TMX428,428P and TMX58 Series Medical Treadmill Service Manual Rev 4 May 2021

TRACKMASTER

Safety Information

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: (316)-283-3344 Fax: (316)-283-9522 Email: [email protected]

(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.

317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

i

Safety Information

TRACKMASTER

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.

ii

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Contents

Content 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... 26 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

3

Contents

TRACKMASTER

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 4

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Contents

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 ... 67 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

5

Contents

TRACKMASTER

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 6

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Contents

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) ... 128 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

7

Contents

TRACKMASTER

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

8

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Ch. 1

Introduction

1

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 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

9

Introduction

Ch. 1

TRACKMASTER

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: o The model number of the device as stated on its identification plate affixed on the device o The serial number of the device o Date of incident o Description of incident, including any patient or user impact/injury o Your contact information (facility, address, contact name, title, and telephone number)

10

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Ch. 1

Introduction

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. 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

11

Introduction

Ch. 1

  



                   12

TRACKMASTER

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. TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

 

Ch. 1

Introduction

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. 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

13

Introduction

Ch. 1

TRACKMASTER

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.

14

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Ch. 1

Introduction

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 RF Emissions CISPR 11

Compliance Group 1

RF Emissions CISPR 11 Harmonics IEC 61000-3-2 Flicker IEC 61000-3-3

Class B Class A

Electromagnetic Environment – Guidance 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. 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.

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 ESD IEC 61000-4-2

IEC 60601 Test Level ±6kV Contact ±8kV Air

Compliance Level ±6kV Contact ±8kV Air

EFT IEC 61000-4-4

±2kV Mains ±1kV I/Os

±2kV Mains ±1kV I/Os

Surge IEC 61000-4-5

±1kV Differential ±2kV Common >95% Dip for 0.5 Cycle

±1kV Differential ±2kV Common

60% Dip for 5 Cycles

60% Dip for 5 Cycles

30% Dip for 25 Cycles

30% Dip for 25 Cycles

>95% Dip for 5 Seconds 3A/m

>95% Dip for 5 Seconds 3A/m

Voltage Dips/Dropout IEC 61000-4-11

Power Frequency 50/60Hz Magnetic Field IEC 61000-4-8

317-160-406 Rev 4 May 2021

>95% Dip for 0.5 Cycle

Electromagnetic Environment – Guidance Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30% Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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 magnetic fields should be that of a typical commercial or hospital environment.

TMX428 TMX428CP & TMX58 Service Manual

15

Introduction

Ch. 1

TRACKMASTER

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 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

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

(V1)=3Vrms

D=(3.5/E1)(Sqrt P) 80 to 800 MHz

(E1)=3V/m

D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz

3 V/m 80 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.

16

Max Output Power (Watts)

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

0.01 0.1 1 10 100

D=(3.5/V1) (Sqrt P) 0.11667 0.36894 1.1667 3.6894 11.667

D=(3.5/E1) (Sqrt P) 0.11667 0.36894 1.1667 3.6894 11.667

D=(7/E1) (Sqrt P) 0.23333 0.73785 2.3333 7.3785 23.333

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Ch. 1

Introduction

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. 317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

17

Introduction

Ch. 1

TRACKMASTER

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.

18

TMX428 TMX428CP & TMX58 Service Manual

317-160-406 Rev 4 May 2021

TRACKMASTER

Ch. 1

Symbol

Introduction

Description/Definition 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.

317-160-406 Rev 4 May 2021

TMX428 TMX428CP & TMX58 Service Manual

19