Cardiac Stress Treadmills Models ST55, TM55, ST65, and TM65 Users Guide Rev A

Copyright © 2008 Cardiac Science Corporation. All rights reserved. Notice: Due to rapid changes in computer technology, the specifications provided in this manual are subject to change without notice. Federal law restricts this device to sale by or on the order of a physician. Trademarks Quinton, Burdick, Q-Stress, and Quest are trademarks or registered trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. For sales and technical support outside the USA, contact your local sales and technical support representative. Liability Notice Failure to follow the conditions set forth below shall limit, to the extent allowed by law, Cardiac Science Corporation responsibility for the safety, reliability, and performance of this equipment: The operator manual must be read in full by each operator before the product is first used. Assembly operations, extensions, readjustments, modifications, or repairs must be carried out only by personnel trained or authorized by Cardiac Science Corporation. The electrical wiring within the treadmill’s setting and the electrical installation of the treadmill must comply with the applicable local or provincial requirements. The equipment must be used in accordance with the instructions for use.

Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, WA 98021, USA (800) 426 0337 (USA and Canada) (425) 402 2000 [email protected] www.cardiacscience.com ii

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MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany TM 55/65 Treadmill 4.0

Contents

Contents Chapter 1: Safety Requirements Safety Terms and Definitions... 1-2 Warnings and Cautions ... 1-3 Safety Notes... 1-6 Symbol Definitions... 1-7 Cleaning ... 1-9 Disinfection... 1-9 Daily ... 1-9 Weekly ... 1-9 Periodic ... 1-9 EMC Declaration Tables ... 1-10 Electromagnetic Emissions ... 1-10 Electronic Immunity ... 1-11 Recommended Separation Distances ... 1-13

Chapter 2: Introduction Overview ... 2-2 Treadmill Configuration... 2-3 Treadmill Controls ... 2-4 Power ... 2-4 Operation ... 2-5 Emergency Stop Button ... 2-5 Indicators... 2-5 Accessories and Options... 2-5

Chapter 3: Operating the Treadmill Guidelines for Safe Operation... 3-2 Instructing the Patient ... 3-3 Starting the Exercise... 3-4 Emergency Stop Button (option)... 3-4 Ending the Exercise... 3-5

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Contents

Chapter 4: Maintenance/Troubleshooting Daily Visual Inspection ... 4-2 Cleaning ... 4-3 Exterior ... 4-3 Interior ... 4-3 Disinfection... 4-3 Adjustments ... 4-4 Belt Tension ... 4-4 Belt Tracking... 4-6 Rear Roller Guards ... 4-7 Electrical Testing ... 4-8 Moving the treadmill ... 4-9 Storing the Treadmill... 4-10 Troubleshooting ... 4-11

Appendix A: Specifications Cardiac Stress Treadmills ...A-2 Power Requirements ...A-3 Speed Vs. Weight Range ...A-4 % Grade vs. Angle Relationship ...A-5

Appendix B: Receiving and Installation Receiving ...B-2 Installation Notice ...B-2 Site Requirements ...B-3 Installation...B-4 Tools ...B-4 Procedure ...B-4 Connecting to the Monitoring System ...B-6 Testing the Treadmill ...B-8

Glossary

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Safety Requirements Contents ◆

Safety Terms and Definitions

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◆

Warnings and Cautions

1-3

◆

Safety Notes

1-6

◆

Symbol Definitions

1-7

◆

Cleaning

1-9

◆

EMC Declaration Tables

1-10

This user guide contains the user and patient safety requirements, operating instructions and maintenance requirements for the Cardiac Stress treadmills, models ST55, TM55, ST65, and TM65. The user guide is intended for use by trained clinicians working in a clinical setting. It is expected that the clinician will instruct the patient in the proper use of the treadmill and its accessories. Before using the treadmill, read the user guide carefully, noting the safety requirements in this chapter. There are no user-serviceable parts in the treadmill. Any attempt by non-authorized personnel to service the equipment may void the warranty. Upon request, we will provide a technical document containing block-level theory of operation, troubleshooting, removal and replacement instructions (by module), maintenance, and other information that will assist appropriately-trained personnel to repair those parts of the equipment designated as repairable.

!

Caution. Use only approved equipment. Accessory equipment connected to analog, digital, or power interfaces must be either equipment offered for sale by Cardiac Science Corporation or equipment that, when connected to such interfaces, maintains the safety and specified performance of the overall system and the individual devices. For example, such safety is maintained if the individual equipment and overall system complies with relevant safety requirements found in International Electrotechnical Commission (IEC) standards.

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Safety Requirements

Safety Terms and Definitions The symbols shown below identify potential hazard categories. The definition of each category is as follows:

! !

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WARNING! This alert identifies hazards that may cause serious personal injury or death.

Caution This alert identifies hazards that may cause minor personal injury, product damage, or property damage.

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Warnings and Cautions

Warnings and Cautions Before operating any treadmill, ensure the following warnings and cautions are understood and followed.

! ! ! ! ! ! ! ! !

WARNING! The treadmill must be on an appropriate, dedicated electrical circuit with a power rating that meets the electrical specification on the treadmill serial number label. Nothing else should be connected to the circuit. WARNING! As long as the treadmill is plugged into a powered outlet and the treadmill circuit breaker is set to ON, the treadmill is receiving power, even when the monitoring system is turned off. Do not place hands beneath the treadmill while it is plugged in. Caution Read this manual in full before operating the treadmill.

Caution Before each use of this equipment, check the power receptacle for signs of damage. Do not operate the equipment if the integrity of these items is in question. Caution Be sure the connection for the optional Emergency Off switch is secure. Test the switch to verify proper operation. Do not operate the equipment if the integrity of these items is in question. Caution Keep the treadmill area clear. Maintain a minimum open space of 1.5 feet (0.5 meter) on each side and 6 feet (2 meters) at the rear. Caution The Cardiac Stress Treadmill should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Cardiac Stress Treadmill should be observed to verify normal operation in the configuration in which it will be used. Caution Do not operate this equipment in the presence of flammable anesthetic mixtures.

Caution Regularly inspect cables and treadmill belts for wear or damage. Do not operate the equipment if the integrity of these items is in question.

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Safety Requirements

! ! ! ! ! ! ! ! ! ! !

Caution Increased risk due to leakage current can result if this equipment is not grounded properly.

Caution To avoid potential safety and electrical problems, use parts and accessories that meet specifications as noted in this user guide and the user guide for your stress monitor. Caution When connecting auxiliary equipment approved for use with the monitoring system, be certain the summation leakage current does not exceed local or provincial standards. Caution Failure to follow these guidelines can produce a serious or possibly fatal electrical shock hazard. Consult a qualified electrician as required. Caution Patients and clinicians should secure long hair and loose clothing before using and/or operating the treadmill. Caution Do not start the treadmill when someone is standing on the belt.

Caution Keep speed and grade at the lowest settings when getting on and off the treadmill belt.

Caution Never place chairs or other objects on treadmills.

Caution Be aware of a moving treadmill belt.

Caution Allow sufficient room for patients to maneuver around the system and to safely mount and dismount the treadmill. Caution Patients should wear shoes when using the treadmill.

Rapid Deceleration If you have purchased the Rapid Deceleration option:

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Warnings and Cautions

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Caution This treadmill is equipped with the rapid deceleration profile, it is specifically designed to come to a rapid stop. This feature requires that attendant(s) are available to support and assist the patient user. Attendants MUST be in a position to support and assist the patient when the belt stops.

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Safety Requirements

Safety Notes This equipment is classified Class I, Type B, ordinary equipment, not protected against fluid ingress. It is rated for continuous operation. Note: Use of accessories or cables other than those specified, with the exception of accessories or cables sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the treadmill. Note: Keep the area underneath and around the treadmill clear. Make sure cables are clear of the treadmill.

The following are safety guidelines for operating the treadmill. Ensure the patient understands the proper treadmill mount and dismount procedure. Properly train new staff.

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Symbol Definitions

Symbol Definitions Your treadmill may display one or more of the following symbols and warning labels for your protection. No single product displays all.

TM 55/65 Treadmill 4.0

Attention: Consult accompanying documents

Earth ground (protective)

Off (power disconnected from mains)

Type B equipment- provides adequate protection against electric shock, particularly regarding allowable leakage current; reliability of the protective earth connection (when present)

On (power connected to mains)

Type BF equipment- contains an F-type isolated patient applied part providing a high degree of protection against electric shock

Alternating current

Type BF equipment with defibrillation protection

High voltage

Type CF equipment- contains an F-type isolated patient applied part and provides a degree of protection against electric shock higher than that for type BF equipment regarding allowable leakage currents

Earth ground (functional)

Type CF equipment with defibrillation protection

Replace fuse only as marked

Fuse

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Safety Requirements

Mains power

Equipotentiality

Down

Up

Faster

Slower

Warning

T

Timed fuse (slo-blo)

Fragile: Do not lift in this location

USB Connector 160-0169-001 Rev A

Hz

Hertz

V

Volts

A

Amperes

VA

Volt Amperes

This is the CE marking of conformity indicating that the device having this symbol on its immediate label meets the applicable requirements of the European Medical Device Directive.

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Cleaning

Cleaning

! !

Caution Turn off the treadmill and unplug the power cord from the wall outlet before cleaning.

Caution Do not let liquid enter the interior of the treadmill. If it does, the equipment must be inspected and tested for safety by an approved technician before it can be used again.

Never wipe the deck beneath the belt, even when changing the belt. Wiping can damage the wax finish. Do not use detergents or cleaning agents on any part of the deck.

Disinfection If it is necessary to disinfect the treadmill, follow the procedures established by your institution. Do not use liquids on the deck surface.

Daily Keep the treadmill free of dust and debris. Clean the exterior and walking belt with a damp sponge; do not soak surfaces. Dry all surfaces thoroughly.

Weekly Elevate the treadmill to maximum grade and vacuum the floor under it to prevent excess dust and dirt from interfering with operation.

Periodic Depending upon the treadmill environment, dust and or lint can accumulate under the hood. Periodic internal cleaning by an authorized technician is recommended (see Service Manual).

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Safety Requirements

EMC Declaration Tables This section lists EMC Declaration Tables. The Cardiac Stress Treadmill requires special precautions regarding EMC and must be installed and put into service according to the guidelines of the EMC declaration tables. Portable and mobile RF communications equipment may affect the Cardiac Stress Treadmill and the recommended separation distances in the EMC declaration tables should be observed.

Electromagnetic Emissions Cardiac Stress Treadmills are intended for use in the electromagnetic environment specified below. The customer or user of this equipment must ensure it is used in such an environment. Table 1-1: Guidance and Manufacturer's Declaration - Electromagnetic Emissions

Emissions Test

RF emissions CISPR 11

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Compliance

Group 1

Electromagnetic Environment Guidance The Cardiac Stress Treadmills use 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.

Class A

Class A

Complies

The Cardiac Stress Treadmills are suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

IEC 61000-3-3 Note: Tests verified with shielded input/output cables only.

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EMC Declaration Tables

Electronic Immunity Cardiac Stress Treadmills are intended for use in the electromagnetic environment specified below. The customer or user of this equipment must ensure it is used in such an environment. Table 1-2: Guidance and Manufacturer's Declaration - Electromagnetic Immunity

IEC 60601 Immunity Test test level Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

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Compliance Level

Electromagnetic Environment - Guidance

Floors should be wood, concrete or ceramic tile. If + 6kV contact + 6kV contact floors are covered with synthetic material, the relative + 8 kV air + 8 kV air humidity should be at least 30%. +2 kV for +2 kV for power supply power supply Mains power quality should lines lines be that of a typical commercial or hospital +1 kV for +1 kV for environment input/output input/output lines lines + 1 kV differential mode

+ 1 kV differential mode

+2 kV common mode

+2 kV common mode

<5% UT

<5% UT

(>95% dip in UT for 0.5 cycle

(>95% dip in UT for 0.5 cycle

(>95% dip in UT for 5 sec

(>95% dip in UT for 5 sec

Mains power quality should be that of a typical commercial or hospital environment

Mains power quality should be that of a typical commercial or hospital <40% UT <40% UT (>60% dip in (>60% dip in environment. If the user of the UT for 5 cycle UT for 5 cycle ST/TM55 or ST/TM65 requires continued operation during power mains interruptions, it <70% UT <70% UT is recommended that the ST/ (>30% dip in (>30% dip in TM55 or ST/TM65 be powered UT for 25 cycle UT for 25 cycle from an uninterruptible power supply or a battery. <5% UT <5% UT

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Safety Requirements

Table 1-2: Guidance and Manufacturer's Declaration - Electromagnetic Immunity

IEC 60601 Immunity Test test level Power frequency (50/ 60 Hz)

3 A/m

Compliance Level

Electromagnetic Environment - Guidance

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

Magnetic field IEC 61000-4-8

Note: UT is the A.C. mains voltage prior to application of the test level. Note: Tests verified with shielded input/output cables only.

Table 1-3: Guidance and Manufacturer's Declaration - Electromagnetic Immunity

IEC 60601 Immunity Test test level

Conducted RF IEC 61000-4-6

Compliance Level

3 Vrms 150 kHz to 80 MHz

3V

Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the ST/TM55 or ST/TM65, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 150 kHz to 80 MHz: d = 1.2 P

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EMC Declaration Tables

Table 1-3: Guidance and Manufacturer's Declaration - Electromagnetic Immunity

IEC 60601 Immunity Test test level

Compliance Level

Electromagnetic Environment Guidance 80 MHz to 800 MHz: d = 1.2 P

800 MHz to 2.5 GHz: d = 2.3 P

Radiated RF IEC 61000-4-3

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

3 V/m 80 MHz to 2.5 GHz

3 V/m Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note: Tests were verified with shielded input/output cables only. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ST/TM55 or ST/TM65 is used exceeds the applicable RF compliance level above, then the ST/TM55 or ST/TM65 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ST/TM55 or ST/TM65. b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distances This section describes recommended separation distances between portable and mobile RF communications equipment and the Cardiac Stress Treadmill. TM 55/65 Treadmill 4.0

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Safety Requirements

The Cardiac Stress Treadmills are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cardiac Stress Treadmills can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cardiac Stress Treadmills as recommended below, according to the maximum output power of the communications equipment. Table 1-4: Recommended Separation Distances

Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

Note: For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note: Tests were verified with shielded input/output cables only.

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Introduction Contents Overview

2-2

Treadmill Configuration

2-3

Treadmill Controls

2-4

Operation

2-5

Emergency Stop Button

2-5

Indicators

2-5

Accessories and Options

2-5

This chapter describes the Cardiac Science stress treadmills.

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Introduction

Overview The Cardiac Stress Treadmills are heavy-duty medical treadmills designed specifically for stress test applications. Four models are available and can be used with the following cardiac stress testing systems: Treadmill Model

Where Used

TM55

Quinton Q-Stress Cardiac Stress System Burdick Quest Exercise Stress System

TM65

Burdick HeartStride Cardiac Stress System

ST55

Quinton Q-4500 Stress Test Monitor System

ST65

Quinton Q710 Stress Monitor & Resting ECG System

All models feature variable speed and grade and a 20-inch-wide walking surface.

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