SunTech Medical SunTech 247 User Manual

Blood pressure device for automated and manual measurement

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Blood Pressure Device

Blood Pressure

SunTech

247

247™ ™ ™ ™

247

® ® ® ®

Device

Device for Automated and Manual

Device

for Automated and Manual

Measurement

User's Manual

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Page 1 SunTech SunTech SunTech SunTech 247™ ™ ™ ™ ® ® ® ® Blood Pressure Blood Pressure Device Blood Pressure Blood Pressure Device Device Device for Automated and Manual for Automated and Manual for Automated and Manual for Automated and Manual...
Page 2 About this 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.
Page 3: Changes And Reissues
Copyright Information SunTech Medical All content in this manual is the proprietary information of and is provided SunTech 247 solely for purposes of operation, maintenance or service of the . This manual and SunTech 247 described in it are protected under copyright law under which they may not...
Page 4 KEYS AND ACRONYMS KEYS AND ACRONYMS KEYS AND ACRONYMS Acronyms Acronyms Acronyms Acronyms Acronyms commonly used in this document include: SunTech proprietary acronym for “All Purpose Cuff” Blood pressure Pulse rate K-sound Korotkoff sound Mean arterial pressure NIBP Non-invasive blood pressure...
Page 5: Indications For Use
Indications for Use 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.
Page 6 For accurate blood pressure measurements, ensure that the circumference of the arm fits within the range markings on the cuff. SunTech 247 is not intended for continuous monitoring. Although the blood pressure cuff and cable are defibrillator proof, the temperature probe and SpO sensor are not.
Page 7 Do not make repairs yourself. Equipment must be returned to authorized service personnel for repairs. Substitution of a component different from that supplied may result in measurement error. SunTech 247 If the is dropped or mishandled, please have it checked by a authorized service center before bringing it back into use.
Page 8 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...
Page 9: Table Of Contents
TABLE OF CONTENTS ................................................................IX IX IX IX ..... SUNTECH 247 SUNTECH 247 SUNTECH 247 SUNTECH 247 GETTING TO KNOW THE GETTING TO KNOW THE GETTING TO KNOW THE GETTING TO KNOW THE ..............
Page 10 ................................16 16 16 16 Protecting Your Patient ....................16 Protecting Yourself ......................16 Protecting Your SunTech 247 ..................16 Mounting Your Device ........ Mounting Your Device ....................................17 17 17 17 Mounting Your Device Mounting Your Device ........
Page 11 Clearing the Last Set of Readings .............................................................32 32 32 32 ....... SUNTECH 247 SUNTECH 247 MAINTAINING THE MAINTAINING THE SUNTECH 247 SUNTECH 247 ............................33 MAINTAINING THE MAINTAINING THE ........
Page 12 APPENDICES APPENDICES APPENDICES APPENDICES........................................................................51 ........ Specifications Specifications ........ Specifications Specifications ........................................................................................51 51 51 51 Compliance Compliance ........ Compliance Compliance ........
Page 13: Getting To Know The Suntech 247
SUNTECH 247 SUNTECH 247 GETTING TO KNOW THE GETTING TO KNOW SUNTECH 247 SUNTECH 247 GETTING TO KNOW GETTING TO KNOW SunTech 247 Your is a powerhouse of functionality, offering consistent blood pressure measurements along with reliable temperature and functional oxygen saturation readings.
Page 14: The Suntech 247 Battery Kit
SunTech 247 Battery Kit SunTech 247 Battery kit consists of a rechargeable battery powered device. The SunTech 247 remainder of its contents matches the kit. Accessory Modules SunTech Accessory modules that you can purchase from your distributor or to enhance...
Page 15: A Bird's Eye View
A Bird’s Eye View A Bird’s Eye View A Bird’s Eye View A Bird’s Eye View BP module Automatic button Power button (recessed) Sphygmode manual button Blood Power pressure hose connector connector (rear panel) Connectors on the main BP module Power Connector: Connects to the power supply.
Page 16 Buttons on the main BP module Button Functionality for the BP Module Button Functionality for the BP Module Button Functionality for the BP Module Button Functionality for the BP Module Button Button Device Status Device Status Action Action Result Result Button Button Device Status...
Page 17: Bp Display
BP display Systolic blood pressure Pressure column Diastolic blood pressure Mean arterial Pulse rate icon pressure icons Pulse rate/ Mean arterial pressure/Status code Warning icon Cuff/hose Power level indicator error icon Information on the BP module display Systolic blood pressure: At the end of a measurement or when the last measurement is •...
Page 18: Optional Temperature And Pulse Oximetry Modules
Warning icon: When displayed, indicates that the system needs to be checked. See • page 40 for details. Pressure column: Displays the pressure in the cuff. Each segment represents • approximately 10mmHg. Optional temperature and pulse oximetry modules Temperature units select (recessed) Temperature mode select...
Page 19 Connectors on the optional temperature module 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 sensor connector: Connects to an SpO extension cable or sensor.
Page 20: Optional Temperature And Pulse Oximetry Displays
Optional temperature and pulse oximetry displays Celsius icon Fahrenheit icon Temperature Warning icon Signal quality Warning icon Information on the optional temperature module display 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.
Page 21: Icons And Cues
Icons and Cues Icons and Cues Icons and Cues Icons and Cues SunTech 247 Your is designed to provide unambiguous visual and auditory cues before, during and after a measurement. For easy reference, all cues are tabulated in this chapter.
Page 22: Visual Cues - Battery Icon
Visual Cues - Battery Icon SunTech 247 If your 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.
Page 23: Visual Cues - Temperature Module
ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY INDICATES… INDICATES… INDICATES… 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.
Page 24: Visual Cues - Pulse Oximetry Module
ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY INDICATES… INDICATES… INDICATES… 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.
Page 25 ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY ICON/DISPLAY INDICATES… INDICATES… INDICATES… 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. value This area also displays the status code when the warning symbol is lit.
Page 26 QUICK START GUIDE QUICK START GUIDE QUICK START GUIDE QUICK START GUIDE If the device is off, turn it on by depressing the power button on the right side. Measuring Blood Pressu Measuring Blood Pressu Measuring Blood Pressu Measuring Blood Pressur r r r e and e and e and Pulse R e and...
Page 27: Measuring Oxygen Saturation
Measuring Temperature Measuring Temperature Measuring Temperature Measuring Temperature To measure temperature orally, remove the blue probe from its holder and secure a disposable cover on it. The display shows the type of measurement, 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.
Page 28: Safety Precautions
SUNTECH 247 SUNTECH 247 S S S S ETTING UP ETTING UP THE SUNTECH 247 SUNTECH 247 ETTING UP ETTING UP Safety Precautions Safety Precautions Safety Precautions Safety Precautions SunTech 247 As a clinically trained professional using the , your responsibilities include safeguarding your patients, yourself and your equipment.
Page 29: Mounting Your Device
A storage basket is included and can be used to hold cuffs, boxes of probe covers for the optional temperature module, and SpO sensors for the optional pulse oximetry SunTech 247 module. All compatible accessories for mounting your can be found in the list SunTech 247 starting on page 61.
Page 30: First
First Time Setup Time Setup Connecting Your Device SunTech 247 To maintain the easy readability and streamlined facade of your , all connections are made through the back or sides of the enclosure. Connectors on the BP enclosure are for: Blood pressure hose •...
Page 31: Selecting Temperature Unit Of Measurement
Powering Up 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 SunTech 247 beep indicates that the is ready. 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.
Page 32: Prepping Your Patient
SUNTECH 247 SUNTECH 247 MEASURING BLOOD PRESSURE WITH THE MEASURING BLOOD PRESSURE WITH THE SUNTECH 247 SUNTECH 247 MEASURING BLOOD PRESSURE WITH THE MEASURING BLOOD PRESSURE WITH THE SunTech 247 Your device is designed to take accurate blood pressure readings by the oscillometric method.
Page 33: Selecting The Right Cuff
Your device comes with durable two-piece All Purpose Cuffs (APC) from Inc. Child Thigh SunTech 247 . Cuffs are available in a range of sizes, from . Note that your works optimally with APC cuffs. Using the table below, select a cuff you estimate to be of the right circumference: Wrap the cuff around the patient’s upper arm midway between the elbow and the...
Page 34: Taking A Measurement
Taking a Measurement Taking a Measurement Taking a Measurement 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;...
Page 35: Taking A Sphygmode Measurement
If there 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.
Page 36: K K K K
K K K K - - - - Sounds: A Primer Sounds: A Primer Sounds: A Primer 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.
Page 37: Temperature Units Of Measurement
SUNTECH 247 SUNTECH 247 MEASURING TEMPERATURE MEASURING TEMPERATURE WITH THE WITH THE SUNTECH 247 SUNTECH 247 MEASURING MEASURING TEMPERATURE TEMPERATURE WITH THE WITH THE SunTech 247 Your 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.
Page 38 Use only Filac FasTemp probe covers with this device. • The device and probe covers are non-sterile. Do not use on abraded tissue. • To limit cross contamination, use blue probes for taking oral and axillary temperature • only. Use red probes for rectal temperatures only. Dispose used probe covers in accordance with current medical practices or local •...
Page 39: Taking An Axillary Temperature
Taking an Axillary Temperature Taking an Axillary Temperature Taking an Axillary Temperature Taking an Axillary Temperature 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, Briefly (less than 2 seconds) press the temperature mode select button until it displays...
Page 40 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 After a few seconds, the device will beep to signify that the probe is ready for placement.
Page 41: Prepping The Patient
SUNTECH MEASURING OXYGEN SATURATION WITH THE MEASURING OXYGEN SATURATION WITH 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.
Page 42: Guidelines For Use
Do not use a damaged sensor as it may cause patient injury or equipment failure. • The use of this sensor is contraindicated in patients with allergies to adhesive tape. • Guidelines for Use When selecting a sensor site, give priority to an extremity free of an arterial catheter, •...
Page 43: Measuring Oxygen Saturation With A Earlobe Sensor
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.
Page 44: Recalling The Last Set Of Readings
To redisplay the last set of readings, depress the automatic button on the BP module for SunTech 247 more than two seconds until the last reading is displayed. If your temperature and/or pulse oximetry modules, the last set of readings includes these readings as well.
Page 45: Routine Maintenance
SUNTECH 247 SUNTECH 247 MAINTAINING MAINTAINING THE SUNTECH 247 SUNTECH 247 MAINTAINING MAINTAINING Routine Maintenance SunTech Establishing simple care guidelines helps protect the performance and life of your . On a routine basis, you should inspect the device, cables and pneumatic hoses for cracks, fraying or kinks and immediately replace any damaged parts.
Page 46: Checking The Calibration Of Your Device
Prying the finger clip sensor to an angle greater than 90° can permanently damage its casing. Checking the Calibration of Your Device SunTech 247 It is recommended that you check the BP calibration of your once a year. To check calibration: Start with the device powered off.
Page 47: Replacing The Rechargeable Battery
5. Connect the wires to the terminals of the replacement battery, ensuring the red wire is attached to the red terminal and the black wire to the black terminal. If SunTech 247 the wires are reversed, no damage will occur, however the...
Page 48: Attaching The Temperature Module
Part B, the probe holder, which holds the • temperature probe and probe cover box. SunTech Using the power button on the right side of the BP module, ensure that the is off. Remove the cover plate from the top of the BP module.
Page 49 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). Rotate the connector upwards until it snaps securely into place (step2 shown above). The black surface faces outward and the cord extends upward.
Page 50: Attaching The Pulse Oximetry Module
BP module. The pulse oximetry module attaches to the bottom of the BP module. Using the power button on the right side of the BP module, ensure SunTech 247 that the is off.
Page 51: Storage, Shutdown, Transport
Storage, Shutdown, Transport Storage, Shutdown, Transport Storage, Shutdown, Transport Storage, Shutdown, Transport Storage SunTech 247 must be stored between -20°C (-4°F) and 50°C (122°F). Relative humidity must be less than 95%. SunTech 247 If you are storing the Battery for 30 days or longer, it is recommended that you disconnect the battery from the device.
Page 52: Troubleshooting - Blood Pressure Module
TROUBLESHOOTING TROUBLESHOOTING TROUBLESHOOTING 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.
Page 53: Troubleshooting - Temperature Module
3. 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. If the error does not recur immediately, take another measurement. SunTech Medical Inc. 4. If the error recurs, contact or an authorized service center.
Page 54: Troubleshooting - Pulse Oximetry Module
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...
Page 55 3. 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. If the error does not recur immediately, take another measurement. SunTech Medical Inc. 4. If the error recurs, contact or an authorized service center.
Page 56 FAQs FAQs FAQs FAQs SunTech 247 Can I obtain replacement copies of the CD and manual? SunTech 247 Copies of the 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.
Page 57 SunTech 247 How accurate is the blood pressure device? SunTech 247 , designed for accuracy, has been manufactured to comply with AAMI SP10 protocol. SunTech 247 What method of blood pressure measurement is used in the SunTech 247 takes 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.
Page 58: Web Resources
SunTech 247 How accurately does the temperature module measure temperature? SunTech 247 temperature module is accurate to +/- 0.2 °F (+/-0.1°C). SunTech 247 What is the accuracy of the pulse oximetry module? SunTech 247 pulse oximetry module is +/- 2% in the 70 to 100% range for no motion and normal perfusion.
Page 59: For Customers In Europe, The Middle East, And Africa
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...
Page 60: 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 common examples SunTech 247 of such circumstances are described here, to assist you in using your optimally under such conditions.
Page 61: Measuring Blood Pressure In The Elderly
SunTech 247 For clinically relevant hypertension in pregnancy, use the to 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.
Page 62: Appendices
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 SunTech part number: 19-0013-00) External power supply for Battery version, rechargeable by Globtek model:...
Page 63: Compliance
Powered Equipment (for battery version); Applied parts: Type BF; Mode of operation: Continuous IP index: IPX0 Compliance Compliance Compliance Compliance SunTech Medical, Ltd. Oakfield Industrial Estate Eynsham, Oxfordshire OX29 4TS Tel: +44. 1865.884.234 Fax: +44. 1865.884.235 Safety Requirements Clinical grade BP measurement accuracy defined by fully meeting the requirements of: AAMI SP-10 2002 •...
Page 64: Emc Statement
Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Symbols Symbols Symbols Symbols SunTech 247 The following symbols are associated with the SYMBOL SYMBOL SYMBOL SYMBOL DESCRIPTION...
Page 65 SYMBOL SYMBOL SYMBOL SYMBOL DESCRIPTION DESCRIPTION DESCRIPTION DESCRIPTION No SpO alarm Attention, consult accompanying documents. Class II isolation equipment CE approval Recognized component certified by UL to both Canada and US requirements TUV Canada and US approval TUV International approval Earth ground Output connection configuration –...
Page 66 Guidance and manufacturer’s declaration electromagnetic emissions electromagnetic emissions electromagnetic emissions SunTech 247 is intended for use in the electromagnetic environment specified below. SunTech 247 The customer or the user of the should assure that it is used in such an environment.
Page 67 Guidance and manufacturer’s declaration – – – – electromagnetic immunity electromagnetic immunity electromagnetic immunity electromagnetic immunity SunTech 247 is intended for use in the electromagnetic environment specified below. SunTech 247 The customer or the user of the should assure that it is used in such an environment.
Page 68 Guidance and manufacturer’s declaration – – – – electromagnetic immunity electromagnetic immunity electromagnetic immunity electromagnetic immunity SunTech 247 device is intended for use in the electromagnetic environment specified SunTech 247 below. The customer or the user of the device should assure that it is used in such an environment.
Page 69: Suntech 247 Suntech 247 Suntech 247 Suntech
Recommended separation distances between portable and mobile RF Recommended separation distances between portable and mobile RF Recommended separation distances between portable and mobile RF communications communications communications communications SunTech 247 SunTech 247 equipment and the equipment and the SunTech 247 SunTech 247...
Page 70: Limited Warranty
Limited Warranty Limited Warranty Limited Warranty 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...
Page 71 SunTech Medical, Inc. This limited warranty contains the entire obligation of 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...
Page 72: Purchasing Parts And Accessories
Purchasing Parts and Accessories Purchasing Parts and Accessories Purchasing Parts and Accessories Purchasing Parts and Accessories SunTech 247 We recommend that you purchase parts and accessories for your from your SunTech 247 authorized distributor. A consolidated list of parts and accessories appears below.
Page 73 Module Module for 39-0028-00 Top/bottom cover for Covers the top or bottom of a SunTech 247 BP SunTech 247 BP device All Purpose se se se - - - - All Purpo All Purpo All Purpo General Clinical General Clinical...
Page 74 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...
Page 75 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 >2.2lbs (>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 >66 lbs (>30 kg), 24/box,...
Page 76 Includes wall mountable basket 98-0150-00 Basket Wall mountable 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 Input: 100-240 V, 50-60 Hz; Output: SunTech 247 Battery +9 V; medical grade...
Page 77 (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 SunTech 247 calibrate the 91-0097-00 BP hose BP hose with mate for threaded screw type connector, 8 ft (2.4 m) length...
Page 78 SunTech Medical, Inc. 507 Airport Boulevard, Suite 117 Morrisville, NC 27560 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.