28
Annual Inspection
EN
8
Annual Inspection
Manufacturer’s specification
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.
Inspection tests
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.
8.1
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 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
μ
A) and
contact current (max. 100
μ
A in normal state and max. 500
μ
A 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.
8.2
Basic Function Tests
The basic function tests check displays, buttons, and general performance of the
system. For this test, you will need:
• Aquilex inflow tube set
• Fluid bags
• Measuring container with marked scale (1 Liter)
• Stop-watch
• Precision weight (e.g., Ohaus 1 kg 49016-11 or 41000-00 or equivalent).
8.3
Scale Test
1. Turn the system on.
2. Once the message
Insert Tube Set
appears, press the
Pause/Resume
button
and the
Zero
button simultaneously.
3.
Scale Test
is shown on the pump display.
4. Place a precision weight on the scale (500 g - 2000 g)
5. The fluid deficit limit display will display the weight.
6. The acceptable tolerance is ±20 g.
7. If a greater difference is detected, a service technician has to re-calibrate the
scale.
8. Remove weight from scale.
9. Press the
Pause/Resume
button to conclude this test.
Record results in the test log in Section 15.1. Test is successful if results fall within
acceptable tolerance limits.
