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Summary of Contents for Mortara Instrument X12+
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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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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.
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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...
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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.
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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.
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• 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.
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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.
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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.
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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...
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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).
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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...
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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...
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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...
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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.
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...
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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...
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.
• 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...
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____________________________________________________________________________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...
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.
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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.
____________________________________________________________________________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.
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.
____________________________________________________________________________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...
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.
____________________________________________________________________________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.
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.
____________________________________________________________________________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.
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…...
____________________________________________________________________________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.
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).
____________________________________________________________________________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.
____________________________________________________________________________________ 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.
__________________________________________________________________________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...
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...
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__________________________________________________________________________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.
__________________________________________________________________________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.
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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...
____________________________________________________________________________ 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.
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Do you have a question about the X12+ and is the answer not in the manual?
Questions and answers