Annual Inspection; Electrical Safety Test; Basic Function Test (In High Flow Operating Mode) - Arthrex Synergy Insufflation FM134 Instructions D'utilisation

Insufflateur pour la laparoscopie
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  • FRANÇAIS, page 141

Annual Inspection

EN
Measured values and tolerances
50
11
Annual Inspection
Each test conducted has to be documented with date and signature on the test
log.
The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
Manometer
Range 0-100 mmHg, error class 1.6
Syringe
60 ml
Silicone tube
8 mm x 2 m
T adapter
8-8-8 mm
Veress cannula
length 100 mm
opening diameter 1.4 mm,
inner cannula diameter 1.6 mm
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.
11.1

Electrical Safety Test

1. Perform a visual inspection. Make sure that
• the fuse corresponds with the specifications indicated by the manufactur-
er,
• labels and stickers on device are legible,
• the mechanical condition of the device allows for its safe use,
• the device is clean to ensure proper and safe functionality.
2. Carry out the measurements for the ground leakage current, short-circuit
current/housing leakage current, and the protective conductor resistance as
per IEC 62353 in the current version or according to the applicable national
standard.
11.2

Basic Function Test (in High Flow Operating Mode)

1. Remove insufflation tube from device.
2. Use the On/Off switch to turn the device on. The device conducts a device
check. A short signal can be heard. Set to High Flow operating mode.
3. The factory default settings are 15 mmHg for the nominal pressure and
3 l/min for the nominal flow.
4. The following values are displayed:
Nominal pressure 15* [mmHg]
Nominal gas flow 3* [l/min]
Actual pressure 0 [mmHg]
Gas consumption 0.0 [l]
*These values correspond with the factory setting. If values in the configura-
tion menu were changed, these changed values are displayed.
5. Start insufflation: Press the START function field. The following values are dis-
played:
Actual pressure 0 [mmHg]
Veress insufflation is displayed. Streaming gas can be heard at the insuffla-
tion tube.
6. Select the max. nominal gas flow. The following values are displayed:
Nominal gas flow max. value [l/min]
Actual pressure 0 [mmHg]
Insufflation: High Flow is displayed. Streaming gas can be heard at the insuf-

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