GE T2100-ST1, T2100-ST2 Operator's Manual

GE Healthcare

T2100-ST1

Treadmill, 110V

T2100-ST2

Treadmill, 220V

Operator’s Manual

2097937-001 Rev E

2 T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 2097937-001 Rev E

12 June 2017

Publication Information

The information in this manual applies only to T2100-ST1 Treadmill, and T2100-ST2 Treadmill,. It does not apply to earlier versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

T2100-ST1, T2100-ST2, CASE, CardioSoft, and MAC are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other marks are the properties of their respective owners.

This product complies with the regulatory requirements concerning medical devices from the following bodies:

T2100-ST1 and T2100-ST2 treadmills 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 6060-1 20053rd edition 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 T2100-ST1 or T2100-ST2 treadmill, follow all precautions listed in this manual and read the entire Operator’s Manual thoroughly. Use the T2100-ST1 and T2100-ST2 treadmills only as described.

Revision History

The document part number and revision 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

20 August 2016

Internal release

9 September 2016

Initial public release

18 November 2016

Power cord configuration

30 March 2017

Authorized Representative Address Change

12 June 2017

Added power cord configuration

To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at

www.gehealthcare.com/documents and click Cardiology.

2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 3 12 June 2017

Contents

1 Introduction............................................................................................................ 7

Intended User ............................................................................................................................... 7

Indications for Use ...................................................................................................................... 7

Prescription Device Statement .............................................................................................. 7

Regulatory and Safety Information .................................................................................... 7

Safety Conventions ........................................................................................................ 8

Safety Hazards ................................................................................................................. 8

Classification of Medical Device ............................................................................ 10

Regulatory and Safety Conformance ................................................................. 11

Responsibility of the Manufacturer ...................................................................... 12

Responsibility of the Customer .............................................................................. 12

Product and Package Information ....................................................................... 14

Symbols ............................................................................................................................ 14

Equipment Identification ....................................................................................................... 18

Product Label ................................................................................................................. 18

Service Information ................................................................................................................. 18

Service Requirements ................................................................................................ 18

Warranty Information ................................................................................................ 19

Additional Assistance ................................................................................................. 19

Manual Information ................................................................................................................ 19

Manual Purpose ............................................................................................................ 19

Document Conventions ............................................................................................. 19

Related Documents ..................................................................................................... 20

Training ......................................................................................................................................... 21

2 Product Overview ................................................................................................ 23

Safety Systems .......................................................................................................................... 24

Treadmill ....................................................................................................................................... 24

Drive System ............................................................................................................................... 24

Speed Range .............................................................................................................................. 24

Incline Range .............................................................................................................................. 24

Running Surface ....................................................................................................................... 24

Communication Ports ............................................................................................................ 25

Floor Surface Footprint .......................................................................................................... 25

Operating and Storage Condition Recommendations ............................................ 25

Power Requirements .............................................................................................................. 25

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3 Assembly and Setup ........................................................................................... 27

Safe Handling Guidelines ...................................................................................................... 27

Initial Setup ................................................................................................................................. 28

Location ........................................................................................................................................ 29

Final Setup - Running Belt Tracking Adjustment........................................................ 30

Final Setup - Running Belt Tension Adjustment ......................................................... 31

Final Setup - Drive Belt Tension Adjustment ................................................................ 31

Final Setup - Test Plug Procedure ..................................................................................... 31

Using the test plug ................................................................................................................... 32

Communication Access Location ..................................................................................... 33

4 Operating Instructions ....................................................................................... 35

Electrical Safety Tests............................................................................................................. 35

Operating Controls .................................................................................................................. 35

Controlling the Treadmill ....................................................................................................... 36

Power Switch .............................................................................................................................. 36

Emergency Stop Switch ........................................................................................................ 36

Emergency Stop Switch Check .......................................................................................... 36

Pull Tether Switch ..................................................................................................................... 36

Pull Tether Switch Check ....................................................................................................... 37

Adjustable Handrail Option ................................................................................................. 37

5 Preventive Maintenance .................................................................................... 39

Daily Maintenance ................................................................................................................... 39

Weekly Maintenance .............................................................................................................. 40

Monthly Maintenance ............................................................................................................ 40

Semiannual Maintenance .................................................................................................... 40

Belt Cleaning and Inspection .............................................................................................. 40

Running Belt Tracking Adjustment ................................................................................... 41

Running Belt Tension Adjustment ..................................................................................... 42

Drive Belt Tension Adjustment ........................................................................................... 42

Exterior Care ............................................................................................................................... 43

Elevation Screw Lubrication ................................................................................................ 43

Running Deck Maintenance ................................................................................................ 43

6 Troubleshooting .................................................................................................. 45

Power Switch Will Not Illuminate ...................................................................................... 45

Facility Circuit Breaker Trips when Powering Up ....................................................... 46

2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 5 12 June 2017

Treadmill Will Not Start .......................................................................................................... 46

Running Belt Slips When In Use ......................................................................................... 46

Running Belt Is Off-Center .................................................................................................... 46

Internal Circuit Breaker Location and Resetting ........................................................ 46

A Maintenance Log ................................................................................................. 47

2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 7 12 June 2017

1 Introduction

This document describes the T2100-ST1 and T2100-ST2 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.

Intended User

This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for completing these examinations.

Indications for Use

The T2100-ST1 and T2100-ST2 treadmills are designed for cardiac stress testing.

Prescription Device Statement

CAUTION:

United States federal law restricts this device to sale by, or on the order of, a physician.

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.

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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.

Safety Conventions

A Hazard is a source of potential injury to a person, property, or the system.

This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE 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

DANGER

Indicates an imminent hazard, which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in moderate or minor injury.

NOTICE

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in loss or destruction of property or data.

Safety Hazards

The following messages apply to the system as a whole. Specific messages may also appear elsewhere in the manual.

WARNING:

The T2100-ST1 and T2100-ST2 treadmills are 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 treadmills have 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 GE Healthcare Service department for all your repair part needs.

WARNING:

The T2100-ST1 and T2100-ST2 treadmills must be grounded to reduce the risk of electrical shock. If a malfunction occurs,

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2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 9 12 June 2017

grounding provides a path of least resistance for an electric current. Ungrounded connections must not be used.

No other equipment may be used on the electrical circuit with the treadmills. Do not use extension cords. Using a shared or unreliable circuit can also cause the treadmills to unexpectedly shut off, potentially resulting in injury to the patient.

Ensure the master power switch is in the off position before plugging in the T2100-ST1 or T2100-ST2. A power surge could damage the sophisticated electronic system of the treadmills.

WARNING:

Before permitting anyone to use the T2100-ST Series, 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 T2100-ST Series as

described in this manual.

 Ask each user to perform a supervised "test usage" at

minimum belt speed to review and practice usage techniques.

 Observe all the precautions listed under “Responsibility of

the Customer“ on page 12 to reduce the possibility of

serious injury as a result of falls or loss of balance.

WARNING:

Serious injury or death could result from electrical shock. To reduce the possibility of electrical shock, carefully observe the following precautions.

 To disconnect the treadmill, set the power switch to the OFF

position, and remove the plug from the outlet. When the power is off, the green light on the power switch is dark.

 Never operate the unit 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 unit when it is wet.

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 Never operate the unit 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.

WARNING:

Consult your physician prior to using this appliance to determine the patient’s physical readiness and capabilities. Stop exercising immediately and seek medical attention if the patient 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.

Classification of Medical Device

This device is classified as follows, according to IEC 60601-1:

Medical Device Classification

Category

Classification

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

T2100-ST1 and T2100-ST2 treadmills 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 6060-1 2005-3rd edition 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 T2100ST1 or T2100-ST2 treadmill, follow all precautions listed in this

manual and read the entire Operator’s Manual thoroughly. Use the

T2100-ST1 and T2100-ST2 treadmills only as described.

UL 1647

Issue: 2011/04/21 Ed: 5 UL Standard for Safety for Motor-Operated Massage and Exercise Machines

CAN/CSA C22.2#68

Issue: 2009/09/01 Ed: 7 Motor-Operated Appliances (Household and Commercial) General Instruction No.1: 2010/02/01 - General Instruction No.2: 2010/09/28

CSA C22.2#60601-1

Issued: 2008/02/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for basic Safety and essential performance

ICES 003 Industry Canada (IC) Verification

Issue: 2004/01/01 Issue No.4 Interference-Causing Equipment Standard, Digital Apparatus

IEC 60335-1 Low Voltage Directive for the European Union (EU)

Issued: 2004/07/01 Ed: 4.1 Household and Similar Electrical Appliances – Safety Part 1: General Requirements; Corrigendum 1: 12/2005; Amendment 2: 05/2006; Corrigendum: 08/2006

IEC 60601-1

Issued: 2005/01/01 Ed: 3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Australia and Israel,

IEC 60601-1-2

Issued: 2007/03/01 Ed: 3.0 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

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AAMI ES60601-1

Issued: 2005/01/01 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

IEC CISPR 11-1 EMC Directive for the European Union (EU)

Issued: A1:2010 Electromagnetic Compatibility Requirements for Household Appliances, Electric Tools and Similar Apparatus Part 1: Emission Edition 5.0;

Federal Communications Commission (FCC) Verification for the United States

FCC 47CFR 15A

Issued: 2011/04/21 Title 47 CFR Part 15 Subpart A General Radiators Class A

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.

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 persons authorized GE Healthcare.

 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, and analog phone lines, and for 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 T2100-ST Series 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.

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 Read this Operator’s Manual before operating the T2100-ST

Series 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.

 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 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.

 The Patient must always wear the Stop Tether lanyard wrist

strap while operating the T2100-ST Series Treadmill

 Place the treadmill on a hard, level and unobstructed surface.

See Chapter 3“Assembly and Setup“ 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.

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14 T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 2097937-001 Rev E

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 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 T2100-ST Series Treadmill 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 T2100-ST Series Treadmill is running.

 Do not allow moisture or oils to accumulate on equipment,

creating a slip hazard.

Product and Package Information

This section describes the location of the labels used on your device and its packaging. It also describes the symbols used on the labels.

Symbols

The following symbols may appear on the device or its packaging. Familiarity with these symbols assists in the safe use and disposal of the equipment. For equipment symbols not shown, refer to the original equipment manufacturers (OEM) manuals.

Symbols are used to convey warnings, cautions, prohibitions, mandatory actions, or information. Any hazard symbols on your device or packaging with markings in color indicates there is certain danger and is a warning. Any hazard symbols on your device or packaging that is in black and white indicates a potential hazard and is a caution.

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2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 15 12 June 2017

Symbols

Symbol

Description

Catalog or Orderable Part Number

Indicates the manufacturer's catalog or part number.

Serial Number Indicates the manufacturer's serial number.

Date of Manufacture (Year-Month) Indicates the original manufacture date for this device.

Manufacturer Name and Address Indicates the name and address for the manufacturer of this device.

CAUTION:

CONSULT ACCOMPANYING DOCUMENTS - There may be specific warnings or precautions associated with the device that are not otherwise found on the label.

Consult the accompanying documentation for more information about safely using this device.

CAUTION:

ELECTRIC SHOCK - Indicates the presence of hazardous energy circuits or electric shock hazards.

To reduce the risk of electric shock hazards, do not open this enclosure. Refer servicing to qualified personnel.

Reading of the Owner’s Manual is mandatory.

Upper Temperature Limit

Indicates the maximum temperature for transportation and handling of this package.

Temperature Limits

Indicates the upper and lower temperature limitations for the transportation and handling of this package.

European Union Disposal Requirements

This equipment complies with the EU WEEE marking requirement for proper disposal of electrical and electronic waste in accordance with the European Directive 2011/65/EE. This directive calls for separation and recovery or reuse of used electrical or electronic equipment upon end of life EEE disposal.

The T2100 must not be disposed of as unsorted municipal waste. Electrical or electronic components must be collected separately and disposed of in accordance with your local requirements and sources. The EEE program minimizes any potential effects on the environment and user health by eliminating the potential presence of hazardous substances in the waste stream. Customers should contact their local authorities or T2100 Distributor for guidance in complying with the directive.

+ 35 hidden pages

GE T2100-ST1, T2100-ST2 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual