Annual Inspection; Electrical Safety Test; Basic Function Test - Stryker Flosteady Manual Del Usuario

12

Annual Inspection

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 de-
vice and increases its safety and service life.
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 in chapter 19.1 "Test Log".
The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
• Original cassette tubing
• Fluid bags
• Graduated measuring cup with 1.0 l scaling
• Stopwatch
WARNING!
If the specified parameters and tolerances are not met, an authorized service
technician must check the device.
12.1

Electrical Safety Test

1. Perform a visual inspection. Make sure that
• the fuse corresponds with the specifications indicated by the manufactur-
er,
• 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. Perform the measurement of the touch current (max. 100 μA in normal con-
dition and max. 500 μA in single fault condition) according to IEC 60601-1 /
EN 60601-1.
As an alternative, perform safety test according to IEC 62353.
12.2

Basic Function Test

A basic function test checks the displays, keys, and performance of the device. For
this test, you will need the following:
• the disposable cassette tube set
• a fluid bag (3 l)
• stopwatch
• one 1-liter measuring cup (100 ml scaling)
Annual Inspection
Manufacturer's specification
Inspection tests
Measured values and tolerances
EN
35