
REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Appendix
COSMED srl
Safety and conformity
Safety
IEC 60601-1
The complete classification of the device is as follows:
•
Class I type BF (when connected to mains).
•
Class Internally Powered Equipment, type BF (when battery operating).
•
Non-sterile device.
•
Device not suitable in the presence of flammable anaesthetics.
•
Continuous functioning equipment.
EMC
IEC 60601-1-2
Telemetry (EU)
ETSI EN 301 489-1
ETSI EN 301 489-17
Quality Assurance
ISO 9001:2015 (Registration n° 387-A, Kiwa)
ISO 13485:2016 (Registration n° 387-M, Kiwa)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476)
Class IIa
Expected device’s life: 7 years
Applied parts
Single use flowmeter (Flow-REE)
Sampling lines
Canopy hose with filter
Face Mask with external turbine flowmeter
FCC/IC
The Q-NRG complies with the following requirements:
•
FCC (Federal Communications Commission) Title 47 Part 15 Paragraph 107, 109.
•
IC (Industry Canada) ICES-003 Issue 6.
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.
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