Safety Test; Safety Test Procedures - EDAN iM80 Servise Manual

iM80 Patient Monitor Service Manual
(Edward's Catheter)
- Flow: 5 l/min
3. Check displayed value against the simulator configuration.
4. Expected test result: C.O.= 5+/－1 l/min

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, IEC/EN60601-1-1, 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 When testing according to IEC 60601-1, system must be tested and not individual
devices.
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