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Tango M2 User Manual

1. Esaote Biosound Esaote Formul Formula Formul Biosound Esaote Formula for Achimed Formula Formul GE CardioSoft v6 01 Case Case 8000 GE CardioSoft Case 8000 GE Marquette Case 12 Case 15 Case 16 Centra Case 12 Case 15 Case 16 or Centra MAC 5000 5500 Mac 5000 5500 MAC VU Mac Vue Stress nde Hellige CardioSys CardioSys Sensormedics Max 1 Max 1 LifeSync Wireless SUNTECH Internal MedSet Flashlight ERGO PADSY by MedSet Medset Midmark Diagnostics IQmark EZ Stress IQmork EZ Stress Mortara X Scribe X Scribe Nasiff Associates Cardio Card Cardio Card Nihon Kohden Cardiofax ECG 1550 1560 ECG 1550 1560 Cardiofax ECG 9320A ECG 1550 1560 Norav Stress ECG SUNTECH Digital Rising StressVue 2nd Gen StressVue Philips StressVue 1st Gen StressVue QRS Card QRS Card Pulse Biomedical QRS Oxtord Medilog Stress Medilog Stress 71 72 Stress System Manufacturer Stress System Pre Configured Setting Create a Custom Setting Protocol ECG Trigger CardioSott CardioSys Max Max Sensormedics Vmax SMC 38 lead SUNTECH Internal CASE 8000 Case 8000 AT10 AT60 AT 10 AT 60 Schiller AT10Oplus AT 10 AT 60 CS 200 CS 200 Viasys Encore Vmax CardioSys Welch Allyn CardioPertect CardioPertect Check for an updated list of Interface Notes available tor download trom the SunTech M
2. Status Messages table below If Tango M2 has a problem taking a blood pressure measurement an audible alarm of 3 beeps will sound and a Status Message will appear on the monitor screen Take action as directed on the screen or as suggested in the NOTE If a blood pressure reading results from a measurement that triggers a Status Message that reading will not appear in the Graph View Press any button to clear a Status Message Status Messages will also be cleared when a BP measurement is initiated either by an external prompt trom the stress system or a timed interval prompt Status Message Reason Solution Displayed in either DKA MODE or OSC MODE Air Leak Check cable connections at cuff and Tango M2 Monitor will terminate a BP reading it target inflation is not reached in 60 seconds Make sure cuff and patient cable are not leaking Make sure patient cable is properly connected to monitor Status Message Reason Solution Cuff Overpressure Check patient cables for kinks Drop arm to side and relax Monitor will terminate a BP reading it air hose or BP cuff has reached an unreasonably high pressure No BP reported Have patient drop arm by their side during BP reading avoid excessive bending of the arm Make sure patient cable is not pinched or blocked Service required Please call SunTech U S 1 800 421 8626 EMEA 44 0 1865 884 234
3. Sin Tech ok Suntech Tango u SunTech Zango uz STRESS BP Automated Blood Pressure Monitor tor Cardiac Stress and Exercise Testing Changes This manual is identified as Part number 80 0055 00 Rev A 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 800 421 8626 919 654 2300 Fax 919 654 2301 Email CustomerService SunlechMed com Web www SunlechMed 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 2012 SunTech Medical All rights reserved Welcome to Tango M2 Thank you for choosing this Tan
4. Testing Summary SpO accuracy motion and low perfusion testing was conducted by Nonin Medical Incorporated as described below SpO Accuracy Testing SpO accuracy testing is conducted during induced hypoxia studies on healthy non smoking light to dark skinned subjects during motion and no motion conditions in an independent research laboratory Study subjects were comprised of male and female participants between the ages of 19 and 35 The measured arterial hemoglobin saturation value SpO of the sensors is compared to arterial hemoglobin oxygen SpO value determined from blood samples with a laboratory co oximeter The accuracy of the sensors in comparison to the co oximeter samples measured over the SpO range of 70 100 Accuracy data is calculated using the root mean squared Arms value for all subjects per ISO 80601 2 61 7 Low Perfusion Testing This test uses an SpO Simulator to provide a simulated pulse rate with adjustable amplitude settings at various SpO levels The module must maintain accuracy in accordance with ISO 80601 2 61 for SpO at the lowest obtainable pulse amplitude 0 3 modulation 10 SpO z SaQ 10 Appendix D Downloading Instructions Please use the following instructions to download the data from the measurement table and convert the data into an easy to understand Excel spreadsheet 1 Insert the USB A key into the Tango M2 monitor it can take the monitor a few moments to ide
5. make sure the correct ECG Trigger is selected If using Internal ECG option make sure a Custom ECG Trigger is set to INTERNAL Make sure cables are correctly seated to their connectors and show no signs of damage Set Wavetorm Display to ECG to verity monitor is receiving ECG Signal Main Menu gt View gt Wavetorm Display Inflation too low K Sounds were detected within 10 mmHg of target cuff inflation pressure BP not reported BP reading may be inaccurate Check Initial Inflate and Max Inflate settings Have patient drop arm by their side during BP reading and avoid excessive movement or bending of the arm Take another BP reading Status Message Reason Solution Displayed only in OSC MODE Excessive Arm Movement If patient Excessive arm movement Set monitor to DKA MODE is exercising press DKA OSC to enter May result in no BP reading DKA EXERCISE Mode Check cuff Check the cuff for correct Weak or no oscillometric signal Make sure cuff is properly connected size and placement Make sure cuff is the right size Exceeded Measurement Time Pneumatic hose blockage Have patient drop arm by their side Check Cuft Air Hose during BP reading and avoid excessive movement or bending of the arm Make sure patient cable is not pinched or blocked 55 Out of Range Measurements If a blood pressure measurement value is outside of Tango M2 s approved limits
6. s Single Patient Use Kit disposable cuff new Tango M2 Table of Contents Welcome to Tango M2 Changes Copyright Informotion What s New What s the Same Table of Contents 1 Safety Considerations Intended Use Indications for Use User Responsibility Precautions amp Possible Adverse Reactions Cautions Warnings and Contraindications Icons Symbols and Abbreviations Icons Symbols Commonly Used Abbreviations 2 Setting up Tango M2 Unpacking the Monitor Rear Panel Configuration With Your Stress System N QO QQ BRB BRN sO N O O Interface Notes E Library Attach Connections to the Monitor 12 13 Select Monitor and Stress System settings 13 Confirm Connections Without a Stress System 3 Getting to know Tango M2 Front Panel Measurement View Graph View Main Menu Monitor Setup Measurement Setup View Alarms Measurement Table End Test 4 Using Tango M2 during a Stress Test Step 1 Blood Pressure Cutt Placement Orbit K Cuff Disposable Cuff Step 2 Contirm ECG Signal Step 3 Take Blood Pressure Readings 14 14 15 15 16 18 20 21 22 24 25 26 28 29 29 29 30 32 32 Display of Readings Readings at Timed Intervals Stopping a Reading STAT Mode DKA MODE vs OSC MODE Monitor Sleep Mode Step 4 Prepare for a New Patient Tips tor conducting an Exercise Stress Test 5 Using Tango M2 without a Stress System Step 1 Blood Pressure Cuff Placement Step
7. Asia amp Pacific 852 2251 1949 Attach Connections to the Monitor Connect the Power Supply to a Power Cable and plug into an available AC power outlet Connect the Power Supply to the DC input connector on the back of the monitor Connect the Patient Cable to the Microphone and Pneumatic connectors on the back of the monitor Follow the instructions provided in the Interface Notes to connect Tango M2 to the stress system Use the ON OFF button on the back of the Tango M2 monitor to turn it on NOTE The blue LED on the top of Tango M2 will be lit whenever the monitor is powered on Within 30 seconds the SunTech Tango M2 logo will appear briefly then be replaced by the Main Display screen Measurement View is the default Select Monitor and Stress System settings 13 Follow the instructions provided in the Interface Notes to select settings for both the Tango M2 monitor and the stress system If you experience difficulty communicating with the stress system contact SunTech Customer Service Email CustomerService SunTechMed com Phone US 800 421 8626 919 654 2300 Europe Mediterranean amp East Africa 44 0 1865 884 234 Asia amp Pacific 852 2251 1949 When the monitor and stress system settings have been selected the installation is complete 14 Confirm Connections Test the combined system by taking a blood pressure measurement to confirm that Tango M2 is working properly with the stress system Follow the instruct
8. Asia amp Pacitic 852 2251 1949 Monitor has a system failure Contact your nearest SunTech Medical Service Department or authorized service agent Monitor must be sent to SunTech Medical for repair Measurement Delayed For patient satety this measurement has been delayed Next reading will occur as scheduled Measurement was delayed due to satety reasons Next BP reading will occur as scheduled Repeat BP Drop arm to side and repeat BP The monitor device could not get a BP reading Start new BP reading via the Stress System or using the Tango M2 START STOP button Have patient drop arm by their side during BP reading avoid excessive bending of the arm 51 52 Status Message Reason Solution Displayed only in DKA MODE Excessive Arm Movement Excessive K sound noise or arm movement Instruct patient to drop arm to side reduce the bending of the arm and relax arm muscles Check ECG ECG signal is weak erratic or missing for more than 3 seconds No BP reported Set Wavetorm Display to ECG to verity monitor is receiving ECG Signal Main Menu gt View gt Wavetorm Display If HR ECG signal are present Press START STOP to take another reading If error repeats patient may have ECG problems which prevent Tango M2 trom reading their blood pressure in DKA mode If ECG signal is not present Make sure that ECG lead connections
9. Display If ECG is selected the signal will be displayed for 60 seconds then Waveform Display will return to K sound meen Graph Display Select value displayed on Graph View below BP reading HR default DP BP Clear After Select time delay before a BP measurement is cleared from display minutes Never 2 3 5 minutes default 10 BP Shrink After Select time delay before a BP measurement is displayed in a smaller font minutes Never 1 minutes default 2 3 5 10 New Patient Select monitor response when ECG signal is dropped for 1 minute If Auto monitor will automatically reset when ECG signal is lost for 1 minute It Prompt monitor will display New Patient prompt and require confirmation before resetting Auto Prompt default BP Pressure Units Select unit of measure for BP readings mmHg default kPa Exit Select to return to Main Menu Alarms Tango M2 can set alarms for the following parameters When an alarm is set if a measurement exceeds the alarm threshold then at the end of the reading an audible alarm of 5 beeps will sound The reading causing the alarm will be displayed in yellow Regulatory alarms will over ride User Detined alarms in the instance they are triggered simultaneously However the tive beeps associated with the alarm will be those of the User Detined alarm The Tango M2 will atte
10. Tango M2 can be set to display a New Patient prompt when the ECG signal drops by selecting the Main Menu gt View gt New Patient option You can also manually reset the monitor tor a new patient by selecting Main Menu gt End Test Tips for Conducting an Exercise Stress Test Here are some helpful suggestions for taking blood pressure measurements during a stress test Practice measurements Take a few measurements before starting exercise Take one or two blood pressure measurements with the patient seated or standing still in DKA mode This creates a baseline BP e As the measurement is being taken watch the cuff pressure and K sounds display You should see K sounds just as you would hear them if taking a manual blood pressure measurement with a stethoscope Once you get a stable baseline blood pressure reading proceed with the stress test If you are having trouble consult the Status Messages amp Alarms section of this guide for more suggestions Make sure your patient s arm is relaxed Have your patient limit the movement of the cuff arm while their blood pressure is being measured A gentle swinging is acceptable bending at the elbow is not Avoid flexing the muscles of the cuff arm If your patient is holding onto the treadmill bar tor support see if they can rest the hand of the cuff arm on the treadmill bar with their palm facing up Another option is to have the patient drop the arm with the cuff to their sid
11. Tel 1 919 654 2300 England 1 800 421 8626 Tel 44 0 1865 884 234 Fax 1 919 654 2301 Fax 44 0 1865 884 235 www Sun TechMed com www SunlechMed com ETL CLASSIFIED SunTech Medical Lid l 2 F of Building A Jinxiongda Technology Park Nio Guonlan Bao an District Shenzhen 518110 PRC nes Tel 86 755 2958 8810 eee EQUIPMENT 86 755 29588986 Sales 86 755 29588665 Service C Fox 86 755 2958 8829 0413 www CN SunlechMed com part RO OOS OO pa A
12. the BP reading that is out of range will be displayed in yellow In Graph View the chart will display out of range values in yellow If only part of a full BP reading is out of range only that part of the bar will be yellow top systolic bottom diastolic If a heart rate measurement value is outside of Tango M2 s approved limits the HR reading will flash from blue to yellow 56 Alarms If a measurement exceeds a set alarm value at the end of the reading an audible alarm of 5 beeps will sound The reading causing the alarm will be displayed in yellow and a yellow prompt will be displayed in the wavetorm display window Alarms are set using Main Menu gt Alarms Regulatory alarms will over ride User Detined alarms in the instance they are triggered simultaneously However the 5 beeps associated with the alarm will be those of the User Detined alarm Tango M2 will attempt to display both alarms it possible but the Regulatory alarm will be the dominate alarm in all cases Alarms for out of range measurements are classitied as low priority trom a regulatory standpoint as it is used to alert the operator when a measurement falls outside the tested range of the monitor It is up to the attending medical professional to determine when an obtained measurement is cause for concern based upon a subject s physical condition Alarms will sound in the range of 65 7OdB Alarm Alarm Range High Systolic BP Fo
13. It Yes monitor will clear readings from display prepare monitor for a new study and return to the Main Menu If No monitor will keep readings and settings and return to the Main Menu Yes default No Using Tango M2 During qo Stress Test Follow these steps to use Tango M2 when connected to a stress system 1 Measure the patient s arm to ensure proper cuff sizing 2 Place a blood pressure cuff on the patient s arm 3 Make sure the monitor is receiving an ECG signal 4 Take blood pressure readings 5 End test prepare system for the next patient You should be familiar with taking blood pressure measurements and conducting ECG stress tests before using Tango M2 with your stress system Step 1 Blood Pressure Cuff Placement Use either a SunTech Orbit K blood pressure cuff or a SunTech Single Patient Use kit containing a disposable blood pressure cuff and microphone pad This section gives directions for proper size selection and placement of either style of cuff 29 NOTE It is important that the cuff is properly fitted to the patient s arm and that the microphone is placed over the brachial artery between the bicep and tricep Improper cuff sizing and a misplaced microphone can lead to missed or poor readings and accuracy Orbit K Cuff The Orbit K cuff is available in four sizes For sizes please see PG 48 Check that the cuff is the correct size Fold the grey sleeve inside th
14. any orientation Connect the tube trom the cuff into the corresponding connector on the Patient Cable and twist ft Use the wrist straps to secure the cables to the patient s wrist 31 jn gt A f NOTE You may find it easier to connect the Patient Cable to the cuff before applying the cuff to the patient 32 Step 2 Confirm ECG Signal Tango M2 requires an ECG signal to take blood pressure measurements during the stress test The monitor receives this ECG signal automatically trom the stress system once the patient ECG connections are in place NOTE Tango M2 can be used in OSC MODE to take blood pressure readings without an ECG signal before exercise begins The patient must remain still while these readings are being taken Refer to the DKA MODE vs OSC Mode section of this guide for more information If patient ECG connections are not already in place follow the instructions provided with your stress system for placement of ECG electrodes and connection of leadwires Make sure that a stable heart rate is displayed on the Tango M2 monitor Step 3 Take BP Readings NOTE Tango M2 must be set to DKA Mode to take BP measurements while the patient is exercising Once the stress test begins the stress system will prompt the monitor to take blood pressure readings The cuff will automatically inflate for each measurement T
15. be connected to o broad range of stress systems Appendix A contains a list of compatible stress systems Connection of Tango M2 to a stress system should be done by a biomedical technician or other person familiar with blood pressure and ECG stress system equipment Your SunTech Medical sales representative may be able to assist you with this installation Interface Notes Interface Notes are available from SunTech Medical for most Tango M2 compatible stress systems Interface Notes provide detailed instructions with supporting illustrations and frequently asked questions about proper setup and use Visit the Suntech Medical website at www SunTechMed com to download Interface Notes for any compatible stress system Go to the Support tab then choose Customer Technical Support gt Download Library gt Stress BP Monitors gt Tango M2 gt Interface Notes for a list of available Interface Notes You may also reference the E Library within your Tango M2 monitor for help with setup between the two systems Main Menu gt Monitor Setup gt E Library gt Interface Notes for a list of available Interface Notes NOTE Refer to the Interface Notes for your stress system before proceeding with installation I your stress system is not listed in the library of Interface Notes contact SunTech Customer Service Email CustomerService SunlechMed com Phone US 800 421 8626 919 654 2300 Europe Mediterranean amp East Africa 44 0 1865 884 234
16. can be reset to take systolic only readings every 2 seconds by selecting the Main Menu gt Measurement Setup gt Stat Mode Key option Full systolic and diastolic measurements can take as little as 30 seconds to appear on the display Systolic only measurements can take as little as 15 seconds to appear Atter 10 minutes or when STAT mode is canceled the monitor will return to the Main Display DKA MODE vs OSC MODE Tango M2 s default DKA MODE uses an auscultatory technique for measuring blood pressure SunTech Medical s proprietary Dimensional K sound Analysis DKA algorithm uses the ECG signal and K sound pattern recognition to filter out noise making DKA MODE highly tolerant to patient movement DKA MODE requires that the monitor receive an ECG signal trom the patient An alternate oscillometric OSC MODE is available to take blood pressure readings without requiring an ECG signal NOTE The patient must remain still while oscillometric measurements are being taken Press the DKA OSC button to select oscillometric OSC MODE The OSC MODE icon will appear with the message NON EXERCISE MODE Patient must remain still There are some differences in monitor behavior while in EE Ber IE fold a OSC MODE BP Readings BP measurements are displayed as a full BP systolic and diastolic reading Systolic only setting is not available in OSC MODE Heart Rate e Heart Rate is not disp
17. displays a greater than zero pressure with no BP cuff attached or a value of oxygen saturation with no SpO 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 apply the BP cuff to a limb being used for IV infusions as the cuff intlation can block the intusion causing harm to the patient WARNING Regarding the effect of blood flow interference and resulting harmful injury to the PATIENT caused by continuous CUFF pressure due to connection tubing kinking WARNING Regarding the need to check for example by observation of the limb concerned 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 SpO sensor 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 flammabl
18. down to select Open Chose My Computer under the Look In column 4 You will need to select the drive where the USB A key is connected should be the same drive that you had above You should now see the file called Results 5 Click on the files called Results Depending on your PC s settings you many have to go to the bottom of this window and select under Files of Type All Files so that the information you just pulled from the Tango M2 can be displayed 6 Select the tile you just loaded onto this USB A key from the Tango M2 and click Open Se 78 A window will open telling you that the file you are trying to open is in a different format than specified by the file extension It will be asking you it you want to open the document select yes A new window will open taking you through 3 Text Import Steps In the 1st window select Delimited may already be selected and change the File Origin to Unicode UTF 8 then click Next In the 2nd window select Tab and Comma Tab may already be selected and click Next In the last window select General may already be selected and click Finish Your Excel Spreadsheet will now be formatted in columns and rows for easy viewing Congratulations on completing this task sinTech Medical Brilliant Blood Pressure Solutions Sunlech Medical Inc SunTech Medical Lid 507 Airport Boulevard Suite 117 Oakfield Estate Morrisville NC 27560 8200 USA Eynsham Oxfordshire
19. is affected by absorption and reflection from structures objects and 3V 3V m Portable and mobile RF communications equipment should be used no closer to any part of the Tango M2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance D 3 5 V1 vP D 3 5 E1 VP 80 Mhz to 800 Mhz D 7 E1 VP 800 Mhz to 2 5 Ghz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequencyb Interference may occur in the vicinity of equipment marked with the following symbol a 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 M2 is used exceeds the applicable RF compliance level above the Tango M2 should be observed to verify normal operation If abnormal pertormance is observed additional measur
20. is connected 17 The SpO field will be blank if no SpO sensor is attached to the monitor Interval Timer e Timer displays in minutes amp seconds When the Interval is displayed as EXT MAN the monitor will take BP readings only when prompted either by a stress system or by a manual button press The timer will count up trom the end of the last BP reading The clock icon is inactive When an Interval time is displayed the monitor will take BP readings at timed intervals also when prompted by a stress system or by a manual button press The timer will count up from the start of the last BP reading The clock icon fills in to show when the next reading will start When in STAT mode the red STAT icon is displayed The timer will count up from the end of the last BP reading Waveform Display The waveform will normally show the K sounds picked up by the microphone in the cuff The waveform can be set to display the ECG channel but it will revert to displaying the K sounds atter 60 seconds Graph View The Graph View screen displays a graphic summary of the most recent blood pressure measurements in addition to numeric display of the other readings available in the Measurement View Blood Pressure amp Heart Rate for Mean Arterial Pressure the Highlighted Reading available outside the US 1 18 2013 2 118 Heart Rate or Double Product 18 SpO Interval Ext Man 00 52 g 5 oSpO 2 Wavefor
21. 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 SpO of adult patients in hospitals medical facilities and subacute environments Presence of arial 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 e Check calibration of this device annually Never knowingly use a defective device Immediately replace parts that are broken worn missing incomplete damaged 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 SunlechMed 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 anyo
22. used as an evaluation reference tool not as a diagnostic tool 41 42 N Taking Care of Tango M2 Cleaning Monitor CAUTION Tango M2 is not sterilizable Do not immerse the monitor in any fluid or attempt to clean with any liquid detergents cleaning agents or solvents Dampen a soft cloth with mild medical grade disinfectant and wipe the monitor to remove surface dust and dirt Orbit K Cuff NOTE Orbit K cuff and patient cable should be cleaned at the conclusion of each stress test Periodically remove the bladder and microphone for cleaning Dampen a soft cloth with a mild medical grade disinfectant and wipe the bladder and microphone let them air dry Clean the cuff sleeve and the inside of the cuff with a mild medical grade disinfectant It is recommended that after heavy use the fabric shell of the Orbit K cuff be machine washed in cold water with a mild disinfectant Line dry this cuff only machine drying can cause damage to the fabric shell of the Orbit K cuff The bladder needs to be inserted back into the cuff sleeve so the pneumatic hose portion of the bladder is outside the sleeve Please note that the pneumatic hose connection should face downward when using the Orbit K cuff on either the right or the left arm CAUTION Do not machine wash bladder or microphone Patient Cable amp ECG Cable CAUTION Do not immerse cable and connectors in fluid To clean use a soft cloth to apply a mild soap and water mix
23. 2 Patient ECG connections Step 3 Take Blood Pressure Readings Step 4 Prepare for a New Patient 6 Using Tango M2 Options Pulse Oximetry SpO Headphones 7 Taking care of Tango M2 Cleaning Preventative Maintenance System Self Checks Replaceable Parts Routine Calibration Software Updates 33 do Ja 34 34 35 30 36 38 38 38 o7 oy 40 40 41 42 42 44 44 44 45 46 Disposal 8 Accessories amp Replacement Parts 9 Status Messages amp Alarms Status Messages Out of Range Measurements Alarms Service Centers 10 Frequently Asked Questions 11 Technical Information EMC Statement Specifications Blood Pressure Measurement Notes on Blood Pressure Data Specitications Pulse Oximetry Limited Warranty Appendix A Compatible Stress Systems Appendix B Cables for Compatible Stress Systems Appendix C SpO Performance Accuracy Appendix D Downloading Instructions 47 48 50 50 55 56 57 58 62 62 67 68 68 68 70 72 74 77 Safety Considerations Intended Use Tango M2 is a non invasive blood pressure monitor with the optional capability to monitor oxygen saturation SpO for use in cardiac or exercise stress testing lt measures and displays a patient s systolic and diastolic blood pressure and with the SpO option percent oxygen saturation of arterial blood Use Tango M2 only with adult patients while they undergo a cardiac or exercise stress test under the supervision
24. 2009 CSA C22 2 No 60601 1 Classifications Equipment Classification Class Mode of Operation Continuous 67 68 Notes on Blood Pressure Data Any blood pressure reading can be affected by the measurement site the position of the patient exercise or the patient s physiologic condition Environmental or operational tactors which can attect the pertormance of the device and or its blood pressure reading are pacemakers and common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation arterial sclerosis poor pertusion diabetes age pregnancy pre clampsia renal diseases patient motion trembling and shivering Specifications Pulse Oximetry Non Motion Accuracy 70 100 2 digits 1 Standard Deviation Low Perfusion 70 100 2 digits 1 Standard Deviation Motion 70 100 3 digits 1 Standard Deviation Standard Deviation is a statistical measure up to 32 of the readings may fall outside those limits A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor Using Nonin SpO simulator model 8000S the Tango M2 monitor will display a reading of approximately 98 SpO The SpO2 Cable has a rating of IPX meaning that the pulse oximeter is protected against harmful effects of dripping water per IEC 60529 Limited Warranty SunTech Medical Inc provides to the original purchaser the fo
25. Kohden Cardiofax 1550 1560 91 0061 00 91 0018 00 Norav Stress 91 0013 00 91 0011 00 Oxford Medilog Stress PBI QRS Card 91 001 3 00 Contact PBI or Oxford Philips Stress Vue 91 0013 00 91 001 1 00 Quinton Q3000 Q4000 710 nee ee nn ee ene 91 0018 00 Quinton Q4500 91 0013 00 91 0018 00 Quinton Q5000 91 0020 00 91 0018 00 73 74 Stress System RS 232 Cable ECG Trigger Coble Quinton Q Stress 91 0013 00 91 0018 00 Schiller AT1 0 AT60 CS 200 91 0035 00 91 0022 00 Welch Allyn CardioPertect Workstation 91 0013 00 91 0018 00 Splitter Cables Stress System Part Number 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 USB Cables Stress System Part Number USB Connectivity Kit cable driver software amp instructions for use 98 1010 00 Appendix C SpO Performance Accuracy The table below shows ARMS values measured using 8000AA with XPod OEM III in a clinical study Statistic Results Specification Bias 70 100 1 54 Bias 70 80 1 41 Bias 80 90 1 97 Bias 90 100 1 28 Between Subject Variance 7 4 Statistic Results Specification Within Subject Variance 0 7 Arms 70 100 1 83 2 Arms 70 80 1 72 2 Arms 80 90 2 17 3 Arms 90 100 1 59 2
26. a lI u O oi aos kE LE VOID IF SEAL TUV Canada and United States Approval PSE Mark Japanese Medical Device Approval No serviceable parts inside please dispose of properly Meets ELSA 2007 CEC efficiency level V EU EC No 278 2009 Phase II Shipping Temperature should be kept between 20 C and 65 C Shipping Humidity should be kept between 15 and 90 Warranty Seal e Pied RoHS T q 0413 E Output connection configurotion positive voltage negative shield For indoor use only Product complies with the requirements of the RoHS directive 2002 95 EC Fragile CE Mark product meets the European Union standards 0413 ltem and shipping container should be kept dry Class II isolation equipment Commonly Used Abbreviqtions BP BPM DKA K sounds MAP DIA Blood Pressure Beats Per Minute Dimensional K sound Analysis Korotkoff sounds Mean Arterial Pressure Diastolic BP NIBP OSC SpO SPU SYS Non Invasive Blood Pressure Oscillometric Percent Oxygen Saturation of Arterial Blood hemoglobin Single Patient Use Systolic BP 10 Setting up Tango M2 Tango M2 is designed to work directly with your stress system When the two devices are properly connected the stress system will automatically prompt the monitor to take blood pressure readings during the stress test study Tango M2 will send blood pressure SpO and h
27. ation of SunTech Medical Inc and no other warranties expressed implied or statutory are given No representative or employee of SunTech Medical Inc is authorized to assume any further liability or grant any turther warranties except as herein 70 Appendix A Compatible Stress Systems The following stress systems are compatible with Tango M2 Many stress systems have pre contigured settings available in Tango M2 s Main Menu It your stress system does not nave a pre configured setting use the custom setting designated Stress System Manufacturer Stress System Pre Configured Setting Create a Custom Setting Protocol ECG Trigger Cardinal Health Oxycon Jaegar Amedtec ECGpro ECGpro Quest Quest Burdick HeartStride SUNTECH Digital Rising Hearlwave Hearlwave Cambridge Heart CH 2000 CH 2000 Quinton Q Stress V4 0 SUNTECH Digital Rising Quinton Q Stress Q Stress Cardiac Science Quinton Q 5000 Q4500 Q5000 Quinton Q 4500 Q4500 Q5000 Quinton Q 3000 Q 4000 710 Q3000 Q4000 SUNTECH Internal Cardioline Cube Stress BOSOTRON Digital Rising Cardiolex EC Sense STANDARD Digital Rising Delmar Reynolds CardioDirect CardioDirect DMS CardioScan SUNTECH Analog EDAN SE 1010 PC ECG SUNTECH Digital Rising EDAN ECG SE 12 Express SUNTECH Digital Rising Stress System Manufacturer Stress System Pre Configured Setting Create a Custom Setting Protocol ECG Trigger
28. ations anemia or low hemoglobin concentrations cardiovascular dyes sensor not at heart level e artificial fingernails and dark colored nail polish Possible Adverse Reactions In the area of the BP cuff SpO sensor 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 intlammation of a vein may be observed P P Cautions 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 Warnings and Contraindications 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
29. available protocols or SunTech Stress System Language Select trigger Select language for monitor display Analog Digital falling Digital rising default Internal English default Francais Deutsch Italiano Espanol Select format and set current date and time Date amp Time Choose Date format then set Date MM DD YYYY DD MM YYYY DD MMM YYYY Choose Time format then set Time 12 hr Format is HH MM AM PM HH 01 12 MM 00 59 24 hr Format is HH MM HH 00 23 MM 00 59 Brightness Set brightness level from 0 to 100 0 is darkest 100 is lightest 70 Never default Prompts MODE Sleep Mode After Select time delay for monitor to enter sleep mode after last activity 10 min 30 mins Reset Warning Use to reset warning prompt for transition from DKA MODE to OSC Yes No 21 22 Menu Option Options Default 1 Interface Notes E Librory Select Tango M2 information to display on screen 2 Tutorials 3 Status Messages Displays firmware version and internal board serial number System Info Select Software Update to begin a software update Software Update Exit Select Exit to return to Monitor Setup menu Exit Select to return to Main Menu Once the language selection has been made the Tango M2 must cycle power to have this language take effect Measurement Setup Menu Option Option
30. blood pressure monitor without being connected to a stress system Getting to know Tango M2 Tango M2 offers two different screens that can be selected as the Main Display for viewing patient readings Measurement View detault setting and Graph View Using the Main Menu you can change the view of your monitor adjust the brightnes of the monitor change the measurement settings set user detined alarms and view your measurement data Each of these screen displays and functions are described later in this guide Front Panel The ON OFF button is blue and located on the top back right corner of the monitor Use the six buttons on the front panel to operate the monitor The blue LED on the top of Tango M2 will be lit whenever the monitor is powered on T Power On LED STAT Start or stop STAT mode UP Scroll through menus amp lists SELECT Choose between Main Display amp Main Menu screen Select menu options DOWN Scroll through menus and lists DKA OSC Choose ascultatory DKA mode or oscillometric OSC mode see the DKA vs OSC mode section of this guide for more info START STOP Start or stop a measrement Measurement View The Measurement View screen displays the current or most recent patient measurements as numeric readings 16 MODE Blood Pressure Reading Cuff Pressure Mean Arterial Pressure available outside the US 1 2 2 kasa j Heort Rote q 9 l iy Double pro
31. cable to the trequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Specificotions Blood Pressure 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 en nu o normal ECG sinus rhythm There are some physical conditions i e Bundle Branch Block Arrhythmias Arial Fibrillation Ventricular Fibrillation Pacemakers etc that may limit the ability of Tango M2 to obtain an accurate reading Pressure DKA Mode Diastolic 20 160 mmHg Systolic 40 270 mmHg Range Heart Rate 40 200 BPM beats per minute Pressure OSC Mode Diastolic 20 160 mmHg Systolic 40 260 mmHg Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff Accuracy stethoscope auscultation method within the limits prescribed by the American National Standard Manual electronic or automated sphygmomanometers ANSI AAMI ISO 81060 2 2009 Conditions for Use Operating 10 C 50 F to 40 C 104 F 15 90 RH non condensing 700 kPa 1060 kPa Operating the monitor in an environment at maximum temperature can produce temperatures exceeding 41 C 41 6 C hig
32. ce Center for help In addition the following items will be needed to verity calibration 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 Service Centers For customers in the Americas SunTech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 800 421 8626 919 654 2300 Fax 919 654 2301 For customers in Europe the Middle East Africa Asia and the Pacitic SunTech Medical Ltd Service Department Oakfield Industrial Estate Eynsham Oxtordshire OX29 4TS UK Tel 44 0 1865 884 234 Fax 44 0 1865 884 235 ew 61 62 11 Technical Tairelaaatelitele EMC Statement This equipment has been tested and found to comply with the limits for medical devices to IEC60601 1 2 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio trequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installa
33. duct L LL SYS x HR 1000 Interval Ext Man 00 55 TS SEA PE TEES ey e ass Fi SpO o SpO Waveform Indicator Interval Indicator amp Display amp Timer rt An orange running man icon with a A green running man icon indicates that ae l Aqa slashed circle indicotes thot the monitor the monitor is set to take blood pressure l a ae ay is set to take blood pressure readings in readings in auscultatory exercise DKA U oscillometric non exercise OSC MODE The patient must remain still See the DKA MODE vs OSC MODE section of this guide for more information PG 34 Notes on Measurement View Full BP vs Systolic only Readings It the SYS field shows a reading but the DIA field is blank the monitor has been set to read systolic only blood pressure readings Mean Arterial Pressure The MAP field will be blank and the MAP icon will not appear when Mean Arterial Pressure is turned off This is a factory setting MAP is not available in the US Heart Rate While a BP measurement is being taken in DKA MODE a blinking heart icon indicates the systolic diastolic range of the reading i e K sounds are detected In OSC MODE HR is not displayed until the end of the BP measurement SpO The SpO field will display dashes if the SpO sensor is attached to the monitor but is not connected to a patient The SpO field is greyed out when SpO is not connected and displayed in blue it SpO
34. e Update A Follow the messages on the monitor screen to complete the update Message Software update in progress Meaning Update is being processed Action Sottware update complete New software was installed It the message includes Tango M2 will now reboot select OK to complete the update process No Flash Drive Found Tango M2 does not detect the flashdrive Wait a few moments then select Retry If the flashdrive is still not detected remove the drive then reinsert the drive Wait a few moments for the Tango M2 to recognize the drive Software is same as or older than currently installed No update will be performed Select Close Disposal The monitor contains a lithium battery Please return Tango M2 to SunTech Medical for disposal Contact SunTech Medical to recieve a prepaid return label WARNING Fire explosion and severe burn hazard The unit contains a lithium battery that must be disposed of properly or returned to SunTech Medical for disposal 47 48 Accessories amp Replacement Parts Contact your SunTech Medical sales representative to purchase the following items Description Part Number Details Orbit K Cuffs amp K Sound Microphone Orbit K packs include K Sound microphone P N 98 0235 00 Small Adult 98 0062 21 18 27 cm Adult 98 0062 22 32 44 cm Adult Plus 98 0062 25 27 40 cm Lor
35. e 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 SpO sensor to become wet DO NOT use a damaged BP cuff or SpO 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 trom that supplied might result in measurement error DO NOT position the monitor so that it is ditticult 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 t
36. e blue cuff away from the Velcro strip Wrap the cuff around the patient s upper arm Make sure the INDEX the end of the cuff falls within the RANGE printed inside the cuff If the INDEX falls outside the RANGE select a new cuff size ie a 30 This section gives directions for proper size selection and placement of either style of cuff a Locate the brachial artery between the bicep and the tricep of the upper arm The left arm is preferred Slide the cuff sleeve up the patient s arm with the ARTERY marker pointing down the arm There is a microphone located under the ARTERY marker Make sure the microphone is placed on the inner portion of the arm directly over the brachial artery between the bicep amp tricep There should be about 3 to 5 cm two finger widths between the edge of the cuff and the elbow d Inser the 3 pin microphone connector trom the cuff into the corresponding connector on the Patient Cable The connector can be inserted in any orientation e Connect the tube from the cuff into the corresponding connector on the Patient Cable and twist L Wrap the cuff around the arm and secure Use the wrist straps to secure the cables to the patient s wrist d e NOTE You may find it easier to connect the Patient Cable to the cuff before applying the cuff to the patient Disposable Cuff The SunTech Sing
37. e during the reading It the patient needs to hold the bar for support advise them to grip the bar as lightly as possible A tight grip on the bar can increase the noise that the k sound microphone hears due to the muscle flexing in the patient s arm To monitor blood pressure more closely If your patient s condition becomes unstable and you need to monitor them more closely you can set the monitor to STAT mode by pressing the STAT button Cancel STAT mode by pressing the START STOP button or the STAT button again Watch for Status Messages and Alarms There is a full description of Tango M2 Status Messages and Alarms in the Status Messages amp Alarms section of this guide 37 38 Using Tango M2 Without a Stress System Follow these steps to use Tango M2 with an Internal ECG option when it is not connected to a stress system Measure patient s arm to ensure proper cuff sizing Place a blood pressure cuff on the patient s arm Set up patient ECG connections Take blood pressure readings End study prepare system for next patient hele ad a You should be familiar with taking blood pressure measurements before using Tango M2 Step 1 Blood Pressure Cuff Placement Use either a SunTech Orbit K blood pressure cuff or SunTech Single Patient Use kit containing a disposable blood pressure cuff and microphone pad NOTE It is important that the cuff is properly fitted to the patient s arm and that the microphone
38. e set to a timed interval the monitor will continue to respond to external prompts from the stress system and to manual prompts using the START STOP button Each external prompt or manual prompt will restart the interval timer aire Stopping a Reading 3 Press the START STOP button to stop a blood pressure measurement in ABORT process The cuff will deflate the monitor will beep once unless the beeper is u m turned off and the message ABORT will appear briefly on the display The blood pressure reading will display dashed lines until the next measurement is fede eu Ener eo re EET T Ti taken npc 34 STAT Mode Press the STAT button to take repeated blood pressure measurements for time sensitive or emergency situations The monitor will take repeated measurements 81 l for 10 minutes The cuff will automatically inflate for each measurement A red E3 aq ee STAT icon will appear on the display and the blood pressure readings will blink as long as the monitor is in STAT mode Cancel STAT mode by pressing the ae a 95 START STOP button or the STAT button again STAT mode will also be canceled tear it the monitor receives a STOP message from the stress system All monitor buttons other than STAT and START STOP are inactive during STAT mode The default setting for STAT mode is to take a full BP that includes both systolic and diastolic readings taken every 10 seconds from the end of each measurement The monitor
39. eart rate measurement data back to the stress system Please reference the E Library inside your Tango M2 monitor for proper monitor to stress system setup With the optional Internal ECG Tango M2 can also be used without being connected to a stress system This section describes how to set up the monitor for either situation Unpacking the Monitor As you unpack your Tango M2 check to make sure you have all the proper components Refer to the separate packing label on the inner tray stating which components you should receive based on the options you ordered with your Tango M2 Rear Panel Configuration All Tango M2 connections are on the back of the monitor E Library inside your Tango M2 to see the correct set up between these two systems Patient Cable amp ECG Cable Detibrillation proof Type BF Applied Part and SpO is a Type BF Applied Part plugged Power On LED USB B USB A SpO Internal ECG Power On BNC External ECG Headphone DC Power RS 232 Patient Cable Patient Cable Connection I Microphone Pneumatic Connect your stress system to the Tango M2 using the BNC external ECG and RS 232 cables You can use the USB cable instead of the RS 232 cable if your Tango M2 came with this option Please view the Interface Notes in the If your Tango M2 has the Internal ECG option then there will be an ECG connector If not the ECG port will be 11 12 With Your Stress System Tango M2 can
40. easure BP When the Tango M2 encounters these situations it returns a reading of 0 0 Microphone placement is critical for reliable operation of the Tango M2 there are many places to find cuff placement help 1 See the E Library within your Tango M2 for quick cuff placement tutorials You can find the E Library under the Main Menu select Monitor Setup gt E Library gt Tutorials 2 Look in the Tango M2 User Manual under the Using Tango M2 during a Stress Test section for details on each type of cuff the Orbit K and the Single Patient Use SPU kit 3 Follow the instructions in the Cuff Tutorial located on the SunTech Medical website under Support gt Customer Technical Support gt Video Tutorials for correct microphone placement Can l use a heart rate or blood pressure simulator to test whether the Tango M2 is working correctly with my stress system You cannot use a heart rate or blood pressure simulator to test whether the Tango M2 is working with your stress system The Tango M2 monitor requires that the ECG signal and the Korotkoff sounds collected by the microphone in the cuff originate from the same source meaning the patient How can adjust the brightness of the Tango M2 display You can adjust the contrast of the Tango M2 display by following these steps When the operating screen is displayed press the SELECT button once This will bring up the Main Menu screen Using the UP or DOWN arrows highlight Monitor Setup and
41. ed service representative DO NOT remove covers or break the warranty seal as this will void the manufacturer s warranty Orbit K Cuff It is recommended that you replace the Orbit K cuffs microphones and patient cable annually to maintain measurement accuracy If the cuff does not need replacement you can replace just the microphone To remove the microphone from cuff open the Velcro strio and gently pull the microphone out of the sleeve SpO Sensor You can replace the SpO sensor by unplugging it from the Tango monitor and replacing it with a new Nonin SpO sensor Routine Calibration Check the calibration of your Tango M2 annually to verity the accuracy of the pressure transducers and indicators Calibration should be done by a biomedical technician or other person familiar with the Tango M2 monitor Please contact SunTech Medical for instructions to access Verity Calibration Instructions are also available in the Tango M2 service manual SunTech Part 27 0139 Al1 For customers in the Americas SunTech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 800 421 8626 919 654 2300 Fax 919 654 2301 For customers in Europe the Middle East Africa Asia and the Pacific SunTech Medical Ltd Service Department Oaktield Industrial Estate Eynsham Oxtordshire OX29 4TS UK Tel 44 0 1865 884 234 Fax 44 0 1865 884 235 a 46 Equipment Required e Calibra
42. edical website www SunlechMed com Appendix B Cables for Compatible Stress Systems Contact your SunTech Medical sales representative to purchase the following items RS 232 amp ECG Interface Cables Stress System RS 232 Cable ECG Trigger Cable AMEDTEC ECGpro 91 0013 00 91 0066 00 Burdick Quest 91 0013 00 91 001 1 00 Cambridge Heart CH 2000 amp Hearlwave II 91 0065 00 RS 232 and ECG SCsdY f Delmar Reynolds CardioDirect with CardioCollect 91 0013 00 91 0066 00 Esaote Formul Biosound Esaote Formul for Archimed 91 0048 00 Formula 91 0049 00 Stress System RS 232 Cable ECG Trigger Coble GE CardioSoft cs 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 Marquette Centra 91 0012 00 91 0013 00 91 0011 00 GE MAC 5500 Stress 91 0010 00 91 0009 00 Marquette Mac VU Stress 91 0010 00 91 0014 00 Marquette Sensormedics Max 1 91 0010 00 91 0009 00 Morquette Hellige CordioSys 91 0013 00 91 0016 00 Medset Flashlight Ergo 91 0013 00 wenn nn nnn nee Midmark Diagnostics Qmark EZ Stress 91 0013 00 91 001 1 00 Mortara X Scribe 91 0013 00 91 001 1 00 Nasiff Associates Cardio Card 91 0013 00 91 0018 00 Nihon Kohden Cardiofax ECG 9320A 91 006 1 00 91 0060 00 Nihon
43. es may be necessary such as reorienting or relocating the Tango M2 b Over the frequency range 150kHz to 80 MHz field strengths should be less than V1 V m 65 66 Recommended separation distances between portable and mobile RF communications equipment and the Tango M2 The Tango M2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Tango M2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Tango M2 as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter meters m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Watts W D 3 5 V1 VP D 3 5 E1 vP D 7 E1 vP 0 01 O12 0 12 0 23 0 1 0 38 0 38 0 73 1 2 12 2 3 10 3 8 3 8 7 3 100 12 12 23 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 appli
44. ess SELECT to reach the Main Menu use the up and down arrow keys to navigate to View gt Main Display gt Graph press the SELECT key to contirm your selection Then press START STOP to return to the Main Display which is now set to Graph View 20 Main Menu Press the SELECT button to view the Main Menu screen Use the Main Menu to set up the monitor adjust measurement and display settings set alarms view and export measurement data and view reference information MAIN MENU Monitor Setup Protocol Suntech Measurement Setup ECG Trigget Digitol Rising Longiuoge English Custom View Alarms Measurement Table Ta End Test 2 hen ee Exit rises W W Ce I Hi ELI TE E Library Sys em inta Dolie ond Time Brightness r ode Alter 0 e Use the UP and DOWN buttons to scroll through screen menus or lists of options e Use the SELECT button to confirm highlighted submenu or item in a list In any menu scroll to EXIT and press SELECT to return to previous menu Press START STOP to return to the Main Display trom any level in the Main Menu The following charts list the Menu Options available choices and default settings Monitor Setup Menu Option Options Default Select a preconfigured setting for your stress system or choose custom settings Choose from a list of available settings or CUSTOM If CUSTOM select protocol and ECG trigger Select protocol Choose from a list of
45. ff with a mild medical grade disinfectant If using the SPU kit discard the used disposable cuff and microphone pad Clean the microphone with a hospital grade mild disinfectant and retain for future use Refer to Step 4 Prepare for a New Patient in the previous section of this guide for information about resetting the monitor 40 Using Tango M2 Options Pulse Oximetry SpO The optional SpO sensor allows you to measure the oxygen saturation of arterial blood and display this reading on the Tango M2 If your Tango M2 did not come with SpO PN 98 0233 00 you can order this option from your local SunTech Medical representative see page 67 Plug the SpO sensor cable into the SpO connector on the back of the monitor NOTE Use the SpO sensor on the arm that does not have the blood pressure cuff NOTE If 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 a Insert a finger preferably the index middle or ring finger into the SpO Sensor until the end of the finger reaches the finger stop Do not use the thumb b Keep the fingernail facing the sensor top Make sure that long fingernails are not interfering with proper finger position NOTE Some nail polish colors particularly dark shades or artificial fingernails may reduce light transmission and affect pulse oximetry accuracy Remove any nail polish or ar
46. ge Adult 98 0062 23 25 35 cm 18 inch K Sound microphone 98 0235 00 Single Patient Use Kits SPU Kits are packaged 20 kits to a box a microphone is not included SPU Kit Small Adult 98 0700 01 17 25 cm SPU Kit Adult 98 0700 02 23 33 om SPU Kit Adult Long 98 0700 03 23 33 cm SPU Kit Large Adult 98 0700 04 31 40 cm SPU Kit Lorge Adult Long 98 0700 05 31 40 cm 12 inch K Sound Microphone 98 0235 01 Description Part Number Details Tango M2 Cables amp Accessories Power Supply 19 0012 01 Patient Cable 15 ft 91 0125 00 ECG Patient Cable 91 0004 00 Only tor Tango M2 with Internal ECG Xpod SpO kit 98 0233 01 Includes Xood and Adult Finger Clip w Adult Finger Clip Sensor Xpod Pulse Oximeter 52 0003 00 Purelight Adult Finger Clip 91 0125 01 Sensor only Pole Rail Clamp w screws 36 0001 01 Wrist Strap 98 0003 00 T tube Kit 98 0030 00 For calibration check Headphones 51 0000 00 Extension cable for headphones 91 0076 00 Documentation amp Extended Warranties Service manual 27 0139 Al User s CD 27 0135 Al Additional One year Warranty 83 0018 00 Extended warranty 1 year Three Year Extended Warranty 83 0019 00 Extended warranty 3 years purchased at one time Appendix B contains a list of cables available from SunTech Medical to connect Tango M2 to various stress systems Status Messages 2 EENE CE ETIS 50
47. go 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 specitically to work with your stress system What s New Full color display Oscillometric non exercise OSC MODE gt BP readings without ECG connection Updated enclosure Power On Off switch USB connection Export BP measurement data Easily upgrade sottware tirmware Improved cuff connector for easier patient connection What s the Same If you have used a SunTech Tango Stress Test Blood Pressure Monitor before you can expect an effortless transition to the Auscultatory DKA MODE technology Reliable BP measurement during exercise Easy to read numeric display of BP and other patient information with a wavetorm 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 SpO option Available Internal ECG option Use with SunTech s Orbit K blood pressure cuff or SunTech
48. h data The Z field is a sequential numbering of measurements it will record NP for the first BP reading each time a New Patient is identified View Full Table Select to view table of measurement data in full screen display Press SELECT to return to Main Menu n a Download Data Select to download data to a USB A flash drive n a Select to return to Main Menu a A Clear measurement table prompt will appear Yes If Yes data will be erased from table No The Measurement Table holds up to 300 individual BP measurements Once 300 BP readings are collected in the table the oldest measurements will be overwritten by new measurements Please see Appendix D for instructions on how to download the data from the measurement table to your flashdrive and how to format the data in Excel MAIN MENU Monitor Setup Measurement Setup View Alarms Measurement Table End Test Exit j ji D Lie Lil 1 ih NP NF T i a Gy a Li i Lik Gil End ew All Readings Download Data Exit mi it Cer il m ft l K la D ba T i Lik L Li T PJ ee Lr RER pI tu r oA Ae CH oc La w ir AD PE Pd 1 ut w J PB RA M i P a 27 28 End Test Use End Test to clear display readings and prepare the monitor for a new patient Menu Option Options Default An End Test prompt will appear
49. he message RELAX ARM BP in progress will be displayed m ii until the measurement is complete then the reading will be displayed You x can also press the START STOP button to manually prompt the monitor to take banak Genie B 05 blood pressure readings This same button con be used to abort a reading if Relax arm BF iin proget necessary Display of Readings Blood Pressure and Double Product readings display in a large font as soon as each measurement is complete After one minute these readings shrink to a smaller font After five minutes these readings reset to dashed lines These times are default settings that can be reset using the Main Menu gt View menu Readings at Timed Intervals If Controlled by the Stress System When the Tango M2 is connected to a stress system the stress system will control the BP intervals The Tango M2 will follow a predetermined BP interval protocol driven by the stress system In this instance the timed intervals do not need to be programmed into the Tango M2 Not Controlled by the Stress System Tango M2 can be set to take additional blood pressure readings at timed intervals trom one to 20 minutes by selecting the Main Menu gt Measurement Setup gt Interval option 33 The selected interval time will appear on the display The timer will count up from the start of the last measurement When the timer reaches the set time interval a new blood pressure reading will be taken Whil
50. he 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 amp 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 DKA MODE for auscultatory measurement OSC MODE for oscillometric measurement of blood pressure during exercise of blood pressure non exercise a NIBP Patient Cable connection for BP cuff e Patient Cable connection for K sound pneumatic L microphone A Warning message A Caution message Symbols The following are standardized symbols that are used on the Tango M2 equipment and packaging spQ SpO Sensor Type BF Applied Part a j pa ECG Input RS 232 Serial communication port 9V DC inpu lI BNC external ECG trigger Headphone USB A or USB B Detibrillator protected Power supply contains materials which are W u ETL Certified hazardous Must be disposed of properly C1 Power On Off No SpO alarm Refer to User Guide 2 z Attention consult accompanying documents Recognized component certitied by UL to Manutactured By Date C both Canada and U S requirements TUV International Approval Earth Ground re a T cm
51. hest recorded on a patient applied part It is up to the operator to determine if this temperature is too high based upon the condition of a patient and if so to ensure the ambient temperature of the environment is 38 C or below Storage 20 C 4 F to 65 C 149 F 15 90 RH non condensing 500 kPa 1060 kPa Performance can be affected if used or stored outside the specified temperature humidity or altitude listed in the ranges above Power External power supply use only SunTech part number 19 001 2 01 Input 100 240 VAC 1 5A max 50 60 Hz Output 9VDC 5A IEC 320 type input connector Calibration The accuracy of cuff pressure transducers indicators should be veritied annually Safety Systems Independent hardware over pressure circuit and redundant software overpressure algorithm to limit cuff pressure to less than 300 mmHg 20 10mmHg Independent hardware timing circuit and redundant software timer algorithm to limit the duration of a blood pressure cycle to less than 180 seconds Dimensions Size 24 0 cm x 17 4 cm x 11 5 cm 9 5 x 6 9 x 4 5 Weight 1 68 kg 3 725 lb 59 6 oz Standards IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 IEC 60601 1 2 2007 IEC 80601 2 30 2009 ISO 80601 2 61 2011 ANSI AAMI ES60601 1 2005 DIN ISO 15223 1 2012 ISO 10993 1 2009 ISO 10993 5 2009 CEN EN ISO 10993 10 2010 ANSI AAMI ISO 81060 2 2009 DS DS EN 50419 2006 EN ISO 14971
52. ions in the Using Tango M2 during a Stress Test section of this guide PG 29 Without a Stress System Tango M2 can be used without attaching it to a stress system NOTE If your Tango M2 has Internal ECG option it can take both auscultatory and oscillometric blood pressure measurements If your Tango M2 does not have the Internal ECG option it can only take oscillometric blood pressure measurements Setup should be done by a trainded biomedical technician or an authorized SunTech distributor that is familiar with automated blood pressure and ECG equipment Connect the Power Supply to a Power Cable and plug into an available AC power outlet Connect the Power Supply to the DC input connector on the back of the monitor Connect the Patient Cable to the Microphone and Pneumatic connectors on the back of the monitor Connect the ECG Cable to the Internal ECG connector on the back of the monitor Use the ON OFF button on the back of the Tango M2 monitor to turn it on NOTE The blue LED on the top of Tango M2 will be lit whenever the monitor is powered on Within 30 seconds the SunTech Tango M2 logo will appear briefly then be replaced by the Main Display screen Measurement View is the default If using Tango M2 with Internal ECG SunTech recommends setting a CUSTOM ECG trigger by selecting Main Menu gt Monitor Setup gt Stress System gt Custom gt Protocol SUNTECH gt ECG Trigger INTERNAL Tango M2 is now ready to use as a
53. is placed over the brachial artery inbetween the bicep and tricep on the inner portion of the upper arm Refer to Step 1 Blood Pressure Cuff Placement in the previous section of this guide for proper size selection and placement of either style of cuff Step 2 Patient ECG connections Prepare and connect 3 ECG electrode sites RL V2 and V6 Place each electrode over a bony area not over a large muscle mass Prepare the skin at each electrode by shaving any excess body hair Clean each site thoroughly with alcohol For best results skin impedance should be less than 5 kohms as measured by a skin impedance meter Connect the ECG cable to the electrodes as follows e Green lead to RL Yellow lead to V2 e Violet lead to V6 Make sure that a stable heart rate is displayed on the Tango M2 monitor Step 3 Take Blood Pressure Readings Press the START STOP button to manually prompt the monitor to take blood pressure readings Take Blood Pressure Readings in the previous section of this guide for information about other Tango M2 functions Readings at Timed Intervals 39 Stopping a Reading STAT Mode DKA MODE vs OSC MODE Monitor Sleep Mode Step 4 Prepare for a New Patient When you are finished taking blood pressure measurements remove the cuff and ECG electrodes from the patient Disconnect the cuff from the Patient Cable NOTE If using the Orbit K cuff clean the cuff sleeve and the inside of the cu
54. layed until the end of each BP measurement The HEART icon does not blink Main Menu Settings Wavetorm Display is inactive e Measurement Mode and Stat Mode can only be set to full BP Fixed regulatory standard settings are used for Max Inflate and Deflate Rate 35 Monitor Sleep Mode The monitor will enter a sleep mode if there is no communication from the stress system and no activity on the monitor for 30 minutes This is a default that can be reset by selecting the Main Menu gt Monitor Setup gt Sleep Mode After option While in Sleep Mode the display will appear blank but the blue LED on the top of the monitor will stay lit Communication from the stress system or a button push on the monitor will wake the monitor Step 4 Prepare for a New Patient When the stress test is finished remove the cuff from the patient s arm Disconnect the cuff from the Patient Cable NOTE If using the Orbit K cuff clean the cuff sleeve and the inside of the cuff with a mild medical grade disinfectant If using the SPU kit discard the used disposable cuff and microphone pad Clean the microphone with a hospital grade mild disinfectant and retain for future use see section 7 36 The monitor will automatically reset for a new patient when the ECG signal has been dropped for over a minute i e when the ECG leads are removed trom the patient All patient information displays will be cleared Instead of automatically resetting
55. le Patient Use SPU kit is available in five sizes Each SPU kit contains one disposable cuff and one disposable microphone pad Use the microphone trom the Orbit K cuff included with the monitor or you can order additional microphones P N 98 0235 00 trom SunTech Medical To remove the microphone from the Orbit K cuff open the Velcro strip and gently pull the microphone out of the sleeve Clean the microphone before using with a mild medical grade disinfectant see section 7 for cleaning Check that the cuff is the correct size 1 Wrap the cuff around the patient s upper arm 2 Make sure the INDEX the end of the cuff falls within the RANGE printed inside the cuff 3 Ifthe INDEX falls outside the RANGE select a new cuff size WARNING Using an incorrect cuff size could result in erroneous and misleading BP measurements a Locate the brachial artery between the bicep and the tricep Place the microphone onto the microphone pad Peel the protective film trom the microphone pad b Place the microphone on the patient s arm making sure that the microphone is placed on the medial part of the arm directly over the brachial artery between the bicep and tricep There should be about 3 to 5 cm two finger widths between the microphone pad and the elbow c Wrap the cuff around the arm and secure Insert the 3 pin microphone connector trom the cuff into the corresponding connector on the Patient Cable The connectors can be inserted in
56. llowing limited warranty trom date of invoice All serialized monitors 24 months Orbit K Cuffs 6 months Accessories i e patient cables 90 days microphone disposables SunTech 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 trom the customer s facility within the United States prepaid to the factory SunTech Medical Inc will repair any component s or part s that it finds to be defective during the period of this limited warranty Should a detect become apparent the original purchaser should first notify SunTech Medical Inc of the suspected detect The instrument should be carefully packaged and shipped prepaid to Suntech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 800 421 8626 919 654 2300 Fax 919 654 2301 Suntech Medical Ltd Service Department 69 Oaktield Industrial Estate Eynsham Oxfordshire OX29 4TS UK Tel 44 0 1865 884 234 Fax 44 0 1865 884 235 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 SunTech Medical Inc This limited warranty contains the entire oblig
57. m Indicator Interval Indicator amp Display amp Timer An orange running man icon with a A green running man icon indicates that l oe slashed circle indicates that the monitor the monitor is set to take blood pressure l Hao G x is set to take blood pressure readings in readings in auscultatory exercise DKA l oscillometric non exercise OSC MODE MODE ae The patient must remain still See the DKA MODE vs OSC MODE section of this guide for more information PG 32 Notes on Graph View BP Trend Graph The graph will display up to 15 readings at a time but will hold 50 BP readings Use the UP and DOWN buttons to scroll back and forth to see the 50 most recent readings Full BP readings are shown with a bar systolic only readings are shown as a dot Measurements with errors or status messages will not be shown on the graph The sequence number BP and heart rate values for the highlighted reading are shown at the top of the screen BP Reading Cuff Pressure The most recent BP reading will appear at the top right of the screen While a measurement is being taken the cuff pressure will appear in the top right of the screen Heart Rate Double Product e Heart Rate is displayed as a default setting monitor can be set to display Double Product instead SpO External Manual vs Interval and Waveform Display Refer to Measurement View 19 To use Graph View as the Main Display screen pr
58. mpt to display both alarms it possible but the Regulatory alarm will be the dominate alarm in all cases Menu Option Options Default Select high systolic pressure threshold to activate alarm SYS High Options are 1 OFF 2 for Systolic Pressure in DKA from 50 270mmHg or 3 for Systolic Pressure in OSC from OFF default 50 260mmHg in increments of 1OmmHg to set alarm Select drop in systolic pressure from previous reading to activate alarm SYS Drop Options are OFF or a drop of from 10 100 mmHg in increments of 5 mmHg to set alarm OFF default This alarm resets when a new patient is started Select high diastolic pressure threshold to activate alarm DIA High OFF default Options are OFF or a diastolic pressure from 20 160 mmHg in increments of 10 mmHg to set alarm Select heart rate threshold to activate alarm HR High OFF default Options are OFF or heart rate from 40 200 beats per minute in increments of 10 bpm to set alarm Exit Select to return to Main Menu 26 Measurement Table If No data will be saved Menu Option Options Default Data for the 6 most recent measurements will appear in a table see note below Date Time Systolic amp Diastolic BP Readings Heart Rate Mean Arterial Pressure Status Messages if any The Measurement Table holds up to 300 measurements Use ARROW buttons to scroll throug
59. ne other than SunTech Medical or authorized service personnel Precautions amp 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 SpO sensor and electrodes it applicable trom 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 Pulse Oximetry Use only Nonin pulse oximeter SpO sensors supplied by SunTech Medical Check the application site of the SpO sensor frequently to contirm proper positioning of the sensor and to check 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 moislure in the sensor improperly attached sensor e incorrect sensor type poor pulse quality venous puls
60. nergy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The Tango M2 Monitor is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Compliance Test Level Level The Tango M2 Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Tango M2 Monitor should assure that it is used in such an environment Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for power supply lines kV for input output lines kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 63 64 Guidance and Manufacturer s Declara
61. ntity the USB A key 2 Using your navigational arrows and select key go into the Main Menu and navigate to the Measurement Table press the Select Key 3 Navigate to the Download Data selection and press the Select Key 4 A message will come up saying Download in Progress when this is complete it will say Download Complete You will be given 2 options Ist to clear the measurement table we recommend doing this after each time you download the data to your flashdrive and 2nd to exit Press the Select Key to Exit You may now remove the USB A Key 5 Connect your USB A Key to your PC When the window opens there will be a file called Results Open this tile 6 Inside the file there will be a document that needs to be identified It will start with the year followed by the month and date and other identifiers set up like YYYYMMDD This is the unique identifier for each new BP data set that is pulled off the Tango M2 you only need to worry with the date code as your identitier Close out to move to the next step Congratulations This is the data that you have just pulled from the Tango M2 77 Tango M2 Excel Formatting of the Data To open this data set as an Excel tile please follow these steps 1 Open the Microsoft Office Excel option in your Windows operating system this should give you a blank Excel Spreadsheet 2 Go to your Office Button where you can select to open save or print what you are working on click on it and move
62. press the SELECT button Using the UP or DOWN arrows highlight Brightness and press the SELECT button Using the UP or DOWN arrows modify the contrast of the screen When you are finished and press the SELECT button to contirm the choice 5 Using the UP or DOWN arrows select EXIT twice to return to the operating screen 59 a SL sa s How can get MAP on my Tango M2 Register your Tango M2 Monitor online or through mail to receive MAP os o function on your Tango M2 monitor Please note that due to FDA Regulations MAP is not available to the United States market Support gt Sales Support gt Product Registration 60 How do I clean the Orbit K cuff after a stress test You can do either of the following 1 Use a medical grade mild disinfectant wipe on the cuff or spray a cleaning solution onto a cloth and wipe the cuff Atterwards lay flat or line dry 2 Remove the bladder and microphone from the outer shell of the Orbit K cuff Machine wash the shell in warm water with a mild detergent 50 140 F or 10 60 C Lay flat or line dry the cuff Do not place the cuff in a dryer CAUTION Do not machine wash bladder or microphone My Tango M2 displays a message Please VERIFY CALIBRATION or Equipment Maintenance and Calibration Required What do do Verification of Pressure Calibration is required every year to maintain the accuracy of the Tango M2 s BP readings You will need to contact the SunTech Medical Servi
63. r DKA mode User settable trom 50 to 270mmHg For OSC mode User settable trom 50 to 260mmHg Drop in Systolic BP User settable from 10 to 1OOmmHg High Diastolic BP User settable from 20 to 160mmHg High Heart Rate User settable trom 40 to 200 beats per minute Service Centers For customers in the Americas SunTech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 800 421 8626 919 654 2300 Fax 919 654 2301 For customers in Europe the Middle East Africa Asia and the Pacitic SunTech Medical Ltd Service Department Oakfield Industrial Estate Eynsham Oxtordshire OX29 4TS UK Tel 44 0 1865 884 234 Fax 44 0 1865 884 235 Coie 57 58 10 Frequently Asked Questions The Tango M2 displays a Status Message What does it mean and what do do There are 2 places where you can find more information about Status Messages 1 See the E Library within your Tango M2 for quick troubleshooting tips You can find the E Library under the Main Menu select Monitor Setup gt E Library gt Status Messages 2 You can also look in the Tango M2 User Manual under the Status Messages amp Alarms section for details on each Status Message and solution The Tango M2 monitor returns a result of 0 0 after blood pressure BP measurements What do need to do to get a BP reading There are certain noisy conditions where the Tango M2 cannot accurately m
64. s Default Measurement Mode Select type of BP reading to be taken BP both systolic and diastolic SYS only systolic not available in OSC MODE BP SYS Interval Select external manual triggering or a time interval for automatic readings Time intervals are in min sec EXT MAN default 1 00 1 30 2 00 2 30 3 00 4 00 5 00 10 00 20 00 Initial Inflate Set initial inflate pressure for cuff from 120 280 mmHg in increments of 10 mmHg 180 mmHg Max Inflate Set maximum inflate pressure for cuff from 120 280 mmHg in increments of 10 mmHg 280 mmHg Menu Option Options Default Deflate Rate Select deflate rate for cuff AUTO approx 4 mmHg heart beat If heart rate is over 100 BPM the monitor may deflate at a higher rate than selected AUTO default 3 mmHg sec 4 mmHg sec 5 mmHg sec 6 mmHg sec 7 mmHg sec 8 mmHg sec Beeper Stat Mode Key Select whether monitor will beep during a BP reading Select type of BP reading to be taken during STAT mode BP both systolic and diastolic SYS only systolic not available in OSC MODE Start Finish default Both Never BP default SYS Exit Select to return to Main Menu 23 24 View Menu Option Options Default Moin Disploy Select view to be the Main Display oo default Waveform Select signal displayed in Waveform Display field fees
65. ted electronic sohygmomanometers or equivalent 500 mL volume or the Orbit K Adult Plus cuff wrapped around something that will not break or crush no glass e Hand Inflation Bulb with bleed valve Tubing Tee pieces and miscellaneous connectors or you can order the T Tube Kit SunTech Part 98 0030 00 Procedure When Verity Calibration is accessed the monitor will close its bleed valves and display the pressure applied to the patient hose connector Verity Tango M2 calibration by manually intlating and checking the sohygmomanometer against the pressure reading on the monitor display The displayed pressure reading should be within 2mmHg of the pressure value on the mercury sphygmomanometer through a range of pressures from O to 300mmH4g If not contact SunTech Medical about calibration Once the calibration has been contirmed press the SELECT button to exit the calibration screen Software Updates If a Tango M2 software update is available you can update your monitor easily using the USB A port Sottware updates should only be installed by a trained technician who is familiar with operation of the Tango M2 Please call your Sunlech Medical Customer Service if you need assistance Download the software update trom the the SunTech Medical website www SunTechMed com onto a USB A flashdrive Insert the USB A flashdrive into the USB A port on the back of the monitor Select Main Menu gt Monitor Setup gt System Info gt Softwar
66. tificial fingernails before using the SpO sensor c Use medical tape around the base of the fingers to secure the sensor cable during the stress test Make sure that the tape securing the cable does not restrict the blood flow NOTE Patient sensitivity to tape may vary due to skin conditions Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive materials An SpO reading will be displayed after a few seconds The SpO measurement data is updated every 1 3rd of a second and the displayed value is updated every second A 4 beat SpO average is used to display a reading Any temporary loss of signal will atfect the accuracy of this reading due to this averaging There is no alarm associated with SpO An SpO reading will not be displayed due to any of the following issues weak or loss of signal or an open circuit due to a damaged cable The Tango M2 will shut down if the cable s voltage is shorted to ground until the fault is removed In the case of a damaged cable remove the SpO cable from the Tango M2 and resume normal use of the Tango M2 Call SunTech Customer Service for assistance with the damaged SpO cable Headphone Kit Headphones allow you to listen to the K sounds that are picked up by the microphone in the cuff These sounds are similar to what you hear when taking a manual BP Plug the headphone jack into the port on the right side of the monitor NOTE Headphones should only be
67. tion Electromagnetic Immunity Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Tango M2 Monitor requires continued operation during power mains interruptions it is recommended that the Tango M2 Monitor be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 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 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 people 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 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
68. tion If this equipment does cause harmful 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 Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected 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 specified may result in increased emissions or decreased immunity of the Tango M2 The Tango M2 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Tango M2 should be observed to verity normal operation in the configuration in which it will be used Guidance and Manufacturer s Declaration Electromagnetic Emissions The Tango M2 Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Tango M2 Monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance Guidance and Manufacturer s Declaration Electromagnetic Emissions RF emissions CISPR 11 Group The Tango M2 Monitor uses RF e
69. to rear panel are secure Make sure patient s skin is properly prepared and that ECG electrodes are correctly placed Review Interface Notes for your stress system Make sure the correct stress system setting is selected If Custom make sure the correct ECG Trigger is selected Status Message Reason Solution Displayed only in DKA MODE Check Mic Check mic position and cable connection Weak missing or no K Sounds detected No BP reported Make sure microphone is positioned over the brachial artery Make sure cuff connections to patient cable are secure Make sure that patient cable connections to rear panel are secure Check microphone It it is bent or its wire is not securely connected replace microphone Test microphone by tapping the cuff check for a signal on the Waveform Display It signal is tlat replace microphone Replace microphone and cuff annually Review Interface Notes for your stress system Make sure the correct stress system setting is selected If Custom make sure the correct ECG Trigger is selected 53 54 Status Message Reason Solution Displayed only in DKA MODE No ECG detected Not receiving ECG signal Check leads and cables for good connections Monitor is not receiving ECG signal Review Interface Notes for your stress system Make sure the correct stress system setting is selected If Custom
70. ture Remove any residue and wipe dry To disinfect use a hospital approved disinfectant such as 1 10 chlorine bleach Lysol disinfectant 2 glutaraldehyde solution or Wescodyne NOTE To control infection follow your facility s established protocol For cleaning use your facility s established protocol SpO Sensors CAUTION Never immerse sensors and clips in fluids Do not pour or spray any liquids onto the sensor Caustic 43 or abrasive cleaners will cause permanent damage Do not open the case of the finger clip sensor more than 45 or the case will be damaged Clean the sensor with a soft cloth dampened with a mild medical grade disinfectant or isopropyl alcohol Remove all tape residues Allow the sensor to dry thoroughly before reusing Preventative Maintenance System Self Checks Tango M2 performs a range of system and software checks during normal operation If Tango detects a problem it will display an error code with a message to contact SunTech Customer Service WARNING DO NOT USE the monitor if it displays a greater than zero pressure with no cuff attached Replaceable Parts On a routine basis inspect the monitor cuff SpO sensor cables and hoses for cracks fraying or kinks Immediately replace any damaged part Refer to the list of Accessories amp Replacement Parts in this guide PG 48 CAUTION The monitor does not contain any user serviceable parts and should only be opened by an authoriz

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