fabian +nCPAP evolution Test Sheet for Service & Maintenance AA-03e Vr 08

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

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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

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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

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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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