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TABLE OF CONTENTS

xviii

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 ................................................................................................................................................... 25

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Summary of Contents for X12 Plus

Page 1: ...5 164 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 ph...

Page 2: ...ormation 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 Mo...

Page 3: ...plies Accessories Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Fax 414 354 4760 Hospital Customers orders us mortara com Physician Practice orderspc us morta...

Page 4: ...back of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved...

Page 5: ...saster affecting the Product s e Alterations and or modifications to the Product s not authorized by Mortara f Other events outside of Mortara s reasonable control or not arising under normal operatin...

Page 6: ...S NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD IN NO EVENT INCLUDING THE CLAIM FOR NEGLIGENCE SHALL MORTARA BE LIABLE FOR INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR ANY OTHER LOS...

Page 7: ...aining options To maintain designed operator and patient safety peripheral equipment and accessories used that can come in direct patient contact must be in compliance with UL 60601 1 IEC 60601 1 and...

Page 8: ...ators and ultrasound machines There is no known safety hazard if other equipment such as pacemakers or other stimulators is used simultaneously with the device however disturbance to the signal may oc...

Page 9: ...paired by qualified service personnel prior to continued use This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance Imaging MRI and Computed Tomography...

Page 10: ...uthorization from such facilities prior to installation and use of the X12 Part 15 section 15 242d e Industry Canada Compliance Statement These devices comply with RSS 210 of the Industry Canada rules...

Page 11: ...e receiving monitoring device As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows Class I equipment or internally powered Type CF defibrillation proof applied parts Ordina...

Page 12: ...USER SAFETY INFORMATION x...

Page 13: ...ying 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 re...

Page 14: ...ct buttons and controls for proper function and appearance Cleaning and Disinfection Refer to section 3 for proper cleaning and disinfection procedures Sterilization EtO sterilization is not recommend...

Page 15: ...EN 60601 1 2 The device should not be used adjacent to or stacked on top of other equipment If the device must be used adjacent to or stacked on top of other equipment verify that the device operates...

Page 16: ...tic 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 enviro...

Page 17: ...and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each fr...

Page 18: ...imum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 KHz to 800 MHz 800 MHz to 2 5 GHz P d 2 1 P d 3 2 0 01 0 1 m 0 2 m 0 1 0 4 m 0 7 m 1 1 2 m 2 3 m 10 4...

Page 19: ...able 9 Patient ECG Hookup 9 Skin Preparation 9 Positioning the Electrodes for 10 wire Hookup 10 Using the Keypad 11 Main Menu 11 Top Level Menu Options 12 Lead Check 12 Checking Impedances 13 Displayi...

Page 20: ...AGES 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...

Page 21: ...ransmitter receiving and delivering real time acquisition and RF transmission of simultaneous 12 lead ECG data while allowing the patient to be ambulatory The device is indicated for use on adult popu...

Page 22: ...SECTION 1 2 X12 with Patient Cable Figure 1 1 Front View Patient Cable LeadForm Patient Cable Figure 1 2...

Page 23: ...SECTION 1 3 X12 in Carrying Pouch Figure 1 3 Carrying Case with Neck Strap...

Page 24: ...SNAP CINCH 9293 017 51 PAT CBL 5WIRE AHA BANANA DO 9293 025 50 PAT CBL 5WIRE IEC BANANA DO 9293 025 51 PAT CBL 10WIRE LEADFORM XL AHA SNAP 9293 026 50 PAT CBL 10WIRE LEADFORM XL AHA SNAP 9293 026 51...

Page 25: ...mpedance check ECG display lead fail battery notification multi purpose call 10 wire 5 wire and 4 wire options Defibrillator Protection Complies with AAMI standards and IEC 60601 2 25 Number of Channe...

Page 26: ...SECTION 1 6...

Page 27: ...apply It may be necessary to obtain written authorization from such facilities prior to installation and use of the X12 Part 15 section 15 242d e Operating frequency ranges are 608 48 to 631 52 MHz 9...

Page 28: ...es or no or the prompt menu will be replaced by the main menu LCD Display Battery Voltage Indicator The X12 is powered with a single AA alkaline battery that requires a minimum of 1 0 volts to operate...

Page 29: ...ration Skin preparation is important to perform before electrode attachment to help ensure good signal quality when transmitting patient data Poor skin electrode contact may cause noise or artifact wh...

Page 30: ...clavicular line V5 C5 Anterior axillary line on same horizontal level as V4 V6 C6 Mid axillary line on the same horizontal level as V4 and V5 NOTE AND CAUTION Placement of the Left Leg LL electrode in...

Page 31: ...electrode placement Using the Keypad The keypad is located on the front lower portion of the X12 Three keys are available for navigating through the LCD menu screens for powering the X12 on off and f...

Page 32: ...nter to select The top level menu includes LEAD CHECK DISPLAY ECG CONFIGURE DONE An operational flowchart of menu options depicts the flow of functionality using the three keys Lead Check LEAD CHECK D...

Page 33: ...e acceptable impedance levels are verified press any of the three keys to return to the top level menu Displaying ECG Leads DISPLAY ECG is used to visually inspect leads I II III V1 V2 V3 V4 V5 and V6...

Page 34: ...ic 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 If ECG signal loss occurs the transmis...

Page 35: ...ANGUAGE is used to select the language displayed in the main menu and all sub menu options From the CONFIGURE menu use Down or Up Right to scroll to LANGUAGE Press Enter to select When finished press...

Page 36: ...nnel number and battery indicator are continuously displayed on the LCD If the battery is removed during a transmission session the X12 stops transmitting A battery must be inserted to continue operat...

Page 37: ...lean disinfect the device or patient cables by submerging into a liquid autoclaving or steam cleaning Never expose cables to strong ultra violet radiation Do not sterilize the device or ECG cable with...

Page 38: ...SECTION 3 18...

Page 39: ...ck if the lead wire is off or the electrode needs to be replaced LA LA fail Check if the lead wire is off or the electrode needs to be replaced LL LL fail Check if the lead wire is off or the electrod...

Page 40: ...placed in service System Information Log Manufacturer Mortara Instrument Inc 7865 N 86th St Milwaukee WI 53224 Product Information Telephone Numbers Domestic 800 231 7437 European 39 51 6650 701 Sale...

Page 41: ...610 32 57 616 32 97 622 32 D7 628 32 18 610 4 58 616 4 98 622 4 D8 628 4 19 610 48 59 616 48 99 622 48 D9 628 48 1A 610 56 5A 616 56 9A 622 56 DA 628 56 1B 610 64 5B 616 64 9B 622 64 DB 628 64 1C 610...

Page 42: ...2446 72 CF 2467 2 10 2406 08 50 2426 56 90 2447 04 D0 2467 52 11 2406 4 51 2426 88 91 2447 36 D1 2467 84 12 2406 72 52 2427 2 92 2447 68 D2 2468 16 13 2407 04 53 2427 52 93 2448 D3 2468 48 14 2407 36...

Page 43: ...5 920 52 06 905 24 46 910 36 86 915 48 C6 920 6 07 905 32 47 910 44 87 915 56 C7 920 68 08 905 4 48 910 52 88 915 64 C8 920 76 09 905 48 49 910 6 89 915 72 C9 920 84 0A 905 56 4A 910 68 8A 915 8 CA 92...

Page 44: ...3 72 B0 918 84 F0 923 96 31 908 68 71 913 8 B1 918 92 F1 924 04 32 908 76 72 913 88 B2 919 F2 924 12 33 908 84 73 913 96 B3 919 08 F3 924 2 34 908 92 74 914 04 B4 919 16 F4 924 28 35 909 75 914 12 B5...

Page 45: ...OSTRAR ECG EKG ANZEIGE TOON ECG CONFIGURE CONFIGURA CONFIGURAR EINSTELLUNG CONFIGUREER CHANNEL CANALE CANAL KANAL KANAAL CABLE CAVO CABLE KABEL KABEL 4 Leadwire 4 Elettrodi 4 Electrodos 4 Elektroden 4...

Page 46: ...RODY DERIVA ES DISPLAY ECG AFFICH ECG EKG MOSTRAR ECG CONFIGURE CONFIGURER USTAWIENIA CONFIGURAR CHANNEL CANAL KANA CANAL CABLE C BLE KABEL CABO 4 Leadwire 4 lectrodes 4 Y OWY 4 el ctrodos 5 Leadwire...

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