Classification Of Medical Device; Regulatory And Safety Conformance - GE T2100-ST1 Service Manual

Classification of Medical Device

This device is classified as follows, according to IEC 60601-1:
Medical Device Classification
Category
Type of protection against
electrical shock
Degree of protection against
electrical shocks
Degree of protection against
harmful ingress or water
Degree of safety of application in
the presence of a flammable
anesthetic mixture with air or with
oxygen or with nitrous oxide
Method(s) of sterilization or
disinfection recommended by the
manufacturer
Mode of operation

Regulatory and Safety Conformance

T2100-ST1 and T2100-ST2 treadmills meet FDA Class 1 motor
operated physical medicine machines. They have been tested by
Intertek Testing Services N.A Inc., and are listed by Engineering
Testing Laboratories (ETL). However, the ultimate conformance
to IEC 60601-1 is the responsibility of the system integrator
when combined with other equipment. Additionally, all
motorized equipment is potentially dangerous if used
incorrectly. Before using the T2100-ST1 or T2100-ST2 treadmill,
follow all precautions listed in this manual and read the entire
Operator's Manual thoroughly. Use the T2100-ST1 and T2100-
ST2 treadmills only as described.
NOTE:
2097937-002 Rev G
11 March 2019
Potential foot crush injury at rearward side rail, rear of side
rail and rear roller exists when treadmill approaches full
elevation. Keep feet and hands away from this area at all
times.
This equipment has been tested and found to comply with
the limits for a Class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when
the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in
accordance with the instruction manual, may cause
T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V
Classification
Class I motor operated physical
medicine machine.
Type B external application applied
part.
Ordinary equipment (enclosed
equipment without protection
against ingress of water).
Equipment is not suitable for use in
the presence of a flammable
anesthetic mixture with air or with
oxygen or with nitrous oxide.
Not applicable
Continuous operation.
Introduction
13