Cosmed Quark PFT - User manual.pdf - Frank's Hospital Workshop
Cosmed Quark PFT - User manual.pdf - Frank's Hospital Workshop
Cosmed Quark PFT - User manual.pdf - Frank's Hospital Workshop
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Safety and conformity<br />
Safety<br />
IEC 601-1 (1988) /EN 60 601-1 (1990);<br />
Find reported below the complete classification of the device:<br />
• Class I type B device<br />
• Protection against water penetration: IP00, ordinary equipment unprotected against<br />
water penetration<br />
• Non sterile device<br />
• Device not suitable in the presence of flammable anaesthetics;<br />
• Continuous functioning equipment;<br />
EMC<br />
The system meets the EMC Directive 89/336<br />
EN 60601-1-2<br />
EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4<br />
Quality Assurance<br />
UNI ISO 9001 (Registration n° 387 Cermet)<br />
Medical Device Directive (CE mark)<br />
MDD 93/42/EEC (Notified Body 0476).<br />
Class IIa<br />
16 - <strong>Quark</strong> <strong>PFT</strong> <strong>User</strong> Manual
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