Users Manual

15. Specification
83
Safety
General Standard:
A
NSI / AAMI ES 60601-1: 2005(R)2012 and
A
1:2012, C1:2009(r)2012 and A2: 2010(r)2012
(Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance)
EMC Standard:
IEC 60601-1-2: 2014
(Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance – Collateral standard:
Electromagnetic disturbances – Requirements and
tests)
The class of protection
against electric shock:
Internally Powered Equipment
The type of protection
against electric shock:
ECG/RESP: Type CF Applied Part
SpO
2
: Type CF Applied Part
Operating Environment
Temperature:
10C to 40C / 50F to 104F
Humidity: 30% RH to 85% RH (non-condensing)
A
tmospheric Pressure: 70 kPa to 106 kPa
Transport / Storage Environment
Temperature:
-10C to 60C / 14F to 140F
Humidity: 10% RH to 95% RH
(40C / 104F, non-condensing)
A
tmospheric Pressure: 70 kPa to 106 kPa