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Annual Inspection
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Manufacturer's specification
Inspection tests
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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. Ensure:
– the fuse corresponds with the specifications indicated by the manufac-
turer,
– labels and stickers on system are legible,
– the mechanical condition of the system allows for its safe use,
– the system is clean to ensure proper and safe functionality.
2.
Perform the measurement of the ground leakage current (max. 500 μA) and
contact current (max. 100 μA in normal state and max. 500 μA on first error)
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 the system
is connected to the power supply. The max. value is 0.2 Ω. As an alternative,
perform safety test according to DIN EN 62353.
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
• 1000 g weight (included with each pump)
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 Flow Rate Test
The flow rate test must be carried out as part of the annual inspection. See Chapter
Flow Rate Test [} 43] for details.
9.2.2 Scale Test
The scale test must be carried out as part of the annual inspection. See Chapter
Scale Test [} 44] for details.
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