Safety Information - Zynex Medical InWave User Manual

Equipment Classification

Per the International Electrotechnical Commission standard IEC 60601-1,
and the European standard EN 60601-1, Medical Electrical Equipment,
General Requirements for Basic Safety and Essential Performance, the
InWave is classified as follows:

Type BF Equipment
Type BF equipment provides a particular degree of protection against
electric shock, particularly regarding allowable leakage current. Type
BF applied part is one that is floating above ground and is isolated
from all other parts of the equipment.

Medical Device Directive (MDD) Classification
The InWave is a Class IIa medical device per the European
Medical Device Directive.

Internally Powered Equipment
The InWave is powered by an internal, 9 VDC, MN1604, battery and
is classified as Internally Powered Equipment.

Electromagnetic Compatibility
Conforms to IEC 60601-1-2.

Environmental Conditions for Operation
Temperature: 10° - 40° C (50° - 104° F)
Relative Humidity: 30 - 75%
Atmospheric Pressure: 50 – 106 kPa
Altitude: 0 - 2500 m (0 - 8202 ft.)

Environmental Conditions for Transportation and Storage
Temperature: -20° - 70° C (-4° - 158° F)
Relative Humidity: 10 - 90%
Atmospheric Pressure: 50 – 106 kPa
Altitude: 0 - 2500 m (0 - 8202 ft.)

Water Ingress
Ordinary equipment. This device does not have protection against
ingress of water.

Safety Information

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