Cardiac Science Burdick 8500 Product Safety Manual page 37

Environmental (Device only)
Operating
temperature
Operating relative
humidity
Operating
atmospheric
pressure
Storage
temperature
Storage relative
humidity
Storage
atmospheric
pressure
Harmful Ingress of
Water
Standards
Conforms to
Regulations
Conforms to
Guidance
Wireless
Specification
70-01047-01 B
50°F to 104°F (10°C to 40°C)
20% to 75% non-condensing
1060 hPa to 700 hPa (-500 ft to 10,000 ft reference to sea
level)
-4°F to 113°F (-20°C to 45°C)
10% to 90% non-condensing
1060 hPa to 190 hPa (-500 ft to 40,000 ft reference to sea
level)
Normal
21 CFR Subchapter H (Title 21 Food and Drugs - Food and Drug
Administration, Department of Health and Human Services
(Parts 1-1299)
2002 No. 236 (Therapeutic Goods (Medical Devices)
Regulations 2002)
93/42/EEC (Council Directive Concerning Medical Devices)
ANSI/AAMI EC57
IEC 60417
IEC/TR 60878
ISO 7000
ISO 15223-1
EN 1041
EN 980
IEEE802.11-2007
Technical specifications
37