Sun-Tech TANGO M2 User manual

Automated Blood Pressure Monitor for
Cardiac Stress and Exercise Testing
User Manual

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Changes
This manual is identified as Part number: 80-0055-00 Rev. E. An updated version may be available for download from
the SunTech Medical website. Should you notice errors or omissions in this manual, please notify us at:
SunTech Medical, Inc.
507 Airport Boulevard, Suite 117
Morrisville, NC 27560 USA
Tel: [phone]
919.654.2300
Fax: [phone]
Email: [email protected]
Web: www.SunTechMed.com
Copyright Information
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.
SunTech and Tango are registered trademarks of SunTech Medical, Inc. All other trademark names are the
trademarks of their respective holders.
The information in this manual is furnished for guidance only, is subject to change without notice, and should not be
construed as a commitment by SunTech Medical. SunTech Medical assumes no liability for errors or inaccuracies
that may appear in this manual.
© 2017 SunTech Medical. All rights reserved.
SunTech Medical, Inc.
507 Airport Blvd, #117
Morrisville, NC 27560-8200
Phone: [phone]
1-800-421-8626
Fax: [phone]
SunTech Medical, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Road
Eynsham, Oxfordshire OX29 4TS
England
Phone: + 44 (0) 1865-884-234
Fax: + 44 (0) 1865-884-235
Other Office Location:
SunTech Medical (Shenzhen) Co., Ltd.
105 HuanGuan South Road, Suite 15 2~3/F
DaHe Community Guanlan,
LongHua District, Shenzhen
GuangDong PRC 518110
Tel: + 86-755-29588810
+ 86-755-29588986 (Sales)
+ 86-755-29588665 (Service)
Fax: + 86-755-29588829
Date of the first CE mark: 2013

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Welcome to Tango M2!
Thank you for choosing this Tango M2 blood pressure monitor.
For over twenty-five years, SunTech Medical has been the preeminent supplier of leading edge technology and
innovative products to obtain blood pressure measurements when manual readings are unreliable or simply not
possible. 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.
What’s New
•Full-color display
•Oscillometric (non-exercise) OSC MODE
oBP readings without ECG connection
•Updated enclosure
•Power On/Off switch
•USB connection
oExport BP measurement data
oEasily upgrade software/firmware
•Improved cuff connector for easier patient connection
What’s the Same
•Auscultatory DKA™ MODE technology
oReliable BP measurement during exercise
•Easy-to-read numeric display of BP and other patient information, with a waveform display of K-sounds
•Alternate graph display shows blood pressure trends
•Intuitive “push button” controls
•Simple menu-driven access to system settings
•Compatible with a broad range of stress systems to automatically receive ECG triggers and deliver readings
•Available SpO2option
•Available Internal ECG option
•Use with SunTech’s Orbit-K blood pressure cuff or SunTech’s Single Patient Use Kit (disposable cuff)
If you have used a SunTech Tango Stress Test Blood Pressure Monitor before, you can expect an effortless transition
to the new Tango M2.

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Table of Contents
Changes..................................................................................................................................................................................2
Copyright Information............................................................................................................................................................2
Welcome to Tango M2! .........................................................................................................................................................3
1. Safety Considerations......................................................................................................................................... 6
Intended Use ..........................................................................................................................................................................6
Indications for Use.................................................................................................................................................................6
User Responsibility ................................................................................................................................................................6
Precautions & Possible Adverse Reactions.........................................................................................................................6
Warnings, Cautions, and Contraindications.........................................................................................................................7
Icons, Symbols and Abbreviations .......................................................................................................................................8
2. Setting up Tango M2 ........................................................................................................................................ 11
Unpacking the Monitor ........................................................................................................................................................11
Rear Panel Configuration ....................................................................................................................................................11
With Your Stress System.....................................................................................................................................................12
Without a Stress System .....................................................................................................................................................13
3. Getting to know Tango M2................................................................................................................................ 14
Front Panel ...........................................................................................................................................................................14
Measurement View..............................................................................................................................................................15
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. Prepare for a New Patient ......................................................................................................................................26
5. Using Tango M2 Without a Stress System......................................................................................................... 27
Step 1. Blood Pressure Cuff Placement.............................................................................................................................27
Step 2. Patient ECG connections........................................................................................................................................27
Step 3. Take Blood Pressure Readings..............................................................................................................................28
Step 4. Prepare for a New Patient ......................................................................................................................................28
6. Using Tango M2 Options .................................................................................................................................. 28
Pulse Oximetry (SpO2) .........................................................................................................................................................28
Headphone Kit......................................................................................................................................................................29
7. Taking Care of Tango M2 ................................................................................................................................. 29
Cleaning................................................................................................................................................................................29
Preventative Maintenance...................................................................................................................................................30
Routine Calibration ..............................................................................................................................................................30

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Software Updates ................................................................................................................................................................31
Product Disposal..................................................................................................................................................................32
Cuff Disposal........................................................................................................................................................................32
8. Accessories & Replacement Parts .................................................................................................................... 32
9. Information Signals and Alarms ........................................................................................................................ 34
Information Signals .............................................................................................................................................................34
Alarms...................................................................................................................................................................................36
Service Centers ....................................................................................................................................................................38
10. Frequently Asked Questions ........................................................................................................................... 38
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? .......................................................................................................................................................................38
Can I use a heart rate or blood pressure simulator to test whether the Tango M2 is working correctly with my stress
system?.................................................................................................................................................................................38
How can I adjust the brightness of the Tango M2 display? .............................................................................................38
How can I get MAP on my Tango M2?...............................................................................................................................39
How do I clean the Orbit-K cuff after a stress test?..........................................................................................................39
My Tango M2 displays a message, “Please VERIFY CALIBRATION” or “Equipment Maintenance and Calibration
Required.” What do I do? ....................................................................................................................................................39
Service Centers ....................................................................................................................................................................39
11. Technical Information..................................................................................................................................... 40
EMC Statement ....................................................................................................................................................................40
Specifications, Blood Pressure Measurement ..................................................................................................................43
Standards .............................................................................................................................................................................44
Notes on Blood Pressure Data............................................................................................................................................44
Specifications, Pulse Oximetry ...........................................................................................................................................44
Limited Warranty..................................................................................................................................................................45
Appendix A. Compatible Stress Systems .............................................................................................................. 45
Appendix B. Cables for Compatible Stress Systems.............................................................................................. 47
RS-232 & ECG Interface Cables ..........................................................................................................................................47
Splitter Cables ......................................................................................................................................................................47
USB Cables (Optional Cable, replaces RS-232 connection) .............................................................................................47
Appendix C. SpO2Performance Accuracy ............................................................................................................. 48
Testing Summary.................................................................................................................................................................48
SpO2Accuracy Testing........................................................................................................................................................48
Low Perfusion Testing.........................................................................................................................................................48
Appendix D. Downloading Instructions.................................................................................................................. 49
Tango M2 Excel Formatting of the Data............................................................................................................................49

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1.Safety Considerations
Intended Use
Tango M2 is a non-invasive blood pressure monitor, with the optional capability to monitor oxygen saturation (SpO2),
for use in cardiac or exercise stress testing. It measures and displays a patient’s systolic and diastolic blood
pressure, and with the SpO2option, 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
The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and
displaying blood pressure, pulse rate, and functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients
in hospitals, medical facilities, and subacute environments.
Presence of atrial or ventricular fibrillation, arrhythmias, pacemakers, etc. may interfere with the normal functionality
of the Tango M2 monitor.
User Responsibility
Your Tango M2 is designed to perform in conformity with the description thereof contained in this operation manual
and accompanying labels and inserts, when assembled, operated, maintained and repaired in accordance with the
instructions provided. It is your responsibility to:
•Check calibration of this device annually.
•Never knowingly use a defective device.
•Immediately replace parts that are broken, worn, missing, incomplete, or contaminated.
•Contact the nearest SunTech approved service center should repair or replacement become necessary.
A list of approved service centers appears in the guide or on our website at www.SunTechMed.com.
•The reliability of the device depends upon conformance with the operation and service instructions,
as detailed in this manual.
Further, the user of the device bears sole responsibility for any malfunction that results from improper use, faulty
maintenance, improper repair, damage or alteration by anyone other than SunTech Medical or authorized service
personnel.
Precautions & Possible Adverse Reactions
Use of Tango M2
Use only blood pressure (BP) cuffs supplied by SunTech Medical.
Observe the patient carefully during the procedure. Ensure pressure compatibility to all patients. If any abnormality
occurs, either in the unit or the patient, suspend the operation immediately and disconnect the BP cuff, SpO2sensor,
and electrodes (if applicable) from the patient.
Accuracy of any blood pressure reading or oxygen saturation measurement may be affected by the position of the
subject, their physical condition, and use outside of the operating instructions detailed in this guide. The
interpretation of blood pressure and oxygen saturation measurements should only be made by a physician.
Safety and effectiveness when used with pregnant women, children under 13 years of age and neonates have not
been established.

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Pulse Oximetry
Use only Nonin pulse oximeter (SpO2) sensors supplied by SunTech Medical. Using other pulse oximeters may cause
improper sensor performance.
CAUTION: Check the application site of the SpO2 sensor frequently to confirm proper positioning of the
sensor and to check the circulation and skin sensitivity of the patient.
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.
CAUTION: Do not use a SpO2 extension cable with the Tango M2 system. An inaccurate SpO2 measurement may
result.
Factors that may affect the accuracy of pulse oximetry:
•electrosurgical interference
•arterial catheters, blood pressure cuffs, infusion lines, etc.
•moisture in the sensor
•improperly attached sensor
•incorrect sensor type
•poor pulse quality
•venous pulsations
•anemia or low hemoglobin concentrations
•cardiovascular dyes
•sensor not at heart level
•artificial fingernails and dark colored nail polish
Possible Adverse Reactions
In the area of the BP cuff, SpO2sensor or electrodes, allergic exanthema (symptomatic eruption) may result, including
the formation of urticaria (allergic reaction including raised edematous patches of skin or mucous membrane and
intense itching) caused by the fabric material of the cuff, sensor, or electrodes.
Following the application of the BP cuff, petechia formation (a minute reddish or purplish spot containing blood that
appears in the skin) or Rumpel-Leede phenomenon (multiple petechia) on the arm, which may lead to idiopathic-
thrombocytopenia (spontaneous persistent decrease in the number of platelets, associated with hemorrhagic
conditions) or phlebitis (inflammation of a vein) may be observed.
Warnings, Cautions, and Contraindications
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
The Tango M2 NIBP monitor is defibrillator protected. The pulse oximeter is not defibrillator protected.
WARNING: No modification of this equipment is allowed.
Ensure that appropriate resuscitation equipment and personnel are available at all times during the procedure.
All alarms indicate a potential increased risk of injury if the test is continued.
DO NOT USE the monitor if it has failed its diagnostic self-test, or if it displays a greater than zero pressure with no BP
cuff attached, or a value of oxygen saturation with no SpO2sensor attached. The values displayed by such a unit may
be inaccurate.
DO NOT USE on neonates, children, and patients known to be readily susceptible to bruising.
This system is contraindicated for use in the presence of a Magnetic Resonance Imaging (MRI) device.
Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an
arteriovenous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.

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CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in
blood flow interference and potentially harmful injury to the patient.
WARNING: Check periodically that operation of the AUTOMATED SPHYGMOMANOMETER does not result
in prolonged impairment of the circulation of the blood of the patient.
DO NOT apply the BP cuff over a wound as this can cause further injury.
DO NOT apply the BP cuff to the arm on the side of a single mastectomy. In the case of double mastectomy use the
side of the least dominate arm.
Too frequent BP measurements can cause injury to the patient due to blood flow interference.
Pressurization of the BP cuff can temporarily cause loss of function of simultaneously used monitoring equipment on
the same limb.
DO NOT attach the SpO2sensor to the same limb as the BP cuff or any other blood flow restrictors. Loss of
monitoring can occur due to the hindering of pulse measurements.
DO NOT USE in the presence of flammable anesthetics; this could cause an explosion. This monitor is not suitable for
use in an oxygen enriched environment.
Avoid compression or restriction of the patient cable tubing as it will affect the BP reading.
EXPOSURE TO FLUIDS: DO NOT immerse the monitor in any fluid, place fluids on top of, or attempt to clean the unit
with any liquid detergents or cleaning agents. This may cause an electrical hazard. Refer to the Cleaning section of
this guide for instructions on cleaning. If any of these situations occur, please contact SunTech Medical. Protection
Against Harmful Ingress of Water or Particulate Matter - Ordinary Equipment (no protection, IPX0)
DO NOT allow the SpO2sensor to become wet.
DO NOT use a damaged BP cuff or SpO2sensor. If the sensor is damaged in any way, discontinue use immediately
and replace the sensor.
DO NOT REMOVE UNIT COVERS. Doing so may expose hazardous voltage and cause electrical shock. The monitor
does not contain any user serviceable components.
DO NOT MAKE REPAIRS YOURSELF: No repair should be undertaken or attempted by anyone not having been service
trained by SunTech Medical or having a thorough understanding of the repair and operation of automatic blood
pressure equipment. (Substitution of a component different from that supplied might result in measurement error).
DO NOT position the monitor so that it is difficult to access and remove the power cord from the electrical supply.
The DC power connection to the monitor of the power cord are the means of disconnection to the supply mains.
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
DO NOT connect the monitor to equipment that does not meet EN60601-1. When the monitor is attached to a patient,
the monitor's 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™ MODE for auscultatory measurement of blood
pressure (during exercise).
SunTech Design
OSC MODE for oscillometric measurement of blood
pressure (non-exercise).
SunTech Design

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Patient Cable connection for BP cuff (pneumatic).
SunTech Design
Patient Cable connection for K-sound microphone.
SunTech Design
Warranty Seal
SunTech Design
ECG Input
SunTech Design
BNC external ECG trigger
SunTech Design
Headphone
SunTech Design
Power connection configuration - positive voltage;
negative shield.
SunTech Design
No serviceable parts inside
SunTech Design
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
•SDO# 5-103, IEC 7000:2014 Graphical symbols for use on equipment —Registered symbols
Symbol
Definition
Standard/Source
Warning message
ISO 7010-W001
Caution message
ISO 7000-0434A
SpO2Sensor. Type BF Applied Part
IEC 60417 - 5333
DC input.
IEC 60417-5031
USB-A or USB-B
Industry
Defibrillator protected
IEC 60417-5333

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ETL Classified
Intertek
Device may contain materials which may be
hazardous to human health.
WEEE Directive
Power On/Off
IEC 60417-5010
Refer to User Guide
ISO 7010-M002
No SpO2alarm
IEC 60417-5319
Attention, consult accompanying documents
ISO 7000-1641
Manufactured By
ISO 7000-3082
Manufacture Date
ISO 7000-2497
PSE Mark: Japanese Medical Device Approval
For indoor use only
IEC 60417-5957
Product complies with the requirements of the RoHS
directive, 2011/65/EU
RoHS Directive
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
and 65˚C
ISO 7000-0632
Shipping Humidity should be kept between 15% and
90%
ISO 7000-2620