Full Vision TRACK MASTER TMX428 User manual

TMX428 Owner’s Manual 317-160-284 Rev 8
June 2023
MEDICAL TREADMILL
OWNER’S MANUAL
TMX428
TMX428CP

TRACKMASTER Safety Information
317-160-284 Rev 8 TMX428 Owner’s Manual i
June 2023
Contact Information
The model TMX428 TRACKMASTER® treadmill is designed to be interfaced with a variety of
ECG and VO2 systems. If you have a question or need assistance, please contact your system
integrator first.
Manufactured by:
3017 Full Vision Drive
Newton, KS 67114 USA
http://www.full-vision.com
http://www.trackmastertreadmills.com
Phone: [phone]
Fax: [phone]
Email: [e-mail]
(Regulatory affairs only)
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
WARNING
MODIFICATION IS PROHIBITED
The TRACKMASTER®treadmill is manufactured to exacting standards both in physical
form and in component selection. The components used in our products have been
selected with performance and medical safety in mind. The treadmill has been engineered
and certified to conform to the list of medical and safety regulatory standards which
appear on the next page. Modification or part substitution of any kind is strictly forbidden.
Any deviation in component replacement, physical or electrical modification will result
in loss of medical safety certification and warranty of this product. Modifications to this
equipment may put the patient at risk of electrical shock or hardware malfunction.
Contact TRACKMASTER®Service department for all your repair part needs.

Safety Information TRACKMASTER
ii TMX428 Owner’s Manual 317-160-284 Rev 8
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Publication Information
The information in this manual applies only to the TMX428 Treadmill, and TMX428CP Treadmill. It
does not apply to earlier versions. Due to continuing product innovation and state of the art design,
specifications in this manual are subject to change without notice.
TRACKMASTER® is a registered trademark. All other marks are the properties of their respective
owners.
This product complies with the regulatory requirements concerning medical devices from the following
bodies:
Date of first CE mark - August 2013
Revision History
The document part number and revision history appear at the bottom of each page. The revision
identifies the document’s update level. The revision history of this document is summarized in the
following table.
Revision
Publication Date
Description
1
August 2013
First Release
2
October 2015
Added Chapter 8 Parts List with Part Numbers
3
August 2016
Update Authorized Representative Address
4
January 2018
Added Chapter 9 Troubleshooting
5
November 2018
Added 4th Edition EMC Tables Chapter 1
6
27 February 2021
Updated to EU MDR 2017/745 label requirements,
added Reprocessing Instructions in Appendix B,
updated the intended use statement.
7
24 March 2022
Implementation of New Motor and Drive
Combination, 3 Wire Hall Effect Speed Sensor and
Harness, Magnetic Pull Tether Clip, Information
Label Symbols Updated, EMC Information. Removed
Chapter 8 See Service Manual
8
June 2023
Updated formatting, updated the EC REP address,
added mounting and dismounting method steps, added
additional warning to Safety Hazards to review
Responsibility of the Customer, added additional
warnings in other sections in regards to the
Emergency Stop Button and Patient Safety Tether
functionality and behavior, removed duplicate
warnings and duplicate paragraphs, added images and
text for the Patient Safety Tether, removed
contradicting information, updated headings and
descriptions, added reference to service manual and
part number, clarified speed metrics

TRACKMASTER Table of Contents
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Table of Contents
Contact Information ............................................................................................................. i
Publication Information ...................................................................................................... ii
1 Introduction....................................................................................................................... 7
Intended User ...................................................................................................................... 7
Intended Use ....................................................................................................................... 7
Regulatory and Safety Information..................................................................................... 8
Reporting of serious incident .............................................................................................. 8
Safety Conventions ............................................................................................................. 9
Safety Hazards .................................................................................................................... 9
Classification of Medical Device...................................................................................... 11
Regulatory and Safety Conformance ................................................................................ 11
Table 1: Guidance and Manufacturer’s Declaration – Emissions .................................... 12
Table 2: Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and
ME Systems ...................................................................................................................... 12
Table 4: Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME
Systems that is NOT Life-supporting ............................................................................... 13
Table 6: Recommended Separation Distances between portable and mobile RF
Communications equipment and the TMX428 Series ME Equipment and ME Systems
that is NOT Life-supporting.............................................................................................. 13
Responsibility of the Manufacturer .................................................................................. 14
Responsibility of the Customer......................................................................................... 14
Product and Package Information..................................................................................... 15
Symbols............................................................................................................................. 15
Label Locations................................................................................................................. 18
Serial Decal Information................................................................................................... 22
Service Information .......................................................................................................... 22
Manual Information .......................................................................................................... 23
Related Documents ........................................................................................................... 23
Training............................................................................................................................. 23
2 Specifications ................................................................................................................... 25
Directional Orientation ..................................................................................................... 25
Safety Systems .................................................................................................................. 26
Treadmill........................................................................................................................... 26
Content

Table of Contents TRACKMASTER
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Drive System..................................................................................................................... 26
Speed Range...................................................................................................................... 26
Incline Range .................................................................................................................... 26
Running Surface................................................................................................................ 26
Communication Ports........................................................................................................ 26
Floor Surface Footprint..................................................................................................... 26
Operating and Storage Condition Recommendations....................................................... 26
3 Power Requirements....................................................................................................... 27
4 Hi-Pot Test Instructions ................................................................................................. 29
5 Uncrating, Setup and Assembly..................................................................................... 31
Safe Handling Guidelines ................................................................................................. 31
Uncrating Instructions...................................................................................................... 32
Initial Setup Instruciton..................................................................................................... 33
TMX428CP & TMX58 Control Assembly ...................................................................... 35
Location ............................................................................................................................ 36
Final Setup - Running Belt Tracking Adjustment ............................................................ 36
Final Setup - Running Belt Tension Adjustment.............................................................. 37
Final Setup - Drive Belt Tension Adjustment................................................................... 37
6 Operating Instructions ................................................................................................... 41
Electrical Safety Tests....................................................................................................... 41
Operating Controls............................................................................................................ 41
Controlling the Treadmill ................................................................................................. 41
Power Switch .................................................................................................................... 41
Emergency Stop Switch.................................................................................................... 41
Emergency Stop Switch Check......................................................................................... 41
Patient Safety Tether Switch............................................................................................. 42
Patient Safety Tether Switch Check ................................................................................. 43
Treadmill Power Up Sequence Mode ............................................................................... 43
Loss of Communication with the Host System................................................................. 43
Loss of Communication due to Timeout .......................................................................... 43
Programmable Control Instructions TMX428CP ............................................................. 45
TESTING MODE DISPLAY ........................................................................................... 45
MANUAL MODE DISPLAY .......................................................................................... 45
Control Panel Display ....................................................................................................... 46
Patient Safety Tether:........................................................................................................ 46
WORKOUT GRAPHICS ................................................................................................. 48

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MANUAL OPERATION: ................................................................................................ 48
BUILT-IN PROGRAM OPERATION............................................................................. 50
Pre-Programmed Protocol Workout Data......................................................................... 50
Pre-Programmed Fitness Workout Data ........................................................................... 53
User Defined Programming .............................................................................................. 56
7 Preventive Maintenance ................................................................................................. 57
Reprocessing Instructions ................................................................................................. 57
Daily Maintenance ............................................................................................................ 57
Weekly Maintenance ........................................................................................................ 57
Monthly Maintenance ....................................................................................................... 57
Semiannual Maintenance .................................................................................................. 58
Belt Cleaning and Inspection ............................................................................................ 58
Running Belt Tracking Adjustment .................................................................................. 58
Running Belt Tension Adjustment.................................................................................... 59
Drive Belt Tension Adjustment ........................................................................................ 60
Exterior Care..................................................................................................................... 61
Elevation Screw Lubrication............................................................................................. 61
Running Deck Maintenance.............................................................................................. 61
8 Troubleshooting .............................................................................................................. 63
Power Switch Will Not Illuminate.................................................................................... 63
Facility Circuit Breaker Trips When Powering Up .......................................................... 63
Treadmill Will Not Start ................................................................................................... 63
Running Belt Slips When In Use ...................................................................................... 64
Running Belt Is Off-Center............................................................................................... 64
Internal Circuit Breaker Location and Resetting .............................................................. 64
A Maintenance Log............................................................................................................. 65
B Reprocessing Instructions .............................................................................................. 67

Introduction Ch. 1 TRACKMASTER
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TRACKMASTER Ch. 1 Introduction
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Introduction
Congratulations on the purchase of your new TRACKMASTER®treadmill. These fine machines
have been in production since 1977 and represent state-of-the-art design for heavy-duty
institutional use. The TRACKMASTER®treadmill has gained worldwide recognition as one of the
best and most dependable treadmills on the market. As a result, TRACKMASTER® has thousands
of successful installations internationally.
This document describes the TMX428 and TMX428CP treadmills also referred to as the “system”,
“device”, or “product”. The document is intended to be used by clinical professionals.
This chapter provides general information required for the proper use of the system and this manual.
Familiarize yourself with this information before using the system.
This manual covers the installation and operation of your new treadmill. If you have questions,
contact your system integrator or TRACKMASTER®dealer. If you need further assistance, please
call the TRACKMASTER®Service Support team at (316)-283-3344.
Intended User
This manual is geared towards helping clinical professionals with the operation of the
TRACKMASTER® Treadmill. Clinical professionals are expected to have working knowledge of
medical procedures, practices, and terminology as required for completing these examinations.
Intended Use
The medical treadmills are intended as stressing devices, by providing motion to patient, to be
interfaced with a variety of cardiac and pulmonary stress testing systems. The treadmill is intended
to be operated by the physician, therapist, or operator acting under authorization of the physician
with training per IFU under the supervision of a physician and / or therapist, with sufficient
knowledge of the indications and contraindications. The medical treadmills are intended to be used
in a medical facility or wellness center.
Certain models have a control panel to operate the treadmill.
Caution: Treadmill does not provide any kind of medical treatment diagnostic or assessment.
Indications:
•Symptoms suggesting myocardial ischemia
•Acute chest pain in patients excluded for acute coronary syndrome (ACS)
•Recent ACS treated without coronary angiography or incomplete revascularization
•Known CAD with worsening symptoms
•Prior coronary revascularization (patients 5 years or longer after Coronary artery
bypass grafting [CABG] or 2 years or less after percutaneous coronary intervention
[PCI])
•Vascular heart disease (to assess exercise capacity and need for surgical intervention)
•Certain cardiac arrhythmias to assess chronotropic competence
•Newly diagnosed heart failure or cardiomyopathy
1

Introduction Ch. 1 TRACKMASTER
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Contraindications:
•Acute myocardial infarction within 2 to 3 days
•Unstable angina not previously stabilized by medical therapy
•Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
•Symptomatic severe aortic stenosis
•Uncontrolled symptomatic heart failure
•Acute pulmonary embolus or pulmonary infarction
•Severe pulmonary hypertension
•Acute myocarditis or pericarditis or endocarditis
•Acute aortic dissection
•High-grade AV blocks
•Severe hypertension (SBP greater than 200 mm Hg, DBP greater than 110 mm Hg, or
both)
•Inability to exercise given extreme obesity or other physical/mental impairment
Regulatory and Safety Information
This section provides information about the safe use and regulatory compliance of this system.
Familiarize yourself with this information and read and understand all instructions before
attempting to use this system. The system was designed and manufactured to the appropriate
medical regulations and controls.
The purchaser is solely responsible for the training, instruction, supervision and safety of all users
of the TRACKMASTER®treadmill, and to use it as intended by the manufacturer. This device is
intended to be used as a motion appliance to facilitate cardiac or VO2 medical evaluation.
NOTE: Disregarding the safety information provided in this manual is considered abnormal use of
this system and could result in injury, loss of data, and void any existing product warranties.
Reporting of serious incident
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is
established.
•To report to manufacturer:
Email: [email protected]
•Please provide the following information:
•The model number of the device as stated on its identification plate
affixed on the device
•The serial number of the device
•Date of incident
•Description of incident, including any patient or user impact/injury
•Your contact information (facility, address, contact name, title, and
telephone number)

TRACKMASTER Ch. 1 Introduction
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Safety Conventions
A Hazard is a source of potential injury to a person, property, or the system.
This manual uses the terms NOTE, CAUTION, and WARNING to point out hazards and to
designate a degree or level of seriousness. Familiarize yourself with the following definitions and
their significance.
Definition of Safety Conventions
Convention
Definition
NOTE
Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in loss or destruction of property or data.
For example:
NOTE:For maximum efficiency, the TRACKMASTER® treadmill
must have its own dedicated power outlet.
CAUTION
Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in moderate or minor injury.
For example:
CAUTION: Do not use silicone sprays to wax your treadmill deck.
Using silicone sprays will void the warranty. Such sprays can bring
surface changes that may cause you to slip.
WARNING
Indicates a potential hazard or unsafe practice, which, if not avoided,
could result in death or serious injury.
For example:
WARNING: Never open the hood of the TRACKMASTER®
treadmill while it is plugged into a power outlet. Line voltage can
cause severe injury or death.
Safety Hazards
WARNING
Before permitting anyone to use the TMX428 or TMX428CP, do the following:
•Warn each user about the risk of falling while the belt is in motion.
•Stress the need for caution.
•Wait until the treadmill belt is moving before stepping onto the belt.
•Demonstrate the proper mounting and dismounting methods.
Mounting methods:
•Step 1: Instruct patient to straddle the belt and hold on to the handrails during
initialization of the treadmill before starting the test
•Step 2: Send start/run command to the treadmill with patient still straddling
the belt, wait a few seconds to ensure there is no uncommanded motion
•Step 3: Instruct patient to carefully step on the belt while holding on to the
handrails, begin walking and continue with the test
Dismounting methods:
•Step 1: Slow the running belt to its minimum speed, then stop the belt
•Step 2: Instruct patient to carefully step off the belt while holding on to the
handrails
•Show each user how to use the device as described in this manual.
•Risk of personal injury –Keep children under the age of 13 away from device.

Introduction Ch. 1 TRACKMASTER
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•Ask each user to perform a supervised "test usage" at minimum belt speed to review
and practice usage techniques.
•Serious injury could result from loss of balance or falls. To reduce the possibility of
serious injury, carefully observe the following precautions.
•Observe all the precautions listed under “Responsibility of the Customer” on pages 14
& 15 to reduce the possibility of serious injury as a result of falls or loss of balance.
WARNING
Serious injury or death could result from electrical shock. To reduce the possibility
of electrical shock, carefully observe the following precautions.
•To disconnect the treadmill, set the power switch to the OFF position, and remove the
plug from the outlet. When the power is off, the green light on the power switch is
dark.
•Never operate the device with a damaged power cord or plug.
•Power cord should be routed through frame mounted clamp and kept clear of the
elevation mechanism.
•Keep the power cord out of traffic areas and away from heated surfaces.
•Never use extension cords.
•Never operate the device when it is wet.
•Never operate the device if it is not operating properly.
•Always unplug the machine before service or maintenance is performed.
•Treadmill should be serviced by authorized technicians only.
•Operator should report any electrical shock when touching the treadmill and
discontinue use immediately.
•Never use the treadmill outdoors.
•Immediately discontinue use and unplug the treadmill if you smell the distinctive odor
of hot electrical components.
WARNING
Serious injury or death could result from electrical shock occurring during
defibrillation. Never allow patient or operators near treadmill during defibrillation.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the treadmill, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING
Consult your physician prior to using the device to determine your physical readiness
and capabilities. Stop exercising immediately and seek medical attention if you
experience chest pain, dizziness or shortness of breath or if you experience symptoms
of overexertion.
WARNING
Serious injury or death could result from operating the treadmill in the presence of
explosive or flammable vapors and antiseptics.

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WARNING
The potential for foot crush injury at frontal end of treadmill at lift mechanism
(landing gear) when treadmill is descending. Keep feet and hands away from this area
at all times.
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.
Classification of Medical Device
This device is classified as follows, according to IEC 60601-1:
NOTE: Class A 60601 Emissions 120V 60 Hz (covers only medical/commercial
installations).
Class B 60601 Emissions 220V 50/60 Hz (covers all market installations).
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.

Introduction Ch. 1 TRACKMASTER
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Table 1: Guidance and Manufacturer’s Declaration – Emissions
The TMX428 Series is intended for use in the electromagnetic environment specified below. The customer
or user of the TMX428 Series should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment –Guidance
RF Emissions
CISPR 11
Group 1
The TMX428 Series uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF Emissions
CISPR 11
Class B
The TMX428 Series is suitable for use in all establishments,
including domestic, and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
Table 2: Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and
ME Systems
The TMX428 Series is intended for use in the electromagnetic environment specified below. The customer
or user of the TMX428 Series should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
–Guidance
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±6kV Contact
±8kV Air
Floors should be wood, concrete
or ceramic tile. If floors are
synthetic, the r/h should be at
least 30%
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV Mains
±1kV I/Os
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV
Differential
±2kV
Common
±1kV Differential
±2kV Common
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage Dips/Dropout
IEC 61000-4-11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the TMX428 Series requires
continued operation during
power mains interruptions, it is
recommended that the TMX428
Series be powered from an
uninterruptible power supply or
battery.
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields
should be that of a typical
commercial or hospital
environment.

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Table 4: Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME
Systems that is NOT Life-supporting
The TMX428 Series is intended for use in the electromagnetic environment specified below. The customer
or user of the TMX428 Series should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment –
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
(V1)=3Vrms
(3V, 6V at
ISM +
Amateur
Frequencies)
(E1)=3V/m
(3 V/m at 80 -
2,700MHz,
AM
Modulation
9-28V/m, 385
- 6,000MHz,
FM or Digital
Modulation)
Portable and mobile communications
equipment should be separated from the
TMX428 Series by no less than the
distances calculated/listed below:
D=(3.5/V1)(Sqrt P)
150kHz to 80MHz
D=(3.5/E1)(Sqrt P)
80 to 800 MHz
D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
Where P is the max power in watts and D
is the recommended separation distance
in meters.
Field strengths from fixed transmitters,
as determined by an electromagnetic site
survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
Table 6: Recommended Separation Distances between portable and mobile RF
Communications equipment and the TMX428 Series ME Equipment and ME Systems that
is NOT Life-supporting
The TMX428 Series is intended for use in the electromagnetic environment in which radiated disturbances
are controlled. The customer or user of the TMX428 Series can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment and the
TMX428 Series as recommended below, according to the maximum output power of the communications
equipment.
Max Output Power
(Watts)
Separation (m)
150kHz to 80MHz
D=(3.5/V1) (Sqrt P)
Separation (m)
80 to 800MHz
D=(3.5/E1) (Sqrt P)
Separation (m)
800MHz to 2.5GHz
D=(7/E1) (Sqrt P)
0.01
0.11667
0.11667
0.23333
0.1
0.36894
0.36894
0.73785
1
1.1667
1.1667
2.3333
10
3.6894
3.6894
7.3785
100
11.667
11.667
23.333

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Responsibility of the Manufacturer
Full-Vision Inc. is responsible for the effects of safety, reliability, and performance of the treadmill
only if the following conditions are met:
•Assembly operations, extensions, readjustments, modifications, or repairs are carried out by
authorized personnel.
•The electrical installation of the relevant room complies with the requirements of the
appropriate local, state, and other government regulations.
•The equipment is used in accordance with the instructions for use.
Responsibility of the Customer
The customer is responsible for providing appropriate desks, chairs, electrical wall outlets, network
connections, analog phone lines, and locating any of the system components described in this
manual in compliance with all local, state, and national codes.
The customer is solely responsible for the training, instruction, supervision and safety of all users
of the TMX428 and TMX428CP, and to use it as intended by the manufacturer. This device is
intended to be used as a motion appliance to facilitate cardiac or VO2 medical evaluation.
•Read this Operator’s Manual before operating the TMX428 and TMX428CP.
•Assist in off-loading the patient in the event of abnormal or unexpected operation of the
treadmill.
•If the treadmill is not responding properly, stop the treadmill, assist in removing the patient off
the running belt, unplug the treadmill power supply, and seek factory authorized repair before
attempting to restart the treadmill.
•Never allow children or pets near the machine without qualified adult supervision.
•Note the location of stop and/or emergency stop controls and their operation before starting a
test or workout.
•The Patient must always wear the Patient Safety Tether lanyard while operating the TMX428
and TMX428CP.
oIn the event the patient falls and the Patient Safety Tether lanyard fails to disengage,
use the Emergency Stop Button on the Treadmill to stop the treadmill as this
disengages the motor and allows the treadmill to freewheel to a stop
•THIS DEVICE IS NOT intended for use by persons with reduced physical, sensory or mental
capabilities, or lack of experience and knowledge unless they have been given supervision or
instruction concerning use of the appliance by a person responsible for their safety.

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•Verify the Patient and Operator understands how to stop the machine in the event of
malfunction or emergency.
•Patient should not wear loose fitting nylon material when exercising on this treadmill to avoid
generating Electrostatic Discharge.
•Never attempt to remove any article of clothing while the running belt is moving.
•All persons on and around the treadmill must wear enclosed, protective footwear. Shoelaces
must be tight and not drape as to cause a trip or catch hazard. Sandals, flip flops, slippers and
the like are not considered enclosed, protective footwear.
•Walk in the center of the running belt. Contact with the side rail and the moving belt could
cause injury.
•Place the treadmill on a hard, level and unobstructed surface. See Chapter 5 of this manual.
•Check input power cord connection and location for hazardous pinch points before use.
•Check input communications cord connection (if equipped) for proper interface with all
equipment.
•Keep all cords clear of patient to avoid trip hazards.
•Never attempt to remove the motor pan hood or do electrical repairs yourself. Repairs should
only be done by a factory authorized repair provider.
•Always unplug the TMX428 and TMX428CP when servicing, inspecting or cleaning the
treadmill.
•Routinely inspect the treadmill for loose parts.
•Inspect handrails and ensure they will support the patient properly.
•Always start the running belt at its slowest speed before starting the patient test.
•Always slow the running belt to its minimum speed before stopping.
•Keep hands, feet, and clothing away from any moving parts.
•Verify no one is near the elevation mechanism before operating. Never put any part of the body
under any part of a running treadmill.
•Never drop or insert objects into any opening.
•Never drape garments, hook-up leads, or other equipment over the side rails or drop objects on
the belt while the TMX428 and TMX428CP is running.
•Do not allow moisture or oils to accumulate on equipment, creating a slip hazard.
Product and Package Information
This section describes the location of the labels used on your device and its packaging. It also
describes the symbols used on the labels.
Symbols
The following symbols may appear on the device or its packaging. Familiarity with these symbols
assists in the safe use and disposal of the equipment. For equipment symbols not shown, refer to
the original equipment manufacturers (OEM) manuals.
Symbols are used to convey warnings, cautions, prohibitions, mandatory actions, or information.
Any hazard symbols on your device or packaging with markings in color indicates there is certain
danger and is a warning. Any hazard symbols on your device or packaging that is in black and
white indicates a potential hazard and is a caution.
Symbols Glossary
Symbol
Description/Definition
Catalog or Orderable Part Number
Indicates the manufacturer's catalog or part number.

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June 2023
Symbol
Description/Definition
Serial Number
Indicates the manufacturer's serial number.
Manufacturer Name, Address and Manufacturing
(Year-Month-Date)
Indicates the name and address for the manufacturer of this
device.
CAUTION:
CONSULT ACCOMPANYING DOCUMENTS -
There may be specific warnings or precautions
associated with the device that are not otherwise found
on the label.
Consult the accompanying documentation for more
information about safely using this device.
CAUTION:
ELECTRIC SHOCK - Indicates the presence of
hazardous energy circuits or electric shock hazards.
To reduce the risk of electric shock hazards, do not
open this enclosure. Refer servicing to qualified
personnel.
Reading of the Owner’s Manual is mandatory.
Elevation incline / decline adjustment, TMX428CP Only
Running belt speed adjustment, TMX428CP Only
Operate Temperature Limit
Indicates the maximum temperature to Operating
Temperature of device.
Storage Temperature Limits
Indicates the upper and lower temperature limitations for the
transportation and handling of this package.
Humidity Limits
Indicates the upper and lower Non-Condensing Humidity
limitations for the transportation, handling of this package and
Operating of device.

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June 2023
Symbol
Description/Definition
This equipment complies with the EU WEEE marking
requirement for proper disposal of electrical and electronic
waste in accordance with the European Directive. This
directive calls for separation and recovery or reuse of used
electrical or electronic equipment upon end of life EEE
disposal.
The TRACKMASTER®must not be disposed of as unsorted
municipal waste. Electrical or electronic components must be
collected separately and disposed of in accordance with your
local requirements and sources. The EEE program minimizes
any potential effects on the environment and user health by
eliminating the potential presence of hazardous substances in
the waste stream. Customers should contact their local
authorities or TRACKMASTER®Distributor for guidance in
complying with the directive.
Keep Dry
Indicates that you need to keep the container away from rain
and other sources of moisture.
CE Mark
Indicates the device or product conforms to applicable EU
(European Union) directives.
Electrical Testing Laboratories
Indicates the device or product has been tested by an
accredited third-party testing laboratory and meets
applicable safety standards for sale and distribution
within North America.
Protective earth (ground).
Alternating current.
Device is suitable for the external application of the type “B”
applied parts.
Unique Device Identification is a unique marking of the
medical device
Follow operating instructions
Medical device
Authorized Representative In European Union
(Regulatory affairs only).
Authorized Representative In Switzerland

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June 2023
Symbol
Description/Definition
United Kingdom Responsible Person
Importer: Indicates the entity importing the medical
device into the locale.
Label Locations
This section identifies the labels and their locations on the product and packaging.
TMX428 & TMX428CP