profile Menu</p><p>4.2 Profile Menu Functions</p><p>5 Basic Profile Configuration</p><p>5.1 Accessing the Basic Profile Configuration</p><p>5.2 Basic Profile Configuration Functions</p><p>6 Maintenance Operations</p><p>6.1 Maintenance Options</p><p>6.1.1 Accessing the Maintenance Options Menu</p><p>6.1.2 Maintenance Date</p><p>6.1.3 Initial Set up</p><p>6.1.4 Data Log Event</p><p>6.1.5 Maintenance Information</p><p>6.2 Running Tests</p><p>6.2.1 Accessing the Tests Menu</p><p>6.2.2 Test 1: Identification</p><p>6.2.3 Test 2: Maintenance</p><p>6.2.4 Test 3: Maintenance Messages</p><p>6.2.5 Test 4: Events</p><p>6.2.6 Test 5: Force</p><p>6.2.7 Test 6: Displacement</p><p>6.2.8 Test 7: Syringe Barrel Clasp</p><p>6.2.9 Test 8: Battery Info</p><p>6.2.10 Test 9: Indication</p><p>6.2.11 Test</p><p>10: Keypad</p><p>6.2.12 Test 11: Ageing Test</p><p>6.2.13 Test 12: Battery Life</p><p>6.2.14 Test 13: Battery Test</p><p>6.2.15 Test 20: Pump Code</p><p>6.2.16 Test 21: Power Info</p><p>6.2.17 Test 22: LCD Voltage</p><p>6.2.18 Test 23: Temperature</p><p>6.2.19 Test 24: Watchdog</p><p>6.2.20 Test 25: Wi-Fi Module Information</p><p>6.2.21 Checking the Pressure Limit Alarm</p><p>6.2.22 Checking the End of Infusion Alarm</p><p>6.2.23 Control the plunger head detection finger and anti-siphon arms movement</p><p>6.2.24 Control the disengagement and plunger head alarms</p><p>6.2.25 Checking the AC Power Supply / Battery Operation</p><p>6.2.26 Electrical Test</p><p>6.3 Quality Control Procedure</p><p>6.3.1 Running a Quality Control</p><p>6.3.2 Quality Control Certificate</p><p>6.4 Testing the Flow Rate</p><p>7 Troubleshooting and Messages</p><p>7.1 Alarm Messages and Information Signals</p><p>7.2 Troubleshooting Guide</p><p>7.3 Error Codes</p><p>8 Intervention Procedures</p><p>8.1 Procedure #1: Battery and Battery Door - Boost Capacitor Discharge</p><p>8.2 Procedure #2: Upper Case</p><p>8.3 Procedure #3: Display Board/LCD Display</p><p>8.4 Procedure #4: CPU Board</p><p>8.5 Procedure #5: Power Supply Board and AC Power Board</p><p>8.6 Procedure #6: Wi-Fi Board</p><p>8.7 Procedure #7: Syringe Barrel Clasp</p><p>8.8 Procedure #8: Syringe Detection System</p><p>8.9 Procedure #9: Motor</p><p>8.10 Procedure #10: Disengagement Flexible Circuit</p><p>8.11 Procedure #11: Force Sensor + Ribbon Cable Kit</p><p>8.12 Procedure #12: Linear Sensor Kit</p><p>8.13 Procedure #13: Plunger Cover and Lever Kit</p><p>8.14 Procedure #14: Plunger Kit</p><p>8.15 Procedure #15: Carriage Kit</p><p>9 Cleaning and Disinfecting</p><p>10 Device Storage</p><p>11 Power Management</p><p>12 Technical Characteristics</p><p>12.1 Power Supply</p><p>12.2 Battery</p><p>12.3 Power Consumption</p><p>12.4 Communication Port</p><p>12.5 Infrared Communication</p><p>12.6 Agilia USB Cable</p><p>12.7 Compliance</p><p>12.8 Dimensions - Weight</p><p>12.9 Electronic Boards</p><p>12.10 Material Characteristics</p><p>13 Specifications</p><p>14 Recycling</p><p>15 Warranty</p><p>16 Guidance and Manufacturer's Declaration on EMC</p><p>17 Spare Parts Catalog</p><p>18 Ordering Information</p><p>18.1 Data Management Cables</p><p>18.2 Associated Software</p><p>18.3 Disposables</p><p>19 Glossary of Terms</p><p>Index</p><p>11103-5_Master_IFU_Agilia_SP_MC_Eng.pdf</p><p>1 Introduction</p><p>1.1 Scope</p><p>1.2 Intended Use</p><p>1.3 Principles of Operation</p><p>1.4 Intended Products to be Infused</p><p>1.5 Intended Users</p><p>1.6 Intended Patients</p><p>1.7 Contraindications</p><p>1.8 Use Environment</p><p>2 Agilia Connect Infusion System</p><p>3 Description</p><p>3.1 Front View</p><p>3.2 Bottom View (Device Identification Label)</p><p>3.3 Back View</p><p>3.4 Keypad</p><p>3.4.1 Keypad Description</p><p>3.4.2 Keypad Details</p><p>3.4.2.1 Selection Keys</p><p>3.4.2.2 Infusion Indicator Lights</p><p>3.4.2.3 Status Indicators</p><p>3.5 Display and Symbols</p><p>3.5.1 Infusion Status</p><p>3.5.2 Screen Options</p><p>3.5.3 Navigation Buttons</p><p>3.5.4 Alarms and Safety Features</p><p>3.5.5 Infusion Features</p><p>3.5.6 Data Communication</p><p>3.6 Packaging</p><p>4 Fundamentals</p><p>4.1 Profiles</p><p>4.1.1 Basic Profile</p><p>4.1.2 Custom Profiles</p><p>4.2 Drug Libraries</p><p>4.3 Drug Lists</p><p>4.4 Drugs</p><p>4.4.1 Infusion Rates</p><p>4.4.2 Drug X (mL/h)</p><p>4.4.3 Hard Limits and Soft Limits</p><p>4.4.4 Infusion Modes</p><p>4.5 Data Set</p><p>5 Installation</p><p>5.1 Types of Installations</p><p>5.2 Using the Rotating Pole Clamp</p><p>5.2.1 Rotating Pole Clamp Description</p><p>5.2.2 Using the Rotating Pole Clamp</p><p>5.2.2.1 Folding the Clamp Down (outward)</p><p>5.2.2.2 Folding the Clamp Up (inward toward the pump)</p><p>5.2.2.3 Rotating the Clamp</p><p>5.3 Attaching the pump(s)</p><p>5.3.1 Attaching to a Pole</p><p>5.3.2 Attaching to a Rail</p><p>5.3.3 Using on a Flat Table</p><p>5.3.4 Attaching Two Pumps Together</p><p>6 Getting Started</p><p>6.1 Flowchart</p><p>6.2 Using the Pump for the First Time</p><p>6.3 Powering on</p><p>6.4 Installing a Syringe</p><p>6.5 Pump Height</p><p>7 Operation</p><p>7.1 Flowchart</p><p>7.2 Selecting a Profile</p><p>7.3 Selecting the Infusion Rate (Flow Rate or Dose)</p><p>7.4 Selecting a Syringe</p><p>7.5 Selecting a Drug</p><p>7.6 Programming an Infusion</p><p>7.6.1 Programming an Infusion by Flow Rate</p><p>7.6.2 Programming an Infusion by Dose</p><p>7.6.2.1 Selecting the Drug Concentration</p><p>7.6.2.2 Selecting the Patient’s Characteristics</p><p>7.6.2.3 Selecting the Infusion Unit</p><p>7.6.2.4 Programming the Infusion</p><p>7.6.2.5 Programming a Loading Dose</p><p>7.6.3 Programming Beyond Soft Limits</p><p>7.7 Starting an Infusion</p><p>7.8 Monitoring an Infusion</p><p>7.8.1 Monitoring an Infusion when Programmed by Flow Rate</p><p>7.8.2 Monitoring an Infusion when Programmed by Dose</p><p>7.9 Functions During Infusion</p><p>7.9.1 Stop</p><p>7.9.2 Rate Titration</p><p>7.9.3 Administering a Bolus</p><p>7.9.3.1 Direct Bolus</p><p>7.9.3.2 Programmed Bolus</p><p>7.10 Completing an Infusion</p><p>7.10.1 Near End of Infusion Alert</p><p>7.10.2 End of Infusion</p><p>7.10.3 Powering off</p><p>7.11 Infusion Modes</p><p>7.11.1 Simple Rate</p><p>7.11.2 Volume/Time & Dose/Time</p><p>7.11.3 Volume Limit</p><p>7.12 Other Functions</p><p>7.12.1 Priming the Syringe and the Extension Set</p><p>7.12.2 Pre-programming the Pump</p><p>8 Menus</p><p>8.1 Overview</p><p>8.1.1 Commands</p><p>8.1.2 Menu Description</p><p>8.2 Profile</p><p>8.3 Pressure</p><p>8.4 Keypad Lock Status</p><p>8.5 Battery Life</p><p>8.6 Volume Infused / Dose Infused</p><p>8.7 Pause</p><p>8.8 Programmed Bolus</p><p>8.9 Patient</p><p>8.10 Day/Night Mode</p><p>8.11 Volume/Time & Dose/Time</p><p>8.12 Volume Limit</p><p>8.13 Alarm Volume</p><p>8.14 Volume-Dose History</p><p>8.15 View Flow Rate History</p><p>8.16 View Pressure History</p><p>8.17 Syringe</p><p>8.18 View Event Log</p><p>8.19 Date / Time</p><p>8.20 Maintenance</p><p>8.21 Library Information</p><p>8.22 Clinical Information</p><p>8.23 Data Set</p><p>9 Options</p><p>9.1 Commands</p><p>9.2 Option Descriptions</p><p>9.3 Pump Settings</p><p>10 Data Communication</p><p>10.1 Overview</p><p>10.2 Communication via Agilia Cables</p><p>10.2.1 Data Communication Cables</p><p>10.2.2 Using the Communication Port</p><p>10.3 Communication via Wi-Fi</p><p>10.4 Data Set Upload</p><p>11 User Test</p><p>12 Alarms and Safety Features</p><p>12.1 Introduction</p><p>12.2 Alarm Descriptions</p><p>12.3 General Remarks</p><p>12.4 List of Alarms</p><p>12.4.1 Syringe Alarms</p><p>12.4.2 Volume Limit Alarms</p><p>12.4.3 Volume/Time & Dose/Time Alarms</p><p>12.4.4 Infusion Alarms</p><p>12.4.5 Pressure Alarms</p><p>12.4.6 Battery Alarms</p><p>12.4.7 Power Alarms</p><p>12.4.8 Keypad Alarms</p><p>12.4.9 Technical Error Alarms</p><p>12.5 Audio-only Information Signals</p><p>13 Syringes</p><p>13.1 Syringe List</p><p>13.2 Preparing a Syringe</p><p>13.3 Operations for Syringes</p><p>13.3.1 Removing a Syringe</p><p>13.3.2 Changing a Syringe</p><p>13.3.3 Syringe Replacement Interval</p><p>13.4 Gravity Infusion in Parallel with a Pump</p><p>14 Device Storage</p><p>14.1 Precautions for Storage</p><p>14.2 Storage and Transport Conditions</p><p>14.3 Preparing the Device for Storage</p><p>14.4 Using the Device After Storage</p><p>15 Specifications</p><p>15.1 Essential Features</p><p>15.2 Flow Rate</p><p>15.3 Volume To Be Infused (VTBI)</p><p>15.4 Dose To Be Infused (DTBI)</p><p>15.5 Infusion Time</p><p>15.6 Concentration</p><p>15.7 Patient Data</p><p>15.8 Pressure Management</p><p>15.9 Accuracy</p><p>15.9.1 Flow Rate Accuracy</p><p>15.9.2 Effects of Pressure Variations on Accuracy</p><p>15.9.3 Occlusion Alarm Accuracy</p><p>15.9.4 Volume Accuracy</p><p>15.9.5 Pressure Accuracy</p><p>15.10 Units and Conversion Rules</p><p>15.10.1 Concentration Units</p><p>15.10.2 Dose Units</p><p>15.10.3 Conversion Rules</p><p>16 Cleaning and Disinfecting</p><p>16.1 When to Clean and Disinfect the Pump</p><p>16.2 Recommended and Prohibited Agents</p><p>16.2.1 Recommended Agents</p><p>16.2.2 Prohibited Agents</p><p>16.3 Instructions for Cleaning and Disinfecting</p><p>16.3.1 Cleaning Instructions</p><p>16.3.2 Disinfecting Instructions</p><p>17 Power Management</p><p>17.1 AC Power Supply Precautions</p><p>17.2 Battery Precautions</p><p>17.3 Battery Operating Mode</p><p>18 Technical Characteristics</p><p>18.1 Power Supply</p><p>18.2 Battery</p><p>18.3 Power Consumption</p><p>18.4 Communication Port</p><p>18.5 Infrared Communication</p><p>18.6 Sound Levels</p><p>18.6.1 Operating Pump Sound Levels (without alarms)</p><p>18.6.2 Alarms Sound Levels</p><p>18.7 Compliance</p><p>18.8 Dimensions and Weight</p><p>18.9 Trumpet and Start-up Curves</p><p>18.9.1 Flow rate: 1 mL/h</p><p>18.9.2 Flow rate: 5 mL/h</p><p>19 Wi-Fi</p><p>19.1 General Information</p><p>19.2 Specifications</p><p>19.2.1 Technical Specifications</p><p>19.2.2 Electromagnetic Compatibility</p><p>19.2.2.1 USA - FCC Notice</p><p>19.2.2.2 Europe - RED</p><p>19.2.3 Protocols and Standards</p><p>20 Troubleshooting</p><p>21 Recycling</p><p>22 Warranty</p><p>22.1 General Warranty Conditions</p><p>22.2 Limited Warranty</p><p>22.3 Warranty Conditions for Accessories</p><p>23 Guidance and Manufacturer's Declaration on EMC</p><p>23.1 Electromagnetic Compatibility</p><p>23.2 Electrostatic</p><p>Discharge (ESD)</p><p>23.3 Electromagnetic Compatibility and Interference Guidance</p><p>23.4 EMC and essential performances</p><p>23.4.1 Table 1 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions</p><p>23.4.2 Table 2 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity</p><p>23.4.3 Table 4 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity</p><p>23.4.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the Agilia Pump</p><p>23.4.5 EMC test deviations and suplementary tests</p><p>24 Servicing</p><p>24.1 Information on Device Servicing</p><p>24.2 Maintenance Requirements</p><p>24.3 Quality Control</p><p>25 Glossary of Terms</p><p>Appendix: Factory Configuration</p><p>Index</p><p>It is the interface of the power supply. The AC power board is located on the angle bracket.</p><p>See figure 2.1, page 8. This allows the power supply board to be changed without the need for soldering.</p><p>This board is connected to other parts with the connectors shown below.</p><p>Legend</p><p>J1 Connector - Connection to Power Supply</p><p>Board</p><p>Line Fuse F1</p><p>J2 Connector - Power Cord Inlet Fuse Identification Label</p><p>Pin n° Signal Description</p><p>1 Neutral Neutral wire</p><p>2 Line Hot wire</p><p>3 GND Ground</p><p>Pin n° Signal Description</p><p>1 Neutral Neutral wire</p><p>2 Line Hot wire</p><p>3 GND Ground</p><p>J1</p><p>J2</p><p>F1 1</p><p>J1 J1F1</p><p>J2 J11</p><p>24</p><p>2.1.7 Wi-Fi Board</p><p>Figure 2.13: Wi-Fi Board (Front View)</p><p>Figure 2.14: Wi-Fi Board (Back View)</p><p>J1 Connector to CPU Board</p><p>For Agilia Wi-Fi pumps only.</p><p>The Wi-Fi board is securely fixed to a holder above the CPU Board.</p><p>A ribbon cable connects it to the CPU Board with the J1 connector.</p><p>Legend</p><p>J1 Connector - Connection to CPU Board</p><p>Pin n° Signal Description</p><p>1 Floating Not used on Agilia VP range. Leave floating</p><p>2 Floating Not used on Agilia VP range. Leave floating</p><p>3 GND Ground</p><p>4 Floating Not used on Agilia VP range. Leave floating</p><p>5 Floating Not used on Agilia VP range. Leave floating</p><p>6 GND Ground</p><p>7 WIFI_VCC +3V3 Wi-Fi power supply</p><p>8 WIFI_VCC +3V3 Wi-Fi power supply</p><p>9 UART-RxD Receive data</p><p>10 UART-TxD Transmit data</p><p>11 UART-RTS Hardware Flow Control (Request to send)</p><p>12 UART-CTS Hardware Flow control (Clear to send)</p><p>13 GND Ground</p><p>14 GND Ground</p><p>J1</p><p>J1</p><p>25</p><p>2.1.8 Back View</p><p>Figure 2.15: Back View</p><p>2.1.9 Mechanical Framework Assembly</p><p>2.1.10 Mechanical Plunger Driver Assembly</p><p>Legend</p><p>Release Button Power Cord Inlet</p><p>Rotating Pole Clamp Infrared Cell</p><p>RS232 Communication Port Attachment Lock Knob</p><p>The mechanical framework assembly is made up of a motor-reducer unit which drives a rack screw-nut</p><p>assembly, made up of 2 flanges and a linear sensor.</p><p>The mechanical assembly also contains a photo-electric cell dedicated to monitoring the motor’s rotation.</p><p>The mechanical plunger driver assembly is located on the mechanical framework. The framework ensures</p><p>the displacement of the plunger via a screw-nut system.</p><p>The plunger driver is equipped with a disengagement control which allows it to disassociate from the</p><p>screw-nut system.</p><p>6</p><p>4</p><p>3</p><p>5</p><p>21</p><p>1 4</p><p>12 35</p><p>3 36</p><p>26</p><p>2.2 Principles of Operation</p><p>2.2.1 Syringe Test and Maintenance Sub-assembly</p><p>2.2.2 Motor Sub-assembly</p><p>2.2.3 External Connection Sub-assembly</p><p>From an operational point of view, the Agilia SP range of pumps is made up of 3 sub-assemblies:</p><p> Syringe test and maintenance</p><p> Motory</p><p> External connection</p><p>The syringe is positioned in its housing and held in place by the syringe barrel clasp.</p><p>Detection of the syringe size (minimum of 5 mL and maximum of 60 mL) is ensured by the potentiometric</p><p>sensor positioned on the syringe barrel clasp.</p><p>The correct positioning of the syringe flanges in the groove is checked by detecting the flanges.</p><p>The motor sub-assembly ensures the displacement of the syringe piston.</p><p>It is set in motion by a motor-reducer linked to a screw-nut system.</p><p>Rotation control is ensured by a pinion attached to a motor shaft end and connected to an opto-electric</p><p>sensor.</p><p>A linear potentiometer mounted on an aluminum profile uses a rolling ball contact to ensure plunger</p><p>displacement control.</p><p>A micro-switch allows the disengagement mechanism position to be checked.</p><p>Correct positioning of the piston against the plunger driver is tested by the anti-siphon arms.</p><p>A force sensor integrated into the plunger driver detects the force exerted on the piston, and triggers an</p><p>alarm when the limit has been reached.</p><p>The Agilia SP range of pumps has two plugs located at the back of the angle bracket. See figure 2.15,</p><p>page 25.</p><p> AC power supply plug</p><p> 8-pin binder plug which, together with various specific Fresenius Kabi accessories, enables the</p><p>following:</p><p>- Continuous external power supply</p><p>- Serial link</p><p>27</p><p>2.3 Operation Diagram</p><p>Opening</p><p>levers</p><p>Stepper</p><p>motor</p><p>Pumping mechanism</p><p>Main microprocessor</p><p>Flash memory</p><p>RAM memory</p><p>Motor driver</p><p>KeypadDisplay</p><p>Interface</p><p>LEDs</p><p>Battery</p><p>Communication</p><p>interface</p><p>Internal</p><p>watchdog</p><p>Sound</p><p>management</p><p>Temperature sensor</p><p>Plunger driver head</p><p>Force</p><p>sensor</p><p>Optical sensor</p><p>(plunger driver</p><p>head)</p><p>Opening</p><p>arms</p><p>Optical sensor</p><p>interface</p><p>Linear</p><p>potentionmeter</p><p>Position sensor</p><p>Electronic</p><p>interface</p><p>Gear</p><p>box</p><p>Half nuts</p><p>Switch</p><p>(disengagement)</p><p>Optical sensor</p><p>(disengagement)</p><p>Force sensor</p><p>Integrated</p><p>amplifier</p><p>communication</p><p>Plunger head</p><p>Electronic</p><p>interface</p><p>Switch (detection)</p><p>Syringe barrel clasp</p><p>Potentiometer</p><p>Syringe installation</p><p>Electronic</p><p>interface</p><p>communication</p><p>Optical</p><p>sensor</p><p>AC</p><p>power supply</p><p>(if present)</p><p>CPU BOARD</p><p>AC POWER BOARD</p><p>Wi-Fi BOARD</p><p>DISPLAY BOARD</p><p>AC/DC</p><p>converterDC supplies</p><p>Power supply</p><p>Safety management</p><p>H</p><p>P</p><p>Different</p><p>voltages</p><p>External connector</p><p>Speaker</p><p>IrDa</p><p>communication</p><p>Microphone</p><p>Communication</p><p>RS232 to USB cable</p><p>POWER SUPPLY BOARD</p><p>Secondary</p><p>microprocessor</p><p>Internal watchdog Interface</p><p>Battery/Battery</p><p>charger</p><p>Supervisory circuit</p><p>Watchdog</p><p>EMC filter</p><p>28</p><p>3 Fundamentals</p><p>3.1 Training</p><p>3.2 Maintenance Schedule</p><p>3.2.1 Preventive Maintenance</p><p>3.2.2 Quality Control</p><p>The following three training levels outline the specifics needed to maintain and preserve the equipment.</p><p>Training level Description / Prerequisites</p><p>1</p><p>Training intended for users for on-site maintenance, using the technical documentation of the pump and</p><p>specific tools.</p><p>This degree of maintenance does not need an important inventory.</p><p> Mechanical and electrical knowledge.</p><p> Biomedical structures knowledge.</p><p>2</p><p>Training intended for technicians specialized in maintenance performed with specific tools and</p><p>procedures.</p><p> Good mechanical and electronics knowledge.</p><p> Two years experience minimum in a biomedical department.</p><p>3</p><p>Training intended for technicians specialized in repair performed in the maintenance department using</p><p>specific procedures and tools, including instruments for measurement and adjustment.</p><p>Complete check-up using this document.</p><p> Good mechanical and electrical knowledge.</p><p> Good computer knowledge.</p><p> Two years experience minimum in a biomedical department.</p><p>INFORMATION</p><p>For training, contact your Fresenius Kabi sales representative.</p><p>Any abnormal functioning or failures must be reported to the qualified technical staff in your organization,</p><p>or to your Fresenius Kabi representative. In these instances, the pump should not be used.</p><p>WARNING</p><p>In order to maintain the pump’s performance, a preventive maintenance inspection must be carried out at</p><p>least once every 3 years. This procedure, which includes changing the battery, should be carried out by</p><p>trained and qualified technical personnel in compliance with this document and procedures. Only</p><p>authorized personnel should attempt to repair the device.</p><p>If these maintenance procedures are not observed, the pump’s correct operation will be impaired.</p><p>Upon request by the healthcare facility, a quality control check can be performed on the device every</p><p>12 months.</p><p>A regular quality check (not included in the guarantee) consists of various inspection operations listed in</p><p>this document. See section 6.2, page 39.</p><p>INFORMATION</p><p>These control checks must be performed by trained technical personnel, and are not covered by any</p><p>contracts or agreements provided by Fresenius Kabi.</p><p>For more information, contact your Fresenius Kabi sales representative.</p><p>29</p><p>3.3 Accessing / Exiting the Operating Functions</p><p>3.3.1 Accessing the Options Menu</p><p>Commands</p><p>3.3.2 Exiting the Options Menu</p><p>The Options menu gives access to the functions for operating the pump. The Options menu allows the</p><p>operator to customize the pump, edit infusion and maintenance parameters, and run tests.</p><p>The Options menu comprises the following:</p><p> Pump Settings</p><p> Basic Profile Configuration / Basic & TCI configuration (for Agilia SP TIVA pumps only)</p><p> Profile Menu</p><p> Maintenance</p><p>When the pump is powered off, simultaneously press both and to access the Options menu.</p><p>Options Menu</p><p>Access code? Description</p><p>Pump Settings No (unless modified by Test20) Please refer to the IFU.</p><p>Profile Yes Section 4, page 30.</p><p>Basic Profile Configuration Yes Section 5, page 32.</p><p>Maintenance Yes Section 6, page 37.</p><p>INFORMATION</p><p>If the wrong access code is entered, Error is displayed.</p><p>As long as the pump remains powered on, the code does not need to be entered again.</p><p>Operation Key</p><p>Scroll options and change selected value (increasing/decreasing) Arrow keys</p><p>Confirm Value / Move to Next Field Confirmation key</p><p>Select -Deselect  Fast Increment key</p><p>Go to parent menu (if any) and cancel option Menu key</p><p>Power the pump off and on again to exit the Options menu and return to standard operation.</p><p>All data, including newly selected and entered option, is saved to memory when the pump is powered off.</p><p>30</p><p>4 Profile Menu</p><p>4.1 Accessing the Profile Menu</p><p>4.2 Profile Menu Functions</p><p>1. Access the Options menu. See section 3.3, page 29.</p><p>2. Press the arrow keys to select Profile menu.</p><p>3. Press enter.</p><p>4. Enter the Profile menu access code "0080".</p><p>5. Press OK.</p><p>Function Choice Action</p><p>Pro 1: Default profile Basic Profile Displays the active profile name, and gives access to</p><p>the profile menu by the confirmation key.</p><p>Selects and loads a profile. See procedure below.</p><p>Profile 1</p><p>Profile 2</p><p>...</p><p>Pro 2: Select profile at power on Select  - Deselect  Activates or deactivates profile selection at startup.</p><p>Pro 3: Restore Basic Profile (Factory settings) - Restores the Basic Profile factory settings to the</p><p>pump.</p><p>Pro 4: Data set information at power on Select  - Deselect </p><p>Activates or deactivates Data set screen at startup.</p><p>This configuration is displayed only if a Data set is</p><p>loaded in the pump.</p><p>Selecting and loading a profile</p><p>1. Access the Profile menu.</p><p>2. Press the arrow keys to select Pro1: Default profile.</p><p>3. Press enter.</p><p>4. Press the arrow keys to select the profile name in the list provided.</p><p>5. Press OK.</p><p>The relevant profile information is displayed:</p><p> Profile name</p><p> Author</p><p> Creation date</p><p> Modification date</p><p> Version</p><p>INFORMATION</p><p>In addition to Basic Profile, the default profile names are available if specified with Vigilant Drug'Lib.</p><p>Vigilant Drug'Lib may not be available in some countries. Contact your Fresenius Kabi sales</p><p>representative.</p><p>31</p><p>6. Press OK to confirm the loading operation, or C to change the profile.</p><p>The drug library associated with the selected profile is loaded.</p><p>32</p><p>5 Basic Profile Configuration</p><p>5.1 Accessing the Basic Profile Configuration</p><p>5.2 Basic Profile Configuration Functions</p><p>The Basic Profile Configuration menu is available only if Basic Profile has previously been selected as the</p><p>default profile. See section 4, page 30.</p><p>1. Access the Options menu. See section 3.3, page 29.</p><p>2. Press the arrow keys to select Basic Profile configuration.</p><p>3. Press enter.</p><p>4. Enter the Basic Profile configuration access code "0200".</p><p>5. Press OK.</p><p>6. Press the arrow keys to select the setting category (User or Ward).</p><p>7. Press enter.</p><p>Function Setting Description Range of Settings</p><p>User 1:</p><p>Screen options Vol-dose information Displays the volume-dose on the</p><p>infusion monitoring screen.</p><p>Enabled / Disabled</p><p>Time information Displays the remaining infusion time</p><p>on the infusion monitoring screen.</p><p>Enabled / Disabled</p><p>Battery life information Displays the battery life information</p><p>on the infusion monitoring screen.</p><p>Enabled / Disabled</p><p>Logo Man Displays a man as infusion in</p><p>progress indicator</p><p>Enabled / Disabled</p><p>Logo Syringe Displays a syringe as infusion in</p><p>progress indicator</p><p>Enabled / Disabled</p><p>User 2:</p><p>Menu items</p><p>Profile Displays or hides menu items</p><p>available for Basic Profile.</p><p>Enabled / Disabled</p><p>Volume limit</p><p>Volume/Time</p><p>or Dose/Time</p><p>Pause</p><p>Patient</p><p>Wake up conc. (for Agilia</p><p>SP TIVA only)</p><p>TCI setup (for Agilia SP</p><p>TIVA only) TCI</p><p>Programmed bolus</p><p>Alarm volume</p><p>Vol-dose history</p><p>View event log</p><p>Library information</p><p>Data Set</p><p>Pro</p><p>VL</p><p>V/T</p><p>D/T</p><p>DS</p><p>33</p><p>User 4: Pressure Mode Selects the mode.</p><p> Variable: One initial pressure</p><p>value that can be adjusted during</p><p>infusion.</p><p> 3 levels: 3 fixed pressure limits</p><p>that can be selected during</p><p>infusion.</p><p>3 levels / Variable</p><p>DPS Activates or deactivates the DPS</p><p>(Dynamic Pressure System) mode</p><p>while an infusion is in progress.</p><p>Yes / No</p><p>Unit Selects the pressure unit. mmHg / kPa (for</p><p>Japanese market only) /</p><p>PSI</p><p>Maximum pressure value If Mode = Variable, defines the</p><p>maximum pressure allowed during</p><p>an infusion.</p><p>50  900 mmHg</p><p>High pressure value If Mode = 3 levels, defines the</p><p>maximum pressure allowed during</p><p>an infusion.</p><p>250  900 mmHg</p><p>Medium pressure value If Mode = 3 levels, defines the</p><p>medium pressure allowed during an</p><p>infusion.</p><p>150  600 mmHg</p><p>Low pressure value If Mode = 3 levels, defines the low</p><p>pressure allowed during an infusion.</p><p>50  300 mmHg</p><p>Limit stored If enabled, the last pressure limit</p><p>adjustment is automatically stored in</p><p>memory for the next startup.</p><p>If disabled, the user has to enter</p><p>pressure limit for the next startup.</p><p>Enabled / Disabled</p><p>Limit If Limit stored is disabled, sets the</p><p>maximum pressure allowed during</p><p>an infusion.</p><p>If Limit stored is enabled, the limit is</p><p>set to ’---’ and cannot be changed.</p><p>50 mmHg  "Maximum</p><p>pressure value"</p><p>Drop threshold If DPS = Yes, sets a pressure drop</p><p>threshold. A message is generated if</p><p>the pressure drops below this</p><p>threshold.</p><p>’----’ (No drop pressure</p><p>monitoring) or:</p><p>100  500 mmHg</p><p>Raise threshold If DPS = Yes, defines a pressure rise</p><p>threshold. A message is generated if</p><p>the pressure rises above this</p><p>threshold.</p><p>50  400 mmHg</p><p>DPS stored If DPS = Yes and DPS stored is</p><p>enabled, the latest DPS adjustments</p><p>during infusion are saved</p><p>automatically at power off for the</p><p>next startup.</p><p>If DPS stored is disabled, the DPS</p><p>adjustments must be entered at the</p><p>next startup.</p><p>Enabled / Disabled</p><p>User 5: KVO KVO1 Sets the KVO1 flow rate. 0.1  5 mL/h</p><p>KVO2 Sets the KVO2 flow rate. 0.1  5 mL/h</p><p>Continuous Activates the Continuous function.</p><p>After the VTBI is completed, the</p><p>infusion continues at the</p><p>programmed flow rate.</p><p>Yes / No</p><p>Silence duration Sets the silence duration alarm in</p><p>KVO.</p><p>1 min  12 hours</p><p>Function Setting Description Range of Settings</p><p>34</p><p>User 12:</p><p>Graph items</p><p>View flow rate history Displays or hides menu item: View</p><p>flow rate history.</p><p>Enabled / Disabled</p><p>View pressure history Displays or hides menu item: View</p><p>pressure history.</p><p>Enabled / Disabled</p><p>View concentration history Displays or hides menu item: View</p><p>concentration history (For</p><p>Agilia SP TIVA only).</p><p>Enabled / Disabled</p><p>User 13:</p><p>Default TCI</p><p>Numerical screen Displays or hides menu item: TCI</p><p>display (For Agilia SP TIVA only).</p><p>Enabled / Disabled</p><p>Graphical screen Enabled / Disabled</p><p>Par 1:</p><p>Key press sound</p><p>Key press sound Turns the key press sound on or off. Enabled / Disabled</p><p>Par 2:</p><p>Alarm Volume</p><p>Alarm Volume Sets the volume for alarms. 7 volume levels</p><p>Par 3:</p><p>Store infusion</p><p>parameters</p><p>Drug and parameters:</p><p> Store drug name only</p><p> Store param. infusion</p><p>Saves the drug name only, or all</p><p>infusion parameters, or nothing.</p><p>Enabled / Disabled</p><p>Same infusion screen:</p><p>Displayed</p><p>If Displayed is enabled, enables the</p><p>display of the same infusion screen.</p><p>Enabled / Disabled</p><p>Same infusion screen:Time Duration of context backup. 1  24 hours</p><p>Volume infused: Cleared If Cleared is enabled, the infused</p><p>volume is reset to 0 at each infusion</p><p>start.</p><p>Enabled / Disabled</p><p>Volume infused: Stored If Stored is enabled, the infused</p><p>volume is saved in memory.</p><p>Enabled / Disabled</p><p>Par 4:</p><p>Maximum rate</p><p>Maximum rate for 50 mL</p><p>syringe</p><p>Sets the maximum infusion rate for</p><p>50 / 60 mL syringes.</p><p>0.1  1200 mL/h</p><p>Maximum rate for 30 mL</p><p>syringe</p><p>Sets the maximum infusion rate for</p><p>30 mL syringes.</p><p>0.1  600 mL/h</p><p>Maximum rate for 20 mL</p><p>syringe</p><p>Sets the maximum infusion rate for</p><p>20 mL syringes.</p><p>0.1  600 mL/h</p><p>Maximum rate for 10 mL</p><p>syringe</p><p>Sets the maximum infusion rate for</p><p>10 mL syringes.</p><p>0.1  350 mL/h</p><p>Maximum rate for 5 mL</p><p>syringe</p><p>Sets the maximum infusion</p><p>rate for</p><p>5 mL syringes.</p><p>0.1  250 mL/h</p><p>Par 7:</p><p>Infusion start</p><p>Infusion start: Mandatory</p><p>prime</p><p>Displays a Mandatory prime</p><p>message, an Advised prime</p><p>message, or no message prior to</p><p>starting an infusion.</p><p>Enabled / Disabled</p><p>Infusion start: Advised</p><p>prime</p><p>Enabled / Disabled</p><p>Par 8:</p><p>Empty syringe</p><p>Empty syringe mode If Empty syringe mode is enabled,</p><p>an "Empty syringe mode" banner</p><p>starts blinking after the</p><p>acknowledgement of a medium-</p><p>priority "End of infusion" alarm.</p><p>Enabled / Disabled</p><p>Par 9:</p><p>Bolus rates</p><p>50 mL Sets the bolus rate for 50 mL</p><p>syringes.</p><p>0.1  1200 mL/h</p><p>30 mL Sets the bolus rate for 30 mL</p><p>syringes.</p><p>0.1  600 mL/h</p><p>20 mL Sets the bolus rate for 20 mL</p><p>syringes.</p><p>0.1  600 mL/h</p><p>10 mL Sets the bolus rate for 10 mL</p><p>syringes.</p><p>0.1  350 mL/h</p><p>5 mL Sets the bolus rate for 5 mL</p><p>syringes.</p><p>0.1  250 mL/h</p><p>Par 15:</p><p>Syringe/ward name</p><p>displays</p><p>Syringe name Displays the syringe or ward name in</p><p>the Infusion monitoring screen.</p><p>Enabled / Disabled</p><p>Ward name</p><p>Function Setting Description Range of Settings</p><p>35</p><p>Par 18:</p><p>Day/Night mode</p><p>Screen brightness low Brightens or darkens the screen at</p><p>next night mode startup.</p><p>Enabled / Disabled</p><p>Infusion indicators low Brightens or darkens the infusion</p><p>indicators at next night mode startup.</p><p>Enabled / Disabled</p><p>Key press sound off Turns on or off the key press sound</p><p>at next night mode startup.</p><p>Enabled / Disabled</p><p>Manual mode Displays or hides "Day/Night mode"</p><p>menu item.</p><p>Enabled / Disabled</p><p>Auto mode Enables/disables the ability to</p><p>automatically activate night mode.</p><p>Enabled / Disabled</p><p>Day/Night mode If Auto mode is enabled, press OK</p><p>to set a daily period for the automatic</p><p>activation of night mode.</p><p>00h00  23h59</p><p>00:00  23:59</p><p>Par 19:</p><p>Other functions</p><p>Direct bolus Activates or deactivates the Direct</p><p>bolus function.</p><p>Enabled / Disabled</p><p>Loading dose or Induction</p><p>dose (Agilia SP TIVA)</p><p>Activates or deactivates the Loading</p><p>dose or Induction dose function.</p><p>Enabled / Disabled</p><p>Programmed bolus Activates or deactivates the</p><p>Programmed bolus function.</p><p>Enabled / Disabled</p><p>Par 20:</p><p>Authorized units</p><p>Concentration units Sets the available concentration</p><p>units: nanog, µg, mg, g, mmol, munit,</p><p>unit, cal, kcal, mEq, /mL, /XmL</p><p>Enabled / Disabled</p><p>Dose rate unit Sets the available dose units:</p><p>nanog/h, nanog/kg/min, nanog/kg/h,</p><p>µg/h, µg/min, µg/kg/min, µg/kg/h,</p><p>mg/min, mg/h, mg/24h, mg/kg/min,</p><p>mg/kg/h, mg/kg/24h, mg/m2/h,</p><p>mg/m2/24h, g/h, g/kg/min, g/kg/h,</p><p>g/kg/24h, mmol/h, mmol/kg/h,</p><p>mmol/kg/24h, munit/min,</p><p>munit/kg/min, munit/kg/h, unit/min,</p><p>unit/h, unit/kg/min, unit/kg/h, kcal/h,</p><p>kcal/24h, kcal/kg/h, mEq/min,</p><p>mEq/h, mEq/kg/min, mEq/kg/h, /mL,</p><p>--mL, mL/kg/h, mL/kg/24h</p><p>Enabled / Disabled</p><p>Par 22:</p><p>Programming modes</p><p>Dose Sets the available modes for the</p><p>profile.</p><p>Enabled / Disabled</p><p>Par 23:</p><p>Patient default</p><p>parameters</p><p>Age (years) Sets the patient age. From 1 year to 150 years</p><p>Min weight (kg) Sets the lower programmable limit of</p><p>patient weight.</p><p>0.25 kg 350 kg</p><p>Max weight (kg) Sets the upper programmable limit of</p><p>patient weight.</p><p>"Min weight (kg)" </p><p>350 kg</p><p>Default weight (kg) Sets the patient default weight. "Min weight (kg)" </p><p>"Max weight (kg)"</p><p>Min height (cm) Sets the lower patient height. 20 cm 250 cm</p><p>Max height (cm) Sets the upper patient height. "Min height (cm)" 250</p><p>cm</p><p>Default height (cm) Sets the default patient height. "Min height (cm)"</p><p> "Max height (cm)"</p><p>Min surface (m²) Sets the lower programmable limit of</p><p>patient BSA.</p><p>0.05 m² 4.5 m²</p><p>Max surface (m²) Sets the upper programmable limit of</p><p>patient BSA.</p><p>"Min surface (m²)"</p><p> 4.5 m²</p><p>Default surface (m²) Sets the default patient BSA. "Min surface (m²)"</p><p></p><p>"Max surface (m²)"</p><p>Function Setting Description Range of Settings</p><p>36</p><p>Note:</p><p> The displayed menu may change depending on the pump configuration and destination country.</p><p> µ = mc or micro.</p><p>Par 25:</p><p>Same therapy</p><p>screen</p><p>Same therapy screen Displays the same therapy screen</p><p>when changing current drug.</p><p>Yes / No</p><p>Par 31:</p><p>Near end of infusion</p><p>alert</p><p>Time Sets the remaining time that triggers</p><p>the Near end of infusion alert.</p><p>1  30 min</p><p>Par 34:</p><p>Rate titration</p><p>While stopped only If While stopped only is enabled,</p><p>allows rate modification after an</p><p>infusion stop only.</p><p>Enabled / Disabled</p><p>Function Setting Description Range of Settings</p><p>37</p><p>6 Maintenance Operations</p><p>6.1 Maintenance Options</p><p>6.1.1 Accessing the Maintenance Options Menu</p><p>6.1.2 Maintenance Date</p><p>6.1.3 Initial Set up</p><p>1. Access the Options menu. See section 3.3, page 29.</p><p>2. Press the arrow keys to select Maintenance.</p><p>3. Press enter.</p><p>4. Enter the Maintenance access code.</p><p>5. Press OK.</p><p>6. Press the arrow keys to select Maintenance options.</p><p>7. Press enter.</p><p>1. Access the Maintenance options menu. See section 6.1.1, page 37.</p><p>2. Press the arrow keys to select Svc 1: Maintenance date.</p><p>3. Press enter.</p><p>The next scheduled maintenance date is displayed.</p><p>4. Press exit to return to the Maintenance options menu.</p><p>INFORMATION</p><p>This date corresponds to the next preventive maintenance date to be carried out.</p><p>See section 3.2.1, page 28.</p><p>The date is displayed for consultation only, and cannot be changed here.</p><p>1. Access the Maintenance options menu. See section 6.1.1, page 37.</p><p>2. Press the arrow keys to select Svc 2: Initial set up.</p><p>3. Press enter.</p><p>4. Select Yes using the arrow keys to ask for the initial configuration to be</p><p>loaded at the next pump startup. Otherwise, select No.</p><p>5. Press OK to confirm the selection.</p><p>38</p><p>6.1.4 Data Log Event</p><p>6.1.5 Maintenance Information</p><p>1. Access the Maintenance options menu. See section 6.1.1, page 37.</p><p>2. Press the arrow keys to select Svc 3: Data log event.</p><p>3. Press enter.</p><p>4. Use the arrow keys to select the desired clinical or technical event.</p><p>5. Press enter.</p><p>The details of the event are displayed.</p><p>6. Press exit to return to the Maintenance options menu.</p><p>1. Access the Maintenance options menu. See section 6.1.1, page 37.</p><p>2. Press the arrow keys to select Svc 4: Maintenance information.</p><p>3. Press enter.</p><p>4. Press to allow or disallow the display of a Maintenance info. screen at the</p><p>next pump startup.</p><p>5. Press OK to confirm the selection.</p><p>39</p><p>6.2 Running Tests</p><p>6.2.1 Accessing the Tests Menu</p><p>List of Tests</p><p>You must systematically run tests after calibrating sensors.</p><p>At the end of a full test cycle, you can obtain certificates. See section 6.3.2, page 69.</p><p>INFORMATION</p><p>Before running Tests/Controls from the pump or with Agilia Partner, it is recommended to work with a</p><p>pump configured with the Basic Profile and with Factory (default) settings. Load the Basic Profile from the</p><p>pump’s maintenance Profile menu: "Pro 3:Restore Basic Profile". See section 4.2, page 30.</p><p>Calibration Associated Tests</p><p>Force sensor  Occlusion alarm</p><p>Syringe barrel clasp  Syringe barrel clasp</p><p>Displacement  Displacement</p><p>1. Access the Options menu. See section 3.3, page 29.</p><p>2. Press the arrow keys to select Maintenance.</p><p>3. Press enter.</p><p>4. Enter the Maintenance access code.</p><p>5. Press OK.</p><p>6. Press the arrow keys to select Tests.</p><p>7. Press enter.</p><p>The Tests screen is displayed.</p><p>Tests Tests</p><p>Test 1 Identification. See section 6.2.2, page 40. Test 11 Ageing test. See section 6.2.12, page 51.</p><p>Test 2 Maintenance options. See section 6.2.3, page 41. Test 12 Battery life. See section 6.2.13, page 52.</p><p>Test 3 Maintenance messages.</p><p>See section 6.2.4, page 41. Test 13 Battery test. See section 6.2.14, page 53.</p><p>Test 4 Events. See section 6.2.5, page 41. Test 20 Pump code. See section 6.2.15, page 55.</p><p>Test 5 Force. See section 6.2.6, page 42. Test 21 Power information. See section 6.2.16, page 55.</p><p>Test 6 Displacement. See section 6.2.7, page 44. Test 22 LCD voltage. See section 6.2.17, page 57.</p><p>Test 7 Syringe barrel clasp. See section 6.2.8, page 46. Test 23 Temperature. See section 6.2.18, page 57.</p><p>Test 8 Battery information. See section 6.2.9, page 49. Test 24 Watchdog. See section 6.2.19, page 58.</p><p>Test 9 Indication. See section 6.2.10, page 50. Test 25 Wi-Fi module information.</p><p>See section 6.2.20, page 59.</p><p>Test 10 Keypad. See section 6.2.11, page 50.</p><p>40</p><p>6.2.2 Test 1: Identification</p><p>Test Description</p><p>This test checks that the Identification parameters of the pump are correct. The Identification</p><p>parameters are displayed for information only. They cannot be modified here.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 1: Identification.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Pump name</p><p> Pump version or revision with software generation date</p><p> Pump serial number</p><p> CPU board serial number</p><p> Power supply board serial number</p><p> Power supply board software version or software revision with the</p><p>generation date</p><p> Battery serial number</p><p> For each language available:</p><p>- Language name</p><p>- Language file version or revision</p><p>- Language file creation date</p><p> For each parameter zone:</p><p>- Parameter zone number + version or revision</p><p>- Parameter zone creation date</p><p>- Last manual modification date</p><p> Boot version or revision</p><p> Boot creation date</p><p> Embedded software version or software revision with the generation date</p><p>5. Press exit to return to the Tests menu.</p><p>41</p><p>6.2.3 Test 2: Maintenance</p><p>6.2.4 Test 3: Maintenance Messages</p><p>6.2.5 Test 4: Events</p><p>Test Description</p><p>Run this test to check that the pump maintenance data is correct.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 2: Maintenance.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Duration: Running time since last preventive maintenance in hours (if less</p><p>than 72 hours), in days (if less than 120 days) or in months</p><p> Date: Last preventive maintenance date</p><p> Total duration: Total running time in hours (if less than 72 hours), in days</p><p>(if less than 120 days) or in months.</p><p> Total distance: Total running distance of the plunger’s driver in m.</p><p>5. Press exit to return to the Tests menu.</p><p>Test Description</p><p>Run this test to check the maintenance messages entered. The maintenance message is</p><p>displayed for information only. It cannot be modified here.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 3: Maintenance messages.</p><p>3. Press enter.</p><p>Informational messages stored by After Sales Service are displayed.</p><p>4. Press exit to return to the Tests menu.</p><p>Test Description</p><p>Run this test to consult the list of pump events, and the details of each recorded technical event.</p><p>The clinical events are not displayed here.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 4: Events.</p><p>3. Press enter.</p><p>The technical events are listed.</p><p>4. Press the arrow keys to select an event.</p><p>5. Press enter.</p><p>The selected event is displayed in detail.</p><p>6. Press the arrow keys to scroll through the event detail screen.</p><p>7. Press exit to return to the list of events.</p><p>42</p><p>6.2.6 Test 5: Force</p><p>Test Description</p><p>The syringe force sensor is used to monitor the pressure and detect occlusions in the syringe.</p><p>Run this test to validate the accuracy of the force sensor.</p><p>This test checks the pressure inside the syringe when an occlusion alarm is triggered.</p><p>The force sensor works properly and is correctly calibrated.</p><p>This test failed if one of these two conditions is encountered:</p><p> The force sensor is not calibrated. Calibrate the force sensor using Agilia Partner</p><p>maintenance software.</p><p> The force sensor is defective, or not correctly connected to the CPU board. This</p><p>problem leads to an error code 22:</p><p>- Check the cable connection to CPU board (J9 connector). See figure 2.7,</p><p>page 16.</p><p>- Replace the force sensor. See section 8.11, page 113.</p><p>Required Tools and Equipment</p><p> 1 Dynamometer</p><p>Prerequisites</p><p> The dynamometer’s calibration certificate is valid.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 5: Force.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Conversion: Sensor value in mV. The displayed voltage value depends on</p><p>the pressure applied on the sensor</p><p> Force: Force value expressed in g</p><p> 0 sensor: Sensor offset value expressed in mV. Value saved during last</p><p>calibration</p><p> Force = 0 kg: Calibration at 0 kg (0 PSI or 0 bar) in mV. Value saved</p><p>during last calibration</p><p> Force = 5 kg: Calibration at 5 kg (11.6 PSI or 0.8 bar) in mV.Value saved during last calibration</p><p> Date: Date of last calibration displayed in the following format:</p><p>Month/Day/Year (mm/dd/yyyy)</p><p> Number: Last calibration number</p><p>5. Press the arrow keys to display the Conversion/Force screen.</p><p>6. Push the disengagement lever down and move the plunger driver to the right.</p><p>7. Apply a force to the sensor, then release it.</p><p>8. Check that the Force value is between -200 g and +200 g.</p><p>CPU BOARD</p><p>Force sensor</p><p>Main</p><p>microprocessor</p><p>Force sensor</p><p>Integrated</p><p>amplifier</p><p>43</p><p>Figure 6.1: Installation of dynamometer</p><p>9. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to</p><p>the right.</p><p>10.Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.</p><p>11.Secure the dynamometer with the syringe barrel clasp.</p><p>12.Slide the arms spacer to the left.</p><p>13.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with</p><p>the plunger head of the dynamometer.</p><p>14.Release the disengagement lever.</p><p>The arms must not be in contact with the arms spacer.</p><p>15.Apply a force of 0.4 bar.</p><p>16.Check that the Force value is between +2200 g and +2800 g.</p><p>17.Press exit to return to the Tests menu.</p><p>18.Open the syringe barrel clasp, push the disengagement lever down,</p><p>and move the plunger driver to the right to zero the pressure.</p><p>19.Start an infusion at 1000 mL/h.</p><p>20.Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than</p><p>60 seconds when 8.0 PSI (0.55 bar) < Pressure < 10.9 PSI (0.75 bar).</p><p>21.Press to silence the alarm.</p><p>22.Press to stop the infusion.</p><p>23.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to</p><p>the right.</p><p>24.Remove the dynamometer.</p><p>44</p><p>6.2.7 Test 6: Displacement</p><p>Test Description</p><p>The Displacement sensor is a linear potentiometer used to control the linear motion of the</p><p>plunger driver and to determine the remaining volume in the syringe.</p><p>Run this test to validate the accuracy of the displacement sensor.</p><p>The plunger’s driver displacement is correctly calibrated.</p><p>This test failed if one of these two conditions is encountered:</p><p> The displacement sensor is not calibrated. Calibrate the displacement sensor using</p><p>Agilia Partner maintenance software.</p><p> The displacement sensor is defective or not correctly connected to the CPU board.</p><p>This problem leads to an error code 21:</p><p>- Check the cable connection to CPU board (J2 connector).</p><p>See figure 2.7, page 16.</p><p>- Replace the displacement sensor. See section 8.12, page 118.</p><p>Required Tools and Equipment</p><p> 1 displacement verification gauge, 2.56 in (65 mm) long</p><p>Prerequisites</p><p> The calibration certificate of the displacement verification gauge is valid.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 6: Displacement.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Conversion: Sensor value in mV. The displayed voltage value depends on</p><p>the plunger head position</p><p> Position: Plunger head position value in mm</p><p> Low (20 mm): Sensor value in mV when the plunger head is positioned at</p><p>20 mm (0.79 in). Value saved during last calibration</p><p> High (115 mm): Sensor value in mV when the plunger head is positioned</p><p>at 115 mm (4.53 in). Value saved during last calibration</p><p> Date: Date of last calibration displayed in the following format:</p><p>Month/Day/Year (mm/dd/yyyy)</p><p> Number: Last calibration number</p><p> Linearization:</p><p>Date of last calibration that included a linearization. This</p><p>date is displayed in the following format: Month/Day/Year (mm/dd/yyyy)</p><p>CPU BOARD</p><p>Displacement</p><p>sensorMain</p><p>microprocessor</p><p>Linear potentiometer</p><p>Interface</p><p>45</p><p>Figure 6.2: Installation of the 2.56 in (65 mm) displacement gauge</p><p>5. Press the arrow keys to display the Conversion/Position screen.</p><p>6. Push the disengagement lever down, and move the plunger driver gently to the right stop.</p><p>7. Check the value displayed for Position. The value must be between 4.67 in and 5.41 in</p><p>(118.5 mm and 137.5 mm).</p><p>8. Push the disengagement lever down, and move the plunger driver gently to the left stop.</p><p>9. Check the value displayed for Position. The value must be between 0.39 in and 0.60 in</p><p>(10 mm and 15.2 mm).</p><p>10.Open the syringe barrel clasp and place the 2.56 in (65 mm) gauge in the syringe cradle, with the</p><p>flanges correctly inserted in the provided slot and the 2.56 in (65 mm) part positioned to the right.</p><p>11.Secure the gauge with the syringe barrel clasp.</p><p>12.Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact</p><p>with the gauge.</p><p>13.Check the value displayed for Position. The value must be between</p><p>2.5 in and 2.62 in (63.5 mm and 66.5 mm).</p><p>14.Open the syringe barrel clasp.</p><p>15.Push the disengagement lever down and move the plunger driver to the right.</p><p>16.Remove the 2.56 in (65 mm) displacement gauge.</p><p>17.Press exit to return to the Tests menu.</p><p>46</p><p>6.2.8 Test 7: Syringe Barrel Clasp</p><p>Test Description</p><p>The Syringe barrel clasp sensor is used to maintain the syringe in the pump, to detect the good</p><p>positioning of the syringe and to measure the diameter of the syringe.</p><p>Run this test to check:</p><p> correct measurement for the syringe diameter</p><p> correct functioning of the syringe fastening system</p><p>The plunger’s driver displacement is correctly calibrated.</p><p>This test failed if one of these two conditions is encountered:</p><p> The syringe barrel clasp sensor is not calibrated. Calibrate the syringe barrel clasp</p><p>sensor using Agilia Partner maintenance software.</p><p> The syringe barrel clasp sensor is defective or not correctly connected to the CPU</p><p>board. This problem leads to an error code 20:</p><p>- Check the cable connection to CPU board (J1 connector). See figure 2.7,</p><p>page 16.</p><p>- Replace the displacement sensor. See section 8.7, page 97.</p><p>Required Tools and Equipment</p><p> V1 diameter verification gauge, 11.5 mm (0.45 in) diameter</p><p> V2 diameter verification gauge, 15.5 mm (0.61 in) diameter</p><p> V4 diameter verification gauge, 28 mm (1.10 in) diameter</p><p>Prerequisites</p><p> The calibration certificates of the diameter verification gauges are valid.</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 7: Syringe barrel clasp.</p><p>3. Press enter.</p><p>CPU BOARD</p><p>Syringe barrel</p><p>clasp</p><p>Main</p><p>microprocessor</p><p>Opening arms</p><p>Interface</p><p>Syringe</p><p>installation</p><p>Optical sensor - disengagement</p><p>(plunger head)Opening levers</p><p>Potentiometer</p><p>Switch (syringe</p><p>detection)</p><p>47</p><p>Figure 6.3: Installation of V1 diameter verification gauge</p><p>Figure 6.4: Installation of V2 diameter verification gauge</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Conversion: Sensor value in mV. The displayed voltage value depends on</p><p>the syringe diameter installed</p><p> Diameter: Syringe diameter in mm. Value measured by the sensor.</p><p> Low (11 mm): Sensor value in mV when the C1 calibration tool</p><p>(diameter = 11 mm) is installed. Value saved during last calibration</p><p> Middle (22.9 mm): Sensor value in mV when the C2 calibration tool</p><p>(diameter = 22.9 mm) is installed. Value saved during last calibration</p><p> High (33 mm): Sensor value in mV when the C3 calibration tool</p><p>(diameter = 33 mm) is installed. Value saved during last calibration</p><p> Date: Date of last calibration</p><p> Number: Last calibration number</p><p>5. Press the arrow keys to display the Conversion/Diameter screen.</p><p>6. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to</p><p>the right.</p><p>7. Place the V1 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in</p><p>the provided slot.</p><p>8. Secure the V1 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.</p><p>9. Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm</p><p>(0.35 in to 0.47 in).</p><p>10.Open the syringe barrel clasp, and remove the V1 diameter verification gauge.</p><p>11.Place the V2 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in</p><p>the provided slot.</p><p>12.Secure the V2 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.</p><p>13.Check the value displayed for Diameter. The value must be equal to 15.5 mm ± 1.5 mm</p><p>(0.55 in to 0.70 in).</p><p>14.Open the syringe barrel clasp, and remove the V2 diameter verification gauge.</p><p>15.Place the V4 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in</p><p>the provided slot.</p><p>16.Secure the V4 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.</p><p>48</p><p>Figure 6.5: Installation of V4 diameter verification gauge</p><p>17.Check the value displayed for Diameter. The value must be equal to 28 mm ± 1.5 mm</p><p>(1.04 in to 1.16 in).</p><p>The test fails if one of these three Diameter values is outside the tolerance zone.</p><p>18.Press exit to return to the Tests menu.</p><p>19.Open the syringe barrel clasp, and remove the V4 diameter verification gauge.</p><p>49</p><p>6.2.9 Test 8: Battery Info</p><p>Test Description</p><p>This test provides information about battery usage time, voltage output, current output, and</p><p>temperature.</p><p>Run this test to check that the battery data is correct.</p><p>The battery capacity is acceptable.</p><p>If this test fails:</p><p> Connect the pump to an AC power supply to charge the battery.</p><p> Run the test again. If the test fails, replace the battery.</p><p>See section 8.1, page 82.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 8: Battery info.</p><p>3. Press enter.</p><p>4. Press the arrow keys to scroll through the information screens.</p><p>The following data is displayed:</p><p> Duration: Battery operating time in hours, days and months</p><p> Cycles: Number of charge/discharge cycles, equivalent to Duration (in</p><p>hours) divided by 7</p><p> Since: Date of the first use on battery</p><p> Conversion and Voltage: Voltage value at the battery terminals in V, and</p><p>conversion into mV</p><p> Conversion and Temperature: Battery temperature in °C, and conversion</p><p>into LSB</p><p> Conversion and Current: Battery charge/discharge current in mA, and</p><p>conversion into LSB</p><p>5. Check that the displayed values are within the limits shown in the table below.</p><p>Value Limits</p><p>Voltage 5.0 V to 8.7 V</p><p>Current - Connected to an AC power supply, battery being charged</p><p>(battery charge status indicator is flashing)</p><p>-135 mA to -165 mA</p><p>Current - Connected to an AC power supply, battery fully charged</p><p>(battery charge status indicator is lit permanently)</p><p>-50 mA to +50 mA</p><p>Current - Pump running on battery</p><p>(battery charge status indicator is off)</p><p>-50 mA to -200 mA</p><p>Temperature +2 °C to +48 °C (+35.6 °F to +118.4 °F) for normal</p><p>room temperatures</p><p>6. Press exit to return to the Tests menu.</p><p>50</p><p>6.2.10 Test 9: Indication</p><p>6.2.11 Test 10: Keypad</p><p>Test Description</p><p>Run this test to check the correct functioning of display, battery charge status indicator, power</p><p>supply indicator, infusion indicator lights, microphone and buzzer.</p><p>The pump screen, indicators, microphone and buzzer work properly.</p><p>If this test fails, replace the display board and LCD display. See section 8.3, page 86.</p><p>Required Tools and Equipment</p><p>No specific tools or equipment are required</p><p>1. Access the Tests menu. See section 6.2.1, page 39.</p><p>2. Press the arrow keys to select Test 9: Indication.</p><p>3. Press enter.</p><p>4. Check that:</p><p> A white screen is displayed.</p><p> The battery charge status indicator,</p>