Introduction
Ch. 1
TRACKMASTER
12
TMX428 Owner’s Manual
317-160-284 Rev 6
February 2021
Classification of Medical Device
This device is classified as follows, according to IEC 60601-1:
Medical Device Classification
Category
Classification
Type of protection against electrical shock Class I motor operated physical medicine
machine.
Degree of protection against electrical
shocks
Type B external application applied part.
Degree of protection against harmful
ingress or water
Ordinary equipment (enclosed equipment
without protection against ingress of water).
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide
Equipment is not suitable for use 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
Not applicable
Mode of operation
Continuous operation.
Regulatory and Safety Conformance
TMX428 and TMX428CP meet the following safety and regulatory standards for 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 TMX428 and TMX428CP, follow all precautions listed in this
chapter and read the entire Owner’s Manual thoroughly. Use the TMX428 and TMX428CP only
as described.
NOTE:
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 harmful interference to
radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required
to correct the interference at owner’s expense.
Summary of Contents for TRACK MASTER TMX428
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