User manual

SENSUS
™
Pain Management User Manual
37
Power continued
Patient Leakage Current, DC < 10 µA
Patient Leakage Current,
Enclosure
< 100 µA
Physical
Dimensions 176 mm x 63 mm x 18 mm
Weight 82 g
Environmental
Operating Temperature Range 10° C to 40° C
Atmospheric Pressure Range 50 kPa to 106 kPa
Relative Humidity Range 30% to 75%
Transport and Storage
Temperature Range
-40° C to 50° C
Atmospheric Pressure Range 50 kPa to 106 kPa
Relative Humidity Range 10% to 90%
Guidance Documents & Standards
FDA Draft Guidance for Industry and
Staff: Class II Special
Control Guidance Document:
Transcutaneous Electrical Nerve
Stimulator for Pain Relief (April 5,
2010)
IEC IEC 60601-1, IEC 60601-1-2, IEC
60601-1-6, IEC 62304