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Copyright © 2015

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. T12 and T12S
are trademarks of Mortara Instrument, Inc. V1.0

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Summary of Contents for T12

Page 1: ...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: ...on 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 T12 and T12S are trademarks of Mortara Instrument Inc V1 0 ...

Page 3: ...pplies 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 mortara com U S Distribution orderspc us mortara com Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel 49 201 18 55 69 70 Fax 49 201 18 55 69 77 Mortara Instrument Netherlands Postbus 3...

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 No part of this document may be photocopied reproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this do...

Page 5: ...isaster 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 operating conditions THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS OR ANY PRODUCT S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE Thi...

Page 6: ...IS 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 LOSS DAMAGE OR EXPENSE OF ANY KIND INCLUDING LOSS OF PROFITS WHETHER UNDER TORT NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW OR OTHERWISE THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES EXP...

Page 7: ...raining 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 IEC 60601 2 25 Only use parts and accessories supplied with the device and available through Mortara Instrument Inc Patient cables intended for use with the device include series resistance 7 Kohm mi...

Page 8: ...ssion critical conditions it is advisable to have a backup device available There is a potential pinch hazard when applying the top cover to the device that could result in minor injury Care should be taken to avoid entrapment of fingers when performing this operation The device is restricted to use on one patient at a time Pulse oximetry sensors must be checked a minimum of every 4 hours and move...

Page 9: ...pulse oximeter sensor may result in pulse oximetry readings that are unreliable Do not pull or stretch patient cables as this could result in mechanical and or electrical failures Patient cables should be stored after forming them into a loose loop The device will only work with receiving devices that are equipped with the appropriate option No user serviceable parts are inside Damaged or suspecte...

Page 10: ...my observatories to ensure compatible use Minimum separation distances from such facilities may apply It may be necessary to obtain written authorization from such facilities prior to installation and use of the device Part 15 section 15 242d e Industry Canada Compliance Statement These devices comply with RSS 210 of the Industry Canada rules Operation is subject to the following two conditions 1 ...

Page 11: ... reproducing that calibration curve The following information is especially useful for clinicians Reusable Sensor Measurement Wavelength and Output Power Red 660nm at 3 5 4 5mW nominal Infrared 905nm at 3 5 4 5mW nominal Disposable Sensor Measurement Wavelength and Output Power Red 660nm at 3 5 4 5mW nominal Infrared 890nm at 3 5 4 5mW nominal If no SpO2 or pulse rate is present alarm conditions a...

Page 12: ... 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 Indicates compliance to applicable European Union directives No alarms Do not dispose as unsorted municipal waste Per European Union Directive 2002 96 requires separate handling for waste disposal according to national requirements IPX2 R...

Page 13: ...ect 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 recommended but may be required for cables and lead wires Frequent sterilization will reduce the useful life of cables and lead wires If required sterilize with ethylene oxide gas EtO at a maximum temperature...

Page 14: ...GENERAL CARE xii ...

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 in an acceptable manner in the configuration in which it will be used Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment See appropriat...

Page 16: ...ctromagnetic 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 Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic m...

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 frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz a Field strengths from fi...

Page 18: ...ximum 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 0 m 7 0 m 100 12 0 m 23 0 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the ...

Page 19: ...ng the T12 T12S On 9 Turning the T12 T12S Off 9 Patient ECG Hookup 9 Positioning the Electrodes for 10 wire Hookup 10 Positioning the Electrodes for 5 wire Hookup 11 Patient Pulse Oximetry Sensor Application 12 Pulse Oximeter Theory of Operation and Recommendations For Use 12 LCD Display Battery Voltage Indicator 14 Using the Buttons 15 Start Up Menu 15 Main Menu 16 Lead Check 17 Display ECG Leads...

Page 20: ... Sensor and Cable 21 Periodic Maintenance 21 Disposal of Waste Materials 21 MESSAGES AND INFORMATION APPENDIX A Table of Messages 23 System Information Log 25 Serial and Part Number Location 25 CHANNEL ASSIGNMENTS APPENDIX B 600 MHz US 27 600 MHz Canada 28 2500 MHz 29 915 MHz 30 TRANSLATIONS APPENDIX C Table of Translations 33 ...

Page 21: ...rdiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring Indicated for use in a clinical setting by qualified medical professionals properly trained for ECG monitoring and use of the system The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvement...

Page 22: ...iagnostic quality SpO2 measurement values and waveform data while allowing the patient to be ambulatory Transmission to a Mortara receiver module allows the cardiac signals and SpO2 measurements to be displayed on a monitoring device without direct connection to an electrocardiograph or separate SpO2 device In addition by using a very high monitoring frequency to transmit cardiac and SpO2 signals ...

Page 23: ...SECTION 1 3 T12S with LeadForm ECG Cable and SpO2 Sensor Cable Figure 1 1 Front View SpO2 Sensor Cable LeadForm ECG Cable Call Button T12 T12S in Carrying Pouch Figure 1 2 ...

Page 24: ...SECTION 1 4 LeadForm ECG Cable 10 wire Figure 1 3 LeadForm ECG Cable and T12S SpO2 Sensor Cable Routed Through the Sleeve Figure 1 4 ...

Page 25: ...Reusable SpO2 Sensor Finger Clip 6901 015 01 Reusable SpO2 Sensor Wrap 6901 015 02 Disposable SpO2 Sensor Adhesive Case of 24 6901 015 53 T12 T12S User Manual XXX language 9515 173 50 XXX T12 T12S Short Form Instruction Card XXX language 9503 173 01 XXX Case of 24 Monitoring Hookup Kits 10 monitoring electrodes 1 abrasive pad 1 gauze wipe 1 razor 2 alcohol prep pads 9294 009 51 Approved Battery Mo...

Page 26: ...ction Complies with AAMI standards and IEC 60601 2 25 Number of Channels 256 user selectable Function Keys Up down and enter keys for on off and menu navigation dedicated call button during transmission Device Classification Type BF SpO2 CF ECG battery operated Weight 4 6 oz 130 g without battery Dimensions 3 x 4 4 x 98 76 mm x 112 mm x 25 mm Battery 1 AA alkaline 24 hour typical life Operating fr...

Page 27: ...y compartment is accessible on the top middle area of the T12 T12S Insert one AA battery into the battery compartment Align the positive and negative indicators of the battery with the designators shown on the device s back label Attaching the LeadForm ECG Cable The LeadForm ECG cable consists of a connector block and a main cable with lead wires connected to the main cable The lead wires are posi...

Page 28: ...the T12S NOTE Be careful to insert the connector block parallel to the input connector Figure 2 2 ECG cable inserted SpO2 sensor cable inserted Battery inserted Closing the Top Cover To close the top cover firmly grasp the lower portion of the device align the middle line horizontally with the ECG and SpO2 cable connectors and turn the cover in the opposite direction of the arrows Application of t...

Page 29: ...ess the Call button to select Yes NOTE The user has five seconds to select yes or no or the prompt will be replaced by the main menu and the power off operation is cancelled Patient ECG Hookup Skin Preparation 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...

Page 30: ...ntal level as V4 V6 C6 Mid axillary line on the same horizontal level as V4 and V5 NOTE QRS morphology may be slightly different from a standard 12 lead ECG due to torso located limb electrode placement NOTE AND CAUTION Placement of the Left Leg LL electrode in the original Mason Likar position increases the similarity of the acquired ECG with a standard 12 lead ECG and is therefore recommended ho...

Page 31: ...preference shown in V1 C1 location 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 labeled LL or F to the LL electrode Connect the next l...

Page 32: ...ensor works by applying a sensor to a pulsating arteriolar vascular bed The sensor contains light emitting diodes that emit light at 660 nm red and 905 nm infrared wavelengths that are measured by a light sensitive detector in the opposite side of the sensor Light emitting diodes Tissue bone venous blood etc normally absorb a constant amount of light from the arterial blood The arteriolar bed norm...

Page 33: ... nails are free of nail polish Ensure that the sensor is positioned on a finger that is free of a blood pressure cuff or any blood flow obstruction Check and reposition reusable sensors a minimum of every 4 hours Check and reposition disposable sensors a minimum of every 4 hours Replace the disposable sensor when it no longer adheres to the skin Certain conditions may result in readings that are u...

Page 34: ...00 75 50 25 or 0 If a battery with unknown voltage is inserted and the main menu does not appear insert a new battery 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 When the battery indicator ...

Page 35: ...up the T12 T12S displays the following information SERVICE displays briefly Battery Symbol 100 75 50 or 25 battery charge Ch XX Transmission channel Patient ID if entered applies to T12S only RL RA LL LA V1 V2 V3 V4 V5 and or V6 Leads in fail SpO2 Fault messages applies to T12S only MENU Press Up to enter the SERVICE configuration menu This can only be done while SERVICE is still displayed at star...

Page 36: ... pulse oximetry sensor is acquiring and transmitting to the receiving device The values will display for 3 seconds The user can select the SpO2 spot check at any time during transmission Press Down to enter the user MENU To send a Call signal press the button on the front of the device CALL will briefly appear on the LCD display to notify the user that a call signal has been transmitted An operati...

Page 37: ...gnal quality and lead amplitude for each lead Lead I is the first lead displayed Use Up Down to scroll from lead to lead Enter Patient ID ENTER ID is used to enter and display an alphanumeric patient identification value To enter the patient ID move the cursor to the desired letter or digit in the alphanumeric table using the Up Down buttons and then select by pressing Call To move the cursor one ...

Page 38: ...session The user may choose from any of 256 channels If ECG signal loss occurs the transmission channel can be changed To enter the channel number move the cursor to the right or left alphanumeric character field by pressing Up To move the cursor one letter or digit at a time press Down When the cursor reaches the end of the characters it will wrap to the beginning Setting the Number of ECG Cable ...

Page 39: ...t hookup quality as explained in this section 5 Use DISPLAY ECG to verify the amplitude and signal quality of each ECG lead as explained in this section 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 operatio...

Page 40: ...on the LCD display to notify the user that a call signal has been transmitted SpO2 Spot Checks At any time during the patient data transmission session the clinician can display the oxygen saturation percentage and pulse rate values that the pulse oximetry sensor is acquiring and transmitting to the receiving device To perform a spot check press Up The values will display for 3 seconds Ending a Tr...

Page 41: ...ING Prevent liquid from penetrating the device and do not attempt to clean 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 Ethylene Oxide EtO gas Cleaning the Reusable SpO2 Sensor and Cable Reusable SpO2 sensors must be cleaned between patients Refer t...

Page 42: ...SECTION 3 22 ...

Page 43: ...numeric characters indicating a patient identification value RA RA fail Check if the lead wire is off or the electrode needs to be replaced RL RL fail Check 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 electrode needs to be replaced A combination of RA LL ...

Page 44: ...or message indicating sensor is searching for a pulse small pulse PROBE OFF T12S SpO2 sensor message indicating sensor is off the patient searching for pulse NO PROBE T12S SpO2 sensor message indicating sensor is disconnected from the transmitter Attention message displayed on the T12S SpO2 spot check screen indicating a probe issue Refer to the T12S main menu screen for more details ...

Page 45: ...placed in service System Information Log Manufacturer Mortara Instrument Inc 7865 N 86th St Milwaukee WI 53224 Product Information Telephone Numbers USA 800 231 7437 European 39 51 6650 701 Sales Department 800 231 7437 Service Department 888 MORTARA Name of Unit Product ____________________________ Date of Purchase ___ ___ _____ Purchased Unit From _____________________________ Serial Number ____...

Page 46: ...APPENDIX A 26 ...

Page 47: ...627 84 12 609 92 52 615 92 92 621 92 D2 627 92 13 610 53 616 93 622 D3 628 14 610 08 54 616 08 94 622 08 D4 628 08 15 610 16 55 616 16 95 622 16 D5 628 16 16 610 24 56 616 24 96 622 24 D6 628 24 17 610 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 72...

Page 48: ... 3D 613 36 7D 619 36 BD 625 36 FD 631 36 3E 613 44 7E 619 44 BE 625 44 FE 631 44 3F 613 52 7F 619 52 BF 625 52 FF 631 52 T12 T12S Canada 600 Channel Assignments Includes reference to UHF TV channel in the same frequency range CH TV37 MHz CH TV37 MHz CH TV37 MHz CH TV37 MHz 00 608 48 11 609 84 22 611 2 33 612 56 01 608 56 12 609 92 23 611 28 34 612 64 02 608 64 13 610 24 611 36 35 612 72 03 608 72 ...

Page 49: ...D3 2468 48 14 2407 36 54 2427 84 94 2448 32 D4 2468 8 15 2407 68 55 2428 16 95 2448 64 D5 2469 12 16 2408 56 2428 48 96 2448 96 D6 2469 44 17 2408 32 57 2428 8 97 2449 28 D7 2469 76 18 2408 64 58 2429 12 98 2449 6 D8 2470 08 19 2408 96 59 2429 44 99 2449 92 D9 2470 4 1A 2409 28 5A 2429 76 9A 2450 24 DA 2470 72 1B 2409 6 5B 2430 08 9B 2450 56 DB 2471 04 1C 2409 92 5C 2430 4 9C 2450 88 DC 2471 36 1D...

Page 50: ... 7F 2441 6 BF 2462 08 FF 2482 56 T12 T12S 915 Channel Assignments CH MHz CH MHz CH MHz CH MHz 00 904 76 40 909 88 80 915 C0 920 12 01 904 84 41 909 96 81 915 08 C1 920 2 02 904 92 42 910 04 82 915 16 C2 920 28 03 905 43 910 12 83 915 24 C3 920 36 04 905 08 44 910 2 84 915 32 C4 920 44 05 905 16 45 910 28 85 915 4 C5 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...

Page 51: ...13 08 A8 918 2 E8 923 32 29 908 04 69 913 16 A9 918 28 E9 923 4 2A 908 12 6A 913 24 AA 918 36 EA 923 48 2B 908 2 6B 913 32 AB 918 44 EB 923 56 2C 908 28 6C 913 4 AC 918 52 EC 923 64 2D 908 36 6D 913 48 AD 918 6 ED 923 72 2E 908 44 6E 913 56 AE 918 68 EE 923 8 2F 908 52 6F 913 64 AF 918 76 EF 923 88 30 908 6 70 913 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...

Page 52: ...APPENDIX B 32 ...

Page 53: ...PO2 PROBE INSF LT LUCE INSUFF LUZ SENSOR SONDENLICHT FOUT LICHT PROBE CHECK CTRL SENSORE COMPR SENSOR PRÜFE SONDE PROBE CHECK LINE FREQ FILTRO AC FREC CA FREQU AC FREQ Off Off Off Aus Uit POWER OFF SPEGNERE APAGAR AUSSCHALTEN SPANNING UIT NO NO NO NEIN NEE YES Sĺ SI JA JA LEAD CHECK DERIVAZIONI TEST ELECT ABL TEST AFL TEST DISPLAY ECG MOSTRA ECG MOSTRAR ECG EKG ANZEIGE TOON ECG CHANNEL CANALE CANA...

Page 54: ...LAY SPO2 AFFICH SPO2 SPO2 MOSTRAR SPO2 PROBE INSF LT SIGNAL FAIBLE BŁAD CZUJNIKA ERRO POUCA LUZ PROBE CHECK VERIF CAPTEUR SPR CZUJNIK CHECK AO SENSOR LINE FREQ FREQ RESEAU CZĘST SIECI FILTERO AC Off Off Wyłącz Off POWER OFF ETEINDRE Wyłączyć Desligar NO NON NIE NÃO YES OUI TAK SIM LEAD CHECK DÉRIVATIONS ELEKTRODY DERIVAÇÕES DISPLAY ECG AFFICH ECG EKG MOSTRAR ECG CHANNEL CANAL KANAŁ CANAL CABLE CÀB...

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