Series 2000 Operators Manual Rev B

127(Due to continuing product innovation, specifications in this manual are subject to change without notice.

Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners. 900 SC, ACCUSKETCH, AccuVision, APEX, AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MANAGED USE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAC RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 12SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®-LAN, CENTRALSCOPE, Corolation, EDIC, EK-Pro, Event-Link Cirrus, Event-Link Cumulus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O2SENSOR, Octanet, OMRS, PHiRes, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Medical Systems Information Technologies. © GE Medical Systems Information Technologies, 1998, 2004. All rights reserved.

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Contents

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Introduction... 1-1 Manual Information... 1-3 Revision History... 1-3 Manual Purpose... 1-3 Conventions... 1-4 Safety Information... 1-5 Responsibility of the Manufacturer... 1-5 General... 1-5 Equipment Symbols... 1-6 Danger and Warnings... 1-7 Service Information... 1-8 Service Requirements... 1-8 Equipment Identification... 1-9

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

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Maintenance... 3-1 Introduction... 3-3 Recommended Maintenance... 3-3 Inspection and Cleaning... 3-4 Visual Inspection... 3-4 Exterior Cleaning... 3-4

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CE Marking Information

CE Marking Information Compliance The Series 2000 Treadmill bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN 55011. 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.

Exceptions The Series 2000 Treadmill EMC: Immunity Performance

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.

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CE Marking Information

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Introduction

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Introduction: Manual Information

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

7 July 1998

Initial release of manual.

B

6 January 2004

Updated to show the new serial number configuration and make editorial changes.

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:

n n n

an explanation of the function of controls and indicators,

n

instructions for operator cleaning, preventive inspection and maintenance.

the sequence of operation, connection and disconnection of detachable parts and accessories, and

Where necessary the manual identifies additional sources of relevant information and/or technical assistance.

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Introduction: Manual Information

Conventions These 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 n

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.

n

Items shown in Italicized text are software terms which identify menu items, buttons, or options in various windows.

n

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.

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n

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.

n

Enter means to press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

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Introduction: Safety Information

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

n

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies.

n

The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

n

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. If the installation of this equipment, in the USA, will use 240 V rather than 120 V, the source must be a center-tapped, 240 V, single-phase circuit. 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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Introduction: Safety Information

Equipment Symbols The following symbols appear on the equipment. This symbol means that you must pay attention to the documents delivered with this equipment. It calls attention to the things to which you must pay special attention during operation and when the equipment is operated in conjunction with other equipment. In Europe, this symbol means dangerous or high voltage. In the United States, this symbol represents the caution notice below:

&$87,21 To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel. Type B equipment. Type B equipment is suitable for intentional external and internal application to the patient, excluding direct conductive connection to the patient’s heart.

Alternating current (AC)

Equipotential (This is the ground lug.)

Protective earth (ground)

M13495, M13504, M13864, M13571, M13574, M13573

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Introduction: Safety Information

Danger and Warnings '$1*(5 Do NOT use in the presence of flammable anesthetics.

:$51,1*6 Replace only with the same type and rating of fuse. This is Class I equipment. The mains plug must be connected to an appropriate power supply. Do NOT contact unit or patient during defibrillation. Wait until treadmill belt is moving before placing feet on belt. Keep hands, hair, jewelry, and loose clothing away from moving parts. Do not place feet under treadmill during elevation changes. Otherwise, serious injury could result. Route the AC power cable away from moving parts. Verify proper operation of the stop switch assembly, pn 88380-006, every month. Operate the treadmill with 6 feet of clearance at the rear (end opposite the motor).

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Introduction: Service Information

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. Regular maintenance, irrespective of usage, is essential to ensure that the Series 2000 treadmill will always be functional when required Technical specifications describing the equipment can be found in the “Series 20000 treadmill field service manual,” PN 409110-004.

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Introduction: Service Information

Equipment Identification The Equipment Identification tag that contains the Serial Number is located where shown below.

Equipment Identification

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

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C

D

E

A

Product Code (ABM = Series 2000 Treadmill)

B

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

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Fiscal Week Manufactured

D

Production Sequence Number

E

Manufacturing Site

F

Miscellaneous Characteristic

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Equipment Overview

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Equipment Overview: Intended Use

Intended Use The Series 2000 Treadmill is intended for use with any one 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.

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Equipment Overview: Preparation for Use

Preparation for Use Safe Handling Guidelines The Series 2000 Treadmill ships preset with an approximate 2% grade. This slight elevation provides for free wheel movement and prevents the shroud from scraping the floor. 127(Assembly and Technical specifications describing the equipment can be found in the “Series 20000 treadmill field service manual,” PN 409110-004. If you are 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. 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.

MD1128-022B

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