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1.      Figure 5  Location of brachial artery       21    b  Slide the cuff sleeve up the patient   s arm  ensuring the ARTERY marker  points down the arm  Figure 6         Figure 6  Sliding of cuff up the arm    c  Place the ARTERY marker  which is where the microphone is located in  the sleeve  over the brachial artery  about 3 5 cm above the elbow  The  microphone should be on the medial part of the arm  not the top of the  bicep  Figure 7         Figure 7  Proper placement of microphone    KS    3  Wrap the cuff around the arm and secure  Figure 8   Use the wrist  strap to secure the cables to the patient        Figure 8  Wrapping of cuff around arm    Replacing the Microphone  When you receive the Tango  cuff  the microphone should already be properly  inserted  If you need to replace the microphone  follow these simple steps     1  Open the Velcro strap on the cuff and pull out the old microphone   2  Insert the new microphone through the sleeve  following the dash line  until  the microphone is touching the bottom of the sleeve and is right under the  ARTERY marker    3  Connect the microphone to the bladder hose  using the rubber ties    4  Close the Velcro flap over the cable      Note  Annual replacement of the microphone is recommended     23  Operation of Tango     Taking a Blood Pressure Measurement    1  The Tango  requires an ECG signal to take a measurement    e For Tango  monitors that are interfaced with a stress system  ensure that  your stress system   s ECG 
2.     Choose from 20 to 150 mmHg  with increments of 10  or set to  Of     When the heart rate exceeds this setting  an alarm sounds   Choose from 40 to 200 beats per minute  with increments of 10   or set to Off        Measurement Table  The Measurement Table shows the most recent blood pressure measurements in a  tabular format     Scrolls up or down the most SYS DIA  recent 50 readings  120 80    Select  Exits table and gives you 120 80  the option to clear all data  from the table     End Test    Use this menu to clear readings and prepare for a new patient     Yes  Choose this to clear readings and prepare the monitor for a new  patient           Keeps the readings and settings     20  Proper Cuff Placement    To accurately measure blood pressure during a stress test  it is important that the  Orbit K cuff is the correct size and is placed correctly on the arm     1  Choose the appropriate Orbit K cuff size   a  Without using the sleeve of the cuff  wrap the cuff around the patient s  upper arm  Figure 4         Figure 4  Sizing of cuff    b  To verity the correct size cuff  make sure the INDEX falls within the  cutt   s RANGE arrow  located on the inside of the cuff   If the INDEX  is outside the RANGE indicator  select a new cuff size  Caution   Remember that using a cuff that is the wrong size will result in false and  misleading measurements     2  Place the Orbit K cuff on the patient   s arm   a  Palpate the brachial artery between the bicep and the tricep  Figure 5 
3.   The diastolic  reading is above   Therefore  dashed lines will appear for that  150 mmHg  20 0   diastolic reading   kPa      SYS  gt  280  mmHg  37 3  kPa     SYS  lt  50  mmHg  6 7  kPa     DIA  gt  150  mmHg  20 0  kPa        DIA  lt  20  mmHg  2 7  kPa      HR  gt  200    BP  gt  280 150    mmHg     37 3 20 0 kPa     BP  lt  50 20    mmHg  6 7 2 7    kPa     The diastolic  reading is below  20 mmHg  2 7   kPa      Heart rate is    above 200 bom     Heart rate is  below 40 bpm     BP reading   both the systolic  and diastolic  readings   are above  280 160 mmHg   37 3 20 0 kPa      BP reading   both the systolic  and diastolic  readings  are  below 50 20  mmHg or     6 7 2 7 kPa      Therefore  dashed lines will appear for that  diastolic reading     Therefore  the reading can not be displayed    Note     this will be displayed in the heart rate  box when the heart rate is out of range      Therefore  the reading can not be displayed    Note     this will be displayed in the heart rate  box when the heart rate is out of range      Therefore  dashed lines will appear tor both  readings     Therefore  dashed lines will appear for both  readings        SYSTEM ERRORS  A System Error  monitor displays a System Error screen with a  5 digit error code  indicates a possible problem with the monitor   s hardware or  sottware  When this error occurs  the alarm will sound continuously  This alarm can  be muted by pressing the Down key  Pressing the Select key will clear the alarm  
4.  War e EE 46    4  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 Tango    This  manual and the Tango  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 is a registered trademark 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        2008 SunTech Medical  All rights reserved        Safety and Effectiveness Considerations  is a non invasive multi parameter      j Ahi O    oxygen saturation for use in cardiac  or exercise stress testing  It measures  and diastolic blood pressure and the  percent oxygen saturation of arterial    monitor measuring blood pressure and  STRESS BP and displays an adult patient   s systolic  blood     Indications for Use  Consider the following safety and effectiveness issues prior to using the Tango    Stress Test Blood Pressure Monitor     e Use Tango  only with adult patients  while they undergo a cardiac or exercise  stress test under the supervision of a physician  Ensure that appropriate  
5.  a greater than zero pressure with  no cuff attached     The monitor does not contain any user serviceable parts and should only be opened  by an authorized service representative  DO NOT remove covers or break the  warranty seal as this will void the manutacturer   s warranty     Calibration  It is recommended that the Tango  have its calibration checked annually to verity the  accuracy of the pressure transducers and indicators     Equipment Required    1  Calibrated electronic manometer or equivalent    2  500mL volume or the Orbit K Adult Plus cuff wrapped around something  that will not break or crush  no glass     3  Hand Inflation Bulb with bleed valve    4  Tubing  Tee pieces  and miscellaneous connectors or you can order the  T Tube Kit  SunTech Part   98 0030 00     Procedure    1  When the Main Measurement View is displayed  press the SELECT button 2  times  This will bring up the MAIN MENU screen    2  Using the UP or DOWN arrows  highlight MONITOR SET UP and press the  SELECT button    3  Using the UP or DOWN arrows  highlight VERIFY CALIBRATION and press  the SELECT button  The monitor will close its bleed valves and will display  on its screen the pressure applied to the patient hose connector    4  Verity the Tango  calibration by manually inflating and checking the  manometer against the pressure reading on the Tango  display  The  Display should be within  2mmHg of the pressure value on the mercury  manometer through a range of pressures trom 0 300mmHg  If n
6.  by  absorption and reflection from structures  objects and people        Field strengths from fixed transmitters such as base stations for radio  cellular cordless  telephones and  land mobile radios  amateur radio  AM and FM radio broadcast and TV broadcast cannot be predicted  theoretically with accuracy  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  is used exceeds the applicable RF compliance level above  the Tango  should be observed  to verify normal operation  If abnormal performance is observed additional measures may be necessary  such as reorienting or relocating the Tango         e Over the frequency range 150kHz to 80 Mhz  field strengths should be less than  V1  V m     4l    Recommended separation distances between portable and mobile RF  communications equipment and the Tango      The Tango  is intended for use in an electromagnetic environment in which  radiated RF disturbances are controlled  The customer or the user of the Tango    can help prevent electromagnetic interference by maintaining a minimum distance  between portable and mobile RF communications equipment  transmitters  and the  Tango  as recommended below  according to the maximum output power of the  communications equipment     Rated Separation distance according to frequency of transmitter meters  maximum  m     output power   150 kHz to 80 MHz   
7.  e Consult the manufacturer or field service technician for help     Portable and mobile RF communications equipment can affect Medical Electrical  Equipment  Use of accessories  transducers  and cables other than those specitied  may result in increased emissions or decreased immunity of the Tango   The  Tango  should not be used adjacent to or stacked with other equipment  If adjacent  or stacked use is necessary  the Tango  should be observed to verify normal  operation in the configuration in which it will be used     Guidance and manufacturer s declaration     electromagnetic emissions    The Tango  Monitor is intended for use in the electromagnetic environment  specified below  The customer or the user of the Tango  Monitor should assure  that it is used in such an environment     Emissions test Compliance   Electromagnetic environment     guidance    The Tango  Monitor uses RF energy only for  RF emissions Cue  its internal function  Therefore  its RF emissions  CISPR 11 are very low and are not likely to cause any   interference in nearby electronic equipment     Harmonic The Tango  Monitor is suitable for use  emissions Class A in all establishments  including domestic  IEC 61000 3 2 establishments and those directly connected to    Voltage the public low voltage power supply network  fluctuations    that supplies buildings used tor domestic  flicker emissions Complies purposes    IEC 61000 3 3       39    Guidance and manufacturer   s declaration     electromagnetic
8.  emissions    The Tango  Monitor is intended for use in the electromagnetic environment  specified below  The customer or the user of the Tango  Monitor should assure  that it is used in such an environment     IEC 60601   Compliance   Electromagnetic environment   Immunity test    test level level guidance    Electrostatic Floors should be wood  concrete or   discharge  ESD   6 kV contact ceramic tile  If floors are covered   IEC 61000 4 2  8 kV air with synthetic material  the relative  humidity should be at least 30       Electrical fast  2 kV for power supply  transient burst lines l l  IEC 61000 4 4  1 kV for input output Mains power quality should be that    lines    environment   Surge    kV differential mode  IEC 61000 4 5  2 kV common mode    of a typical commercial or hospital    Voltage dips   lt 5   U   gt 95   dip in U   short for 0 5 cycle Mains power quality should be that  interruptions of a typical commercial or hospital  and voltage 40   U  60   dip in U     environment  If the user of the  variations on for 5 cycles Tango  Monitor requires continued  power supply operation during power mains  input lines 70   U  30   dip in UI   interruptions  it is recommended that  IEC 61000 4 1 for 25 cycles the Tango  Monitor be powered   from an uninterruptible power    lt 5   U    gt 95   dip in U     supply or a battery   for 5 sec    Power  frequency   50 60 Hz   magnetic field    IEC 61000 4 8    NOTE  U  is the a c  mains voltage prior to application of the test l
9.  is erratic     Weak  missing  or no K sounds  detected  No BP  reported     The monitor will  terminate a BP  reading if the  patient cable   or BP cuff has  reached an  unreasonably   high pressure    No BP reported     Excessive  K sound noise or  arm movement   May result in no   BP reading     Review the solutions for CHECK ECG and  CHECK MIC     e Check that the microphone is positioned  over the brachial artery on the patient  see  Proper Cutt Placement  page 20     e Check that the patient cable microphone  and the connection to rear panel of the  Tango  are secure    e Review instructions for your stress system  interface with the Tango   Check that the  ECG trigger  under Main menu  gt  Monitor  setup B   Stress System  is correctly set    e Check that the microphone is flat  not bent   and that its wire is securely connected  It  they are not  the microphone needs to be  replaced    e Test microphone by tapping the cuff and    checking for a rising and falling signal  on the Waveform Display  If there is no  movement in the signal  the microphone  needs to be replaced    e Replace microphone and cuff annually     e Instruct your patient to drop his arm by  his side while a BP reading is in progress   avoid excessive bending of the arm     e Check that the patient cable is not being  pinched or blocked     Instruct your patient to drop his her arm by  their side and relax their arm while the BP  reading is in progress        K sounds were   BP reading may be inaccur
10.  monitor     NOTE  During a stress test  some patients    K sounds may continue to a very low  pressure or  in some cases  all the way to O mmHg  This is due to increased arterial  compliance  occurring as arteries dilate in response to exercise  When this occurs   there is usually a point where the K sound amplitude drops off sharply  continuing at  a reduced level  The pressure at which this sudden decrease in amplitude occurs will  be reported as the first diastolic reading  If the K sounds continue past that point for  10 mmHg or more  the second and final diastolic  diastolic tail  will be reported as  the cuff pressure where the sound disappears  An example of how this is displayed is  as follows     BP   180 93 58 mmHg    where    180    is systolic     93    is first diastolic and    58    is the second diastolic   K sound disappears   If the difference between the two diastolic points is less than 10  mmHg  only the first diastolic is displayed  If interfaced with a stress system  the Tango  will report the BP result as the systolic and first diastolic blood pressure to the stress  system     REES Kit  The headphone option of the Tango  will allow you to listen to the sounds  that are picked up by the microphone in the cuff  These sounds are similar  to those heard when taking a manual BP  Simply plug in the headphones to  the phono jack on the Tango    e The headphone kit should only be used as an evaluation reterence tool  The  headphones should not be used as a di
11.  the patient seated or  standing still    a  With the patient sitting or standing still  take a measurement using your  stress system or by pressing the START STOP button    b  As the measurement is being taken  watch the display for the cuff  pressure and wavetorm display    With the waveform display showing  K sounds  you should see K sounds  just as you would hear them it taking  a manual BP measurement with a  stethoscope    c  Once you take a reliable measurement  with Tango   you can proceed with  the stress test  If  after two attempts   you are unable to get an accurate  measurement with the Tango    consult the manual for Advice and  Troubleshooting tips  page 34      movement during a BP  reading    2  Conduct the Stress Test    a  Advise and support your patient to get  accurate BP measurements during the  stress test  Make sure the patient   s  arm is relaxed while a BP is measured   Below are a few tips tor keeping the  arm relaxed during a stress test    e If the patient is holding onto the  treadmill bar for support  advise ih  the patient to lightly grip the bar  is       Alternatively  ask the patient to turn This is an unacceptable  his her hand over so that the palm arm movement during a BP  is facing upward and resting on the reading  treadmill bar    e   Help your patient relax his her Figure 10  Limitations to  arm when a measurement is taken arm movement during     see Figure 10   stress test    26    As you take measurements with the Tango   pay close 
12. 0087 00 T SpO2 kit  Adult   Includes Xpod and Adult Finger Clip  Finger Clip See    9 1 0088 00    52 0003 00 Purelight   Adult Finger  ell Sensor    80 0001 06  30 00020 Se  27 0054 B1 Tutorial CD    99 0027 06 e Sie eas Extended warranty       year  arranty  99 0027 07 oe one Neat mace Extended warranty       year  Warranty  99 0027 08 E tec Extended warranty       year  Warranty  99 0027 09 Three Year Extended Extended warranty     3 years  purchased  Warranty           one time     51 0000 00    91 0076 00 Extension cable for  headphones       29  RS 232  amp  ECG Interface Cables    RS 232      AMEDTEC ECGpro 91 0013 00   91 0066 00  Burdick Quest 91 0013 00   91 0011 00    Cambridge Heart CH 2000  amp  91 0065 00  RS 232 and ECG     Hearlwave II    Delmar Reynolds CardioDirect with 91 0013 00   91 0066 00   CardioCollect   Esaote Formul   Biosound Esaote 91 0048 00 Formula P N 91 0049 00  Formul  for Archimed l i Formul  P N 91 0072 00  GE CardioSoft 91 0013 00   91 0009 00   GE CASE 91 0013 00   91 0009 00   GE CASE 8000 91 0013 00   91 0009 00   Marquette CASE 12 91 0012 00   91 0011 00    Marquette CASE 15 91 0012 00   91 0011 00  Marquette CASE 16 91 0012 00   91 0011 00    91 0012 00  Marquette Centra 91 0013 00 91 0011 00    Marquette Mac 5000 5500  Marquette Mac VU Stress  Marquette Sensormedics Max     Marquette Hellige CardioSys    Midmark Diagnostics  Qmark EZ Stress   91 0013 00   91 001 1 00  Mortara X Scribe 91 0013 00   91 001 1 00    Nasiff Associates Car
13. 80 MHz to 800 MHz   800 MHz to 2 5 GHz    of transmitter  ya 7  Watts  W    Se e         Note 1  at 80 MHz and 800 MHz  the separation distance for the higher frequency range applies   Note 2  These guidelines may not apply in all situations  Electromagnetic propagation is affected by  absorption and reflection from structures  objects and people        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 frequency of the transmitter  where P is the maximum  output power rating of the transmitter in watts  W  according to the transmitter  manufacturer     42    Frequently Asked Questions  FAQ s     Q     A      gt     How do   set up the Tango  monitor to work with my stress system    To setup the Tango  with your stress system  please visit the Tango  Interface  Notes on the Sunlech Medical website at www SunTechMed com and select  Customer Service    Downloads and under the Products section  select Tango    If your stress system is not listed  please contact us at 1 800 421 8626     The Tango  displays a status message  What does it mean and what do    do    See the reference guide  that is attached to your Tango   or the Advice and  Troubleshooting section  pg  34  for details on the Status Message and solution     The Tango  monitor returns results of 0 0 after blood pressure  measurements  What do   need to do to get a BP reading    There are certain 
14. ECG signal and the Korotkoff sounds  collected  by the microphone in the cuff  originate from the same source  meaning the patient     DISCLAIMER  If the stress ECG system manufacturer modifies the  communication protocol with the Tango  monitor without informing  SunTech Medical  you may experience difficulties communicating with  the stress system     13        At a Glance  Front Display   Main Measurement View   Double Product Heart Rate  Blood Pressure Result   SpO         Stat Key   Up Key   Down Key  Select Key    E Start Stop Key    Interval Indicator    Timer          Waveform Indicator  Status Display Cuff Pressure    Waveform Display    Figure 2  Front Display   Main Measurement View           STAT KEY     Starts or stops the Stat mode   page 24   UP DOWN   Helps you navigate through the screens     Selects measurement views of the data  Main Mea   SELECT KEY   surement View or Graph View  Also  lets you access  the Main Menu Selection and settings   page 16     START STOP Initiates a measurement or terminates one in prog   ress  Also  lets you stop the Stat mode        14    When the monitor is turned on  the Main Measurement View is displayed  This  screen displays the following elements while you take a measurement     e Blood Pressure Result  Displays latest or most current blood pressure     e Double Product  Displays the current workload on the heart in mmHg beats  per minute  SYS x HR 1000      e  SpO   Displays the current percentage of oxygen saturation in 
15. SE    SunTech Tango     STRESS BP             User Guide                 0 ES    115   83  2    BP MODE        Table of Contents    Copyright Int  rmalion gange gesteet Aeren 4  Safety and Effectiveness Considerations               cceccscceeeeecceccecceeesececeecees 5  IVAN Fs enee ed 5  buerger eege 5  Warnings and Contraindications               cccceeceecseceeceecsceececsceeeeeceeceesenees 6  stane el 7  dere TS ee Ee 7  Rear Pone  Oe I Eed EE dE 8  We ee 9  Power Supply Ledeieevtiesdtesd  uet erenn re ANE EAR Get  10  CO TNOCN IIS  reos EN 1   oiress Systemi E 12  E ENEE eet 13  Front Display   Main Measurement View    LS  Froni Display    raphi ENEE EE kee la  Main Menu Selections and Geittngs 16  E E ea a E EE 16  Neier E 17  IEF E AE fo passed EE 18  EE 19  Measurement Table             cccccceccceecceeeeeeueeeeueeeeueeeeueeeeueeeeueeteueeeeaeeeeneeees 19  E dE 19  Proper Cuff PIGCEMEGIN E 20  Operation of Tangot egesgd  eegugteeheer eege ege 23  Taking a Blood Pressure Measurement          0    ceccceccceeceeeeeeeueeeeuneeenneeenes 29  Beer Mii cererea E EE ER 24  EE 24  CG  ndudihg an Exercise eege To ssincswncinsiained sbsuavansntienvanaaninbiersanenspnuiiiane 25  EE eebe 27  SE E 2   Pe Oe ECO Inerace Cables ssureiiis oran 29  Maintenance and Cleonmg  31  Advice  amp  Troubleshooting BEE 34  SE tee 34  SC 38  Frequently Asked Questions IEACHTel  42  Slop hee Mele  EE 43  Specifications  Blood Pressure Measurement              cceeceecesceeceeceeeeeeeness 44  Lieti
16. Tango   See Figure 1   The  monitor will turn on  If the monitor is attached to a stress system  the Tango    will turn on and off along with the stress system    c  Connect the patient cable  P N 91 0001 00  to the K sound Microphone and  Pneumatic Hose Connector on the rear of the Tango   See Figure 1      It the Tango  has the Internal ECG option  the unit will come with an ECG patient  cable  P N 91 0004 00   Connect the ECG patient cable to the Internal ECG con     nection on the rear of the Tango   See Figure 1         Figure 1  Rear panel connections  DC Power In  BNC External ECG Pneumatic Hose   Connector  RS 232  K Sound Microphone    SpO   optional  Connector  Power Reset Switch Internal ECG  optional     8    Rear Panel Connections    Symbol    Power Reset Switch   RESET Resets the power on the monitor     For measurement of oxygen saturation     Type BF Applied Part     eg  se sas  Serial communication port for interfacing  RS 232 with stress systems or computers     BNC TTL port that allows a stress system  BNC External ECG to send an external analog or digital ECG  trigger signal to the monitor     SPO Option    DC Power In le   9V DC input    ECG patient cable connection     Internal ECG Option Detibrillator protected     J Connection for the patient   s cable  K Sound Microphone Ze microphone cable  Defibrillator  protected     Connection for the patient cable   s air    P tic Hos ibri  NEUMNO OSS hose  Defibrillator protected     Located on the side of the u
17. agnostic tool     Stat Mode    Tango  has the ability to take continuous BP measurements for time sensitive or  emergency situations by pressing the STAT key  The monitor will continue to take  measurements every 2 10 seconds for up to 15 minutes or until the STAT or START   STOP key is pressed    e   Stat Mode will measure either a Systolic and Diastolic BP measurement or  just Systolic BP measurement  Go to the Main Menu  gt  Measurement Setup   gt  Stat Mode Key to set the type of BP measurement to be taken in Stat  Mode  BP  Systolic and Diastolic  or SYS  Systolic only     e Full BP measurements can take as little as 30 seconds to display a  measurement    e Sys measurement can take as little as 15 seconds to display at measurement    e The measurement displayed on the screen will flash to indicate that the  monitor is in STAT mode  When the STAT mode is ended  the monitor will  return to its previous mode     25    Conducting an Exercise Stress Test  Atter your patient is properly prepared and a heart rate is displayed on Tango      you are ready to conduct a stress test  Remember  you can stop a measurement in  process by pressing the START STOP button     If your patient   s condition becomes unstable  and you need to monitor their BP more  closely  remember that you can place the monitor into Stat mode by pressing the  STAT Key  You can stop a measurement and or exit Stat mode by pressing the STAT  or START STOP button     1  Take 1 2 blood pressure measurements with
18. and  the monitor will rerun its internal tests  If the error occurs repeatedly  please contact  the SunTech Service Department or an authorized service agent     To test the System Error alarm tunction  press the Up key when power is applied to  the monitor  System Error    30000    should appear on the screen  Pressing the Down  key will mute the alarm  Pressing the Select key will end the test  the monitor will  complete its power up sequence and display the Main Measurement View     38  EMC Statement    This equipment has been tested and tound to comply with the limits for medical  devices to IEC60601 1 2  2001  These limits are designed to provide reasonable  protection against harmful interference in a typical medical installation  This  equipment generates  uses and can radiate radio frequency energy and  it   not installed and used in accordance with the instructions  may cause harmtul  interterence to other devices in the vicinity  However  there is no guarantee that  interterence will not occur in a particular installation  It this equipment does cause  harmtul interference to other devices  which can be determined by turning the  equipment off and on  the user is encouraged to try to correct the interference by one  or more of the following measures     e Reorient or relocate the receiving device    e Increase the separation between the equipment    e Connect the equipment into an outlet on a circuit different from that to which  the other device s  are connected   
19. ar  Fibrillation  Pacemakers  etc  that may limit the ability of Tango    to obtain an accurate reading     Range  Pressure  Heart Rate  40 200 BPM  Dia 20 150 mmHg  beats per minute   Sys  50 280 mmHg    Accuracy  Blood pressure measurements determined with this device are  equivalent to those obtained by a trained observer using the cuff   stethoscope auscultation method  within the limits prescribed by  the American National Standard  Manual  electronic or automated  sphygmomanometers     Conditions for   Operating   Use  10  C  50  F  to 40  C  104  F  Less than 95  RH non condensing     Storage    20  C   4  F  to 50  C  122  F  Less than 95  RH non condensing     The system might not meet its performance specifications if used or  stored outside the specified temperature and humidity ranges listed  above     Power  External power supply  use only SunTech part number 19 0012 00   Input  100 240 VAC   1 6A max  50 60 Hz  Output  9VDC    5A IEC 320 type input connector     Calibration  The accuracy of cuff  pressure transducers indicators should be  verified annually     Safety Systems    Independent hardware over pressure circuit and redundant  software overpressure algorithm to limit cuff pressure to less than  300 mmHg   20  1O0mmHg   Independent hardware timing  circuit and redundant software timer algorithm to limit the duration  ot a blood pressure cycle to less than 180 seconds     Dimensions  Sizes 77 6 cm  x 15 7 cm  x 9 7 ep ET xX 6 5  KAT   Weight  1 2 Kg  42 6 
20. arterial    blood   e Heart Rate  Displays current heart rate in beats per minute     e Waveform Display  Displays either the K sound or the ECG signal   see View  gt  Waveform Display on page 18     e Waveform Indicator  Displays K for K sound or E for ECG     e Status Display  Displays current measurement mode  BP or SYS   see Measurement Setup    Measurement Mode on page 17     e   Interval Indicator  Displays the interval mode the monitor is in   see Measurement Setup  gt  Interval on page 17     e   Timer  When Interval Indicator is set to MAN  displays how old the BP  measurement is  When set to a time interval  the timer displays the time until  next reading occurs     e Cuff Pressure  Displays current pressure in the cuff     15  Front Display   Graph View    Current BP  Cuff    Graph of all BP results Pressure Selected measurement       Figure 3  Front Display   Graph View    If you are on the Main Measurement View  pressing the SELECT key once will  navigate to the Graph View  The Graph view displays the same information in the  bottom section as the Main Measurement View  The top of the Graph View shows the  following elements while you take a measurement     e Graph of all BP results  Displays all blood pressure results in a study  up  to 30 measurements   Use UP DOWN buttons to navigate through the  measurements     e Note  Measurements with status messages will be omitted from the graph     e Current BP Cuff Pressure  Displays current blood pressure at the end o
21. asurement  Select a setting trom 120 to 280 mmHg   increments of 10    Deflate Rate  Choose AUTO for normal deflation of the cuff pressure   Otherwise  enter a rate for special situations  such as standards  testing  Enter a rate trom 3 to 8 mmHg sec     Beeper  Choose when the Tango  will make a sound indicating when the  measurement is started or completed   BOTH  Beeps at the beginning and end of a measurement   NONE  The system will not beep   START  Beeps at the beginning of a measurement   FINISH  Beeps at the end of a measurement   Stat Mode Key    Choose the measurement made by the monitor when in Stat  mode   BP  systolic and diastolic measurements  SYS  systolic measurements only  All measurements are made with the AUTO deflate rate        18    View  Use to modity the display settings     Waveform Choose the type of waveform that will be displayed    Display  K sound  This will display the Korotkott sounds detected by  the Orbit K cuff microphone  Choose this tor normal  operation    ECG  Choose this when you are checking for a proper  triggering signal    Note  ECG waveform is not for patient diagnosis  ECG  wavetorm will automatically reset to the K sound mode  atter 60 seconds     Graph Display    Choose the measurement you want to view in the Graph view   HR  DP  or SpOsz   BP Reset After    Set how long the last BP displays  Choose between  in minutes   1  2  3  5  10 or select Never to always display the last BP    BP Shrink Set how long the last BP displays 
22. ate  Advise the  detected within   patient to drop arm to the side during the  1O0mmHg of   BP reading  avoid excessive bending   Take  the target another BP reading   cuff inflation  pressure  DP   Note     Cuff will inflate to max pressure on  reported  next BP reading     INFLATION  TOO LOW    Due to safety  reason  a BP  MEASUREMENT   measurement  DELAYED could not be  taken at that   time     The next BP reading will occur as scheduled     e Review instructions for your stress system  interface with the Tango   See Tango   Setup  page 7   Check to see that your  Stress System  if Custom  check the ECG  The monitor is Trigger  is correctly set   not receiving an      Check that the cables referred to in the  ECG signal  instructions are correctly seated to their  connectors and show no signs of damage   e Set the Waveform Display  under View    NO ECG  DETECTED    in the Main Menu  to ECG to verity the  monitor is receiving an ECG Signal     The BP  measurement   Initiate a new BP reading via the Stress  needs to be System or the Tango  START STOP key   repeated     REPEAT BP    Contact your nearest Sun lech Medical  SERVICE Service Department or authorized service  REQUIRED agent  The unit must be sent to SunTech  Medical tor repair     Systolic reading  is above 280   Therefore  dashed lines will appear for that  mmHg  37 3   systolic reading   kPa      The systolic  reading is below   Therefore  dashed lines will appear for that  50 mmHg  6 7   systolic reading   kPa  
23. attention to the  status display and waveform display  It the status display shows a status  message  consult the manual tor Advice and Troubleshooting tips  page    34      3  End Study     a     When the stress test is over and you no longer need to take blood  pressures  press the SELECT key to display the main menu  Select END  TEST and YES to clear the display of the last measurement and prepare  the monitor for the next patient    If you have the New Patient setting  under Main Menu  gt  View  gt  New  Patient  see page 18 for details  set to AUTO  Tango  will automatically  prepare for a new patient once the ECG trigger signal is lost for 1  minute     27  Accessories    Pulse Oximetry  SpO   optional    The Tango  is equipped with an option for pulse oximetry  P N 98 0087 00   This  option allows you to measure the oxygen saturation of arterial blood  Simply plug   in the sensor module cable to the Spa receptacle on the rear panel of the Tango    and attach the sensor to your patient as described below  After a few seconds    a measurement will be displayed on the main measurement screen  The Sp    value is updated once per second  Spa can also be displayed in the graph view   Go to Main menu  gt  View  gt  Graph Display and choose Sp  Please note the  precautions that apply to pulse oximetry  You can replace the sensor by unplugging it  from the module and plugging in the new sensor     CAUTION  Patient sensitivity may vary due to medical status or skin  condition  D
24. connections are properly prepared and connect  the electrodes to the patient    e For Tango  monitors with the Internal ECG option  prepare and connect  the 3 ECG electrode sites  RL  V2  and V6 to the patient  Figure 9         Figure 9  ECG Connections    o Ensure that each electrode is placed over a bony area and not  over a large muscle mass which may cause excessive noise   o Prepare the skin at each electrode by shaving any body hair and  cleaning the site thoroughly with alcohol   o For best results  the skin impedance should be less than 5  kohms as measured by a skin impedance meter   o Connect the ECG cable to the electrodes as follows   o Green lead to RL  o Yellow lead to V2  o Violet lead to V6    2  Place the Orbit K cuff on the patient   e Ensure the cuff is properly placed on the arm for reliable and accurate  blood pressure measurements     3  Ensure a stable heart rate is displayed on the monitor   e A stable heart rate must be displayed on the monitor tor Tango  to be  able to obtain an accurate reading   e  fno heart rate is displayed on the monitor  or the heart rate is erratic     consult the NO ECG DETECTED status message located in the Advice  and Troubleshooting section of this manual  page 34      24    4  Take a Blood Pressure Reading  e tthe Tango  is interfaced to a stress system  prompt Tango  for a  measurement via the stress system   e    f the Tango  has the Internal ECG option  prompt Tango  for a  measurement by pressing the START STOP on the
25. dio Card  Nihon Kohden Cardiofax ECG 9320A  Nihon Kohden Cardiofax 1550 1560  Norav Stress  Oxford Medilog Stress PBI QRS Card  Philips Stress Vue  Quinton T a e    Quinton Q4500 91 0013 00   91 0018 00    Medset Flashlight Ergo 91 0013 00       30  RS 232  amp  ECG Interface Cables    RS 232 A    Quinton Q5000 91 0020 00   91 0018 00    91 0013 00   91 0018 00  Schiller AT10 AT60 CS 200 91 0035 00   91 0022 00  Welch Allyn CardioPerfect Workstation   91 0013 00   91 0018 00       Splitter Cables    GE CASE   use with echocardiograph 91 0053 00  GE CASE 8000   use with echocardiograph 91 0053 00       Marquette Sensormedics Max 1   use with echocardiograph 91 0053 00  Marquette MAC 5000 5500   required 91 0069 00    31  Maintenance and Cleaning    Preventative Maintenance   Establishing simple care guidelines helps protect the performance and life of your  Tango   Ona routine basis  you should inspect the device  cables and pneumatic  hoses for cracks  traying or kinks and immediately replace any damaged parts     The monitor performs a range of system and software checks during normal  operation  reporting to the user the operational status via the Status Display  Once  the monitor is on and the Main Measurement View is displayed  ensure that the  monitor   s status display indicates the correct measurement mode  Also  verity that the  cuff pressure is 0 mmHg when no cuff is attached  DO NOT use the monitor if it has  failed any of its diagnostic self tests or if it displays
26. e following stress systems are compatible with Tango      AMEDTEC ECGpro   Burdick Quest   Cambridge Heart CH 2000 Hearlwave II   Delmar Reynolds CardioDirect with CardioCollect  Esaote Formul   Biosound Esaote Formul  for Archimed  GE CASE  CASE 8000   GE CardioSott   Marquette CASE 12  15  16  Centra  Marquette Hellige CardioSys   Marquette MAC 5000 5500   Marquette MAC VU Stress  Marquette Sensormedics Max      Medset Flashlight Ergo   Midmark IQmark EZ Stress   Mortara X Scribe   Nasitt Associates Cardio Card   Nihon Kohden ECG 9320A  1550 1560   Norav Stress ECG   Oxtord Medilog Stress   Pulse Biomedical QRS Card   Philips StressVue   Quinton Q Stress  Q 5000  Q 4500  Q 4000  Q 3000  710  Schiller AT 10  AT 60  CS 200   Sensormedics Vmax   Viasys Encore Vmax    Welch Allyn CardioPertect    12  Stress System Setup    To setup the Tango  with your stress system  please visit the Tango  Interface Notes  on the SunTech Medical website at www SunTechMed com  Select Customer Service   gt  Downloads and under the Products section  select Tango   If your stress system is  not listed  please contact      1 919 654 2300  US    44 0  1865 884 234  EMEA    852 2251 1949  Asia  amp  Pacific     To test the stress system setup with Tango    you will need to hook up a patient with  ECG leads and take a blood pressure measurement  You cannot use a heart rate or  blood pressure simulator to test whether the Tango  is working with your stress system   The Tango  monitor requires that the 
27. elf by pressing any key  If you turn it on  the  monitor will turn off after the time selected in this setting     System Info  Displays firmware version and internal serial board number of  the Tango      Power Off After    Set the time after which the monitor turns off after no activity        17    Measurement Setup  Use to modity the blood pressure measurement settings     Measurement   Choose the monitor measurement  BP or SYS    Mode  BP includes both systolic and diastolic measurements and  detlates at the specified deflate rate  see Deflate Rate below    SYS is a systolic measurement only and detlates at the AUTO  deflate rate  resulting in faster measurement times     Interval  Set to MAN when interfacing a stress system with Tango   so the  stress system can prompt Tango  tor a measurement  Also used  it you want to initiate each measurement using the START STOP  key    Otherwise  select a time interval  in minutes  between BP  measurements  The time intervals are 1 00  1 30  2 00  2 30   3 00  4 00  5 00  10 00  or 20 00  It a specitic time interval  is chosen  you must press the START STOP key for Tango  to  take the first measurement  The Tango  will then automatically  initiate BP measurements at the specitied interval     Initial Inflate    Choose the pressure to which the cuff will inflate on the first  measurement of a study  Select a setting trom 120 to 280 mmHg   increments of 10      Max Inflate  Choose the maximum pressure allowed in the cuff during a  me
28. equently to determine the positioning of the  sensor and the circulation and skin sensitivity of the  patient     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    Adverse Reactions   In the area of the cuff or sensor  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 cuff  petechia  a  minute reddish or purplish spot containing blood   that appears in the skin  formation 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     Tango  Setup  Tango  Hardware Setup    Your Tango  will come with a power supply  a patient cable  and an Orbit K cuft s   with a microphone    a  Connect the power supply to a power cable and plug the cable into an avail   able outlet    b  Connect the power supply  P N 19 0012 00  to 
29. evel    In the event of a power loss to the monitor  all data and user settings are saved  The  monitor will power up with the same settings and data as prior to the power loss     Power frequency magnetic fields  should be at levels characteristic  of a typical location in a typical  commercial or hospital environment        40    Immunity   IEC 60601   Compliance Electromagnetic environment   test test level level guidance    Portable and mobile RF communications  equipment should be used no closer   to any part of the Tango   including  cables  than the recommended  separation distance calculated trom the  equation applicable to the frequency of  the transmitter     Recommended separation distance    d    22  vp    V   ai 3 Vrms J9  150 kHz to  Ge 80 MHz S  61000 4 6 d   j 800 Mhz to 2 5 GHz  3 V m a  Radiated Where P is the maximum output  80 MHz to Sep  RF IEC 25 GHz power rating of the transmitter in  6 1000 4 3 watts  W  according to the transmitter  manufacturer and d is the recommended    separation distance in meters  m        VP 80 Mhz to 800 Mhz    Field strengths from fixed RF transmitters  as determined by an electromagnetic  site survey     should be less than the  compliance level in each frequency        Interference may occur in the WI  vicinity of equipment marked  with the following symbol    Note 1  At 80 MHz and 800 MHz  the higher frequency range applies    Note 2  These guidelines may not apply in all situations  Electromagnetic propagation is atfected
30. f a  measurement  Displays current pressure in the cuff during a measurement     e Selected Measurement  Displays one of the following measurements  HR    SpO   or Double Product   See View  gt  Graph Display on page 18      16  Main Menu Selections and Settings    Press the Select key to access the MAIN MENU  Press the UP DOWN keys to  navigate through the MAIN MENU and then press the SELECT key to confirm your  choice  To exit out of the MAIN MENU  select EXIT and you will return to the Main    Measurement View     MAIN MENU  MONITOR SETUP  MEASUREMENT SETUP  VIEW  ALARMS    MEASUREMENT TABLE  END TEST  EXIT       Monitor Setup    Use to set up and maintain the monitor     Select your stress system model that will interface to the  Tango   Fora custom model  select CUSTOM and then  choose the correct protocol and type of ECG trigger    If you are using the Internal ECG option  you must select    CUSTOM and then set the ECG Trigger to INTERNAL     Choose English  French  German  Italian  or Spanish  Set this to the current time  Defaults as 00 00     Contrast  Set monitor contrast for optimum display trom   0 255 where O is darkest and 255 is lightest   Verify Displays cuff pressure for veritying calibration of the monitor   Calibration  Press the Select Key to quit     Stress System    Set it to 10 minutes  30 minutes  or Never     If Tango  is attached to a stress system  the Tango  turns on  and off along with the stress system  However  you can turn the  monitor on yours
31. f a blood pressure reading  To avoid this problem with  subsequent measurements  follow the appropriate solutions below     The monitor will  terminate a BP   eCheck that the cuff or the patient cable is  reading if the not leaking on inflation   target inflation is    Check that the patient cable is properly  not reached in connected to the monitor   60 seconds     AIR LEAK    Ensure that a heart rate is displayed on the  Tango   If so  try again     Set the Waveform Display  under View in the  Main Menu  to ECG to verity the monitor is  receiving an ECG Signal    elt the signal is present  take another BP  reading  It it fails to measure a BP the  patient may have ECG problems which  prevent the Tango  trom working properly    elf the signal is not present    eCheck ECG lead connections are secure  along the ECG patient cable and at the  electrodes    e Ensure electrodes are correctly positioned   prepared and attached    e Review instructions for your stress system  interface with the Tango    See Tango    Setup  page 7   Check to see that your  Stress System  if Custom  check the ECG  Trigger  is correctly set    e Check that the cables referred to in the  instructions are correctly seated to their  connectors and show no signs of damage     ECG signal is  weak  erratic or  CHECK ECG   missing for more  than 3 seconds   No BP reported        CHECK ECG   MIC    CHECK MIC    CUFF OVER   PRESSURE    EXCESSIVE  ARM  MOVEMENT    Weak or missing  K Sounds and  the ECG signal   
32. in a larger font  Choose  After  between  in minutes  1  2  3  5  10 or select Never to always  display the larger font     New Patient  Set how the monitor prepares for a new patient   Auto  The system automatically prepares for a new patient   Prompt  The system will ask you if you have a new patient     To prepare the monitor for a new patient  Tango   will do the  following   e   Set back to the Initial Inflate Pressure  e The Main Measurement View will display           for all  parameters until they are measured  e The Graph View will not display any data points     BP Pressure Choose the units of measurement you want the BP measurements  Units  to be displayed in  mmHG or kPa       19    Alarms   Alarms alert you to changes in blood pressure or heart rate  Alarms are only  activated at the end of a BP measurement  An alarm of 5 beeps will sound along with  a message in the status display  Alarms can be set for systolic blood pressure being  too high  SYS HIGH  or too rapid of a decrease  SYS DROP   and for diastolic blood  pressure or heart rate being too high  DIA HIGH or HR HIGH  respectively     Sys High  When the systolic BP exceeds this setting  the alarm sounds   Choose trom 50 to 280 mmHg  with increments of 10  or set to  Off    Sys Drop  When a drop in systolic BP between measurements exceeds this  setting an alarm sounds  Choose from 10 to 100 mmHg  with  increments of 5  or set to Off     Dia High  When the diastolic BP exceeds this setting  an alarm sounds 
33. iscontinue use of adhesive tape strips if the patient exhibits an  allergic reaction to the adhesive materials     Preparing the Patient for Pulse Oximetry   Finger Application  CAUTION  Some nail polish colors  particularly dark shades  or artificial  nails may reduce light transmission and affect pulse oximetry accuracy   Remove any nail polish or artificial nails betore using the sensors     To Attach the Adult Articulated Finger Clip Sensor     1  Insert a finger  preferably the index  middle or ring finger  into the Adult  Articulated Finger Clip Sensor  Figure 13  until the end of the finger reaches the  finger stop  Keep the fingernail facing the sensor top  Ensure that long tingernails  are not interfering with proper finger position     2  For the best results when using the sensor for data collection  secure the sensor  cable independently from the sensor with medical tape  preterably around the  base of the fingers  Make sure that the tape securing the cable does not restrict  the blood tlow  The thumb is not recommended for use with the Adult Articulated  Finger Clip Sensor        Figure 13    Note  It the sensor is not positioned properly  light may by pass the tissue  and result in pulse oximetry inaccuracies  Proper sensor placement is critical  for good performance     28    Se  19 0012 00  Powersu   O OOS  71 0001 00  Patient Cobi 15  SSS    91 0004 00   ECG Patient Cable   only for Tango  with internal    SCrewsS    28 0003 00  98 0030 00 For  a check    98 
34. lbrand disinfectant  2  glutaraldehyde  solution  or Wescodyne  If disinfectants are intended to control infection  use your  facility   s established protocol  For sterilizing  use your tacility   s established protocol   Do not use the following methods for sterilization  autoclave  radiation  or steam   When necessary  cables and leads can be sterilized in ethylene oxide  ETO  gas     SpO  Sensors   Clean the sensor with a soft cloth dampened with a mild detergent or isopropyl  alcohol  Ensure that all tape residues are removed  Allow the sensor to dry  thoroughly before reusing     CAUTION  Never immerse sensors and clips in fluids  Do not pour or  spray any liquids onto the sensor  Caustic or abrasive cleaners will cause  permanent damage     NOTE  Do not open the case of the adult tinger clip sensor more than 90    or the case may be damaged  Figure 11 shows the appropriate opening of  the case for cleaning        34  Advice  amp  Troubleshooting    Status Messages   If there is significant noise  as you may note on the Waveform Display  during a  measurement  the Tango  will have problems getting a reliable measurement   Status messages appear over the Status Display in the Main Measurement view or  the Graph View immediately atter a reading to indicate that there was a problem  during that measurement  Some errors will produce prompts that will appear over  the BP measurement that provide suggestions to resolving an issue  Status messages  inform you of the validity o
35. lly packaged and shipped prepaid  To     Sunlech Medical  Inc  OR Suntech Medical  Ltd   Service Department Service Department  507 Airport Boulevard  Suite 117 Oaktield Industrial Estate  Morrisville  NC 27560 8200 USA Enysham  Oxtordshire OX29 4TS UK  Tel    1 919 654 2300 Tel   44  0  1865 884 234    1 800 421 8626 Fax   44  0  1865 884 235    Fax    1 919 654 2301    The instrument will be repaired in the shortest possible time and returned prepaid by  the same shipping method as received by the factory     This limited warranty is void if the instrument has been damaged by accident  misuse   negligence  act of God or serviced by any person not authorized by Sun lech Medical   Inc     This limited warranty contains the entire obligation of Sun lech Medical  Inc  and  no other warranties expressed  implied or statutory are given  No representative or  employee of Sun lech Medical  Inc  is authorized to assume any further liability or  grant any further warranties except as herein     48    Index    A    C    F    M  Main Menu    P    S    T    Accessories    Interface Cables  Pulse Oximetry  Finger Application  Pulse Oximetry  SpO2    Copyright Information    EMC Statement    Front Display    Graph View    Main Measurement View    Alarms   End Test  Measurement Setup  Measurement Table  Monitor Setup   View    Proper Cuff Placement    Replace Microphone    Safety and Effectiveness    Indications for Use  User Responsibility    Specifications    BP Measurement  Pulse Oximet
36. modify the contrast of the screen  When  you are finished  and press the SELECT button to confirm the choice    5  Using the UP or DOWN arrows  select EXIT twice to return to the Main  Measurement View     43    Q  How do   clean the cuff after a stress test   A  To clean the cuff after a stress test  you can do either of the following   e Remove the bladder and microphone trom the shell  Machine wash the shell  in warm water with a mild detergent  50 140  F or 10 60  C   Line dry the  cuff     e Use a medical grade mild disinfectant on the cuff  Afterwards  line dry     Service Centers    For customers in the Americas   Sunlech Medical  Inc   Service Department  507 Airport Boulevard  Suite 117  Morrisville  NC 27560 USA  Tel  919 654 2300  Fax  919 654 2301    For customers in Europe  the Middle East  Africa  Asia  and the Pacific   Sunlech Medical  Ltd   Service Department  Oaktield Industrial Estate  Eynsham  Oxtordshire OX29 4TS  United Kingdom  Tel   44  0  1865 884 234  Fax   44  0  1865 884 235    44    Specifications  Blood Pressure Measurement    Measurement    Auscultatory  using R wave gating and k sound analysis  during  all static and active phases of stress testing  Systolic pressures  correlate to a K 1 Korotkoff sound  Diastolic pressures correlate  to K 5 Korotkoff sound    The device is designed to function in the presence of a normal  ECG sinus rhythm  There are some physical conditions  i e   Bundle Branch Block  Arrhythmias  Arial Fibrillation  Ventricul
37. nit next to the    Headphone Kit Power Reset switch  not pictured above        Tango  Rear Labels    ETL Certitied    Y Power supply contains materials which are hazardous  Must be  disposed of properly     No SpO  alarm    A Attention  consult accompanying documents     Class Il isolation equipment     C CE Approval  413    A   im    ech Warranty Seal  BROKEN  my Manutactured By    Manufacture Date       10  Power Supply Labels    External power supply  only use the Sun lech power supply with Tango     Input   100 240 VAC   1 6A max  50 60 Hz  Output  9VDC   5A    Em    Recognized component certitied by UL to both Canada and U S      A  requirements    TUV International Approval    Attention    Class Il Isolation Equipment    Earth Ground    TUV Canada and United States Approval    Power Supply contains material which are hazardous  Must be  disposed of properly    seg connection configuration   positive voltage  negative shield  PSE Mark       11    Compatible Stress Systems    Tango  can be setup to work directly with your stress system  If the Tango  is  interfaced with a stress system  the stress system can prompt Tango  to take a BP  measurement while you are conducting a stress test  In addition  some stress systems  will transfer the blood pressure measurement and heart rate trom Tango  to your  stress system where it will be displayed on the screen and printed on any reports  The  Tango  can be used as a stand alone only if the unit has the Internal ECG option     Th
38. noisy conditions where the Tango  cannot accurately measure  BP When the Tango  encounters these situations  it returns a reading of   0 0  Placement of the microphone attached to the cuff is critical for reliable  operation of the Tango   Follow the instructions in the Cuff Tutorial located on  the Sunlech Medical website at www SunlechMed com and select Products  gt   Tango     amp  View Orbit K Cuff Tutorial for correct microphone placement  Follow  steps 1 and 2 in Conducting the Stress Test in the User   s Guide to provide the  best conditions to obtain a measurement     Can   use a heart rate or blood pressure simulator to test whether the  Tango  is working correctly with my stress system    You cannot use a heart rate or blood pressure simulator to test whether the  Tango  is working with your stress system  The Tango  monitor requires that the  ECG signal and the Korotkotf sounds  collected by the microphone in the cuff   originate from the same source  meaning the patient       cannot clearly see the Tango  display  How do   fix this    If you cannot clearly read Tango   you can adjust the contrast of the display by   following these steps    1  When the Main Measurement View is displayed  press the SELECT button 2  times  This will bring up the MAIN MENU screen    2  Using the UP or DOWN arrows  highlight MONITOR SET UP and press the  SELECT button    3  Using the UP or DOWN arrows  highlight CONTRAST and press the SELECT  button    4  Using the UP or DOWN arrows  
39. ntraindications    CAUTION  Federal  U S   law restricts this device to    sale by or on the order of a physician     DO NOT USE THE MONITOR IF it   has failed its diagnostic self test or if it   displays a greater than zero pressure   with no cuff attached or a value of   saturation with no sensor 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     DO NOT ATTACH THE CUFF to a limb being used  for IV infusions as the cuff inflation can block the  intusion  causing harm to the patient     DO NOT ATTACH THE PULSE OXIMETER  SENSOR to the same limb as the 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     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 Maintenance  amp  Cleaning  for instructions on cleaning  If any of these situations  occur  please contact SunTech Medical     DO NOT REMOVE UNIT COVERS     Doing so may expose hazardous voltage and cause    electrical shock  The monitor does not contain any    user serviceable components  Refer to Maintenance  amp   Cleaning for service instructions     DO NOT MAKE REPAIRS YOURSELF  No repair  should be undertaken or at
40. ot  contact  Sun lech Medical about calibration    5  Once the calibration has been completed  press the SELECT button to exit  the calibration screen  Then press the UP or DOWN arrows to select EXIT  twice and return to the Main Measurement View     32    Disposal   This symbol indicates the monitor contains materials  such as  electrical components  which are hazardous  Please return to  SunTech Medical tor disposal     WARNING  Fire  explosion and severe burn hazard  The unit  contains a lithium battery that must be disposed of properly  or returned to Sun lech Medical tor disposal        Pulse Oximeter  Cautions     Do not immerse the sensor in liquid     Do not use caustic or abrasive cleaning agents on the sensors     33  Cleaning    Monitor  Betore cleaning  disconnect the power supply from the monitor  Wipe the device with  a soft  damp cloth to remove surface dust and dirt     CAUTION  The Tango  is not sterilizable  Do not immerse the monitor in  any fluid or attempt to clean with any liquid detergents  cleaning agents  or  solvents     Cuffs    Use a mild medical grade disinfectant on the cuff sleeve and inside of the cuff  between patients  Periodically  remove the bladder  machine wash the shell of the cuff  in cold water and line dry     ECG Cables    For routine cleaning  use a soft cloth to apply a mild soap and water mixture  Remove  any residue and wipe dry  For disinfecting the cables  use a hospital approved  disintectant such as 1 10 chlorine bleach  Lyso
41. oz        Standards  UL60601 1  CAN CSA C22 2 601 1  EN 60601 1  IEC 60601 2 30  IEC 60601 1 2  EMC   IEC  60601 2 49  ISO 9919  AAMI SP10 2002   Al 2003    Meets EN 1060 1  Specitication for non invasive    sphygmomanometers     Part 1  General requirements and   EN 1060 3  Non invasive sohygmomanometers     Part 3   Supplementary Requirements for Electro Mechanical BP Measuring  Systems     Classifications    Equipment Classification  Class Il  Mode of Operation   Continuous        Specifications  Pulse Oximetry       70   100    2 digits    1 Standard Deviation           Standard Deviation is a statistical measure up to 32  of the readings may  fall outside those limits     46  Limited Warranty    Sunlech Medical  Inc  provides to the original purchaser the following limited  warranty trom date of invoice     All serialized monitors 24 months  Orbit K Cuffs 6 months  Accessories  i e  patient 90 days    cables  disposables    Sunlech Medical  Inc  warrants each instrument to be free from defects in material  and workmanship  Liability under this warranty covers servicing of the instrument  when returned from the customer   s facility within the United States prepaid to the  factory  Sunlech 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 Sun lech Medical  Inc  of the  suspected defect  The instrument should be carefu
42. resuscitation equipment and personnel are available at all times during the  procedure    e The Tango  BP monitor is defibrillator protected  The pulse oximeter is not  defibrillator protected    e All alarms indicate an increasing risk of injury if the test is continued    e The reliability of the device depends upon conformance with the operation and  service instructions  as detailed in this manual     User Responsibility   Your Tango  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     e Check calibration of this device annually    e Never knowingly use a defective device    e Immediately replace parts that are broken  warn  missing  incomplete  damaged  or contaminated    e Contact the nearest factory approved service center should repair or replacement  become necessary  A list of approved service centers appears on page 42 or on  our website at www SunlechMed com    e 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  fault maintenance  improper repair  damage or alteration by  anyone other than SunTech Medical or authorized service personnel     6    Warnings and Co
43. ry    Tango  Operation    Calibration  Cleaning   Cuffs   ECG Cables   Monitor   SpO2 Sensors  Disposal  Exercise Stress Test  Headphone Kit  Maintenance  Pulse Oximeter  Stat Mode  Taking BP Measurement    38    13  15  13    23  3   33    33  33    Ee  25    3   32    23    Tango  Setup  Hardware Setup  Power Supply Labels  Rear Panel Connections  Stress Systems  Stress System Setup  Tango  Rear Labels   Troubleshooting  FAQ s  Service Centers  Status Messages    W    Warnings  Warranty    10    1   12    34  42    34                SunTech Medical    Sum lech Medical  Inc    507 Airport Boulevard  Suite 117   Morale Fan Oa solo ene VA0 ORUNYAN   Tel    1 919 654 2300  1 800 421 8626   Fax    1 919 654 2301    www SunlechMed com    Sun Tech Medical  Ltd    Oakfield Industrial Estate    Eynsham  Oxfordshire OX29 4TS  UK  Tel   44  0  1865 884 234   Fax   44  0  1865 884 235    Ee    www SunlechMed com    SunTech Medical  Ltd   Level 25  Bank of China Tower  1  Garden Road Central    Hong Kong  Te 832223 e C        Rone 9322253119250 0413    www  Sun TechMed com par  80 0001 06 Rev  F   11 10 08       
44. tempted by anyone not  having been service trained by Sun lech 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 allow the pulse oximeter sensor to become  wet     DO NOT use a damaged pulse oximeter sensor     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  CAN ONLY BE CONNECTED TO EQUIPMENT  THAT MEETS EN60601 1     PRECAUTIONS  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 cuff  pulse oximeter sensor  and electrodes  if  applicable  trom the patient     Accuracy of any blood pressure recording or oxygen  saturation measurement may be affected by the  position of the subject  his or her physical condition  and use outside of the operating instructions detailed  in this manual  The interpretation of blood pressure  and oxygen saturation measurements should only be  made by a physician     Satety and effectiveness in pregnant women  children  under the age of 18 years of age and neonates have  not been established     Only use pulse oximeter sensors supplied by SunTech    Medical     Check the application site of the pulse oximeter  sensor fr
    
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