X12+ User Manual Rev A1

Copyright © 2005 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 is a registered trademark of Mortara Instrument, Inc. Ambulatory X12+ is a trademark of Mortara Instrument, Inc.

TECHNICAL SUPPORT AND SERVICE

Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com Europe Economic Community Representative Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour 7 40016 S. Giorgio di Piano, BO Tel: +39.051.6654311 Fax: +39.051.6651012 Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 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 Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument GmbH (Germany) Kaninenberghöhe 50 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313 Mortara Instrument B.V. (The Netherlands) H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel: +31.30.2205050 Fax: +31.30.2201531

24 Hour Technical Support Same Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

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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 only by persons authorized by Mortara Instrument, Inc. • The device (Ambulatory X12+) is used in accordance with the instructions for use. Responsibility of the Customer The user of this product 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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WARRANTY INFORMATION

Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c) Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides; d) Accident, a disaster affecting the Products; e) Alterations or modifications to the Products not authorized by Mortara; f) 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 PRODUCTS 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 Products (i) of all carrier charges with respect to any Products 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, 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 therefrom relating to the Products. 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 when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS.

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Warranty Information (Continued)

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 PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS 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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USER SAFETY INFORMATION

Warning

Means there is the possibility of personal injury to you or others.

Caution

Means there is the possibility of damage to the equipment.

Note

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

Federal law restricts this device for sale to or on the order of a physician.

Warning • Device (Ambulatory X12+) transmits data reflecting a patient’s physiological condition to a properly equipped electrocardiograph and when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis. • To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 60601-1, IEC 60601-1 and IEC 60601-2-25. • FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. • To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc. • To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient. • A possible explosion hazard exists; do not use the device in the presence of flammable mixtures with air, oxygen or nitrous oxide. • Defibrillation protection is guaranteed only if the original patient cable is used. • Simultaneous connection to other equipment may increase leakage current. • Some stimulators may cause interference with the signal. • ECG electrodes could cause skin irritation and should be examined daily. Reposition and change electrodes every 24 hours, though it may be necessary to do so sooner if signs of irritation or inflammation occur. • Before attempting to use the device for clinical applications the operator must read and understand the contents of the manual and any documents accompanying the device.

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User Safety Information (Continued)

Caution • To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use fingertips. • Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning. • Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant, and then dry with a clean cloth. • Conductive parts of the patient cable, electrodes and associated Type CF connections, including the neutral conductor of the patient cable and electrode, should not come into contact with other conductive parts, including earth ground. • The Ambulatory X12+ and Patient Cable should be cleaned between each use. • Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop. • The Ambulatory X12+ will only work with electrocardiographs that are equipped with the appropriate option. • No user serviceable parts are inside. Any modification of this device may alter defibrillator protection. Any modification to any part of this device is to be performed by qualified service personnel only. • The following equipment may cause interference with the RF channel: microwave ovens, diathermy units with LANs (spread spectrum), amateur radios and government radar. • To prevent possible damage to the device during transport and storage (while in original packaging) the following environmental conditions must be adhered to: Ambient Temperature Range: -20°C to 65°C (-4°F to 149°F) Relative Humidity Range: 5% to 95% (non-condensing) Atmosphere Pressure: 700 hPa to 1060 hPa • Allow the device to stabilize within its intended operating environment for a minimum of two hours prior to use. The allowable operating environment is as follows: Ambient Temperature Range: 0°C to 45°C (32°F to 113°F) Relative Humidity Range: 5% to 95% (non-condensing) Atmosphere Pressure: 700 hPa to 1060 hPa

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User Safety Information (Continued)

FCC Compliance Statement In the United States, use of the X12+ transmitters is regulated by Federal Communications Commission (FCC). FCC ID: HJR-X12-600-15 FCC ID: HJR-X12P-2500 These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. • The X12+ (600) must be used solely on the premises of health care facilities (see Part 15, section 15.242a). • A health care facility operating the X12+ (600) must coordinate with the directors of existing nearby TV stations and Radio Astronomy Observatories to ensure compatible use. Minimum separation distances from such facilities may apply. It may be necessary to obtain written authorization from such facilities prior to installation and use of the X12+ (Part 15, section 15.242d,e).

Industry Canada Compliance Statement This device complies with RSS-210 of the Industry Canada rules. Certification Number: 3758A-104616 This telemetry device is only permitted for installation in hospitals and health care facilities. Devices shall not be operated in mobile vehicles (even ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Penticton radio astronomy station (British Columbia latitude: 49° 19' 12" N, longitude: 118° 59' 56" W). For medical telemetry systems not meeting this 80 km separation (e.g. the Okinagan valley, British Columbia) the installer/ user must coordinate with and obtain the written concurrence of the Director of the Penticton radio astronomy station before the equipment can be installed or operated. The Penticton contact is Tel: 250-493-2277/ Fax: 250-493-7767. Note • Proper patient preparation is important to proper application of ECG electrodes and operation of the device. • Patient cables should be checked for cracks or breakage in their exterior properties prior to use.

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User Safety Information (Continued)

• As defined by IEC 601-1 and IEC 601-2-25, the device is classified as follows: - Internally powered - Not suitable for use in the - Type CF applied parts presence of flammable mixtures - Ordinary equipment with air,oxygen or nitrous oxide - Continuous operation • The X12+ is a UL classified device: Medical Equipment WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY, IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC60601-1 AND IEC60601-2-25. 5P35

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EQUIPMENT SYMBOLS Symbol Delineation

Attention, consult accompanying documents

Defibrillator-proof type CF input

Battery

Indicates compliance to applicable EEC directives

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Equipment Symbols (Continued)

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Electromagnetic compatibility with surrounding devices should be assessed when using the X12+ Transmitter. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the X12+ Transmitter according to the international standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2). The X12+ Transmitter should not be used adjacent to, or stacked on top of other equipment. If the X12+ Transmitter must be used adjacent to or stacked on top of other equipment, verify that the X12+ Transmitter operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the X12+ Transmitter.

Accessories and Cables Warning The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the X12+ Transmitter. Description

Reference Number

10-wire LeadForm Patient Cable/Domestic • Standard • Large

9293-017-50 9293-026-50

10-wire LeadForm Patient Cable/International • Standard • Large

9293-017-51 9293-026-51

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Electromagnetic Compatibility (EMC) (Continued)

Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The X12+ Transmitter is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment: Guidance

RF Emissions CISPR 11

Group 2

The X12+ Transmitter must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF Emissions CISPR 11

Class B

Harmonic Emissions IEC 61000-3-2

Not Applicable

The X12+ Transmitter is suitable for use in all establishments, including domestic establishments 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

Not Applicable

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Electromagnetic Compatibility (EMC) (Continued)

Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The X12+ Transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test

Compliance

Compliance Level

Electromagnetic Environment: Guidance

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 Not Applicable power supply line +/- 1 kV for input/output lines

Surge IEC 61000-4-5

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

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

<5% UT Not Applicable (>95% dip in UT) for 5 cycles 40% UT (60% dip in UT) for 0.5 cycle

Power frequency (50./60 Hz) magnetic field

3 A/m

Not Applicable

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 a.c. mains voltage prior to application of the test level.

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Electromagnetic Compatibility (EMC) (Continued)

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The X12+ Transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the X12+ Transmitter should assure that it is used in such an environment. Emissions Test

IEC 60601 Text Level

Compliance Level

Electromagnetic Environment: Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the X12+ Transmitter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Radiated RF IEC 61000-4-3

3 Vrms 80 MHz to 2.5 GHz

3 Vrms 80 MHz to 2.5 GHz

80 MHz to 800 MHz 80 MHz to 2.5 MHz 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:

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 X12+ Transmitter is used exceeds the applicable RF compliance level above, the X12+ Transmitter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the X12+ Transmitter. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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Electromagnetic Compatibility (EMC) (Continued)

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the X12+ Transmitter. The X12+ Transmitter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the X12+ Transmitter can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the X12+ Transmitter as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter W

Separation Distance According to Frequency of Transmitter (m) 150 KHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.1 m

0.2 m

0.1

0.4 m

0.7 m

1

1.2 m

2.3 m

10

4.0 m

7.0 m

100

12.0 m

23.0 m

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 1: At 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people.

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Electromagnetic Compatibility (EMC) (Continued)

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TABLE OF CONTENTS

INTRODUCTION SECTION 1 X12+ Overview... 1-1 Manual Purpose... 1-1 Audience... 1-1 Indications for Use... 1-1 System Description... 1-2 Equipment Included... 1-2 X12+ Transmitter with Patient Cable, Front View, Figure 1-1... 1-3 LeadForm Patient Cable, Figure 1-2... 1-3 X12+ Transmitter in Carrying Pouch, Figure 1-3... 1-4 Mortara Part Numbers/ X12+ Ambulatory Transmitter... 1-5 Mortara Specifications / X12+ Ambulatory Transmitter... 1-6

OPERATION SECTION 2 Read Instructions... 2-1 Battery Installation/Removal and Opening/Closing the Battery Door... 2-1 Turning the Ambulatory X12+ ON... 2-2 Turning the Ambulatory X12+ OFF... 2-2 LCD Display Battery Voltage Indicator... 2-2 Attaching the Patient Cable... 2-3 Patient Hook-Up... 2-3 Skin Preparation... 2-3 Positioning the Electrodes... 2-4 Using the Keypad... 2-5 Main Menu... 2-5 Top Level Menu Options... 2-6 Lead Check... 2-7 Checking Impedances... 2-7 Displaying ECG Leads... 2-8 Configuring the Ambulatory X12+ Transmitter... 2-8 Setting the Transmission Channel Number... 2-9 Setting the Number of Patient Cable Leadwires... 2-10 Setting Language... 2-10 Viewing Software Version Number... 2-10 Viewing Battery Voltage... 2-10 Starting a Patient Transmission Session... 2-11 Sending (Optional) Call Signals... 2-12 Ending a Transmission Session... 2-12

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Table of Contents (Continued)

MAINTENANCE SECTION 3 Cleaning the Ambulatory X12+ Transmitter and Patient Cable... 3-1 Periodic Maintenance... 3-1 Disposal of Waste Material... 3-1

MESSAGES AND INFORMATION APPENDIX A Table of Messages... A-1 System Information Log... A-2 Serial Number and Part Number Location... A-2

CHANNEL ASSIGNMENTS APPENDIX B 600MHz... B-1 2500MHz... B-2

TRANSLATIONS APPENDIX C Table of Translations... C-1

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