fabian Therapy evolution Test protocol for service & maintenance V08

Test protocol for service & maintenance Technik & Support

Process owner: G.Focic

fabian Therapy evolution

SN prefix AT-

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

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 test Connect fabian to gas supply. For these test you have to work with the following gas standards:

Gas standardisation: Gas type:

20/1013 Air

Switch off fabian 4.1

Blender is not leaking. No flow coming out of the inspiration port

4.2

Tightness calibration valves.

TS-FB-12e V08 TPS fabian Therapy evolution

pass / fail

Page 1 von 5

Test protocol for service & maintenance Technik & Support

Process owner: G.Focic

fabian Therapy evolution

SN prefix AT-

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 device and connect Air / O 2 restart device 5.4

P insp. ( p mix.) Sensor 0 mbar

570 ±10

P insp. ( p mix.) Sensor 60 mbar

2400 ±10

Pressure sensor ( prox. ) calibration 0 mbar 5.5

Pressure sensor ( prox. ) calibration 60 mbar

5.6

Touch screen calibration

5.7

Pressure relief valve

450 – 600 mbar

21% 5.8 5.9

100% Flow sensor calibration

optional

Close the device now! 6) O2 / Air blender All tests have to be done with the Gas Standard ATP Activate also “enable O2 comp. in “Service-Menu / Calibration” Connect fabian to gas supply and switch on the device Fastest way is to work with an open tube set. Setting O2 [%]

Reading fabian

Reading Test device

Tolerance

21

± 3 Vol%

40

± 3 Vol%

60

± 3 Vol%

100

± 3 Vol%

TS-FB-12e V08 TPS fabian Therapy evolution

pass / fail

Page 1 von 5

Test protocol for service & maintenance Technik & Support

Process owner: G.Focic

fabian Therapy evolution

SN prefix AT-

7) NCPAP Mode Be sure that the “leakage compensation” is activated This point is in the Ventilation - Menu 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

8) DUOPAP Mode Mode

DUOPAP

CPAP

3 mbar

P DUO

8 mbar

Frequenz

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

9) System Alarms What to do

Expected alarm message

pass / fail

Disconnect Inlet pressure O2

Oxygen supply pressure (red blinking Info-bar)

Disconnect Inlet pressure Air

Air supply pressure (red blinking Info-bar)

Disconnect Inspiration Tube

Patient disconnected (red blinking Info-bar)

Disconnect Proximal Tube

Patient disconnected (red blinking Info-bar)

(if module installed) ☐

10) 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

TS-FB-12e V08 TPS fabian Therapy evolution

pass / fail

Page 1 von 5

Test protocol for service & maintenance Technik & Support

Process owner: G.Focic

fabian Therapy evolution

SN prefix AT-

11) Maintenance Set the next maintenance date We recommend to use this function

12) Setting check Checklist

pass / fail

Load hospital settings or factory defaults Check if the Service Password is activated (Service Mode, System) Check if the O2 comp. is enabled

Restart fabian. fabian is working properly

13) 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.

14) Battery calibration Checklist

pass / fail

Battery calibration cycle performed

15) Completion Test results: Checked / Tested by: Date: Next Test: Remarks:

TS-FB-12e V08 TPS fabian Therapy evolution

Page 1 von 5