®

4.2 Inspection and maintenance test protocol

4.2 Inspection and maintenance test protocol

This test protocol documents six- and twelve-monthly maintenance as

prescribed by F. STEPHAN GMBH.

Type: SOPHIE

Seral number:

Serial number patient

component:

Software version:
Inspected by:
Signature:
Date:
Customer.
Product combinations:

The manufacturer's instructions issued by F. Stephan GmbH prescribe

six-monthly maintenance and safety checks.

Six-monthly
maintenance:
Twelve-monthly
maintenance:
Safety checks as per
MPG:

© F. Stephan GmbH SA-039-0309V1.2-HAO-en 47

4 Inspection and maintenance

Inspection and maintenance: neonatology ventilator SOPHIE

No. Inspection Test parameters/ Implementation/ Results
Setpoints measured results
ok n. ok
1. Temperature Ohmic resistance
sensor hose
at 18°C: at 18°C:
system
setpoint :6.84 kΩ act. value: ___ kΩ

at 20°C: at 20°C:
setpoint :6.24 kΩ act. value: ___ kΩ
at 22°C: at 22°C:
setpoint :5.70 kΩ act. value: ___ kΩ
at 25°C: at 25°C:
setpoint :5.00 kΩ act. value: ___ kΩ
at 28°C: at 28°C:
setpoint :4.38 kΩ act. value: ___ kΩ
2. Patient hose Setpoint :26 Ω
system tol. : +/- 1 Ω act. value:____ Ω
3. Heating cartridge Setpoint 17 Ω
in patient tol. : +/- 2 Ω act. value:____ Ω
component
4. Temperature at 18°C: at 18°C:
sensor in patient setpoint :6.84 kΩ act. value:____ kΩ
component
at 20°C: at 20°C:
setpoint :6.24 kΩ act. value:____ kΩ
at 22°C: at 22°C:
setpoint :5.70 kΩ act. value:____ kΩ

at 25°C: at 25°C:
setpoint :5.00 kΩ act. value:____ kΩ
at 28°C: at 28°C:
setpoint :4.38 kΩ act. value:____ kΩ

5. Device fuse Fuse value

2 x 3.15 A 2 x ______ A

48 SA-039-0309V1.2-HAO-en © F. Stephan GmbH

 ®

4.2 Inspection and maintenance test protocol

Inspection and maintenance: neonatology ventilator SOPHIE

No. Inspection Test parameters/ Implementation/ Results
Setpoints measured results
ok n. ok
6. Gas inlet block
6.1 Membrane dryer Soiling Clean,
(if present) replace every twelve
months
6.2 Filter unit Soiling Replace every six
months
7. PNT head Soiling Clean, replace O-rings
if nec.
8. Patient
component
8.1 Injector patient Soiling injector nozzle Clean,
component replace O-rings every
six months

8.2 Patient valve Soiling double valve Clean,

housing/pistons, O-rings replace if nec.
8.3 Emergency air Soiling sealing piston Replace every six
valve months
8.4 Pressure safety Pressure limit Adjust and fasten
valve
8.5 Expiration emer- Soiling Clean
gency air valve
8.6 Inspiration emer- Soiling Clean
gency air valve
9. Side panel
9.1 Seals Flat seal Replace

9.2 Interlocking Interlocking place Check,

patient component replace if nec.

9.3 Position measuring Soiling

Clean
system
10. Internal tubing
10.1 Pressure Soiling Check,
measuring hoses replace if nec.

© F. Stephan GmbH SA-039-0309V1.2-HAO-en 49

4 Inspection and maintenance

Inspection and maintenance: neonatology ventilator SOPHIE

No. Inspection Test parameters/ Implementation/ Results
Setpoints measured results
ok ok
11 Modules

11.1 Mainboard Soiling Clean

11.2 Pneumatic module Cell voltage of oxygen Replace if nec.

cell
Replace cell for cell
voltage 8.5 mV< or
>11.5 mV
12. Fan filter Soiling Replace

13. Battery voltage Check charge capacity,

min. operating time 30 Replace if nec.
min.

50 SA-039-0309V1.2-HAO-en © F. Stephan GmbH

 ®

4.3 Test protocol safety check

4.3 Test protocol safety check

Safety checks must be carried out every six months by the manufacturer
or the authorized Customer Service of F. STEPHAN GmbH

For safety checks, use metal test lung to put ventilator in standby status.

No. Inspection Test parameters Implementation Results

ok n. ok
1. Visual visual impression
inspection
1.1 Housing Nameplate Visual inspection for
completeness
Certification number damages and flaws
soiling, adhesions and
Safety plate signs of wear with a
detrimental effect on
safety
Housing

Lines (Gas)

Adjusting parts

Display device

Wording

Marking of adjusting
parts
Wear parts

© F. Stephan GmbH SA-039-0309V1.2-HAO-en 51

4 Inspection and maintenance

No. Inspection Test parameters/ Implementation/ Results

Setpoints Measuring results ok n. ok
1. Visual Visual impression
inspection
1.2 Accessories Patient component P7 Serial No.:

Patient component P7 Serial No.:

Pneumotachograph Batch No.: Type

Tubing system Visual inspection for

completeness
Pressure measuring
hose damages and flaws
Y-piece soiling, adhesions and
signs of wear with a
Temperature sensor
detrimental effect on
Power cable safety

Operating manual
Logbook (optional )

1.3 Gas supply Connections to supply ZGA standard, type:

hoses

Coded as per

Color coding:

Connected to:

52 SA-039-0309V1.2-HAO-en © F. Stephan GmbH

 ®

4.3 Test protocol safety check

No. Inspection Test parameters/ Implementation/ Results

Setpoints Measuring results ok n. ok
2. Electrical safety testing as per DIN IEC
601/1
2.1 Equipotential Equipotential bonding Check
bonding connected
2.2 PE conductor Act. value < setpoint =
resistance 0.2 Ω Act. value __________Ω
2.3 Insulation Act. value > setpoint =
resistance 70 M Ω Act. value __________Ω
2.4 Earth leakage Act. value < setpoint =
current N.C. 0.5 mA Act. value ___________mA
2.5 Earth leakage Act. value < setpoint =
current S.F.C 1 mA Act. value ___________mA
3. System test Automatic system test Start device, check
4. Substitution Substitution for failure of Disconnect oxygen supply line
a supply gas and air supply line in
succession, check substitution
5. Test / Front Function of all buttons & Check all buttons and the IGR
IGR
6. Respiratory Heating cartridge; hose Switch heating on and set to
gas humid- heating 39 oC
ifying Display changes from
"Heating off" to "H1+H2 on".
Heating warms up
7. Water bath Sensor function Activate heating without filled
humidifier bottle. Alarm
"Water level" must show.
Repeat test with filled
humidifier bottle. No alarm
must occur.

© F. Stephan GmbH SA-039-0309V1.2-HAO-en 53

4 Inspection and maintenance

No. Inspection Test Implementation/ Results

parameters/ Measuring results ok n. ok
Setpoints
8. Oxygen Adjusted O2 Start device. Compare Check
concentration concentration at adjusted oxygen concentration tolerance
electronic air/oxygen with connected calibrated ± 5 % of
mixer reference device (e.g. PF 300) setpoint

Adjusted O2 concentration
displayed in reference device

21 %
Act. value ______ %

25 %
Act. value ______ %
30 %
Act. value ______ %
50 %
Act. value ______ %
75 %
Act. value ______ %
90 %
Act. value ______ %
100 %
Act. value ______ %
9. Extra functions Aerosol
Preoxy
Insp. Hold

For volume test, always use Sophie test lung (103561315) for pediatric
ventilator SOPHIE

54 SA-039-0309V1.2-HAO-en © F. Stephan GmbH

 ®

4.3 Test protocol safety check

No. Inspection Test Implementation/ Results

parameters/ Measuring results ok n. ok
Setpoints
10 Accuracy test
Tolerance: +/- 10 % or 2 ml

Volume Sophie display Compare display with

measurement calibrated measuring device
Settings: (e.g. PF 300)

Oxygen/air mixer
21 %
Pmax: 25 mbar
PEEP: 0 mbar
Insp.: 0.75 sec
Exp.: 1.0 sec
Pattern: rectangle
10mbar
Act. value _____ml Act. value ______ml
5ml ( +/- 2ml )

15mbar
Act. value _____ml Act. value ______ml
7.5ml ( +/- 2ml )
20mbar
Act. value _____ml Act. value ______ml
10ml ( +/- 2ml )
25mbar
Act. value _____ml Act. value ______ml
12.5ml ( +/- 2ml )
30mbar
Act. value _____ml Act. value ______ml
15ml ( +/- 2ml )
40mbar
Act. value _____ml Act. value ______ml
20ml ( +/- 2.1ml )
50mbar
Act. value _____ml Act. value ______ml
25ml ( +/- 2.5ml )
60mbar
Act. value _____ml Act. value ______ml
30ml ( +/- 2.9ml )

© F. Stephan GmbH SA-039-0309V1.2-HAO-en 55

4

No. Inspection Test Implementation/ Results

parameters/ Measuring results ok n. ok
Setpoints
11. Alarm test Visual and auditory Activation of MP; MHP and
alarm HP alarm; check auditory and
visual alarm

12. Positive end- PEEP setting on Compare adjusted PEEP

expiratory SOPHIE setpoints with calibrated
pressure reference device (e.g. PF 300)

0 mbar Act. value ______ mbar

8 mbar Act. value ______ mbar

20 mbar Act. value ______ mbar

30 mbar Act. value _____ mbar

13. Pressure safety Pressure limit Adjust pressure safety valve

valve on patient component to stated
pressure limit and check
function
open against atmosphere
Setpoint 40 mbar Act. value _______mbar
Setpoint 50 mbar Act. value _______mbar
Setpoint 60 mbar Act. value _______mbar
14. Ventilation Trigger limit Operate device with test lung
and exceed trigger limit to
trigger mechanical stroke of
breath
15. CPAP Continuous airway Adapt silicone test lung,
pressure generate pressure fluctuations
Adjust at :
0, 8, 20 and 30 mbar
16. Pressure sensors Pressure difference Generate pressure difference
of > 8 mbar between Pdist and
Pprox. A visual and auditory
alarm must be triggered

56 SA-039-0309V1.2-HAO-en © F. Stephan GmbH