Safety - Arthrex AR-8315 Handbuch

Safety

The information presented in this section is important for the safety of both the patient
and the operator and also serves to enhance equipment reliability. This section describes
how the terms Warning, Caution, Important, and Note are used throughout the manual. In
addition, Arthrex Inc's. standard equipment symbols are defined.
General Information
General Use
If the footswitch is cold to the touch or below ambient temperature, allow
it to stabilize before use.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
-use of the accessory in the PATIENT VICINITY
-evidence that the safety certification of the ACCESSORY has
Periodically, whenever the integrity of the switch is in doubt, test all
functions.
Responsibility of the manufacturer
Arthrex Inc. is responsible for the effects on safety, reliability, and
performance if:
 Assembly operations, extensions, readjustments, modifications, or
 The switch is used in accordance with the instructions for use.
been performed in accordance to the appropriate IEC 60601-1
and/or IEC 60601-1-1 harmonized national standard.
repairs are carried out by persons authorized by Arthrex Inc.
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