Cosmed microQuark, Руководство пользователя

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Safety and conformity
Safety
IEC 60601-1/EN 60601-1;
The complete classification of the device is as follows:
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Class I type B
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Protection against water penetration: IPX1
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Non sterile device
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Device not suitable in the presence of flammable anaesthetics
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Continuous functioning equipment
EMC
The system meets the Standard IEC 60601-1-2.
Quality Assurance
UNI EN ISO 9001:2008 (Registration n° 387-A Cermet)
UNI EN ISO 13485:2003 (Registration n° 387-M Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
Appendix - Safety and conformity - 37