1 Device configuration
1.1 Serial number
Control unit N/A
Ventilation unit N/A
Inspiratory valve N/A
Disposable expiratory valve (YES/NO) N/A
Adult expiratory valve (reusable) N/A
Second adult expiratory valve (reusable) N/A
(Option) MCable Mainstream CO2 (CO2 sensor) N/A
(Option) neonatal expiratory valve N/A
(Option) second neonatal expiratory valve N/A
(Option) GS500 N/A
(Option) PS500 N/A
(Option) PS500, part number N/A
(Optional) trolley N/A
(Option) nebulizer ejector (no serial number) (YES/NO) N/A
(Option) neonatal flow measurement (no serial number) (YES/NO) N/A
1.2 Software version
2 Maintenance parts
2.1.1 Maintenance Intervals, overview
2.1.1 Maintenance Intervals and required sets and parts
2.2. Maintenance parts by specified Interval
2.2.1 Ventilation unit, internal battery M7
2.2.1 Ventilation unit, particle filter (O2 filter)
2.2.3 Ventilation unit, Air filter (medical compressed air filter)
2.2.4 (Option) GS500, room air filter (filter mat)
2.2.4 (Option) GS500, air filter blower unit (microfilter)
2.2.4 (Option) PS500, battery set PS500 (Service) 15Ah
2.2.4 (Option) PS500, battery set PS500 (Service) 24Ah
2.2.4 (Option) Medication nebulizer, pressure regulator (O2-side)
2.3 Maintenance parts as required
3 Electrical safety
3.1 Electrical safety In accordance with DIN EN 62353 (IEC 62353, YY/T 08-41) {formtext: name=N/A; default=N/A}
3.1.2 Visual inspection {formtext: name=N/A; default=N/A}
Protective earth resistance {formtext: name=N/A; default=N/A}
Maximum measured value of the ME equipment {formtext: name=N/A; default=N/A}
Maximum measured value of ME system {formtext: name=N/A; default=N/A}
3.1.3 Protective earth resistance measuring points {formtext: name=N/A; default=N/A}
3.1.4 Test adapters for equipment leakage current {formtext: name=N/A; default=N/A}
3.1.5 Equipment leakage current {formtext: name=N/A; default=N/A}
3.1.6 Applied parts for leakage current from applied part test {formtext: name=N/A; default=N/A}
3.1.7 Applied part leakage current, mains on applied part, type BF {formtext: name=N/A; default=N/A}
3.2 Electrical safety according to IEC 60601-1
3.2.1 Visual inspection {formtext: name=3.2.1_Visual Inspection; default=OK}
3.2.2 Protective earth resistance
Protective earth resistance, ventilation unit {formtext: name=3.2.2_ESI Ohms; cols=3}Ω
Optional protective earth resistance GS500 {formtext: name=3.2.2_ESI2 Ohms; cols=3}Ω
3.2.3 Earth leakage current of medical device
Normal condition (N.C.) IEC 60601-1 {formtext: name=3.2.3_Elkg_normal; cols=3}µA
Single fault condition (S.F.C.) IEC 60601-1 {formtext: name=3.2.3_Elkg_fault; cols=3}µA
3.2.4 Patient leakage current
Normal condition (N.C.) DC IEC 60601-1 {formtext: name=3.2.4_Plkg_normal; cols=3}µA
Normal condition (N.C.) AC IEC 60601-1 {formtext: name=3.2.4_Plkg_normal2; cols=3}µA
Single fault condition (S.F.C.) DC IEC 60601-1 {formtext: name=3.2.4_Plkg_single; cols=3}µA
Single fault condition (S.F.C.) AC IEC 60601-1 {formtext: name=3.2.4_Plkg_single2; cols=3}µA
4 Function and condition test
4.1 General condition check
4.1.1 Medical device OK
4.1.2 Accompanying documents OK
4.1.3 Medical devices book OK
4.1.4 Rating plates, labels and notices on the medical device OK
4.1.5 Rating plates, labels and notices on the installed options OK
4.1.6 Control unit OK
4.1.7 Ventilation unit OK
4.2 Condition test, options
4.2.1 (Option) MCable Mainstream CO2 module M11.1 (CO2 sensor) OK
4.2.2 (Option) M11.3 CO2 mainstream sensor OK
4.2.3 (Option) Neonatal flow measurement OK
4.2.4 (Option) medication nebulizer (white housing) OK
4.2.5 (Option) Trolley OK
4.2.6 (Option) Gas cylinder holder OK
4.2.7 (Option) Hose holder OK
4.2.8 (Option) GS500 OK
4.2.9 (Option) PS500 OK
4.2.10 (Option) Cable duct OK
4.3 Fuse rating and readout of software version and operating data
4.3.1 Fuse value OK
4.3.2 Software version {formtext: name=4.3.2_SW Version; cols=6}
4.3.3 Batteries
Replacing the PS500 batteries in XX months {formmenu: 12; default=24; name=4.3.3_Ps500 battery interval; cols=2}
4.4 Preparations for the function tests OK
4.5 Control Unit
4.5.1 Optical Alarm OK
4.5.2 Rotary Encoding Lighting OK
4.5.3 Acoustic Alarm OK
4.6 Ventilation unit module M1.3 (gas delivery module)
4.6.1 Self-tests of the ventilation unit
4.6.2 Zeroing all flow sensors {formmenu: OK; Fail; name=4.6.2_Zero Flow sensor; cols=4}
4.6.3 Relative flow difference S2/S3 {formtext: name=4.6.3_R_Flow_S1_S3}L/min
4.6.4 Relative flow difference S1/S3 {formtext: name=4.6.4_R_Flow_S1/S3}
4.6.5 Leakage LPSV V3 {formtext: name=4.6.5_Leakage_LPSV_V3; cols=4}
4.6.6 Valve calibration for workplaces with the GS500 OK
4.6.7 Comparator shut-off pressure {formtext: name=4.6.7_comparator_off}mbar
4.6.8 Comparator switch-on pressure {formtext: name=4.6.8_comparator_on}mbar
4.6.9 Air proportional valve 120 Umin {formtext: name=4.6.9_APV1}A
4.6.10 Air proportional valve 5 Umin {formtext: name=4.6.10_APV2}A
4.6.11 Proportional valve O2 120 Umin {formtext: name=4.6.11_propV1}A
4.6.12 Proportional valve O2 5 Umin {formtext: name=4.6.12_propV2}A
4.6.13 System Leakage Test (M1V3) OK
4.6.14 Leakage of the Air proportional valve {formtext: name=4.6.14_apropV1}mbar
4.6.15 Leakage of the central O2 supply non-return valve (PATO){formtext: name=4.6.15_o2PATO}L/min
4.6.16 Leakage of the central O2 supply non-return valve (PIA) {formtext: name=4.6.16_o2PIA}L/min
4.6.17 Leakage O2 proportional valve {formtext: name=4.6.17_lkgo2pv}mbar
4.6.18 Leakage of the central Air supply non-return valve (PATO) {formtext: name=4.6.18_CairPato}L/min
4.6.19 Leakage of the central Air supply non-return valve (PIA) {formtext: name=4.6.19_CairPIA}L/min
4.6.20 Comparative pressure measurement, Plank and Inspiratory pressure sensor OK
4.6.21 Comparative flow measurement M1.3 OK
4.7 Ventilation unit module O2 sensor OK
4.7.1 Calibration of the O2 sensor OK
4.7.2 Measurement accuracy OK
4.8 Ventilation unit module M4.1 (pressure/flow temperature monitoring)
4.8.1 Calibrating the pressure sensors OK
4.8.2 Offset of the Inspiratory pressure sensor{formtext: name=4.8.2_OiPS}mV
4.8.3 Offset of the expiratory pressure sensor {formtext: name=4.8.3_OePS}mV
4.8.4 Temperature measurement of module M4.1 OK
4.8.5 Calibrating the expiratory flow sensor OK
4.8.6 Reference voltage of module M4.1 OK
4.9 Safety devices
4.9.1 Emergency expiratory valve SV2 OK
4.9.2 Emergency respiratory valve SV3 OK
4.9.3 Non-return valve in expiratory valve OK
4.9.4 Expiratory resistance of adult expiratory valve OK
4.10 Ventilation unit power supply module M7.3 Plus
4.10.1 Fan OK
4.10.2 Supply voltage OK
4.10.3 Internal temperature OK
4.11 Emergency backup battery of the ventilation unit, part 1 OK
4.12 Ventilation unit Pl self-tests
4.12.1 Self-tests of the ventilation unit
4.12.2 Flush flow M12.4 OK
4.12.3 1ST Airway Pressure Measurement OK
4.12.4 Pneumatic Release Logic Test OK
4.12.5 Pressure sensors S2 and SB
S2 - Deviation from the determined ambient pressure {formtext: name=4.12.5_S2}mbar
S8 - Variation from the measured ambient pressure {formtext: name=4.12.5_S8}mbar
4.12.6 Expiratory flow measurement N/A
4.13 Emergency backup battery of the ventilation unit, part 2
4.13.1 Battery Parameters OK
4.14 Ventilation unit, Interior temperature
4.14.1 Testing OK
4.15 Ventilation Unit, Piezo
4.15.1 Function test OK
4.16 (Option) Nurse call
4.16.1 Nurse call with nurse call box (8417370) OK
4.17 Ventilation unit, expiratory valve heating
4.17.1 Function test OK
4.18 (Option) Ventilation unit, nebulizer
4.18.1 Function test OK
4.19 (Option) medication nebulizer (white housing) OK
4.20 (Option) MCable Mainstream CO2 module M11.1 (CO2 sensor)
4.20.1 Function test OK
4.21 (Option) M11.3 CO2 mainstream sensor
4.22 (Option) Neonatal expiratory valve
4.22.1 Function test OK
4.23 (Option) Neonatal flow sensor
4.23.1 Function test OK
4.24 (Option) GS500
4.24.1 Function test OK
4.25 Medical device, function tests in operation mode
4.25.1 Self-test OK
4.25.2 System test OK
4.25.3 Breathing circuit test OK
4.25.4 Function tests in ventilation mode OK
4.25.5 Non-return valves in the gas inlet OK
4.25.6 Display of the ventilation unit OK{=`n/a`}
4.25.7 Alarm silence key OK
4.26 On/Off logic test OK
4.27 (Option) PS500
4.27.1 Function test
Mains power supply (LED) OK
Removing fuse F1 OK
Fuse rating of fuse F1 OK
Inserting fuse F1 and removing fuse F2 OK
Fuse rating of fuse F2 OK
Power supply OK
4.28 Final procedures
4.28.1 Device status report OK
4.28.2 Device handover with test label OK
5 Test equipment
5.1 Test equipment subject to mandatory calibration OK
5.2 Test equipment not subject to mandatory calibration{=`n/a`}