Acutronic Medical Systems
fabian Ventilator Systems
fabian Therapy evolution Test protocol for Service and Maintenance TS-FB-12e_V11_TPS
Test Protocol
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Page 1
Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
Manufacturer: Acutronic Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Type: Modell:
Customer:
Neonatal / Infant Respirator fabian Therapy evolution
fabian SN Inventory. No. Use in combination with the corresponding “Calibration and Test instruction” document.
1) Configuration
PMK-Kit: 1 year / 4 year 121194
PMK, fabian Therapy evo, 1 year
Ref.-No.
Product
Device-ID
111267
Gas inlet filter fabian Series
GUI SW Version
498101
O2 cell OOM204 Dual Cathode
Monitor PIC
121215
Housing filter, blue, QTY 2
Blender PIC
121195
PMK, fabian Therapy evo, 4 year, FAS
Serial number < AT11BB-0090
Kernel Version
Ref.-No.
Product
Lot-/Serial-No.
Language Version
121194
PMK, fabian Therapy evo, 1 year
121253
Powerpack, 13.2V/4.5Ah, NiMH
111234
Calibration valve, blender
111233.03
MIM kit for FAS-blenders
111235
Input pressure regulator KUHNKE
121196
PMK, fabian Therapy evo, 4 year, MIM
Serial number ≥ AT11BB-0090
Ref.-No.
Product
Lot-/Serial-No.
121194
PMK, fabian Therapy evo, 1 year
121253
Powerpack, 13.2V/4.5Ah, NiMH
111234
Calibration valve, blender
111233.02
Proportional valve "MIM"
111235
Input pressure regulator KUHNKE
Device Information:
FW/SW Version
Preventive Maintenance Kit
Lot-/Serial-No.
Conductor PIC
Working hours Module
Hours
Device Battery
Test equipment:
Type / Model
Serial no.
Version
Last cal.
Next cal.
Pressure
Citrix H5
BB104500
H5
Dec 2020
Dec 2021
Flow
Citrix H5
BB104500
H5
Dec 2020
Dec2021
Oxygenation
Citrix H5
BB104500
H5
Dec 2020
Dec 2021
Rigel
30G-0660
288
Dec 2021
Dec 2022
SpO2 Electrical Safety
TS-FB-12e_V11 TPS fabian Therapy evolution
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Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
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 test ok 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_V11 TPS fabian Therapy evolution
pass / fail
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Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
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
Settings: 5.3 Blender calibration
Mode I - Flow E - Flow PEEP P Insp Frequency I - Time Oxygen O2 - Flush
IPPV -----------------
5.7 Pressure Relief valve calibration O2 Therapy 10 l/min
Mode CPAP P manual
nCPAP 5 mbar 15 mbar
21 Vol. % 100 Vol. %
Close the device now!
TS-FB-12e_V11 TPS fabian Therapy evolution
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Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
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. Mode
IPPV
O2 Therapy
I – Flow
---
3 l/min
E – Flow
Setting O2 [%]
Reading fabian
Reading Test device
Tolerance
21
± 3 Vol%
---
40
± 3 Vol%
PEEP
---
60
± 3 Vol%
P Insp
---
100
± 3 Vol%
I – Time
---
Frequency
---
pass / fail
7) NCPAP Mode Be sure that the “leakage compensation” is activated This point is in the Ventilation - Menu Mode
NCPAP
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
TS-FB-12e_V11 TPS fabian Therapy evolution
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Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
8) DUOPAP Mode Mode
DUOPAP
Trigger Settings External Analyzer
CPAP
3 mbar
Resp. Mode
Pediatric
P DUO
8 mbar
Trigger Source
Internal Low Flow
Frequency
10 bpm
Delay
10 ms
I - Time
2.00 sec.
Baseflow
Disabled
0,0 l/min
Start condition
P Diff
5,00 mbar
Positive edge
Stop condition
P Diff
5,00 mbar
Negative edge
Start condition
P Diff
7,00 mbar
Positive edge
Stop condition
P Diff
7,00 mbar
Negative edge
Start condition
P Diff
12,00 mbar
Positive edge
Stop condition
P Diff
12,00 mbar
Negative edge
Oxygen
P-DUO
21 Vol.%
8 mbar
10 mbar
15 mbar
Settings
Reading fabian
CPAP [mbar]
P-DUO [mbar]
3
8
5
10
10
15
PIP ±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
pass / fail
11) Maintenance Set the next maintenance date We recommend to use this function
TS-FB-12e_V11 TPS fabian Therapy evolution
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Test protocol for service & maintenance
SN prefix
fabian Therapy evolution
AT-
Technik & Support
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 Verify that SPO2 lower alarm limit is set to 90%
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
(if necessary) ☐ pass / fail
Battery calibration cycle performed
15) Completion Test results: Checked / Tested by: Date: Next Test: Remarks:
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