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Safety and compliance standards
The product conforms to the following standards and laws:
1. IEC 60601-1:2005+A1:2012 Medical electrical equipment-Part 1: General
requirements for basic safety and essential performance 2. IEC 60601-
1-11:2015 Medical Electrical Equipment - Part 1-11: General Requirements
For Basic Safety And Essential Performance - Collateral Standard:
Requirements For Medical Electrical Equipment And Medical Electrical
Systems Used In The Home Healthcare Environment
3. IEC 60601-2-10: 2012+A1:2016 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
4. IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance - Collateral
Standard: Electromagnetic Disturbances - Requirements And Tests
EMC & electrical standards/requirements
IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance - Collateral
Standard: Electromagnetic Disturbances - Requirements And Tests
The equipment is intended for use in the electromagnetic environment
specified below.
The customer or the user of the EQUIPMENT should assure that it is used in
such an environment.
This Transcutaneous Electrical Nerve Stimulators is suitable for use in a
professional health care environment, not including areas where there are
sensitive equipment or sources of intense electromagnetic disturbances,
such as the RF shielded room of a magnetic resonance imaging system,
in operating rooms near active AF surgical equipment, electrophysiology
laboratories, armored rooms or areas where short wave therapy
equipment is used.
