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CLASSIFICATION OF MEDICAL ELECTRICAL EQUIPMENT
EQUIPMENT CLASSIFICATION
Class IIb Internally Powered Type BF medical device.
CONFORMITY
Directive 93/42/EEC
CellAED® INGRESS PROTECTION
IP 22
MODE OF OPERATION
Continuous, infrequent single event use only
ELECTRODE SPECIFICATIONS
ELECTRICAL CONNECTING CABLE
1 m, 28 AWG
CONTACT AREA
Total combined area: 166 cm
2
ELECTRODE MATERIAL
Hydrogel
ELECTRODE DIMENSIONS
9 cm x 9.25 cm
ENVIRONMENTAL SPECIFICATIONS
OPERATING CONDITIONS
0
º
C to 35
º
C (32
º
F to 95
º
F), 0% to 95% RH (relative humidity) (non-condensing)
STANDBY/STORAGE CONDITIONS
15
º
C to 35
º
C (59
º
F to 95
º
F), 0% to 95% RH (relative humidity) (non-condensing)
TRANSPORT CONDITIONS
0
º
C to 35
º
C (32
º
F to 95
º
F), 0% to 95% RH (relative humidity) (non-condensing)
ALTITUDE
-100 m to 4,000 m
ATMOSPHERIC PRESSURE
60 kPa to 102 kPa
