T2100-ST Series Operator Manual Rev G Jan 2019

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:

Date of first CE mark – 2012. 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 60601 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 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

A

20 August 2016

Internal release

B

9 September 2016

Initial public release

C

18 November 2016

Power cord configuration

D

30 March 2017

Authorized Representative Address Change

E

12 June 2017

Added power cord configuration

F

27 June 2018

Revised regulatory and safety conformance

G

03 January 2019

Added EMC Declaration section

To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at http://apps.gehealthcare.com/servlet/ClientServlet?REQ=RNEW&MODALITY=Cardiology.

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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 ... 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 ... 13 Table 3: Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME Systems that is NOT Life-supporting ... 14 Table 6: Recommended Separation Distances between portable and mobile RF Communications equipment and the T2100-ST Series ME Equipment and ME Systems that is NOT Life-supporting ... 15 Responsibility of the Manufacturer ... 15 Responsibility of the Customer ... 16 Product and Package Information ... 17 Symbols ... 18 Equipment Identification ... 21 Product Label ... 21 Service Information ... 22 Service Requirements... 22 Warranty Information ... 22 Additional Assistance ... 22 Manual Information ... 23 Manual Purpose ... 23 Document Conventions... 23 Related Documents ... 24 Training ... 24

2

Product Overview ... 27 Safety Systems ... 28 Treadmill ... 28 Drive System ... 28 Speed Range ... 28 Incline Range ... 28 Running Surface ... 28

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Communication Ports ... 29 Floor Surface Footprint ... 29 Operating and Storage Condition Recommendations ... 29 Power Requirements ... 29 3

Assembly and Setup ... 31 Safe Handling Guidelines ... 31 Initial Setup ... 32 Location ... 33 Final Setup - Running Belt Tracking Adjustment ... 34 Final Setup - Running Belt Tension Adjustment ... 35 Final Setup - Drive Belt Tension Adjustment ... 35 Final Setup - Test Plug Procedure ... 35 Using the test plug ... 36 Communication Access Location ... 37

4

Operating Instructions ... 39 Electrical Safety Tests ... 39 Operating Controls ... 40 Controlling the Treadmill ... 40 Power Switch ... 40 Emergency Stop Switch ... 40 Emergency Stop Switch Check ... 40 Pull Tether Switch... 41 Pull Tether Switch Check... 41 Adjustable Handrail Option ... 41

5

Preventive Maintenance ... 43 Daily Maintenance ... 43 Weekly Maintenance ... 44 Monthly Maintenance ... 44 Semi-annual Maintenance ... 44 Belt Cleaning and Inspection ... 44 Running Belt Tracking Adjustment ... 45 Running Belt Tension Adjustment ... 46 Drive Belt Tension Adjustment ... 46 Exterior Care ... 47 Elevation Screw Lubrication... 47

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Running Deck Maintenance ... 48 6

Troubleshooting ... 49 Power Switch Will Not Illuminate ... 49 Facility Circuit Breaker Trips when Powering Up... 50 Treadmill Will Not Start ... 50 Running Belt Slips When in Use ... 50 Running Belt Is Off-Center ... 50 Running Belt Hesitation or Slippage in High Speed Application ... 50 Internal Circuit Breaker Location and Resetting ... 51

A

Maintenance Log ... 53

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1 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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Introduction

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.

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Introduction

WARNING: The T2100-ST1 and T2100-ST2 treadmills must be grounded to reduce the risk of electrical shock. If a malfunction occurs, 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 16 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.

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Introduction

• 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. • 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: 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 T2100-ST Series, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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.

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Introduction

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

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 T2100-ST1 and T2100-ST2 treadmills meet the 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 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.

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Introduction

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.

Table 1: Guidance and Manufacturer’s Declaration Emissions The T2100-ST Series is intended for use in the electromagnetic environment specified below. The customer or user of the T2100-ST Series should ensure that it is used in such an environment.

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Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF Emissions CISPR 11

Group 1

The T2100-ST 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

Harmonics IEC 61000-3-2

Class A

Flicker IEC 61000-3-3

Complies

The T2100-ST Series is suitable for use in all establishments, including domestic, and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

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Introduction

Table 2: Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and ME Systems The T2100-ST Series is intended for use in the electromagnetic environment specified below. The customer or user of the T2100-ST 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

±8kV Contact ±15kV Air

±8kV Contact ±15kV 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 61000-411

>95% Dip for 0.5 Cycle

>95% Dip for 0.5 Cycle

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

>95% Dip for 5 Seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the T2100-ST Series requires continued operation during power mains interruptions, it is recommended that the T2100-ST Series be powered from an uninterruptible power supply or battery.

30 A/m

30 A/m, 50/60Hz

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

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Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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Introduction

Table 3: Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME Systems that is NOT Life-supporting The T2100-ST Series is intended for use in the electromagnetic environment specified below. The customer or user of the T2100-ST 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

3 Vrms 150 kHz to 80 MHz

3V, 6V at ISM + (Amateur Frequencies

Portable and mobile communications equipment should be separated from the T2100ST Series by no less than the distances calculated/listed below:

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

3 V/m at 80 2,700MHz, AM Modulation 9-28V/m, 385 - 6,000MHz, FM or Digital Modulation

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.

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Introduction

Table 6: Recommended Separation Distances between portable and mobile RF Communications equipment and the T2100-ST Series ME Equipment and ME Systems that is NOT Life-supporting The T2100-ST Series is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the T2100-ST Series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the T2100-ST Series as recommended below, according to the maximum output power of the communications equipment. Max Output Power (Watts)

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

D=(3.5/V1)(Sqrt P)

D=(3.5/E1)(Sqrt P)

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

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:

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•

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.

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Introduction

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.

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Introduction

•

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.

•

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.

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Introduction

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 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.

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Introduction Symbol

Description 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. Keep Dry Indicates that you need to keep the container away from rain and other sources of moisture. CE Mark Indicates the device or product conforms with applicable EU (European Union) directives. Eurasian Conformity mark Conformity to applicable technical regulations of Customs Union. Electrical Testing Laboratories Indicates the device or product has been tested by an accredited third-party testing laboratory and meets applicable safety standards for sale and distribution within North America. PCT (GOST-R) Mark Indicates the device or product conforms with applicable Russian Gosstandard technical and safety standards.

Protective earth (ground).

Alternating current. Device is suitable for the external application of the type “B” applied parts. Unique Device Identification is a unique marking of the medical device

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Introduction

Label Locations This section identifies the labels and their locations on the product and packaging.

Refer to the previous illustrations for the locations of the labels identified in the following table. For detailed descriptions of the symbols that appear on the labels, refer to “Symbols” on page 12. Item

20

Label

Location

Description

1

Front of device

Identifies the product model.

2

Front of device

Identifies Listing Standards

3

Front of device

Contains the European Union disposal requirements.

4

Front of device on Hood

Identifies the Caution Electrical shock hazard.

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Introduction Item

Label

Location

Description

5

On Power Cord

Identifies DC Hi-Pot Caution.

6

Front of device

Identifies Power switch.

7

Shipping Package

Identifies the following information for shipping:

8

Front of device

•

Model number

•

Reference number

•

Serial number

•

Storage conditions

•

Regulatory compliance

•

Country of origin

•

EC Representative information

Identifies Unique Device Identifier

Equipment Identification Product Label

Product Label Format Item

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Name

Description

1

Manufacturer

Full Vision Inc.

2

Private Label Manufacturer

GE Medical Systems Information Technologies, Inc.

3

Model Number

Identifies model of treadmill

4

Manufacturer Model Number

Identifies manufacturing model of treadmill

5

Serial Number

Manufacturer assigned serial number

6

REF

GE Medical Systems reference part number

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