System Specifications - Synthes Battery Power Line II Instructions For Use Manual

System Specifications

The device meets the following standards
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance:
IEC 60601-1 (2012) (Ed. 3.1),
EN 60601-1 (2006) + A11 + A1 + A12,
ANSI/AAMI ES60601-1:2005/(R)2012,
CAN/CSA-C22.2 NO. 60601-1:14
Medical electrical equipment – Part 1–2: Collateral Standard:
Electromagnetic disturbances – Requirements and tests:
IEC 60601-1-2 (2014) (Ed. 4.0),
EN 60601-1-2 (2015)
Medical electrical equipment – Part 1–6:
Collateral Standard: Usability:
IEC 60601-1-6 (2010) (Ed. 3.0) + A1 (2010)
Temperature
Relative humidity
Atmospheric pressure
Altitude
Transportation*
Temperature Duration
–29 °C; –20 °F 72 h
38 °C; 100 °F 72 h
60 °C; 140 °F 6 h
*products have been tested according to ISTA 2A
Warning: The machine must not be stored or
operated in explosive atmospheres.
Operation
40 °C
104 °F
10 °C
50 °F
90 %
30 %
1060 hPa
1.06 bar
500 hPa
0.5 bar
0 – 5000 m
Humidity
uncontrolled
85 %
30 %
E352266
Medical General Medical Equipment as to
electrical shock, fire and mechanical hazards
only in accordance with:
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)
Storage
10 °C
50 °F
30 %
500 hPa
0.5 bar
0 – 5000 m
Battery Power Line II Surgical Technique DePuy Synthes
40 °C
104 °F
90 %
1060 hPa
1.06 bar
75