User's Manual

Chapter 1 Safety Information
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1. SAFETY INFORMATION
1.1 Warnings
MiroCam® Capsule Endoscope System has been manufactured to
conform with the International Standard for Medical Electrical
Equipment: IEC 60601-1, together with the Collateral Standard for
Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2.
MiroCam® Capsule Endoscope System has been manufactured to
conform to the electric shock, fire and mechanical hazard standards as
defined in CAN/CSA C22.2 NO.601.1.
Based on request of the buyer, IntroMedic will provide the labeling, such
as ID labels, and the User Manual in the national language(s) of
European countries. Translated documents will be evaluated by a local
language expert, and will be confirmed by a native speaker of the
respective national language.