X12+Ambulatory Transmitter User Manual Rev C1

Copyright © 2010 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. X12+ is a trademark of Mortara Instrument, Inc.

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 Representative Mortara Rangoni Europe, Srl (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 E-mail: [email protected] Mortara Instrument Germany Kaninenberghöhe 50 45136 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 Unit 11, 7 Inglewood Place Baulkham Hills NSW 2153 Australia Tel: +61 2 8824 5499 Fax: +61 2 8814 5399

24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

i

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 is used in accordance with the instructions for use.

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.

ii

WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s 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 Product/s caused by any or all of the following circumstances or conditions: a)

Freight damage;

b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara; c)

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

d) Accident; a disaster affecting the Product/s; e)

Alterations and/or modifications to the Product/s 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 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 therefrom 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. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE MEDIUMS. 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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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 device.

Note:

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

Warning(s) •

This manual gives important information about the use and safety of this device. Deviating from operating procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the device.

•

Device transmits data reflecting a patient’s physiological condition to a properly equipped receiving device that 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.

•

Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this device. Before attempting to use this device for clinical application, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the device. Contact Mortara service for additional training options.

•

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. Only use parts and accessories supplied with the device and available through Mortara Instrument, Inc.

•

Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.

•

Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive parts including earth ground.

•

ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.

•

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.

•

Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of this device may alter defibrillator protection.

•

This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions.

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USER SAFETY INFORMATION

•

To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.

•

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 device.

•

A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.

•

The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.

•

The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines.

•

There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the device; however, disturbance to the signal may occur.

•

Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.

•

The battery operated device transmits data reflecting a patient’s physiological condition to a receiving device. During operation failure, data transmission and LCD information will cease to occur. In mission critical conditions, it is advisable to have a backup device available.

•

There is a potential pinch hazard when applying the battery compartment cover to the device that could result in minor injury. Care should be taken to avoid entrapment of fingers when performing this operation.

•

The device is restricted to use on one patient at a time.

•

The performance of the device may be compromised by excessive motion.

•

Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.

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USER SAFETY INFORMATION

Caution(s) •

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 as this may damage equipment or reduce its usable life. Use of unspecified cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the device. Do not sterilize the device or patient cables with Ethylene Oxide (EtO) gas.

•

The device and patient cable should be cleaned between each use. Inspect cable and connections for damage or excessive wear prior to each use. Replace cable if damage or excessive wear is noted.

•

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 device will only work with receiving devices that are equipped with the appropriate option.

•

No user-serviceable parts are inside. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use.

•

This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.

•

The following equipment may cause interference with the RF channel: microwave ovens, diathermy units with LANs (spread spectrum), amateur radios, and government radar.

•

When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations.

•

Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant and then dry with a clean cloth.

•

AA batteries are known to leak their contents when stored in unused equipment. Remove battery from device when not used for an extended period of time.

•

•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: Relative Humidity Range: Atmosphere Pressure:

•

-20°C to 65°C (-4°F to 149°F) 5% to 95% (non-condensing) 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: Relative Humidity Range: Atmosphere Pressure:

0°C to 45°C (32°F to 113°F) 5% to 95% (non-condensing) 700 hPa to 1060 hPa

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USER SAFETY INFORMATION

FCC Compliance Statement In the United States use of this device is regulated by the Federal Communications Commission (FCC). The device with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure. 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 device. X12+ (600) X12+ (2500) X12+ (915)

FCC ID: HJR-X12-600-15 FCC ID: HJR-X12P-2500 FCC ID: HJR-X12P-915

These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions: 1. 2.

This device may not cause harmful interference, and 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 healthcare facilities (see Part 15, section 15.242a).

•

A healthcare 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 These devices comply with RSS-210 of the Industry Canada rules. Operation is subject to the following two conditions: 1. 2.

This device may not cause interference, and This device must accept any interference, including interference that may cause undesired operation of the device.

X12+ (915)

IC: 3758-X12P915

The term "IC:" before the certification/registration number only signifies that the Industry Canada technical specifications were met. X12+ (600)

Certification Number: 3758A - 104616

This telemetry device is only permitted for installation in hospitals and healthcare facilities. Devices shall not be operated in mobile vehicles (even ambulances and other vehicles associated with healthcare 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.

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USER SAFETY INFORMATION

Note(s) •

Proper patient preparation is important to proper application of ECG electrodes and operation of the device.

•

If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault for the lead(s) where the condition is present.

•

For additional instructions and warnings, refer to the user manual of the receiving monitoring device.

•

As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows: - Class I equipment or internally powered - Type CF defibrillation-proof applied parts - Ordinary equipment - Equipment not suitable for use in the presence of a flammable anesthetic mixture - Continuous operation

•

The device will automatically turn off (blank screen) if the batteries have been severely discharged.

•

The device is UL classified: 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.

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USER SAFETY INFORMATION

x

EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents

Defibrillator-proof, Type CF input

Battery

Indicates compliance to applicable EEC directives

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

xi

GENERAL CARE Precautions • • •

Turn off the device before inspecting or cleaning. Do not immerse the device in water. Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces.

Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. • Verify that all cables and connectors are securely seated. • Check the case for any visible damage. • Inspect cables and connectors for any visible damage. • Inspect buttons and controls for proper function and appearance.

Cleaning and Disinfection Refer to section 3 for proper cleaning and disinfection procedures.

Sterilization EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum temperature of 50°C/122°F. After EtO sterilization, follow the recommendations from the sterilizer manufacturer for required aeration.

Cautions Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device.

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ELECTROMAGNETIC COMPATIBILITY (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the device. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device 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 device should not be used adjacent to, or stacked on top of other equipment. If the device must be used adjacent to or stacked on top of other equipment, verify that the device 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 device. The use of accessories and cables other than those specified below, may result in increased emissions or decreased immunity of the device.

Part Number

Description

9293-017-50 9293-017-51 9293-025-50 9293-025-51 9293-026-50 9293-026-51

PAT CBL 10WIRE LEADFORM AHA SNAP PAT CBL 10WIRE IEC SNAP CINCH PAT CBL 5WIRE AHA BANANA DO PAT CBL 5WIRE IEC BANANA DO PAT CBL 10WIRE LEADFORM XL AHA SNAP PAT CBL 10WIRE LEADFORM XL IEC SNAP

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-1 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 2

The equipment 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 equipment 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

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

Not Applicable

Surge IEC 61000-4-5

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

Not Applicable

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 cycle 40% UT (60% dip in UT) for 5 cycles

Not Applicable

Power frequency (50/60 Hz) magnetic field

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.

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ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-3 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. Emissions 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 IEC 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

⎡ 3 .5 ⎤ d=⎢ ⎥ P ⎣ 3Vrms ⎦

⎡ 3. 5 ⎤ d=⎢ ⎥ P ⎣ 3V / m ⎦

80 MHz to 800 MHz

⎡ 7 ⎤ d=⎢ ⎥ P ⎣ 3V / m ⎦

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:

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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ELECTROMAGNETIC COMPATIBILITY (EMC)

Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table 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

d = 1 .2 P

d = 2 .3 P

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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TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ...1 Audience...1 Indications for Use ...1 System Description...1 X12+ with Patient Cable, Figure 1-1, Front View ...2 LeadForm Patient Cable, Figure 1-2 ...2 X12+ in Carrying Pouch, Figure 1-3...3 Part Numbers ...4 Specifications ...5

OPERATION SECTION 2 Read Instructions ...7 Battery Installation ...7 Turning the X12+ On ...8 Turning the X12+ Off...8 LCD Display Battery Voltage Indicator ...8 Attaching the Patient Cable ...9 Patient ECG Hookup ...9 Skin Preparation ...9 Positioning the Electrodes for 10-wire Hookup ...10 Using the Keypad ...11 Main Menu ...11 Top Level Menu Options...12 Lead Check...12 Checking Impedances ...13 Displaying ECG Leads...13 Configuring the X12+ ...13 Setting the Transmission Channel Number...14 Setting the Number of Patient Cable Lead Wires ...15 Setting Language...15 Viewing Software Version Number ...15 Viewing Battery Voltage...15 Starting a Patient Transmission Session ...16 Sending (Optional) Call Signals ...16 Ending a Transmission Session ...16

MAINTENANCE SECTION 3 Cleaning the X12+ and Patient Cable...17 Periodic Maintenance ...17 Disposal of Waste Materials...17

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TABLE OF CONTENTS

MESSAGES AND INFORMATION APPENDIX A Table of Messages ...19 System Information Log...20 Serial and Part Number Location ...20

CHANNEL ASSIGNMENTS APPENDIX B 600 MHz...21 2500 MHz...22 915 MHz...23

TRANSLATIONS APPENDIX C Table of Translations...25

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INTRODUCTION SECTION 1

Manual Purpose The X12+™ digital ambulatory transmitter user manual explains how to: • Acquire and transmit 12-lead ECG signals to a receiving device • Setup device configurations

Audience This manual is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Indications for Use •

The device is indicated for use in a clinical setting by a physician, or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

•

The device is indicated for use to acquire and output electrocardiographic data obtained during physiologic stress exercise testing.

•

Indicated for use as a radiofrequency physiological signal transmitter, receiving and delivering real-time acquisition and RF transmission of simultaneous 12-lead ECG data while allowing the patient to be ambulatory.

•

The device is indicated for use on adult populations, typically symptomatic.

•

The device is not intended to be used as a vital signs physiological monitor.

System Description The X12+ represents state-of-the-art wireless electrocardiographic technology. It provides a means to acquire and transmit 12-lead cardiac signals without direct connection to an electrocardiograph. Design innovations implemented in the X12+ achieve real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality to a Mortara receiver module while allowing the patient to be ambulatory. In addition, by using a very high monitoring frequency to transmit cardiac signals, the diagnostic bandwidth of the signals is maintained. The X12+ affords the patient complete freedom of movement. Unlimited range can also be obtained with the addition of Mortara’s antenna network box(s). The X12+ uses a single AA alkaline battery. The following equipment is necessary to use the X12+: • One AA battery, 1.5V • Mortara receiver module with antennas • Patient cable • Antenna network

1