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

Annual Inspection

en
Manufacturer's specification
Inspection tests
34
9 Annual Inspection
The manufacturer stipulates that qualified personnel or biomedical technicians
must regularly test the system to assess its functionality and technical safety.
These inspections must be carried out annually. Regular inspections will assist in
early detection of possible malfunctions. This helps maintain the system and in-
creases its safety and service life.
The following tests are designed specifically for trained personnel or a biomedi-
cal technicians. System operation, functionality, and serviceability are easily
checked. Each test conducted must be documented by signing and dating the
test log.
WARNING!
If the specified parameters and tolerances are exceeded, the system must be re-
turned to Hologic for evaluation.
9.1

Safety Test

1. Perform a visual inspection. Ensure:
• the fuse corresponds with the specifications indicated by the manufactur-
er,
• labels and stickers on system are legible,
• the mechanical condition of the device allows for its safe use,
• the device 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 single fault
condition) 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 to be measured with a
connected power cord; however, the cord may not be connected to the mains
power supply. The max. value is 0.2 Ω.
As an alternative, perform safety test according to DIN EN 62353. Measuring the
protective conductor resistance should be carried out only according 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 bags
• Measuring cup with marked scale of 1 liter
• Stopwatch
• Precision weights (e.g., Ohaus 1 kg 49016-11 or 41000-00 or equivalent)
NOTE!
If the device does not work as described and the test fails the device must be sent
to the service.