Specifications
Applicable Standards, Environmental Conditions
and Transportation
The device meets the following
standards
Medical electrical equipment – Part 1: General require-
ments for basic safety and essential performance:
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012
(or IEC 60601-1:2012 reprint)
EN 60601-1:2006, A1:2013 (Ed.3.1)
ANSI/AAMI ES60601-1:2005 and A1:2012, C1:2009/
(R)2012 and A2:2010/(R)2012
CAN/CSA-C22.2 NO. 60601-1:14
Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests:
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment – Part 1-6:
General requirements for basic safety and essential
performance – Collateral Standard: Usability:
Environmental Conditions
Operation
Storage
Temperature
40 °C
104 °F
10 °C
50 °F
40 °C
104 °F
10 °C
50 °F
Relative humidity
95 %
10 %
No condensation
95 %
10 %
No condensation
Atmospheric pressure
1060 hPa
1.06 bar
500 hPa
0.5 bar
1060 hPa
1.06 bar
500 hPa
0.5 bar
Altitude
0 – 5000 m
0 – 5000 m
Transportation*
Temperature
Duration
Humidity
–29 °C; –20 °F
72 h
uncontrolled
38 °C; 100 °F
72 h
85 %
60 °C; 140 °F
6 h
30 %
Medical General Medical Equipment as to electrical
shock, fire and mechanical hazards only in accordance
with:
ANSI/AAMI ES60601-1:2005 and A1:2012, C1:2009/
(R)2012 and A2:2010/(R)2012
CAN/CSA-C22.2 NO. 60601-1:14
IEC 60601-1-6:2010 (Third Edition), AMD1:2013
CAN/CSA-C22.2 NO. 60601-1-6:11, AMD1
*products have been tested according to ISTA 2A or ISTA 3A.
▲ WARNING:
UNIUM Devices must not be stored or operated in an explosive atmosphere.
IEC 60601-1-6:2010 (Third Edition), AMD1:2013
CAN/CSA-C22.2 NO. 60601-1-6:11, AMD1
EN 60601-1-6:2010 (Third Edition), A1:2015
Medical devices – Part 1: Application of usability engi-
neering to medical devices:
IEC 62366-1:2015, AMD:2020
EN 62366-1:2015, A1:2020
E352266
45
UNIUM
™
• Instruction for Use
