Acutronic Medical Systems
fabian +nCPAP evolution Test Sheet for Service & Maintenance AA-03e Vr 08
Test Sheet for Service & Maintenance
6 Pages
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Page 1
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
Manufacturer: Acutronic Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Type: Modell:
SN prefix
fabian +nCPAP evolution
AN-
Customer:
Neonatal / Infant Respirator fabian +nCPAP evolution
fabian SN: Inventory. No. Use in combination with “TS-AA-03e V08 TI fabian +nCPAP evolution”
1) Configuration
Working hours
Firmware Versions: FW / SW Version
Module
Device ID
Device
GUI Software Version
Battery
Hours
Monitor PIC Conductor PIC Blender PIC Accu PIC Kernel Version Language Version Altitude
Test equipment Tester used for
Type / Model
Serial no.
Version
Last cal.
Next cal.
Pressure Flow Oxygenation SpO2 Electrical Safety
TS-FB-21e V08 TPS fabian +nCPAP evolution
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Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian +nCPAP evolution
SN prefix AN-
2) Visual Inspection fabian is switched off
pass / fail
General device condition Housing without cracks or mechanical damage All cables without damages Check all connectors Expiration membrane and holder ( correctly mounted )
3) Start-up / Self-test Connect fabian to mains and gas supply. Connect Test circuit and Test lung Switch on fabian
pass / fail
LCD screen backlight. LCD pixel. Up to 3 pixel failures are acceptable. Selftest ok Alarm sound Warning LED Red flashes two times at start up Disconnect mains cable Alarm sound on (Power Fail Alarm function) Orange LED on (Battery mode on) Connect mains cable Alarm sound off (Power Fail Alarm Off function) Orange LED off (Battery mode off)
4) Blender / purge flow Gas standardisation: 20/1013 Gas type: Air Connect fabian to gas supply. Switch off fabian 4.1
Blender is not leaking. No flow coming out of the insp. port.
4.2
Tightness calibration valves
pass / fail
Switch ON fabian in IPPV mode Settings see Test and calibration instruction fabian +nCPAP evolution 4.3
Purge flow OK? (150 – 350ml)
Switch OFF fabian
TS-FB-21e V08 TPS fabian +nCPAP evolution
Page 1 of 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian +nCPAP evolution
SN prefix AN-
5) Calibration Connect Air und O2, power on the device 5.1
Value
pass / fail
Set time and date
Set O2 to 60% and start fabian Pressure Air
2400 ± 200
Pressure O2
2400 ± 200
5.2 Connect Air / O2 with AIR, restart fabian 21% calibrate to
9.5 l/min ± 0.1 l/min
100% calibrate to
9.5 l/min ± 0.1 l/min
5.3 Power off fabian, connect Air / O2, restart device P insp. (p mix.) Sensor 0 mbar
570 ±10
P insp. (p mix.) Sensor 60 mbar
2400 ±10
5.4 Pressure sensor ( prox. ) calibration 0 mbar 5.5 Pressure sensor ( prox. ) calibration 60 mbar 5.6
Touch screen calibration
5.7
Exhalation valve calibration
5.8
Pressure relief valve
450 – 600mbar
21% 5.9 100% 5.10
Flow sensor calibration
Close the device now! 6) Functional test All tests have to be done with the Gas Standard ATP Activate also “enable O2 comp.” in “Service-Menu / Calibration” and also to have the correction factors for flow sensors to 0.960 Connect fabian to gas supply and switch on the device Mode
IPPV
I - Flow
8 l/min
E - Flow
5 l/min
PEEP
0 mbar
P Insp
10 mbar
Frequency
30 bpm
I - Time
1.00 sec.
Oxygen
21 Vol.%
Settings
Reading fabian
P Insp [mbar]
PEEP [mbar]
10
0
60
0
30
5
Ppeak / PIP ±1
TS-FB-21e V08 TPS fabian +nCPAP evolution
Comparison from fabian to Tester Pmean
PEEP ±1
Ppeak ±2
Pmean ±1
pass / fail
PEEP ±1
Page 1 of 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian +nCPAP evolution
SN prefix AN-
7) Trigger Check pass / fail 7.1
Trigger function
(if licence installed) ☐
8) Volume guarantee Check Settings Volume Guarantee
Set FiO2
Reading fabian Vte
Reading Test device Vte
5
21%
± 0,5 ml
5
100%
± 0,5 ml
10
21%
± 0,5 ml
10
100%
± 0,5 ml
Tolerance
pass / fail
Ensure O2 compensation on test device is also enabled! 9) O2 / Air blender Setting O2 [%]
Reading fabian
Reading Test device
Tolerance
21
± 3 Vol%
40
± 3 Vol%
60
± 3 Vol%
100
± 3 Vol%
pass / fail
10) Patient Alarms Reading fabian 10.1
Tube leak and Apnea
10.2
Check ET tube
10.3
Pressure HIGH
pass / fail
11) System Alarms What to do
Alarm messages on device
Disconnect Inlet pressure O2
Oxygen supply pressure (red blinking Info-bar)
Disconnect Inlet pressure Air
Air supply pressure (red blinking Info-bar)
See Test instruction
Tube occlusion (red blinking Info-bar)
See Test instruction
Tube occlusion (red blinking Info-bar)
Disconnect Proximal tube
Patient disconnected (red blinking Info-bar)
TS-FB-21e V08 TPS fabian +nCPAP evolution
pass / fail
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Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian +nCPAP evolution
SN prefix AN-
12) CPAP Mode Mode
CPAP
CPAP
5 mbar
Oxygen
21 Vol.%
Man. Breath
15 mbar
CPAP Settings
Reading fabian Pmean ± 1 mbar
Reading Testdevice Pmean ± 1 mbar
pass / fail
5 10 Manual breath 15 mbar ± 1 mbar
(if licence installed) ☐
13) DUOPAP Mode
Be sure that the “leakage compensation” is activated This point in the Ventilation - Menu Mode
DUOPAP
CPAP
3 mbar
P DUO
8 mbar
Frequency
10 bpm
I - Time
2.00 sec.
Oxygen
21 Vol.%
Settings
Reading fabian
CPAP [mbar]
P-DUO [mbar]
3
8
5
10
10
15
Ppeak ±1
Pmean
Comparison from fabian to Tester
PEEP ±1
Ppeak ±2
Pmean ±1
pass / fail
PEEP ±1
(if module installed) ☐
14) SpO2 functional check
The values that have to be reached are printed on the backside of the MASIMO Tester. Parameter
Tester value
Reading fabian
Tolerance
SpO2
±3%
PR
± 1 bpm
pass / fail
15) Maintenance Set the next maintenance date We recommend to use this function
TS-FB-21e V08 TPS fabian +nCPAP evolution
Page 1 of 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian +nCPAP evolution
SN prefix AN-
16) Setting check Checklist
pass / fail
Load hospital settings or factory defaults Check if the Service Password is activated (Service Mode, System) Check if the Altitude is set Check if the O2 comp. is enabled
Restart fabian fabian is working properly
17) Electrical Safety Test Check for the electric safety according to IEC 62353, or your local law. The printed results of the measurements should be attached to the inspection results.
18) Battery calibration Checklist
pass / fail
Battery calibration cycle performed
19) Completion Test results: Checked / Tested by: Date: Next Test: Remarks:
TS-FB-21e V08 TPS fabian +nCPAP evolution
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