Safety Test; Safety Test Procedures - EDAN iM3 Service Manual

Vital Signs Monitor Service Manual

4.3 Safety Test

4.3.1 Safety Test Procedures

Use the test procedures outlined here only for verifying safe installation or service of the product.
These tests are not a substitute for local safety testing where it is required for an installation or a
service event.
When performing a safety test, you must use a standard safety analyzer such as Fluke 601Pro
Series safety analyzer or equivalent; perform the test according to your local regulations, for
example, in Europe according to IEC/EN60601-1, in USA according to UL60601-1. For the test
setup, please refer to the Instructions for Use of the test equipment used.
Additional test may be required by your local regulations.
You are recommended to document the result of the safety test.
NOTE:
1 After the system is installed or set up, safety test must be performed according to IEC
60601-1.
2 Systems must be handled as devices.
3 A system is a combination of several devices of which at least one is a medical
electrical device which is connected to other devices by functional connections or by
a transportable multiple socket outlet.
4 With devices that are connected to other devices by means of a data cable, this
connection must be disconnected prior to performing the electrical safety check, in
order to avoid incorrect measurements.
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Test and Maintenance