Acutronic Medical Systems
fabian Ventilator Systems
fabian HFO Test protocol for service & maintenance V06
Test protocol for service & maintenance
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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 HFO
20-, AH-, AK-, AI-, AL-
Customer:
Neonatal / Infant Respirator fabian HFO
fabian SN: Inventory. No. Use in combination with “TS-AA-17e V06 TI fabian HFO”
1) Configuration
Working hours
Firmware Versions: FW / SW Version
Module
Hours
Device ID
Device
GUI Software Version
Battery
Monitor PIC
HFO*
Conductor PIC
*if equipped
HFO 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-27e V06 TPS fabian HFO
Page 1 von 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
2) Visual Inspection fabian HFO is switched off 2.1
General device condition
2.2
Housing without cracks or mechanical damage
2.3
All cables without damages
2.4
Check all connectors
2.5
Expiration membrane and holder ( correctly mounted )
pass / fail
3) Start-up / Self-test Connect fabian to mains and gas supply. Connect Test circuit and Test lung Switch on fabian 3.1
LCD screen backlight. LCD pixel. Up to 3 pixel failures are acceptable.
3.2
Selftest ok
3.3
Alarm sound (two times at start up)
3.4
Warning LED Red flashes (two times at start up)
pass / fail
Disconnect mains cable 3.5
Alarm sound on (Power Fail Alarm function)
3.6
Orange LED on (Battery mode on)
Connect mains cable 3.7
Alarm sound off (Power Fail Alarm Off function)
3.8
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 valve.
pass / fail
Switch ON fabian in IPPV mode Settings see Test Instruction Chapter 4.3 4.3
Purge flow OK ?
Switch OFF fabian
TS-FB-27e V06 TPS fabian HFO
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Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
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 5.2
Pressure Air
2400 ± 200
Pressure O2
2400 ± 200
Connect Air / O2 with AIR, restart fabian 5.3
21% calibrate to
9.5 l/min ± 0.1 l/min
100% calibrate to
9.5 l/min ± 0.1 l/min
Power off fabian, connect Air / O 2, restart device 5.4 HW 1-3
P insp. ( p mix.) Sensor 0 mbar
1480 ±10
P insp. ( p mix.) Sensor 60 mbar
2940 ±10
5.4 HW 4
P insp. ( p mix.) Sensor 0 mbar
1095 ±10
P insp. ( p mix.) Sensor 60 mbar
2255 ±10
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
5.9 5.10
450 - 600mbar
21% 100% Flow sensor calibration
Close the device now! 6) Functional ventilation 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 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
TS-FB-27e V06 TPS fabian HFO
Ppeak / PIP ±1
Comparison from fabian to Tester Pmean
PEEP ±1
Ppeak ±2
Pmean ±1
pass / fail
PEEP ±1
Page 1 von 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
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
(if equipped) ☐
10) HFO Settings
fabian
Ampl. [mbar]
P mean [mbar]
Freq [Hz]
10
10
5
40
20
10
10
10
20
80
40
20
P mean [mbar] ± 1
Freq. [Hz] ± 10%
Test device ( compared to fabian ) P mean Freq. [mbar] ± 1.5 [Hz] ± 10%
pass / fail
11) Patient Alarms Reading fabian 11.1
Tube leak and Apnea
11.2
Check ET tube
11.3
Pressure HIGH
TS-FB-27e V06 TPS fabian HFO
pass / fail
Page 1 von 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
12) System Alarms What to do
Alarm messages on device
pass / fail
12.1
Disconnect Inlet pressure O2
Oxygen supply pressure (red blinking Info-bar)
12.2
Disconnect Inlet pressure Air
Air supply pressure (red blinking Info-bar)
12.3
See Test instruction
Tube occlusion (red blinking Info-bar)
12.4
See Test instruction
Tube occlusion (red blinking Info-bar)
12.5
Disconnect Proximal tube
Patient disconnected (red blinking Info-bar)
13) 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) ☐
14) 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
TS-FB-27e V06 TPS fabian HFO
Ppeak ±1
Pmean
Comparison from fabian to Tester
PEEP ±1
Ppeak ±2
Pmean ±1
pass / fail
PEEP ±1
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Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
(if module installed) ☐
15) 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
16) etCO2 functional check
pass / fail
(if module installed) ☐ pass / fail
Does the device show an etCO2 value?
17) Maintenance Set the next maintenance date We recommend to use this function
18) 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
19) 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.
20) Battery calibration Checklist
pass / fail
Battery calibration cycle performed
TS-FB-27e V06 TPS fabian HFO
Page 1 von 6
Test protocol for service & maintenance Technik & Support
Process owner: G.Focic
fabian HFO
SN prefix 20-, AH-, AK-, AI-, AL-
21) Completion Test results: Checked / Tested by: Date: Next Test: Remarks:
TS-FB-27e V06 TPS fabian HFO
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