TM55 and TM65 Stress Treadmills User Manual Rev D1 Nov 2015

Copyright © 2015 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara, Burdick, Quinton, Quest, and Q-Stress are registered trademarks of Mortara Instrument, Inc. HeartStride is a trademark of Mortara Instrument, Inc. 2015-11

TABLE OF CONTENTS 1. GENERAL STATEMENTS ... 1 TECHNICAL SUPPORT AND SERVICE ...1 2. NOTICES ... 2 MANUFACTURER’S RESPONSIBILITY ...2 RESPONSIBILITY OF THE CUSTOMER ...2 EQUIPMENT IDENTIFICATION ...2 COPYRIGHT AND TRADEMARK NOTICES ... 2 OTHER IMPORTANT INFORMATION...2 3. WARRANTY INFORMATION ... 3 YOUR MORTARA WARRANTY ...3 4. USER SAFETY INFORMATION ... 5 WARNING(S) ... 5 CAUTION(S)... 5 NOTE(S) ... 7 5. EQUIPMENT SYMBOLS AND MARKINGS ... 9 SYMBOL DELINEATION ... 9 6. GENERAL CARE ... 11 DISINFECTION ...11 DAILY ... 11 WEEKLY ... 11 PERIODIC ... 11 7. ELECTROMAGNETIC COMPATABILITY (EMC) ... 13 8. INTRODUCTION ... 17 OVERVIEW ... 17 TREADMILL CONFIGURATION ...17 TREADMILL CONTROLS ...18 Power ... 18 OPERATION ... 18 EMERGENCY STOP BUTTON ...19 INDICATORS ... 19 ACCESSORIES AND OPTIONS ...19 9. OPERATING THE TREADMILL ... 21 GUIDELINES FOR SAFE OPERATION ...21 INSTRUCTING THE PATIENT ...21 STARTING THE EXERCISE ...22 EMERGENCY STOP BUTTON (OPTION) ... 22 ENDING THE EXERCISE ...22 10. MAINTENANCE/TROUBLESHOOTING ... 23 DAILY VISUAL INSPECTION ...23 CLEANING ... 23 Exterior ... 23

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TABLE OF CONTENTS

Interior ... 23 DISINFECTION ...24 ADJUSTMENTS ...24 Belt Tension ...24 Belt Tracking ...25 REAR ROLLERS GUARDS ...26 ELECTRICAL TESTING ...26 MOVING THE TREADMILL ...27 STORING THE TREADMILL ...27 TROUBLESHOOTING...27 TROUBLESHOOTING GUIDE ...29 11. SPECIFICATIONS ... 31 CARDIAC STRESS TREADMILLS ...31 POWER REQUIREMENTS ...31 SPEED VS WEIGHT RANGE ...32 % GRADE VS ANGLE RELATIONSHIP ...33 12. RECEIVING AND INSTALLATION ... 35 RECEIVING... 35 INSTALLATION NOTICE ...35 SITE REQUIREMENTS ...35 INSTALLATION ...36 Tools... 36 Procedure ...36 CONNECTING TO THE MONITORING SYSTEM ... 38 TESTING THE TREADMILL ...39

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TABLE OF FIGURES Figure 1 Example of a Treadmill ... 17 Figure 2 Example of Hood Configuration Plate for Treadmill ... 18 Figure 3 Example of Emergency Stop Button ... 22 Figure 4 Adjustment bolts ... 24 Figure 5 Roller Guard ... 26 Figure 6 Speed vs. Weight graph ... 32 Figure 7 %Grade vs. Angle Graph... 33 Figure 8 Example of Treadmill front ... 36 Figure 9 Example of Monitoring System Connections... 38

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1. GENERAL STATEMENTS Technical Support and Service Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

European Union Mortara Instrument Europe s.r.l. (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 Hospital Customers: Physician Practice: U.S. Distribution:

[email protected] [email protected] [email protected]

Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Instrument UK Ltd Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel: +44.1786.444980 Fax: +44.1786.446630

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2. NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: •

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by Mortara Instrument, Inc.

•

The device is used in accordance with the instructions for use.

•

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

Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards.

Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.

Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Mortara Instrument, Inc.

Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

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3. WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of thirteen (13) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Supplies, accessories and internal parts NOT approved by Mortara; c)

Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;

d) Accident; e) A disaster affecting the Product/s; f)

Alterations and/or modifications to the Product/s not authorized by Mortara;

g) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

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WARRANTY INFORMATION

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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4. USER SAFETY INFORMATION 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.

Note:

Provides information to further assist in the use of the device.

NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording.

Warning(s) 

This user guide contains the user and patient safety requirements, operating instructions and maintenance requirements for the Cardiac Stress treadmills, models TM55, 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.



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.



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(s) 

Use only approved equipment. Accessory equipment connected to analog, digital, or power interfaces must be either equipment offered for sale by Mortara Instrument 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.



Read this manual in full before operating the treadmill.



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. 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.



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USER SAFETY INFORMATION



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.



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.



Do not operate this equipment in the presence of flammable anesthetic mixtures.



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



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



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.



When connecting auxiliary equipment approved for use with the monitoring system, be certain the summation leakage current does not exceed local or provincial standards.



Failure to follow these guidelines can produce a serious or possibly fatal electrical shock hazard. Consult a qualified electrician as required.



Patients and clinicians should secure long hair and loose clothing before using and/or operating the treadmill.



Do not start the treadmill when someone is standing on the belt.



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



Never place chairs or other objects on treadmills.



Be aware of a moving treadmill belt.



Allow sufficient room for patients to maneuver around the system and to safely mount and dismount the treadmill.



Patients should wear shoes when using the treadmill.



This treadmill may be equipped with the rapid deceleration profile (optional); if so, 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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USER SAFETY INFORMATION

Note(s) 

This equipment is classified Class I, Type B, ordinary equipment, not protected against fluid ingress. It is rated for continuous operation.



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.



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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USER SAFETY INFORMATION

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5. EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Your treadmill may display one or more of the following symbols and warning labels for your protection. No single product displays all.

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

Mains power

Equipotentiality

Down

Up

Faster

Slower

Warning

T

Timed fuse (slo-blo)

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EQUIPMENT SYMBOLS AND MARKINGS

USB Connector

Hz

Hertz

V

Volts

A

Amperes

VA

Volt Amperes

Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements

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Fragile: Do not lift in this location

6. GENERAL CARE 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. Period internal cleaning by an authorized technician is recommended (see Service Manual).

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

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GENERAL CARE

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7. ELECTROMAGNETIC COMPATABILITY (EMC) 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. Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

Group 1

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.

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Class A

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.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Complies

NOTE: Tests verified with shielded input/output cables only.

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ELECTROMAGNETIC COMPATABILITY (EMC)

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Electromagnetic Environment: Guidance

Immunity Test

IEC 60601 Test Level

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

+/- 2 kV for power supply lines +/- 1 kV for input/output lines

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

Surge IEC 61000-4-5

+/- 1 kV differential mode +/- 2 kV common mode

+/- 1 kV differential mode +/- 2 kV common mode

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

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

<5% UT (>95% dip in UT) for 0.5 cycles <40% UT (>60% dip in UT) for 5 cycles <70% UT (>30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0.5 cycles <40% UT (>60% dip in UT) for 5 cycles <70% UT (>30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

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

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

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

NOTE: UT is the AC Mains voltage prior to application of the test level. NOTE: Tests verified with shielded input/output cables only.

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ELECTROMAGNETIC COMPATABILITY (EMC)

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF EN 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

d = 1.2

150 kHz to 80 MHz

d = 1.2

80 MHz to 800 MHz

d = 2.3

800 MHz to 2.5 GHz

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). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. 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 radios, 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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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