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
June 2023
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

TRACKMASTER Table of Contents
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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)