Stryker PneumoSure, Instructions For Use Manual

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78
Annual Inspection
EN
13 Annual Inspection
Measured values and tolerances 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:
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.
13.1 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. Measure leakage currents according to IEC 60601-1 / EN 60601-1.
3. Measure protective conductor resistance according to IEC 60601-1 / EN
60601-1. The protective conductor resistance is measured while device is
connected to the power supply. The max. value is 0.2

.
4. Measure the insulation resistance with 500-700 V DC. The min. value is
50 M

The electric strength with high voltage cannot be measured.
As an alternative, perform safety test according to IEC 62353 / EN 62353.
13.2 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 mm Hg for the nominal pressure and 3 l/
min for the nominal flow.
4. The following values are displayed:
Nominal pressure 15* [mm Hg]
Nominal gas flow 3* [l/min]
Actual pressure 0 [mm Hg]
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 [mm Hg]
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 [mm Hg]
Insufflation: High Flow is displayed. Streaming gas can be heard at the insuf-
Manometer Range 0-100 mm Hg, 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