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.
® Copyright © 2004 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. Ambulatory X12+ is a trademark of Mortara Instrument, Inc.
Technical Support and Service Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com Sales Support/ Supplies & Accessories Europe Economic Community Representative Mortara Instrument GmbH (Germany) Kaninenberghöhe 50 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313 Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour 7 40016 S. Giorgio di Piano, BO Tel: +39.051.
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 (Ambulatory X12+) is used in accordance with the instructions for use. Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule.
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. The warranty period is defined as twelve (12) months following the date of shipment from Mortara.
User Safety Information Warning Caution Means there is the possibility of personal injury to you or others. Means there is the possibility of damage to the equipment. Provides information to further assist in the use of the device. Note Federal law restricts this device for sale to and use by or on the order of a physician.
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. • Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant, and then dry with a clean cloth.
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.
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.
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).
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 RF Emissions CISPR 11 Group 2 The X12+ Transmitter must emit electromagnetic energy in order to perform its intended function.
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.
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.
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.
Table of Contents 1 Introduction Manual Purpose ..............................................................................................................................................1-1 Audience..........................................................................................................................................................1-1 System Description....................................................................................................................................
Appendix A Messages and Information Table of Messages ..........................................................................................................................................A-1 System Information Log...................................................................................................................................A-2 Serial Number and Part Number Location ......................................................................................................
_____________________________________________________________________Section 1 1 Introduction X12+ Overview Manual Purpose The X12+ User Manual explains how to operate the Ambulatory X12+ Transmitter. It shows 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.
X12+_________________________________________________________________________ X12+ Transmitter with Patient Cable Front View, Figure 1-1 Patient Cable LeadForm Patient Cable, Figure 1-2 1-2
_____________________________________________________________________Section 1 X12+ Transmitter in Carrying Pouch, Figure 1-3 Carrying Pouch with Neck Strap 1-3
X12+_________________________________________________________________________ Mortara Part Numbers/ X12+ Ambulatory Transmitter X12+ Transmitter Description Part Numbers X12+ Transmitter X12PLUS-XXX-XXXXX X12+ Battery Door 8346-003-50 X12+ Carrying Pouch with Belt and Neck Strap 8485-020-50 10-wire LeadForm Patient Cable/ Domestic • Standard • Large 9293-017-50 9293-026-50 10-wire LeadForm Patient Cable/ International • Standard • Large 9293-017-51 9293-026-51 X12+ User Manual / English 9515-1
____________________________________________________________________________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 608.48 MHz to 631.52 MHz or 2400.96 MHz to 2482.
X12+_______________________________________________________________________________ 1-6
____________________________________________________________________________Section 2 2 Operation Please Read Instructions before Operating this Device 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. 2.
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. 2) Press down on the battery door arrow symbol and slide the battery door out. 3) Insert one AA alkaline battery into the battery compartment.
____________________________________________________________________________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.
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. Insert the connector block into the input connector on the top of the X12+ Transmitter.
____________________________________________________________________________Section 2 Positioning the Electrodes Lateral View, Precordial Electrode Placement (top) Precordial Electrodes AAMI IEC V1 C1 Fourth intercostal space at the right sternal border V2 C2 Fourth intercostal space at the left sternal border V3 C3 Midway between V2 and V4 V4 C4 Fifth intercostal space at the left of the midclavicular line V5 C5 Anterior axillary line on the same horizontal level as V4 V6 C6 Mid-axilla
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. These include the Up/Right, Down and Enter keys. Menu Up/Right Off Down Enter CALL = Any Key Main Menu The X12+ Transmitter Main LCD menu displays the following information.
____________________________________________________________________________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. • • • • LEAD CHECK DISPLAY ECG CONFIGURE DONE An operational flowchart of Menu options depicts the flow of functionality using the Up/Right, Down and Enter keys.
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. Lead I is the first lead displayed on the screen.
X12+_______________________________________________________________________________ CONFIGURE Operational Flow Chart CONFIGURE CHANNEL CABLE VERSION DONE Select between 256 channels Select between: 10-Leadwire 5-Leadwire 4-Leadiwre Software version and transmission frequency VERSION 1.
____________________________________________________________________________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. The CABLE menu includes the following options. • • • 4-Leadwire 5-Leadwire 10-Leadwire Use the Down or Up/Right key to scroll to the desired option and press the Enter key.
X12+_______________________________________________________________________________ Starting a Patient Transmission Session Note: 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). 4. Verify the quality of the hook-up by checking the electrode to skin impedances.
____________________________________________________________________________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.
X12+_______________________________________________________________________________ 2-14
____________________________________________________________________________________ Section 3 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. Sterilization is not allowed.
X12+ _______________________________________________________________________________ 3-2
__________________________________________________________________________Appendix A A p p e n d ix A M e s s a g e s a n d In fo r m a tio n The following table describes messages that are displayed on the X12+ during patient hook-up and Transmission. Table of Messages Message Solution Battery power is low. Replace existing battery with a fully charged battery. Battery power is at 50%. Battery power is at 75%. Battery power is at 100% (fully charged). CALL A Call signal has been transmitted.
X12+_______________________________________________________________________________ The following system information log is provided for your convenience. You need this information to set up your system if it needs servicing. Be sure to update the information log when you add options or your system has been serviced. Record the model and serial number of all components, dates of removal, and/or replacement of components, and the name of the vendor from whom the component was purchased and/or installed.
__________________________________________________________________________Appendix A System Information Log For questions and service information, when calling have serial number and part number available. The Serial Number and Part Number (REF) are found under the battery, in the battery compartment on the backside of the unit similar to the one pictured below.
X12+_______________________________________________________________________________ A-4
__________________________________________________________________________Appendix B Appendix B 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 CH# 00 01 02 03 04 05 06 07 08 09 0A 0B 0C 0D 0E 0F 10 11 12 13 14 15 16 17 18 19 1A 1B 1C 1D 1E 1F 20 21 22 23 24 25 26 27 28 29 2A 2B 2C 2D 2E 2F 30 31 32 MHz 608.48 608.56 608.64 608.72 608.8 608.88 608.96 609.04 609.12 609.2 609.28 609.
X12+ _______________________________________________________________________________ X12+-2500 Channel Assignments CH# 00 01 02 03 04 05 06 07 08 09 0A 0B 0C 0D 0E 0F 10 11 12 13 14 15 16 17 18 19 1A 1B 1C 1D 1E 1F 20 21 22 23 24 25 26 27 28 29 2A 2B 2C 2D 2E 2F 30 31 32 33 34 35 36 37 38 39 3A 3B 3C 3D 3E 3F B-2 MHz 2400.96 2401.28 2401.6 2401.92 2402.24 2402.56 2402.88 2403.2 2403.52 2403.84 2404.16 2404.48 2404.8 2405.12 2405.44 2405.76 2406.08 2406.4 2406.72 2407.04 2407.36 2407.68 2408 2408.32 2408.
__________________________________________________________________________Appendix C Appendix C Translations Table of Translations English Italian ITALIANO Spanish ESPAÑOL German DEUTSCH Dutch HOLLAND CH: CH: C: KAN: CH: Menu Menu Menu Menu Menu CALL CHIAMA LLAMAR RUF OPROEP Off Off Off Aus Uit POWER OFF? SPEGNERE? ¿APAGAR? AUSSCHALTEN? SPANNING UIT? NO NO NO NEIN NEE YES SI’ SI JA JA LEAD CHECK DERIVAZIONI TEST ELECT ABL.TEST AFL.
X12+_______________________________________________________________________________ English French FRANÇAIS Polish POLSKI Portuguese PORTUGUES CH: CH: KAN: CANAL: Menu Menu Menu Menu CALL APPEL Dzwonek Chamar Off Off Wyłącz Off POWER OFF? ETEINDRE? Wyłączyć zasilanie? Desligar? NO NON NIE NÃO YES OUI TAK SIM LEAD CHECK DÉRIVATIONS ELEKTRODY DERIVAÇÕES DISPLAY ECG AFFICH.
____________________________________________________________________________ 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. Precordial leads (V1-V6) Unipolar chest leads.
X12+ _______________________________________________________________________________ G-2
_______________________________________________________________________________Index Index A Ambulatory X12+ Transmitter 1-2 Ambulatory X12+ Specifications 1-5 Attaching the Patient Cable 2-4 Audience 1-1 B Back View 2-2 Battery Installation 2-2 C Call 2-6, 2-13 Channel Settings 2-6, 2-9, 2-11 Configuring the X12+ 2-9 P Patient Hook-Up 2-4 Pouch 1-3 Positioning Electrodes 2-5 S Specifications 1-5 Starting a Patient Transmission Session 2-12 Supplies 1-4 System Description 1-1 T Turning the X12+ ON 2-3 Tur
X12+_______________________________________________________________________________ I-2
