Mortara X12 Plus User Manual
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Mortara X12 Plus User Manual

Mortara X12 Plus User Manual

Ambulatory transmitter
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REF 9515-164-50-ENG Rev D1
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
X12+
AMBULATORY TRANSMITTER
USER MANUAL

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  • Page 1 REF 9515-164-50-ENG Rev D1 X12+ AMBULATORY TRANSMITTER USER MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 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.
  • Page 3 Physician Practice: orderspc.us@mortara.com European Union U.S. Distribution: orderspc.us@mortara.com Representative Mortara Instrument Germany Bonifaciusring 15 Mortara Instrument Europe, s.r.l. 45309 Essen (European Headquarters) Germany Via Cimarosa 103/105 Tel: +49.201.18 55 69 70 40033 Casalecchio di Reno (BO) Fax: +49.201.18 55 69 77...
  • 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 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...
  • Page 6 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.
  • Page 7 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. ...
  • Page 8 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.
  • Page 9 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.
  • Page 10 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.
  • Page 11 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.
  • Page 12 USER SAFETY INFORMATION...
  • Page 13 EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Defibrillator-proof, Type CF input Battery Indicates compliance to applicable European Union directives Do not dispose as unsorted municipal waste. Per European Union Directive 2002/96, requires separate handling for waste disposal according to national requirements...
  • Page 14 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.
  • Page 15 See appropriate EMC table for recommended separation distances between the radio equipment and the device. The use of accessories and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the device.
  • Page 16 ELECTROMAGNETIC COMPATIBILITY (EMC) 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...
  • Page 17 ELECTROMAGNETIC COMPATIBILITY (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. IEC 60601 Test Compliance Emissions Test...
  • Page 18 ELECTROMAGNETIC COMPATIBILITY (EMC) 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.

  • Page 19: Table Of Contents

    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 .................................
  • Page 20 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 ..............................

  • Page 21: Introduction Section

    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.

  • Page 22: X12+ With Patient Cable, Figure 1-1, Front View

    SECTION 1 X12+ with Patient Cable Figure 1-1, Front View Patient Cable LeadForm Patient Cable Figure 1-2...

  • Page 23: X12+ In Carrying Pouch, Figure 1-3

    SECTION 1 X12+ in Carrying Pouch Figure 1-3 Carrying Case with Neck Strap...

  • Page 24: Part Numbers

    PAT CBL 10WIRE LEADFORM XL AHA SNAP 9293-026-50 PAT CBL 10WIRE LEADFORM XL AHA SNAP 9293-026-51 HOOKUP KIT MONITORING 10E SINGLE 9294-009-50 SHORT FORM INSTR CARD X12+ (xxx = language) 9503-164-01-xxx X12+ USER MANUALS 9515-164-50-CD To order additional supplies, contact a Mortara Instrument customer service representative.

  • Page 25: Specifications

    SECTION 1 Specifications Feature Specifications Instrument Type 12-lead ECG digital transmitter Input Channels Continuous 12-lead signal acquisition and transmission ECG 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 904.76 MHz to 925.16 MHz or 2400.96 MHz to 2482.56 MHz Special Functions...
  • Page 26 SECTION 1...

  • Page 27: Read Instructions

    SECTION 2 Read Instructions before Operating this Device The user is cautioned that any changes or modifications not expressly approved by Mortara Instrument, Inc. could void the user’s authority to operate this device. This device complies with part 15 of the FCC rules. Operation is subject to the following conditions: 1.

  • Page 28: Turning The X12+ On

    SECTION 2 Turning the 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.

  • Page 29: Attaching The Patient Cable

    SECTION 2 Attaching the Patient Cable The LeadForm patient cable consists of a connector block, a main cable, and lead wires connected to the main cable. Each lead wire terminates in a snap connector. The lead wires are positioned on the main cable to follow the contour of the torso.

  • Page 30: Positioning The Electrodes For 10-Wire Hookup

    SECTION 2 Positioning the Electrodes for 10-wire (12-lead) Hookup Limb Electrodes AAMI Placement Right clavicle as shown Left clavicle as shown Reference or ground lead, placed to maximize patient comfort Lower left side of body, as close to hip as possible, on the iliac crest (original Mason-Likar position) or lowest rib on the left side of chest (modified Mason- Likar position) Precordial Electrode...

  • Page 31: Using The Keypad

    SECTION 2 When the electrode sites have been identified and prepped, remove the clear electrode covering and apply an electrode to each of the sites. Secure each electrode by exerting slight pressure around the outer edge and inner ring of the electrode. To connect the lead wires, begin with connecting the LL lead wire (Red –...

  • Page 32: Top Level Menu Options

    SECTION 2 Top Level Menu Options To select menu options, press and hold Up/Right for approximately three seconds. Use Up/Right and Down to scroll and Enter to select. The top level menu includes:  LEAD CHECK  DISPLAY ECG  CONFIGURE ...

  • Page 33: Checking Impedances

    SECTION 2 Checking Impedances LEAD CHECK is the first option displayed on the LCD screen after patient hookup and is a valuable tool for verifying and optimizing signal quality before starting a patient session. From the main menu, use Down or Up/Right to scroll to LEAD CHECK. Press Enter to select. A graph depicting the impedance measured at the right arm (RA), left arm (LA), left leg (LL), and V1 through V6 electrodes is displayed from left to right in vertical columns on the screen.

  • Page 34: Setting The Transmission Channel Number

    SECTION 2 The CONFIGURE menu includes:  CHANNEL  CABLE  LANGUAGE  VERSION  BATTERY  DONE Use Down or Up/Right to scroll through the CONFIGURE menu options. Press Enter when the desired option is displayed. Select DONE and press Enter to return to the top level menu. Scroll to DONE and press Enter to return to the main menu.

  • Page 35: Setting The Number Of Patient Cable Lead Wires

    SECTION 2 Setting the Number of Patient Cable Lead Wires CABLE is used to set the number of lead wires for the patient cable. From the CONFIGURE menu, use Down or Up/Right to scroll to CABLE. Press Enter to select. The CABLE menu includes: ...

  • Page 36: Starting A Patient Transmission Session

    SECTION 2 Starting a Patient Transmission Session 1. Hookup the patient. 2. Ensure that there is an AA alkaline battery in the battery compartment (see note below). 3. Press Up/Right to turn the X12+ on (if not already powered on by battery insertion). 4.

  • Page 37: Cleaning The X12+ And Accessories

    MAINTENANCE SECTION 3 Cleaning the X12+ and Accessories 1. Remove cables and disconnect power source from device before cleaning. 2. Wash the carry case by hand with fabric detergent and then air dry. Do not machine dry the case. 3. For general cleaning, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Wipe and air dry.
  • Page 38 SECTION 3...

  • Page 39: Messages And Information

    MESSAGES AND INFORMATION APPENDIX A The following table describes messages that are displayed on the X12+ during patient hookup and transmission. Table of Messages Message Solution Battery power is low. Replace existing battery with a fully charged battery. Battery power is at 25%. Battery power is at 50%.

  • 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 Manufacturer: Telephone Numbers: Mortara Instrument, Inc. Domestic: 800-231-7437 7865 N. 86th St. European: +39-51-6650-701 Milwaukee, WI 53224...

  • Page 41: Channel Assignments

    CHANNEL ASSIGNMENTS APPENDIX B X12+600 Channel Assignments Includes reference to UHF TV channel occupying the same frequency range. TV38 TV39 TV40 608.48 614.48 620.48 626.48 608.56 614.56 620.56 626.56 608.64 614.64 620.64 626.64 608.72 614.72 620.72 626.72 608.8 614.8 620.8 626.8 608.88 614.88...

  • Page 42: 2500 Mhz

    APPENDIX B TV38 TV39 TV40 612.96 618.96 624.96 630.96 613.04 619.04 625.04 631.04 613.12 619.12 625.12 631.12 613.2 619.2 625.2 631.2 613.28 619.28 625.28 631.28 613.36 619.36 625.36 631.36 613.44 619.44 625.44 631.44 613.52 619.52 625.52 631.52 X12+2500 Channel Assignments 2400.96 2421.44 2441.92...

  • Page 43: 915 Mhz

    APPENDIX B 2415.68 2436.16 2456.64 2477.12 2416 2436.48 2456.96 2477.44 2416.32 2436.8 2457.28 2477.76 2416.64 2437.12 2457.6 2478.08 2416.96 2437.44 2457.92 2478.4 2417.28 2437.76 2458.24 2478.72 2417.6 2438.08 2458.56 2479.04 2417.92 2438.4 2458.88 2479.36 2418.24 2438.72 2459.2 2479.68 2418.56 2439.04 2459.52 2480 2418.88...
  • Page 44 APPENDIX B 907.88 918.12 923.24 907.96 913.08 918.2 923.32 908.04 913.16 918.28 923.4 908.12 913.24 918.36 923.48 908.2 913.32 918.44 923.56 908.28 913.4 918.52 923.64 908.36 913.48 918.6 923.72 908.44 913.56 918.68 923.8 908.52 913.64 918.76 923.88 908.6 913.72 918.84 923.96 908.68 913.8...

  • Page 45: Translations

    TRANSLATIONS APPENDIX C 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 APPENDIX C 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 CONFIGURAR CHANNEL...

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