Trackmaster TMX428 User manual

TMX428 TMX428CP & TMX58 Service Manual 317-160-406 Rev 4
May 2021
MEDICAL TREADMILL
SERVICE MANUAL
TMX428
TMX428CP
TMX58

TRACKMASTER Safety Information
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May 2021
Contact Information
The model TMX428 TRACKMASTER® treadmill is designed to be interfaced with a variety of
ECG and VO2systems. 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
Prinsessegracht 20
2514AP The Hague
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
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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
August 2016
Update Authorized Representative Address
3
November 2018
Added 4th Edition EMC Tables Chapter 1
4
04 May 2021
Updated to EU MDR 2017/745 label requirements,
added Reprocessing Instructions in Appendix B,
updated the intended use statement.

TRACKMASTER Contents
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Table of Contents
Contact Information ............................................................................................................. i
Publication Information ...................................................................................................... ii
Chapter 1 Introduction................................................................................................................. 9
Intended User ...................................................................................................................... 9
Intended Use ....................................................................................................................... 9
Regulatory and Safety Information................................................................................... 10
Reporting of serious incident ............................................................................................ 10
Safety Conventions ........................................................................................................... 11
Safety Hazards .................................................................................................................. 11
Classification of Medical Device...................................................................................... 14
Regulatory and Safety Conformance ................................................................................ 14
Table 1: Guidance and Manufacturer’s Declaration – Emissions .................................... 15
Table 2: Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and
ME Systems ...................................................................................................................... 15
Table 4: Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME
Systems that is NOT Life-supporting ............................................................................... 16
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.............................................................................................. 16
Responsibility of the Manufacturer .................................................................................. 17
Responsibility of the Customer......................................................................................... 17
Symbols............................................................................................................................. 18
Product and Package Information..................................................................................... 21
Serial Decal Information................................................................................................... 24
Training............................................................................................................................. 24
Chapter 2 Specifications............................................................................................................. 25
Directional Orientation ..................................................................................................... 25
Safety Systems .................................................................................................................. 26
Treadmill........................................................................................................................... 26
Drive System..................................................................................................................... 26
Speed Range...................................................................................................................... 26
Incline Range .................................................................................................................... 26
Running Surface................................................................................................................ 26
Content

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Communication Ports........................................................................................................ 26
Floor Surface Footprint..................................................................................................... 26
Operating and Storage Condition Recommendations....................................................... 26
Chapter 3 Power Requirements ................................................................................................ 27
Chapter 4 Hi-Pot Test Instructions ........................................................................................... 29
Chapter 5 Uncrating, Setup and Assembly .............................................................................. 31
Uncrating Instructions...................................................................................................... 31
Initial Setup Instruciton..................................................................................................... 33
TMX428CP & TMX58 Control Assembly ...................................................................... 34
Safe Handling Guidelines ................................................................................................. 35
Location ............................................................................................................................ 35
Final Setup - Running Belt Tracking Adjustment ............................................................ 36
Final Setup - Running Belt Tension Adjustment.............................................................. 36
Final Setup - Drive Belt Tension Adjustment................................................................... 36
Final Setup - Test Plug Procedure .................................................................................... 37
Communication Access Location ..................................................................................... 38
Chapter 6 Operating Instructions ............................................................................................. 39
Electrical Safety Tests....................................................................................................... 39
Operating Controls............................................................................................................ 39
Controlling the Treadmill ................................................................................................. 39
Power Switch .................................................................................................................... 39
Emergency Stop Switch.................................................................................................... 40
Emergency Stop Switch Check......................................................................................... 40
Pull Tether Switch............................................................................................................. 40
Pull Tether Switch Check ................................................................................................. 40
Programmable Control Instructions TMX428CP ............................................................. 41
TESTING MODE DISPLAY ........................................................................................... 41
MANUAL MODE DISPLAY .......................................................................................... 41
Control Panel Display:...................................................................................................... 42
Stop Tether:....................................................................................................................... 42
Control Panel Button Descriptions: .................................................................................. 43
WORKOUT GRAPHICS ................................................................................................. 45
MANUAL OPERATION: ................................................................................................ 45
BUILT-IN PROGRAM OPERATION............................................................................. 47
Pre-Programmed Protocol Workout Data......................................................................... 47

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Pre-Programmed Fitness Workout Data ........................................................................... 50
User Defined Programming .............................................................................................. 53
Chapter 7 Preventive Maintenance........................................................................................... 55
Reprocessing Instructions ................................................................................................. 55
Daily Maintenance ............................................................................................................ 55
Weekly Maintenance ........................................................................................................ 55
Monthly Maintenance ....................................................................................................... 55
Semiannual Maintenance .................................................................................................. 56
Belt Cleaning and Inspection ............................................................................................ 56
Running Belt Tracking Adjustment .................................................................................. 56
Running Belt Tension Adjustment.................................................................................... 57
Drive Belt Tension Adjustment ........................................................................................ 58
Exterior Care..................................................................................................................... 59
Elevation Screw Lubrication............................................................................................. 59
Running Deck Maintenance.............................................................................................. 59
Chapter 8 Product Requirements.............................................................................................. 61
INTRODUCTION ............................................................................................................ 61
SCOPE .............................................................................................................................. 61
OPERATIONAL OVERVIEW ........................................................................................ 61
SOFTWARE REQUIREMENTS ..................................................................................... 62
SPEED CONTROL .......................................................................................................... 62
ELEVATION CONTROL ................................................................................................ 62
COMMUNICATION HARDWARE (RS-232 Option) ................................................... 63
COMMUNICATION HARDWARE (USB Option) ........................................................ 63
COMMAND PROTOCOL ............................................................................................... 63
A - INPUT COMMANDS ................................................................................................ 63
B - INPUT COMMAND ACKNOWLEDGEMENT ....................................................... 64
C - STATUS REQUEST .................................................................................................. 64
D - STATUS RESPONSE ................................................................................................ 64
COMMUNICATION NOTES.......................................................................................... 65
Self-test MODE ................................................................................................................ 66
CALIBRATION ............................................................................................................... 66
DIP SWITCH SETTINGS................................................................................................ 66
ELECTRICAL INPUTS ................................................................................................... 67
ELECTRICAL OUTPUTS ............................................................................................... 67

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ELECTRICAL CONNECTIONS..................................................................................... 68
PHYSICAL REQUIREMENTS AND RESTRICTIONS ................................................ 68
UNIVERSAL POWER SUPPLY BOARD 3.1 Edition (FGLF0495-1) .......................... 69
UNIVERSAL POWER SUPPLY BOARD 4th Edition (FGLF0495-3) ........................... 70
Chapter 9 Troubleshooting ........................................................................................................ 71
Incoming Power 110-240VAC Flow Chart 1A ................................................................ 71
Incoming Power Inline Filter Flow Chart 1B ................................................................... 72
Incoming Power Drive PC2303-012-N Flow Chart 1C.................................................... 73
Smart Power Supply Incoming Power 110-240VAC Flow Chart 1D .............................. 74
Emergency Stop Flow Chart 1E ....................................................................................... 75
Pull Tether Flow Chart 1F ................................................................................................ 75
Communication RS232 Flow Chart 1G............................................................................ 76
Communication RS232 Flow Chart 1H............................................................................ 77
Smart Power Supply Error Code Identification Flow Chart 1I ........................................ 78
Smart Power Supply Error Code 1 Flow Chart 1J “Bad Speed Calibration” ................... 79
Smart Power Supply Error Code 2 Flow Chart 1K “Elevation Error” ............................. 80
Smart Power Supply Error Code 3 Flow Chart 1L “Missing Speed Signal From Motor
Controller” ........................................................................................................................ 81
Smart Power Supply Error Code 4 Flow Chart 1M “Over Speed Error Based on Motor
Controller Signal” ............................................................................................................. 82
Smart Power Supply Error Code 5 Flow Chart 1N “Missing Signal from External Speed
Sensor”.............................................................................................................................. 83
Smart Power Supply Error Code 6 Flow Chart 1O “Over Speed Base On External Speed
Sensor”.............................................................................................................................. 84
Smart Power Supply Error Code 7 Flow Chart 1P “Excessive Speed Mismatch”........... 85
Smart Power Supply Error Code 8 Flow Chart 1Q “Motor Control Reports Fault” ........ 87
Smart Power Supply Error Code 9 Flow Chart 1R “Start Belt Command Received During
Initialization” .................................................................................................................... 88
Smart Power Supply Error Code 10.................................................................................. 88
Control Console Communication Flow Chart 1S ............................................................. 89
Drive PC2303-012-N Status LED Code List.................................................................... 90
Chapter 10 Removal and Replacement of Components.......................................................... 91
Hood Removal Procedure TMX428 Series ...................................................................... 91
Drive Motor Replacement TMX428 Series...................................................................... 92
Drive Replacement TMX428 Series................................................................................. 94
Front Roller Replacement TMX428 Series ...................................................................... 95
Rear Roller Replacement TMX428 Series ....................................................................... 96

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Running Belt Replacement TMX428 Series..................................................................... 97
Running Deck Replacement TMX428 Series................................................................... 99
Deck Cushion Replacement TMX428 Series ................................................................. 100
Motor Drive Belt Replacement TMX428 Series ............................................................ 101
Elevation Actuator Replacement/Adjustment TMX428 Series...................................... 102
Replacing the Speed Sensor from 2 Wire to 3 Wire....................................................... 103
Replacing the Speed Sensor 3 Wire to 3 Wire................................................................ 105
Smart Power Supply Relay Board Replacement TMX428 Series.................................. 106
Circuit Breaker Replacement.......................................................................................... 107
Relocate Emergency Stop Button (ESB) & Stop Tether Switch (STS) ......................... 108
Validate Relocate ESB and STS Operation .................................................................... 109
Replacing the Center Handrail........................................................................................ 109
Replacing the Right or Left Handrail.............................................................................. 110
Removing and Reinstalling the Handrails for Moving ................................................... 111
Replacing the Main power switch................................................................................... 112
Replacing the Power cord ............................................................................................... 113
Replacing the CE filter.................................................................................................... 113
Replacing the Relay ........................................................................................................ 114
Chapter 11 Established Component Replacement Time ..................................................... 115
Chapter 12 Calibration TMX428 Series ................................................................................ 117
Belt Speed Calibration Procedure (Calibration Program) .............................................. 117
Belt Speed Calibration Procedure (Controller Interface)................................................ 118
Verifying Belt Speed Calibration (in the field)............................................................... 119
Elevation Calibration Procedure (Calibration Program)................................................. 120
Elevation Calibration Procedure (Controller Interface).................................................. 122
Elevation Chart TMX428, TMX428CP, and TMX58 .................................................... 124
TMX428, TMX428CP, and TMX58 Elevation Actuator Adjustment ........................... 124
TMX428CP & TMX58 PARAMETER SCREEN ......................................................... 125
TMX428CP & TMX58 STOP HISTORY...................................................................... 125
Firmware Download FGLF0495-1 (3rd Edition Smart Power Supply) .......................... 126
Firmware Download FGLF0495-3 (4th Edition Smart Power Supply)........................... 126
Firmware Download FGLF0496 (3rd Edition LCD Control).......................................... 126
Firmware Download FGLF0698-00 (4th Edition LCD Control) .................................... 127
Dip Switch Configuration............................................................................................... 127
Log File Retrieval FGLF0495-3 (4th Edition Smart Power Supply) .............................. 128

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Chapter 13 Parts List with Part Numbers.............................................................................. 129
Motor Mount Assembly.................................................................................................. 129
3rd Edition Circuit Board Assembly................................................................................ 130
3rd Edition Final Assembly Circuit Board Connection ................................................... 130
4th Edition Circuit Board Assembly................................................................................ 131
4th Edition Final Assembly Circuit Board Connection ................................................... 131
Elevation Assembly ........................................................................................................ 132
Pull Tether Assembly...................................................................................................... 132
Emergency Stop Assemblies........................................................................................... 133
Motor Pan Assembly....................................................................................................... 134
Motor Pan Assembly....................................................................................................... 135
Motor Pan Assembly Wiring .......................................................................................... 136
Motor Pan Assembly Wiring .......................................................................................... 137
Motor Pan Assembly Wiring .......................................................................................... 138
Frame Assembly ............................................................................................................. 139
Deck Assembly ............................................................................................................... 141
Final Assembly ............................................................................................................... 143
3rd Edition TMX428CP Controller Assembly ................................................................ 145
4th Edition TMX428CP Controller Assembly ................................................................ 147
TMX58 Controller Assembly ......................................................................................... 149
Appendix A Maintenance Log ................................................................................................. 151
Appendix B Reprocessing Instructions................................................................................... 153

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

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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.
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.
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:
oThe model number of the device as stated on its identification plate
affixed on the device
oThe serial number of the device
oDate of incident
oDescription of incident, including any patient or user impact/injury
oYour contact information (facility, address, contact name, title, and
telephone number)

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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.
Demonstrate the proper mounting and dismounting methods.
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.
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.
Read this Owner’s Manual before operating the treadmill.
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.

Introduction Ch. 1 TRACKMASTER
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Never allow children or pets near the machine without qualified adult supervision.
Note the location of the emergency stop controls and their operation before starting a
test or workout.
The Patient must always wear the Stop Tether lanyard wrist strap before operating
the treadmill.
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 treadmill by a person
responsible for their safety.
Verify the Patient and Operator both know 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 Electro Static 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.
Shoe laces 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 Assembly / Set-up
instructions in 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 device 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 your workout.
Do not step onto belt when it is moving.
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.

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Never drape garments, hook-up leads, or other equipment over the side rails or drop
objects on the belt while the treadmill is running.
Do not allow moisture or oils to accumulate on equipment, creating a slip hazard.
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.
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.

Introduction Ch. 1 TRACKMASTER
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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.

TRACKMASTER Ch. 1 Introduction
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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.

Introduction Ch. 1 TRACKMASTER
16 TMX428 TMX428CP & TMX58 Service Manual 317-160-406 Rev 4
May 2021
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
(E1)=3V/m
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

TRACKMASTER Ch. 1 Introduction
317-160-406 Rev 4 TMX428 TMX428CP & TMX58 Service Manual 17
May 2021
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.
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.
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 Electro Static 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. Shoe laces 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.
The Patient must always wear the Stop Tether lanyard wrist strap while operating the TMX428
and TMX428CP.
Place the treadmill on a hard, level and unobstructed surface. See Chapter 5 Uncrating, Setup and
Assembly.
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.

Introduction Ch. 1 TRACKMASTER
18 TMX428 TMX428CP & TMX58 Service Manual 317-160-406 Rev 4
May 2021
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.
Do not step onto belt when it is moving.
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.
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.
Serial Number
Indicates the manufacturer's serial number.
Manufacturer Name, Address and Manufacturing
(Year-Month-Day)
Indicates the name and address for the manufacturer of this
device.