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Introduction
Degree of safety of application in the presence
of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Mode of operation
Certification Information
22
Equipment not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide
Not applicable
Continuous operation
The MAC 600 system bears the CE mark "CE-0459", notified body
GMED, indicating its conformity with the provisions of the Council
Directive 93/42/EEC, concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
The medical device has a lifetime of 7 years with respect to the
Council Directive 93/42/EEC essential requirement #4.
Medical Equipment
Classified with respect to electric shock, fire, mechanical, and
other specified hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 No. 601.1, IEC 60601-2-25, IEC 60601-1, IEC
60601-1-2, IEC 60601-2-51.
MAC™ 600
2047426-001K
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