Technical Specifications - Eurosets COLIBRI SYSTEM Instructions For Use Manual

11. TECHNICAL SPECIFICATIONS

Regulations
Classification
Reference standards
Conditions of use
Conditions of use
Safety of use in the presence of
flammable anesthetic mixtures
with air or oxygen or nitrous
oxide:
Environment
46
Classified in accordance with Regulation (EU) 2017/745 (MDR)
•
IEC 60601-1:2005+AMD1:2012+AMD2:2020
•
IEC 60601-1-2: 2014+AMD1:2020
•
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020
•
IEC 62304:2006 + AMD1:2015
•
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020
•
IEC 60601-1-12:2014+AMD1:2020
•
IEC 62366-1:2015+AMD1:2020
•
IEC 62353:2014
•
EN ISO 14971:2019
•
UNI EN 1789:2020
•
BS EN IEC 62311:2020
•
ETSI EN 301 489-1 V2.2.3 2019
•
ETSI EN 301 489-17 V3.2.4 2020
•
ETSI EN 300 328 V2.2.2 2019
•
UNI EN13718-1 2014 + A1 2020
•
RTCA DO160G: section 4, 6, 7, 8, 20, 21, 26 - only AW139 helicopter model
Device for continuous operation
Device not suitable for use in the presence of flammable anesthetic mixtures
with air or oxygen or nitrous oxide.
During operation:
•
Temperature:10 to +40°C,
•
Humidity: 15-90%,
•
Pressure range of 760-1060 hPa.
During transient operation:
•
Temperature:10 to +40°C,
•
Humidity: 15-90%,
•
Pressure range of 760-1060 hPa.
During storage/transport, when the device is not operating:
•
Temperature:-18 to +50°C,
•
Humidity: 15-90%,
•
Pressure range of 620-1060 hPa.
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