SunTech TANGO M2 User Manual
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SunTech TANGO M2 User Manual

Automated blood pressure monitor for cardiac stress and exercise testing
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Automated Blood Pressure Monitor for
Cardiac Stress and Exercise Testing
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Summary of Contents for SunTech TANGO M2

  • Page 1 Automated Blood Pressure Monitor for Cardiac Stress and Exercise Testing User Manual...

  • Page 2: Changes

    All content in this manual is the proprietary information of SunTech Medical and is provided solely for purposes of operation, maintenance or service of the Tango M2. This manual and the Tango M2 described in it are protected under copyright law under which they may not be copied, in whole or in part, without written consent of SunTech Medical.

  • Page 3: Welcome To Tango M2

    Today, we remain focused on the continual advancement of clinical grade blood pressure technology. Tango M2 is the latest in our line of Tango Stress Test Blood Pressure Monitors, designed specifically to work with your stress system.

  • Page 4: Table Of Contents

    Graph View ................................... 16 Main Menu .................................... 17 Applied Parts ..................................22 4. Using Tango M2 During a Stress Test ....................... 22 Step 1. Blood Pressure Cuff Placement ..........................23 Step 2. Confirm ECG Signal ..............................24 Step 3. Take BP Readings ..............................24 Step 4.
  • Page 5 The Tango M2 displays an Information Signal. What does it mean and what do I do? ..........38 The Tango M2 monitor returns a result of 0/0 after blood pressure (BP) measurements. What do I need to do to get a BP reading? ..................................

  • Page 6: Safety Considerations

    It measures and displays a patient’s systolic and diastolic blood pressure, and with the SpO option, percent oxygen saturation of arterial blood. Use Tango M2 only with adult patients, while they undergo a cardiac or exercise stress test under the supervision of a physician. Indications for Use...

  • Page 7: Warnings, Cautions, And Contraindications

    CAUTION: Monitor patient to ensure that all cables to the patient are secured to prevent entanglement with the patient during the use of the Tango M2 system. If necessary, use the wrist straps to secure the cables to the patient’s wrist.

  • Page 8: Icons, Symbols And Abbreviations

    RS-232 connector & USB-B port must only be connected to equipment that meets EN60601-1. Icons, Symbols and Abbreviations Icons The following icons used in this guide, on Tango M2 equipment and packaging are unique to SunTech Medical. Icon Definition Standard/Source DKA™...
  • Page 9 European Authorized Representative SunTech Design Symbols The following are standardized symbols that are used on the Tango M2 equipment and packaging. The standards referenced in the Standard/Source column are: • SDO # 5-102, IEC 60417:2002 DB Graphical symbols for use on equipment •...
  • Page 10 Meets ELSA 2007, CEC efficiency level V EU (EC) No 278/2009 Phase II Fragile ISO 7000-0621 Shipping Temperature should be kept between -20˚ C ISO 7000-0632 and 65˚C Shipping Humidity should be kept between 15% and ISO 7000-2620 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 10...

  • Page 11: Setting Up Tango M2

    • Connect your stress system to the Tango M2 using the BNC external ECG and RS-232 cables. You can use the USB cable instead of the RS-232 cable if your Tango M2 came with this option. Please view the Interface Notes in the E-Library inside your Tango M2 to see the correct set-up between these two systems.

  • Page 12: With Your Stress System

    Patient Cable & ECG Cable “Defibrillation-proof Type BF Applied Part” and SpO is a “Type BF Applied Part.” • If your Tango M2 has the Internal ECG option, then there will be an ECG connector. If not, the ECG port will be plugged. Power On LED...

  • Page 13: Without A Stress System

    Test the combined system by taking a blood pressure measurement to confirm that Tango M2 is working properly with the stress system. Follow the instructions in the Using Tango M2 during a Stress Test section of this guide (PG #29).

  • Page 14: Getting To Know Tango M2

    The ON/OFF button is blue and located on the top back right corner of the monitor. Use the six buttons on the front panel to operate the monitor. The blue LED on the top of Tango M2 will be lit whenever the monitor is powered on.

  • Page 15: Measurement View

    SpO is not connected and displayed in blue if SpO is connected. • The SpO field will be blank if no SpO sensor is attached to the monitor. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 15...

  • Page 16: Graph View

    The graph will display up to 15 readings at a time but will hold 50 BP readings. Use the UP and DOWN buttons to scroll back and forth to see the 50 most recent readings. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 16...

  • Page 17: Main Menu

    In any menu, scroll to EXIT and press SELECT to return to previous menu. Press START/STOP to return to the Main Display from any level in the Main Menu. The following charts list the Menu Options, available choices and default settings. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 17...
  • Page 18 Warning Yes / No DKA MODE to OSC MODE. Prompts 1. Interface Notes E-Library Select Tango M2 information to display on screen: 2. Tutorials 3. Information Signals Displays firmware version and internal board serial number. System Info Select “Software Update” to begin a software...
  • Page 19 *Once the language selection has been made the Tango M2 must cycle power to have this language take effect. Measurement Setup Menu Option Options (Default) Measurement Select type of BP reading to be taken: BP – both systolic and diastolic / SYS – only...
  • Page 20 Select low systolic pressure threshold to activate alarm. SYS Low Options are: “OFF” or a systolic pressure from 40-110 mmHg, in increments of OFF (default 10 mmHg, to set alarm. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 20...
  • Page 21 If “No”, data will be saved. The Measurement Table holds up to 300 individual BP measurements. Once 300 BP readings are collected in the table, the oldest measurements will be overwritten by new measurements. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 21...

  • Page 22: Applied Parts

    Make sure the monitor is receiving an ECG signal Take blood pressure readings End test / prepare system for the next patient You should be familiar with taking blood pressure measurements and conducting ECG stress tests before using Tango M2 with your stress system. 80-0055-00-MO-Rev F 2018-2-20...

  • Page 23: Step 1. Blood Pressure Cuff Placement

    Disposable Cuff The SunTech Single Patient Use (SPU) kit is available in five sizes. Each SPU kit contains one disposable cuff and one disposable microphone pad. Use the microphone from the Orbit-K cuff included with the monitor, or you can order the 12"...

  • Page 24: Step 2. Confirm Ecg Signal

    ECG signal automatically from the stress system once the patient ECG connections are in place. NOTE: Tango M2 can be used in OSC MODE to take blood pressure readings without an ECG signal before exercise begins. The patient must remain still while these readings are being taken! Refer to the DKA MODE vs. OSC Mode section of this guide for more information.
  • Page 25 If Controlled by the Stress System When the Tango M2 is connected to a stress system, the stress system will control the BP intervals. The Tango M2 will follow a predetermined BP interval protocol driven by the stress system. In this instance, the timed intervals do not need to be programmed into the Tango M2.

  • Page 26: Step 4. Prepare For A New Patient

    The monitor will automatically reset for a new patient when the ECG signal has been dropped for over a minute (i.e., when the ECG leads are removed from the patient). All patient information displays will be cleared. Instead of automatically resetting, Tango M2 can be set to display a “New Patient?” prompt when the ECG signal drops, by selecting the Main Menu >...

  • Page 27: Using Tango M2 Without A Stress System

    5. Using Tango M2 Without a Stress System Follow these steps to use Tango M2 with an Internal ECG option when it is not connected to a stress system: Measure patient's arm to ensure proper cuff sizing. Place a blood pressure cuff on the patient’s arm...

  • Page 28: Step 3. Take Blood Pressure Readings

    Step 3. Take Blood Pressure Readings Press the START/STOP button to manually prompt the monitor to take blood pressure readings. Take Blood Pressure Readings in the previous section of this guide for information about other Tango M2 functions: • Readings at Timed Intervals •...

  • Page 29: Headphone Kit

    The Tango M2 will shut down if the cable's voltage is shorted to ground until the fault is removed. In the case of a damaged cable remove the SpO cable from the Tango M2 and resume normal use of the Tango M2.

  • Page 30: Preventative Maintenance

    Preventative Maintenance System Self Checks Tango M2 performs a range of system and software checks during normal operation. If Tango detects a problem, it will display an error code with a message to contact SunTech Customer Service. WARNING: DO NOT USE the monitor if it displays a greater than zero pressure with no cuff attached.

  • Page 31: Software Updates

    If a Tango M2 software update is available, you can update your monitor easily using the USB-A port. Software updates should only be installed by a trained technician who is familiar with operation of the Tango M2. Please call your SunTech Medical Customer Service if you need assistance.

  • Page 32: Product Disposal

    Electronic and Electrical Equipment (WEEE). The SunTech Tango M2 device encloses a small lithium ion battery and Printed Circuit (PC) board that contain materials which may be hazardous to human health. The battery cannot be easily removed and therefore the Tango M2 must be disposed of in an environmentally responsible way or returned to SunTech Medical.
  • Page 33 Three Year Extended Warranty 83-0019-00 Extended warranty (3 years, purchased at one time) Appendix B contains a list of cables available from SunTech Medical to connect Tango M2 to various stress systems 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 33...

  • Page 34: Information Signals And Alarms

    Information Signals and Alarms Information Signals If Tango M2 has a problem taking a blood pressure measurement, an audible alarm of 3 beeps will sound and an Information Signal will appear on the monitor screen. Take action as directed on the screen, or as suggested in the table below.
  • Page 35 Replace microphone and cuff annually. Review Interface Notes for your stress system. Make sure the correct stress system setting is selected. (If “Custom”, make sure the correct ECG Trigger is selected.) 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 35...

  • Page 36: Alarms

    Alarms Alarm Types The Tango M2 can set clinical alarms for different patient physiological parameters as listed in the table below. The Tango M2 uses two types of high priority alarms, Patient Physiological (clinical) alarms and Technical (equipment limitation) type alarms. All alarms indicate a potential of injury if the alarm is ignored or misunderstood. Ensure that appropriate resuscitation equipment and personnel are available at all times during the procedure.
  • Page 37 High Heart Rate User settable from 90 to 200 beats per minute The operator of the device should remain within viewable distance of the Tango M2 in order to be able to see the visual alarm indicators. To verify the functionality of the alarm system, follow these steps: 1) Setup the Tango M2 for a reading following the instructions in this manual.

  • Page 38: Service Centers

    Monitor Setup > E-Library > Tutorials. Look in the Tango M2 User Manual under the Using Tango M2 during a Stress Test section for details on each type of cuff; the Orbit-K and the Single Patient Use (SPU) kit. Follow the instructions in the Cuff Tutorial (located on the SunTech Medical website under Support >...

  • Page 39: How Can I Get Map On My Tango M2

    How can I get MAP on my Tango M2? Register your Tango M2 Monitor online or through mail to receive MAP as a function on your Tango M2 monitor. Please note that due to FDA Regulations MAP is not available to the United States market.

  • Page 40: 11. Technical Information

    Tango M2. The Tango M2 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Tango M2 should be observed to verify normal operation in the configuration in which it will be used.
  • Page 41 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Tango M2 Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Tango M2 Monitor should assure that it is used in such an environment.
  • Page 42 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Tango M2 is used exceeds the applicable RF compliance level above, the Tango M2 should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Tango M2.

  • Page 43: Specifications, Blood Pressure Measurement

    Performance can be affected if, used or stored outside the specified temperature, humidity, or altitude listed in the ranges above. External power supply, use only SunTech part number 19-0012-01. Input: 100-240 VAC @ 1.5A Power: max, 50-60 Hz. Output +9VDC @ 5A IEC 320 type input connector.

  • Page 44: Standards

    70 – 100% ± 2 digits (± 1 Standard Deviation*) Motion 70 – 100% ± 3 digits (± 1 Standard Deviation*) * Standard Deviation is a statistical measure up to 32% of the readings may fall outside those limits. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 44...

  • Page 45: Limited Warranty

    United States prepaid to the factory. SunTech Medical, Inc. will repair any component(s) or part(s) that it finds to be defective during the period of this limited warranty. Should a defect become apparent, the original purchaser should first notify SunTech Medical, Inc.
  • Page 46 SUNTECH; Internal CASE 8000 Case 8000 Viasys Encore Vmax CardioSys Welch Allyn CardioPerfect CardioPerfect Check for an updated list of Interface Notes available for download from the SunTech Medical website: www.SunTechMed.com. 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 46...

  • Page 47: Appendix B. Cables For Compatible Stress Systems

    Appendix B. Cables for Compatible Stress Systems Contact your SunTech Medical sales representative to purchase the following items: RS-232 & ECG Interface Cables Stress System RS-232 Cable ECG Trigger Cable AMEDTEC ECGpro 91-0013-01 91-0066-01 Burdick Quest 91-0013-01 91-0011-01 Cambridge Heart CH 2000 & HearTwave II...

  • Page 48: Appendix C. Spo 2 Performance Accuracy

    Simulator to provide a simulated pulse rate, with adjustable amplitude settings at various levels. The module must maintain accuracy in accordance with ISO 80601-2-61 for SpO at the lowest obtainable pulse amplitude (0.3% modulation). 80-0055-00-MO-Rev F 2018-2-20 SunTech Tango M2 User Manual | 48...

  • Page 49: Appendix D. Downloading Instructions

    YYYYMMDD########. This is the unique identifier for each new BP data set that is pulled off the Tango M2 – you only need to worry with the date code as your identifier.

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