Health & Life 2ABTAHNL85CB AutomaticUpper Arm Blood Pressure Monitor User Manual
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Instruction Manual Automatic Upper ArmBlood Pressure Monitor Model No. HL858CB 1 Table of Contents Medical Disclaimer……………………………………………………………………………03 Intended Use………………………………………………………………………………..…03 About Blood Pressure………………………………………………………………………04 Measurement Method…………....……………………………………………………06 Accuracy……………………….…………………………………………………………………06 Precautions………………….…………………………………………………….…………….. 07 Device Overview……………………………………………………………………………….09 Symbol Definitions………………………………………………………………………….12 Features………………………………………………………………………………………….13 InstallingBatteries………………………………………………………………………….18 Using the AC Adapter………………………………………………………………………19 Applying the Cuff…………………………………………………………………………….20 Measurement Procedure………….…………………………………………………….21 Bluetooth Transmission………………………………………………………………………25 Memory Function…………………………………………………………………………….26 Storage and Maintenance……………………………………………………………….29 Troubleshooting……………………………………………………………………………….30 Warranty & Recalibration……………….……………………………………………….31 Specifications………………………………………………………………………………….32 Note………………………………………………………………………………………….…….34 Appendix…………………………………………………………………………………….…….36 Blood Pressure Diary……………….……………………………………………….…….38 2 Medical Disclaimer This manual and product are not meant as a substitute for advice provided by your doctor. You are not to use the information contained herein, or this product for diagnosing or treating a health problem or prescribing any medication. If you have or suspect that you have a medical problem, promptly consult your healthcare provider. Intended Use This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s arm. All values can be read out in one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging fromapprox.9 inches to 17 inches (23 cm to 43 cm) and for home use. 3 About Blood Pressure 1. What is blood pressure? Blood pressure is the measurement of the force of blood pushing against the walls of the arteries. Arterial blood pressure is constantly fluctuating during the course of the cardiac cycle. The highest pressure in the cycle is called the systolic blood pressure, and represents the pressure in the artery when the heart is beating. The lowest pressure is the diastolic blood pressure, and represents the pressure in the artery when the heart is at rest. Both the systolic and the diastolic pressure are necessary for a physician to evaluate the status of a patient's blood pressure. Many factors such as physical activity, anxiety or the time of day, can influence your blood pressure. Blood pressure is typically low in the mornings and increases from the afternoon to the evening. It is on average lower in the summer and higher in the winter. 2. Why is it useful to measure blood pressure at home? Having one's blood pressure measured by a doctor in a hospital or a clinic, is often associated with anevent called “White Coat Hypertension” where the patient becomes nervous or anxious, thus raising his blood pressure. There are also numerous other factors that might cause your blood pressure to be raised at a specific time of day. This is why medical physician recommend home monitoring as it is important to get readings of blood pressure during different times of the day to really get an idea of your real blood pressure. Medical physicians generally recommend the “Rule of 3”, where you are encouraged to take your blood pressure three times in a row (at 3 ~ 5 minute interval), three times a day for three days. After three days you can average all the results and this will give you an accurate idea of what your blood pressure really is. 4 Abou A ut Blood Pres ssurre A. Standards fo or assess sment of high or low blood pres ssure without rega ard to age, have been b established d by the WHO, W and classifica c ationsad dapted fr rom JNC7: WHO O: W World Health Orga anization JNC 7: The Seventh Re eport of the Joint J National Com mmittee on Preventiion, Detection, Evaluation, and Treatm ment of h Blood Pressure e. NIH High Publication No o.04-5230 August 2004 However the above ch hart is nott exact fo or classific cation of blood pressure and d it's in ntended to be used as s a guid de in unde erstanding non-in nvasive blood b pre essure m measurem ments. Pleas se consult with your physic cian for prroper diag gnosis. B. Variations in n blood pressure p e: Indiv vidual blo ood press sures varry greatly y both on n a daily and a seas sonal basiis. These variation ns are even more pronounc ced in hype er tense patients. p N Normally the blood d pressure rises wh hile at work k and is at a its lowe est during g sleeping g period. (hyp per tens se: mea ans a person who w has s high blood b pres ssure sym mptom.) ) The graph below illlustrated the varia ations in blood pre essure ov ver a wholle day witth measu urement taken everry five minutes. The thick line e represen nts sleep.. The rise in blood pressure at 4 PM (A in the graph) g an nd 12 PM (B ( in the graph) g co orrespond to an attack of pain. 5 Measurement Method HL858CB Automatic Upper Arm Blood Pressure Monitor measures blood pressure and heart rate by oscillometric method, meaning the fluctuations in pressureare measured. Once the cuff is wrapped around your upper arm, just turn on the monitor and inflation automatically starts.The inflation of the cuff creates pressure around the arteriesinside upper arm. Within the cuff is a gauge which senses thefluctuations (oscillations) in pressure. The fluctuation measured represents the degree of intensity that your arteries contracting with each heart beat,andalso aresult of the pressure that the cuff has placed on the upper arm. The monitormeasures these contractions and converts the informationto a digital value. This is the result displayed on the monitorscreen. Once the measurement is complete, the cuff will automaticallydeflate. Accuracy HL858CB Automatic Upper Arm Blood Pressure Monitor has been clinically tested against a scientificdevice called sphygmomanometer, considered thegold standard in blood pressure measurement. All HL858CBAutomatic Upper Arm Blood Pressure Monitors have performed equivalent to measurements takenwith this scientific device and are within the accuracy limitsprescribed by the American National Standard for Electronicor Automated Sphygmomanometers. The SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013. *We suggest our users have their blood pressure monitor checked every 2 years. This operation should only be performed by Manufacturer or by authorized representatives. 6 Precautions * Do not use this manual and product as a substitute for advice, diagnosing or treating a health problem or prescribing any medication by your doctor. If you have a medical problem, promptly consult your healthcare provider. * Read the Instruction Manual thoroughly before measuring and keep it at hand for your reference at any time. * This device uses the oscillometric method to measure systolic and diastolic blood pressure as well as your heart rate. It’s recommended for use by people over the age of 18 and not to be used on infant or children. * The device is designed for home use and not suitable for clinical use. Do not take a measurement in a low (less than 41℉/5℃) and high (more than 104 ℉/40 ℃) temperature, nor in a place outside humidity ranges (15 % ~ 93 % R.H.), and altitude ranges (700 ~ 1060 hPa),or you may get inaccurate readings. Wait 30 ~ 45 minutes before measurement if you’ve just consumed caffeinated beverages or smoked cigarettes. Rest at least 5 ~ 10 minutes before taking a measurement. To allow your blood vessels to return to the condition prior to taking the measurement, please wait at least 3 ~ 5 minutes in between measurements. You may need to adjust the wait time according to your personal physiological situation. We recommend you using the same arm (preferably the left arm) and measuring around the same time each day. Sit down comfortably and place your elbow on the table with your feet flat on the floor, and back supported.Please do not cross your legs during measurements. Keep the cuff at heart level. Relax your hand with the palm facing up. Perform measurements in a quiet and relaxed environment at room temperature. Do not move or shake the device during a measurement. Please keep quiet and do not talk during measurements. This product is not suitable for: Pregnant women. People with arrhythmias Undergoing intravenous injection on any limb Currently in a dialysis treatment In pre-eclampsia condition 7 Precautions For those who have had mastectomy surgery (especially whose’ lymph nodes removed), it’s recommend take a measurement on the unaffected side. When used among medical electronic equipments on the same limb, pressurization of the cuff may cause temporarily malfunction toother devices. Keep in mind that blood pressure naturally varies from time to time throughout the day and is affected by lots of different factors such as stress, eating, smoking, alcohol consumption, medication, and physical activity, etc. Normally the blood pressure rises while at work and is at its lowest during sleeping period. Blood pressure measurements should be interpreted by a physician or a trained health professional who is familiar with your medical history. Using the unit and recording the results regularly for your physician to interpret, you will keep your physician informed of the continuing changes in your blood pressure. If you have one of the circulatory problems as arteriosclerosis, diabetes, liver disease, kidney disease, severe hypertension, peripheral circulation….., please consult your healthcare professional before using the device. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method and are within the accuracy limits prescribed by the American National Standard for Manual, electronic, or Automated Sphygmomanometers. *Attention! 1. Do not use the device on infants, children, or those who cannot express their own intention. 2. The device is equipped with sensitive electronic components. While measuring, avoid strong electrical or electromagnetic fields, e.g. mobile phones, microwave ovens, etc; or it may lead to temporary reading error or inaccuracy. 3. To avoid accidental strangulation, keep thisproduct away from children and do not drapetube around neck. 4. Consider the electromagnetic compatibility of the device (ex. power disturbance, radio frequency interference etc.) Please use it indoor only. 5. Over high frequency measurements may result in blood flow interference, which is likely to cause uncomfortable sensations, such as partial subcutaneous hemorrhage, or temporary numbness to your arm. In general, these symptoms should not last long. However, if you do not recover in time, please seek your medical physicians for help. 8 Device Overview Part names and product components LCD Display Battery Cover (located on bottom of Unit) MEMORY BUTTON RIGHT BUTTON LEFT BUTTON USER-SELECT BUTTON START / STOP BUTTON AA(LR6) (1.5V) ALKALINE BATTERY X 4 ARM CUFF WITH TUBE 9 Device Overview DATE/ TIME SET BUTTON AM/PM AVERAGE BUTTON REST ASSURE TRIPLE-CHECK FUNCTION SWITCH MODE SWITCH DC JACK 6V 1A AC Adapter *Caution! Substitution of a component different from that supplied might result in measurement error. 10 Device Overview Unit display Low Battery Symbol Irregular Heartbeat Detector Error Symbol Risk Category Indicator Rest Assure Mode Symbol Bluetooth Symbol Systolic Rate Triple-Check Function Indicator AM/PM Average Symbol User Symbol Diastolic Rate Combine Date and Time display Also represents Year value Pulse Symbol Heart Rate 11 S bol Defin Symb D nition ns SYMBOL LS Definittions his symbol appears wh hen the battterypower is excessiv vely lowor Th th he polarity reverses. LowBattery Symbol S Î We sugge est you replace all battterieswith n new ones, and a make su ure the +/-polarities are a properly y positioned d. Errror Symb bol:Error display. O Once pulse is s detected, the symbo ol flashes with each pullse beat. Pulse Sym mbol Co ompares re eadings aga ainst blood pressure g guidelines. See next pa age for more informattion. Risk Category Indicator I REST Trriple-Chec ck Functio on Symbo ol:Appears when Trip ple-Check fu unction is tu urned On. AverageSym mbol: Dis splayed when viewing a Trip ple-Check verage. av R Rest Assure e Mode Sy ymbol: 1.. Rest mod de on: The REST symb bol will appear on mon nitor, that countdow wns for 5 minutes before e starting g single measurem ment. 2.. Triple che eck mode on: o The RE EST symbol will flash among 3 measurem ments durin ng countdown. Under Blueto ooth Data Transmissio T n/ Link Mod de, LCD dis splays this sy ymbol. Bluetooth Symbol Trriple-Chec ck Function Result: Indicates w which meas surement is being take en, or which h measurem ment is being viewed from a Trriple-Check k average re eading. M Memory Av verage:Disp play averag ge of last 3 readings. AM/PM Ave eraging:Indicates the e reading being displayed is an verage fro om the last l 3 morning m orr last 3 evening av m measuremen nts. User 1 User 2 Irrregular Hea artbeat Detector Us ser 1: Appe ears when the monito or is operate ed by User 1. Us ser 2: Appe ears when the monito or is operate ed by User 2. his symbol appears when the e user was talking, moving, Th sh haking, orr an irregular heartt beat wa as detected d during m measuremen nts. Î Our sugge estion: Please do no ot talk or move m during g measurem ments. epeat the measureme m nt after res sting for at lleast 5 minutes, and Re re estart your measurem ment while sitting dow wn comforttably and qu uietly. 12 Features Risk Category Indicator This device is equipped with Risk Category Indicator which classifies your blood pressure measurements into four stages (Normal, Pre-hypertension, Stage 1 Hypertension to Stage 2 Hypertension) based on the blood pressure standards established by the U.S. Department of Health and Human Services and the National Institutes of Health.The indicator symbols are defined as following classifications: You may use the function to effectively track your blood pressure. Yet the above standards and classifications are general guidelines for your reference as an individual’s blood pressure varies among different people, age groups, ets. It is important that you consult with your physician to know your normal blood pressure range as well as the point at which you will be considered at risk. 13 Features For adults 18 and older who are not on medicine for high bloodpressure, are not having a short-term serious illness, and do nothave other conditions, such as diabetes and kidney disease.To determine category of risk when systolic and diastolicreadings fall into two areas, use the higher of the two numbers forclassification. There is an exception to the above definition of highblood pressure for people with diabetes and chronic kidney disease.A blood pressure of 130/80 mmHg or higher is considered highblood pressure for those individuals. *Note ! The above table is not exact for classification of blood pressure and it's intended to be used as a guide in understanding non-invasive blood pressure measurements. Usually this is not a cause for concern; however we recommend you consult with your physician for proper diagnosis or seek medical advice. Please note that the device does not appropriate to diagnose hypertension, and it is only for user reference on blood pressure monitoring. 14 Features Rest Assure Function Before measurement, it is suggested that you sit quietly for 5 minutesbefore measurement as measurements taken in a relaxed stateaccording to JNC7 report to have a greater accuracy. HL858CBprovides users a helpful countdown function(REST ASSUREon/off switch) for 5 minutesbefore the measurementthat helps users to get accurate results.To turn this feature OFF, slide the switch on the back to the OFF position. JNC7: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No.04-5230 August 2004 Triple-Check Function The Triple-CheckFunction automatically takes and averages 3 readings in a row, with 1 minute rest intervals in between each measurement. To deactivate this feature and take only a single reading, slide the switch on the back to the OFF position. 15 Features Irregular Heartbeat Detector The symbol will appear on screen indicating a certain heartbeat irregularity was detected during measurement. The heartbeat rhythm that is more than or less than 25% from the average rhythm is usually defined as an irregular heartbeat rhythm. Talking, moving, shaking or an irregular pulse during the measurement can result in the appearance of this symbol. Usually this is not a cause for concern, however if the symbol appears often, we recommend you seek medical advice. And please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. *Note! y The pulse display is not suitable for checking the frequency of heart pacemarkers. If a certain pulse irregularity is detected during measurement often, we recommend you seek medical advice y As a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your device. y The IHB function is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmic problem. In order to filter the unstable status of user and avoid affecting the detection of heart rate from any movement, shaking or talking in the beginning of measurement, the method of averaging heart beat intervals of subject device is calculated with the three proper heart beat pulses detected in the beginning of measurement and that is different from a strict mathematical averaging of all recorded intervals. y At least 3 beats with at least 25% difference from the average heart beat interval will generate the IHB icon on the screen. 16 Features Bluetooth Data Transmission HL858CB features a built-in “Bluetooth Data Transmission” function, which enables the device automatically transmit measuring results to paired Bluetooth device. Bluetooth compatibility with blood pressure monitor for Bluetooth-enabled device is: Bluetooth 4.0 for Android 4.3 or above, Bluetooth 4.0 foriOS 5.0 or above *Note! HL858CB is subject to and complies with electromagnetic compatibility (EMC) standard of IEC 60601-1-2,EN 301 489-1, EN 301489-3, EN 302 291 andU.S. federal guidelines, Part 15 of the FCC (Federal Communications Commission) rules for devices with RF capability. These guidelines help ensure that your device will not affect the operation of other nearby devices. Additionally, other devices should not affect the use of your device. Other wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless network, may prevent or delay the transmission of data from your device to paired Bluetooth device. Moving away from the source of the interference or turning off these devices to resolve the problem. Make sure HL858CB and paired Bluetooth device are within acceptable distance (no more than 10 meters) with each other. If not, put them closer. If you plan to transmit test results to paired Bluetooth device, be sure to select User 1, or 2before measurements, in case other people’s results may be transmitted to your paired Bluetooth device or included in your past results. About Bluetooth Data Transmission Function The Bluetoothdata transmission function might not be workable to some Bluetooth devices because of the compatibility of Android system. Some issuesthat the Bluetooth implementations on these devices have unresolved errors. It is not because of the Bluetooth module in monitor is not supported. 17 Insta alling g Battterie es When LOW W W BATTER RY SYMB BOL appears s on the display, or no re eaction to owardoperation, pllease change batte eries. Replace all worn-ou R ut batterie es with ne ew ones and a do no ot mix new w and used battteries. Do D not mix m alka aline,standard (ca arbon-zinc) or echargeab ble (cadm mium) battteries eitther.Such action m may shorte en the re ba attery life e or cause e the dev vice to ma alfunction n. Slide the battery b cover and in nsert 4 AA A (LR6) allkaline ba atteries into the ba attery co ompartme ent as shown on the t figure e below. Make surre the po olarities “+” and “–” end ds areco oinciding with sim milar marrkings engraved on o the ba attery hou using. *Atttention! y Batteries B are e hazardou us waste. Do not dispo ose of them m together w with the ho ousehold garbage. Ple ease discarrd worn-ou utbatteries to the recycling site according to local re egulations. y Keep K the battery away from children in case e they chok ke on it. y Iff the device e is not to be used for over o 2 months, please e remove th he batteries from its co ompartmen nt for powe er-saving. y After A replaciing the batteries, rese et date and time. y Please repla ace all worrn-out batteries with new ones when you are operating the Bluetooth transmission B n function, and a the LOW W BATTERY Y SYMBOL display. 18 appearrs on the Using the AC Adapter This monitor is designed for operation with batteries or an AC adapter. Please use only a compatible AC adapter with required voltage and current as indicated in this manual. Note: No batteries are needed when operating with an AC adapter. Please unload the batteries when operating with an AC adapter for an extended period of time. Leaving the batteries in the compartment for a long time may cause leakage, which may lead to damage of the unit. Recommend Adapter specification: Model: Fuhua, UE08WCP-060100SPA Rating: Input: 100 ~ 240V, AC, 50 ~ 60 Hz, 400mA Output: 6V, DC, 1A, Note! When you use the blood pressure monitor with AC adapter, do not position the device to make it difficult to disconnect the adapter plug. 19 Applying the Cuff Press your brachial artery approximately 1 inch (2 ~ 3 cm) above the elbow on the inside of your left arm to determine where your strongest pulse is. Slide the end of arm cuff furthest from the tube through the metal ring to a loop. The smooth cloth should be on the inside of the cuff. If the cuff is located correctly, the velcro will be on the outside of the cuff and metal ring will not touch your skin. Put left arm through the cuff loop. The bottom of the cuff should be approximately1 inch (2 ~ 3 cm) above the inner elbow. The tube should lie over the brachial artery on the inner part of the arm. Pull the cuff so that the top and bottom edges aretightened around your arm. When the cuff is positioned properly, press the velcro firmly against the pile side of the cuff. Sit on a chair and lay your forearm on the table sothat the cuff is at the same level as your heart. Relax your arm and turn your arm upward. Make sure there are no kinks in the air tube. *Note! y Fit the cuff snugly, leaving enough space for 1 inch (2 ~ 3 cm) between the inner elbow and the lower edge of the cuff, or the measurement may not be accurate. y This monitor comes with one size of arm cuff: 9” ~ 17” (23 ~ 43 cm). y In case the cuff kept pumping up non-stop, open the cuff at once. y Do not wrap the cuff around any body part other than your arm. y The device is not supposed to be used when your arm is wounded or injured. 20 M surem Meas ment Pro oced dure Swittch on the Monitor A. Put in 4 AA (LR R6) alkalin ne batteries B. All seg gments appear on the scree en for 3 seconds. s C. The m monitor will automa atically turn to pow wer saving g mode (a all LCD segme ent cleare ed) Setting Year, Tim me and dDate A To ad A. djust the date an nd time, press the e Date/ Time Set Butto on. B. Press s buttton ("YEA AR" flashe es). Press sor bu utton to adjust a YEAR Rvalue (20 015 is deffined initially). Press s agaiin to confirm the entries, and a the d device turns to stand dby mode e. C. Change the MONTH, M D DATE, HOUR and MINUTE M a as describ bed in step B above. Takin ng a Measur M rementt A. Chec ck and select functions ofTriple-Check Mode and Rest Assure A Mode e if neede ed. 1. If functions offTriple-Ch heck Mode e and Res st Assure Mode are e both on, press key to start 5 minute count c dow wn and have a multti-measurrement. 2. If functions ofTriple-Ch heck Mode is on an nd Rest A Assure Mo odeare key to t start multi-me easurement witho out 5 off, press minu ute count down. 3. If fun nction of Triple-Che T eck Mode e is off and d Rest Ass sure Mode e is on, press ke ey to startt 5 minutte count down d and d have a single measurementt. 4. If fun nctions off Triple-Ch heck Mod de and Res st Assure Mode are e both off, press key to o start single s me easureme ent witho out 5 minu ute count down. 21 M surem Meas ment Pro oced dure B. Selec ct User (s see LCD Displays D below). b C. Press s butto on to conffirm the chosen c us ser. D-1. Sta art a Sing gle Meas suremen nt: 1. Mak ke sure th he Triple-Checkfun nctionswittch turned d off. 2. If REST R ASSU URE MOD DE is on, with w the cu uff wrappe ed around d your upp per arm,press button to starrt a 5 min nutes coun ntdown (““REST” flas sh). 3. Tim me end, allunits app pear on th he screen n for3 seco onds, and d start st the 1 meas surement. 4. When the measurem m ment is finished, f the systtolic pres ssure, dias stolic pre essure, and a heart rate with RIS SK CATE EGORY IND DICATOR will be displayed d and sa ave results to me emory automatically (Time & Date ch hanged pe er 2 secon nds). (Bluetooth h Symbol fla ashing) 5 mins m countdown All Segments Measure ement result art a Sing gle Meas suremen nt: D-2. Sta 1. Mak ke sure th he Triple-Checkfun nctionswittch turned d off. 2. If REST R ASSU URE MOD DE is off, with w the cu uff wrappe ed around d your upp per arm,p press buttton to sta art the measurem m ment.All display unitts appearr on the screen s forr 3 second ds. the systtolic pres 3. When the measurem m ment is finished, f ssure, dias stolic pre essure, a and heart rate with RIS SK CATE EGORY IND DICATOR will be displayed d and sa ave results to me emory automatically (Time and a Date changed per 2 sec conds). (Bluetoo oth Symbol flashing) A Segments All Start Inflation Meas surement result 22 M surem Meas ment Pro oced dure E-1.Start a Multi-M Measure ement:wiill take continua c tive 3 tim mes m measurem ments. 1. Mak ke sure th he Triple-Check functionswiitch turne ed on. 2. If REST R ASSU URE MOD DE is on, with w the cu uff wrappe ed around d your upp per arm, press p buttton tostarrt a 5 min nutes coun ntdown (““REST” flas sh). 3. Tim me end, allunits app pear on the screen n for3 sec conds,and d start the 1st me easureme ent. (“M MEASUREM MENT 1”” flash while mea asuring). 4. Afte er the 1stmeasurem m ment finis shed, mea asuring re esultwill not n be sho owed,and display turned to 1 minu ute countdown diirectly nd (“REST” flash) for the e 2 mea asurement. nd 5. Tim me end, sttarting th he 2 me easureme ent (“MEA ASUREMENT 2” flas sh and “MEASUREM MENT 1”n non-flash while me easuring) nd 6. Afte er the 2 measurem ment finis shed, mea asuring re esult will not n be sho owed, and d display turned to t 1 minute coun ntdown diirectly rd (“REST” flash) for the e 3 measurementt. 7. Tim me end, starting s the 3rd measurem m ent(“MEA ASUREMENT 3” flas sh and “MEASUREM MENT 1 & 2” non-fflash while measurring) 8. When the measurrement is finish hed, the e averag ge of Multi-measurement (systolic ( pressure, p diastolic pressure e, and hea art rate with w RISK CATEGOR RY INDIC CATOR) will be disp played and d save res sults to memory m automatica ally. 5 mins countdown erage of Ave Multi-me easurement st All Segm ment 1 Inflation rd 1 min countdown 3 Inflatio on 23 1 min n countdown nd 2 Inflation M surem Meas ment Pro oced dure E-2.Start a Multi-M Measure ement:wiill take continua c tive 3 tim mes m measurem ments. 1. Mak ke sure th he Triple-Checkfun nctionswittch turned d on. 2. If REST R ASSU URE MOD DE is off, with w the cu uff wrappe ed around d your upp per arm, press button tosta art the measurem m ment.All display unitts appearr on the sc creen for 3 seconds, and willl automatically s st starrt the 1 measurrement (“MEASUR ( REMENT 1” flash while mea asuring). 3. Afte er the 1stmeasurem m ment finis shed, mea asuring re esult will not n be sho owed, and d display turned to t 1 minute coun ntdown diirectly (“REST” flash) for the e 2nd mea asurement. me end, sttarting th he 2nd me easureme ent (“MEA ASUREMENT 2” 4. Tim flas sh and “MEASUREM MENT 1” non-flash n while me easuring)) nd 5. Afte er the 2 measurem ment finis shed, mea asuring re esult will not n be sho owed, and d display turned to t 1 minute coun ntdown diirectly (“REST” flash) for the e 3rd measurementt. 6. Tim me end, starting s the 3rd measurem m ent(“MEA ASUREMENT 3” flas sh and “MEASUREM MENT1 & 2” non-flash while e measuriing) 7. When the measurrement is finish hed, the e averag ge of Multi-measurement (systolic ( pressure, p diastolic pressure e, and art rate with w RISK CATEGOR RY INDIC CATOR) will be disp played hea and d save res sults to memory m automatica ally. A Segments All st 1 Inflatio on wn 1 min countdow Avera age of Multi-Measurement rd 3 Inflation nd 2 Infla ation 1 min co ountdown *Note! 1. Do nott inflate the e cuff until it is wrapped around your upperr arm. 2. Withou ut any operration for 1 minute, de evice turns to the pow wer saving mode. m 2. To sto op measurement, pres ss START/S STOPbutto on. 3. Press MEM key to t memory mode. 4. Press key to Date/ Time e Setting Mode. 5. Press USER 1/2 to Change e User. 6. Press START/ST TOP key to stop meas surement to o Power Saving Mode.. 7. Press AM/PM A Av verage key y to display y AM/PM av verage. 24 B tooth Bluet h Tra ansm mission To o activate e Bluetootth functio on, please e make su ure your A Android device d have down nloaded APP. A There are 2 ways to o process s Bluetootth functio on: Single Measure ement Multi Measurrement M Measurem ment Com mpleted:: Bluettooth Sym mbol Flash Bluetootth Symbol Flash 1. After meas surementt complete ed, th he device activates s Bluetooth fu unction au utomatica ally, (B Bluetooth h Symbol flashing) 2. HL858CB receive the da ata re equest from m APP, pa airedBlue etooth device automatica ally starts do ownloadin ng measuringresu ults frrom blood d pressurre monito orif it’s in an acceptable e range(n no more than 10 meters) m witheach other. o (B Bluetooth h Symbol display constantly y) 3. HL858CB can only pair up with one e Bluetoo oth device eat a tim me. To trransmit measuring m g results to otherr Bluetooth device e, please retry Steps1 ~ 2. 2 P Press and d hold b button fo or 3 seco onds: 1. Under sleep s mod de, pressing and hold button fo or 3 secon nds to wake up u the device and turn on o Blueto ooth func ction(Blue etooth Symbol flashing)) 2. HL858C CB receive e the data a request from APP,, pairedBlluetooth device d automatically sttarts dow wnloading g measuringresultts from blood pressurre monito orif it’s in n an acce eptable range(no more tha an 10 meters)) witheach other. (Bluetooth ( h Symbol display c constantly y) CB can only pair up p with one e Bluetoo oth device eat a time e. 3. HL858C To transmit mea asuring results to other Bluetooth device, please p s mention n above. retry as Fail conne ection: Iff HL858CB B cannot connect to t paired Bluetooth de evice ove er 15 seco onds, LCD D will disp play Errorr m message “ “E4”.(Blue etooth Symbol disp play co onstantly) *Note! Withou ut any operation o in 1 minute, m t the devic ce shuts off automatically and Blueto ooth Transmission OFF. Please do not turn on more m tha an one Blluetooth transmiss sion functio on of Mon nitors. 25 M ory Func Mem ction n Storring da ata After eac ch measu urement, the systo olic and diastolic d p pressure, heart rate, Risk k Categorry Indicato or and Irrregular he eartbeat d detector (if ( any) with date e and time will be automatically storred. The mon nitor can store up p to 120memory sets for per userr, and automatically repllace the oldest o datta with ne ew one. Mem mory Fu unction Press MEM Mand AM/PM Avera age keyto o activate Memory--Select Mode. 1. Press MEM M buttton to se ee previou us measu uring results, including average e of last 3 measurements,a aTriple-Ch heck meas surementt, and th th st individu ual measu urement (120 ( , 11 19 , …1 result). 2. PressAM M/PM Ave erage buttton to se elect an average a o of 3 AM or o PM measurrements. Reviewing your morning m (A AM) and n nighttime e (PM) blood pressure p can provide imp portant in nformatio on about your health condition c . verage of Triple-Ch heck measurement An av (Pres ss / key k to rev view indiv vidual rea adings) An av verage of Last 3 Measureme ents An av verage off Last 3 Morning M Measureme ents (4:00 0 AM – 12:00 1 PM) An av verage off Last 3 Nighttime Measurem ments (6:00 0 PM – 2:00 2 AM) Note: A Triple-Ch heck averrage and its 3 ind dividualm measurem ments are c counted a 4 readings when stored in memory. as 26 M ory Func Mem ction n Reca alling Data D in n Average Memory y Mode e A. Sele ect User first. f B. Press MEM key k to entter Memo ory Mode, andLCD disp playsan average off the last 3 memories. (If a Triple-C Check result includ ded, the average a of it willbe included, but itts individu ual measu urements s will be not. See S the example e as a below.)) Avera age of Lastt 3 Meas surements t < <e.g. 119th measurrement is a Triple-Checkres sult :> ¾ Prress/key to t read 3 results(1 118th, 117 7th and 11 16th) of Trriple-Chec ck averag ge (119th) 119thTriple e-Check res sult th (Average of o 118 , 11 17th, th and d 116 ) ¾ 8th result 118 117th re esult 116th resultt Av verage off the last 3 measurements is the ave erage of 120 1 th, t 11 19th (118th , 117th and a 116th individua al results a are exclud ded) and th 11 15 resullts. C. Kee ep pressingMEMbu uttonto sc croll throu ugh all stored measuring m results in n sequenc ce. th t th st (12 20 , 119 ,… 1 ). 120th signal resu ult D. Pre ess MEM button b ag gain and return r to Standby Mode. E. Pre ess START T/ STOP button b to return to o Power S Saving Mo ode. 27 M ory Func Mem ction n Reca alling Data D in n Average Memory y Mode e A. Sellect User first. B. Pre ess AM/PM Mbutton to t enter Memory M M Mode. LCD D displays average e of latestt 3 AM measureme ents. C. Pre ess AM/PM Mbutton again, a LCD displays ave erage of latest P measu urements. 3 PM Averrage of Las st 3 AM Measureme ent Averrage of Lastt 3 PM Measureme M ent D. When done, press ME EM button again an nd return tto Standb by Mode. Eras sing da ata A. Sellect User first. B. Pre ess MEM button b to enter Me emory Mo ode. C. Pre ess and hold sam me time e, the and data buttons b a the at wiill be e erased auttomatically. LCD Displays s “CLR” for 3 sec conds. D. To confirm deletion,, press MEM M buttton and no data should app pear. Notte: Once deleted, your da ata can NOT N be rrestored. 28 S age and Stora a Main ntena ance e Gene eral Us se Do not in any wa ay twist the t cuff. Do not press button iff the cuff is not wra appedaro ound yourrupper arm. Do not drop the product a and avoid d any stro ong impac cts. Main ntenan nce Use a piece p of cloth with water or mild cleansing age ent to wip pe the device and a dry itt immedia ately with h a dry clo oth. Do not use deterrgent or any a strong chemic cals to cle ean the de evice. Use only a dry cloth to wipe the cu uff. Do not attempt to t disasse emble or change any a parts of themo onitor, includin ng arm cu uff, due to substitution of a compo onent diffferent from that supplie ed might result in measure ement error. If any suggestio on or se ervice is requested, please e consultt your service station. Storrage If the device d is not n to be used forr a long tiime, plea ase remov ve the batterie es from the t device e (leaking g of batttery acid can caus se the device to t malfun nction). Always store the e unit in the t storag ge case affter use. Do not p place the device diirectly under sunlig ght, in hig gh temperrature, or in hu umid or dusty places. Do not store the e device in i extrem mely low (less ( than n –13℉/– –25℃) and hig gh(more than t 158 ℉/70 ℃) temperature, no or in a pla ace its humiditty exceed ds 93% R.H. 29 T Trou bleshootting SYMB BOLS/SYM MPTOMS Unit does d not turrn on when pushe ed. IND DICATION N/ CORRECTION N Rep place them m with 4 new w AA (LR6)) alkaline battteries. CON NDITIONS/CAUSES W Worn-out b batteries. butto on is Battery pola B arities have e been p positioned incorrectly. Re--insert the battteries in th he corrrectpositions. C Cuff has been placed incorrectly. Wrrap the cufff operlyso tha at it is pro pos sitioned corrrectly. Measu uring Error Symbol appea ars when blood Did you talk D k or move during d pressu ure valuedisplayed m measureme ent? is exce essively low w or high. S Shaking of the arm with the cuff on. Air circuit abnormality A a y. Cuff tube e may n be plugged into monitor corre ectly. Meas suring Errorr Symbol not Meas suring Errorr Symbol Meas suring Errorr Symbol Fail Connec F ction Error Symbol IInflation m mmHg. p pressure exceeding e 300 E Error determ mining mea asurement data. HL858CB ca H annot connect to B Bluetooth-e enabled dev vice over 15 5 s seconds. Bluetooth-e B enabled dev vice pair with a w wrong devic ce. B Bluetooth fu unction is not n turn on. T distanc ce between BPM and BPM cannot c communicate The B Bluetooth-e enabled dev vice is out of o with Bluetooth--enabled t transmitting g range. device Use an inco U ompatible B Bluetooth-e enabled dev vice. U non-Blu Use uetooth-ena abled devic ce. Unexpected U d loss of e electrical/m mechanical integrity. Me easure again n. Keep arm m steady du uring me easurementt. Che eck cuff con nnection. Measure M aga ain. Sw witch the un nit off, the en measure e again. Me easure again. Plea ase refer to o Pag ge 25 “Bluettooth Tran nsmission” to retry aga ain. Plea ase re-pairiing the BPM M and Blue etooth-enabled dev vice with ea ach othe er. Plea ase press and a hold button fo or 3 seco onds underr sleep mod de. ase make sure s the Plea acceptable dis stance 10 meters) with (≦1 eac ch other. Plea ase refer to o Pag ge 17 “Bluettooth com mpatibility”& & Pag ge 33 "RF F Specificatiion” Re-insert the batteries b d try again. and Return the dev vice to ur local distributor you orim mporter. Note: If I "EP" appe ears on the display, d just return r the de evice to your local distributor or imp porter. 30 Warranty & Recalibration Warranty For One Year from the manufacturing date Please note that this warranty does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; loss of power; dropped product; malfunction or damage of an operating part from failure to provide manufacturer’s recommended maintenance; transportation damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of importers or distributors. Recalibration Notice To ensure continued measurement precision, all digital blood pressure monitors require recalibration regularly. After 2 years from the manufacturing date, we recommend you have your monitor recalibrate at the local distributor or importer. The recalibration service plus the charge of shipping and handling fee shall be charged accordingly. 31 Specifications Model Number HL858CB Measurement Method Oscillometric RatedRange of Cuff Pressure 0~300 mmHg RatedRange of Determination MeasurementRange of Heart Rate Accuracy Inflation Deflation Display Memory Unit Dimensions Unit Weight Cuff Size Storage/ Transportation Environment Operation Environment Power Supply BatteryLife Power-saving Mode Accessories 40~280 mmHg 40~199 beats/minute Pressure: ±3 mmHg Pulse: ±5% Max. Automatic Inflation (Air Pump) Automatic Air Release Control Valve TN LCD (with backlight) 240 Memory Total for 2 Users 114 X 153 X 70.5 mm (L X W X H) 4.49 X 6.02 X 2.78 inch (L X W X H) 393g ± 10 g(13.86oz ± 0.35oz) (Without Batteries) 23 ~ 43 cm(9 ~17 inch) Temperature: -25°C ~70°C (-13°F ~158 °F) Humidity: ≤ 93% R.H. Temperature: 5°C ~40°C (41°F ~104°F) Humidity: 15% ~ 93% R.H. Altitude: 700 ~ 1060 hPa 1. AA (LR6) (1.5V) Alkaline Battery x 4 2. 6V 1A AC Adapter (Model: Fuhua, UE08WCP-060100SPA) (Rating: Input :100-240V, 50/60Hz, 400mA Output: 6V, DC 1A) Approx. 200Measurements Without any operation for 1 minute, device automatically shuts off 4 AA (LR6) Alkaline Batteries, 6V 1A AC adaptor, Arm Cuffwith Tube, Instruction Manual, Storage Pouch. *The contents of this manual and the specifications of the device covered by this manual are subject to change for improvement without notice. 32 Specifications RF Type Bluetooth 4.0 BLE RF Modulation GFSK Effective Radiated Power 0dBm Data Throughput 0.2Mbps Expected Delay (Latency Range) in Wireless (RF) Communication The latency time is less than 0.3ms from sender to receiver. Integrity Channel Quality-Driven Data Rate (CQDDR) technology increases the effective data rate and integrity in noisy environments. Security AES-128 and application layer user defined Wireless Operation Distance RF Frequency / Need for Spectrum Management Class 2 (Maximum: 10 meter) 2402 - 2480 MHz (allowing for guard bands) Maximum Limitation Unlimited Maximum Permitted Power 2.5 mW Proximity of Other In-band up to 40 bands (2 MHz spacing; centered Transmitters Used in from 2402 to 2480 MHz) Vicinity Wireless Communication Profile Wireless Coexistence GATT – Client and Server Support for 802.11 Coexistence System requirement of the Android 4.3 or above, iPhone 4S or above Bluetooth device 33 Note Follow instructions for use. BF Classification: - The applied part is cuff - Internally powered equipment - BF type applied part - IP22 - Not suitable for use in presence of flammable anesthetic mixture with air or with Oxygen or nitrous oxide - Continuous operation with short-time loading To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipments, do not use the device near a mobile phone or microwave oven.At least keep a maximum output power of 2 W yields and adistance 3.3m away from this equipment. Discard the used product to the recycling collection point according to local regulations. Manufacturer: HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan. www.healthandlife.com.tw 34 Note *Note! This equipment has been tested and found to comply with the limits for a Class Bdigital device, pursuant to Part 15 of the FCC Rules. These limits are designed toprovide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if notinstalled and usedin accordance with the instructions, may cause harmful interferenceto radio communications. However, there is no guarantee thatinterference will not occur in a particular installation. If this equipment does causeharmful interference to radio or television reception, which can be determined byturning the equipment off and on, the user is encouraged to try to correct theinterference by one or more of the following measures: The user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and the receiver. Connect the equipment into an outlet on a circuit different from that to which thereceiver is connected. Consult the dealer or an experienced radio/TV technician for help. CAUTION: To assure continued FCC compliance: 1. Any changes or modifications not expressly approved by the grantee of this devicecould void the user's authority to operate the equipment. 2. This equipment complies with FCC radiation exposure limits set forth for anuncontrolled environment. This equipment should be installed and operated withminimum distance 20cm between the radiator & your body. FCC Label Compliance Statement: This device complies with Part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) this device may not cause harmful interference, and (2)this device must accept any interference received, including interference that may cause undesired operation. *Note! “Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment”. Essential Performance compliance criteria: HL858CB essential performance compliance criteria of IEC 60601-1-2 forimmunity testing: The following degradations that associated with basic safety and essentialperformance should not be allowed. - Component failure; -Change in programmable parameters; -Reset to factory default and the unintended default would interfere withdiagnosis, treatment, or monitoring; False alarm; -Initiation of any unintended operation, including unintended oruncontrolled motion, even if accompanied by an alarm; -Error of a display numerical value sufficiently large to affect diagnosisor treatment or monitoring. -Noise on a waveform in which the noise would interfere with diagnosis ortreatment or monitoring. 35 Appendix Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments: Emissions test RF emissions CISPR 11 Compliance Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Class B Class A Complies Electromagnetic environment – guidance RF energy is used only to maintain device’s operation. Therefore, its RF emissions are so low that it’s not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments: Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601 test level ± 6 kV contact ± 6 kV contact ± 8 kV air ± 3 A/m 30 A/m ± 2 kV for power supply lines ± 2 kV for power supply lines ± 1 kV for input/output lines ± 1 kV line(s) to line(s) ± 1 kV for input/output lines ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth ± 2 kV line(s) to earth <5 % UT (>95 % dip in UT) for 0,5 cycle <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 5 sec Compliance level Electromagnetic environment – guidance The relative humidity should be at least 5 %. 15 kV air 36 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Recommended separation distance I r = ──── (m) 188 whereI is the current in amperes in a power bus or an appliance wire and r is the recommended separation distance between your device and the power bus or appliance wire, in meters (m). Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Appendix Recommended separation distances between portable and mobile RF communication equipment and the device. The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter: Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.1 1 10 100 d = 1.2 d = 1.2 d = 2.3 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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. Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments: Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz Recommended separation distance 6Vrms d = 1.2 3 V/m d = 1.2 d = 2.3 80 MHz to 800 MHz 800 MHz to 2.5 GHz whereP is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,ashould 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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 37 Blood Pressure Diary Date: □Before □After Time: Systolic / Diastolic: Date: Pulse: □Before □After Time: Systolic / Diastolic: Date: □Before □After Time: □Before □After Time: □Before □After Time: □Before □After Time: □Before □After Time: □Before □After Time: □Before □After Time: Meal Pulse: □Before □After Time: Systolic / Diastolic: P/N:XXXXXXXXX Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Pulse: Systolic / Diastolic: Date: Meal Meal Pulse: VER:A001 38 YYYYMMDD
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