Cosmed K4B2 - Safety and conformity

18 - K4 b
2
User Manual
Safety and conformity
Safety
IEC 601-1 (1988) /EN 60 601-1 (1990);
Find reported below the complete classification of the device:
• Class I type B device
• Protection against water penetration: IP00, ordinary equipment unprotected against
water penetration
• Non sterile device
• Device not suitable in the presence of flammable anaesthetics;
• Continuous functioning equipment;
EMC
The system meets the EMC Directive 89/336
EN 60601-1-2
EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4
Telemetry
I-ETS 300 220, CEPT T/R 01-04
pr ETS RES 0908 (CE type conformity)
Transmission frequency and output power can be changed upon request according to the
destination country requirements.
Quality Assurance
UNI EN ISO 9001:2000 (Registration n° 387-A Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
FCC (only USA version)
FCC ID: SN7-K4B2T-USA (transmitter)
FCC ID: SN7-K4B2R-USA (receiver)
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may cause
undesired operation.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.