Stryker FLUID SAFE - Annual Inspection and Testing; Safety Test Procedures

Annual Inspection
38
EN
10 Annual Inspection
Manufacturer’s specification The manufacturer stipulates that qualified personnel or hospital technicians
must regularly test the device to assess its functionality and technical safety.
These inspections 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 increases its safety and service life.
Inspection tests The following tests are designed specifically for trained personnel or a hospital
engineer. 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 in the test log.
Measured values and tolerances The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
•Original tube set
•Fluid bags
• Graduated measuring cup with 0.5 l scaling
An authorized service technician has to check the device if the specified
parameters and tolerances are exceeded.
10.1 Safety Test
1. Perform a visual inspection. Make sure that
• labels and stickers on device are legible,
• the mechanical condition of the device allows for its safe use.
• Check all accessible mountings and screw connections: bag holder,
monitoring holder, deflecting frame, support plate, handles, load
controller, wall mount and especially all screws and base mountings.
• Check the alignments – especially of carrier plate, load controller and
containers.
• Check to ensure no safety-impairing soiling is present.
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 must not exceed 0.2 Ω.
4. Measure the insulation resistance with 500-700 V DC. The min. value is 50
MΩ. The electric strength with high voltage cannot be measured.
As an alternative, perform safety test according to DIN VDE 0751 Section 1.
DANGER