Safety standards – ITC ProTime Microcoagulation System User Manual
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SAFETY STANDARDS
The ProTime 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/
UL/IEC 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
Directives: 89/336/EEC and as amended by 91/263/EEC, 92/31/EEC, 93/68/EEC and 98/13/EC, 98/79/EC
Equipment Classifications As Defined Per UL 60601-1:2003/ IEC60601-1 2nd Edition
•
Protection against electrical shock: Class II, 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” DOES NOT MEAN
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.