ITC Avoximeter 1000E Whole Blood Oximeter - Manual (Page 76)

ITC AVOXimeter 1000E Operator’s Manual
70
8 Safety Standards
The ITC AVOXimeter 1000E 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.