Annual Inspection; Electrical Safety Test; Basic Function Tests; Scale Test - Hologic Aquilex Instrucciones De Uso

9

Annual Inspection

The manufacturer stipulates that qualified personnel or hospital technicians must
regularly test the device to assess its functionality and technical safety. These in-
spections have to be carried out on an annual basis. Regular inspections will assist
in early detection of possible malfunctions. This helps preserve the device and in-
creases its safety and service life.
The following tests are designed specifically for trained personnel or a hospital
technician. The operation of the device as well as its functionality and serviceability
are easily checked. Each test conducted has to be documented with date and signa-
ture in the test log.
WARNING!
Parameters and tolerances exceeded
If the specified parameters and tolerances are exceeded, the system must be re-
turned to Hologic for evaluation.
9.1

Electrical Safety Test

1. Perform a visual inspection. Make sure that
– the fuse corresponds with the specifications indicated by the manufac-
turer,
– 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 cur-
rent/housing leakage current, and the protective conductor resistance as per
IEC 62353 in the current version or according to the applicable national standard.
Measuring the protective conductor resistance should be carried out only accord-
ing to IEC 60601-1 / EN 60601-1 using a current of 25 A AC.
9.2

Basic Function Tests

The basic function tests check displays, buttons, and overall system performance.
You need the following for this test:
• Aquilex® inflow tube set
• Fluid bag containing at least 1.5 l of fluid, to prevent the bag from running
empty during the test procedure
• Measuring cup with marked scale (1 Liter)
• Stopwatch
• Precision weights (e.g., Ohaus 1 kg 49016-11 or 41000-00 or equivalent)
• 1000 g weight (included in the scope of delivery of the fluid monitoring unit)
NOTE!
Function test fails
If the device does not work as described and the test fails the device must be sent
to the service.

9.2.1 Scale Test

The scale test must be carried out as part of the annual inspection. Enter the res-
ults into the test log in section Test log [} 56]. The test is successfully completed
when the results are within the permissible tolerance limit.
See Chapter Scale Test [} 39] for details.
Annual Inspection

Manufacturer's specification

Inspection tests

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