GE T2100-ST1 Manual de usuario
GE Healthcare
T2100-ST1Treadmill, 110V / T2100-ST2 Treadmill, 220V
English
© 2016-2017 General Electric Company
All Rights Reserved
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 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
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
1Introduction............................................................................................................ 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
2Product 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
4 T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 2097937-001 Rev E
12 June 2017
3Assembly 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
4Operating 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
5Preventive 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
6Troubleshooting .................................................................................................. 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
AMaintenance Log................................................................................................. 47
1
2097937-001 Rev E T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 7
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1Introduction
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.
Introduction
8 T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 2097937-001 Rev E
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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,
Introduction
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.
Introduction
10 T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V 2097937-001 Rev E
12 June 2017
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
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).
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