Annual Inspection; Safety Test - Stryker 150 Handbuch

Annual Inspection

US
Manufacturer's Specification
Inspection Tests
Measured Values and Tolerances
WARNING
46
13 Annual Inspection
The manufacturer stipulates that qualified personnel or hospital technicians
must regularly test the device to assess its functionality and technical safety.
These tests must be performed on an annual basis. Regular inspections will assist
in early detection of possible malfunctions. This helps extend the service life of
the device and increases its safety.
The tests described in this chapter 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 signature -Test Log (see chapter 17 Appendix, page 52).
The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
• Tube set
• 1 Measuring beaker (1 L) with 100 ml scaling
• 1 Fluid bags
• Ruler 50 cm
If the specified parameters and tolerances are not met, an authorized service
technician must check the device.

13.1 Safety Test

1. Perform a visual inspection. Of particular importance is that
• the fuse corresponds with the specifications indicated by the
manufacturer,
• 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 DIN EN 60601-1/IEC 60601-1.
3. Measure protective conductor resistance according to DIN EN 60601-1/IEC
60601-1. The protective conductor resistance is measured while device is
connected to the power supply. The max. value may not exceed 0.2
4. Measure the insulation resistance with 500-700 V DC. The min. value is
Ω
50 M . The electric strength with high voltage cannot be measured.
As an alternative, perform safety test according to DIN VDE 0751 Section 1.
Ω
.