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P/N 9515-164-50-ENG
X12+
User
Manual
__________________________________________________________________________________________
CAUTION: Federal law restricts this device for sale to and use by or on the order of a physician.

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Summary of Contents for Mortara Instrument X12+

  • Page 1 P/N 9515-164-50-ENG X12+ User Manual __________________________________________________________________________________________ CAUTION: Federal law restricts this device for sale to and use by or on the order of a physician.
  • Page 2 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.
  • Page 3 Technical Support and Service Headquarters Sales Support/ Mortara Instrument, Inc. Supplies & Accessories 7865 North 86th Street Mortara Instrument, Inc. Milwaukee, WI 53224 7865 North 86th Street Tel: 414.354.1600 Milwaukee, WI 53224 Tel: 800.231.7437 Tel: 414.354.1600 Fax: 414.354.4760 Fax: 414.354.4760 Internet: http://www.mortara.com...
  • Page 4 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.
  • Page 5 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.
  • Page 6 • 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.
  • Page 7 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.
  • Page 8 Warning(s) In some countries the use of the X12+ transmitter (2400 MHz version) has been limited as follows: Spain: use is limited to channels in the range 8B to E6 (inclusive). France: use is limited to channels in the range 8E to A5 (inclusive). The channel setting of the X12+, when used in the above listed countries, must be set accordingly, as explained in this manual at section 2.
  • Page 9 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. • As defined by IEC 601-1 and IEC 601-2-25, the device is classified as follows: - Internally powered - Type CF applied parts - Ordinary equipment...
  • Page 10 Indicates compliance to applicable EEC Directives 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).
  • Page 11 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...
  • Page 12 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...
  • Page 13 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 Compliance...
  • Page 14 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.
  • Page 15: Table Of Contents

    Table of Contents 1 Introduction Manual Purpose ..............................1-1 Audience................................1-1 System Description............................1-1 Equipment Included............................1-1 X12+ Front View ..............................1-2 LeadForm Patient Cable..........................1-2 X12+ Transmitter in Carrying Pouch .......................1-3 X12+ Ambulatory Transmitter Part Numbers ....................1-4 Supplies Contact .............................1-4 Ambulatory X12+ Specifications........................1-5 Operation Read Instructions ............................2-1 Battery Installation/Removal/Battery Door .....................2-2 Turning the Ambulatory X12+ ON ........................2-3 Turning the Ambulatory X12+ OFF ........................2-3...
  • Page 16 Appendix Messages and Information Table of Messages ............................A-1 System Information Log...........................A-2 Serial Number and Part Number Location ......................A-3 Appendix Channel Assignments 600MHz ................................B-1 2500MHz .................................B-2 Appendix Translations Table of Translations ............................C-1 Glossary ..............................G-1 Index ................................I-1...
  • Page 17: Introduction

    Text on the LCD screen of the X12+ appears in regular Arial font. System Description The Mortara Instrument Ambulatory X12+ Telemetry Module represents the state-of-the-art in Wireless Electrocardiographic Technology. It provides a means to acquire and transmit 12-lead cardiac signals without direct connections to an electrocardiograph.
  • Page 18: Leadform Patient Cable

    X12+_________________________________________________________________________ X12+ Transmitter with Patient Cable Front View, Figure 1-1 Patient Cable LeadForm Patient Cable, Figure 1-2...
  • Page 19: X12+ Transmitter In Carrying Pouch

    _____________________________________________________________________Section 1 X12+ Transmitter in Carrying Pouch, Figure 1-3 Carrying Pouch with Neck Strap...
  • Page 20: Supplies Contact

    • 1 4x4 Gauze wipe • 1 Razor • 2 Alcohol Prep Pads To order additional supplies, contact a Mortara Instrument customer service representative at: Mortara Instrument, Inc. 7865 N. 86 Street Milwaukee, WI 53224 Phone: 1-888-MORTARA (667-8272) Fax: (414) 354-4760...
  • Page 21 ____________________________________________________________________________Section 1 Mortara Specifications/ X12+ Ambulatory Transmitter X12+ Ambulatory Transmitter FEATURE Specifications INTRUMENT TYPE 12-Lead ECG Transmitter INPUT CHANNELS Continuous 12-lead signal acquisition and transmission STANDARD LEADS TRANSMITTED I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6 FREQUENCY RANGE* 608.48 MHz to 631.52 MHz or 2400.96 MHz to 2482.56 MHz...
  • Page 22 X12+_______________________________________________________________________________...
  • Page 23: Operation

    The user of this device is cautioned that any changes or modifications not expressly approved by Mortara Instrument, Inc., could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC rules. Operation is subject to the following conditions: 1.
  • Page 24 X12+_______________________________________________________________________________ Battery Installation / Removal and Opening / Closing the Battery Door The battery compartment is accessible via the battery door of the Ambulatory X12+ Transmitter. 1) Position the X12+ Transmitter with its back facing you to open the battery door.
  • Page 25: Turning The Ambulatory X12+ On

    ____________________________________________________________________________Section 2 Turning the Ambulatory X12+ ON The X12+ will power up as soon as a battery with a minimum of 1.0 Volts has been inserted into the battery compartment. If the X12+ was turned off after its last use, the user has two options to power the X12+ ON: 1) Remove and re-insert the AA alkaline battery, or 2) Press the Up/Right arrow key on the front of the X12+ Transmitter The X12+ will power up and display the Main LCD Menu within three seconds.
  • Page 26: Attaching The Patient Cable

    X12+_______________________________________________________________________________ Attaching the Patient Cable The LeadForm Patient Cable consists of a connector block, main cable and leadwires connected to the main cable. Each leadwire terminates in a snap connector. The leadwires are positioned on the main cable to follow the contour of the torso.
  • Page 27: Positioning The Electrodes

    ____________________________________________________________________________Section 2 Positioning the Electrodes Lateral View, Precordial Electrode Placement (top) Precordial Electrodes AAMI Fourth intercostal space at the right sternal border Fourth intercostal space at the left sternal border Midway between V2 and Fifth intercostal space at the left of the midclavicular line Anterior axillary line on the same horizontal level as V4...
  • Page 28: Using The Keypad

    X12+_______________________________________________________________________________ Using the Keypad The keypad is located on the front, lower portion of the Ambulatory X12+ Transmitter. Three keys are available for navigating through the LCD Menu screens, for powering the X12+ ON/OFF and for sending calls during transmission.
  • Page 29: Top Level Menu Options

    ____________________________________________________________________________Section 2 Top Level Menu Options To select Menu options, press and hold the Up/Right arrow key for approximately three seconds. Use the Up/Right and Down arrow keys to scroll and the Enter key to select. The top level menu includes the following options.
  • Page 30: Lead Check

    X12+_______________________________________________________________________________ Lead Check The LEAD CHECK, DISPLAY ECG and CONFIGURE tasks are performed prior to starting a new patient. LEAD CHECK, DISPLAY ECG and DONE are typically selected prior to each new session. Checking Impedances LEAD CHECK is the first option displayed on the LCD screen after patient hook-up and is a valuable tool for verifying and optimizing signal quality before starting a patient session.
  • Page 31: Displaying Ecg Leads

    ____________________________________________________________________________Section 2 Displaying ECG Leads DISPLAY ECG is used to visually inspect leads I, II, III, V1, V2, V3, V4, V5 and V6 before starting a transmission session. Check the signal quality and lead amplitude for each lead. From the Main menu, scroll to ECG Preview using the Down or Up/Right keys. Press the Enter key to select this option.
  • Page 32: Setting The Transmission Channel Number

    X12+_______________________________________________________________________________ CONFIGURE Operational Flow Chart CONFIGURE CHANNEL CABLE VERSION DONE Select between: Software version and 10-Leadwire transmission frequency Select between 256 Return to Configure 5-Leadwire VERSION 1.00 channels Menu 4-Leadiwre ISM 2400 LANGUAGE BATTERY Select Language: English / Italian / Display real time German / French…...
  • Page 33: Setting The Number Of Patient Cable Leadwires

    ____________________________________________________________________________Section 2 Setting the Number of Patient Cable Leadwires CABLE is used to set the number of leadwires for the patient cable. From the CONFIGURE menu, scroll to CABLE using the Down or Up/Right keys. Press the Enter key to select this option.
  • Page 34: Starting A Patient Transmission Session

    X12+_______________________________________________________________________________ Starting a Patient Transmission Session 1. Hook-up the patient. 2. Ensure that there is an AA alkaline battery in the battery compartment (see note below). 3. Press the Up/Right arrow key to turn on the X12+ Transmitter (if not already powered ON by insertion of the battery).
  • Page 35: Sending (Optional) Call Signals

    ____________________________________________________________________________Section 2 Sending (Optional) Call Signals During the patient data transmission session, the patient may be instructed to transmit call signals from the X12+ to a receiving device for monitoring purposes. To send a call signal, press any one of the three keys on the X12+. The CALL message is displayed in the Main Menu on the LCD display to inform the user that a call was sent.
  • Page 36 X12+_______________________________________________________________________________ 2-14...
  • Page 37: Maintenance

    ____________________________________________________________________________________ Section 3 Maintenance Cleaning the Ambulatory X12+ and Patient Cable Turn off the Ambulatory X12+, and clean the outside with a damp cloth. Dry the equipment completely before use. WARNING: The Ambulatory X12+ is not water-proof. Prevent liquid from penetrating, and avoid submerging the Ambulatory X12+ in any liquid.
  • Page 38 X12+ _______________________________________________________________________________...
  • Page 39: Table Of Messages

    __________________________________________________________________________Appendix A A p p e n d ix M e s s a g e s a n d I n f o r m a t i o n The following table describes messages that are displayed on the X12+ during patient hook-up and Transmission. Table of Messages Message Solution...
  • Page 40: System Information Log

    In addition to having records of this information, the system information provides a warranty record of when your system was placed in service. System Information Log Telephone Numbers: Manufacturer: Domestic: 800-231-7437 Mortara Instrument, Inc. European: +39-51-6650-701 7865 N. 86th St. Milwaukee, WI 53224 Sales Department: 800-231-7437 Service Department: 888-MORTARA...
  • Page 41 __________________________________________________________________________Appendix A System Information Log The Serial Number and Part Number (REF) For questions and service are found under the battery, in the battery information, when calling have serial compartment on the backside of the unit number and part number available. similar to the one pictured below.
  • Page 42 X12+_______________________________________________________________________________...
  • Page 43: Appendix B Channel Assignments

    __________________________________________________________________________Appendix B Appendix Channel Assignments X12+-600 Channel Assignments (FCC Part 15 Compliant) Includes reference to UHF TV channel occupying the same frequency range. TV37 TV38 TV39 TV40 608.48 614.48 620.48 626.48 608.56 614.56 620.56 626.56 608.64 614.64 620.64 626.64 608.72 614.72 620.72 626.72...
  • Page 44 X12+ _______________________________________________________________________________ X12+-2500 Channel Assignments 2400.96 2421.44 2441.92 2462.4 2401.28 2421.76 2442.24 2462.72 2401.6 2422.08 2442.56 2463.04 2401.92 2422.4 2442.88 2463.36 2402.24 2422.72 2443.2 2463.68 2402.56 2423.04 2443.52 2464 2402.88 2423.36 2443.84 2464.32 2403.2 2423.68 2444.16 2464.64 2403.52 2424 2444.48 2464.96 2403.84 2424.32...
  • Page 45: Appendix C Translations

    __________________________________________________________________________Appendix C Appendix Translations Table of Translations English Italian Spanish German Dutch ITALIANO ESPAÑOL DEUTSCH HOLLAND KAN: Menu Menu Menu Menu Menu CALL CHIAMA LLAMAR OPROEP POWER OFF? SPEGNERE? ¿APAGAR? AUSSCHALTEN? SPANNING UIT? NEIN SI’ LEAD CHECK DERIVAZIONI TEST ELECT ABL.TEST AFL.
  • Page 46 X12+_______________________________________________________________________________ English French Polish Portuguese FRANÇAIS POLSKI PORTUGUES KAN: CANAL: Menu Menu Menu Menu CALL APPEL Dzwonek Chamar Wyłącz POWER OFF? ETEINDRE? Wyłączyć zasilanie? Desligar? NÃO LEAD CHECK DÉRIVATIONS ELEKTRODY DERIVAÇÕES DISPLAY ECG AFFICH. ECG MOSTRAR ECG CONFIGURE CONFIGURER USTAWIENIA...
  • Page 47: Glossary

    ____________________________________________________________________________ Glossary Glossary TERM DEFINITION Limb lead Bipolar lead that represents the differences of electrical potential between two selected sites (leads I, II, III). Muscle noise Grossly uneven baseline caused by patient body tremor or other muscle movement. The artifact may be so large that it overtakes the complex.
  • Page 48 X12+ _______________________________________________________________________________...
  • Page 49: Index

    _______________________________________________________________________________Index Index Patient Hook-Up 2-4 Pouch 1-3 Ambulatory X12+ Transmitter 1-2 Positioning Electrodes 2-5 Ambulatory X12+ Specifications 1-5 Attaching the Patient Cable 2-4 Audience 1-1 Specifications 1-5 Starting a Patient Transmission Session 2-12 Supplies 1-4 Back View 2-2 System Description 1-1 Battery Installation 2-2 Turning the X12+ ON 2-3 Call 2-6, 2-13...
  • Page 50 X12+_______________________________________________________________________________...

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