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5503.320 9036363 Revision 1.0WARNING! The proper servicing and testing of this de- vice requires a full understanding of this Technical Documentation. Carefully read this Technical Documentation and any ap- plicable Instructions for Use prior to any use of the device. Technical Documentation Oxylog 2000 plus Emergency and Transport Ventilator This page has been intentionally left blank. C op yr ig ht re se rv ed . K 55 03 32 0I E C IV Z. fm 1 1. 03 .0 8 3 Contents Abbreviations 1 Explanation 6 General 1 Symbols and Definitions 8 2 Notes 8 Function Description 1 General 10 2 Functional principle 10 3 Pneumatic assembly 11 3.1 Inlet ....................................................................................................................................... 11 3.2 Restrictor .............................................................................................................................. 11 3.3 Sensors and safety functions ............................................................................................... 11 3.4 PEEP valve .......................................................................................................................... 12 3.5 Ambient pressure conditions ................................................................................................ 13 4 Electronics 13 4.1 Charging Circuit PCB ........................................................................................................... 13 4.2 Sensor PCB .......................................................................................................................... 14 4.3 Front membrane cover ......................................................................................................... 14 4.4 Control PCB ......................................................................................................................... 14 Maintenance Procedures 1 Replacing the replaceable battery 16 2 Replacing the filter element 17 Schematics and Diagrams 1 General 20 Annex Parts Catalog Test instructions C op yr ig ht re se rv ed . K5 50 33 20 IE C IV Z. fm 1 1. 03 .0 8 4 Contents This page has been intentionally left blank. 5 Abbreviations This chapter contains a list of the abbreviations used in this manual. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ A bk ue rz un ge n_ P. fm 6 5503.320 Abbreviations Oxylog 2000 plus 1 Explanation Abbreviation Explanation BTPS English acronym for “Body Temperature, Pressure, Sat- urated” (current conditions in the patient's lung, i.e. body temperature 37 °C, ambient pressure, water-vapor satu- rated gas). DC English acronym for “Direct Current”. EEPROM English acronym for “Electrically Erasable Programma- ble Read-Only Memory”. EL display Electroluminescence display. EPROM English acronym for “Erasable Programmable Read- Only Memory”. LED English acronym for “Light Emitting Diode”. MV English acronym for “Minute Volume”. PC English acronym for “Personal Computer”. PEEP English acronym for “Positive End Expiratory Pressure”. RAM English acronym for “Random Access Memory”. VC-CMV English acronym for the ventilation mode “Volume Con- trol - Controlled Mandatory Ventilation”. VC-SIMV English acronym for the ventilation mode “Volume Con- trol - Synchronized Intermittent Mandatory Ventilation”. VT English acronym for “Tidal Volume”. 7 General This chapter contains general notes and definitions that are important for the use of this manual. C op yr ig ht re se rv ed . 6. 0_ P rin te d on _0 5. 03 .0 8_ G en er al _T ec hn ic al _D oc um en ta tio n. fm 8 5503.320 General Oxylog 2000 plus 1 Symbols and Defini- tions 2 Notes This Technical Documentation conforms to the IEC 60601-1 standard. Read each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment. The maintenance procedures described in this Technical Documentation may be performed by properly trained service personnel only. These maintenance procedures do not replace inspections and servicing by the manufacturer. This Technical Documentation is for informational purposes only. Product information contained in this Technical Documentation does not supersede Product information provided in the Instructions for Use enclosed with the product at the time of delivery. WARNING A WARNING statement provides important information about a poten- tially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other pro- perty. NOTE A NOTE provides additional information intended to avoid inconvenience during operation or servicing of the equipment. Definitions: Inspection = examination of actual condition Maintenance = measures to maintain specified condition Repair = measures to restore specified condition Servicing = inspection, maintenance, and repair CAUTION If you deviate from the instructions and/or recommendations in this Techni- cal Documentation, the equipment may operate improperly or unsafely, or the equipment could be damaged. CAUTION Dräger recommends that only Dräger supplied repair parts be used for maintenance. Otherwise the correct functioning of the device may be com- promised. NOTE Unless otherwise stated, reference is made to laws, regulations or stan- dards (as amended) applicable in the Federal Republic of Germany for equipment used or serviced in Germany. Users or technicians in all other countries must verify compliance with local laws or applicable international standards. NOTE If the test values are not met, please contact your local service organiza- tion. 9 Function Description This chapter contains descriptions of the device's technical functions. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ F5 50 34 03 T0 1_ Fu nk tio n. fm 10 5503.320 Function description Oxylog 2000 plus 1 General The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards. For use by and under supervision of trained health care professionals. 2 Functional principle Oxylog 2000 plus primarily comprises the pneumatic components with the connection and metering block and the control and display electronics (Fig. 1). The connection block supplies a constant pressure to the metering block, contains the safety functions such as the emergency air and safety valves, control the pressure (PEEP) during expiration and, together with the ventila- tion accessories, provides the interface to the patient. The metering block passes defined volumes of gas of approx. 40% or 100% oxygen to the connection block. The control and display electronics evaluate the measurement signals, con- trol the valves and provide the interface to the operator. Fig. 1 Functional principle 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ F5 50 34 03 T0 1_ Fu nk tio n. fm 11 Oxylog 2000 plus Function description 3 Pneumatic assembly The following description relates to the pneumatics diagram of the Oxylog 2000 plus. The Control PCB evaluates the measurement signals of the sen- sors and actuates the valves. 3.1 Inlet The compressed oxygen passes through the filter F1 and the pressure regu- lator DR to the valves V1 to V3. The pressure regulator regulates the pres- sure to 3 bar. This is done to attain a stable flow control. The Control PCB monitors this pressure, which is measured with sensor S3. 3.2 Restrictor Valves V1 to V3 are proportional valves, eachdelivering a flow proportional to the overall flow of 0 to 35 L/min. The flow sensor S1 measures the delivered flow and the Control PCB corrects the valve operation as necessary. Valve V3 comprises two parallel configured valves, to produce a total flow greater than 100 L/min. With the valve V1 and the ejector E1 ambient air can additionally be drawn in. Valve V1 meters a flow through the ejector. The resultant negative pressure draws ambient air through the filter F2, the flow sensor S2 and the non-return valve V9. Valve V2 adds oxygen to the ambient air depending on the selected O2 con- centration (40 or 100%). The proportion of ambient air may be a maximum of 75%. The minimum oxy- gen concentration may thus be 40%. At flows less than 9 L/min the volume of intake air is so low that an oxygen concentration of 40% is no longer guaranteed. At flows greater than 35 L/min oxygen is added accordingly. An oxygen concentration of 40% is no longer guaranteed. In a flow range from 9 to 35 L/min an oxygen concentration of 40% or 100% can be set. The non-return valve V9 prevents oxygen escaping into the ambi- ent air. L1 prevents swirling, and ensures a uniform oxygen concentration. 3.3 Sensors and safety functions The flow sensor S1 measures the inspiratory flow inside the unit and the Con- trol PCB corrects the operation of valves V1 to V3 as necessary based on the measured value. The safety valve SV opens at a pressure greater than 80 mbar, to prevent the patient from being exposed to high pressure in the event of unit malfunctions. The emergency breathing valve NV allows the patient to breathe spontane- ously in case the unit fails. The pressure sensor S4 measures the internal patient pressure inside the unit and the PEEP pressure at the ventilation valve V10. The pressure sensor S6 measures the differential pressure above the flow sensor S8 located close to the patient (Fig. 2). From it, the Control PCB cal- culates the flow. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ F5 50 34 03 T0 1_ Fu nk tio n. fm 12 5503.320 Function description Oxylog 2000 plus Fig. 2 Functional principle of the external flow sensor Pressure sensor S5 measures the pressure at the patient. Based on this pressure value, the Control PCB makes calculations including for actuation of the PEEP valve V6. Valves V7 and V8 switch the connections of S6, S5 against atmosphere at cyclic intervals. The Control PCB calibrates the sensors and any offset drift is prevented. 3.4 PEEP valve The PEEP valve V6 controls the PEEP setting of the ventilation valve V10. The Control PCB actuates a coil which delivers a pressure to a diaphragm. The internal tubing system vents to this pre-set PEEP pressure during expira- tion. This PEEP pressure also acts on a valve diaphragm in the ventilation valve V10 (Fig. 3/1). On expiration the pre-set PEEP pressure is established at the patient. During expiration an internal flow of 0.5 L/min flows through the PEEP valve V6 to hold the diaphragm of the PEEP valve still and ensure uniform opening of the PEEP valve. During inspiration the PEEP valve V6 is closed by an actuation current of 130 mA. 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ F5 50 34 03 T0 1_ Fu nk tio n. fm 13 Oxylog 2000 plus Function description Fig. 3 Ventilation valve 3.5 Ambient pressure conditions Oxylog 2000 plus meters the tidal volume under BTPS conditions. Sensors S7 and S9 measure the ambient pressure. S5 measures the current pressure level in the lung. In this way the Control PCB can balance fluctuating ambient pressure and the BTPS conditions (Body Temperature, Pressure, Saturated. Measurements referred to conditions of the patient's lung, body temperature 37 °C, ambient pressure, water vapor saturated gas). 4 Electronics The following description relates to the Electronics block diagram and repre- sents only the principle of operation. The connections of the individual mod- ules are only indicated indirectly, and are made by cable harnesses, connectors and the conductors on the individual PCBs. 4.1 Charging Circuit PCB The Charging Circuit PCB controls charging of the internal replaceable bat- tery and selection of the voltage supply (mains, on-board system or internal battery). The Charging Circuit PCB accommodates the input for the external voltage supply. The input is isolated from the remaining electronics by a protective circuit. The Charging Circuit PCB directly activates the power indicator LEDs. The LEDs are located on the front membrane cover. The Charging Circuit PCB has its own processor system, and thus its own software. This software is also located on the Control PCB, and is loaded from there onto the Charging Circuit PCB. The internal replaceable battery has various dummy resistors, depending on the type used. The Charging Circuit PCB detects on the basis of the resistor which type is fitted (nickel metal hydride or lithium ion). The temperature and charge capacity of the internal replaceable battery is determined by the battery itself. These data are transmitted from the Char- ging Circuit PCB to the Control PCB. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ F5 50 34 03 T0 1_ Fu nk tio n. fm 14 5503.320 Function description Oxylog 2000 plus 4.2 Sensor PCB The Sensor PCB holds all the pressure sensors of the pneumatic system and the internal temperature gauge. The Sensor PCB is the interface for pressure measurement and valve actuation between the pneumatic and electronic sys- tems. 4.3 Front membrane cover On the front membrane cover are the keys, the LEDs and the rotary knob. Together with the display, the rotary knob and the potentiometers, the front membrane cover is the interface between the unit and the operator. The dis- play is an EL display. EL stands for electroluminescent. 4.4 Control PCB The Control PCB holds the electronic ON/OFF switch components, the voltage generation of the individual internal operating voltages, and the microprocessor system for control and monitoring of ventilation. The electronic ON/OFF circuit is directly controlled (switched on or off) by the ON/OFF switch on the device. If the device is ON and the power fails, an alarm generator generates an audible alarm signal. A Goldcap capacitor delivers the voltage for the signal. The voltage generator generates the various operating voltages from the sup- ply voltage. For example the +5 V for the microprocessor. The microprocessor system comprises the microcontroller, an EEPROM, a flash EPROM, a RAM, and a real-time clock (RTC). The EEPROM holds the calibration data, software options, ID number, unit and service operating hours and the start-up conditions. The flash EPROM holds the medical device software and the software for the Charging Circuit PCB. The real-time clock generates the time and date. The real-time clock's RAM also holds the logs. The microprocessor system evaluates the measurement signals from the sensors, the settings of the potentiometers and the rotary knob and operates the valves and the display accordingly. On a change of software the unit no longer needs to be opened. The infrared interface transfers the data from the PC/laptop to the microcontroller and vice versa. 15 Maintenance Procedures This chapter describes the measures required to maintain the specified condition of the device. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ W 55 03 40 3T 06 _W ec hs el ak ku .fm 16 5503.320 Maintenance procedures Oxylog 2000 plus 1 Replacing the replaceable battery 1. Slacken the screw Fig. 1/1 of the battery compartment cover anti-clock- wise until the cover can be opened. 2. Fold the cover Fig. 1/2 down. 3. Pull the replaceable battery Fig. 1/3 forward by its taband withdraw it. Fig. 1 Removing the replaceable battery 4. Press the button on the new replaceable battery and check the charge. The LEDs on the replaceable battery indicate the charge condition in percent. 5. Charge the replaceable battery as necessary. 6. Fit the replaceable battery. 7. Switch on the Oxylog 2000 plus and check the battery capacity indicated on the display. NOTE The replaceable battery can be charged by the battery charger station or by the external power supply in the Oxylog 2000 plus. 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _0 5. 03 .0 8_ W 55 03 40 3T 03 _F ilt er ei ns at z. fm 17 Oxylog 2000 plus Maintenance procedures 2 Replacing the filter element 1. Switch off the device. 2. Remove screws Fig. 2. Fig. 2 Removing the filter element 3. Remove the filter element. 4. Install the new filter element. 5. Carry out a unit test. 6. Place the fully functional unit at the user's/owner's disposal. NOTE Note fitting position of filter element. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _0 5. 03 .0 8_ W 55 03 40 3T 03 _F ilt er ei ns at z. fm 18 5503.320 Maintenance procedures Oxylog 2000 plus This page has been intentionally left blank. 19 Schematics and Diagrams This chapter contains schematics and diagrams that can be of help when servicing the device. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 20 5503.320 Schematics and diagrams Oxylog 2000 plus 1 General This section presents the diagrams and overviews of the Oxylog 2000 plus, such as the pneumatic components diagram and the block diagram of the electronics. These schematics and diagrams are partly used as reference to the function description. Fig. 1 Overview; for legend see Table 1 Table 1 Legend Fig. 1 Item Designation 1 Front panel with potentiometers, rotary knob, membrane keypad, and insert strip 2 Signal generator 3 Loudspeaker 4 Display 5 Control PCB (see also Fig. 6) 6 Cover plate for pneumatic assembly 7 Pneumatic assembly and Sensor PCB (see also Fig. 3) 8 Handle 9 Filter element to filter the ambient air intake 10 Charging Circuit PCB 11 Rear panel 12 Battery compartment cover 13 Replaceable battery 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 21 Oxylog 2000 plus Schematics and diagrams Fig. 2 Pneumatic components diagram, for legend, see Table 2 Table 2 Legend Fig. 2 and Fig. 3 14 DC voltage socket 15 Sockets for flowmeter tubes, ventilation tube and compressed gas tube 16 Base plate Item Designation 1 Connection block 2 Metering block DR (PR) Pressure regulator E1 Ejector F1 Filter in O2 compressed gas connection port F2 Filter for intake air L1 L1 makes sure there is an even flow NV Emergency-air valve S1 Flow sensor to measure internal inspiratory flow S2 Flow sensor to measure the ambient air intake S3 Pressure sensor (Pv) to measure supply pressure for valves V1 to V3 S4 Pressure sensor (Pint) to measure unit-internal patient pressure Item Designation C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 22 5503.320 Schematics and diagrams Oxylog 2000 plus Fig. 3 Overview of pneumatic components, for legend see Table 2 S5 Pressure sensor (Paw) to measure pressure close to patient S6 Pressure sensor (delta P) to measure differential pressure at external flow sensor S7 and S9 Pressure sensors to measure ambient pressure S8 External flow sensor SV Safety valve V1 to V3 Metering valves V10 Ventilation valve V6 PEEP valve V7 and V8 Switching valves to calibrate pressure sensors S5 and S6 V9 Non-return valve Item Designation 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 23 Oxylog 2000 plus Schematics and diagrams Fig. 4 Tubing diagram, for legend, see Table 3 Table 3 Legend Fig. 4 Item Designation 1 Sensor PCB 2 Connection block 3 Metering block 4 Tube 4x1 PAE not colored (nc) 5 Tube 2x1.5 Si not colored (nc) 6 Tube 2x1 Si blue (bu), red (rd), orange (og) C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 24 5503.320 Schematics and diagrams Oxylog 2000 plus Fig. 5 Electronics block diagram Fig. 6 Control PCB, for legend, see Table 4 5503.320 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 25 Oxylog 2000 plus Schematics and diagrams Table 4 Legend Fig. 6 Item Designation 1 EEPROM 2 Goldcap capacitor 3 Microcontroller 4 Real-time clock with battery A Control PCB mounting screws X120 Connection to signal generator X200 Connection to Sensor PCB X220 Connection to potentiometers X270 Connection to loudspeaker X312 Jumper to trigger a reset X400 Connection to flow sensor S1 X440 Connection to flow sensor S2 X609 Jumper to perform bootstrap download X665 Connection to rotary encoder X700 Connection to Charging Circuit PCB X730 Connection to front membrane (keys). X740 Connection to front membrane (LEDs) X760 Connection to display X790 Pin strip for bootstrap download C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ S 55 03 40 3D 01 _U eb er si ch te n. fm 26 5503.320 Schematics and diagrams Oxylog 2000 plus This page has been intentionally left blank. Annex Parts Catalog This chapter contains a list of the device's orderable parts. Test instructions This chapter contains the measures required to determine the actual condition of the device. This page has been intentionally left blank. Parts catalog Oxylog 2000 plus 5503.320 Revision: 00 2008-04-28 Oxylog 2000 plus Item No. Order No. Description Qty. Qty.unit Remark Revision: 00 Product concerned Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts C op yr ig ht r es er ve d. Oxylog 2000 plus Set, 2-yearly Item No. Order No. Description Qty. Qty.unit Remark 1 2M86341 Filter Mat 1.000 St 2 2M86733 Battery Lithium-Ionen 1.000 St Revision: 00 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts C op yr ig ht r es er ve d. Oxylog 2000 plus Accessories/Consumables Item No. Order No. Description Qty. Qty.unit Remark 1824481 Power Cable CE,3m,10A,C13L,bk 1.000 St 1868160 Cable TH/BR,3m,C13,black RoHS 1.000 St 1844342 Power cable DK, 3 m, 10 A 1.000 St 1844369 Power cable Great Britian 3m black 1.000 St 1844377 POWERCORD CH 3M 1.000 St 1851705 Cable Australia,3m,10A,C13 1.000 St 1859706 Power cable 10A,3m,black,China 1.000 St 2M86729 Battery Charger 1.000 St 2M86730 AC/DC power pack 1.000 St 2M86731 DC/DC Converter 1.000 St 2M86733 Battery Lithium-Ionen 1.000 St ME05133 Conversion kit reusable 1.000 St ME05134 Conversion Kit Disposable 1.000 St 5703307 Carrying Belt 1.000 St 5704216 All-round Wall Holder 1.000 St 5704217 Quick Power Connector 1.000 St 5704218 Wall Holder Adaptation Plate 1.000 St 5704641 All round Wall Holder USA 1.000 St 2M86900 Equipment holder 1.000 St 5704640 Equipment Holder USA 1.000 St Revision: 00 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare partsC op yr ig ht r es er ve d. Oxylog 2000 plus Item No. Order No. Description Qty. Qty.unit Remark 5704441 Hose O2 DISS-DISS gr 1,5m 1.000 St 5704447 Hose O2 DISS-DISS gr 3 m 1.000 St 5704440 Hose O2 DISS-DISS gr 1,5m spr 1.000 St 5704442Hose O2 DISS-DISS gr 3 m spr 1.000 St 2M86975 Carrying System 1.000 St CP-Catalog Accesso./Consumabl. 1.000 St Revision: 00 Accessories/Consumables Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts C op yr ig ht r es er ve d. Oxylog 2000 plus Carrying System Item No. Order No. Description Qty. Qty.unit Remark 2 8412716 O2-Connector Tube 0,5m 1.000 St Revision: 00 Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare partsC op yr ig ht r es er ve d. Oxylog 2000 plus Item No. Order No. Description Qty. Qty.unit Remark 5 5704500 Gas Supply System 1.000 St 6 5704216 All-round Wall Holder 1.000 St Revision: 00 Carrying System Parts catalog Items that are shown in the illustration but are not listed below the illustration are not available as spare parts C op yr ig ht r es er ve d. This page has been intentionally left blank. - Oxylog 2000 plus Revision 1.0 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ E N _I M AP _T L_ P_ Fr on t.f m 1 of 20 Test instructions (TL) Oxylog 2000 plus General: All results must be documented in the Test Report. NOTE The procedures described in this Test List can be carried out using commercially available test equipment and tools; however, this Test List does not replace inspections and mainte- nance by the manufacturer. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ E N _I M AP _T L_ P _F ro nt .fm 2 of 20 - Oxylog 2000 plus Revision 1.0 This page has been intentionally left blank. C op yr ig ht re se rv ed . P 55 03 32 0_ TL IV Z. fm 1 1. 03 .0 8 3 of 20 Contents 1 Device configuration 1.1 Oxylog 2000 plus device configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 1.1.1 Serial number of the Oxylog (if not otherwise recorded) .....................................................................6 1.1.2 Serial number of the power supply unit (if not otherwise recorded) ....................................................6 1.1.3 Software version ..................................................................................................................................6 2 Electrical safety 2.1 Electrical safety according to VDE 0751/IEC 60601-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 2.1.1 Oxylog 2000 plus - not applicable - .....................................................................................................8 2.1.2 Power supply unit visual check ............................................................................................................8 2.1.3 Protective earth conductor of power supply cord ................................................................................8 3 Function and condition test 3.1 Condition test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 3.1.1 Labels and Instructions for Use .........................................................................................................10 3.1.2 Basic unit, outside .............................................................................................................................10 3.1.3 Carrier system and accessories ........................................................................................................10 3.2 Basic unit function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 3.2.1 Unit test .............................................................................................................................................11 3.2.2 Buttons and potentiometer ................................................................................................................11 3.2.3 Loudspeaker, buzzer, LEDs and display ...........................................................................................11 3.2.4 Voltage supply ...................................................................................................................................11 3.2.5 Supply pressure/emergency air valve ...............................................................................................12 3.2.6 Safety valve .......................................................................................................................................13 3.3 Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 3.3.1 Volume-controlled ventilation ............................................................................................................14 3.3.2 Trigger function ..................................................................................................................................14 3.4 Device handover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 4 Test equipment 4.1 Test equipment list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 5 Annex 5.1 Accessing service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 5.1.1 Accessing the Customer Service Mode .............................................................................................20 C op yr ig ht re se rv ed . P5 50 33 20 _T LI V Z. fm 1 1. 03 .0 8 4 of 20 Contents This page has been intentionally left blank. 5 of 20 1 Device configuration C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ C on fig ur at io n. fm 6 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Oxylog 2000 plus device configuration 1.1 Oxylog 2000 plus device configuration 1.1.1 Serial number of the Oxylog (if not otherwise recorded) Action • Read the serial number on the Oxylog 2000 plus (the serial number is located on the name plate). Entry Oxylog 2000 plus serial number [________txt] 1.1.2 Serial number of the power supply unit (if not otherwise recorded) Action • Read the serial number on the power supply unit. Entry Serial number of the power supply unit [________txt] 1.1.3 Software version Action • Read out and enter the software version later under „Function and condi- tion test“ (the software version is displayed immediately after power-on). Entry Software version Oxylog 2000 plus [________txt] 7 of 20 2 Electrical safety C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ VD E _I E C _S ch ut zl ei te r_ TL .fm 8 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Electrical safety according to VDE 0751/IEC 60601-1 2.1 Electrical safety according to VDE 0751/IEC 60601-1 2.1.1 Oxylog 2000 plus - not applicable - 2.1.2 Power supply unit visual check Test The power supply unit, the power supply cord, and the connecting cable to the Oxylog are neither damaged nor contaminated. Result Condition checked. [________OK] 2.1.3 Protective earth conductor of power supply cord Test The value of the protective earth conductor resistance must not exceed 0.1 ohms. Result Protective earth conductor resistance [________Ohm] NOTE The power supply unit (2M86730) conforms to the requirements of protec- tion class 2. 9 of 20 3 Function and condition test C opyr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ co nd iti on .fm 10 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Condition test 3.1 Condition test Prerequisites The device is fully assembled. 3.1.1 Labels and Instructions for Use Test – Labels and markings are complete and legible. – The Instructions for Use are available (according to user/owner). – Only applicable in Germany: The medical product log is available (accord- ing to user/owner). Result Condition checked. [________OK] 3.1.2 Basic unit, outside Test – The housing, connections, front membrane, control elements, and handle are neither contaminated nor damaged. – The ventilation tube and ventilation valve are not hardened or damaged. Result Condition checked. [________OK] 3.1.3 Carrier system and accessories Test – The carrier system and accessories are not damaged. – The connecting cables are not porous, severely kinked or damaged. – Check that the wall mount (if present) is attached securely. Action • Latch the Oxylog onto the wall mount (if present). Test – The „external mains power“ LED lights up. Result Condition and function checked. [________OK] - Oxylog 2000 plus Revision 1.0 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ de vi ce _c he ck _T L. fm 11 of 20 Test instructions (TL) Basic unit function 3.2 Basic unit function 3.2.1 Unit test Action • Connect the unit to the electrical power and to the O2 compressed gas supply. • Connect the ventilation tube and the ventilation valve to the flow sensor and the flowmeter tubes. • Connect the test lung (test thorax). • Switch on the unit and press and hold down the rotary knob until the menu for selection of the unit test appears. • Select and activate the unit test. • Follow the on-screen instructions. Test The unit test runs without error. Result Function checked. [________OK] 3.2.2 Buttons and potentiometer Action • Switch the unit to Customer Service Mode. • Activate „Test buttons and potentiometer” test step. • Press all buttons on the unit one after the other. Test When a button is pressed a corresponding „X“ appears on-screen. If the but- ton has an integral LED, the LED lights up while the button is being pressed. If there is no LED, the yellow warning LED is lit. Action • Turn the potentiometer to various settings and compare them against the values displayed on-screen. Test The pre-set and displayed values are identical. Result Function checked. [________OK] 3.2.3 Loudspeaker, buzzer, LEDs and display Action • Activate „Test loudspeaker, buzzer, LEDs and display” test step. • Run the complete test. Test The tests of the loudspeaker, the buzzer, the LEDs and the display were suc- cessful. Result Function checked. [________OK] 3.2.4 Voltage supply Action • Switch off the device. • Connect the ventilation tube instead of the manometer. Test The „external mains power“ LED lights up green. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ de vi ce _c he ck _T L. fm 12 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Basic unit function The “charge” indicator LED of the internal replaceable battery lights up in the following colors: – yellow: when the replaceable battery is charging – green: when the replaceable battery is fully charged, – red: when no functional replaceable battery is inserted or the replaceable battery cannot be charged, such as because the unit is being used outside the temperature range of 0 to 35 °C. Action • Switch on the device. • Set ventilation mode VC-CMV. • Remove internal replaceable battery. Test The unit continues ventilating. The display shows the message „No battery“. The charge indicator LED is lit red. An audible alarm sounds. Action • Fit the internal replaceable battery. Test The charge indicator LED is lit green. The audible alarm is deactivated. Action • Press the „Alarm Reset“ button. Test The „No battery“ message is no longer displayed. Action • Remove external power supply. Test The unit continues ventilating. The „external mains power “ LED is off. The „charge status“ LED of the internal replaceable battery is off. An audible alarm sounds. The display shows the message „Battery operating“. Action • Press the „Alarm Reset“ button. Test The „Battery operating“ message is no longer displayed. Action • Remove internal replaceable battery. Test Ventilation stops. An acoustic alarm sounds for at least 7 seconds. Action • Fit the internal replaceable battery. • Connect the external power supply. Test Ventilation is resumed with the previous settings. Result Function checked. [________OK] 3.2.5 Supply pressure/emergency air valve Action • Remove compressed gas supply. Test – An audible alarm sounds. – The display shows the message „!!Supply pressure low“. – The yellow alarm LED comes on. – Ventilation stops. Action • Simulate spontaneous breathing with the test thorax. Test Ventilation through the emergency air valve is possible. Action • Connect the compressed gas supply. Test – The audible alarm stops. – The yellow alarm LED is no longer lit. – Ventilation is resumed with the previous settings. - Oxylog 2000 plus Revision 1.0 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ de vi ce _c he ck _T L. fm 13 of 20 Test instructions (TL) Basic unit function Action • Press the „Alarm Reset“ button. Test – The „!!Supply pressure low“ message is no longer displayed. Result Function checked. [________OK] 3.2.6 Safety valve Action • Set Pmax and PEEP to maximum. • Set the frequency to 10 1/min. • Connect a manometer instead of the ventilation tube (the connection must be tight). Test – The maximum pressure is 85 mbar (110 mbar for the USA unit). Result Function checked. [________OK] Action • Disconnect the manometer and reconnect the ventilation tube. C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ br ea th in g_ ch ec k. fm 14 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Ventilation 3.3 Ventilation Prerequisites – Unit is connected to electrical power and to O2 compressed gas supply. – Ventilation tube, ventilation valve with flow sensor and flowmeter tubes are connected. – Test lung (breathing bag and catheter connector) is connected to flow sen- sor with elbow adapter. – Unit is switched on. 3.3.1 Volume-controlled ventilation Action • Make the following settings: – Ventilation mode = VC-CMV – Frequency = 10 1/min – Alarm limit Pmax = 60 mbar (Oxylog 100 cmH2O - USA = 100 mbar) – PEEP = 5 mbar – FiO2 = O2Airmix – I/E = 1:1 – Tplat = 50% – Trigger = off – VT = see table • Using the „Values 1“ button, select the VT or MV measured value, as appli- cable, and set and check the following values: Test Result Measured values checked. [________OK] 3.3.2 Trigger function Action • Connect the test thorax instead of the test lung. • Change or set, as applicable, the following values: – Ventilation mode = VC-SIMV – Frequency = 5 1/min – PEEP = 10 mbar – VT = 500 mL – Ti = 1 second – Flow trigger = 3 L/min – Flow ramp = not applicable, or standard Test The test thorax inflates to a PEEP pressure of 10 mbar. No self-triggering occurs. Action • Trigger using the test thorax, see the following figure. VT MV 200 mL 1.3 L/min to 2.3 L/min 500 mL 3.7 L/min to 5.3 L/min 1000 mL 8 L/min to 10.3 L/min - Oxylog 2000 plus Revision 1.0 C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ br ea th in g_ ch ec k. fm 15 of 20 Test instructions (TL) Ventilation Fig. 1 Trigger Test The unit triggers and activates a mandatory breath. At thesame moment a „star“ appears on the top line of the display. Result Function checked. [________OK] Item Designation 1 Unsynchronized mandatory breath 2 Synchronized mandatory breath 3 Trigger window C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ Fu nc tio n_ P ro du ct .fm 16 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Device handover 3.4 Device handover Entry Place fully functional device at the user's/owner's disposal. [________OK] 17 of 20 4 Test equipment C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ te st _t oo ls _T L. fm 18 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Test equipment list 4.1 Test equipment list Test equipment Digital manometer up to 1000 mbar Test lung (test thorax) Breathing bag, 2-liter Catheter connector 7 mm Tester for electrical safety test 19 of 20 5 Annex C op yr ig ht re se rv ed . R ev is io n 1. 0_ P rin te d on _1 1. 03 .0 8_ P 55 03 32 0_ An ne x_ SM _T L. fm 20 of 20 - Oxylog 2000 plus Revision 1.0 Test instructions (TL) Accessing service mode 5.1 Accessing service mode 5.1.1 Accessing the Customer Service Mode Action • Turn the controls Fig. 2/1 fully clockwise. • Switch on the unit by the key Fig. 2/3 and at the same time press and hold down the keys Fig. 2/2 until Customer Service Mode appears. Fig. 2 Accessing the Customer Service Mode • Now the appropriate test can be selected and activated. To quit service mode switch off the unit. The values set in Customer Service Mode are retained and reactivated every time ventilation is started following power- up. Institution: 1/1 Test Report (TL) Serial no.: Other: Delivery date: Revision 1.0 Oxylog 2000 plus OK Para Name Result OK Para Name Result 1 Device configuration 1. 1 Oxylog 2000 plus device configuration 1. 1. 1 Serial number of the Oxylog (if not otherwise recorded) 1. 1. 2 Serial number of the power supply unit (if not other 1. 1. 3 Software version 2 Electrical safety 2. 1 Electrical safety according to VDE 0751/IEC 60601-1 2. 1. 2 Power supply unit visual check 2. 1. 3 Protective earth conductor of power supply cord Ohm 3 Function and condition test 3. 1 Condition test 3. 1. 1 Labels and Instructions for Use 3. 1. 2 Basic unit, outside 3. 1. 3 Carrier system and accessories 3. 2 Basic unit function 3. 2. 1 Unit test 3. 2. 2 Buttons and potentiometer 3. 2. 3 Loudspeaker, buzzer, LEDs and display 3. 2. 4 Voltage supply 3. 2. 5 Supply pressure/emergency air valve 3. 2. 6 Safety valve 3. 3 Ventilation 3. 3. 1 Volume-controlled ventilation 3. 3. 2 Trigger function 3. 4 Device handover Report: Test has been performed according to the test instructions (TL). Name: ________________________ Date/signature: ________________________ Manufacturer: Distributed in the USA by: Dräger Medical b.v. Draeger Medical, Inc. Kanaaldijk 29 3135 Quarry Road 5683 CR BEST Telford, PA 18969 The Netherlands USA Phone: (+31) 499 331 - 331 Phone: (215) 721-5400 Fax: (+31) 499 331 - 335 (800) 4DRAGER (800 437-2437) Web: http://www.draeger.com Fax: (215) 723-5935 Subject to change without notice. Will not be replaced in the event of modifications. © Copyright March 2008 by Dräger Medical AG & Co. 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