T2100 Operators Manual Rev C May 2015

NOTE The information in this manual only applies to the T-2100 Treadmill. It does not apply to earlier product versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: +1 414 355 5000 1 800 558 7044 (USA only) 1 800 668 0732 (Canada only) Fax: +1 414 355 3790

GE Medical Systems Information Technologies GmbH Munzinger Straße 5 79111 Freiburg GERMANY Tel: +49 761 45 43-0 Fax: +49 761 45 43-233

MAC and CASE are trademarks owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare. © 2005, 2007, 2012 General Electric Company. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

EMC Immunity Performance WARNING RF sources - Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration. Refer to the service manual for detailed exceptions and compliance information.

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Contents 1

Introduction...1-1 Manual Information... 1-2 Revision History...1-2 Manual Purpose...1-2 Intended Audience...1-2 Conventions... 1-3 Safety Messages...1-3 Definitions...1-3 Safety Information... 1-4 Responsibility of the Manufacturer...1-4 General...1-4 Equipment Symbols...1-5 Warnings and Dangers...1-6 Cautions...1-9 Service Information... 1-9 Service Requirements...1-9 Equipment Identification...1-10 Serial Number...1-10

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T-2100 Treadmill Overview...2-1 Intended Use... 2-2 Preparation for Use... 2-2 Safe Handling Guidelines...2-2 Operating Instructions... 2-3 Electrical Safety Tests...2-3 Calibrating Treadmill...2-4 Operating Controls... 2-5 Power Switch...2-5 Emergency Stop Switch...2-5 Emergency Stop Switch Check...2-5 Controlling the Treadmill... 2-6

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Maintenance...3-1 Introduction... 3-2 Recommended Maintenance...3-2 Inspection and Cleaning... 3-2 Visual Inspection...3-2 Exterior Cleaning...3-2 Disposal of the Product...3-2

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Introduction

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Introduction

Manual Information Revision History Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level. The revision history of this document is summarized in the table below. Revision

Date

Comment

A

2005-02-07

Initial release of manual.

B

2007-08-15

Revised equipment symbols and warnings.

C

2012-05-08

Changes on page CE-1

Manual Purpose This manual contains the instructions necessary to operate the equipment safely in accordance with its function and intended use. These instructions include but are not limited to: an explanation of the function of controls and indicators, the sequence of operation,  connection and disconnection of detachable parts and accessories, and  instructions for operator cleaning, preventive inspection and maintenance. Where necessary the manual identifies additional sources of relevant information and/or technical assistance.  

Intended Audience 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.

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Introduction

Conventions Below are the conventions used in this manual.

Safety Messages DANGER safety messages indicate an imminently hazardous situation which, if not avoided, WILL result in death or serious injury. WARNING safety messages indicate a potentially hazardous situation which, if not avoided, COULD result in death or serious injury. CAUTION safety messages indicate a potentially hazardous situation which, if not avoided may result in minor or moderate injury. NOTE messages provide additional user information.

Definitions 

 





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Items shown in Bold text are keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment. Items shown in Italicized text are software terms which identify menu items, buttons, or options in various windows. To perform an operation which appears with a plus (+)sign between the names of two keys, you press and hold the first key while pressing the second key once. This is called a keystroke combination. For example, “Press Ctrl+Esc” means to press and hold down the Ctrl key while pressing the Esc key. When instructions are given for typing a precise text string with one or more spaces, the point where the spacebar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the spacebar when required. Enter means to press the Enter or Return key on the keyboard. Do not type Enter.

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Introduction

Safety Information Responsibility of the Manufacturer GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if: 

 

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies. The electrical installation of the relevant room complies with the requirements of the appropriate regulations. The equipment is used in accordance with the instructions for use.

General This device is intended for use under the direct supervision of a licensed health care practitioner. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Contact GE Medical Systems Information Technologies for information before connecting any devices to this equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:  

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use of the accessory in the PATIENT VICINITY; and evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.

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Equipment Symbols The following symbols may appear on the equipment. Caution, consult accompanying documents.

Dangerous voltage.

Type B applied part complying with IEC 60601-1.

Alternating current (AC) Equipotential (This is the ground lug.)

Protective earth (ground)

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. Manufacturer’s identification

Date of manufacture. The number found under this symbol is the date of manufacture in the YYYY-MM format. YYYY-MM

SN

Serial number Catalogue number Authorized representative in the European community

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Introduction

Medical Equipment With Respect to Electric Shock, Fire, and Mechanical Hazard Only, In Accordance with UL 60601-1 and CAN/CSA C22.2 No.601.1 Input/Output

Input

Fuse

Serial Interface Emergency stop

General symbol for recovery/recyclable

T 0.5AL, 250V

Time Lag, 0.5 Amp, Low breaking capacity, 250Vac rated fuse

Warnings and Dangers WARNING CONNECTION TO MAINS - This is class 1, type B electrical safety equipment. The mains plug must be connected to an appropriate power supply.

WARNING DEFIBRILLATOR PRECAUTIONS - Do not come into contact with patients or unit during defibrillation. Otherwise, serious injury or death could result.

WARNING EMERGENCY STOP - The emergency stop switch is a safety device for use only in emergency situations to stop the treadmill. The walking belt will stop quickly. Once stopped and while the switch is depressed the treadmill walking belt will not lock to allow for removal of foreign objects.

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WARNING EQUIPMENT MALFUNCTION - Replace only with the same type and rating of fuse.

WARNING EXPLOSION HAZARD - Flammable anesthetic vapors or liquids can cause explosions. Do NOT use in the presence of flammable anesthetic vapors or liquids.

WARNING MOVING PARTS - To avoid injury, follow physicians’ or qualified health care providers’ instructions carefully during use of the equipment.

WARNING MOVING PARTS - To avoid injury, keep hands, hair, jewelry, loose clothing and patient cables away from moving parts.

WARNING MOVING PARTS - To avoid injury to patient, operate the treadmill with 6 feet of clearance at the rear (end opposite the motor).

WARNING MOVING PARTS - While the emergency stop switch is depressed or when power is not applied to the treadmill the walking belt is not locked. The walking belt in this condition is allowed to move which could cause a person to lose balance and fall if they are standing on the belt. Note, the risk of belt movement is increased with higher treadmill grades or inclines.

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Introduction

WARNING SHOCK HAZARD - Improper use of this device presents a shock hazard. Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the user, and bystanders. To reduce the risk of electric shock do NOT remove cover (or back). Refer servicing to qualified personnel. When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord. Devices may be connected to other devices or to parts of systems only after making certain that there is no danger to the patient, the operators, or the environment as a result. Standards IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.

WARNING SITE REQUIREMENTS - Do not route cables in a way that they may present a stumbling hazard. Do not route cables underneath the equipment. For safety reasons, all connectors for patient cables and leadwires are designed to prevent inadvertent disconnection, should someone pull on them. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient.

WARNING TREADMILL CHANGES - Rapid changes in treadmill speed and/or grade during a stress test may result in injury. DO NOT rapidly change treadmill speed and/or grade during a stress test.

WARNING TREADMILL CHANGES - DO NOT place feet under the treadmill during operation or while decreasing the treadmill grade to avoid injury.

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Cautions CAUTION INJURY - Do not use the treadmill without proper footwear as injury to feet may result. Always wear proper footwear when using the treadmill.

CAUTION POWER REQUIREMENTS - Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit's label. If this is not the case, do not connect the system to the power line until you adjust the unit to match the power source. This equipment is suitable for connection to public mains as defined in CISPR 11.

CAUTION RESTRICTED SALE - U.S. federal law restricts this device to sale by or on the order of a physician.

CAUTION SUPERVISED USE - This equipment is intended for use under the direct supervision of a licensed health care practitioner. Make sure all users are under the direct supervision of a licensed health care practitioner.

Service Information Service Requirements Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only. Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of their authorized agents. Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

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Introduction Regular maintenance, irrespective of usage, is essential to ensure that the T-2100 Treadmill will always be functional when required. Technical specifications describing the equipment can be found in the T2100 Treadmill Service Manual shipped with your system.

Equipment Identification The Equipment Identification tag contains the Serial Number, and is located on the back of the treadmill.

Serial Number Every GE Medical Systems Information Technologies device has a unique serial number for identification. An explanation of the Serial Number code is shown below.

A

B

C

D

E

F

001

A

Product Code

B

Year Manufactured (00-99) 00 = 2000 01 = 2001 02 = 2002 (and so on)

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C

Fiscal Week Manufactured

D

Production Sequence Number

E

Manufacturing Site

F

Miscellaneous Characteristic

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T-2100 Treadmill Overview

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T-2100 Treadmill Overview

Intended Use The T-2100 Treadmill is intended for use with any of the several GE Medical Systems Information Technologies exercise testing systems or the MTC-1 (manual treadmill controller), for administering a controlled exercise load during a diagnostic stress test. Standard features include the emergency stop switch, a full handrail set, and a long, 60-inch walking surface. The emergency stop switch is intended for emergency situations where immediately stopping the treadmill is required to deliver appropriate emergency care to the patient or health care provider, as implied by the American Heart Association “Guidelines for Clinical Exercise Testing Laboratories” (1995). It is not intended for routinely stopping the treadmill.

Preparation for Use Safe Handling Guidelines The T-2100 Treadmill ships preset with an approximate 2% grade. This slight elevation provides for free wheel movement and prevents the shroud from scraping the floor. Before moving the treadmill after it has been in operation, use the controlling equipment to set the grade to approximately 7%. Then remove power and disconnect all cables to the treadmill before moving the unit. Follow the steps below to move the treadmill. We recommend that two people work together since the treadmill may be too heavy for some individuals to lift and lower safely. NOTE We recommend the treadmill not be placed on carpet or carpet tile floors as a final location, as continual movement of the wheels may eventually damage the carpet and possibly the treadmill.

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WARNING INJURY OR DAMAGE - The treadmill is too heavy to lift, lower or move safely by one person. Serious bodily injury or damage to the treadmill may result. A minimum of two people are required when lifting, lowering or moving the treadmill. 1. Lift the end of the bed assembly to about knee height, keeping knees bent and backs straight as you lift. 2. Rotate the treadmill in the direction you want to go (the treadmill will pivot on its wheels) and push forward. 3. When you have maneuvered the treadmill into its new location, gently lower the end of the bed assembly to the floor.

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Operating Instructions Electrical Safety Tests The electrical safety of this installation is the responsibility of the customer, not GE Medical Systems Information Technologies. In hospitals, contact your in-house biomedical technician, electrician, or technically qualified personnel. Outside of hospitals, contact your hospital affiliation for these services. Otherwise, contact GE Medical Systems Information Technologies and open a customer-billable service call.

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T-2100 Treadmill Overview Before using the treadmill, have qualified personnel perform the tests listed below. AC line voltage test to verify the power outlet is properly wired.  Ground continuity test to verify all exposed metal is properly grounded.  Leakage tests to verify the equipment passes all applicable leakage tests. Your in-house biomedical technician, electrician, or technically qualified personnel can find instructions for performing these tests in the T-2100 Treadmill Service Manual shipped with your system. 

Calibrating Treadmill It is recommended that the treadmill be calibrated each time it is moved. Refer to the steps below to activate the T-2100 Treadmill self-calibration feature: 1. Connect the AC power cable on the treadmill to the wall outlet. WARNING POWER CABLES - Route the AC Power cable away from moving parts. An AC power cable caught in moving parts could cause injury to the user and equipment. 2. Turn the power switch on the treadmill to On. 3. Remove controlling device cable or turn off the controlling device. WARNING During calibration, the treadmill will move and reach maximum elevation. Injury may result. Make sure you monitor the site at all times. Make sure there are no customers or patients near the treadmill during calibration. 4. A push button is located at the rear panel. Hold down the push button and power cycle the unit. Hold the push button in for at least 4 seconds after power up for calibration to occur. The software calibrates the speed and grade from the minimum points to the maximum points.

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T-2100 Treadmill Overview

Operating Controls The treadmill has two operating controls, the power switch and the emergency stop switch. The power switch is located on the rear panel, and the emergency stop switch is on the front handrail.

Power Switch The power switch controls the AC power to the treadmill. The On position (I) applies power. The Off position (0) removes power.

Emergency Stop Switch The emergency stop switch is a safety device for use in emergency situations to stop the treadmill. Press the STOP push-button and the treadmill promptly stops. Please note the belt will not lock after the treadmill is stopped, allowing for removal of foreign objects. To release the emergency stop switch, turn the push-button 1/4-turn in either direction.

Emergency Stop Switch Check NOTE Verify proper operation of the stop switch assembly every month. 

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With the belt moving at a relatively high speed, press the emergency stop switch. The treadmill belt will stop promptly but the belt will not lock, allowing for removal of foreign objects. To release the switch, turn the button 1/4-inch turn in either direction. Use the controlling equipment to terminate the exercise session and turn off the treadmill.

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