Mortara T12 User Manual
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Mortara T12 User Manual

Ambulatory transmitter
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REF 9515-173-50-ENG Rev C1
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.
T12/T12S
AMBULATORY TRANSMITTER
USER MANUAL

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  • Page 1 REF 9515-173-50-ENG Rev C1 T12/T12S 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 Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. T12 and T12S are trademarks of Mortara Instrument, Inc. V1.0...
  • 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, disposable SpO sensors) must not be reused. To maintain safety and effectiveness, electrodes and SpO sensors must not be used beyond their expiration date. ...
  • Page 9 USER SAFETY INFORMATION Caution(s)  To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, 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 2. This device must accept any interference received, including interference that may cause undesired operation.  The T12/T12S-600 must be used solely on the premises of health care facilities (see Part 15, section 15.242a).  A health care facility operating the T12/T12S-600 must coordinate with the directors of existing nearby TV stations and radio astronomy observatories to ensure compatible use.
  • Page 11 USER SAFETY INFORMATION Note(s)  Proper patient preparation is important to proper application of ECG electrodes, pulse oximetry sensors, 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 EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents Turn battery cover in this direction for removal from unit Align battery cover with ECG and SpO sensor cable connectors for application to device Defibrillator-proof type CF applied part Defibrillator-proof, type BF applied part Call button Battery with notification: See operating instructions for type of cell to be used...
  • Page 13 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 14 GENERAL CARE...
  • 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: Electromagentic 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

    System Description ................................ 2 T12S with LeadForm ECG Cable and SpO Sensor Cable, Figure 1-1, Front View ............ 3 T12/T12S in Carrying Pouch, Figure 1-2 ........................3 LeadForm ECG Cable (10 wire), Figure 1-3 ......................... 4 LeadForm ECG Cable and T12S SpO Sensor Cable Routed Through the Sleeve, Figure 1-4 ........
  • Page 20 TABLE OF CONTENTS MAINTENANCE SECTION 3 Cleaning the Transmitter, ECG Cable, and Accessories ..................... 21 Cleaning the Reusable SpO Sensor and Cable ......................21 Periodic Maintenance ..............................21 Disposal of Waste Materials ............................21 MESSAGES AND INFORMATION APPENDIX A Table of Messages ............................... 23 System Information Log ..............................

  • Page 21: Introduction Section

    INTRODUCTION SECTION 1 Manual Purpose The T12™/T12S™ digital ambulatory transmitter user manual explains how to:  Acquire and transmit 12-lead ECG signals to a receiving device  Acquire and transmit pulse oximetry (SpO ) signals to a receiving device ...

  • Page 22: System Description

    The T12 incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory. Transmission to a Mortara receiver module allows the cardiac signals to be displayed on a monitoring device without direct connection to an electrocardiograph.

  • Page 23: T12S With Leadform Ecg Cable And Spo

    SECTION 1 T12S with LeadForm ECG Cable and SpO Sensor Cable Figure 1-1, Front View Sensor Cable LeadForm ECG Cable Call Button T12/T12S in Carrying Pouch Figure 1-2...

  • Page 24: Leadform Ecg Cable (10 Wire), Figure 1-3

    SECTION 1 LeadForm ECG Cable (10 wire) Figure 1-3 LeadForm ECG Cable and T12S SpO Sensor Cable Routed Through the Sleeve Figure 1-4...

  • Page 25: Part Numbers

    Alkaline, AA-type, 1.5V Various Various Lithium, AA-type, 1.5V Energizer NOTE: Replace cells with only those listed above. Use of other cells may present a risk of fire or explosion. To order additional supplies, contact a Mortara Instrument customer service representative.

  • Page 26: Specifications

    Battery 1 AA alkaline, 24-hour typical life * Operating frequency range is dependent on the T12/T12S part number. ** Verified by clinical tests where measured values of the sensors were compared with arterial CO-oximetry in adult subjects over the specified SpO range.

  • Page 27: Opening The Top Cover

    The lead wires are positioned on the main cable to follow the contour of the torso. Each lead wire terminates in a snap connector. Securely insert the ECG cable connector block into the ECG input connector on the top of the T12/T12S. NOTE: Be careful to insert the connector block parallel to the input connector.

  • Page 28: Attaching The Spo Sensor Cable

    SECTION 2 Attaching the SpO Sensor Cable The SpO sensor cable consists of a connector block and a main cable with a SpO sensor connected to the main cable. Securely insert the SpO sensor cable connector block into the SpO input connector on the top of the T12S.

  • Page 29: Turning The T12/T12S On

    Turning the T12/T12S On The T12/T12S will power up as soon as a battery with a minimum of 1.0 volts has been inserted into the battery compartment and the cover applied. If the T12/T12S was turned off after its last use, the user has two options to power the T12/T12S on: 1.

  • 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: Positioning The Electrodes For 5-Wire Hookup

    SECTION 2 Positioning the Electrodes for 5-wire Hookup Electrodes AAMI Placement Right clavicle as shown Left clavicle as shown Reference or ground lead, should be placed to maximize patient comfort Lower left side of body, as close to the hip as possible Any precordial position according to clinician preference (shown in V1/C1 location) When the electrode sites have been identified and prepped, remove the clear electrode covering and apply an...

  • Page 32: Patient Pulse Oximetry Sensor Application

    SECTION 2 Patient Pulse Oximeter Sensor Application Select a suitable site for the SpO sensor. The patient’s first or index finger is the preferred location. Alternative sites recommended are the thumb or little finger. Refer to the user instructions accompanying the sensor type being used for proper application.
  • Page 33 SECTION 2 In addition to the digital readout of O saturation, the clinician can display a plethysmographic waveform to help distinguish an artifactual signal from the true signal. If readings are lower than expected or there is artifact in the pleth wave signal, reposition the sensor.

  • Page 34: Lcd Display Battery Voltage Indicator

    An option to display the actual battery voltage is also available in the configuration menu and will be explained later in this section. NOTE: If battery voltage is below 1.0 volts, the T12/T12S may not power on. Insert a new AA battery to continue operation.

  • Page 35: Using The Buttons

    SECTION 2 Using the Buttons Three buttons located on the front and side of the T12/T12S are available for powering the T12/T12S on/off, navigating through the LCD menu screens, and for sending calls during transmission: Up, Down, and Call. Figure 2-4...

  • Page 36: Main Menu

    SECTION 2 Main Menu During patient monitoring, the T12/T12S displays the following information:  SPO2 ► (applies to T12S only)  Battery Symbol = 100%, 75%, 50%, or 25% battery charge  Ch:XX = Transmission channel  Patient ID (if entered; applies to T12S only) ...

  • Page 37: Lead Check

    NOTE: The cursor cannot be moved in the left or up direction. NOTE: Patient ID information entered on the T12/T12S may not be supported by the receiver; check the receiver device user manual. Displaying SpO DISPLAY SPO2 is used to visually display the plethysmographic waveform together with the pulse rate, the oxygen saturation percentage value, and any probe error codes (used for Mortara service troubleshooting).

  • Page 38: Configuring The T12/T12S

    To return to the main menu, navigate to DONE and press Call. Setting the Transmission Channel Number The T12/T12S transmits the patient’s cardiac signals to the electrocardiograph using a specific channel number. CHANNEL is used to enter the optimal transmission channel number before starting a patient session. The user may choose from any of 256 channels.

  • Page 39: Viewing Software Version Number

    6. Use DISPLAY SPO2 to verify the pulse oximetry sensor application quality as explained in this section. 7. Return to the main menu. NOTE: If battery voltage is below 1.0 volts, the T12/T12S may not power on. Insert a new AA battery to continue operation.

  • Page 40: Sending Call Signals

    T12/T12S to a receiving device for monitoring purposes. To send a call signal, press the Call button on the front of the T12/T12S. CALL will briefly appear on the LCD display to notify the user that a call signal has been transmitted.

  • Page 41: Cleaning The Transmitter, Ecg Cable, And Accessories

    ECG cable before each use to ensure they are not damaged or broken. Disposal of Waste Materials The T12/T12S uses one AA battery and disposable monitoring electrodes. Disposal must be in accordance with the following procedures: Battery: applicable disposal or recycling standards...
  • Page 42 SECTION 3...

  • Page 43: Messages And Information

    MESSAGES AND INFORMATION APPENDIX A The following table describes messages that are displayed on the T12/T12S during patient hookup and transmission. Table of Messages Message Solution Battery power is low. Replace existing battery with a fresh battery. Battery power is at 25%.
  • Page 44 APPENDIX A Table of Messages (continued) Message Solution PROBE INSF LT T12S SpO sensor error indicating insufficient light meaning pulse signal is too low. PROBE CHECK T12S SpO sensor message indicating sensor is searching for a pulse (small pulse). PROBE OFF T12S SpO sensor message indicating sensor is off the patient (searching for pulse).

  • Page 45: System Information Log

    In addition to having records of this information, the system information log provides a warranty record of when your device was placed in service. System Information Log Manufacturer: Telephone Numbers: Mortara Instrument, Inc. USA: 800-231-7437 7865 N. 86th St. European: +39-51-6650-701 Milwaukee, WI 53224...
  • Page 46 APPENDIX A...

  • Page 47: Channel Assignments

    CHANNEL ASSIGNMENTS APPENDIX B T12/T12S US 600 Channel Assignments Includes reference to UHF TV channel in the same frequency range. TV37 MHz TV38 MHz TV39 MHz TV40 MHz 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...

  • Page 48: 600 Mhz Canada

    APPENDIX B T12/T12S US 600 Channel Assignments (continued) TV37 MHz TV38 MHz TV39 MHz TV40 MHz 612.16 618.16 624.16 630.16 612.24 618.24 624.24 630.24 612.32 618.32 624.32 630.32 612.4 618.4 624.4 630.4 612.48 618.48 624.48 630.48 612.56 618.56 624.56 630.56 612.64...

  • Page 49: 2500 Mhz

    APPENDIX B T12/T12S 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...

  • Page 50: 915 Mhz

    APPENDIX B T12/T12S 2500 Channel Assignments (continued) 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...
  • Page 51 APPENDIX B T12/T12S 915 Channel Assignments (continued) 906.68 911.8 916.92 922.04 906.76 911.88 922.12 906.84 911.96 917.08 922.2 906.92 912.04 917.16 922.28 912.12 917.24 922.36 907.08 912.2 917.32 922.44 907.16 912.28 917.4 922.52 907.24 912.36 917.48 922.6 907.32 912.44 917.56 922.68...
  • Page 52 APPENDIX B...

  • Page 53: Translations

    TRANSLATIONS APPENDIX C Table of Translations English Italian Spanish German Dutch ITALIANO ESPAÑOL DEUTSCH HOLLAND KAN: Menu MENU MENU MENÜ MENU Enter ID INTRO ID PATIENT ID GEEF ID Del (delete) Canc Borr Entf Fine Ende SERVICE GESTIONE SERVICIO SERVICE SERVICE CALL CHIAMA...
  • Page 54 APPENDIX C Table of Translations (continued) English French Polish Portuguese FRANÇAIS POLSKI PORTUGUES KAN: CANAL: Menu MENU MENU MENU Enter ID ENTREZ ID WPISZ ID ID PACIENTE Del (delete) Apagar SERVICE REGLAGE OBSŁUGA SIECI SERVIÇO CALL APPEL Dzwonek Chamar SPO2 SPO2 SPO2 SPO2...

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