Blood Pressure Monitor User manual

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1 Blood Pressure Monitor User manual Well-being KD-551 V

2 XXXXX Contents Introduction Parts Setting up your Blood Pressure Monitor Using your Blood Pressure Monitor Interpretation of Blood Pressure (BP) Results Additional Information on Blood Pressure Specifications Troubleshooting Storage Battery Information Maintenance and Cautions Disposal Customer Feedback Warranty Explanation of Symbols on the Blood Pressure Monitor Blood Pressure Record Table

3 XXXXX Introduction Parts XXXXX Thank you for purchasing and using the Betterlife Blood Pressure Monitor. This monitor is an easy to use and accurate way to measure your blood pressure. Before you start, it is important that you read this user manual. Blood pressure testing is easy. To get the most out of this product, please follow our recommendations in this user manual. If you have any questions, please contact your healthcare professional and if necessary, consult your pharmacist or doctor before using this monitor if: Systolic Pressure Display Diastolic Pressure Display Pulse Rate Display (Alternating) Date/Time Display (Alternating) Blood Pressure Level Classification Indicator Low Battery Indicator Ready to inflate Indicator Irregular Heartbeat Symbol Memory Indicator LCD Display You have had a mastectomy/mastectomies You have an arteriovenous (A-V) shunt or have intravascular access in your arm Cuff (included) Start Button You suffer from atrial or ventricular premature beats or atrial fibrillation It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer. Memory Button Connector 2 3

4 PUL /min START MEMORY SYS mmhg DIA mmhg Setting XXXXX up your Blood Pressure Monitor Setting up your Blood Pressure Monitor Loading batteries a. Open the battery cover on the base of the monitor b. Insert four AAA batteries, observing correct polarity c. Close the battery door Replacing batteries When the LCD screen displays new batteries must be inserted immediately to ensure accurate results Connecting the cuff Insert the plug end of the rubber tubule firmly into the cuff socket located on the front of the monitor to ensure there is no air leakage The cuff should be ready to use. Ensure the end is passed through the metal loop making sure the hook and loop fastening is facing outwards. There are 4 pre-programmed pressurisation values which are set at 190mmHg 228mmHg 266mmHg 295mmHg. When automatic inflation begins, the unit will inflate to 190mmHg 228mmHg 266mmHg 295mmHg. If a systolic pressure is not detected, the unit will continue to inflate automatically to the next pressurisation level. This will continue to a maximum level of 295mmHg If you feel any discomfort or pain during this time, turn the unit off and remove the cuff immediately. consult your local pharmacist or healthcare professional for advice It is recommended that you rest for at least 5 minutes before taking your blood pressure measurement. Allow at least 3 minutes rest between measurements to allow the blood circulation in your arm to recover. The Blood Pressure Monitor is designed for use by adults and should not be used on infants or young children. We recommend that you carry out your test whilst sitting at a table with both of your feet flat on the floor, do not cross your legs. Ensure that the cuff is at the same height as your heart as this will place the monitor and your arm in an ideal position for the best results. Place the cuff on your selected arm (please refer to Your first test on how to select an arm). Ensure the cuff is secure. Do not inflate the cuff when it is not wrapped around the upper arm. Avoid compression or restriction of the rubber tubule during measurement as this may cause an inflation error due to continuos cuff pressure. If this occurs, switch the unit off immediately by pressing the START button. Do not move your arm, body or the monitor and do not move the rubber tubule during measurement and do not talk. Setting the time and date Press the START and MEM buttons simultaneously, the monitor will beep and the month will flash. Press MEM repeatedly to select the month, press START to confirm. Follow the same process to select the date and time (hours and minutes). 4 5

5 Setting up your Blood Pressure Monitor Setting up your Blood Pressure Monitor Putting on the cuff: Place the cuff 1~2cm above the elbow joint. Measuring can be done on light clothing such as a shirt or blouse. However, if you have a weak pulse, it is recommended you test on a bare arm. Remove any tight or restrictive clothing from your arm. For example, restriction caused by rolling up a shirt sleeve. 2. Place hand on a flat surface with the palm facing up and with the rubber tubule running down the centre of the arm. 3. Turn the cuff end outwards and tighten it by pulling it through the metal loop and pressing the hook surface of the cuff on to the loop surface of the cuff. To get the correct tightness, you should be able to fit two fingers under the cuff. 4. Use your free hand to adjust the tightness of the cuff until it is firm. The cuff can be cleaned by hand with warm, soapy water. Rinse thoroughly with cold water and towel dry. PLEASE DO NOT IRON. ONLY USE THE CUFF SUPPLIED WITH THIS MONITOR. If a larger size is required you can purchase an extra large cuff from Your first test We recommend that for your first test you test both your arms. This will determine which arm should be used for future measurements. Take note of your systolic (higher number) reading on both arms. The arm which gives the higher systolic reading should be used in the future for testing. Note: Ensure you do not suffer from any medical conditions which will prevent you from having your blood pressure measured in both arms. Example: Left arm: 132 (systolic) 86 (diastolic) Right arm: 128 (systolic) 84 (diastolic) Reading your results The example above shows that you should use your left arm in future testing as it has the highest systolic reading. 6 7

6 XXXXX Using your Blood Pressure Monitor Once you are in a comfortable position press START Measuring Process a. Once the cuff has automatically inflated, the LCD screen will display a flashing heart whilst the pressure is gradually reduced and the monitor takes an automatic measurement b. The monitor will faintly beep when the automatic measurement has finished. It is advised to use the monitor in a quiet room in order to hear the beep. The reading will be displayed on the screen along with the pulse rate. If the reading displays this shows that the monitor has detected an irregular heartbeat which will be caused by common arrhythmias. This will result in an inaccurate reading. It is advisable to restart again after a short time delay. If it occurs again it is advisable to check with your doctor to obtain an accurate assessment. If there is an error or abnormal reading, please refer to the Abnormality & Troubleshooting section. c. During measurement, you can press the START button to turn off the monitor manually. Using your Blood Pressure Monitor Memory Press MEM button in time mode to select the memory function, the LCD will display the average value of the last three results. By pressing the MEM button again the most recent result will be displayed. The memory can store 2 x 60 sets of measurements, which also include the date and time of the reading. The results will be automatically stored. In memory mode, press START to switch the U1 or U2, then press MEM to confirm. U1 or U2 will be displayed depending on which memory store you are using. Press MEM continuously to display the previously stored measurements one by one. Once the memory has been filled with 60 sets of data, the 61st measurement when taken will be stored as the most recent reading whilst the first reading you took will be automatically deleted. You can delete stored memory readings by pressing MEM for 3 seconds, and all results in the memory will be deleted and you will hear 3 consecutive beeps. 8 9

7 Using your Blood Pressure Monitor What the results mean a. The LCD screen will automatically display the systolic and diastolic pressure reading in mmhg and the pulse rate in pulse/min after each measurement. b. Record date, time, systolic reading, diastolic reading and pulse rate on your record table which you will find in the back of the user manual (including anything which may have influenced your blood pressure reading e.g. stress, anxiety). This will help you monitor trends. Please take this record card with you on your visits to your doctor, pharmacist or healthcare professional. NOTE: Measurements should ideally be taken at the same time, under the same conditions and in the same position each time Please be aware that blood pressure can fluctuate since it responds to minute changes in the body. It is unusual to continuously remain at the same value, hence it is recommended that the blood pressure be determined based on an average of multiple measurements. If you experience a higher than normal reading, do not panic as this can happen. Relax and take a break for at least 10 minutes before measuring your blood pressure again. Low blood pressure (Hypotension) and high blood pressure (Hypertension) can only be diagnosed by a qualified healthcare professional, such as a doctor or pharmacist. If you have any concerns or questions, please contact your local pharmacist or healthcare professional. Using your Blood Pressure Monitor To get an accurate value: Measure at least one hour after eating and avoid measuring immediately after bathing Measure one hour after smoking or drinking alcohol/coffee Relax for 5 minutes before taking a measurement and remain relaxed whilst measuring Do not move or talk during measurement, as this will affect the accuracy If you suffer from atrial or ventricular premature beats or atrial fibrillation you may get an inaccurate reading. Re-measuring If you want to measure again, press start button to switch off and press start button again. Leave at least three minutes between measurements to allow blood circulation to the arm to return to normal Do not measure your blood pressure too many times in one session as it may cause discomfort in the arm If you feel any discomfort or pain, turn the monitor off and remove the cuff immediately The unit will return to standby mode, displaying the day and month, after 1 minute if not being used 10 11

8 XXXXX Interpretation of Blood Pressure (BP) Results Savere Hypertension Moderate Hypertension Mild Hypertension High-normal Normal Optimal BLOOD PRESSURE CLASSIFICATION SYSTOLIC mmhg DIASTOLIC mmhg W.H.O INDICATOR Optimal GREEN Advice on Results Practice a healthy lifestyle. Consult of low BP (e.g. fainting). Normal GREEN Practice a healthy lifestyle. High Normal Mild Hypertension Moderate Hypertension Severe Hypertension GREEN Practice a healthy lifestyle YELLOW ORANGE RED Practice a healthy lifestyle. Re-measure BP over the next 4 weeks. If high levels ( 140/90) persist (e.g. 2 high readings on 2 separate occasions) consult your pharmacist or doctor. Practice a healthy lifestyle. Re-measure BP over the next 2 weeks. If high levels ( 140/90) persist (e.g. 2 high readings on 2 separate occasions) consult your pharmacist or doctor. We would recommend that you see your doctor urgently. WHO (World Health Organisation) Definitions and Classification of Blood Pressure Levels. * If systolic and diastolic BP fall into different categories, the higher value should be taken for classification e.g. if your BP is 141/83 you should read the advice in the Hypertension category (not the normal category). Your BP should be re-assessed professionally at least once every 5 years unless you have high BP in which case it should be re-assessed at least once a year - speak to your pharmacist or healthcare professional. 12 XXXXX Additional Information on Blood Pressure Your heart is just like a pump which works all the time to make the blood flow through all blood vessels. Blood pressure measures the force on the wall of the blood vessels caused by the pressure of the blood. The output of blood from the heart when it pushes blood around the body is called systolic blood pressure. Diastolic blood pressure is the measurement of the blood returning to the heart. Blood pressure is normally written as, for example: 120 (systolic) 80 (diastolic) Fluctuation of Blood Pressure Blood pressure fluctuates constantly during the day. Its value in the day time is higher than in the evening with the lowest level being at midnight. The pressure begins to rise again at 03:00am and reaches its highest level any time during the day so it is impossible to get a consistent reading. For this reason, please take your measurements at the same time of day. Systolic Diastolic 13

9 XXXXX Specifications (1) (2) (3) (4) (5) Model: KD-551 Digital display system Measuring method: Oscillometric method Measuring Accuracy: Within ±3mmHg Cuff pressure range: 0mmHg~300mmHg Pulse rate range: 40~180/min Pulse rate accuracy: Within±5% (6) (7) (8) Power source: 4 x 1.5V AAA batteries (9) Classification: Internal powered Equipment Type BF (10) Pressurisation: Automatic air inflation by an air pump (11) Deflation: Automatic exhaust Automatic standby: To go into standby mode after 1 minute of non use to save energy Battery life: Approx. 500 times Environmental temperature for operation: 10~40 ºC (50ºF-104ºF) Environmental temperature for storage: -20ºC~50 ºC (-4ºF - 122ºF) Environmental humidity for operation: 85% RH Environmental humidity for storage: 85% RH Transport condition: Humidity range: Less than 85% Ambient temperature range: -20ºC -50ºC (-4ºF-122ºF) The expected lifetime of this product is 3 years, under normal usage. This is a class IIA medical device and fulfils the provisions of the Medical Devices Directive 93/42/EEC. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by EU standard EN1060 non invasive sphygmomanometers. All components belonging to the pressure measuring system, including accessories: Pump, Valve, LCD, Cuff, Sensor. (12) (13) (14) (15) (16) (17) (18) XXXXX Troubleshooting LCD screen shows battery symbol LCD shows Er 0 LCD shows Er 1 LCD shows Er 2 Abnormality Reason Action The cuff does not inflate or the display shows low pressure during inflation LCD screen shows abnormal results No response when buttons pressed Pressure loss due to air leakage in socket or cuff Cuff is not connected properly Batteries are low Cuff is not tight or is positioned incorrectly Patient was excited/nervous or spoke/moved during measurement Wrong position Some interference during inflation or incorrect operation during measurement Incorrect operation Pressure system is unstable before measurement Systolic pressure detect fail Diastolic pressure detect fail Check the connection between the socket and monitor Reconnect the cuff Change the batteries - refer to the Loading the Batteries section Tighten the cuff and refer to the section setting up your Blood Pressure Monitor Re-test. Do not speak and take 2-3 deep breaths before to relax. Stay calm and remain steady Adjust your position - refer to page 5 Refer to the section Using your Blood Pressure Monitor Take out the batteries for a few minutes, then re-insert them, following directions in section Loading the Batteries Do not move and try again 14 15

10 Troubleshooting LCD shows Er 3 LCD shows Er 4 LCD shows Er 5 LCD shows Er 6 LCD shows Er 7 LCD shows Er 8 LCD shows Er A Storage Pneumatic system blocked or cuff is too tight during inflation Pneumatic system leakage or cuff is too loose during inflation Inflation above 300mmHg Over 3 minutes while pressure above 15 mmhg EEPROM accessing error Device parameter check error Span error Position the cuff correctly and try again Measure again after 5 minutes. If the monitor is still abnormal, please contact Betterlife. Remove the batteries from the unit if you are not going to use it for a long period of time. Leaking batteries can damage the unit Do not make any sharp kinks in the cuff After use, turn off and store safely out of the reach of children Do not expose the device to direct sunlight and protect it against dirt and moisture Store the device in a cool, well-ventilated place Never place any heavy objects on the device Battery Information 1. Please use 4 x AAA batteries supplied 2. Remove the batteries if the device is not in use for long periods of time 3. Do not mix old and new batteries or different types of batteries 4. Warning: If batteries leak and come into contact with skin or eyes, wash immediately with copious amounts of water 5. Batteries must be handled by an adult. Keep batteries out of reach of children 6. Only batteries of the same or equivalent type are recommended 7. Do not use rechargeable batteries 8. Remove exhausted batteries from the unit 9. Supply terminals are not to be short circuited 10. Dispose of batteries safely according to battery manufacturer s instructions Maintenance and Cautions 1. Do not drop this blood pressure monitor or subject it to strong impact 2. Avoid exposure to high temperatures, direct sunlight and contact with water 3. If the monitor is stored at temperatures below freezing, do not use immediately. Leave at room temperature for at least one hour before use 4. Do not attempt to disassemble the monitor 5. Do not leave the batteries in the monitor if it is not in use for a long period of time No component can be maintained by user in the monitor. The circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user s appropriately qualified technical personnel to repair those parts of equipment which are designated repairably can be supplied. and It is recommended the cuff should be disinfected 2 times every week if needed. Wipe the inner side (the side contacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl alcohol 16 (75-90%), then dry the cuff by airing. 17

11 Disposal 6. Information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference please see part at the back of this booklet. 7. No component can be maintained by user in the monitor. Please contact the service center. 8. It is recommended the performance should be checked every 2 years or after repair. Please contact the service center. 9. Please do not share the cuff with other infective persons to avoid cross-infection. 10. Clean the monitor with a dry, soft cloth or a damp, soft cloth moistened with water or a mild, diluted detergent. 11. Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clean it by hand in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it. We recommend cleaning the cuff after approximately 200 uses. 12. The cuff integrity is maintained after 1,000 open close cycles of the closure. Used, fully discharged batteries must be disposed of in a specially labelled collection container, at toxic waste collection points or through an electrical retailer. You are under legal obligation to dispose of batteries correctly. NOTE: You will find these markings on batteries containing harmful substances: Pb = battery containing lead, Cd = battery containing cadmium, Hg = battery containing mercury. Please dispose of the device in accordance with the directive 2012/19/EU-WEEE (Waste Electrical and Electronic Equipment). If you have any queries, please refer to the local authorities for waste disposal. XXXXX Customer Feedback We are constantly striving to delight our customers with our products and customer service. We value your opinion and feedback on our devices as this helps to develop and continually improve. We would be grateful if you share your thoughts in reviewing this product. Please visit

12 XXXXX Warranty This product is guaranteed for a period of three years from the date of purchase against mechanical and electrical manufacturing defects. There are no user serviceable parts inside the instrument. Any attempted repair by unauthorised persons invalidates the warranty. This does not affect your statutory rights. An electronic version of the User Manual is available for download from: (The sign background colour: blue.the sign graphical symbol: white) Symbol for "WARNING" The cuff is type BF applied part Andon Health Co. Ltd., No. 3 Jingping Street, YaAn Road, Nankai District, Tianjin , China Lotus Global Co. Ltd., 1 Four Seasons Terrace, West Drayton, Middlesex, London, UB7 9GG, United Kingdom 20 21

13 XXXXX Blood Pressure Record Table Please log the date, time and your SYS (Systolic), DIA (Diastolic) and Pulse Rate blood pressure levels. We recommend you share this information with your Doctor. Name: Date Time SYS (Systolic) DIA (Diastolic) Pulse Rate Comments Table 1 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture s declaration - electromagnetic emissions The [KD-551] is intended for use in the electromagnetic environment specified below. The customer or the user of the [KD-551] should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Not applicable The [KD-551] uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The [KD-551] is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

14 Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration - electromagnetic immunity The [KD-551] is intended for use in the electromagnetic environment specified below. The customer or the user of the [KD-551] should assure that it is used in such an environment. IMMUNITY Electromagnetic IEC 60601test level Compliance level test environment - guidance Electrostatic ± 6 kv contact ± 6 kv contact Floors should be wood, discharge (ESD) ± 8 kv air ± 8 kv air concrete or ceramic tile. If IEC floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer s declaration - electromagnetic immunity The [KD-551] is intended for use in the electromagnetic environment specified below. The customer or the user of the [KD-551] should assure that it is used in such an environment. IMMUNITY test Radiated RF IEC IEC 60601test level 3 V/m 80 MHz to 2.5 GHz Compliance level 3 V/m Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the [KD-551], including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d 1. 2 P 80 MHz to 800 MHz d 2. 3 P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the 25

15 recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b 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. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [KD-551] is used exceeds the applicable RF compliance level above, the [KD-551] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [KD-551]. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3V/m. 26 Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the [KD-551] The [KD-551] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the [KD-551] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the [KD-551] as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output m power of transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W d 1. 2 P d 1. 2 P d 2.3 P 0, , For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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. 27

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