ITC Hemochron Signature Elite Whole Blood Microcoagulation System - Manual (Page 80)

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SAFETY STANDARDS
The HEMOCHRON Signature Elite instrument complies with the following safety standard requirements and
directives:
CSA C22.2. 601.1. Medical Electrical Equipment – General Requirements for Safety
EN 60601-1 /
IEC 60601-1/
UL 60601-1 Medical Electrical Equipment – General Requirements for Safety
EN 60601-1-2 /
IEC 60601-1-2 Medical Electrical Equipment – Part 1-2 – General Requirements for
Safety – Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests
EN 60825-1 Safety of Laser Products – Part 1: Equipment Classification Requirements,
Classification, and User’s Guide
For Class 2 Laser Instruments:
CAUTION: CLASS 2 LASER RADIATION WHEN OPEN. DO NOT STARE INTO
THE BEAM.
EN 61000-3-2 Electromagnetic Compatibility – Limits – Limits for Harmonic Current
Emissions
EN 61000-3-3 Electromagnetic Compatibility – Limits – Limitation of Voltage Changes,
Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems
EN 55011 Industrial, Scientific and Medical (ISM) Radio Frequency Equipment –
Radio Disturbance Characteristics – Limits and Methods of Measurement
EN 61326 Electrical Equipment for Measurement, Control and Laboratory Use –
EMC Requirements
Directives: 89/336/EEC and as amended by 91/263/EEC, 92/31/EEC, 93/68/EEC, 98/13/EC, and
98/79/EC.
Equipment Classifications As Defined Per UL 60601-1:2003/ IEC60601-1 2 nd Edition
Protection Against Electrical Shock: Class I, Internally Powered Equipment with no applied parts
Protection Against Ingress of Liquids: Ordinary (no protection as defined by IEC 529)
Product Cleaning and Disinfection: Only according to recommendations of the manufacturer’s accompanying
documentation
Mode of Operation Of Equipment: Continuous
Degree of Safety of Application in the Presence of Flammable Anesthetic Mixture With Air, Oxygen or Nitrous
Oxide: Not Suitable
NOTE: as defined in the above standards, the classification of Not Suitable is not intended to indicate that the
instrument is not suitable for use in an Operating Room (OR) environment. Rather, it is intended to indicate
that the instrument is not suitable for use in the direct presence of a flammable anesthetic mixture with air,
oxygen or nitrous oxide.
All relevant documentation is kept on file at ITC in Edison, NJ