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Technical Service Manual OXYMAG – Emergency and Transport Ventilator Part Number: 1600185 Ver: 01 Software Ver: 1.n Copyright 2012 Magnamed Tecnologia Médica S/A Magnamed Tecnologia Médica S/A Rua São Paulino, 221 – Vila Mariana CEP: 04019-040 – São Paulo – SP – Brasil Tel: +55 (11) 5081-4115 / Fax: +55 (11) 5084-5297 E-mail: magnamed@magnamed.com.br Website: www.magnamed.com.br CNPJ: 01.298.443/0001-73 Inscrição Estadual: 149.579.528.111 http://www.magnamed.com.br/ 3 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 1 Revision History Designed by: Checked by: Approved by: Gilmar Wataru Ueda Toru M Kinjo Date( dd/mm/yyyy) Date (dd/mm/yyyy) Date (dd/mm/yyyy) 01/08/2012 01/08/12 10/08/2012 REV DESCRIPTION (dd/mm/yy) 01 Initial Revision 19/12/11 02 Inclusion of the exchange step of the display of mounted Pci and testing circuit battery charger and battery. 10/08/12 4 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 2 Index 1 REVISION HISTORY .............................................................................................................................. 3 2 INDEX ..................................................................................................................................................... 4 3 DEFINITIONS AND INFORMATIONS ..................................................................................................... 6 4 DESCRIPTION ........................................................................................................................................ 7 4.1 OPERATING PRINCIPLE ...................................................................................................................... 7 4.1.1 Electronic Description ................................................................................................................. 8 4.1.2 Pneumatic Description .............................................................................................................. 10 4.2 COMPONENT IDENTIFICATION ........................................................................................................... 11 4.2.1 Front Panel ............................................................................................................................... 11 4.2.2 Pneumatic Manifold .................................................................................................................. 12 5 MAINTENANCE .................................................................................................................................... 15 5.1 PREVENTIVE MAINTENANCE ............................................................................................................. 15 5.1.1 Check Points ............................................................................................................................ 15 5.1.2 Internla Li-Ion Battery ............................................................................................................... 16 5.1.3 Internal O2 Concentration Sensor ............................................................................................. 16 5.1.4 Ambient Air Replacement ......................................................................................................... 17 5.2 TROBLESHOOTING........................................................................................................................... 18 5.3 CORRECTIVE MAINTENANCE ............................................................................................................ 22 5.3.1 Device checking on reception ................................................................................................... 23 5.3.2 Corrective Maintenance Procedure .......................................................................................... 23 5.3.3 Oxymag disassembly ............................................................................................................... 29 5.3.4 Pneumatic Manifold Disassembly ............................................................................................. 31 5.3.5 Pneumatic Manifold Tests ........................................................................................................ 33 5.3.6 Front Panel Disassembly .......................................................................................................... 33 5.3.7 Front Panel Tests ..................................................................................................................... 34 5.3.8 Change the display of the pci complete mounted......................................................................35 5.3.9 Fixing the rotary button in the front panel ............................................................................... 356 5.3.10 Oxygen Sensor Replacement ................................................................................................. 377 5.3.11 Pneumatic Manifold Assembly ........................................................................................... 399 5.3.12 Oxymag Assembly Procedure .............................................................................................. 41 5.3.13 Oxymag Calibration Procedure .......................................................................................... 555 5.4 LIMPEZA, DESINFECÇÃO E ESTERILIZAÇÃO...................................................................................... 566 5.5 OXYMAG VENTILATOR ................................................................................................................... 566 5.6 CLEANING, DISINFECTION AND STERILIZATION PROCEDURES ........................................................... 577 6 TECHNICAL SPECIFICATION ........................................................................................................... 599 6.1 CLASSIFICATION ............................................................................................................................ 599 6.2 STANDARDS.................................................................................................................................. 599 6.3 SPECIFICATIONS ........................................................................................................................... 599 6.3.1 Electrical Characteristics .......................................................................................................... 60 6.3.2 Connection to Oxygen Supply .................................................................................................. 60 6.3.3 Environmental and Physical Specifications .............................................................................. 61 6.3.4 Ventilation Modes ..................................................................................................................... 61 6.3.5 Ventilation Parameter Adjustment Specifications ..................................................................... 62 6.3.6 Ventilation Monitor Specification............................................................................................... 65 6.3.7 Safety and Alarm Systems ....................................................................................................... 66 6.3.8 Oxygen concentration x respiratory circuit pressure ................................................................. 67 6.3.9 Performance Specifications ......................................................................................................67 6.3.10 Calibration and Maintenance Specification: ......................................................................... 68 5 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6.3.11 Expiratory Limb Resistence Specification: ......................................................................... 688 6.4 ELETROMAGNETIC COMPATIBILITY.................................................................................................. 699 7 GARANTIA ......................................................................................................................................... 744 ANEXO A – PERFORMANCE TESTS ........................................................................................................ 755 ANNEX B – PNEUMATIC MANIFOLD TEST INSTRUCTIONS .................................................................. 855 ANNEX C – FRONT PANEL TEST INSTRUCTION .................................................................................... 933 ANNEX D – OXYMAG CALIBRATION INSTRUCTIONS ........................................................................... 999 6 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 3 Definitions and Informations Warning Warns the user about the possibility of injury, death or other serious adverse reaction due to the misuse of the equipment. Caution Warns the user about the possibility of equipment failure associated with the use or misuse. Like equipment malfunction, damage or third party property damage and indirectly to patient injury. Notes These notes state important information. 7 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4 Description 4.1 Operating Principle The Oxymag - Electronic Transport and Emergency Ventilator is a ventilatory support for patients with respiratory failure, covering the range of patients from neonatal to adult. The available ventilation modes are volume controlled, pressure-controlled and time cycled, and intended for use in patients with tidal volume from 3 mL. The Oxymag has an oxygen concentration control to be delivered to the patient in the range of 35% to 100% (depending on the parameter adjustment). The mixture of gases is accomplished through a venturi chamber, where ambient air is drawn and mixed with oxygen gas. Its principle of operation can be explained by Oxymag block diagram, shown in Figure 1, where the equipment can be divided into two main blocks, Electronic Block, composed of PCI and Oxymag Touch Screen Display, and the Pneumatic Block consisting of pneumatics and Expiratory Valve. Electronic Block is responsible for all Human Machine Interface (HMI), where the user can adjust the type of patient, ventilation modes, settings and alarms through the Touch-Screen Display buttons. It is also responsible for controlling the pneumatic block to effectively establish the parameters previously set. All the control of Man-Machine Interface (HMI) and the block is performed by Pneumatic Electronic Control Board (PCB Oxymag). Its structure and operation will be detailed in section 4.1.1. Figure 1 – Oxymag block diagram The block is formed by the pneumatic assembly and the expiratory valve. It is composed of valves and sensors, together with the electronic control boards that controls the entire gas flow and pressure. The 8 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 pressure and flow sensors are responsible for sending the information present in the flow and pressure transducers to set Pneumatic Electronic Control Board. With this information, the Electronic Control Board performs the necessary controls of the current to the valves to control the flow and concentration of oxygen. Its structure and operation will be detailed in section 4.1.2. 4.1.1 Electronic Description The electronic board operates according to the diagram below. Figure 2 – Electronic board block diagramDiagrama de blocos da placa eletrônica The electrical power is provided by na external AC/DC converter, it converts 100 – 240 VAC ot +12VDC . This tension is enhanced to 13.5V to charge the Li-Ion battery. The led indicates the connection to an electrical AC power and it is powered by a 12 VDC, before the ON-OFF switch allowing connection indication even if the device is turned off. The battery charger circuit has a dedicated IC with an optimized current control and to switch from internal battery to external power supply and vice-versa. The battery charger circuit has an overload protection system when the battery discharges to a level below its safety limit, the equipment shuts off automatically preserving its integrity. In this case, minutes before, an high priority alarm will be shown. 9 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 The battery temperature is monitored by a sensor that interrupts the charging process if the battery overheats (above 70C). Even if the device is turned off, the above circuits will be power supplied by the battery an they are high efficient and are low power consumption allowing long period lasting for the battery. After the ON-OFF switch, there are DC/DC converter to generate the following voltages: DC Power : Voltage that varies from 9V to 13V depending on the connection to an AC power inlet. Power supplies all valves and solenoids. 5V Analog: Used to supply voltage to all the analog circuit and to the transducers. 3v3: Used to suppy voltage to the IC’s, including the microcontroller. 5V Digital: Used to supply voltage to all other IC´s. 3v3 VREF: Used as a reference voltage to the A/D and D/A converters. The OxyMag – MAGNAMED’s Emergency and Transport Ventilator is comprised of: Electronic Control Board – it has two microprocessors to achieve the control of the pneumatic system to ventilate lungs and the other to the central command that performs the Human Machine Interface (HMI) . o Pneumatic control system: The penumatic system is comprised of a pressure regulating valve that adequates the inlet pressure (O2 cylinder or wall oxygen outlet) to the internal operating pressures. The reduced oxygen pressure is applied to the input port of the solenoid valves One of the solenoid valves is used to control the overpressure valve. The other two solenoid valves are used to zero the flow transducer. To deliver the gas flow in a set oxygen concentration there are other two solenoid valves that carry on the mixing of the oxygen with the ambient air through a venture system (aspirates ambient air). According to the current applied to these valves there is a determined oxygen concentration and gas flow. These solenoid valves are controlled by high performance digital circuits that reduces the electrical power consumption enhancing the efficiency of the battery system. There are three diferential pressure transducers to measure the total gas flow, patient inspiratory and expiratory flow and the airway pressure. Basically the pneumatic control microprocessor receives the commands from the adjustment and command central, translates these informations to valves driving timing, both flow valves and expiratory valveto control the patient ventilation. The signals from the transducers are used in feedback control system of the flow control valves and the expiratory valve. The system carries on the measurement of the oxygen concentration in the gas flow to the patient. Command and adujstment central: This central is controlled by a second microprocessor and carries on the data acquisition fo the keyboard, touch screen or from the Rotary button to get the parameters adjustment desired by the device operator. The results of the adjustments and the data received from the pneumatic controller are presented in a liquid crystal display as a graph and numerically. Once the required adjustments are done they are sent to the pneumatic controller that carries on the ventilation determined by the device operator During the ventilation process the pneumatic controller sends the main parameters of the patient ventilation continuously, such as instant pressure, instant volume, instant flow, tidal volume, mean pressure, inspiratory and expiratory time, frequency and other parameters. The received data are shown on the display. Another function of the command central is to receive the alarm information and put the in priority order show them on the display and sound. Caution Discharge the battery according to local legislation. 10 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.1.2 Pneumatic Description The pneumatic block diagram of the Oxymag is shown in figure 3. The high pressure oxygen (O2) is connected to the pneumatic assembly (maximum pressure 150 PSI and the minimum working pressure is 40 PSI). The inlet pressure is reduced through a pressure regulating valve ( 1 ) allowing na adequate working pressure, at this point there are a inlet pressure measurement ( 2 ) and if the measured pressure is below the minimum required for operating the low pressure alarm is turned on. After the pressure regulator the oxygen is sent to the low flow valve ( 3 ) and to the high flow valve ( 5 ), where the gas flow is electronically controlled and its oxygen concentration is measured by a oxygen sensor ( 9 ). According to the oxygen concentration adjusted by the device operator, the electronic control actuates on the low flow valve and through the venturi principle the ambiente air is aspirated through na unidirectional valve ( 6 ) and is mixed to the oxygen in the venturi chamber ( 7 ). The total flow is monitored by an internal flow sensor ( 11 ) and then passes the conical connector ( 12 ). In order to complete the respiratory circuit, the inspiratory limb is connected to the conical connector and the expiratory limb to the expiratory valve ( 14 ) the patient proximal side of the respiratory circuit is connected to the “Y” piece and then to the proximal flow sensor ( 13 ) that monitor the gas flow to the patient. The proximal flow sensor is connected to the pneumatic assembly through the flow sensor lines and internally connected to a set of zeroing solenoid valves ( 10 ), that is periodically switched to adjust the offset of the measurement. The exhalation cycle of the patient is digitally controlled by the expiratory valve ( 14 ). This valve also controls the PEEP (Positive End Expiratory Pressure). In case of a overpressure in the respiratory circuit, the alarm sounds simultaneously to the opening of the solenoid valves ( 4 ), the pressure relief valve ( 8 ) and closing of the proportional valves ( 3, 5 ) this procedure releases the pressure in the respiratory circuit. Figure 3 – Pneumatic Diagram 11 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.2 Component Identification 4.2.1 Front Panel The figure below shows the front panel with its main components. Figure 4 – Front Panel – Complete PCB Assembly Figure 5 – Front Panel - Display 12 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.2.2 Pneumatic Manifold The figures below shows the pneumatic manifold assembly indicating every componente shown in the pneumatic diagram. Figure 6 – Pneumatic Manifold Assembly – Front Viewl Figure 7 – Pneumatic Manifold Assembly – Top View 13 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Figure 8 – Pneumatic Manifold Assembly – Rear View Figure 9 – Pneumatic Manifold Assembly – Bottom View 14 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Figure 10 – Pneumatic Manifold Assembly – Right View Unscrewing the conical connector, the Internal flow sensor can be seen as shown in figure 10. 15 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5 Maintenance Warning The OxyMag ventilator is a life support device and all service must be done by authorized personel only (MAGNAMED will issue a certificate). Do not use the device if it is not working according to the specifications presented in the operation manual. 5.1 Preventive Maintenance 5.1.1 Check Points Daily checking or before use Device cleanliness; AC/DC converter and cable integrity; Alarm system including audio alarm; Clean ambient air filter installed; Liquid Crystal Display; Battery Charged; Touch Screen; Front panel keys; Rotary Button; Correct installation of the respiratory circuit (including checking the exhalation valve diaphragm). Warning The daily checking should be done disconnected from the patient. 16 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.1.2 Internla Li-Ion Battery This battery is used to keep the device working even in the abscense of the electrical power and it lasts in normal operation as specified in chapter 6. Caution The battery should be replaced as indicated in the specification shown in chapter 6 in order that the working hour be approximately 360 minutes. Warning In order to use the device only with the internal battery it is important that the device be kept connected to an AC power supply to charge it completely. 5.1.3 Internal O2 Concentration Sensor The oxygen concentration sensor is a cell that generates na electrical signal proportional to the oxygen concentration present in the gas mixture provided to the patient and this signal intensity is due to the chemical reaction. This cell lasts, according to the manufacturers specification 10.000 hours at 100% oxygen concentration, it is more than one full year in continuous operation. Caution The oxygen concentration sensor shoud be replaced according to the specifications (chapter 6). The replacement of the oxygen concentration cell shoud be done only by authorized personnel. To discharge the oxygen concentration cell follow local legislation.17 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.1.4 Ambient Air Replacement To replace the ambiente air filter follow the procedure below: Figure 11 – Ambient Air Filter Replacement (1) Remove the filter cover at the left side of the ventilator item 3 figure 11. (2) Remove the old filter, item 1 figure 9. (3) Clean the filter seat with a soft cloth soaked in a water and soap solution. Caution Do not use compressed air to clean it, otherwise it can introduce dust and dirt in the gas mixturing system. (4) After drying it, set a new ambiente air filter. (5) Install the filter cover and check if it is closed. Caution Do not operate this device without this filter, otherwise the oxygen / ambiente air mixture system could be damaged Use ony ambiente air filters provided by Magnamed. 18 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.2 Trobleshooting In this chapter the problems and its possible solutions are presented. The majority are of simple solution that can be carried out by the equipment operator. Warning Do not use the device if a problem cannot be solved. Problem Possible Causes Solutions Inoperative Alarm 1. General Electrical Failure. 1. Call for Technical Assistance Disconnection Alarm 1. Respiratory Circuit Disconnection. 2. Lack of Inspiration Flow. 3. Change in patient’s respiratory mechanics. 4. Exhalation valve’s disc incorrectly assembled or damaged. 5. Electronic pressure control system failure. 1. Find the disconnection point and firmly reconnect it. 2. Check if there is inspiration flow and enhance it if necessary. 3. Set new parameters for ventilation support. 4. Place the disc in its correct position or replace it by a new one. 5. Call for Technical Assistance High Pressure Alarm 1. Change in patient’s respiratory mechanics. 2. Obstruction in the respiratory circuit’s expiratory limb or in the exhalation valve. 3. Patients airway obstruction. 1. Set new parameters for ventilation support. 2. Remove obstructions. 3. Remove obstructions or carry out a patient’s airway secretion suction. Low Pressure Alarm 1. Change in patient’s respiratory mechanics. 2. Excessive leakage in respiratory circuit 1. Set new parameters for ventilation support. 2. Find the leakage and correct it. 19 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Problem Possible Causes Solutions Low Battery Alarm 1. Battery charge ending after using the equipment without electrical power supply. 2. Failure in the internal battery charger, even with the presence of electrical power. 1. Restablish the electrical power connection immediately or disconnect the equipment from the patient and provide means to keep patient’s ventilation support. 2. Call for Technical Assistance Electrical Power Failure Alarm 1. Electrical power cord disconnection. 2. Electrical power failure. 1. Re-establish the electrical power connection to the equipment or use it with internal battery back-up to conclude short term surgery. 2. Re-establish the electrical power. Operating test procedure Warning The Test Sequence MUST be done with the patient disconnected. SEQ Procedure Tela 1 OxyMag’s Initial Screen. Press the test button and the internal test procedure will be activated. Follow the instructions presented on screen. Notice the presented messages. 2 Activating the test sequence a three “beep” should be heard together with the lightining of the alarm indicator. If the “beep” sound is not heard nor visual indication of the alarm is seen right above the LCD display then press the NO BUTTON, otherwise press YES BUTTON to preceed to the next test sequence. Test 20 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 SEQ Procedure Tela 2.1 Pressing NO the following screen will be shown 3 Notice that the tests are carried out sequentialy and right after the ending of the test there is an approved or failed report. Caution If any test shows up a diagnostic then carry out a necessary repair. After finishing the valves testing it will be asked for occluding the “Y” connector of the respiratory circuit right after the flow sensor. Press after verifying that the circuit is obstructed. Fail Next 21 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 SEQ Procedure Tela 4 After ending all tests notice that all the items are APPROVED and check the compliance, resistance and the leakage of the respiratory circuit in order to use de ventilator. Press to finish testing. 5 The initial screen of the ventilator will be shown. Beyond this point continue with norma initialization of the ventilator. The table below shows the actions that can be taken in order to correct the failure condition indicated in the test sequence. After repairs done the device should be reinitiated and another test sequence should be carried out, in case of failure persistence contact technical service. The consequence column indicates what could occur if the device is used with that failure. Warning In case of DEVICE INOPERATIVE message the device MUST NOT be used and the techical services should be contacted to solve the problem. Failure Menssage Action Consequencea END 22 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Failure Menssage Action Consequencea O2 Flow Internal Sensor “Check the inlet pressure” Set the oxygen inlet pressure in the range between 60 to 150 psi (414 to 1035 Pa) Low Inlet Pressure Alarm Indication “Device Inoperative” Contact Technical Services Pressure monitoring failure. DO NOT USE THE DEVICE Flow Air + O2 “Disobstruct the inspiratory limb” Disobstruct the inspiratory limb O2 Concentration delivery error O2 Sensor Cell “O2 Sensor Cell Failure” Call techinical service to replace the internal O2 sensor cell. O2 concentration readings coud be erratic. Proximal Sensor “Sensor Error” Check the flow sensor and respiratory circuit connections. The message “Sensor OFF” will be shown indicating that the flow sensor is not recognized in the circuit. It could be a variation in volume up to 10%. entregue. Only the following parameters will be monitored in this condition: Pmáx, PEEP, P.plat., Pmean and the graph Pressure x Time. The flow trigger will be disabled. Exhalation Valve “Device Inpoerative” Check the diaphragm of the exhalation valve. It should be replaced if damaged. Pressure monitoring failure. DO NOT USE THE DEVICE. Pressure Sensor 5.3 Corrective Maintenance Warning The OxyMag Ventilator is a life support device and MUST be serviced by authorized personnel only. 23 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.1 Device checking on reception Cleanliness of device; Integrity of the warranty seal AC/DC Converter and cable integrity. Accessories checklist. 5.3.2 Corrective Maintenance Procedure To detect operating failures it was establiched a general corrective maintenance procedure. The procecure sequence can be seen in the figure 12 and its description below: 1 – Preliminary Tests: These tests are done to check and identification of the device sent to servisse. At this stage initial tests and efficiency test of the device are done (section 5.3.2.1). 2 – Device disassembly: Correct sequence to disassemble the device (section 5.3.3), in order to set a part the main blocks of the dvice: 3 – Pneumatic Manifold; 6 – Front Panel. 4 – Tests of the Pneumatic Manifold: Procedure to test the pneumatic manifold (section 5.3.5). 5 – Disassembly and Pneumatic Manifold Replacement: Correct sequence to disassemble the pneumatic manifold and its replacement 5.3.4.). 7 – Front Panel Tests: Test procedure of the Front Panel (section 5.3.7.). 8 – Disassembly and Front Panel Replacement: Correct sequence to disassemble the front panel and its replacement (section 5.3.6). 9 – Setting a part to assemble the device: If the tests of the Pneumatic Manifold and Front Panel are good, then they should be kept a part to assemble the device. 10 – Device Assembly: Correct procedure to assemble the device 5.3.11). 11 – OxyMag Calibration: OxyMag calibration procedure (section 5.3.12). 12 – Return to the customer: Sending the device to the customer. 24 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Figure 12: Corrective Maintenance General Procedure 5.3.2.1 Tests 5.3.2.1.1 Initial Tests Before efficiency tests check if the OxyMag functionally works. Turn the device on and follow the sequence below: SEQ Procedure Tela 25 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 SEQ Procedure Tela 1 OxyMag’s Initial Screen. Press the test button and the internal test procedure will be activated. Follow the instructions presented on screen. Notice the presented messages. 2 Activating the test sequence a three “beep” should be heard together with the lightining of the alarm indicator. If the “beep” sound is not heard nor visual indication of the alarm is seen right above the LCD display then press the NO BUTTON, otherwise press YES BUTTON to preceed to the next test sequence. 2.1 Pressing NO the following screen will be shown Test 26 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 SEQ Procedure Tela 3 Notice that the tests are carried out sequentialy and right after the ending of the test there is an approved or failed report. Caution If any test shows up a diagnostic then carry out a necessary repair. After finishing the valves testing it will be asked for occluding the “Y” connector of the respiratory circuit right after the flow sensor. Press after verifying that the circuit is obstructed. 4 After ending all tests notice that all the items are APPROVED and check the compliance, resistance and the leakage of the respiratory circuit in order to use de ventilator. Press to finish testing. Fail Next END 27 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 SEQ Procedure Tela 5 The initial screen of the ventilator will be shown. Beyond this point continue with norma initialization of the ventilator. Failure Diagnostics The table below shows the actions that can be taken in order to correct the failure condition indicated in the test sequence. After repairs done the device should be reinitiated and another test sequence should be carried out, in case of failure persistence contact technical service. The consequence column indicates what could occur if the device is used with that failure. Warning In case of DEVICE INOPERATIVE message the device MUST NOT be used and the techical services should be contacted to solve the problem. Failure Menssage Action Consequencea O2 Flow Internal Sensor “Check the inlet pressure” Set the oxygen inlet pressure in the range between 60 to 150 psi (414 to 1035 Pa) Low Inlet Pressure Alarm Indication “Device Inoperative” Contact Technical Services Pressure monitoring failure. DO NOT USE THE DEVICE Flow Air + O2 “Disobstruct the inspiratory limb” Disobstruct the inspiratory limb O2 Concentration delivery error O2 Sensor Cell “O2 Sensor Cell Failure” Call techinical service to replace the internal O2 sensor cell. O2 concentration readings coud be erratic. 28 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Failure Menssage Action Consequencea Proximal Sensor “Sensor Error” Check the flow sensor and respiratory circuit connections. The message “Sensor OFF” will be shown indicating that the flow sensor is not recognized in the circuit. It could be a variation in volume up to 10%. entregue. Only the following parameters will be monitored in this condition: Pmáx, PEEP, P.plat., Pmean and the graph Pressure x Time. The flow trigger will be disabled. Exhalation Valve “Device Inpoerative” Check the diaphragm of the exhalation valve. It should be replaced if damaged. Pressure monitoring failure. DO NOT USE THE DEVICE. Pressure Sensor 5.3.2.1.2 Performance Tests The performance tests should be carried on according to the Annex A. 29 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.3 Oxymag disassembly 1 – Remove the screws from the back panel as shown in the figures above 2 – Open the box and take out the transducer tubes that are fixed in the RA-9 clamp that is fixed over the block. 3 – Take out the tubings that are fixed in the RA-9 clamp fixed on the top of the fornt panel. 4 – Take out the transducer tubings that are fixed on the side of the back box as shown in the figure. 30 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5 – Let the front panel in a horizontal position and take out all the connectors and the transducer tubings to set apart the Front Panel from the Back Panel of the OxyMag. 31 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.4 Pneumatic Manifold Disassembly - Tooling - wrench n. 18 - Allen hex wrench n.3 - Conical fixture 22 Back panel with the pneumatic manifold 1 – Remove the O2 Inlet Connector 2 – Use the n. 18 wrench to unscrew 3 – Remove the O´ring and check it and hold the piece to assemble 4 – Remove the 22mm conical connector 5 – Use the conical fixture to unscrew the conncetor6 – Remove the internal o’ring check it and hold it to assemble 32 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 7 – Pneumatic Manifold Removal 8 – Unscrew the allen screw indicated in the figure 9 – Use the hex wrench n.3 10 – Remove the pneumatic manifold from the back panel. 33 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.5 Pneumatic Manifold Tests The instructions and test forms are in the Annex A. Do the tests and in case of any non conformity set it apart and replace with a new approved pneumatic manifold. The damaged pneumatic manifold should be sent to Magname to check the failure. 5.3.6 Front Panel Disassembly Procedure 1 – Set the Front Panel apart and remove the screws indicated by the arrows in the figure using a Philips screw driver. Don’t forget to disconnect the Rotary button and Alarm led connectors. 34 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 2 – Take out carefully the PCB and the Liquid Crystal Display. 5.3.7 Front Panel Tests The instructions and the test forms are in Annex B. Do the tests and in case of any failure separate the PCB with the Display and replace it with an approved set. The failed set should be send to Magnamed to check the cause of failure. 35 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.8 Change the display of the complete PCI mounted - Components and Tooling 1pc – 5.7inch LCD Display (2702126-00) Soldering and Desoldering station, solder wire Antistatic bubble wrap Procedimento 1 – Using the soldering iron with the vacuum suction, desolder the pins of the display that are soldered in the PCI. 2 – Take the display damaged, clean the contacts using the soldering iron with vacuum suction if necessary and place the new. 36 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.9 Fixing the rotary button in the front panel - Components and Tooling 1pc – Optical Encoder (2202298) 1pc – Rotary button (3202295) Socket Wrench 1pc – allen screw M4x5mm (3002881) Hex wrench 2mm Procedure 3 – Solder the header connector of the display, clean the solder flux layer with a brush and isopropyl alcohol. 4 – End of the process to change the display. 37 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 1 – Insert the optical encoder in the front panel 2- Set the lock washer 3 – Set the locking nut from the front of the front panel 4 – use the socket wrench to fix the nut 5 – Check if the optical encode ris completely fixed to the front panel and leave it with the chamfer down 6 – Set the rotary button in the optical encoder 7 – Insert the allen screw and using the hex wrench screw it fixing the Rotary button to the optical encoder. 8 – Check if the button rotates freely sounding the ticks of the movement 9 – Check the final assembly of the optical encoder to the front panel. 5.3.10 Oxygen Sensor Replacement - Components 1pc – Oxygen concentration sensor cell (3902020) Procedure 1 – Open the Oxymag and locate the oxygen sensor cell 2 – Disconnect the P2 plug 3 – Unscrew the oxygen sensor cell 38 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4 – Replace the oxygen sensor cell with a new one and firmly screw it. 5 – Screw it until it is tight to avoid leakeage. 6 – Reconnect the P2 plug. End of procedure 39 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.11 Pneumatic Manifold Assembly - Components 1pc – Oxymag Pneumatic Manifold (3802368) 1pc – Conical Connector (3803119) 1pc – O2 Inlet Connector (3501964) O´rings and allen screw - Tooling - Socket wrench - Allen hex wrench - Conical 22 fixture Procedure 1 – Position the pneumatic manifold as shown in the figure 2 – Insert the allen screw as indicated in the figure 3 – Fix the pneumatic manifold to the back panel screwing it with hex allen wrench n.3 3803119 3501964 3100029 3100023 3003008 40 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4 – Insert the o’ring 3100029 as shown in the figure 5 – Assemble the conical conector screwing it to the penumatic manifold using the conical 22 fixture 6 – Check if the conical conector is firmly fixed to the back panel 7 – Insert oring 3100023 in the oxygen inlet port 8 – Assemble the oxygen inlet conector screwing it with the socket wrench n. 18 until it is tight (use LOCTITE) 9 – Check if the oxygen inlet conector is firmly screwed and tight 10 – End of the pneumatic manifold assembly procedure 41 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.12 Oxymag Assembly Procedure The Oxymag assembly procedure Electrical cable connection and routing. Transducers tubings connection and routing. Fix the Back Panel to the Front Panel. Figure 13 – Electrical Connection Diagram Part Number and Oxymag Cable Description 2802399 – ON-OFF Switch 2702236 – Battery Pack 5000240 – Linear Actuator 5002304 – Valve 30LPM 5001631 – Valve 200LPM 2803209 – Solenoid Valve 2602389 – O2 Sensor Cell 2202298 – Optical Encoder 2802589 – SpO2 / CO2 Sensor 2802397 – Inlet Pressure Sensor 2802760 – Alarm Led 2802393 – Serial Cable 2802391 – Speaker 2802394 – Battery Temperature Sensor 2802398 – DC Cable 42 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.12.1 Electrical Cable Connection and Routing - Components 13 pc – NYLON Clamp 2,5 3X100mm (3003016) Routing Procedure 3 – DC Connector 4 – Connect the DC conector at position CN19 5 – ON-OFF Connector 6 – Connect ON-OFF conector CN18 43 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 7 – Battery Cable 8 – Battery conector position CN21 9 – Attach the three cables (DC, ON-OFF and Battery) tiethem with the Nylon Clamp as shown in the figure above 10 – Expiratory Valve Cable 11 – Connect the Expiratory Valve Connector to CN11 44 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 12 – Valve 30LPM 13 – Connect the Valve 200LPM to CN12 14 – Valve 200LPM 15 – Connect the Valve 200LPM to CN13 16 – Attach the three cables (Expiratory Valve, Valve 200 LPM and Valve 30 LPM) tie them with the Nylon Clamp as shown in the figure 45 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 17 – Solenoid Valve Connector 18 – Connect the Solenoid Valve to CN16 19 – Zeroing Solenoid Valves Connector 20 – Connect the Zeroing Solenoid Valves to CN9 21 – Oxygen Sensor Connector 22 – Connect Oxygen Sensor to CN17 46 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 23 – Attach the three cables (Solenoid Valve, Zeroing Solenoid Valves and Oxygen Sensor) tie them with a Nylon Clamp as shown in the figure 24 – Serrial Cable Connector 25 – Connect the Serial Cable to CN2 26 - Speaker Connector 27 – Connect the speaker conector to CN4 47 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 28 - Battery Temperature Sensor Connector 29 – Connect the Battery Temperature Sensor to CN20 30 – Attach the three cables (Serial, Speaker and Battery Temperature Sensor) tie them with a nylon clamp as shown in the figure 31 - Inlet Pressure Sensor Connector 32 – Connect the Inlet Pressure Sensor to CN14 48 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 33 - EtCO2 Sensor Connector 34 – Connect the EtCO2 connector to CN6 35 – Attach the two cables (inlet pressure sensor and EtCO2) tie them with a nylon clamp as shown in the figure 36 – Pass these cables through the lower part of the PCB and fix them to the R13 clamp in the front panel 37 – Connect the optical encoder conector to CN7 38 – Pass the cables (Solenoid Valve, Zeroing Solenoid Valve and Oxygen Sensor) throgh the lower part of the PCB and fix them in the R13 clamp in the front panel 49 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 39 – Pass the cables (Expiratory Valve, Valve 200 LPM and Valve 30 LPM) through the lower part of the PCB and fix them in the R13 clam in the front panel 40 – Pass the cables (DC, ON-OFF and Battery) through the lower part of the PBC and fix them in the R13 clamp in the front panel 41 – End of the Connection and Routing the Oxymag Cables 50 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.12.2 Transducer Tubings Connection and Routing Figure 13 – Transducer Tubings Connection Diagram. 51 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 - Components 4pc – Silicone Tubing 3901056 length 200mm 1 pc – Silicone Tubing DI=2,0mm DE=4,0mm Transducers Tubings Connection 1 – Connect one end of the tube to the Oxygen Sensor Adapter. 2 – Connect the other end to the PCB inner port of the left transducer as shown in the figure 3 – Connect another tubing end to the port nearest to the Oxygen Sensor adapter 4 – Connect the other end ot the other port of the left transducer 5 – Connect a tube end to the left port of the Zeroing solenoid valve block 6 – Connect the other end to the outer port of the right transducer 52 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 7 – Conenect another tube end to the right port of the zeroing solenoid valve block 8 – Connect the other end to the other port of the right transducer 9 – Connect one end of the Silicone Tube DI=2,0mm DE=4,0mm to the port located nearest to the right side of the back panel 10 – Connect the other end to the transducer TR2 superior port. The lower port should be kept open to the ambient Transducer Tubings Routing 1 – Pass the TR2 tubing inside the RA-9 Clamp 2 – Pass the other two tubings that connects to the left side transducer inside the same RA-9 clamp 53 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 3 – Pass the two tubings connected to the transducer inside the RA-13 clamp RA-13 4 – Pass the other two tubings inside the same clamp 5 – Pass the two tubings from the zeroing solenoid valves through the RA-9 clamp fixed over the pneumatic manifold 6- Close the cabinet carefully attempting to the right tubings connection 54 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.12.3 Closing the case - Components - 4 screws 3003390 - 1 screw 3001277 - 1 screw 3003392 - 4 washers 3001022 - 2 washers 3001023 - 6 locking washers 3001026 Procedure Each closing hole labeled by a letter follows the combination of washer/locking washer and a screw. The assembly order is first flat washer them locking washer A – Flat washer 3001022 – Locking Washer 3001026 and screw 3003390 B – Flat washer 3001022 – Locking Washer 3001026 and screw 3003390 C – Flat washer 3001022 – Locking Washer 3001026 and screw 3003390 D – Flat washer 3001022 – Locking Washer 3001026 and screw 3003390 E – Flat washer 3001022 – Locking Washer 3001026 and screw 3003392 F – Flat washer 3001022 – Locking Washer 3001026 and screw 3003390 A – top left side B – central left side C – bottom left side D – top right side E – central right side F – bottom right side 3001022 3001026 3003390 3003392 3001277 A B D E F C 3001023 55 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.3.13 Oxymag Calibration Procedure After fixing the device it is necessary to calibrate the ventilator and carry on new performance tests to check if the failure is eliminated The calibration procedure shoud be done according to Annex D. 56 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 16001855.4 Limpeza, Desinfecção e Esterilização This chapter presents the cleaning, sterilization and disinfection procedures of the equipment and its accessories. Warning Before the first use of the equipment and its accessories should be cleaned, sterilized or disinfected in an appropriate way. Caution The accessories and removable parts of the anesthesia ventilator module submitted to many cleaning, disinfection or sterilization procedure has its lifetime shortened and should be replaced by new ones according to the table presented in chapter 11. The accessories and removable parts of the anesthesia ventilator module that shows some degradation or damage signs should be replaced and its use should be avoided. 5.5 OxyMag Ventilator The external parts of the ventilator can be cleaned with a soft cloth with appropriate germicide solution (detergent) moisture, ensuring to completely dry and don’t let any residue in the serial communication connector, DC power supply connector, inspiratory flow connector, expiratory valve connector, flow sensor’s pressure line connector. Establish an appropriate cleaning, disinfection or sterilization routine to the ventilator’s parts. A. The external parts of the ventilator can be cleaned with a soft cloth with an appropriate germicide solution (detergent), ensuring to completely dry and don’t let any residue in the serial communication connector, DC power supply connector, inspiratory flow connector, expiratory valve connector, flow sensor’s pressure line connector. After cleaning, use a clean soft cloth to completely dry the module. B. The parts that come into contact with respiratory gases should be periodically disassembled for cleaning, sterilization or disinfection procedure. This includes flow sensor and line that accompanies the ventilator. Use appropriate germicide solution or Ethylene Oxide. C. Do not use abrasive agent to carry out the cleaning procedure. D. Do not use alcohol to clean plastic parts. E. Do not sink the Ventilator in any kind of liquid. Warning Ventilator’s parts that comes into contact with patient’s fluids or mucous membranes or skin wounds (respiratory circuit, flow sensor, etc) are potentially contaminated. These accessories are classified as semi-critical, due to the potential risk they pose for transmitting infection and before discarding (at the end of their lifetime) or sending them for maintenance or repair they require a high-level disinfection procedure or be sterilized. In case of discard: INDICATE – HOSPITAL WASTE POTENTIALLY INFECTED When sending the ventilator and its parts to maintenance it should be cleaned, sterilized or disinfected APPROPRIATELY EQUIPMENTS VISIBLY INFECTED BY PATIENT’S FLUIDS WILL BE RETURNED WITHOUT ANY MAINTENANCE OR SERVICE PROCEDURE. 57 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.6 Cleaning, Disinfection and Sterilization Procedures Figure 27 – Sequences for Cleaning, Sterilization and Disinfection (1) Cleaning The cleaning procedures should be done by mechanical friction with a soft cloth with soap and water moisture. (2) Washing ALLWAYS wash all parts before high-level disinfection or sterilization procedures. It is the most important step in decontamination. It can be done by immersion in neutral soap and water solution or with an enzyme detergent with temperature at 35ºC to 60ºC for 5 to 10 minutes and followed by mechanical friction for dirty and organic material removal. (3) Immersion Chemical Disinfection Carry out a chemical disinfection by immersion in a 2% Glutaraldehyde solution for 40 minutes. Completely remove chemical residues from components and parts with sterilized and distilled water, after that dry them completely in a clean ambient. (4) Immersion Chemical Sterilization Carry out a chemical sterilization by immersing in a 2% Glutaraldehyde solution for 12 hours. Completely remove chemical residues from components and parts with sterilized and distilled water, after that dry them completely in a clean ambient. (5) Autoclave Carry out autoclave sterilization with the following parameters: Pressure: 96 kPa (14 psi) Temperature: 120 ºC Time: 15 minutes (6) Ethylene Oxide (ETO) Carry out sterilization with ethylene oxide according to the chemical product manufacturer’s recommendations. Contaminated Material Soft cloth with detergent Washing Store Sterilize Disinfection 58 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Description Process Cycles (Life time) External part of the Ventilator (1) NA Flow sensor’s SILICONE line connector and tubing (2), (3), (4), (5), (6) 50 Autoclavable flow sensors (Polysulfone) (2), (3), (4), (5), (6) 50 Autoclavable expiratory valve (Polysulfone) (2), (3), (4), (5), (6) 50 Sterilizible flow sensors (Polycarbonate) (2), (3), (4), (6) 50 PVC tubings (2), (3), (4), (6) 50 Silicone line (2), (3), (4), (5), (6) 50 NA – Not Aplicable 59 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6 Technical Specification 6.1 Classification Equipment Class II (IEC – 60601), energized internally, type BF for continuous operation. Equipment IPX4 splash-proof. 6.2 Standards ISO 13485:2003 – Medical Devices: Quality management systems – Requirements for regulatory purposes ISO 9001:2008 – Quality management systems ISO 14971:2007 – Medical Devices: Application of risk management to medical devices EN 980:2008 – Symbols for use in the labeling of medical devices EN 60601-1-4:2006 – Medical Electrical equipment – Part 1-4: General requirements for safety – Collateral Standards: Programmable electrical medical systems DIN EN 794-3: – Lung Ventilators – Part 3 – Particular requirements for emergency and transport ventilators DIN EN 794-3:2009-12 – Lung Ventilators – Part 3 – Particular requirements for emergency and transport ventilators (Includes Amendment A2:2009-12) IEC 62304:2006 – Medical Device Software – Software life cycle processes ISO 10651-3:1997 – Lung Ventilators for Medical Use – Parte 3 – Particular requirements for emergency and transport ventilators ISO 5356-1:2004 Anesthetic and respiratory equipment – Conical connectors – Part1: Cones and sockets ISO 5359:2008 Low-pressure hose assemblies for use with medical gases EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests EN 60601-1:1990 A1:1993 A2:1995 - Medical electrical equipment - General requirements for safety EN 60601-1-1:2001 Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems. Section 1.1 Collateral standard: Safety requirements for medical electrical systems IEC CISPR 11 Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics – Limits and methods of measurement 6.3 Specifications The OxyMag Transport and Emergency Ventilator are composed by the following components: LCD DISPLAY with touch screen and 320 x 240 pixels; Electronic Control Board with: o Present data on the display; o RS-232C Serial Interface; o Quick access keys to: HOLD; O2 100%; NEXT (Next page of adjustment parameters); MANUAL (Manual Inspiratory Cycle - Trigger); LOCK (Lock the touchscreen and keys); o Respiratory Circuit Pressure Reading; o Respiratory Circuit Flow Reading; o Inlet O2 Pressure Reading; o Barometric Pressure Reading; o O2 Concentration Reading; o Intelligent Battery Charger; 60 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Loudspeaker to indicate alarms and alerts; RED LED to indicate alarm conditions; GREEN LED to indicate electrical power connection; External AC/DC Adaptor (100-240 VAC – 50 – 60 Hz +12 VDC); On/Off Switch; Internal O2 Concentration Measurement Cell Neonate Flow Sensor for the range 20 L.min -1 ; Infant Flow Sensor for the range 50 L.min -1 ; Adult Flow Sensor for the range 150 L.min -1 . Respiratory Circuit for NEONATE, INFANT and ADULT; Plastic ABS case impact resistant. Handbag for transportation (Optional); 6.3.1 Electrical Characteristics External AC/DC Adapter 100-240 VAC – 50 – 60 Hz +12 VDC (2402568): Item Parameter Unit Specification Tolerance 1 Electrical Voltage (50/60Hz) (1) VAC 100 to 240 10% 2 Maximum Power Consumption W 50 10% 3 Outllet 12VDC – 4 vias VDC 12 10% 4 Current A 2,5 --- (1) Connector 3 (three) pins, NBR-14136:2002, where the central pin is EARTH Internal Li-Ion Battery: Item Parameter Unit Specification Tolerance 1 Internal Li-Ion Battery 11,8VDC mAh 4000 15% 2 Internal Battery Duration (with full charge) min 300 15% 3 Maximum time to recharge (ventilator and operation) (1) h 4,0 15% (1) The battery charging should be done in ambient temperature 5 to 35 ºC Electromagnectic Compatibility o Imunity: IEC 60601-1-2 o Emission: CISPR11 o Aprovals: EN/IEC 60601-1 Class IIb – According to CE/93/42/CEE anex IX Respiratory Accessories Class of Protection (Dischargeable or Reusables): Type BF (Body Floating) 6.3.2 Connection to Oxygen Supply Oxygen Inlet – DISS male 9/16” 18 threads o OPTIONAL – NIST Standard Oxygen Gas Pressure: 40 to 150 PSI (345 to 1035 KPa) Hoses: According to ISO 5359:2000 The aluminum oxygen cylinder (1.7 L) lasts for 40 minutes with the device configured as: o Adult Patient o VCV Mode o Volume – 500 mL o Frequency – 12 min -1 61 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 o I:E Ratio – 1:2 o PEEP – 5 hPa o Pause – 30% o FiO2 – 100% o Flow Type - Square All Materials that comprise the product are compatible with air, compressed air and oxygen. 6.3.3 Environmental and Physical Specifications Item Parameter Unit Specification Tolerance 1 Dimensions (basic unit) 2 Height (with holder) mm 176 (231) 2 3 Width mm 254 2 4 Depth (with holder) mm 134 (185) 2 5 Weight Kgf 3,25 0,1 6 Operation 7 Temperature ºC -10 a 50 --- 8 Barometric Pressure hPa 600 a 1100 --- 9 Relative Humidity (no condensation) % 15 a 95 --- 10 Storage 11 Temperature ºC -20 a 75 --- 12 Barometric Pressure hPa 500 a 1200 --- 13 Relative Humidity (no condensation) % 5 a 95 --- 14 Oxygen Cylinder Consumption at the following conditions: Tidal Volume = 500 mL Frequency = 12 min -1 O2 Concentration = 40% min/LO2-CYLINDER 92 10% 6.3.4 Ventilation Modes Mode (1)(4)(5) Description Apnea Backup Mode VCV Volume Controlled Ventilation (Assisted Cycles can be set) NA PCV Pressure Controlled Ventilation (Assisted Cycles can be set) NA PLV Pressure Limited Ventilation – Time Cycled. Available when configured to Neonate Mode (Assisted Cycles can be set) NA V-SIMV + PS Synchronized Intermittent Mandatory Ventilation – Pressure Support can be set IMV – Volume Controlled Intermitent Mandatory Ventilation 62 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Mode (1)(4)(5) Description Apnea Backup Mode P-SIMV + PS Synchronized Intermittent Mandatory Ventilation – Pressure Support can be set IMV – Pressure Controlled Intermitent Mandatory Ventilation PSV Pressure Support Ventilation PCV (adult and infant) / PLV (neonate), OFF. Programable by Operator DualPAP (2) Two Positive Continuous Pressure Ventilation Backup frequency CPAP Continuous Positive Airway Pressure NO BACKUP NIV Non Invasive Ventilation NA (1) Non Invasive Ventilation (NIV) with mask can be activated in all ventilation modes and in this case there is leakeage compensation. (2) The APRV (Airway Pressure Release Ventilation) can be obtained through the DualPAP ventilation mode with appropriate adjustment of the timing and pressures. (3) Automatic compliance and small leakage compensation in the respiratory circuit. (5) When the ventilator is in NEONATAL mode (IBW ≤ 6,0 Kg) the ventilation modes available are: PLV, BIPAP, CPAP, PSV, DualPAP 6.3.5 Ventilation Parameter Adjustment Specifications Item Parameter Unit Specification Resolution 1 Tidal Volume (Adult) mL 10 to 1000 10 mL L 1 to 2.5 50 mL 2 Tidal Volume (Infant) mL 20 to 100 5 mL mL 100 to 300 10 mL 3 Respiratory Frequency min -1 0 to 150 (1) 1 min -1 4 Rise Time s 0 to 2.0 0.1 s 5 Pause % 0 to 70 10% 6 Maximum Pressure hPa 0 to 60 1 hPa 7 Inspiratory Pressure hPa 1 to 60 1hPa 8 ∆PS hPa OFF; 5 a 60 1 hPa 9 PEEP hPa 0 to 40 1 hPa 10 Assisted Sensibility (Pressure) hPa OFF; -0.2 to -2.0 - 0.2 hPa -2 to -10 - 1 hPa 11 Assisted Sensibility (Flow) L.min -1 OFF, 0.5 to 30.0 0.5 L.min -1 12 Inspiratory Flow (Neonate) L.min -1 4 to 20 1 L.min -1 13 Flow Cycling in Pressure Support % 5 to 80 1 % 14 O2 Concentration % vol 35 to 100 1 % 15 Inspiratory Time s 0.1 to 0.7 0.01 s 0.7 to 1 0.05 s 63 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Item Parameter Unit Specification Resolution 1 to 10 0.1 s 16 Inspiratory Flow Waveform --- Square, Decelerated, Accelerated, Sinusoidal --- 17 CPAP hPa 1 to 40 1 hPa 18 Hight Pressure hPa 1 to 60 1 hPa 19 Low Pressure hPa 0 to 40 1 hPa 20 Time Higth s 0.20 to 0.70 0.01 s 0.70 to 1.00 0.05 s 1.00 to 59.80 0.10 s 21 Time Low s 0.20 to 0.70 0.01 s 0.70 to 1.00 0.05 s 1.00 to 59.80 0.10 s 22 Ratio 1:4 a 4:1 1:0.1 23 Backup - (2) OFF;PLV; PCV; VCV --- 24 Base Flow L.min -1 4 to 20 1 L.min -1 25 Time to apnea alarm s OFF, 5 to 60 1 s 26 IBW-Ideal Body Weight (1) Kg 0.5 to 5.0 0.1 Kg 5.0 to 10 0.5 Kg 10 to 200 1 Kg 27 Nebulizaer Flow (2) (synchronized with the inspiratory flow) – 100% Oxygen L.min -1 5 to 8 --- 28 TGI FLOW (2) (Tracheal Gas Insuflation) – 100% Oxygen – The flow is activated when the exhaled flow achieves 25% of the Maximum Expired Flow and the end is determined by the beginning of the next inspiratory cycle L.min -1 5 to 8 --- 29 Flow (Flowmeter) L.min -1 0 to 15 1 L.min -1 (1) In CPAP mode the ventilatory rate is zero. (2) PSV backup options. If it is set OFF the PSV mode not start backup mode when reach the time to apnea alarm. (1) Depending on the adjusted weight the ventilator will be configured to operate in: IBW ≤ 6.0 Kg Ventilator set to NEONATE Mode with PLV as a initial ventilation mode – NEONATE FLOW SENSOR (NEO) 6.0 Kg < IBW ≤ 10.0 Kg Ventilator set to INFANT Mode with PCV as a initial ventilation mode – INFANT FLOW SENSOR (INF) 10.0 Kg < IBW ≤ 25.0 Kg Ventilator set to INFANT Mode with VCV as initial ventilation mode– INFANT FLOW SENSOR (INF) IBW ≥ 25 Kg Ventilator set to ADULT Mode with VCV as initial ventilation mode – ADULT FLOW SENSOR (ADU) (2) The TGI or nebulization flow cannot be programmed simultaneously. Caution Minimum Pressure Limit: 5 hPa The maximum pressure limits the pressure in the respiratory circuit. o In VCV this will be the maximum pressure in the respiratory circuit. The exhalation valve opens to the ambient to keep this maximum pressure during the inspiratory 64 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 cycle, if this maximum pressure is exceeded by 5 hPa the ventilator cycles to the expiratory phase (pressyre cycle). This ventilator DOES NOT GENERATE NEGATIVE PRESSURE WHEN THE PATIENT IS EXHALING. 65 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6.3.6 Ventilation Monitor Specification Item Parameter Unit Range Resoluti on Tolerance (1) 1 Instantaneous Measured Pressure hPa (2) -20 to 100 1 (1 hPa or 2% of reading) 2 Maximum Inpiratory Pressure hPa 0 to 100 1 (1 hPa or 2% of reading) 3 Mean Pressure hPa 0 to 100 1 (0.5 hPa or 2% of reading) 4 Plateau Pressure hPa 0 to 100 1 (1 hPa or 2% of reading) 5 PEEP – Positive End Expiratory Pressure hPa -20 to 100 1 (1 hPa or 2% of reading) 6 Intrinsic PEEP at the end of expiratory phase hPa -20 to 100 1 (1 hPa or 2% of reading) 7 Measured Flow (Adult Sensor) L.min -1 -150 to 150 1 ± (2.0L.min -1 or 5% of reading) 8 Measured Flow (Infant Sensor) L.min -1 -50 to 50 0.5 ± (0.5L.min -1 or 5% of reading) 9 Measured Flow (Neonate Sensor) L.min -1 -20 to 20 0.2 ± (0.2L.min -1 or 5% of reading) 10 Measured Volume (Adult Sensor – ADU) mL 100 to 995 5 (20mL or 5% of measured value) L 1 to 3 0.01 (0.02L or 5% of measured value) 11 Measured Volume (Infant Sensor – INF) (3) mL 20 to 1000 2 (10mL + 5% of measured value) 12 Measured Volume (Neonate Sensor – NEO) (3) mL 1 to 200 0.1 (3mL + 5% of measured value) 13 Minute Volume (MV) (Adult Sensor – ADU) L 0.1 to 99.0 0.001 (0.18L or 3% of measured value) (4) 14 Minute Volume (MV) (Infant Sensor – INF) L 0.01 to 50.0 0.001 (0.10L or 3% of measured value) (4) 15 Minute Volume (MV) (Neonate Sensor – NEO) L 0.001 to 20.0 0.001 (0.06L or 3% of measured value) (4) 16 Inspiratory Time s 0.05 to 60.0 0.01 0.01s 17 Expiratory Time s 0.05 to 60.0 0.01 0.01s 18 I:E Ratio --- 1:100.0 to 100.0:1 1:0.1 2% 19 Respiratory rate min -1 0 to 200 0,1 (0,1min -1 + 1% of measured value) 20 Airway Resistance – RAW hPa/L/s 0 to 600 1 10% 21 Dynamic Compliance mL.hPa -1 0 to 300 0,1 (1 mL.hPa -1 or 10% of measured value) 22 Static Compliance mL.hPa -1 0 to 300 0.1 (1 mL.hPa -1 or 10% of measured value) 23 FiO2 (Inspired Fraction of Oxygen) %O2 0 to 100 0.1 ±(1% em vol + 2% of reading) 24 Flow(Flowmeter) L.min -1 0 to 20 0.1 ± (0.2L.min -1 ou 5% da leitura) 66 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Item Parameter Unit Range Resoluti on Tolerance (1) 25 Barometric Pressure hPa (mbar) 700 (3) to 1200 1 ±(1hPa + 2% of reading) 26 Respiratory Work J/min 0 to 99 0.1 10% 27 Rapid shallow breathing index (iT) 1/min/L 0 to 9000 1 10% 28 Pipeline pressure (Ppipeline) psi 0 to 1500 1 3,75 psi 29 O2 Consumption L/min 0 to 180 0.1 ±(1 L/min or 10% of reading) (1) When it indicates two tolerances consider the greatest one. (2) 1 mbar (milibar) = 1 hPa (hectoPascal) = 1,016 cmH2O (centimeters of water). In practical this units cannot be differentiated and can be used as: 1 mbar = 1 hPa ≈ 1 cmH2O (3) For airway resistances above 150 cmH2O/L/s the tolerance of the expired monitored volume should be changed to 10%. In this case the inspired volume will not change. (4) This tolerance was calculated to a respiratory rate of 12, 20 and 60 rpm respectively to adult, infant and neonate sensors. (5) 700 hPa corresponds to an altitude of 3048m (6) All monitored date are considered at ATPD (Ambient, Temperature and Pressure Dry). (7) The ventilator does not generate negative pressure in the expiratory phase. 6.3.7 Safety and Alarm Systems Anti-asphyxiation valve to protect against oxygen gas supply failure; Safety Relief Valve 100 hPa – Basic Ventilator Standard to avoid overpressure in the respiratory circuit; ACTIVE overpressure valve – when an obstruction is detected it is activated to reduce the pressure in the patient’s respiratory circuit. Item Alarm Unit Adjust 1 High Pressure Alarm hPa OFF, 1 to 80 2 Low Pressure Alarm hPa OFF, 1 to 80 3 High PEEP Alarm hPa OFF; 1 to 20 4 Low PEEP Alarm hPa OFF; 1 to 19 5 High Minute Volume Alarm L OFF, 0.1 to 100.0 6 Low Minute Volume Alarm L OFF, 0.1 to 100.0 7 Apnea Alarm Time s 5 a 60 8 High Respiratory Rate Alarm min -1 OFF; 0,5 a 200 9 Low Respiratory Rate Alarm min-1 OFF; 0,5 a 200 10 High etCO2 Alarm mmHg OFF; 1 a 80 11 Low etCO2 Alarm mmHg OFF; 1 a 80 12 Inspiratory CO2 Alarm mmHg OFF; 1 a 80 Alarms related to the device and ventilation Low Battery Alarm; Low O2 Inlet Pressure Respiratory Circuit Obstruction Apnea 67 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 AC Input Fail Alarms related to the external sensors Capnographu Sensor o Attention IRMA Adaptor o Reset IRMA o Change IRMA o CO2 Out of Range o IRMA Reading Error o Calibrate IRMA SpO2 Sensor o Attention SpO2 Sensor (Sensor out of finger) 6.3.8 Oxygen concentration x respiratory circuit pressure Figure 29 – Oxygen concentration curve as function of respiratory circuit pressure 6.3.9 Performance Specifications Item Parameter Unit Specificaton Tolerance 1 Valves Response Time T0..90 ms 5 20% 2 Maximum flow in pressure support and spontaneous breathing L.min -1 180 10% 3 Control Principle --- Time Cycled, Constant Volume and Pressure Controlled --- 4 MTBF (Mean Time Between Failure) hours (POH – Power On Hours) 10.000 --- 68 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6.3.10 Calibration and Maintenance Specification: Item Description Unit Specification Tolerance 1 Revision and REPLACEMENT OF DIAPHRAGM (3800248) Hours (POH) 5.000 or 1 year 500 2 Revision and REPLACEMENT OF O2 CELL(3902020) Hours (POH) 10.000 or 2 years 500 3 Revision and REPLACEMENT OF BATTERY (2702236) Hours (POH) 10.000 or 2 years 500 4 Expiratory Valve (3200251) Cycles of autoclave: Fast: 4 minutes @ 136°C 220kPa Normal: 20 minutes @ 120°C 96kPa Note: The processing time is after specified temperature and pressure stabilization Cycles 50 @ Fast e 100 @ Normal --- 5 Revision of OxyMag Year 1 1 month 6 Calibration of OxyMag Year 2 1 month 7 REPLACEMENT OF AMBIENT FILTER (1702656) Hours (POH) 500 (depends on how dirt is the ambient air where this equipment is used) 20 Notes Magnamed keeps available to the users (upon agreement) electrical schematics, part lists,calibration instructions and other documents. 6.3.11 Expiratory Limb Resistence Specification: Respiratory Circuit (P/N) Flow L.min -1 Expiratory Resistence (hPa or cmH2O) Circuit Circuit + Flow Sensor Circuit + Flow Sensor + HME Filter Circuit + Flow Sensor + CO2 Sensor + HME Filter Neonate (1702655) 5,0 0,6 1,7 Infant (1702654) 30,0 0,4 3,4 4,1 4,3 Adult (1702653) 60,0 0,8 1,4 3,1 3,5 Adult (3902629) 60,0 3,8 4,4 6,1 6,5 Table - Expiratory resistence as function of the respiratory circuit type and accessories connected 69 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6.4 Eletromagnetic Compatibility Changes or modifications done in this device without MAGNAMED’s permission can cause EMC problems to this or to other devices. Contact MAGNAMED’s service assistance to get technical advice. This equipment was designed and tested to comply with applicable EMC standards as described below. Warning The use of cellular phones or other equipments emitting radio-frequency (RF) near the equipment can cause unexpected or adverse results. Monitor the equipment working if radio-frequency emitting devices are nearby. The use of other electrical equipments in the system or nearby can cause interference. Before its use in the patient check if the equipment works properly in the defined configuration. 70 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Directive and Manufacturer’s Statement – Electromagnetic Emissions The system is adequate to be used in specified electromagnetic environment. The customer or operator should verify that the equipment is used in environment described below. Emission Tests Compatibility Electromagnetic Environment Directive CISPR 11 – RF Emission Group 1 The system uses RF energy only for internal functioning. The RF emissions are very low and are not likely to cause interferences in nearby equipments. CISPR 11 – RF Emission Class B The system is adequate to use in all places, including domestic and installations directly connected to low voltage electrical power supply of residential edifications. Harmonic Radiation IEC 61000-3-2 Class A Class A Voltage fluctuation/ Fluctuating emissions IEC 61000-3-3 Compatible Directive and Manufacturer’s Statement – Electromagnetic Immunity The system is adequate to be used in specified electromagnetic environment. The customer or operator should verify that the equipment is used in environment described below. Immunity Test IEC-60601-1-2 Test Level Compatibility Electromagnetic Environment Directive IEC 61000-4-2 – Eletrostatic Discharge (ESD) ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air The pavement should be of wood, ceramics or concrete. If the pavement revetment is made in synthetic material, the minimum relative humidity should be 30%RH IEC 61000-4-4 – Fast transient/ Electrical Impulse ± 2 kV for power line ±1 kV for input/output line ± 2 kV for power line ±1 kV for input/output line The quality of the power electrical line should be hospital or commercial grade. IEC 61000-4-5 - Overvoltage ± 1 kV differential mode ±2 kV common mode ± 1 kV differential mode ±2 kV common mode The quality of the power electrical line should be hospital or commercial grade. Voltage “Burst”, short interruptions and voltage variations in input power line IEC 61000-4-11 < 5% UT (hole > 95% in UT) during 0.5 cycle 40% UT (60% hole in UT) during 5 cycles 70% UT (30% hole in UT) during 25 cycles < 5% UT (hole > 95% in UT) during 5 sec. < 5% UT (hole > 95% in UT) during 0.5 cycle 40% UT (60% hole in UT) during 5 cycles 70% UT (30% hole in UT) during 25 cycles < 5% UT (hole > 95% in UT) during 5 sec. The quality of the power electrical line should be hospital or commercial grade. Electrical power frequency magnetic field (50/60 Hz) IEC 61000-4-8 3 3 A/m 3 A/m Note: UT is the alternating current line voltage before the test application. Radiated Immunity 71 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Immunity Test IEC-60601-1-2 Test Level Compatibility Electromagnetic Environment Directive Recommended Separation Distance Any portable equipment and radio-frequency cellular communication device should not be used nearby any part of the system, including cables, except at recommended separation distance, calculated from the equations appropriate to the transmitter frequency. Conducted RF IEC 61000-4-6 3 Vrms 150 kHz a 80 MHz at ISM band 1 Vrms (V1) D=3.5√P 10 Vrms 150 kHz a 80 MHz at ISM band 1 Vrms (V2) D=12√P Radiated RF IEC 61000-4-6 10 V/m 10 V/m (E1) D=1.2√P 80 MHz to 800 MHz 80 MHz to 2.5 GHz D=3.5√P 800 MHz to 2.5 GHz According to the transmitter manufacturer, P is the maximum nominal value of the supply in watts (W) and D is the recommended separation distance in meters (m). According to the local electromagnetic examination the permanent RF transmitter field intensity should be lower than the conformity levels in different frequency bands. ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are in the range of 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The goal of the conformities levels in ISM frequency bands between 150 kHz and 80 MHz and in the frequency band between 80 MHz and 2.5 GHz is to reduce the probability of interference caused by portable communication devices localized non-intentionally near the patients. That is the reason to use the 10/3 additional factor to calculate the recommended separation distance of the transmitters in these frequency bands. It is not possible to precisely preview the permanent transmitter fields intensity such as base stations for radio telephone (wireless cellular phones) and terrestrial mobile services, radio-amateur, AM and FM radio-diffusion and TV emission. It is advisable to carry out a local electromagnetic examination to evaluate the electromagnetic environment due to radiofrequency transmitters. Check the normal operation of the system if the measured field intensity in place exceeds the RF conformity level applicable described above. If an abnormal operation occurs, it will be necessary additional measures, such as reorientation or system placement change. The field intensity in frequency bands above the range of 150 kHz to 80 MHz should be lower than 1 V/m. Note: This directive is not applicable to all situations. The structures, objects and persons absorption or reflection can affect the electromagnetic propagation. Recommended Separation Distances The system can be used in an electromagnetic environment in which the radiated RF interferences are controlled. The customer or the system operator can help in preventing electromagnetic interference, keeping minimum distance between the portable equipment and cellular communication by RF (transmitters) and the system, according to the following recommendations and accordingly to the maximum power output from communication device.72 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Separation Distance in meters (m) according to the transmitter frequency Transmitter’s maximum output nominal power watt (W) 150 kHz to 80 MHz Out of ISM band 150 kHz to 80 MHz In the ISM band 80 MHz to 800 GHz 800 MHz to 2.5 GHz P V D 1 5.3 P V D 2 12 P E D 1 12 P E D 1 23 0.01 0.35 1.2 0.12 0.23 0.1 1.1 3.8 0.38 0.73 1 3.5 23 1.2 2.3 10 11 38 3.8 7.3 100 35 120 12 23 The recommended separation distance D in meters (m) from the transmitters that does not have the maximum nominal output power shown above can be determined by the applicable equation to the transmitter’s frequency where P is the transmitter’s nominal maximum output supply value in watts (W), according to the transmitter’s manufacturer. Note 1: From 80 MHz to 800 MHz, higher frequency band separation distance is applicable. Note 2: The ISM bands (Industrial, Scientific and Medical) in the range of 150 kHz to 80 MHz are of 6.765 MHz to 6.795 MHz; from 13.553 MHz to 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 MHz to 40.70 MHz. Note 3: The additional 10/e factor is used to calculate the recommended transmitter separation distance in the frequency ISM bands between 150 kHz and 80 MHz and in the frequency band of 80 MHz to 2.5 GHz to reduce the probability of interference caused by portable communication devices localized non-intentionally near the patients. Nota 4: This directive is not applicable to all situations. The structures, objects and persons absorption or reflection can affect the electromagnetic propagation. Electrical Safety The system has connections to the display module through a serial communication cable. Below are presented the precautions that should be observed when these devices (non-medical equipment) with the system. Warning The items that does not comply with the IEC 60601-1 standards cannot be placed less than 1.5 m from the patient. All the items (medical or non-medical equipment) connected to the system with input/output signal should be powered by an alternating current supply that uses separate transformer (according to the IEC-60989 standard) or having an additional earth ground conductor. Portable multiple plugs with interrupter used in alternating current supply should comply with the IEC 60601-1-1 standard and cannot be installed on the ground. Do not use more than one portable multiple plug with interrupter. Do not connect any non-medical device to the wall alternating current supply. Use an AC power supply with appropriate transformer. Otherwise, the leakage current enhances above the limits accepted by IEC 60601-1 standards under normal conditions of one single failure. This can cause dangerous electrical shock to the operator or to the patient. After connecting any device in these power plugs, submit the hole system to a complete leakage current test (according to the IEC 60601-1 standard). 73 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 The electro-medical system operator should not touch any non-medical electrical device and the patient simultaneously. This can cause dangerous electrical shock to the operator or to the patient. 74 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 7 Garantia The products manufactured and commercialized by MAGNAMED TECNOLOGIA MÉDICA S/A are guaranteed against material and manufacture defect according to the paragraphs below. The guarantee responsibility limits to the replacement, repair and labor, for parts that are defective or do not complies with the specification contained in this instruction manual. And the warranty is limited to the products used under normal conditions and which preventive maintenance and part substitutions and repairs are carried out accordingly to the procedures contained in this instruction manual. The warranty does not cover defects caused by inappropriate use or installation, accidents, inadequate sterilization, service, installation, operation or modifications carried out by non-authorized or disqualified personnel. The lack of sealing label or its rupture by non-authorized or disqualified personnel voids this warranty. The warranty is valid for a period of 365 days for the equipment, 90 days for batteries and 60 days for accessories, if its original characteristics are maintained, and is counted from the MAGNAMED TECNOLOGIA MÉDICA S/A Commercial Invoice issue date to the first owner of the equipment. Parts subject to degradation or deterioration under normal use conditions, adverse use conditions, and inappropriate use or fortuity accidents are not covered by this warranty. This warranty does not cover eventual costs and risks with equipment transportation. MAGNAMED TECNOLOGIA MÉDICA S/A cannot be considered by any means for any damage including beside others, eventual, consequential or specials. There is no other explicit or implicit guarantee other than the stated above. 75 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Anexo A – Performance Tests 1. Objective The objective of this document is to presente the performance tests of the Oxymag Emergency and Transport Ventilator. 2. Form 6002772-NE-52 – Assembly Test Form 3. Required Instruments and Fixtures Oxygen hose AC/DC Converter Power Supply Respiratory Circuit Adult Respiratory Circuit Neonatal 2 90° elbow connector Ventmeter – Magnamed’s gas flow analyzer Oxymag’s flow sensors (ADU, INF and NEO) USB – Serial Cable Rp 20 and Rp 50 resistance O2 Sensor connector Adapter 22F / 22F O2 Sensor Cell Cable P2 – P2 Notebook with Pulmotrend Software installed 4. Test Execution Setup 4.1. Turn on the Ventmeter to stabilize the electronic circuit and the differential pressure transducer. 4.2. Connect the O2 hose to the device. 4.3. Connect the other end of the O2 hose to the pressure line. 4.4. Connect the power supply to the device under test. 4.5. Connect the AC/DC Converter to the electrical power outlet. 4.6. Connect the serial cable/USB to the VentMeter serial connector 4.7. Connect the other end to the USB of the computer. 4.8. Turn on the computer and run the Pulmotrend software 4.9. Click the ícone File and Open 76 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.10. Open the updated version of the TST file that should be used to carry on the tests 4.11. Click the communication icon and the port where the USB is connected 4.12. Check if the communication bar becomes green indicating it is active 4.13. Running the tests. 77 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5. Performance Tests. 5.1. Setup the system according to the figure below. Fig.21. Setup for Adult Performance Test 5.2. Carry on the Oxymag performance test according to the adjustments indicated in the 6002772-NE-53-XX form and record the results. 5.3. VCV Modality tests 5.4. PCV Modalitytests 5.5. Setup the system according to the schematic diagram indicated in figures 22 and 23. . Fig.22. Neonatal Performance Tests Setup 78 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Fig.23. Neonatal Performance Test Setup * In order to carry on the flow measurement disconnect the neonatal simulator lung and set the VentMeter to measure flow and record the results in the 6002772-NE-53-XX form. 5.6. Carry on the Oxymag performance tests according to the adjustment in the 6002772-NE-53-XX and record the results. 6. Alarm Checking Carry on the thest to check the alarm system according to the steps below and record the results in the form 6002772-NE-53-XX. Initialy set the ventilator in adult mode with default parameters. 6.1. Disconnect the externa power supply from the AC electrical power outlet and check if the electrical power connection indication led lights off. 6.2. Check if there is an indication of the “AC Input Fail” and the indication that the device is running on battery. 6.3. Reconect the power supply to the AC outlet and check if the electrical power indication led lights on. 6.4. Shut off the gas connection and check if the “Low Inlet Pressure” alarm appears on the screen. 6.5. Open the gas connection and check if the alarm ceases. 6.6. Disconnect the respiratory circuit and check if the “DISCONNECTION” alarm appears on the screen. 6.7. Reconnect the respiratory circuit and check if the “DISCONNECTION” alarm ceases. 6.8. Disconnect the flow sensor line and check if the “SENSOR OFF” alarm appears on the screen. 6.9. Reconnect the flow sensor line and check if the “SENSOR OFF” alarm ceases. 6.10. Disconnect the expiratory limb from the expiratory valve and obstruct it. Check if the “OBSTRUCTION” alarm appears on the screen and the relief valves opens reducing the pressure in the respiratory circuit. 6.11. Reconect the expiratory limb to the expiratory valve and check if the “OBSTRUCTION” alarm ceases. 6.12. Press the key “O2 100%” and check if the “O2 100%” appears on the display during 90 seconds. 79 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 6.13. Press the key “ MANUAL” and check if the message “ASSIST MAN TRIG.” appears on the display. 6.14. Adjust the PEEP to zero and press the key “INSP/EXP HOLD” during the exhalation cycle and check if in the flow graph it remains in ZERO. 6.15. Connect the the SpO2 Sensor to the Oxymag and check if the message “SPO2 SENSOR” appears. Connect the sensor to the finger and select the SpO2 graph and check if there is an indication of the Cardiac Frequeny (Heart Rate). 6.16. Go to the Engineering Screen of the Oxymag and check the date and time are correct. To check this key the following values in the field V as indicated in Fig 24 and do the checking according to the following correspondence table. Fig. 24 Code Description F1 Minutes F2 Hour F3 Day of week (00 – Sunday / 06 – Saturday) F4 Day of Month F5 Month F6 Year 6.17. Check if the hourmeter is zeroed. To do this go to the Ventilator Configuration Screen and check if the total hours is in the range between 48 and 100. 6.18. In the Engineering screen do the coefficients KpV, KiV, KpF, KiF, KpP and KiP checking. Check if the coefficients are according to what is indicated in the form. 6.19. Connect the Oxymag to the PC/notebook through the USB cable adapter as indicated in Fig. 25. In the PC/Notebook, run the Oxymag test program and check if the communication bar indicates communication connection (indicated in green in Fig. 26). 80 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Fig. 25 – Communication connection: Oxymag to PC/Notebook Fig. 26 – Oxymag serial communication screen 81 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Performance Test Form O.E: Serial N° Oxymag: Pneumatic Serial N°: Sw IHM: Sw Vent: DATE: Executed by: Signature: Ítem Description Result 5 Initial Working Checkings Visual alarm and double beep Initial Screen OK? Engineering Screen OK? The VentMeter is ready for calibration procedure? □ OK □ NOK □ OK □ NOK □ OK □ NOK □ OK □ NOK 7 Differential Pressure Transducer Calibration for Adult Flow Sensor – Inspiratory Flow □ OK □ NOK 8 Adult Inspiratory Flow (RISING) FLOW VALUE TOLERANCE RESULT INTERNAL EXTERNAL 5 5 ± 2 □ OK □ NOK 10 10 ± 2 □ OK □ NOK 20 20 ± 2 □ OK □ NOK 30 30 ± 2 □ OK □ NOK 50 50 ± 2 □ OK □ NOK 70 70 ± 2 □ OK □ NOK 90 90 ± 2 □ OK □ NOK 9 Adult Inspiratory Flow (FALLING) FLOW VALUE TOLERANCE RESULT INTERNAL EXTERNAL 90 90 ± 5 □ OK □ NOK 70 70 ± 5 □ OK □ NOK 50 50 ± 5 □ OK □ NOK 30 30 ± 5 □ OK □ NOK 20 20 ± 5 □ OK □ NOK 10 10 ± 5 □ OK □ NOK 11 Differential Pressure Sensor Transducer Calibration for Adult Flow Sensor – Expiratory Flow □ OK □ NOK 82 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 12 Adult Expiratory Flow FLOW VALUE TOLERANCE RESULT 5 -(5 ± 2) □ OK □ NOK □ OK □ NOK 10 -(10 ± 2) □ OK □ NOK 20 -(20 ± 2) □ OK □ NOK 30 -(30 ± 2) □ OK □ NOK 50 -(50 ± 2) □ OK □ NOK 70 -(70 ± 2) □ OK □ NOK 100 -(100 ± 2) □ OK □ NOK 14 Differential Pressure Transducer Calibration for Infant Flow Sensor – Inspiratory Flow □ OK □ NOK 5 Infant Flow Sensor Inspiratory Flow FLOW VALUE TOLERANCE RESULT 2 2 ± 0,5 □ OK □ NOK 5 5 ± 0,5 □ OK □ NOK 10 10 ± 1 □ OK □ NOK 20 20 ± 1 □ OK □ NOK 30 30 ± 1 □ OK □ NOK 40 40 ± 1 □ OK □ NOK 50 50 ± 1 □ OK □ NOK 16 Differential Pressure Transducer Calilbration for Neonatal Flow Sensor – Inspiratory Flow □ OK □ NOK 17 Minimum Current Value P value in address: 00 08 = __________ P value in address: 00 0A = ___________ 83 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Results and notes: AD Flow Flow Condition RESULT Valve 200 LPM P Value Flow equals zero? □ OK □ NOK P Value + 200 Flow initiates? □ OK □ NOK AD Flow Flow Condition RESULT Valve 30 LPM P Value Fluxo igual a Zero? □ OK □ NOK P Value + 200 Flow initiates? □ OK □ NOK 18 Neonatal Inspiratory Flow Checking Item 16.1 checking table FLOW VALUE TOLERANCE RESULT 1 1 ± 0,5 □ OK □ NOK 3 3 ± 0,5 □ OK □ NOK 5 5 ± 0,5 □ OK □ NOK 7 7 ± 0,5 □ OK □ NOK 10 10 ± 0,5 □ OK □ NOK 15 15 ± 0,5 □ OK □ NOK 20 20 ± 0,5 □ OK □ NOK 19 Pressure transducer calibration The pressure transducer calibration was carried on successfully? □ OK □ NOK 20 Pressure Transducer Check Item 20.12 checking table PRESSURE VALUE TOLERANCERESULT 10 10 ± 0,5 □ OK □ NOK 20 20 ± 0,5 □ OK □ NOK 22 Expiratory Valve Calibration Expiratory Valve tests successfull Pressure sensor tests successfull □ OK □ NOK □ OK □ NOK 23 Oxygen Concentration Sensor Calibration Oxygen Concentration Sensor calibration successfull? □ OK □ NOK 84 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 VentMeter: □ VentMeter Id: ___ Callibration Validity: / / ( ) Pass ( ) Fail Approved by: Signature: Date: / / 85 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 ANNEX B – Pneumatic Manifold Test Instructions 1. Objective Establish a check procedure for the pneumatic manifold before integrating to the electronics. 2. References 3802368-NE-52-RR Assembly Tests Form 3. Required Equipmentos Fixture to measure the pilot valve of the Oxymag P/N 4003301 15M Fixture P/N 4003302 Cup with water Timer DC power supply with test jig High pressure manometer Flowmeter Oxymag Front Panel Test fixture to seal the O2 sensor cell spacer of the Oxymag P/N 4003034 Test fixture to test the relief valve leakeage P/N 4102764 O2 concentration measurement equipment Low pressure manometer Needle valve Device to rework nozzle P/N 4003190 VentMeter 1L test balloon Expiratory Valve Fixture to screw the relief valve cover P/N 4003215 “T” form fixture to the 6mm hose P/N 4302423 4. Procedure 4.1. Adjust adult VCV with FiO2 60% for the following volumes 300mL, 500mL and 800mL and check the flow graph if it is a inspiratory square wave. During the inspiratory cycle the flow curve should be without oscilation: 86 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.3. Check the resistance of the differential pressure connectors 4.3.1. Setup the following circuit as shown in the figure below. 4.3.2. Connect the hose to the left differential pressure and adjust a 0.5 LPM flow. 4.3.3. Check if the reading value is in the range specified in the form. 4.3.4.Repeat the item 4.3.2 to the right conector and check if the Reading value is in the range specified in the form. 4.4. Pressure regulator valve calibration, check leakeage and low flow oscilation 4.4.1. Setup the test circuit as shown in figure below. 87 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.4.2. Open the gas to the inlet at 75 ± 5psi. 4.4.3. Check the pressure indicated in the manometer and calibrate the pressure regulator valve to 55±5 psi. 4.4.4. Check leakeage from the pressure regulator cover at the adjusting screw and at the hole in the manifold as shown in the pictures below. 4.4.5. Check if the pressure remains stabilized in 55 ± 5 psi (check high pressure manometer). 4.4.6. Close the gas and check if the pressure indicated in the high pressure manomenter falls of 7 psi (0,5 bar) in less than 20 seconds. If a pressure drop occurs it is an indication that there is a leakeage. 4.4.7. Open again the gas and turn on the Valve 200LPM, connecting it to a 12V power supply and check if the pressure indication in the manometer remains stable. 4.4.8. With the Valve 200LPM turned on, lower the supply voltage and adjust a flow of 100, 70, 50, 30, 20, 15, 10, and 5 lpm. For every adjusted flow check if the pressure remains stable (without oscilations). 4.5. Check leakeage through solenoid valve and 30LPM/200LPM Valves a) Relief Valve Solenoid 4.5.1. With relief valve solenoid turned off check leakeages in the solenoid housing. Turn on the solenoid valve connecting it to a 12V and check again if any leakeage is detected through the solenoid housing and through the relief valve cover. 88 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Note: Use a brush with soap and water. After checking leakeages use a cotton swab to remove excess. 4.5.2. Keep the solenoid driven. 4.5.3. Connect the relief valve leakeage detection fixture as shown in the picture. 4.5.4. Dip the end of the hose in a glass of water to see if there are bubbles that indicates leak. 4.5.5. Disconnect the fixture. b) Valve 200 LPM 4.5.7. Drive the Valve 200 LPM with 9V and check if there is a high flow from the patient connector 4.5.8. Turn off the Valve 200 LPM and dip the patient output in a gass of water to see if there are bubbles that indicates leak. c) Valve 30 LPM 4.5.9. Drive the Valve 30 LPM with 9V and check if there is a high flow from the patient connector 4.5.10. Turn off the Valve 30 LPM and dip the patient output in a gass of water to see if there are bubbles that indicates leak. 4.6. Valve 200LPM performance 4.6.1. Open the gas, drive the relief valve solenoid with 12V, and the VentMeter should be connected to the patient conector configured for Adult. Drive the Valve 200LPM with 12V and check if the value is in the range specified in the form. 4.6.2. In the maximum flow condition, check if the pressure at the output of the pressure regulating valve remains in the range specified in the form. 4.6.3. Lock the approved pressure regulating valve in the leakeage tests, oscilation and maximum flow with Loctite (cover and adjusting screw). 89 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Note: Be careful with excesso of glue. 4.6.4. Disconnect from the gas outlet and take out the manometer and the pressure regulating fixture. 4.6.5. Clean the screw of the pressure measuring point. 4.6.6. Tight a screw in the measuring point. 4.6.7. Pressurize the manifold and check if there is any leakeage with brush with soap and water. 4.7. 4.8. Valve 30 LPM performance 4.8.1. Use compressed air instead of oxygen. 4.8.2. Drive the relief valve solenoid with 12V. 4.8.3. Connect Valve 30 LPM to the power supply. 4.8.4. Connect the flowmeter to the patient connector. 4.8.5. Adjust the supply voltage to 12 V and record the reading value in the flowmeter 4.9. Unidirectional valve performance 4.9.1. Connect the Valve 200LPM to the power supply and let the relief solenoid valve driven with 12V. 4.9.2. Connect the VentMeter’s sensor to the patient conector and a test balloom (0,5L or 1L). 4.9.3. Drive the Valve 200LPM until the indicated pressure reaches 30 cmH2O. 4.9.4. When the pressure reaches this value turn off the power supply to the Valve 200LPM. 4.9.5. Check if the pressure drops in the manometer. Leaking can be checked if the pressure drops more than 0,5 cmH2O in less than 2s. 4.9.6. Drive the Valve 200LPM until the pressure reaches 5 cmH2O. 4.9.7. When the pressure reaches this value turn off power supply. 4.9.8. Check if the pressure drops in the manometer. Leaking can be checked if the pressure drops more than 0,5 cmH2O in less than 2s. 4.10. Relief Valve Performance 4.10.1. Keep the 12V power supply to the Valve 200LPM and to the relief solenoid valve. 90 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.10.2. Connect the relief valve leakeage testing device. 4.10.3. Connect a hose to the patient conector and the other end to a VentMeter’s flow sensor (Adult Configuration). Note: Set the VentMeter to read both flow and pressure at the same time. 4.10.4. Keep the output of the flow sensor to the ambient. 4.10.5. Drive the Valve 200LPM to generate a 50±5 LPM. 4.10.6. Cause a resistance in output in order to create a pressure of 50±5cmH2O (to cause such resistance put your finger partially obstructing the flow sensor output). 4.10.7. Check if there is any leak dipping the hose in a glass of water. 4.10.8. Disconnect the relief valve leakeage testing devvice. 4.10.9. Keeping the pressure in the range of 50±5cmH2O in the circuit turn off the 12V from the relief solenoid valve and check if there is leak through the relief valve. 4.10.10. Check if in the moment that the relief solenoid is turned off there is a pressure drop. 4.10.11. Obstruct totally the patient conector in order that all the flow passes through the relief valve. 4.10.12. Record the pressure indicated by the VentMeter (relief valve resistance). 4.10.13. Clear the output to the patient and turn on the relief solenoid valve and check again if it is possible to generate a 50cmH2O with finger at the output of the flow sensor. 4.10.14. Turn off the power supply to Valve 30LPM, Valve 200LPM and to the relief solenoid valve. 4.11. Offset Test 4.11.1. Connect two hoses to the output of the manifold and connect to the VentMeter ports configured in Neonatal Mode; 4.11.2. Connect a 1L test balloom to the neonatal sensor. 4.11.3. Connect the flow sensor line to the manifold. 4.11.4. Pressurize the balloom and obstruct the output of the flow sensor. Check variations in the flow. The flow should be 0L/min. 4.11.5.Change the configuration of the VentMeter to graphic mode and repeat the procedure from 4.10.4. Check variations in flow. The flow should be 0L/min. 4.11.6. With the test balloom pressurized turn on the manifold with 12V and check if there is any pressure drop. 4.11.7. With the test balloom pressurized with 12 V applied the flow should be zero and cannot change. Pneumatic Manifold Test Form O.E.: Block: Date: Executed by: Signature: Item Description Value Range Value Result 4.3 Differential pressure conector resistance 4.3.3 Left conector value 0 - 60 cmH2O □ OK □ NOK 91 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.3.4 Right conector value 0 - 60 cmH2O □ OK □ NOK 4.4 Leakeage check and pressure regulator valve oscilation 4.4.5. Stabilized pressure value 55 ± 5 psi □ OK □ NOK 4.4.6. Pressure drop? No □ OK □ NOK 4.4.8.Flow in 100, 70, 50, 30, 20, 15, 10, 5 LPM Flow and pressure should not oscilate □ OK □ NOK 4.5 Leakeage through relief solenoid valve and Valve 300LPM, Valve 30LPM 4.5.1. Leakeage through the relief solenoid valve housing and through the relief valve cover No □ OK □ NOK 4.5.4. Leak through pressure relief valve No □ OK □ NOK 4.5.8. Leak through Valve 200 LPM No □ OK □ NOK 4.6 Valve 200 LPM performance 4.6.1. Flow at 12,0 ± 0,5 V ≥ 120 L/min □ OK □ NOK 4.6.2. Pressure regulator output pressure ≥ 26 psi □ OK □ NOK 4.6.3. Loctite 290 applied to the pressure regulator cover and screw. Ues □ OK □ NOK Item Description Value Range Value Result 4.7 Venturi Performance 4.7.5. Voltage 12 ± 0,5 V applied to the solenoid Flow only O2 12-14 L/min □ OK □ NOK Flow mixture ≥60L/min □ OK □ NOK [O2] 35 ± 5 % □ OK □ NOK 4.7.10 Pressure of 6 cmH2O and flow of 6l/min ≤81% □ OK □ NOK 4.7.12 Maximum flow @ 12V applied to the solenoid and pressure of 6 cmH2O ≥ 60l/min □ OK □ NOK 4.7.13 Maximum flow @ 12V applied to the solenoid and pressure of 30 cmH2O ≥ 30l/min □ OK □ NOK 4.8 Valve 30LPM performance 4.8.5. Flow @ 12,0 ± 0,5 V ≥60L/min □ OK □ NOK 4.9 Unidirectional Valve Performance 4.9.5 Pressure @ 5cmH2O No leakeage. Pressure drop less than 0,5 cmH2O in 2s □ OK □ NOK 4.9.8 Pressure @ 30cmH2O No leakeage. Pressure drop less than 0,5 cmH2O in 2s □ OK □ NOK 4.10 Pressure Relief Valve Performance 4.10.7. Pressure relief valve leakeage No □ OK □ NOK 4.10.9. Flow from the pressure relief valve Yes □ OK □ NOK 4.10.10. Pressure drop in manometer Yes □ OK □ NOK 4.10.12. Pressure < 6 cmH2O □ OK □ NOK 4.10.13. Respiratory Circuit Pressurized Yes □ OK □ NOK 92 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.11 Offset tests 4.11.4 Check leakeage through manifold Should not leak □ OK □ NOK 4.11.5 Check leakeage through manifold Should not leak □ OK □ NOK 4.11.6 Pressure drop Yes □ OK □ NOK 4.11.7. Differential pressure No □ OK □ NOK Results and Notes: Equipments: □ VentMeter Id: _________________________ Calibration Validity: / / □ Manometer Id__________________________ Calibration Validity: / / ( ) PASS ( ) FAIL Responsible:: Signature: Date: / / 93 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 ANNEX C – Front Panel Test Instruction 1. Objective Establish a test instruction for the OxyMag PCB – 2502358. 2. References P025-03 Production Ambient. 3. Instruments and Requirede Equipments Bench with antistatic surfasse - 1x105 /sq e 1x109 /sq grounded. Antistatic wrist strap connected to the the antistatic mat (should be tested) Power Supply Soldering Iron Two way cable with ON/OFF switch for tests Test Display 4 way cable to connect the power supplay to the PCB. 2 way cable to connect the battery to the PCB Cable (VM) to connect TP8-Power Supply. 4. Procedure 4.1. Initial Setup: a) OXYMAG PCB without display and transducer assembled;b) Jumper J1, J2. 4.2. Instruments Utilization: a) Bench and Antistatic Wrist Strap ALL THE ELECTRONIC TEST OR ASSEMBLY/DISASSEMBLY PROCEDURES SHOULD BE DONE IN A GROUNDED BENCH WITH ANTISTATIC MAT AND ANTISTATIC WRIST STRAP PROPERLY TESTED IN DAYLY BASIS. b) Test Display c) 4 way cable to connect Power Supply to PCB: o Power Supply Cable to PCB. o Connect it to CN19. o Black wire of the conector connected to the black port of the Power Supply. o Red wire of the conector connected to the red porto f the Power Supply. 5. Tests 5.1. OXYMAG PCB preparation for tests 5.1.1. Setup the OXYMAG PCB for tests. Connect the DC CABLE to the PCB. Connect the ON-OFF CABLE to the PCB. 5.1.2. Adjust the Power Supply to 12 V. 94 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.1.3. Turn off the power supply and connect the grips of the Power Supply to the respective wires of the POWER SUPPLY CABLE. 5.1.4. Check if the ON-OFF switch is OFF. 5.1.5. Turn on the Power Supply and measure the 12V in the PCB (points +12 V and GND). In case of no voltage, turn the power supply off and put this PCB apart to check lately. 5.1.6. Turn on the ON-OFF switch. 5.1.7. If it is Ok, setup for tests finished. 5.1.8. Turn off the ON-OFF switch. Fig. – OxyMag PCB 95 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.2. Checking operation of the battery circuit charger and battery 5.2.1. To test whether the temperature sensor is working properly, measure the voltage at TP 19 with a multimeter, as shown in the figure, this value should be close to 3.3 volts which means that the temperature sensor is allowing the battery to charge. 5.2.2. Check the temperature of the battery by the TP 20, each 40mV corresponds 1 º C, for example 800mV= 20°C. 5.2.3. Make the circuit above, Variable source (simulating a battery) connected in series with amperimeter. TP 19 TP 20 96 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 5.2.4. Adjust the variable source in 12V, disconnect the AC/DC input (external source). 5.2.5. Turn on the equipment, a LED will blink. 5.2.6. Decrease the voltage of variable source. When get close 9V he goes off, check the current at this time, this should not exceed 40µA. 5.3. Display checking 5.3.1. Check if the firmware loading procedure is complete. 5.3.2. Turn on the ON-OFF switch. 5.3.3. Check if there is “back-light” in the display. 5.3.4. Check if the mais screen is shown as in the figure below. 5.3.5. If OK, the display is working correctly. Fig. – Initial Screen 5.4. Function Selection Key, Touch Screen and Rotary Button Check 5.4.1. Turn on the ON-OFF switch. 5.4.2. Check if the OxyMag initial screen shows up correctly, if affirmative, press START if the touch-screen is working properly. 5.4.3. Check the function selection keys (LOCK, HOLD INSP., MANUAL, O2 100%, PAG.). 5.4.4. Check the Rotary button turning it to increment, decrement values and confirm the new value pressing it. 5.4.5. If OK, the function selection keys, touch screen and the rotary button are working properly. 5.5. Firmware and analog input checking 5.5.1. Go to the Engineering Screen. 5.5.2. To do this press 5 times the rotary button and then press the LOCK key (top key on the righ side) 97 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Fig. – Engineering Screen 5.5.3. Check if the “DISPLAY” option is enabled (if not, just press the field indicated in the picture above). Check the firmware version sendidng the address “2” in the “F” field and record it. 5.5.4. After that press the “DISPLAY” option to select the “VENTILATOR”. Check the firmware version sendidng the address “2” in the “F” field and record it. 5.5.5. The following steps should be recorded with the option “VENTILATOR” enabled. 5.5.6. Press “Zero Offset” in the display. 5.5.7. AIN_FL_PACX10. In field “P”, send the address 0XE000. Record the data in “Value”. 5.5.8. AIN_ FLUXO. Send address 0XE100. Record the data in “Value”. 5.5.9. AIN_FL_TOTAL. Send address 0XE200. Record the data in “Value”. 5.5.10. AIN_PR_CIRC. Send address 0XE300. Record the data in “Value”. 5.5.11. AIN_PR_BAR. Send address 0XE400. Record the data in “Value”. 5.5.12. Connect the FiO2 sensor to CN17. 5.5.13. AIN_FiO2. Send address 0XE500. Record the data in “Value”. 5.5.14. AIN_VBAT. Send address 0XE600. Registre dado lido em “Valor”. 5.5.15. AIN_VSYS. Send address 0XE700. Record the data in “Value”. 5.5.16. AIN_REDE_O2. Send address 0XE800. Record the data in “Value”. 5.5.17. AIN_TEMPER_BAT. Send address 0XE900. Record the data in “Value”. 98 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Formulário de Testes do Painel Frontal OS Nº: PCB Serial Number: Date: Responsible: Signature: Item Procedure Value Value Range Result 5.2 Display Tests Initial Screen OK? □OK □ NOK 5.3 Key working, Touch screen and Rotary Button Touch Screen □OK □ NOK LOCK □OK □ NOK HOLD INSP. □OK □ NOK MANUAL □OK □ NOK O2 100% □OK □ NOK PAG. □OK □ NOK CHAVE ÓPTICA □OK □ NOK 5.4.3 Display Firmware (F - 0X0002) □OK □ NOK 5.4.4 Ventilator Firmware (F - 0X0002) - □OK □ NOK 5.4.7 AIN_FL_PACX10 (P - 0XE000) 2030 ± 300 □OK □ NOK 5.4.8 AIN_ FLUXO (P - 0XE100) 2040 ± 100 □OK □ NOK 5.4.9 AIN_FL_TOTAL (P - 0XE200) 3060 ± 100 □OK □ NOK 5.4.10 AIN_PR_CIRC (P - 0XE300) 150 a 300 □OK □ NOK 5.4.11 AIN_PR_BAR (P - 0XE400) 800 a 2400 □OK □ NOK 5.4.13 AIN_FiO2 (P - 0XE500) 750 ± 100 □OK □ NOK 5.4.14 AIN_VBAT (P - 0XE600) 1200 ± 100 □OK □ NOK 5.4.15 AIN_VSYS (P - 0XE700) 110 ± 20 □OK □ NOK 5.4.15 AIN_REDE_O2 (P - 0XE800) 150 ± 20 □OK □ NOK 5.4.16 AIN_TEMPER_BAT (P - 0XE900) 25 ± 18 □OK □ NOK Equipments: Results: PASS FAIL RNC Nº Responsible: Signature: Date: 99 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Annex D – Oxymag Calibration Instructions 1. Objective This document has the objective to establish the calibration instructio of the Oxymag. 2. Form 6002772-NE-58 3. Jigs and Instruments VentMeter Monometer Power Supply 12V DC O2 Hose Two 90o elbow Oxymag’s flow sensor and sensor line. Note: Before starting the calibration procedure keep the Oxymag turned on for 30 minutes. Calibrate the VentMeter pressing simultaneously the keys F1 and F2 during the initial screen. Assembly Instructions OP Description Figure 4.1 Connect the O2 hose to the Oxymag inlet. Connect the other end to a regulated pressure output 5Kgf/cm2.100 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.2 Connect the DC power supply to the Oxymag. 4.3 Connect the adult flow sensor, 900 elbow and the line. The other end of the line should be connected to the VentMeter. 4.4 Set the above assembly to the patient conector (INS OUTPUT). Connect to the sensor output the line and the Oxymag flow sensor to be tested as shown in the figure. 2 101 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 4.5 Connect the serial cable to the VentMeter and to the SpO2 connector of the Oxymag. Initial working check 6. Internal and External Differential Pressure Transducer Calibration The differential pressure transducer of the patient flow sensor calibration shoul be carried on for each type of flow sensor (Adult, Infant and Neonate). The choice of the type of patient should be made in the initial screen. 7. Differential Pressure Transducer Calibration for Adult Flow Sensor – Inspiratory Flow OP Description Figure 5.1 Turn on the Oxymag and select the Adult Patient. 5.2 In the option setup screen, press 5 times the rotary button and the Lock key to go to the engineering screen. 102 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 OP Description Figure 7.1 Select the option “Zero offset” 7.2 In the field “F”, indicated in the figure select it and change it to “FA 05”. 7.3 Wait while the VentMeter calibrates the Oxymag until 120 L/min and finishes. Press the key “Grava tab” in Oxymag, in order to all date is recorded in the module Attention: In case of the calibration procedure does not reach 120 L/min, stop the procedure and check the non conformity END Inspiratory Flow Adult (Rising flow) OP Description Figure 8.1 Turn off Oxymag Select Adult Patient Go to the Engineering Screen, zero the Offset and Select Flow Tab 103 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 8.2 In “P” press the sencond square and through the Rotary button select the value “00 06” Press Enter of the Rotary button. 8.3 Select the field “F”, as shown in the figure. Through the Rotary button incremente the value in the field “F” and adjust the inspiratory flow until it reaches 10 L/min on VentMeter . 8.4 Record the values shown in field “F” (Internal) and in field “P” (External) in the form. Note 1: Check if there is no oscilation in the 10 L/min flow measured by Ventmeter beyond the specified tolerance. Attention: If the values are out of range, stop the test and check the non conformity. Repeat the verification for the values according to the calibration form. 9. Inspiratory Flow Adult (Falling flow) 9.1. Repeat all the steps of the inspiratory flow with descendin flow. 9.2. The adjusted flow should be in the order shown in the form. 10. AD value for the inspiratory flow 3 L/min (FaduI10). 104 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 10.1 Select the field ARMAZ and incremente with the Rotary button to “3” and check the value in the field FaduI10. Note: The presented value should be greater than 20. If the value is inferior, carry on a new calibration procedure for the inspiratory flow adult ( Ítem 7 ). In case of persistence of the value less than 20 set the OxyMag apart to future investigation 11. Differential Pressure Transducer for Adult Flow Sensor – Expiratory Flow 11.1. Repeat all the steps in Item 7 in order to record the values in “Adult Expiratory Flow" 11.2. For the expiratory flow, invert the mounting position of the OxyMag flow sensor as shown in the picture. 11.3. In the space ahead of the field “F” change the value to: FA 0A. 11.4. After the 120 L/min Reading in the VentMeter, press the field “Grava tab”, in order to record the values in the OxyMag. 12. Adult Expiratory Flow Checking 12.1 Repeat all the steps of the Item 8 to get the expiratory flow values. 12.2 Record the values presented in field “F” in the form. Atention: If the values are out of range, stop the test and check the non-conformity. Repeat the verification for the values 10, 20, 30, 40, 50, 70 and 100 L/min. 105 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 13. AD values for 3 L/min adult expiratory flow (FaduE10) 13.1 Select the field ARMAZ and incremente the value to “3” and check if the value shown in the field FaduE10 is greater than 20. If the value is less than 20, repeat the adult expiratory flow calibration ( Item 11 ). Note: If the value is less than 20 consistently, than set the OxyMag apart to future investigation . Differentila Pressure Transducer Callibration – Infant Flow Sensor – Inspiratory Flow OP Description Figure 14.1 Replace the adult flow sensors by infant flow sensors in both OxyMag and VentMeter 14.2 Turn on the OxyMag and select Infant Patient. Go to the Engineering Screen, zero the offset and select the Flow Tab. 14.3 Turn off and turn on the VentMeter. Select the Infant Sensor, zero the transducer and select the flow screen. 14.4 Zero Offset. In the space ahead of the field “F” set the value to “FA 05” Wait while the VentMeter calibrates the Oxymag until 50 L/min. 106 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 15. Infant Inspiratory Flow Checking 14.5 When the VentMeter reaches 50 L/min and ceases the flow, press the button “Grava tab” in OxyMag in order to record the data in the equipment. Attention: If the calibration does not reach 50 L/min, stop the procedure and check the non conformity. 15.1 Turn off and turn on the OxyMag. Select Infant Patient. Go to the Engineering Screen. Selecit the Flow Tab. Press Zero Offset. 15.2 Select the field “F”. Increment the value in the field “F” and adjust the inpiratory flow seen in VentMeter to 2 L/min 15.3 Record the value shown in field “F” in the form. Note 1: Check if there is no oscilation of the 2 L/min flow shown in VentMeter beyond the specified range. Repeat the verification for other values according to the form.107 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 16. Differential Pressure Transducer Calibration for Neonatal Flow Sensor – Inspiratory Flow. OP Description Figure 16.1 Turn off Oxymag. Replace the infant flow sensors by neonatal flow sensors in both Ventmeter and Oxymag. 16.2 Turn off and turn on the Ventmeter. Select Neonatal Mode, zero the transducer and select the flow screen. 16.3 Zero the Offset. In space ahead of the field “F” set the value “FA 05” 16.4 Wait while VentMeter calibrates the OxyMag until the flow reaches 20 L/min. When the VentMeter reaches 20 L/min and ceases the flow press the button “Grava tab” in Oxymag, in order to record the data in the module. . Minimum current to start the flow 17.1 Turn off and turn on the Oxymag and select Neonatal Patient. Go to Engineering Screen. Select the field “P” (in red) and set the value to: “00 08”. Record the value indicated in field “P” in the form. 108 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 17.2 Select the field “F”. Adjust the value to the same as recorded right before. Check if the VentMeter indicates zero flow. In field “F” add 200 to the value and set it in this field. (Ex. read value = 1342, new set value: read valule + 200 = 1542.) Check in VentMeter if the flow starts. If affirmative continue the tests, otherwise restart the calibration procedure for Neonatal Flow Sensor. 18. Neonatal Inspiratory Flow Checking 18.1 Turn off and turn on the Oxymag. Select neonatal patient. Go to Engineering Screen. Select Flow Tab. Zero Offset. 18.2 Select the field “F”. Increment the value in field “F” and adjust a flow of 1 L/min 18.3 Record the value shown in field “F” in the form. Note 1: Check if there is no oscilation of the 1 L/min beyond the specified range. Attention: If the values are out of range stop the test and check the non conformity. Repeat the verification for the following values 3, 5, 7,10,15 and 20 L/min. 19.0 Pressure Transducer Calibration: 109 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Note: To calibrate the pressure transducer of the Oxymag it is required the all three flow sensors ( Adult, Infant and Neonatal ). In this procedure use the Neonatal Flow Sensor to do the calibration. OP Description Figure 19.1 Connect the neonatal flow sensor to the patient conector INS OUTPUT of the Oxymag. At the output of the sensor connect a hose and the other end should be connected to the Expiratory Valve. 19.2 In the space of the field “F” set the value “FA 0F” 110 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 . Pressure Transducer Check 20.1 Turn off and turn on the Oxymag. Select neonatal patient. Go to Engineering Screen. Select Flow Tab. Zero Offset. 20.2 Turn off and turn on the Ventmeter. Select Neonatal Mode, zero the offset nad select the Pressure Screen. 20.3 Increment/Decrement the “F” and “P” and set the pressure to 10 cmH2O 19.3 Observe in the VentMeter the value reaching 10 cmH2O The pressure stabilizes at 10 cmH2O then falls to zero, and return again stabilizing in 30 cmH2O and smoothly returns to zero ending the calibration procedure. Attention: If the calibration procedure does not reaches the values indicates then stop the test and check non conformity. 111 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 20.4 Record the value in field “P”, indicated in figure 2. Check if the value is in the range shown in the form. If it is out of range repeat the calibration procedure. In case of persistence put this Oxymag apart to future verification Set the pressure to 20cmH2O and repeat the verification and record the values in the form and check if the value is inside the specified range. 21.0 Calibração da Válvula Expiratória OP Descrição Figura 21.1 Turn off and turn on the Oxymag. Press the key “TEST” 21.2 Notice the presence of the visual and audible signal. If OK press YES. 112 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 21.3 Clear the “Y” conector If OK press the key YES. 21.4 On the screen press “Next” Note: Before pressing “NEXT” check if all the results are OK. In case of “FAIL” condition stop the procedure and check the non conformity. 21.5 Obstruct the “Y” conector Press OK 21.6 In the expiratory valve test screen check if it is OK Exp Valve Pressure Sensor Oxygen Sensor Calibration 113 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 22.1 Turn off and turn on the Oxymag. Select Adult Patient Select the “Config” option 22.2 Press the button “O2/CO2” 22.3 Press the button “Calibration” Check if at the end of the calibration appears “OK”. Oxymag Calibration Form O.S: Serial N° Oxymag: Serial N° Pneumatic Manifold: Sw IHM: Sw Vent: DATE: Executed by: Signature: Item Description Result 5 Initial Veriification Double beep and visual alarm Initial Screen Engineering Screen □ OK □ NOK □ OK □ NOK □ OK □ NOK 114 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Ventmeter is ready for calibration procedure □ OK □ NOK 7 Differential Pressure Transducer Calibration for Adult Flow Sensor – Inspiratory Flow □ OK □ NOK 8 Adult Inspiratory Flow (Rising Flow) FLOW MEASURED VALUE TOLERANCE RESULT INTERNAL EXTERNAL 5 5 ± 2 □ OK □ NOK 10 10 ± 2 □ OK □ NOK 20 20 ± 2 □ OK □ NOK 30 30 ± 2 □ OK □ NOK 50 50 ± 2 □ OK □ NOK 70 70 ± 2 □ OK □ NOK 90 90 ± 2 □ OK □ NOK 9 Adult Inspiratory Flow (Falling Flow) FLOW MEASURED VALUE TOLERANCE RESULT INTERNAL EXTERNAL 90 90 ± 5 □ OK □ NOK 70 70 5 □ OK □ NOK 50 50 ± 5 □ OK □ NOK 30 30 ± 5 □ OK□ NOK 20 20 ± 5 □ OK □ NOK 10 10 ± 5 □ OK □ NOK 11 Differential Pressure Transducer Calibration for Adult Flow Sensor – Expiratory Flow □ OK □ NOK 12 Adult Expiratory Flow FLOW MEASURED VALUE TOLERANCE RESULT 5 -(5 ± 2) □ OK □ NOK □ OK □ NOK 10 -(10 ± 2) □ OK □ NOK 115 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 20 -(20 ± 2) □ OK □ NOK 30 -(30 ± 2) □ OK □ NOK 50 -(50 ± 2) □ OK □ NOK 70 -(70 ± ) □ OK □ NOK 100 -(100 ± 2) □ OK □ NOK 14 Differential Pressure Transducer Calibration for Infant Flow Sensor – Inspiratory Flow □ OK □ NOK 15 Infant Inspiratory Flow FLOW MEASURED VALUE TOLERANCE RESULT 2 2 ± 0,5 □ OK □ NOK 5 5 ± 0,5 □ OK □ NOK 10 10 ± 1 □ OK □ NOK 20 20 ± 1 □ OK □ NOK 30 30 ± 1 □ OK □ NOK 40 40 ± 1 □ OK □ NOK 50 50 ± 1 □ OK □ NOK 16 Differential Pressure Transducer Calibration Neonatal Flow Sensor – Inspiratory Flow □ OK □ NOK 17 Minimum Current Value Value in P at address: 00 08 = __________ Value in P at address: 00 0A = ___________ AD Flow Flow Condition RESULT Valve 200LPM Value in P Flow is zero? □ OK □ NOK Vaue in P + 200 Flow starts? □ OK □ NOK AD Flow Flow Condition RESULT Valve 30 LPM Value in P Flow is zero? □ OK □ NOK Vaue in P + 200 Flow starts? □ OK □ NOK 116 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 18 Neonatal Inspiratory Flow Verification Table of the item 16.1 FLOW MEASURED VALUE TOLERANCE RESULT 1 1 ± 0,5 □ OK □ NOK 3 3 ± 0,5 □ OK □ NOK 5 5 ± 0,5 □ OK □ NOK 7 7 ± 0,5 □ OK □ NOK 10 10 ± 0,5 □ OK □ NOK 15 15 ± 0,5 □ OK □ NOK 20 20 ± 0,5 □ OK □ NOK 19 Pressure Transducer Calibration The pressure transducer calibration has successfully ended □ OK □ NOK 20 Pressure Transducer Checking Item 20.12 verification table PRESSURE MEASURED VALUE TOLERANCE RESULT 10 10 ± 0,5 □ OK □ NOK 20 20 ± 0,5 □ OK □ NOK 22 Expiratory Valve Calibration The expiratory valve calibration has successfully ended The pressure sensor tests has successfully ended □ OK □ NOK □ OK □ NOK 23 Oxygen Concentration Calibration The oxygen concentration calibration has successfully ended □ OK □ NOK 24 Timer Calibration The minutes are correctly recorded The hour is correctly recorded The day of week is correctly recorded The day is correctly recorded The month is correctly recorded The year is correctly recorded □ OK □ NOK □ OK □ NOK □ OK □ NOK □ OK □ NOK □ OK □ NOK □ OK □ NOK 117 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Results and notes: Equipments: □ VentMeter Id: _____________________ Calibration Validity: / / ( ) PASS ( ) FAIL Appproved by: Signature: Date: / / 25 Hourmeter Calibration Hourmeter calibration has successfully ended □ OK □ NOK 26 Barometric Pressure Calibration Barometric Pressure calibrations has successfully ended □ OK □ NOK 118 MAGNAMED OxyMag – Emergency and Transport Ventilator P/N: 1600185 Manufacturer Magnamed Tecnologia Médica S/A Rua São Paulino, 221 – Vila Mariana CEP: 04019-040 – São Paulo - SP – Brasil Tel: +55 (11) 5081-4115 Fax: +55 (11) 5084-5297 E-mail: magnamed@magnamed.com.br Website: www.magnamed.com.br European Authorized Representative Obelis s.a. Bd. Général Wahis 53 1030 Brussels, Belgium Tel: +32.2.732.59.54 Fax: +32.2.732.60.03 E-mail: mail@obelis.net Website: www.obelis.net MAGNAMED Tecnologia Médica S/A CNPJ: 01.298.443/0001-73 Inscrição Estadual: 149.579.528.111 Made in Brazil