BIOMED
Contents
1. BIOMED Owner s Manual Arm type Fully Automatic Digital Blood Pressure Monitor BSP 12 Model Document No DBP 3704 002 Version Z Date of Issue 2014 01 The product is in compliance with the requirements of MDD 93 42 EEC 0197 is the identification number of notify body C E0197 Shanghai International Trading Corp GmbH Hamburg Eiffestrasse 80 20537 Hamburg Germany Contents Safety NOtiCE ccccccscssscssscnsccnsccsccnsccnscensceesceeseeenee Unit Illustration oo cecccecceecceeceesceesceesceesceeseeees Important Testing Guidelines ssessessesssseesseoeesesseesecee Quick Start csiscisiesnesdssavtistanessvsedsssaesescevavedansiessosesesess Unit Operation ccccesccssccsecceeceesceesceesceesceesseeseeees Battery Installation cccccceceseceesceecceesceesseeeeees System Settings ccecescceccsccersccercescercesceeessceeoes Applying the Arm Cuff ccseccsecceecceeeceeseeveeeeees DKEA T ccc cisccossicescossconetassocasensscsscerscosacesccvaseseccesesescos Power Off Memory Cheek cigscccscisscnseconsccsscaxnesseccnvanstecuneosecessessa Memory Deletion sscccecccseccssccecccscececeesceeseeens Last 3 Tests AVerage ccescseesccevesceeresceeresceereseeens Low Battery Indicator Troubleshooting lt 0sccscesssecessosesevascosseoussdnceoscsess sonsaoss Blood Pressure Information Blood Pressure Q amp A u ccccsssccssseccessccsssccesecen2. This marking shown on the product indicates that it should not be disposed with other household waste at the end of its life To prevent potential harm to the environment or to human health please separate this product from other types of wastes and recycle it responsibly When disposing this type of product contact the retailer where product was purchased or contact your local government office for details regarding how this item can be disposed in an environmentally safe recycling center Business users should contact their supplier and check the terms and conditions of the purchasing agreement This product should not be mixed with other commercial wastes for disposal This product is free of hazardous materials Warranty The Blood Pressure Monitor is guaranteed for 2 year from the date of purchase If the Blood Pressure Monitor does not function properly due to defective components or poor workmanship we will repair or replace it freely The warranty does not cover damages to your Blood Pressure Monitor due to improper handling Please contact local retailer for details 30
3. product conforms to the requirements of the EC Directive MDD 93 42 EEC on medical devices AA MA 2 oO a Manufacturer m O H m U Authorised Representative in the European Community Safety Notice Unit Illustration VAN Caution a r Monitor Unit ___ World Health Organization WHO Individuals with serious circulation problems may experience discomfort Blood Pressure Classification Indicator Consult your physician prior to use LCD Contact your physician if test results regularly indicate abnormal readings Do not attempt to self treat these symptoms without consulting your physician first Systolic Blood Pressure Diastolic Blood Pressure Product is designed for its intended use only Do not misuse in any way Product is not intended for infants or individuals who cannot express Pulse Rate their intentions Do not disassemble or attempt to repair Do not use cell phones and other devices which generate strong electrical or electromagnetic fields near the device as they may cause incorrect readings and interference or become interference source to the device Only use arecommended AC adapter complying with EN 60601 1 and EN 60601 1 2 see page 6 An unauthorized adapter may cause fire and electric shock Battery Precautions F A Air Jack p L__ M Button Do not mix new and old batteries simultaneously START STOP But
4. readings Power Off The START STOP button can be pressed to turn off the unit in any mode The unit can turn off the power itself about 3 minutes no operation in any mode Safety Precaution If pressure in arm cuff becomes too extreme while testing press the START STOP button to turn power off The cuff pressure will rapidly dissipate once the unit is off Unit Operation Memory Check With power off you may check past test results by using the M button The most recent test result and oldest test result in memory can be viewed by pressing and holding the M button upon activating test results you can press the M button to scroll through all test results stored in memory aw f Ba mm l 330 v Ea D No ba l a ioe D Note Previous test results will only be displayed from the most recently used memory group To check previous test results in other memory groups you must first select the desired group and then turn monitor off See Select Memory Group on Page 10 Unit Operation Memory for a selected group may be deleted while in Memory Check mode Press and hold Memory Deletion the SET button for approximately 3 seconds to delete all memory records from the selected group The monitor will beep indicating successful deletion and then transfer into testing mode Press the START STOP button to turn the unit off Note Memory cannot be recovered once it has been
5. 8 above the elbow joint For best results apply cuff to bare arm and keep level with heart while testing Note Do not insert air plug into opening located on right side of monitor unit This opening is designed for an optional power supply only Unit Operation Testing 1 Power On Press and hold START STOP button until a beep sounds The LCD screen will appear for one second as unit performs a quick diagnosis A long tone indicates device is ready for testing K X a robia Too A 13 45 Not Note Unit will not function if residual air from previous testing is present in cuff The LCD will flash y until pressure is stabilized Initial pressure is first pumped to 190mmHg Ifthe current user s systolic blood pressure Unit Operation 2 Pressurization is over 190mmHeg the unit will automatically re inflate to the proper shelf g p ss ee Ub mmHg gog mM LRR Note Pressurization will gradually subside and ultimately stop when cuff is not properly applied to the arm Ifthis occurs press START STOP button to turn the unit off After cuff inflation air will slowly subside as indicated by the corresponding cuff pressure Unit Operation 3 Testing value A flashing Y will appear simultaneously on screen signaling heart beat detection B29 mr v La Ra Note Keep relaxed during testing Avoid speaking or moving body parts 4 Result Display Th
6. cation Indicator The BSP 12 is equipped with a classification indicator based on established guidelines from the World Health Organization The chart below color coded on monitor unit indicates test results a Severe Hypertension Moderate Hypertension a Mild Hypertension High normal Optimal Normal I Blood Pressure Classification Indicator Blood Pressure Information Health Reminder Hypertension is a dangerous disease that can affect the quality of life It can lead to a lot of problems including heart failure kidney failure and cerebral hemorrhaging By maintaining a healthy lifestyle and visiting your physician on a regular basis hypertension and relative diseases are much easier to control when diagnosed in their early stages Systolic mmHg A 180 160 140 130 120 Moderate Hypertension Mild Hypertension High normal Normal Optimal Diastolic mmHg 80 85 90 100 110 Note Do not be alarmed if an abnormal reading occurs A better indication of an individual s blood pressure occurs after 2 3 readings are taken at the same time each day over an extended period of time Consult your physician if test results remain abnormal Blood Pressure Q amp A Q What is the difference between measuring blood pressure at home or at a professional healthcare clinic A Blood pressure readings taken at home are now seen to give a more acc
7. deleted Unit Operation Last 3 Tests Average With power off press the M button to activate screen display After the unit performs a self diagnosis the screen will display the average test results from the last 3 readings of the last group used The AVG symbol will appear along with the corresponding WHO Blood Pressure Indicator The Memory Check mode can be accessed by pressing the M button To check the average results from other groups select the desired group first prior to activating the M button in the off position See Select Memory Group on Page 10 OFAN B30 mn yb Unit Operation Low Battery Indicator 4 short warning beeps sound when battery life is depleting and unable to inflate cuff for testing The X appears simultaneously for approximately 5 seconds prior to shutting off Replace batteries at this time No memory loss will occur throughout this process Unit Operation Troubleshooting Problem Possible Cause Solution Firmly reposition cuff approximately1l 2cm 1 2 above the elbow joint See Page 12 Cuff is too tight or not properly positioned on the arm Blood pressure results are not within typical range Sit ina relaxed position with arm placed near heart Avoid speaking or moving body parts while testing Make sure the monitor unit is placed ina Inaccurate test results due to body movement or monitor movement A i stationary position througho
8. esceeseeeeees Maintenance caviccesccvctseccsccccecsnscessccevssevcoseedsocedsenseseuese Specificati nis oss ccccsscicsssascceussesedcescwseoscseasseveccssessesev ses Warranty cess ccuscesscexcessescstensees a E EEEE 02 04 07 08 09 09 10 12 13 16 17 18 19 20 21 22 25 26 28 30 Safety Notice Thank you for purchasing the BSP 12 Blood Pressure Monitor The unit has been constructed using reliable circuitry and durable materials Used properly this unit will provide yeas of satisfactory use This device is intended for non invasive measuring an adult individual s systolic diastolic blood pressure and heart rate using the oscillometric method The device is not intended for use on infants and children The device is designed for home or clinical use All values can be read out in one LCD DISPLAY Measurement position is on adult upper arm only Please read this manual thoroughly before using the unit Please retain this manual for future reference For specific information about your blood pressure please CONSULT YOUR DOCTOR To avoid risk and damage follow all warning precautions Operate unit only as intended Read all instructions prior to use WARNING SIGNS AND SYMBOLS USED Caution Mandatory Prohibited Type BF Equipment Consult Instructions For Use Serial Number Discard the used product to the recycling collection point according to local regulations be gt 41olel gt The
9. f in water Apply a small amount of rubbing alcohol to a soft cloth to clean cuff s surface Use a damp cloth water based to wipe clean Allow cuff to dry naturally at room temperature 5 Do not use petrol thinners or similar solvents 6 Remove batteries when not in operation for an extended period of time 7 Do not disassemble product 8 Itis recommended the performance should be checked every 2 years 9 Expected service life Approximately three years at 10 tests per day Specifications 28 Product Description Model Arm type Fully Automatic Digital Blood Pressure Monitor BSP 12 Display LCD Digital Display Size 84 1mmX55 1mm 3 31 x 2 17 Measurement Method Oscillometric Method Pressure OmmHg 300mmHg Measurement Range Pulse 30 to 180 Beats Minute Pressure 3mmHg Measurement Accuracy Pulse 5 Pressurization Automatic Pressurization Memory 120 Memories in Two Groups with Date and Time Irregular Heartbeat Detection WHO Classification Indicator Function Last 3 Results Average Low Battery Detection Automatic Power Off Power Source 4 AA batteries or Medical AC Adapter DC6 0V 600mA recommended not provided Battery Life Approximately 2 months at 3 tests per day Unit Weight Approx XXXg 14 99 oz excluding battery Unit Dimensions Approx 148x100x56mm 5 83 x3 94 x2 21 LxWxH Cuff Circumference Appro
10. gative outside with a 2 1mm coaxial joint Do not use another type of AC adapter as it may harm the unit AC Adapter Jack With power off press SET button to activate System Settings The Memory Group icon flashes Unit Operation System Settings 1 Select Memory Group While in the System Setting mode you may accumulate test results into 2 different groups This allows multiple users to save individual test results up to 60 memories per group Press M button to choose a group setting Test results will automatically store in each selected group 2 Time Date Setting Press SET button again to set the Time Date mode Set the month first by adjusting the M button Press SET button again to confirm current month Continue setting the day hour and minute in the same way Every time the SET button is pressed it will lock in your selection and continue in succession month day hour minute Unit Operation 3 Saved Settings While in any setting mode press START STOP button to turn the unit off All information will be saved Note If unit is left on and not in use for 3 minutes it will automatically save all information and shut off Unit Operation Applying the Arm Cuff 1 Firmly insert air plug into opening located on left side of monitor unit 2 With sticky nylon section facing outward insert end of cuff underneath metal ring of cuff 3 Fasten cuff about 1 2cm 0 4 0
11. l phones 6 Wait 3 minutes or longer before re testing 7 Try to measure your blood pressure at the same time each day for consistency 8 Test comparisons should only be made when monitor is used on the same arm in the same position and at the same time of day 9 This blood pressure monitor is not recommended for people with severe arrhythmia 10 Do not use this blood pressure monitor if the device is damaged Quick Start 1 Install batteries See Figure A 2 Insert cuff air plug into the left side of monitor unit See Figure B Figure A Figure B 3 Remove thick clothing from the arm area 4 Rest for several minutes prior to testing Sit down in a quiet place preferably at a desk or table with your arm resting on a firm surface and your feet flat on the floor See Figure C Figure C 5 Apply cuff to your left arm and keep level with your heart Bottom of cuff should be placed approximately 1 2cm 0 4 0 8 above elbow joint See Figures D amp E Figure D Figure E 6 Press START STOP Button to start testing Unit Operation Battery Installation Slide battery cover off as indicated by arrow Install 4 new AA alkaline batteries according to polarity Close battery cover AC adapter jack is on the back side of the monitor Medical AC adapter DC 6 0 V 600mA can be used with the device recommended not provided The adapter connect pin should be positive inside and ne
12. ree short beeps sound when testing is complete The screen will display measurements for systolic and diastolic blood pressure An indicator representing the current measurement will appear next to the corresponding WHO Classification a 4r LL mmHg Ir 4 230 WT ia D al Indicator Note Refer to Page 23 24 for detail WHO Blood Pressure Classification Information If the monitor detects an irregular heart rhythm two or more times during the measuring Unit Operation Irregular Heartbeat Indicator process the Irregular Heartbeat Symbol V appears on screen along with measurement results Irregular heartbeat rhythm is defined as rhythm that is either 25 slower or faster than the average rhythm detected while measuring systolic blood pressure and diastolic blood pressure Consult your physician if the Irregular Heartbeat Symbol x V frequently appears with your test results 5 Deleting Storing Test Results User may delete their current test result due to unfavorable testing conditions or for any other reason To delete the last test result press the SET button after result is displayed If result is not deleted it will automatically store by date within the previously configured Memory Group Note Be sure the appropriate Memory Group selection is made prior to testing If the number of tests surpasses the allotted 60 memories per group the most recent tests will appear first thus eliminating the oldest
13. ton Replace batteries when Low Battery Indicator appears on screen SET Button Be sure battery polarity is correct Do not mix battery types Long life alkaline batteries are recommended Remove batteries from device when not in operation for more than 3 months Battery cover Dispose batteries properly observe local laws and regulations L AC Adapter Jack Unit Illustration Unit Illustration Arm Cuff Contents Owner s Manual Arm type Fully Automatic Digital Blood Pressure Monitor 6g Modei BSP one j BSP 12 ae eat za 2 Owner s Manual Air Plug Air Tube 1 Monitor Unit Display Groups Systolic Blood Pressure Low Battery Indicator 4 Storage Bag WHO Blood Pressure Classification Indicator Last 3 Results Average ee Diastolic Irregular Heartbeat Indicator Blood Pressure Time Date Pulse Rate 5 Medical AC Adapter DC6 0 V 600mA recommended not provided Important Testing Guidelines 1 Avoid eating exercising and bathing for 30 minutes prior to testing 2 Sitin a calm environment for at least 5 minutes prior to testing 3 Do not stand while testing Sit ina relaxed position while keeping your arm level with your heart 4 Avoid speaking or moving body parts while testing 5 While testing avoid strong electromagnetic interference such as microwave ovens and cel
14. urate account as they better reflect your daily life Readings can be elevated when taken in a clinical or medical environment This is known as White Coat Hypertension and may be caused by feeling anxious or nervous Note Abnormal test results may be caused by 1 Improper cuff placement Make sure cuff is snug not too tight or too loose Make sure bottom of the cuff is approximately 1 2cm 1 2 above the elbow joint 2 Improper body position Make sure to keep your body in an upright position 3 Feeling anxious or nervous Take 2 3 deep breaths wait a few minutes and resume testing Q What causes different readings A Blood pressure varies throughout the course of a day Many factors including diet stress cuff placement etc may affect an individual s blood pressure Q Should I apply the cuff to the left or right arm What is the difference A Either arm can be used when testing however when comparing results the same arm should be used Testing on your left arm may provide more accurate results as it is located closer to your heart Q What is the best time of day for testing A Morning time or any time you feel relaxed and stress free Maintenance 1 Avoid dropping slamming or throwing the unit 3 When cleaning the unit use a soft fabric and lightly wipe with mild detergent Use a damp cloth to remove dirt and excess detergent Maintenance RT 4 Cuff Cleaning Do not soak cuf
15. ut the testing period See Page 7 Make sure hose is properly Cuff fails to inflat rl P AS OTAR PROBE Y fastened to cuff and monitor unit Read user manual carefully and Improper operation re test properly Err displayed Pressurization is over 300mmHg Read user manual carefully and re test properly Blood Pressure Information Blood Pressure Blood pressure is the force of blood pushing against the walls of arteries Itis typically measured in millimeters of mercury mmHg Systolic blood pressure is the maximum force exerted against blood vessel walls each time the heart beats Diastolic blood pressure is the force exerted on blood vessels when the heart is resting between beats An individual s blood pressure frequently changes throughout the course of a day Excitement and tension can cause blood pressure to rise while drinking alcohol and bathing can lower blood pressure Certain hormones like adrenaline which your body releases under stress can cause blood vessels to constrict leading to a rise in blood pressure If these measuring numbers become too high it means the heart is working harder than it should 200 Upper curve systolic blood pressure Lower curve diastolic blood pressure 150 F E mal ILE el 50 T T T T 6 12 18 24 Time of day Example fluctuation within a day male 35 years old Blood Pressure Information WHO Blood Pressure Classifi
16. x 135 W x485 L mm Medium cuff Fits arm circumference 22 36 cm Operating Environment Temperature 10 C 40 C 50 F 104 F Humidity 15 90 RH Pressure Atmospheric Pressure Specifications 29 Temperature 20 C 55 C 4F 131F 15 90 RH Storage Environment Humidity Ingress Protection Rating IP 22 Internal Powered Equipment Type BF Cuff is the Applied Part Classification Specifications are subject to change without notice This Blood Pressure Monitor complies with the European regulations and bears the CE mark CE 0197 This blood pressure monitor also complies with mainly following standards following standards included but not limited Safety standard EN 60601 1 Medical electrical equipment part 1 General requirements for safety EMC standard EN 60601 1 2 Medical electrical equipment part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Performance standards EN 1060 1 Non invasive sphygmomanometers General requirements EN 1060 3 Non invasive sphygmomanometers Supplementary requirements for electromechanical blood pressure measuring systems EN 1060 4 Non invasive sphygmomanometers Test procedures to determine the overall system accuracy of automated non invasive sphygmomanometers Correct Disposal of This Product Waste Electrical amp Electronic Equipment
Download Pdf Manuals
Related Search