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User`s Manual SunTech® 247™ Blood Pressure Blood Pressure

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1. Do not use the device if it has failed its diagnostic self test or if it displays a greater than zero pressure with no cuff attached or a value of functional oxygen saturation or temperature with no sensor attached vi Prevent water or other fluids from entering any connectors or vents on the device Should this happen all connectors should be dried with warm air Then check the calibration of the device and operating functions before reusing Do not make repairs yourself Equipment must be returned to SunTech or authorized service personnel for repairs Substitution of a component different from that supplied may result in measurement error If the SunTech 2471s dropped or mishandled please have it checked by a authorized service center before bringing it back into use The SunTech 247is not intended for patients connected to a cardiopulmonary bypass machine At least every three months inspect probes cords and accessories for fraying or other mechanical damage Replace as necessary Check the calibration of your SunTech 247at least once a year vil If Luer Lock connectors are used in the constructions of tubing there is a possibility that they might be inadvertently connected to intravascular fluid systems allowing air to be pumped into a blood vessel viii TABLE OF CONTENTS Changes and Relssues n sees ened scassuad stn sacacdasadascasducgacdedad
2. Three long beeps Please refer to page 41 for troubleshooting One short beep followed You have aborted this BP by a long beep measurement Visual Cues Battery Icon If your SunTech 247 does not have a battery all segments of the battery icon are lit when the power supply is connected If your device has a battery then the icon indicates the status of the power supply as follows ICON DISPLAY INDICATES Tor Lo o om As the charge level drops the segments will be turned off in sequence from the right to the left The battery charge is very low Recharge before using segment flashing Visual Cues Blood Pressure Module Icons and numeric displays on your device assist you in taking quick and accurate readings The systolic BP read in mmHg displays immediately below this symbol The diastolic BP read in mmHg displays immediately below this symbol Unit of measurement for SYS DIA and MAP Pulse rate in beats per minute displays immediately below this symbol 10 ICON DISPLAY INDICATES If this icon is lit on power up MAP mode is enabled After a measurement this icon is lit when MAP is displayed in the space below These letters are displayed in the pulse rate display area when you are checking the device s calibration Indicates an issue associated with the cuff its position or connection Please check the cuff and hose and try again Additionally check page 40 for
3. 19 0013 00 External power supply for Battery version rechargeable by Globtek model GTM21089 1509 T3 SunTech part number 19 0014 00 Calibration Check once per year for BP and Temperature 50 Safety systems Independent hardware over pressure circuit and redundant software overpressure algorithm to limit cuff pressure to less than 330 mmHg Independent hardware timing circuit and redundant software timer algorithm to limit the duration of a blood pressure cycle to less than 180 seconds Dimensions Length 5 5 inches Height 11 5 inches Width 3 8 inches Length 14 0 cm Height 29 2 cm Width 9 7 cm Standards UL60601 1 CAN CSA C22 2 601 1 IEC 60601 1 IEC 60601 1 2 EMC IEC 60601 1 4 ISO 9919 AAMI SP10 2002 ASTM E 1112 EN 12470 3 Meets EN 1060 1 Specification for non invasive sphygmomanometers Part 1 General requirements and EN 1060 3 Non invasive Sphygmomanometers Part 3 Supplementary Requirements for Electro Mechanical BP Measuring Systems Classification Protection against electric shock Class II for non battery version Internally Powered Equipment for battery version Applied parts Type BF Mode of operation Continuous IP index IPXO Compliance Ce 0413 SunTech Medical Ltd Oakfield Industrial Estate Eynsham Oxfordshire OX29 4TS UK Tel 44 1865 884 234 Fax 44 1865 884 235 Safety Requirements Clinical grade BP measurement accuracy defined by fully meeting the
4. symbol on button v Momentary switch that selects oral vs axillary measurements for the oral temperature probe and selects predictive vs direct measurement methods for all probes 6 Connectors on the optional temperature module e Temperature unit connector Located on the temperature module connects to the temperature probe housed in the temperature probe well Temperature probe connector Temperature unit connector not shown Buttons on the optional pulse oximetry module None Connectors on the optional pulse oximetry module e SpO2 sensor connector Connects to an SpO extension cable or sensor See page 63 for compatible accessories Optional temperature and pulse oximetry displays n Celsius icon a Fahrenheit icon peer oo LI 0 t Temperature Warning icon 1 z ILLI nn Qi Ob e cm LILI sunTech se gs Signal quality Meere ds Ii m SpO2 ILILI Warning icon A Information on the optional temperature module display e Temperature At the end of a measurement the patient s temperature is displayed During a measurement displays the probe type and related information If the warning icon is lit displays the status code See page 41 for details e Celsius icon When lit the value below is displayed in degrees Celsius e Fahrenheit icon When lit the value
5. 247 ssssesssssssssssesees eene enn nhe ee nni hh arena anna nah aan ana ester nnne nn nns 16 Mounting Your Device seossenicrie pni arro rr era eH RI DAN I M PM Ce IP CEPR HENRY TiTe FUE 17 Mounting the Device on a Wall erere aerea aere a raaa nnne nnne nns 17 Affixing the Device to a Mobile Stand ssssssssssssssssseeeeeneern nennen eene eren 17 Placing the Device on a Tabletop sessssssssseeeeeeeee nennen nennen nennen nnne nnns 17 First TIME Setup ode soca ca cca a ole tela ce des ace sleet nde stus Dur Dus Du dua Dus a tenet ante 18 Connecting Your Device EE 18 Charging the Battery ninnbenssinnsinssens ieesS BnnsSsusnSncyssppdrigeeizug 18 Selecting Temperature Unit of Measurement iria 19 P wenng UP f M 19 MEASURING BLOOD PRESSURE WITH THE SUNTECH 247 eene 20 Prepping Your Patent eec 20 Selecting the Right Cuff ccs ees sees dees tees dees Sees sa e eek Se ee eee ese deg de pci ee e teat 21 Taking Meas rement nete aa pad heen pee 22 Taking an Automated Measurement ssssssssseseeee eene nnne nnne nnn nnne nnns 22 Taking a Sphygmode Measureme nt cccccceeeeeeeeeeee eee e eee eaaeeeeeeaaeeeeeaaaaeeesaaaeeseaaaeeeeeaaes 23 Reems Primer eene iss acct pcan eda d M ae Na MI EN VETAT cise ITE DU e ee TTL 24 MEASURING TEMPERATURE WITH THE SUNTECH 247 sees 25
6. common examples of such circumstances are described here to assist you in using your SunTech 247 optimally under such conditions You can find recommendations on dealing with each of these special situations in the American Heart Association s current scientific statement on recommendations for blood pressure measurement or the British Hypertension Society s current guidelines for management of hypertension Measuring Blood Pressure in Children Typically children exhibit greater variability in blood pressure than do adults They are more likely to be crying eating or restless in a clinical situation further increasing the potential for variability Measuring Blood Pressure in Obese Patients There appears to be a positive correlation between obesity and hypertension Due to the increased arm circumference of obese patients use of a standard cuff may lead to blood pressure being erroneously elevated a condition known as cuff hypertension Selecting an Appropriate Cuff for Obese Patients e For larger than normal upper arms use a wider and longer cuff than you would otherwise use e Prominent biceps in a muscular upper arm require a large cuff Measuring Blood Pressure in the Presence of Arrhythmia Irregular cardiac rhythms can result in a large variation in blood pressure from beat to beat If you are using the SunTech 2470n a patient with known arrhythmia we recommend that you follow up with a Sphygmode BP reading as a c
7. distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation distance TEC 61000 4 6 150 kHz to 80 MHz 3V d 3 5 Vi VP Radiated RF 3V m 3 V m d 3 5 E VP 80MHz to 800MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 7 E VP 800MHz to 2 5GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range gt Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SunTech 247 device is used exceeds the applicable RF c
8. final temperature value Visual Cues Pulse Oximetry Module ICON DISPLAY INDICATES I The unit is taking a measurement gt Traveling dash in SpO display Warning Indicates an error in the optional pulse oximetry module Please refer to the troubleshooting section on page 42 12 ICON DISPLAY INDICATES Indicates signal strength and quality from the pulse oximeter sensor If there is no measurement and the signal quality is low try a different site or sensor Indicates the functional oxygen saturation SpO value This area also displays the status code when the warning symbol is lit 13 QUICK START GUIDE If the device is off turn it on by depressing the power button on the right side Measuring Blood Pressure and Pulse Rate Automatically 1 Wrap an appropriately sized cuff sizes are tabulated on page 21 snugly around the upper arm midway between the elbow and shoulder 2 Ask the patient to stay still and quiet before taking the measurement 3 Press the automatic button on your unit The cuff begins to inflate and the cuff pressure is shown in the systolic display 4 In about 35 40 seconds depending on the size of the cuff you will hear a beep to indicate cycle completion The systolic and diastolic values are shown in their respective locations If MAP mode is enabled the pulse rate and MAP values will alternate Measuring Blood Pressure Using Sphygmode 1 Wrap
9. greater than 90 can permanently damage its casing Checking the Calibration of Your Device It is recommended that you check the BP calibration of your SunTech 247once a year To check calibration 1 Start with the device powered off While holding down the automatic button on the front of the BP module toggle on the power button on the right side of the main enclosure The CAL message is displayed in the pulse rate display to indicate that the system is in the calibration mode During this mode the system pressure displays in the systolic BP display area 2 Using a T connector connect a calibrated pressure reference and control such as a manometer and inflation bulb to the pressure hose connector of the SunTech 247 See page 61 for details on ordering the calibration kit which includes a T connector 3 Compare the pressure reference to the SunTech 247throughout the pressure range 0 to 270mmHg If the difference between the pressure reference and the SunTech 247 is no larger than 2mmHg the SunTech 247 is calibrated correctly for operation If the SunTech 247needs calibrating contact an authorized service center on page 47 4 Exit the calibration check by pressing the automatic button again Once the display shows dashes as the systolic BP you are now ready to take a measurement It is recommended that you check the temperature calibration of your Sun Tech 247 temperature module annually A FasTemp Calibration Plug see
10. is displayed in degrees Fahrenheit e Warning icon When displayed indicates that the system needs to be checked See page 41 for details Information on the optional pulse oximetry module display e SpO2 At the end of a measurement the functional oxygen saturation of the patient is displayed If the warning icon is lit displays the status code See page 42 for details e Signal quality During a measurement indicates the quality of signal from the pulse oximeter sensor e Warning icon When displayed indicates that the system needs to be checked See page 42 for details Icons and Cues Your SunTech 247is designed to provide unambiguous visual and auditory cues before during and after a measurement For easy reference all cues are tabulated in this chapter e Audible cues or beeps identify stages in the measurement cycle e Icons illuminated within a module s display indicate measurement modes processes or warnings Auditory Cues The temperature and BP modules of the SunTech 247are programmed with auditory cues A listing of these cues appears below NUMBER OF BEEPS INDICATES The device i d d One short beep after power up or Ro CD de ready use or the device is right before powering down y about to turn off One short beep after Success measurement taking a measurement taken BP measurement error Three short beeps Please check or take another measurement A system error has occurred
11. o e E E DU Sires 49 3 Slide part A of the temperature module along the guides on the Pim top of the BP module from front to back until it snaps into place All the segments of the temperature module display will light when the modules have been connected correctly 36 4 Attach the temperature probe connector to part B as follows with the black surface facing downward hold the probe connector end against the notches on the probe holder as shown in red step 1 shown below Side view of probe in place Front view of probe in place 5 Rotate the connector upwards until it snaps securely into place step2 shown above The black surface faces outward and the cord extends upward 6 Slide part B onto part A as shown this connects the temperature probe connector to the temperature unit connector and insert the temperature probe into the well 7 Turn the device on using the power button on the right side of the BP module At the end of the start up sequence the temperature module display will Temperature unit connector not i shown blank except for the appropriate temperature unit icon F or C A short beep indicates that the Sun Tech 247 is ready Note If the temperature module does not appear to be working properly cycle the power several times using the power button on the right side of the BP module This will synchronize all the
12. or loose Take another BP reading 40 Status Codes 800 900 910 970 980 or 990 A Problem System error Solutions 1 2 Take another measurement If this is unsuccessful power down then power up the unit using the power button on the right side of the unit Ifthe error does not recur immediately take another measurement If the error recurs remove power from the unit unplug any power supplies and remove the battery if there is one then reconnect the power Ifthe error does not recur immediately take another measurement If the error recurs contact SunTech Medical Inc or an authorized service center Troubleshooting Temperature Module Status Code 5 Problem Temperature probe missing or outside of well Solutions 1 2 Remove and then place the probe in the well Ensure that the temperature well the rear portion of the temperature module is well seated on the display Along the top of the module the edge of the well should be flush with the display Remove and carefully slide the well onto the display When properly fixed the error should no longer be displayed Take a new measurement Status Code 10 Problem Defective temperature probe Solutions 1 2 Remove and then place the probe in the well Ensure that the temperature well the rear portion of the temperature module is well seated on the display Along the top of the module the edge of the well should be flush with
13. page 61 for details is available to check accuracy of the Filac FasTemp technology It replaces the regular probe and verifies the accuracy of the temperature electronics Replace the temperature module if error is greater than 0 1 C To check the calibration 1 Remove the Temperature Well from the Temperature Module 34 Replace the Temperature Probe with the Calibration Plug 3 Replace the Temperature Well Initiate a measurement by inserting and removing the Temperature probe from the well 5 Verify the accuracy of the measurement Probe accuracy can be checked by using the thermometer as you would on a patient in any mode with a cover but place it in a calibrated water bath Direct mode is accurate to 0 1 C of the calibrated water bath temperature Predictive mode accuracy is accurate to 0 2 C of the calibrated water bath temperature Replacing the Rechargeable Battery Replace the battery According to your regular maintenance schedule When the battery no longer charges After heavy use if necessary To replace the battery 1 Remove the four screws securing the battery bay door 2 Carefully remove the battery from the battery bay being careful not to pull on the wires attached to the battery terminals 3 Disconnect the wires from the battery terminals The rechargeable battery contains lead Please dispose of the old battery properly 5 Connect the wires to the terminals of the replacement bat
14. pressures from 60 to 270 mmHg and diastolic pressures from 30 to 170 mm Hg lie within the range of your device In most cases you will be able to take accurate blood pressure BP and pulse rate HR measurements within 35 40 seconds Steps in taking a BP measurement are e Prepping the patient and attaching the cuff e Taking the measurement Prepping Your Patient Ensure that the patient e Is not wearing any constricting clothing on the selected arm e Has no injury or tissue damage on the selected arm e Keeps the cuffed arm at heart level e Keeps the cuffed arm motion free and relaxed without any muscle tension in the biceps and triceps during the measurement e Does not cross his her legs for the measurement Keep aware of current practices as recommended by the American Heart Association British Hypertension Society and other medical practice associations LU M 1 Ready the patient into a sitting W standing E or supine position Remember that a patient s BP can vary with position The stress of being in a clinical situation often causes patients to undergo white coat hypertension leading to higher than normal readings Help your patient to relax as you prepare to take the measurement 20 Selecting the Right Cuff Your device comes with durable two piece All Purpose Cuffs APC from SunTech Medical Inc Cuffs are available in a range of sizes from Childto Thigh Note that your SunTech 247 works optimally with
15. probe Insert the probe gently 1 cm inside the sphincter Tilt the probe to keep it in place and hold it in position to sd ensure tissue contact During measurement a traveling dash Lis displayed measurement ue Note that proper placement of the probe is essential to the accuracy of the After 10 15 seconds a long beep signals the end of the measurement The result will be displayed for two minutes or until you initiate a new measurement Remove the probe discard the probe cover and place back in the probe holder Note the reading If the temperature reading is out of range the device will beep and flash the s limit that is exceeded So if the reading is greater than 109 4 F 43 0 C c 109 4 or 43 0 will flash on the display followed by a sequence of rising LED s If the reading is less than 86 0 F 30 0 C 86 0 or 30 0 will flash on the display followed by a sequence of falling LED s 28 MEASURING OXYGEN SATURATION WITH THE SUNTECH 247 The SunTech 247 optional pulse oximeter module measures functional oxygen saturation ranging from 40 to 100 A signal strength display assists the clinician in the proper placement of the sensor uo The SunTech 247is a spot check device and is not used for patient c monitoring Therefore there are no SpO alarms Steps for measuring functional oxygen saturation e Prepping the patient and affixing the sensor e Taking a reading Prepping
16. requirements of e AAMI SP 10 2002 e EN 1060 4 51 EMC Statement This equipment has been tested and found to comply with the limits for medical devices to IEC60601 1 2 2001 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity This equipment should not be used adjacent to or stacked with other equipment If this is necessary the equipment should be observed to verify normal operation in the configuration in which it will be used However even if used properly there is no guarantee that interference will not occur in a particular installation 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 e Reorient or relocate the receiving device e Increase the separation between the equipment e Connect the equipment into an outlet on a circuit different from that to which the other device s are connected e Consult the manufacturer or field service technician for help Use only SunTech approved cables and accessories with this device Use of unauthorized cables or accessories may result in increased e
17. temperature The SunTech 247 temperature module is accurate to 0 2 F 0 1 C What is the accuracy of the SunTech 247pulse oximetry module The SunTech 247 pulse oximetry module is 2 in the 70 to 100 range for no motion and normal perfusion For motion or low perfusion the accuracy is 3 When does the warranty period begin The warranty for your SunTech 247 begins on the date of shipment of your device How do I make a warranty claim for the SunTech 247 Simply contact an authorized service center on page 47 Web Resources www SunTechMed com Service Centers For customers in the Americas SunTech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 1 919 654 2300 Fax 1 919 654 2301 46 For customers in Europe the Middle East and Africa SunTech Medical Ltd Service Department Oakfield Industrial Estate Eynsham Oxfordshire OX29 4TS United Kingdom Tel 44 0 1865 884 234 Fax 44 0 1865 884 235 For customers in Asia and the Pacific SunTech Medical Co Ltd 2 F of Building A Jinxiongda Technology Park Guanlan Bao an District Shenzhen China Tel 86 775 2958 8860 Fax 86 775 2958 8829 47 SPECIAL SITUATIONS Special Situations Unique circumstances such as the patient s age or physiological disturbances require you to take special care while measuring blood pressure or vital signs The more
18. troubleshooting details Warning The device is unable to take a valid reading See page 40 for troubleshooting details A measurement is in progress If the column is rising the cuff is being inflated if the column is falling the cuff is deflating Each segment lit is approximately equivalent to 10 mmHg Visual Cues Temperature Module ICON DISPLAY INDICATES E Temperature shown in degrees Fahrenheit Temperature shown in degrees Celsius The unit is taking a measurement in predictive measurement mode Traveling dash in temperature display Warning There is an error in the measurement or module Please check the status code in the troubleshooting section on page 41 for details and solutions 11 ICON DISPLAY INDICATES The device is set to measure an oral temperature The device is set to measure an axillary temperature The device is set to measure a rectal temperature The unit is taking a measurement in direct measurement mode The display of alternates with the current probe temperature The unit is taking a measurement in direct Temperature value flashes measurement mode but the reading is currently out of range Temperature value flashes in an upward Final measurement is greater than direction 109 4 F 43 0 C Temperature value flashes in a downward Final measurement is less than 86 F 30 0 C direction Temperature value is steady no flashing This is the
19. 0 All Purpose Cuff package Includes Small Adult Adult Adult Adult Long Large Adult cuffs with threaded screw type connectors 98 0145 00 All Purpose Cuff package Includes Child Child Long Small Pediatric Adult Small Adult Long cuffs with threaded screw type connectors 98 0084 22 All Purpose Cuff Child Blood Pressure Cuff with threaded screw type connector Range 12 19 cm Color Green 61 98 0084 23 All Purpose Cuff Child Blood Pressure Cuff with threaded LONG screw type connector Range 12 19 cm Color Green 98 0084 24 All Purpose Cuff Small Blood Pressure Cuff with threaded Adult screw type connector Range 17 25 cm Color Royal Blue 98 0084 25 All Purpose Cuff Small Blood Pressure Cuff with threaded Adult LONG screw type connector Range 17 25 cm Color Royal Blue 98 0084 26 All Purpose Cuff Adult Blood Pressure Cuff with threaded screw type connector Range 23 33 cm Color Navy Blue 98 0084 27 All Purpose Cuff Adult Blood Pressure Cuff with threaded LONG screw type connector Range 23 33 cm Color Navy Blue 98 0084 28 All Purpose Cuff Large Blood Pressure Cuff with threaded Adult screw type connector Range 31 40 cm Color Burgundy 98 0084 29 All Purpose Cuff Large Blood Pressure Cuff with threaded Adult LONG screw type connector Range 31 40 cm Color Burgundy 98 0084 30 All Purpose Cuff Thigh Blood Pressure Cuff with threaded screw type connector Range 38 50 cm Color Brown Pulse Oximetry A
20. 2 4 m length 17 0014 00 Rechargeable battery 6V sealed lead acid battery 65 stinTech Medical Brilliant Blood Pressure Solutions www SunTechMed com SunTech Medical Inc 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 1 919 654 2300 1 800 421 8626 Fax 1 919 654 2301 SunTech Medical Ltd Level 25 Bank of China Tower 1 Garden Road Central Hong Kong Tel 852 2251 1949 Fax 852 2251 1950 SunTech Medical Ltd Oakfield Industrial Estate Eynsham Oxfordshire OX29 4TS United Kingdom Tel 44 1865 884 234 Fax 444 1865 884 235 Ce 0413 Part 80 0040 00 Rev C 66
21. 9 0068 00 SunTech 247 Wall System BP amp SpO 99 0069 00 SunTech 247 Battery Tabletop System BP Temperature amp SpO2 99 0070 00 SunTech 247 Battery Tabletop System BP 60 BP Device with SpO Temp Rechargeable Battery and mobile stand amp basket BP Device with Rechargeable Battery and mobile stand amp basket BP Device with Temp Rechargeable Battery and mobile stand amp basket BP Device with SpO Rechargeable Battery and mobile stand amp basket BP Device with SpO Temp and wall mount kit amp basket BP Device and wall mount kit amp basket BP Device with Temp and wall mount kit amp basket BP Device with SpO and wall mount kit amp basket BP Device with SpO2 Temp Rechargeable Battery and tabletop stand BP Device with Rechargeable Battery and tabletop stand 99 007 1 00 SunTech 247 Battery BP Device with Temp Rechargeable Tabletop System BP amp Battery and tabletop stand Temperature 99 0072 00 SunTech 247 Battery BP Device with SpO2 Rechargeable Tabletop System BP amp Battery and tabletop stand SpO2 SunTech 247 Accessories 98 0128 00 SunTech 247Temperature Thermometry Module for SunTech Module 247 BP 98 0129 00 SunTech 247SpO Module SpO Module for SunTech 247 BP 39 0028 00 Top bottom cover for Covers the top or bottom ofa SunTech 247 BP SunTech 247 BP device All Purpose General Clinical Use Cuffs 98 0144 0
22. APC cuffs Using the table below select a cuff you estimate to be of the right circumference SENS Child 12 19 cm SENE Child Long 12 19 cm SENE Small Adult 17 25 cm GEN SmallAdult Long 17 25cm GENER duit 23 33 cm SEN Adult Long 23 33 cm GEN Large Adult 31 40 cm GENE Large AdultLong 31 40 cm SENE Thigh 38 50 cm 2 Wrap the cuff around the patient s upper arm midway between the elbow and the shoulder 3 Ensure the ARTERY arrow is over the brachial artery between the biceps and triceps muscles on the inside of the arm 4 Use the range indicator WeRange and che INDEX line on the inside of the cuff to check that the arm circumference falls within the specified range of the cuff If the arm is within range this cuff size is correct for your patient If the measurement is outside the RANGE indicator use the appropriate larger or smaller cuff and re check Using a cuff that is too small commonly called undercuffing can result in overestimating a patient s BP Using a cuff that is too large or overcuffing can result in underestimating a patient s BP For most accurate results take care in selecting the appropriate size cuff for your patient 5 Ensure that the BP pressure hose is connected to the cuff Confirm that the hose is neither compressed nor kinked 6 Ask the patient to stay still and quiet before taking the measurement Do not place the cuff on an arm currently being used for other procedures such
23. ATURE WITH THE SUNTECH 247 Your SunTech 247 device can measure temperature with the optional temperature module This module enables you to take rapid accurate temperature measurements ranging from 86 F 109 4 F Typically predictive readings are obtained within ten to fifteen seconds and direct readings within two minutes The module is equipped with the temperature probe for oral axillary measurement color coded blue A rectal probe that is color coded red is optionally available Temperature Units of Measurement The device displays the temperature measurement in e Celsius e Fahrenheit To choose a unit of measurement depress the recessed button on the left side of the temperature module The icon for the selected unit is illuminated This is now the default selection Temperature Measurement Modes The device can measure temperature via three modes e Oral indicated by oon the display and measured using the blue probe e Axillary indicated by oL H onthe display and measured using the blue probe e Rectal indicated by Ec onthe display and measured using the red probe All three modes can be used for both predictive and direct measurement In the default predictive mode your Sun Tech 247 predicts temperature in 10 15 seconds with an accuracy of 0 2 F 0 1 C When a fever is detected the measurement may last longer In direct mode the display continually updates until a stable reading is reached This mode
24. D ACRONYMS Acronyms Acronyms commonly used in this document include APC A SunTech proprietary acronym for All Purpose Cuff BP Blood pressure HR Pulse rate K sound Korotkoff sound MAP Mean arterial pressure NIBP Non invasive blood pressure Document Key This manual uses the following icons to call attention to specific instructions or guidance TIP A step or process that eases or enhances your use of your SunTech 247 device A NOTE Indicates something you must do to use your device correctly and effectively A CAUTION Warns you that not following these instructions can cause injury harm or serious damage iv Indications for Use The SunTech 247 NIBP Temperature and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures pulse rate temperature and functional oxygen saturation SpO of adult and pediatric patients in hospitals medical facilities clinics physicians offices and other sub acute environments User Responsibility Your SunTech 247 product is designed to perform in conformity with the description 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 the device annually e Never knowingly use a defective device e Immediately replace parts that are broken worn mi
25. Pacific eene 48 SPECIAL SITUATIONS i1 ti pesi eterni bare ertet prr tte anaes 49 Special Sittiatlotis 375551 cctecstecstecatccheceie Cas aGe Todd 49 Measuring Blood Pressure in Children eira ereraa amarra 49 Measuring Blood Pressure in Obese Patients sssssssssssssseseeseneeene ener 49 Measuring Blood Pressure in the Presence of Arrhythimia c ceccseeeeeeeeeeeeeeaeeeeeeeaaes 49 Measuring Blood Pressure During PreQnanCy ccccseeeeeeeeeeeeeeeeeeeeeeaaeeeeesaaeeeeeaaaeeeeaaaes 49 Measuring Blood Pressure in the Elderly sssesessssesssseeeeeneenennennn enne 50 Measuring Blood Pressure in the Emergency Room iria 50 Measuring Blood Pressure in the Presence of Orthostatic Hypotension esss 50 xi APPENDICES asus ine dg aaee raeas RG SA dent DANS EaD Sans UND ASS raiak ondt deia anat 51 SpeciticatioDs cere ee en AA onda apad m dM MM eae 51 Compliance a RES 52 Safety Requirements decet Rea hee eee ies On Bog ee dec eek ee RS 52 EMG State ments 2 25 ccccedss sacs cvedcccecdgicascavescccedusccncsdissccca di Rasa cada Ra ceca secs sosscdectenssecscaascdesees 53 SY nio LANI ERE 53 Limited Warranty esa 59 Purchasing Parts and Accessories eese eeeeeeee een ene tn tnn enses tns tnstnetnene 61 xii GETTING TO KNOW THE SUNTECH 247 Your SunTech 247 is a powerhouse of functionality offering con
26. SunTech Medical SunTech 247 Blood Pressure Device for Automated and Manual Measurement gt mmm I AN i SUnTech User s Manual About this Manual This manual describes features and uses of the SunTech 247 by SunTech Medical Inc a non invasive clinical grade automated device to measure blood pressure pulse rate and mean arterial pressure Optional modules to measure temperature and functional oxygen saturation are available and their use is also described in this manual e This manual accompanies all the versions of the SunTech 247 SunTech 247 Versions SunTech 247 BP amp BP device with temperature Temperature SunTech 247 BP amp SpO BP device with SpO SunTech 247 BP Temperature BP device with SpO and amp SpO temperature SunTech 247 Battery BP BP device with rechargeable battery SunTech 247Battery BP amp BP device with temperature Temperature and rechargeable battery SunTech 247 Battery BP amp SpO BP device with SpOz and rechargeable battery SunTech 247 Battery BP BP device with SpO Temperature amp SpO temperature and rechargeable battery This document is designed to help you quickly familiarize yourself with your SunTech 247 and subsequently to use it to its full potential Dispersed throughout the body of the manua
27. TAINING THE SUNTECH 247 eerte nenne trennen nnn 33 Routirie Mairntenarces eret akg ee PPS N Ihn ES 33 ELIO 33 Checking the Calibration of Your Device eesssesssssesesneeee eene nnne nnns 34 Replacing the Rechargeable Battery ssssssssssssseeseseneneeenen nennen nnns en nnns 35 Attaching the Temperature Module iria hne n nnn n renes 36 Attaching the Pulse Oximetry Module ii nennen hern nnne nnn 38 Storage Sh tdown Lranspoft so oro necp ber d c A GU Aeneas 39 SLOTAG mer EET 39 Moving Your Device iini rea RR ER RER ERR ER IEEE ER AREE AURA AR RR EERALRRA RR DNA SENSA coca ic nica nd ga RAS 39 TROUBLESHOOTING ui r aaa e eo eoru eno o rae een ra Eo ed riva eid veces 40 Troubleshooting Blood Pressure Module estrear 40 Troubleshooting Temperature Module ssseeseseseeeeen nennen nnne nnne 41 Troubleshooting Pulse Oximetry Module estrear 42 E OS mirins aca AA ticle 45 Web Resources ec 47 Service Centers oceano inte RAR AAA ROA Aas nay ante iene e pU ES 47 For customers in the AMESiCaS cccccsssssseeeeceeseceeseeeeeeeeeeeecenseceeseeeeseeoeseceeseeeeseneenteeeeees 47 For customers in Europe the Middle East and Africa cccccceeccecececeeeeceeeeeeaeeeeeseeees 48 For customers in Asia and the
28. Temperature Units of Measurement sssssssssssssseeeee nennen nnne nnne nnns nnn nnne nnn 25 Temperature Measurement Modes ssssssssssssssseeeee nene nennen nnne nennen nnn nnn nn nnns 25 Using temperature probe and probe covers ssssssesseseeeeee nennen nennen nnne nns 25 Takitig an Oral Tem perature RN 26 Taking an Axillary Temiperat rte 25eenieet tote eete ee te t e eer ute 27 Taking a Rectal Tempera tia ess so iss ssssesndesedodncusnsadd ossdecstesssusesusnsenie taf otedatatuc dateien 27 MEASURING OXYGEN SATURATION WITH THE SUNTECH 247 29 Prepping the Patieht iio eei deret ibat hee d edi db dane suave ed 29 Selecting the Right Sensor dienen eun rna dano cana danada Sadino an ad IDA RRRRR IER SERE a Land na remada 29 Protecting Your Pulse Oximetry Sensors esssssssssssssssesesenen eene nnns nnne nnn 29 Guidelines for Use anne tete ote torte ooo erre arado Re erae erede assa Eee iege duis 30 Measuring Oxygen Saturation with Sensor on Finger eese 30 Measuring Oxygen Saturation with a Earlobe Sensor eee 31 MANAGING READINGS sas pasa A eae ea ee n Ux Fen us 32 Recalling the Last Set of Readings sssscsssssssssssssesssssesssessensessccsscessceessescesseossee es 32 Clearing the Last Set of Readings eee e eeee esee eee eee eese tineis sta stns snae 32 MAIN
29. acy has been manufactured to comply with AAMI SP10 protocol What method of blood pressure measurement is used in the SunTech 247 The SunTech 247takes automated BP measurements using the oscillometric method It supplements this with the ability to take measurements as you would if you were using a mechanical sphygmomanometer Can I upgrade my current version of SunTech 247at a later date To upgrade your SunTech 247 device please review the list of accessories on page 61 or on our website Contact your local distributor for details Could I use the SunTech 247to measure blood pressure during a stress test Although your SunTech 247 is a robust device that has been manufactured with motion tolerance it is not intended for use during stress testing Please use an alternate device like Tango for treadmill stress or Cycle for ergometer stress both monitors from SunTech Medical Should I wait between temperature measurements Yes Accurate temperature measurement requires the probe to be at normal room temperature After taking a measurement wait for the probe to return to room temperature or wipe the probe with an alcohol wipe before taking a subsequent measurement Do I need to calibrate the temperature or pulse oximetry modules For calibration or service on the SunTech 247temperature and pulse oximeter modules contact an authorized service center on page 47 45 How accurately does the SunTech 247temperature module measure
30. adacedadadedadadadavaeadadaieiaassatss iii Copyright Information ccccccccccseceeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeseeeeea sees nnne nnne nnne nnne nnne iii KEYS AND ACRONYMS ecce pee Ee eia copus iae eua c ERE Ce Eee ERO e yeu ee E asa en e SR mas EUR UNE IV Pato co job qua ARS irn ho atte date d te RAD O D D aded MR dE iv Document Key 2 2 22 2 22 HEEL OE EH DR aee te dere teu iv Indications for re V User Resporisibilitys2 e eden de ato curencie neo decd eavaceidhcouacatbuetacaticetecesbesteueucestcceMiastersteustsestea V Warnings and Contraindications rice hne nnn nnn nnn nnne tnn nsns V TABLEOF CONTENTS 2 22202525000005520005 0551500 055 0EDALODMADIGSSSSADSOL LOC eect SO OUT Itai IX GETTING TO KNOW THE SUNTECH 247 eee eeenanena amena 1 Package GonDEerts oe nfs etn zh ena ona eb dd d den Fo i nd E AE 1 The SunTechi 247 Kit EE cissatasanza idea cise atasasaa saad cdeacaasasai saad ANNASA SNR APPRIME 1 The SunTech 247 Battery KE serie erre errar a nana e e aot nnne nnn 2 Accessory Modules uii uiuo seize aana a E Ea E a A EE Ra Eie 2 Other ACCeSSOFIeS inii dina rri dono dado soda aa da dedo ash a dado da doca dero Sa aa dado da daaa cave ada do daaa da Eada dada 2 A Bird s Eye VI6W asa ie Ie ci DU A nas Gori ic a E eet cC eeu DN 3 BP module CC 3 BP display i REP NRP deus cate vee nutes epe eR ree RR ANN RPPN RD RA 5 Optional temperature and pulse oximetry MOCUIES cccccseeeeseeeeseeeeseeeeseeeese
31. an appropriately sized cuff sizes are tabulated on page 21 snugly around the upper arm midway between the elbow and shoulder 2 Ask the patient to stay still and quiet 3 Press and hold the Sphygmode manual button O to inflate the cuff Watch the pressure displayed and release the button to start deflating the cuff at 3 mmHg sec Place your stethoscope on the brachial artery to take a Sphygmode measurement ue If you see the O cuff and or warning icon A you will need to take another measurement Please refer to the troubleshooting section on page 40 14 Measuring Temperature 1 To measure temperature orally remove the blue probe from its holder and secure a 1 i RE disposable cover on it The display shows the type of measurement L 2 Wait for the device to beep before placing the probe carefully under the patient s tongue as denoted by the heat pockets shown to the right The posterior medial sublingual pocket is preferred for accuracy Hold the probe in place so that its tip maintains tissue contact Close the patient s mouth During measurement a traveling dash C1 is displayed In approximately 10 15 seconds you will hear a long beep and the Heat pockets temperature reading will display 3 Remove the probe from the patient s mouth discard the probe cover by pressing the button on the end of the probe handle and replace the probe in its holder ready for the next measurement Measuring Oxygen Saturati
32. as intravenous infusions or oximetry readings 21 Taking a Measurement The SunTech 247 allows you to take BP measurements automatically like a monitor or manually like a sphygmomanometer using Sphygmode In automatic mode the cuff inflates and deflates automatically Initial inflation reaches a cuff pressure of 160 mmHg the cuff then re inflates as necessary to obtain a reading Deflation is optimized to reduce measurement time and obtain an accurate result In Sphygmode you inflate the cuff manually using the Sphygmode MAN button in place of an inflation bulb of a sphygmomanometer When you release the Sphygmode MAN button the cuff automatically deflates at the AHA recommended rate of 3mmHg sec Simply use your stethoscope to determine your patient s blood pressure Taking an Automated Measurement 1 With the patient prepped as described earlier page 20 and the device powered on depress the automatic button that is located in front of the BP module and denoted by the cuffed arm icon The cuff inflates to approximately 160 mmHg as indicated in the systolic area of the display 2 Oncethe cuff pressure reaches its target the device controls the deflation and in some instances re inflation of the cuff in order to accurately measure BP The cuff pressure displays in the systolic area and is also indicated by the vertical LED bar to the left When you hear a single short beep indicating the end of the measurement cycle read th
33. be covers for the optional temperature module and SpO sensors for the optional pulse oximetry module All compatible accessories for mounting your SunTech 247can be found in the list starting on page 61 All versions of the SunTech 247can be mounted in the following ways Mounting the Device on a Wall Mount the SunTech 247 on the wall in place of an aneroid manometer To affix your SunTech 247to the wall 1 Attach the bracket to the wall using 4 wall screws and the basket using 2 screws 2 Attach the wall bracket adapter to the rear panel of the BP device using the 3 screws 3 Position the adapter onto the rivets of the wall bracket and slide the device down until it locks into place never exceed five pounds Please do not store heavy items in the storage 1 The weight of the contents of the wall mounted storage basket should basket Affixing the Device to a Mobile Stand Attaching the SunTech 247to a mobile stand facilitates portability To mount the SunTech 247to the mobile stand l Assemble the mobile stand according to the manufacturer s directions Placing the Device on a Tabletop Use the SunTech 247 with the tabletop stand to make it easier to carry with you To mount the SunTech 247to the tabletop stand 1 Using the three thumb screws secure the rear panel of the BP device to the stand 17 First Time Setup Connecting Your Device To maintain the easy readability and streamlined facade of your Su
34. be with 9 ft 2 7 m extended cord 63 98 0147 00 Red Rectal Well Rear piece of the temperature module that holds the rectal probe and box of probe covers 98 0130 01 Disposable Probe Covers 10 trays 25 boxes tray 20 probe 5000 covers box 98 0131 01 Disposable Probe Covers 25 boxes 20 probe covers box 500 52 0004 02 Calibration plug Kendall part number 202099 Miscellaneous Accessories 98 0154 00 Mobile stand kit Includes base pole power supply holder storage basket handle and assembly instructions 98 0149 00 Tabletop stand kit Includes power supply holder 98 0148 00 Wall mount kit Includes wall mountable basket 19 0013 00 Power supply for the Input 100 240 V 50 60 Hz Output SunTech 247 6 V medical grade 19 0014 00 Power supply for the SunTech 247 Battery 91 0003 05 EU power cord Power or mains lead with Type E and F hybrid CEE 7 7 two pin plug 8 2 ft 2 5 m length 91 0003 06 UK power cord Power or mains lead with Type G BS1363 three pin plug 8 2 ft 2 5 m length 64 Input 100 240 V 50 60 Hz Output 9 V medical grade 91 0003 00 US power cord Power or mains lead with Type B NEMA 5 15 three pin plug 8 2 ft 2 5m length 98 0030 02 BP calibration check kit T tube and calibration instructions 98 0156 00 BP calibration kit Interface cable and software to calibrate the Sun Tech 247 BP 91 0097 00 BP hose BP hose with mate for threaded screw type connector 8 ft
35. ccessories Dolphin 52 0005 00 Adult digit reusable Reusable finger sensor with 36 91 oximetry sensor 2010 m cable and DB 9M connector for adults and pediatrics gt 88 lbs gt 40 kg Nellcor compatible sensor DS 100A 62 52 0005 01 Y multi site reusable Reusable universal Y sensor oximetry sensor 2210 including ear clip with 36 91 m cable and DB 9M connector for all patients gt 2 2lbs gt 1 kg Nellcor compatible sensor D YS and D YSE 52 0005 02 Adult digit disposable Single use finger sensor with 18 oximetry sensor 3311 46 m cable and DB 9M connector for adults gt 66 lbs gt 30 kg 24 box foam Nellcor compatible sensor D 25 52 0005 03 Pediatric digit disposable Single use finger sensor with 18 oximetry sensor 3312 4 6 m cable and DB 9M connector for pediatrics 22 110 Ibs 10 50 kg 24 box foam Nellcor compatible sensor D 20 52 0005 04 6 foot Extension Cable Reusable cables with DB 9 M amp F 2411 connectors 52 0005 05 10 foot Extension Cable Reusable cables with DB 9 M amp F 2421 connectors Thermometry Accessories Kendall FASTemp 98 0155 00 Red Rectal Temperature Kit Includes rectal probe well and box of probe covers 52 0004 00 Blue Oral Axillary Probe Oral axillary probe with 9 ft 2 7 m extended cord 98 0146 00 Blue Oral Axillary Well Rear piece of the temperature module that holds the oral axillary probe and box of probe covers 52 0004 01 Red Rectal Probe Rectal pro
36. ce using the retention clip b poz u ES lt i 6 Turn the device on All display segments light up for three to five seconds A short beep indicates that the Sun Tech 247is ready Vir1 ILILI po Note If the pulse oximetry module does not appear to be working properly cycle the power several times using the power button on the right side of the BP module This will synchronize all the modules The modules are synchronized when after you turn the power on all segments on all module displays light simultaneously for 3 to 5 seconds followed by a short beep and all displays go to their ready state BP battery icon and middle segments of the systolic value are lit Temperature appropriate temperature units icon is lit Pulse Oximetry the SpO2 icon is lit 38 Storage Shutdown Transport Storage The SunTech 247 must be stored between 20 C 4 F and 50 C 122 F Relative humidity must be less than 95 If you are storing the SunTech 247 Battery for 30 days or longer it is recommended that you disconnect the battery from the device Moving Your Device To pack your device for repair or transport 1 Detach the cuff temperature probe SpO sensor power supply and other ancillary products from the device 2 Disconnect the battery and remove it from the device 3 Place the device in the original shipping ca
37. d Pulse rate Mean arterial pressure MAP At the end of a measurement or when the last measurement is recalled the patient s pulse rate is displayed When the MAP feature is enabled MAP toggles with pulse rate If the cuff hose error and warning icons are lit a status code may appear in this space See page 41 for details Pulse rate icon When displayed the value below is the patient s pulse rate Mean arterial pressure icon When displayed the value below is the patient s MAP Power level indicator Displays connection to AC power or for the battery version the charge level of the battery Cuff hose icon When displayed indicates that the cuff and or pneumatic hose need to be checked and adjusted in order to take a measurement See page 40 for details e Warning icon When displayed indicates that the system needs to be checked See page 40 for details e Pressure column Displays the pressure in the cuff Each segment represents approximately 10mmHg Optional temperature and pulse oximetry modules Temperature units select recessed 410171 ti 4 select Temperature mode d Suntech SpO2 sensor connector Buttons on the optional temperature module e Temperature units select Recessed momentary switch that toggles the display between F and C e Temperature mode select
38. de manual button O until you inflate the cuff to a level at least 30 mmHg higher than the patient s systolic pressure 3 Once the cuff has been inflated to the desired level release the Sphygmode manual button The cuff begins to deflate at approximately 3mmHg sec and the device displays the cuff pressure 4 While listening to your stethoscope note the systolic and diastolic pressures corresponding to the first and last Korotkoff sounds K sounds heard Press the Sphygmode manual button O to re inflate the cuff Press the automatic button if you need to rapidly release all the air from the cuff Circulation AHA Scientific Statement Recommendations for Blood Pressure Measurement in Humans and Experimental Animals Part 1 Blood Pressure Measurement in Humans A Statement for Professionals From the Subcommittee of Professional and Public Education of the American Heart Associations Council on High Blood Pressure Research Thomas G Pickering MD DPhil John E Hall PhD Lawrence J Appel MD Bonita E Falkner MD John Graves MD Martha N Hill RN PhD Daniel W Jones MD Theodore Kurtz MD Sheldon G Sheps MD Edward J Roccella PhD MPH 2005 111 697 716 23 K Sounds A Primer Korotkoff sounds commonly called K sounds are the sounds you detect through your stethoscope when you measure blood pressure with a sphygmomanometer or an aneroid device Named for the Russian physician who identified them there are five phase
39. e systolic and diastolic pressures displayed under the SYS and DIA symbols and the pulse rate displayed under the V min symbol By default your Sun Tech 247 measures systolic and diastolic BP and HR O To obtain a Mean Arterial Pressure MAP reading hold down the ie Sphygmode manual button O as you toggle power to on On power up the MAP icon lights up on the LED display Now once measurements are Wanta MAP complete the display will alternate between HR and MAP To exit MAP reading mode power the device off and again hold down the Sphygmode manual NOTE Not o i button as you toggle power to on On power up the MAP icon will available in the US flash and disappear MAP will no longer be displayed 22 3 Ifthere is an error in obtaining a measurement indicated by three beeps please refer to the troubleshooting tips on page 40 and take the appropriate remedial measure Taking a measurement on each arm helps rule out dissecting aneurysms coarctation of the aorta vascular obstruction and possible errors in measurement You can find more tips like this in the American Heart Association s current scientific statement on recommendations for blood pressure measurement Taking a Sohygmode Measurement 1 With the patient prepped as described earlier page 20 and the device powered on palpate the brachial artery at the antecubital fossa Place your stethoscope over this space 2 Press and hold the Sphygmo
40. ech 247 CD and manual Copies of the SunTech 247 manual are available through the Customer Service area of our website To download the manual please visit http www SunTechMed com and navigate to Customer Service For a replacement CD please email Customer Service at CustomerService SunTechMed com How do I clean the SunTech 247 device The SunTech 247requires only minimal cleaning Wipe it down occasionally with a soft damp cloth Never immerse the device or apply cleaning fluid or solvents How do I install the rechargeable battery in the SunTech 247 Remove the battery bay cover and position the rechargeable battery within ensuring proper alignment of polarities Replace the cover securely and connect the device to AC mains power via the power supply to turn the device on Ensure the battery is fully charged before use See page 35 for detailed instructions Why won t my SunTech 247 Battery turn on Ensure that the rechargeable battery is properly connected refer to the instructions on page 35 Make sure to connect the device to AC mains power via the power supply before using the device How often should I calibrate the BP Module for the Sun Tech 247 You should check the calibration once a year If there is a difference larger than 2 mmHg against the pressure reference then contact an authorized service center on page 47 44 How accurate is the Sun Tech 247blood pressure device The SunTech 247 designed for accur
41. eeeseeeeaeeeeees 6 Optional temperature and pulse oximetry iSplayS cccccccsesceceeeeeeeeeseeeeeeeseeeeeeeeeseeenes 8 Icons and Cues ssi san asec es nina saga dal aE nada HP M 9 Auditory CUES sic arame nan ana eve inne exec UE eT dade sane even Qua St cu een VEM AEn de E Ee ce vaneted du EU EE NEUE aa 9 Visual Cues Battery ICON isa asas iiec cinere be nene rara ru Fa rodeada ER VR E ERR E VAR REV VR do ea Rem VR EEN Rr 10 Visual Cues Blood Pressure Module sssssee meer 10 Visual Cues Temperature Module essessssesseseseeeen nennen nennen nennen nennen 11 Visual Cues Pulse Oximetry Module sess nnne 12 QUICK START GUIDE itd oen asas tus eon ds an Stoa ss cars 14 Measuring Blood Pressure and Pulse Rate Automatically esee 14 Measuring Blood Pressure Using Sphygmode eene 14 Measuring lemperat re eerie eee o rte een erento errato SEHE PX este eae ee PEE PEE 15 Measunng Oxygen Saturation ies onere trei et ises ssa ded dados 15 SETTING UP THE SUNTECH 247 oen koe eaae ox Ene REEF Cou uo ERE etx een Eea Eaa 16 ix Safety Pre Ca GOS Me c cata aaeads 16 Protecting VOUP PAU ON Garsc citastcncbcevicacdtanseatssscadectentnencntacatnadtanacasitasdlaedtanadardiaeseacoentarecates 16 Protecting Yourself unu cei decade cuc ce d cara e e cadere da adea decus bees 16 Protecting Your SunTech
42. he Pacific SunTech Medical Ltd Service Department Oakfield Industrial Estate Eynsham Oxfordshire OX29 4TS UK Tel 44 1865 884 234 Fax 44 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 58 This limited warranty contains the entire obligation 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 further warranties except as herein 59 Purchasing Parts and Accessories We recommend that you purchase parts and accessories for your SunTech 247from your authorized SunTech 247 distributor A consolidated list of parts and accessories appears below SunTech 247Systems 99 0061 00 SunTech 247 Battery Mobile System BP Temperature amp SpO 99 0062 00 SunTech 247 Battery Mobile System BP 99 0063 00 SunTech 247 Battery Mobile System BP amp Temperature 99 0064 00 SunTech 247 Battery Mobile System BP amp SpO 99 0065 00 SunTech 247 Wall System BP Temperature amp SpO 99 0066 00 SunTech 247 Wall System BP 99 0067 00 SunTech 247 Wall System BP amp Temperature 9
43. in Ur for 5 cycles 40 Ur 60 dip in Ur for 5 cycles of the Sun Tech 247 requires continued operation during power supply power mains interruptions it is input lines 70 Ur 30 dip 70 Ur 30 dip recommended that the Sun Tech IEC 61000 4 in Uh for 25 in Ur for 25 cycles 247be powered from an 11 cycles uninterruptible power supply or a battery 596 Ur 59596 dip 596 Ur 59596 dip in Ur for 5 sec in Ur for 5 sec Power Power frequency magnetic fields frequency should be at levels characteristic 50 60 Hz 3 A m 3 A m of a typical commercial or magnetic field IEC 61000 4 8 hospital environment NOTE Ur is the AC mains voltage prior to application of the test level In the event of a power loss to the device all user settings are saved The device will power up with the same settings as prior to the power loss The device does not store patient data 55 Guidance and manufacturer s declaration electromagnetic immunity The SunTech 247 device is intended for use in the electromagnetic environment specified below The customer or the user of the Sun Tech 247 device should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the SunTech 247 including cables than the recommended separation
44. is used in certain difficult conditions when a predictive reading is not preferred or possible f Axillary and rectal modes are preferred for children and compromised patients Using temperature probe and probe covers In addition to the safety instructions for your SunTech 247 here are some additional tips on using the probe and probe covers for the optional temperature module 25 e Use only Filac FasTemp probe covers with this device e The device and probe covers are non sterile Do not use on abraded tissue e To limit cross contamination use blue probes for taking oral and axillary temperature only Use red probes for rectal temperatures only e Dispose used probe covers in accordance with current medical practices or local regulations regarding disposal of infectious biological medical waste e Note that proper placement of the probe is essential to the accuracy of the measurement Taking an Oral Temperature 1 Remove the blue probe from its holder and secure a disposable cover on it The probe pre heating process begins with the flashing display of the type of measurement ari 2 After a few seconds the device will beep to signify that the probe is ready for placement After the beep place the probe carefully under the patient s tongue as denoted by the heat pockets shown to the right The posterior medial sublingual pocket is preferred for accuracy Hold the probe in place so that its tip maintains tissue contact C
45. isplay 30 2 When you remove the sensor from the patient s finger the display will flash the last measurement for 8 seconds The measurement will then be displayed for 2 minutes or until another measurement is made Note the patient s reading and confirm normal venous return Measuring Oxygen Saturation with a Earlobe Sensor 1 Rub the earlobe vigorously for five seconds to stimulate blood flow Insert paddles into the ear clip so that pegs on back of sensor paddles have slid completely to the top of each clip arm Place ear clip with sensor onto earlobe so that the detector side identified by raised dot on back of paddle is behind the earlobe Press sensor paddles into measurement site once to ensure firm sensor placement The SpO determination will begin Once the SpO determination begins a traveling dash E win be displayed until a measurement is determined usually in 10 seconds This reading will be updated once per second SpO can be measured without interruption for up to 10 minutes Along with the functional oxygen saturation value the signal strength will also display 2 Note the patient s reading and remove the clip gently When you remove the sensors from the patient s ear the display will flash the last measurement for 8 seconds The measurement will then be displayed for 2 minutes or until another measurement is made Note the patient s reading and confirm normal venous return After 10 minu
46. l are tips notes and warnings to enable you to use your SunTech 247 easily safely and effectively li Changes and Reissues This manual is identified as Part Number 80 0040 00 Changes occurring between issues of this document are addressed through change information sheets addenda or replacement pages If none of these accompany this manual the manual is correct as printed Should you notice errors or omissions in this manual please notify us at SunTech Medical 507 Airport Boulevard 117 Morrisville North Carolina 27560 8200 USA Phone 919 654 2300 Fax 919 654 2301 E mail CustomerService SunTechMed com Copyright Information All content in this manual is the proprietary information of SunTech Medical and is provided solely for purposes of operation maintenance or service of the SunTech 247 This manual and the SunTech 247 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 SunTechis a registered trademark of Sun Tech 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 O 2007 SunTech Medical All rights reserved ii KEYS AN
47. l Adult Adult Adult Long and Large Adult e An APC Pediatric cuff package contains one each of the following cuff sizes Child Child Long Small Adult Small Adult Long e A rectal temperature kit compatible with the temperature module e Other disposable and reusable pulse oximetry sensors A Bird s Eye View BP module sys Ii LL Automatic Eu button z Wn l1 Power button Sphygmode Lis pee recessed manual MAP Yimin button o Pit fw EE Blood Power L mmHg pressure hose connector A0 nn connector rear panel SunTech Connectors on the main BP module e Power Connector Connects to the power supply e Blood Pressure Hose Connector Connects to the 8 foot pressure hose Buttons The buttons are used for all actions on the interface and provide tactile feedback when pressed Buttons on the main BP module Button Functionality for the BP Module Button Device Status Action Result Select for less than 2 Start an automatic BP seconds Measurement Select for 2 to 5 Redisplay last measurement values Idle seconds for all modules Select for more than 5 Clear last measurement values for seconds all modules Taking an Select Aborts the BP measurement in P automatic or progress da Sphygmode BP In Calibration Select Device exits Calibration Check Check mode mode and is ready to take measure
48. lose the patient s mouth During measurement a traveling dash L is Heat pockets displayed 3 After 10 15 seconds a long beep signals the end of the measurement cycle The temperature will display for two minutes or until you initiate a new measurement 4 Remove the probe from the patient discard the probe cover by pressing the end of the probe handle and return the probe to the probe holder Note the temperature reading By default the predictive method is selected To select direct measurement from the start press the temperature mode select button located on left side of the temperature module for three seconds or until you hear two short quick beeps When using direct measurement the display will alternate displaying dir and the current probe temperature A long beep signals the final temperature result 26 Taking an Axillary Temperature 1 Remove the blue probe from its holder and secure a disposable cover on it The probe pre heating process begins with the flashing display of the type of measurement ari 2 Briefly less than 2 seconds press the temperature mode i 3 After a few seconds the device will beep to signify that the probe is ready for T l LI i select button until it displays lt for axillary placement After the beep lift the patient s upper arm and place the probe high under the patient s axilla Apply pressure gently to assure good contact between the
49. ments Idle Select Inflates the cuff as long as the button is selected Taking a Select Re inflates the cuff as long as the Sphygmode BP button is selected Taking an Select Aborts the BP measurement in Sphygmode i automatic BP progress Manual 7 E In Calibration Select Device exits Calibration Check Check mode mode and is ready to take measurements 5 Power off Select Turns on the device Power Power on Select Turns off the device Automatic Power off Hold the Automatic Device enters the Calibration Power button down while Check mode selecting the Power button Sphygmode Power off Hold the Sphygmode Device enables disables MAP Manual button down while mode Power selecting the Power button BP display sys Systolic blood pressure Pressure column 3 3 Diastolic blood Lc DIA La HUMAN oe N Mean arterial Pulse rate icon Pulse rate Mean arterial pressure Status Sd Tech Ae Warning icon Cuff hose Power level code error icon indicator Information on the BP module display Systolic blood pressure At the end of a measurement or when the last measurement is recalled the patient s systolic BP is displayed During a measurement the cuff pressure is displayed Diastolic blood pressure At the end of a measurement or when the last measurement is recalled the patient s diastolic BP is displaye
50. missions or decreased immunity Portable and mobile RF communications equipment can affect Medical Electrical Equipment Symbols The following symbols are associated with the SunTech 247 SYMBOL DESCRIPTION Manufactured by ETL certified Power supply contains materials which are hazardous Must be disposed of properly 52 SYMBOL DESCRIPTION RR E Class II isolation equipment C CE approval WW Recognized component certified by UL to E rr both Canada and US requirements TUV Canada and US approval TUV International approval Earth ground Output connection configuration positive voltage negative shield 53 Guidance and manufacturer s declaration electromagnetic emissions The SunTech 247is intended for use in the electromagnetic environment specified below The customer or the user of the SunTech 247should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The SunTech 247uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The SunTech 247is suitable for use in all CISPR 11 establishments including domestic establishments and Harmonic emissions Class A those directly connected to the public low voltage IEC 61000 3 2 power supply network
51. modules The modules are synchronized when after you turn the power on all segments on all module displays light simultaneously for 3 to 5 seconds followed by a short beep and all displays go to their ready state BP battery icon and middle segments of the systolic value are lit Temperature appropriate temperature units icon is lit Pulse Oximetry the SpO2 icon is lit 37 Attaching the Pulse Oximetry Module Should you need to attach or remove the pulse oximetry module the following instructions give an overview of its attachment to the BP module The pulse oximetry module attaches to the bottom of the BP module 1 Using the power button on the right side of the BP module ensure E E that the SunTech 247 is off gh E OL O cm 2 Remove the cover plate from the bottom of the main BP module Eus E 3 Slide the pulse oximetry module along the guides on the bottom of the T main BP module from front to back until it snaps into place All the segments of the pulse oximetry module display will light when the modules have been connected correctly er 7 4 Turn the device on using the power button on the right side of the BP module At the end of the start up sequence the pulse oximetry module display will blank except for the SpO2 symbol 5 Turn the device off Connect the adult reusable sensor to the 6 extension cable and then the cable to the connector on the module Secure the cable to your devi
52. nTech 247 all connections are made through the back or sides of the enclosure Connectors on the BP enclosure are for e Blood pressure hose e Power supply Connectors on the optional modules are for e A pulse oximetry sensor on the pulse oximetry module e A temperature probe on the temperature module To connect the SunTech 247 1 For blood pressure measurements the blood pressure hose should already be attached to the BP device If not push the open end of the blood pressure hose one without the plastic connector over the blood pressure hose connector on the module Secure the end with the plastic connector to an appropriately sized cuff by twisting the two mating connectors together 2 Fortemperature measurements remove the tape holding the temperature probe in the well and place the box of probe covers in the well next to the probe 3 For SpO measurements attach the pulse oximetry sensor to the extension cable Flip the retention clip forward Then connect the other end of the extension cable to the connector on the module Finally push the clip backward over the SpO connector to hold the connector in the module 4 Connect the power supply to the main BP module Then connect the power supply to an AC mains power source The device will turn on automatically 5 Attach the numbered quick reference card to the front of the basket using the 4 plastic ties Charging the Battery The SunTech 247 Battery is powe
53. nsmissions and affect pulse oximetry accuracy Clean off nail polish or detach artificial nails before applying the sensors e Secure sensor cable firmly but lightly at the base of the finger e Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity Patient sensitivity may vary due to medical status or skin condition Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive materials Measuring Oxygen Saturation with Sensor on Finger For best results clip the sensor on the index middle or ring finger avoiding the little finger or thumb 1 For the reusable finger sensor insert the patient s digit index most preferable into the sensor Ensure that the tip of the digit touches the rear guide posts of the sensor and the sensor cable extends along the top of the patient s hand For disposable finger sensors place one sensor paddle on top of the finger and the other on the bottom of the same finger Secure sensor with wrap tape or bandage SpO measurement will begin automatically Once the SpO determination begins a traveling dash IZI will be displayed until a measurement is determined usually in 10 seconds This reading will be updated once per second SpO can be measured without interruption for up to 10 minutes Along with the functional oxygen saturation value the signal strength will also d
54. ode reading If you would like confirmation for an SpO or temperature reading please use an alternate device After taking confirmatory readings check the device for proper functioning e Arrange the power supply and cabling so that it does not constitute a hazard to your patient your co workers or yourself Protecting Yourself e Removing the cover or the back of the device can cause electric shocks Do not attempt to service your SunTech 247unless you are authorized Protecting Your SunTech 247 e Do not use your SunTech 247around flammable substances e Use only SunTech approved accessories to power your SunTech 247 A listing of these is in the Appendix on page 61 e Use only those batteries supplied by SunTech or an authorized service representative e The SunTech 247 must be placed on a stable slip proof surface Only recommended hardware should be used to mount your device to a wall pole or tabletop carrier e Atno point should the contents of the storage basket exceed five lbs in weight e Do not immerse the device in water or attempt to gas sterilize or autoclave it e The reliability of your SunTech 247 depends upon conformance with the operation and service instructions as detailed in this manual 16 Mounting Your Device For convenience you may mount your unit on the wall or attach it to a mobile stand or a tabletop stand A storage basket is included and can be used to hold cuffs boxes of pro
55. of the transmitter in watts W according to the transmitter manufacturer 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 57 Limited Warranty SunTech 247 Device SunTech Medical Inc provides the original purchaser the following limited warranty from date of invoice All serialized modules 24 months APC Cuff s 6 months Accessories i e patient cables disposables power 90 days supplies 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 from 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 defect become apparent the original purchaser should first notify SunTech Medical Inc of the suspected defect The instrument should be carefully packaged and shipped prepaid to For customers in the Americas SunTech Medical Inc Service Department 507 Airport Boulevard Suite 117 Morrisville NC 27560 USA Tel 1 919 654 2300 Fax 41 919 654 2301 OR For customers in Europe Middle East Africa Asia and t
56. ompliance level above the SunTech 247 device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SunTech 247 device gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 56 Recommended separation distances between portable and mobile RF communications equipment and the SunTech 247device The SunTech 247 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SunTech 247device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SunTech 247 device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800MHz to 2 5GHz W d 3 5 Vi VP d 3 5 Vi VP d 7 Ei VP 0 01 0 12 0 12 0 23 0 10 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating
57. on 1 For the reusable finger sensor insert the patient s digit index most preferable into the sensor You will see a traveling dash until a valid reading is available typically in 10 20 seconds This reading is displayed along with the signal strength f When selecting a sensor site give priority to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion 2 Detach the sensor carefully and replace it in the basket At the end of the measurement the last valid reading will flash for 8 seconds and then be displayed for two minutes or until the next measurement 15 SETTING UP THE SUNTECH 247 Safety Precautions As a clinically trained professional using the SunTech 247 your responsibilities include safeguarding your patients yourself and your equipment Many setup functions will be performed either only once or very occasionally and it is important that you pay close attention Before you set up your SunTech 247 please review these safety guidelines Protecting Your Patient e While your SunTech 247 is designed for accurate reliable vital signs measurement for adults and children it is not to be used on patients connected to cardiopulmonary bypass machines patients needing continuous monitoring or patients under three years of age e If you feel that a particular blood pressure reading is questionable use the SunTech 247 and your stethoscope to take a second Sphygm
58. onfirmatory measure In patients with severe regular bradycardia take Sphygmode rather than automatic readings Measuring Blood Pressure During Pregnancy Hypertension is a common medical disorder of pregnancy occurring in about ten percent of pregnancies Detection of elevated blood pressure is essential to optimal prenatal care 48 For clinically relevant hypertension in pregnancy use the SunTech 247to take a Sphygmode measurement Measuring Blood Pressure in the Elderly In the elderly the combination of hypertension and ageing can manifest as a decrease in arterial compliance Variability in blood pressure can lead to a number of circadian blood pressure patterns that are best identified using ambulatory blood pressure measurement The clinical consequence of this blood pressure variability is inaccurate readings Measuring Blood Pressure in the Emergency Room Measuring blood pressure in the emergency room can be done through automated blood pressure measurements For critically ill or injured patients blood pressure should be measured through the invasive arterial pressure method Measuring Blood Pressure in the Presence of Orthostatic Hypotension Orthostatic hypotension is defined as a decrease in systolic blood pressure of 20 mmHg or more or diastolic blood pressure of 10 mmHg or more measured after three minutes of standing up from a supine position Food ingestion time of day age and hydration can impact this form of h
59. probe and axilla and make sure there is no interference such as clothing Hold the probe in place so that its tip maintains tissue contact Place the arm by the patient s side During measurement a traveling dash Ll is displayed uo Note that proper placement of the probe is essential to the accuracy of the OS measurement 4 After 10 15 seconds a long beep signals the end of the measurement cycle The temperature will display for two minutes or until you initiate a new measurement 5 Remove the probe discard the probe cover and place back in the probe holder Note the temperature reading Taking a Rectal Temperature 1 Remove the blue probe and well by sliding the pieces upward until they detach 2 Place the red probe in the holder of the red well and the probe connector in the notched space as shown to the right see page 37 for detailed instructions Slide the red well vertically onto the back of the module thus replacing the blue well Notched space Probe connector 3 Assist patient into a prone facedown position and ensure that the patient is relaxed 27 Remove the red probe from its holder and secure a disposable cover on it The probe pre heating process begins with the flashing display of rec After a few seconds the device will beep to signify that the probe is ready for placement After the beep separate the patient s buttocks and apply a thin coat of water based lubricant for smooth entry of the
60. recent set of readings for two minutes If patient privacy is a concern you can clear these readings from the display before collecting vital signs from another patient 32 MAINTAINING THE SUNTECH 247 Routine Maintenance Establishing simple care guidelines helps protect the performance and life of your SunTech 247 On a routine basis you should inspect the device cables and pneumatic hoses for cracks fraying or kinks and immediately replace any damaged parts Remember to check the calibration of the BP module annually If available a biomedical technician may help in maintaining your equipment Cleaning Cleaning the Device 1 Wipe the device with a soft damp cloth to remove surface dust and dirt Never immerse the device in any fluid or attempt to employ cleaning fluids or solvents Cleaning the Cuffs 1 Between uses wipe cuff sleeves and the insides of cuffs with a medical grade cleaning agent 2 Periodically remove the bladders and machine wash the cuffs in cold water 3 Line dry Cleaning the SpO2 Sensors 1 Clean sensors and clips with a soft cloth dampened with water a mild soap solution or isopropyl alcohol 2 Remove all tape residues by rubbing off 33 3 Dry sensors and clips thoroughly before re use Never immerse sensors and clips in fluids Do not pour or spray any liquids on them either Caustic or abrasive cleaners will cause permanent damage Prying the finger clip sensor to an angle
61. red by a rechargeable 6V lead acid battery or by AC power To turn the device on for the first time connect the device to the power supply then the power supply to an AC mains power source Leave it connected for 8 to 12 hours to fully charge the battery 18 The charging status is indicated by the rotating sequence of lit segments fin the battery icon When the battery is fully charged all segments will be lit BEN A fully charged battery provides enough power for the device to make at least 200 measurements within a 12 hour period Selecting Temperature Unit of Measurement With the device powered on select the unit of measurement for temperature by depressing the recessed button on the side of the temperature module to toggle between the C and F icons The selected icon will be lit in the display and becomes your default selection Powering Up 1 Depress the power button located on the right side of the main enclosure The power up sequence begins All display segments light up for three seconds A short beep indicates that the Sun Tech 247 is ready 2 Check the status of the power level indicator If the power level indicator shows one segment flashing connect the device to the power supply before using You are now ready to use your SunTech 247 19 MEASURING BLOOD PRESSURE WITH THE SUNTECH 247 Your SunTech 247 device is designed to take accurate blood pressure readings by the oscillometric method Systolic
62. roblem Poor sensor position signal is inadequate for a reliable measurement 42 Solution Adjust position of sensor on patient by placing sensor on opposite hand or ear or alternate site Avoid fingers with nail polish or artificial nails Status Code 05 Problem The sensor has been disconnected from the device Solution Reconnect the sensor If you wish you may leave the sensor disconnected as this code is only displayed once at the time the sensor is disconnected Status Code 10 Problem Defective sensor Solution Replace the sensor and take a new measurement Status Code 20 Problem Hardware error Solutions 1 Take another measurement 2 Ifthis is unsuccessful power down then power up the unit using the power button on the right side of the unit If the error does not recur immediately take another measurement 3 Ifthe error recurs remove power from the unit unplug any power supplies and remove the battery if there is one then reconnect the power If the error does not recur immediately take another measurement 4 Ifthe error recurs contact SunTech Medical Inc or an authorized service center Problem Inadequate signal strength Solution If there is no measurement and the signal quality is low try a different site or sensor Avoid fingers with nail polish or artificial nails If there is no improvement in signal quality then discontinue use 43 FAQs Can I obtain replacement copies of the Sun T
63. rton preferably with its original packing material 4 Ensure that the device will be kept at between 20 C 4 F and 50 C 122 F and in relative humidity less than 95 during transshipment 39 TROUBLESHOOTING The troubleshooting chart provides pointers on diagnosing issues associated with error or status codes Troubleshooting Blood Pressure Module Problem Wrong size cuff Misplaced cuff or Blocked brachial artery Solutions 1 Check that the cuff is in the correct position 2 Check that the cuff is properly tightened 3 Check that there is no excessive clothing between the arm and the cuff 4 Check that the cuff applied is of the correct size 5 The patient may have been moving too much 6 Take another BP reading Problem Too much patient or environment motion or conditions causing tremors Solutions 1 Check that the cuff is in the correct position 2 The patient may have been moving too much 3 Take another BP reading NO Problem Air leak Loose cuff or Blocked or pinched hose S OO Oy a Toga cs Solutions Check that the hose has no sharp bends or is pinched Check that the patient is not lying on the cuff Check that the cuff is in the correct position Check that the hose is connected to the system and the cuff Check that the cuff is properly tightened Check that the correct size cuff is being applied Check that the cuff is not leaking air Check that the hose connections are not damaged
64. s of K sounds each phase characterized by a distinct volume and quality of sound K sounds are heard through the stethoscope as the blood pressure cuff deflates The first sound K 1 is heard when cuff pressure equals systolic pressure K 1 is a sharp tapping sound The K 2 phase is characterized by a swishing sound caused by the swirling currents in the blood as the flow through the artery increases In the K 3 phase there is a resumption of crisp tapping sounds similar to those heard during phase 1 An abrupt muffling of sound identifies K 4 the fourth phase The end or fifth phase is the point at which sounds cease to be heard altogether Systolic pressure is registered at K 1 and diastolic at K 5 K 4 or K 5 There exists some debate about whether K 4 or K 5 should be recorded as the diastolic BP In most cases K 5 is preferred However if the sound persists even after the cuff is completely deflated it is recommended that K 4 be recorded as the diastolic blood pressure You can find more tips like this in the British Hypertension Society s current guidelines for management of hypertension B Williams NR Poulter MJ Brown M Davis GT McInnes JF Potter PS Sever S McG Thom British Hypertension Society Guidelines Guidelines for management of hypertension report of the fourth working party of the British Hypertension Society 2004 BHS IV Journal of Human Hypertension 2004 18 139 185 24 MEASURING TEMPER
65. sistent blood pressure measurements along with reliable temperature and functional oxygen saturation readings Package Contents The SunTech 247 is available in two versions with and without a rechargeable battery Contents for each version are listed below f Upon opening your kit please ensure that all listed contents are included If any contents are missing or damaged please contact Sun Tech The SunTech 247 Kit The SunTech 247kit contains your AC powered device Your kit will also contain e An 8 foot blood pressure hose e Adult and large adult size all purpose cuffs e A wall mounting kit e A power supply e A geography specific power cord e ACD with this manual e A quick start guide e A warranty card The SunTech 247 Battery Kit The SunTech 247Battery kit consists of a rechargeable battery powered device The remainder of its contents matches the SunTech 247kit Accessory Modules Accessory modules that you can purchase from your distributor or SunTech to enhance usability of your Sun Tech 247 include e A temperature module that includes the oral axillary probe and one box of disposable probe covers e A pulse oximetry module with an adult reusable finger sensor and 6 foot sensor extension cable Other Accessories Many other accessories and sources for purchasing them are listed in the Appendix on page 61 A few to note include e An APC Adult package contains one each of the following cuff sizes Smal
66. ssing incomplete damaged or contaminated e Contact the nearest factory approved service center should repair or replacement become necessary A list of approved service centers appears on page 47 or on our website at www SunTechMed com Further the user of the device bears sole responsibility for any malfunction that results from improper use faulty maintenance improper repair damage or alteration by anyone other than SunTech Medical or authorized service personnel Warnings and Contraindications Please read this manual thoroughly before starting to use your SunTech 247 Only those clinicians trained to measure record and interpret vital signs should use this device neonates A Do not use this device on pediatric patients under 3 years old infants or For accurate blood pressure measurements ensure that the circumference of the arm fits within the range markings on the cuff The SunTech 247is not intended for continuous monitoring Although the blood pressure cuff and cable are defibrillator proof the temperature probe and SpO sensor are not Do not leave the device unattended while taking measurements on a patient Only use such accessories as are recommended for use with this device A list of recommended accessories is on page 61 Do not operate the SunTech 247near flammable anesthetics or volatile vapors An explosion may result Compressing the pneumatic tubing may cause system errors
67. tery ensuring the red wire is attached to the red terminal and the black wire to the black terminal If the wires are reversed no damage will occur however the SunTech 247 will not operate Be sure to use SunTech part number 17 0014 00 for the replacement battery in order to maintain optimum performance Re secure the battery bay door with the four screws removed in step 1 7 Connect the power supply to turn the device on and charge the replacement DL onsec edad E JA If the rechargeable battery is disconnected for any reason the device must K a be connected to AC mains power via the power supply before the unit will turn on this is required even if the battery has been properly reconnected Disposal This symbol indicates the device contains materials such as electrical components which are hazardous Please return to SunTech Medical for disposal 35 Attaching the Temperature Module Should you need to attach or remove the temperature module the following instructions give an overview of its attachment to the BP module The temperature module attaches to the top of the BP module It is made up of the following two pieces e Part A with the display e Part B the probe holder which holds the temperature probe and probe cover box 1 Using the power button on the right side of the BP module ensure that the Sun Tech 247 is off t a re t E IM 2 Remove the cover plate from the top of the BP module Hi
68. tes of continuous measurement the measurement is automatically terminated and status code 01 is displayed To view the last measurement prior to automatic termination press and hold the automatic button for more than two seconds see page 32 for details 31 MANAGING READINGS Recalling the Last Set of Readings To redisplay the last set of readings depress the automatic button on the BP module for more than two seconds until the last reading is displayed If your SunTech 247has temperature and or pulse oximetry modules the last set of readings includes these readings as well If the last attempted reading resulted in an error and or warning then this will be displayed The device will display dashes if no reading is in memory a reading was aborted or the previous BP was a Sphygmode measurement For the pulse oximetry module In the event of the 10 minute measurement timeout the module will terminate the measurement and status code 01 will display on the main module The last valid reading recorded at the end of the ten minute period will be the recalled reading Clearing the Last Set of Readings To clear the values from the last automatic BP measurement and the accessories press and hold the automatic button more than 5 seconds Previous values will be displayed momentarily Then the display blanks On redisplay you will see dashes for all the values that have been cleared Your SunTech 247 displays the most
69. that supplies buildings used for Voltage fluctuations Complies domestic purposes flicker emissions IEC 61000 3 3 54 Guidance and manufacturer s declaration electromagnetic immunity The SunTech 247is intended for use in the electromagnetic environment specified below The customer or the user of the SunTech 247should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete discharge 8 kV air 8 kV air or ceramic tile If floors are ESD TEC covered with synthetic material 61000 4 2 the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be transient burst supply supply that of a typical commercial or IEC 61000 4 4 1 kV for 1 kV for hospital environment input output lines input output lines Surge IEC 1 kV differential 1 kV differential Mains power quality should be 61000 4 5 mode mode that of a typical commercial or 2 kV common 2 kV common hospital environment mode mode Voltage dips lt 5 Ur gt 95 dip 596 Ur gt 95 dip Mains power quality should be short in Ur for 0 5 cycle in Ur for 0 5 cycle that of a typical commercial or interruptions hospital environment If the user and voltage variations on 40 Ur 60 dip
70. the Patient Selecting the Right Sensor Your choice of sensor is affected by many factors including e Patient s body weight e Patient activity e Infection control concerns For most patients greater than 30kg use an adult sensor for patients 10 50kg a pediatric sensor may provide better fit Disposable sensors can provide a more secure connection to the patient Protecting Your Pulse Oximetry Sensors In addition to the safety instructions for your SunTech 247 here are some additional tips on caring for the sensors of the optional pulse oximetry module e To prevent damage do not autoclave or immerse the sensor in liquid e For peak performance and accurate measurements do not expose the sensors to excessive ambient light electromagnetic interference dysfunctional hemoglobin low perfusion intravascular dyes finger nail polish and long or artificial finger nails 29 e Do not use a damaged sensor as it may cause patient injury or equipment failure e The use of this sensor is contraindicated in patients with allergies to adhesive tape Guidelines for Use e When selecting a sensor site give priority to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line e Clean reusable sensors after use e Ensure that the optical components of the sensor are properly affixed to the patient and aligned e Artificial nails or dark shades of nail polish may reduce light tra
71. the display Remove and carefully slide the well onto the display 41 When properly fixed the error should no longer be displayed Turn the device off After it has shut down turn it on The error should no longer be displayed Take a new measurement Status Code 15 Problem Stuck button Solution Depress the Temperature units select button and or the Temperature mode select button until the button becomes unstuck When the button is unstuck the error will no longer be displayed If you cannot un stick the button contact SunTech or an authorized service center Status Code 20 Problem Hardware error Solutions 1 Take another measurement 2 If this is unsuccessful power down then power up the unit using the power button on the right side of the unit Ifthe error does not recur immediately take another measurement 3 Ifthe error recurs remove power from the unit unplug any power supplies and remove the battery if there is one then reconnect the power Ifthe error does not recur immediately take another measurement 4 Ifthe error recurs contact SunTech or an authorized service center Troubleshooting Pulse Oximetry Module Status Code 01 Problem Measurement time out The measurement time exceeded the 10 minute time limit Solution Remove the sensor from the patient Redisplay the last measurement prior to the timeout or take a new measurement by placing the sensor on the patient Status Code 02 P
72. ypotension as can a history of Parkinsonism diabetes or multiple myeloma 49 APPENDICES Specifications Patient population Adult and pediatric patients age 3 and above Method of measurement Oscillometric Initial inflation pressure 160mmHg 20mmHg Blood pressure range mmHg 60 lt Systolic BP lt 270 30 lt Diastolic BP lt 170 Blood pressure accuracy Measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Manual electronic or automated sphygmomanometers Blood pressure determination time 35 40 seconds typical for Adult cuff Pulse rate range 30 200 bpm 2 or 3 bpm whichever is greater Temperature range 86 F 30 0 C 109 4 F 43 0 C Temperate accuracy 0 2 F 0 1 C Functional oxygen saturation range 40 100 Functional oxygen saturation accuracy 70 100 2 digits Note because pulse oximeter equipment measurements are statistically distributed only about two thirds of pulse oximeter equipment measurements can be expected to fall within 2 digits of the value measured by a CO oximeter Operating conditions 10 C 50 F to 40 C 104 F Less than 95 RH Storage conditions 20 C 4 F to 50 C 122 F Less than 95 RH Power External power supply for non battery version Globtek model GTM21089 1506 T3 Sun Tech part number

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