Microlife WatchBP Home A Navigation Manual
Contents
1. Accurate home blood pressure measurements with the WatchBP home A Instruction Manual microlife Microlife WatchBP Home A is the world s first digital blood pressure measurement device that strictly follows European Society of Hypertension ESH and American Heart Association AHA recommendations for home blood pressure measurement Using the WatchBP Home A device helps you collect accurate home blood pressure measurements your doctor can trust This WatchBP Home A device has been clinically validated according to the ESH protocol O Brien E Asmar R Beilin L Imai Y et al European Society of Hypertension recommendations for conventional ambulatory and home blood pressure measurement European Society of Hypertension Working Group on Blood Pressure Monitoring J Hypertens 2003 21 821 848 Stergiou GS et al A tool for reliable self home blood pressure monitoring designed according to the European Society of Hypertension recommendations The Microlife WatchBP Home monitor Blood press Monit 2007 12 127 131 3 Stergiou GS Giovas PP Gkinos CP Patouras JD Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to The International Protocol Blood Press Monit 2007 12 3 185 188 microlife Table of Contents Before using WatchBP Home A for the first time Product description aicccccsscamasmeneseterarcqueeuioues 6 7 Activating the device ti ste csccisesersnc2. Store the USUAL mode data Click Download Usual Mode Data the file name is formed automatically from the patient s identity number and the suffix Umode xls Print the data sheet Click Print Delete the memories Click Clear Memory Close the program Click Exit Please store the data before using Clear Memory or Exit Batteries and power adaptor Battery indicator When the batteries have 1 4 power supply left the Battery Symbol will flash each time the device is switched on USUAL cs PM reer ma BEATE Log o DT Dl al N CU iw Ei Replacing low batteries When the batteries need to be replaced the Battery Symbol will flash each time the device is switched on 1 Open the battery compartment at the back of the device 2 Replace the batteries ensure correct polarity as shown by the symbols in the compartment Use 4 new long life 1 5V size AA batteries Do not use batteries beyond their date of expiry Remove batteries if the device will not be used for a prolonged period 28 microlife WatchBP home ony S Using a power adaptor The WatchBP Home A device can also be operated using a Microlife power adaptor DC 6V 600mA Only use Microlife branded power adaptors 1 Plug the adaptor cable into the Power Plug in the WatchBP Home A device 2 Plug the adaptor plug into the wall socket When the power adaptor
3. United States Microlife Medical Home Solutions Inc 2801 Youngfield St Suite 241 Golden CO 80401 USA Tel 1 303 274 2277 Fax 1 303 274 2244 Email watchbp mimhs com www watchbp com C 0 044 NM 04 pH the instructions carefully before using this device microlife Canada Central South America Microlife USA Inc 1617 Gulf To Bay Blvd 2nd Floor Clearwater FL 33755 USA Tel 1 727 442 5353 Fax 1 727 442 5377 Email msa microlifeusa com www watchbp com IB WatchBP Home A 3MX1 3 EN 121211
4. Compartment Mode Switch p ay Power Socket M Button Memory 6 microlife WatchBP home Mode Indication Morning Data Doctor Symbol Evening Data Atrial Fibrillation Detection Date Time Outside Measurement Time Systolic Value Diastolic Value Battery Display Delete Memory Data Pulse Indicator Stored Value Pulse Rate Number of Stored Data Before using WatchBP Home A for the first time Activating the Device Pull out the protective strip from the battery compartment 1 Set the year Upon removing the protective strip or installing new batteries the Year number flashes in the display Use the M Button to select the Year Press the ON OFF Button to confirm your selection Press M Button to make selection Press ON OFF Button to confirm BEEPS 2 Set the month Press the M Button to set the Month Press the ON OFF Button to confirm Sosa p 0 3 Set the day Press the M Button to set the Day Press the ON OFF Button to confirm Saas 8 microlife 4 Set the time Once you have set the Hour and Minutes and pressed the ON OFF Button the date and time are set and the current time is displayed D D cpi J S IN C3 I eu MIZ MIZ aT eg ble i iy a x JE A i SORE b e 5 If you want to change the date and time take out one battery from the battery compartment briefly and put it back The Year number
5. the individual readings of the day In USUAL Mode 1 When the M Button is pressed the number of readings with Afib detected is displayed 2 Press M Button again the number of total readings stored e g N 63 is displayed followed immediately by the average of all measurements stored in memory or USUAL T M A ma M t g Ls WatchBP homem rI a l gt 0 1 AUS aa 3 All individual readings can be viewed by repeatedly pressing the M Button Individual Reading me ot a Ba Viewing deleting and transferring measurements cont Deleting measurements Before deleting data be sure to ask your doctor if the measurement data is still required Only delete the stored Data from DIAG and USUAL can be deleted measurements when you are sure that you no longer need independent of each other the data ft ft DIAG Em y e y 24 microlife 1 Use the Mode switch to select the mode of measurements you want to delete hi of j GIS E 2 Press the M Button and hold it for 7 seconds until the delete symbol flashes Press and hold for 7 seconds WatchBP home 3 Release the M Button and press it once more while the delete symbol flashes The deleting is confirmed by the beep sound sus Only measurements in the selected mode will be deleted Viewing deleting and transferring measurements cont Tr
6. IAG mode Sit upright and lean comfortably against the chair s One measurement cycle includes two measurements backrest Press the start button The device will Once the first measurement is complete continue to initiate a 60 second countdown in DIAG mode or a relax as you wait for the second measurement The 15 second countdown in USUAL mode During the second measurement will start after 60 seconds During measurement do not move cross your legs or tense this time avoid any movement your arm muscles Breath normally and do not talk HT Gs T r WatchBP home 1 4 2 hy e 16 microlife Step 7 in DIAG mode Once the two readings are complete measurement data is automatically stored for future reference by your doctor If an error displays after the readings please repeat the first six steps once again SYS mmHg DIA mmHg Pulse Automatically stored WatchBP homem Step 8 in DIAG mode When seven days of measurements have been collected the Doctor Symbol will flash on the display Do not forget to take your WatchBP Home A device with you on your next visit to the doctor Note the doctor symbol is only displayed for measurements in DIAG Mode Q Special Function Atrial fibrillation detection This device is designed to screen for atrial fibrillation during blood pressure measurements both in USUAL Mode and DIAG Mode If atrial fibri
7. ansferring measurements Installation of the software program 1 Put the CD in the CD ROM drive of your computer Alternatively click on setup exe in the CD s directory 2 Follow the instructions provided in the installation window on the computer screen 3 When the installation is finished be sure to restart the computer before a the program System Requirements 550MHz CPU re A 256MB Memory 1024x768 pixel tweens resolution 256 color CD ROM drive O 1 free USB port 40MB free hard disk i 8 space Microsoft Windows XP Vista J Win7 f Or download the latest version from http www watchbp com Transferring data to the computer 1 Start the software program and connect the device to the computer using the cable supplied 2 A successful connection is displayed by Connected on the computer screen 3 Enter name identity number if required and date of birth to create a new record 26 microlife WatchBP home Software commands Refer to the software user manual for detailed information and instructions Transfer DIAG mode data Click Download Corresponding value You can remove the check mark and the corresponding value will not be used to calculate the average Store data Click Save the file name is formed automatically from the patient s identity number and the suffix Dmode xls View the data Click Patient Files
8. atrial fibrillation is detected by the device at home we suggest another reading done in the doctor s office If the atrial fibrillation icon is not displayed then the previous abnormal readings may have been due to transient atrial fibrillation If the atrial fibrillation icon is displayed then EKG performance is suggested for determining the exact rhythm abnormality 21 Viewing deleting and transferring measurements Viewing measurements 1 Use the Mode switch to first select the type of measurements you wish to view 2 Then press the M Button In DIAG Mode rt oo OLA A is displayed when the number shown is 1 When the M Button is pressed it briefly displays the total number of measurements stored e g N 20 and then switches to the average of all readings A Mee 0 q Bey a Dey Lima Z 1 2 ros p al the average of all data Cp vs l7 will display when the number of measurements is less than 12 a a S 22 microlife 2 Press the M Button again to display the average of all morning data Press the M Button once again to show the average of all evening data zo d ma A TES o Pt oa T PT ose D io Z gm pag D 0s Pe Pe v Oo 3 Press the M Button repeatedly to review all the individual readings one by one 4 The daily average is displayed after
9. encerseeeuensatecssrbaaneretaaarsl 8 Selecting the correct cuff seri snassiocctusrvarnctacuocescesievinaauenete 9 Taking measurements using WatchBP Home A XDIAG MOG x ocsuassacsnsensentednencesendeancaveaniaunarnnennesadt 10 12 cd USS 7 De 91 2a ee a en 13 Eight steps for measure blood pressure properly Blood pressure measurement procedures 14 17 Special Function Atrial Fibrillation Detection ccccccccccccccecsceeeeeeeeeeees 18 About Atrial Fibrillation cccccccccccscccccccceceeeeeeeeeeeenes 19 Atrial Fibrillation Detector cccccccccccccccceceeeeeseeeeeeees 20 WatchBP home Atrial fibrillation detection instructions 00 21 Information for the GOCtOF cccceeeessssscccccccecceeeeeee 21 Viewing deleting and transferring measurements VIEWING measurements rscasssvacsaceneaceenenconveenseraance 22 25 Deleting Measurements cceeeeseeseeeteeeeeteeees 24 25 Transferring measurements ceesesseeeeeeeeteesees 26 27 Appendix Batteries and power adaptor ou cceeeeeeeeeeees 28 29 Safety care accuracy test and disposal 30 31 ENOT MESSIOS cerisa R niaaa EAE 32 33 important facis acesceceosaescecsenedssrenrcecsateneeanenanns 34 35 Technical specifications socsncndessessecsaossszonsentessatiacstncsnecces 36 WatchEP homea microlife WatchBP WatchBP home Serial Port n o OFF Button Battery
10. es if necessary per minute Relax for 5 Repeat the measurement minutes and repeat the measurement Er 5 Abnormal The measuring signals are result inaccurate and no result LO Pulse too The pulse is too low less can therefore be displayed low than 40 beats per minute Read through the checklist Repeat the measurement for performing reliable measurements and then repeat the measurement Important facts about blood pressure and home measurements Are home blood pressure measurements valuable Yes The American Heart Association and European Society of Hypertension have demonstrated that home blood pressure measurements are important in determining accurate blood pressure e Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart Two data readings the systolic upper value and the diastolic lower value are always measured e The pulse rate is the number of times the heart beats in a minute e Permanent high blood pressure can damage your health and therefore must be treated e Always discuss your home blood pressure measurement data with your doctor and tell him her if you have noticed anything unusual or feel unsure Never rely on single blood pressure readings e There are many causes of excessively high blood pressure Your doctor will explain them in more detail and offer treatment when appropriate e Blood pressure is subject to wide
11. fluctuations as the day progresses and can be impacted by emotions physical exertion and other conditions 34 microlife Evaluating blood pressure data The table on the right classifies blood pressure data for adults in accordance to the guidelines of the European Society of Hypertension ESH Data in mmHg The higher value is the one that determines the evaluation Example a readout value between 150 85 or 120 98 mmHg indicates Grade 1 Hypertension WatchBP home Category Systolic Diastolic Optimal lt 120 lt 80 Normal 120 129 80 84 High normal 130 139 85 89 Grade 1 Hypertension 140 159 90 99 Grade 2 Hypertension 160 179 100 109 Grade 3 Hypertension gt 180 gt 110 Isolated Systolic gt 140 lt 90 Hypertension Technical specifications Operating temp Storage temp Weight Dimensions Measuring procedure Method Measurement range Cuff pressure display Voltage source Microlife reserves the right to alter technical specifications without prior written notice 10 to 40 C 50 to 104 F 20 to 50 C 4 to 131 F 15 90 relative maximum humidity 385 g including batteries 150 x 100 x 50 mm Oscillometric corresponding to Korotkoff Phase I systolic Phase V diastolic 30 280 mmHg blood pressure 40 200 beats per minute pulse Range 0 299 mmHg Resolution 1 mmHg Static accuracy pressure
12. ife to arrange for an accuracy test WatchBP home Cuff care DO NOT wash the cuff DO NOT iron the cuff cover Yes dDo not wash the cuff A Do not iron the cuff Disposal Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations and not as domestic waste 31 EE Error messages If an error occurs during measurement the measurement is interrupted and an error message Er is displayed a ep gt mm A ah S USUAL DIAG HECHE d e Please consult microlife if ae a this or any other problem ba J occurs repeatedly y e Ifyou think the results are rae unusual please read through the information in this instruction manual carefully Error Description Potential cause and remedy Er1 Signal too The pulse signals on the cuff weak are too weak Re position the cuff and repeat the measurement Er 2 Errorsignal During the measurement error signals were detected by the cuff caused for instance by movement or muscle tension Repeat the measurement keeping your arm still 32 microlife WatchBP home Er 3 Nopressure An adequate pressure HI Pulse or cuff The pressure in the cuff in the cuff cannot be generated in pressure too is too high over 300 the cuff A leak may have high mmHg OR the pulse is occurred Replace the too high over 200 beats batteri
13. is connected no battery power is consumed Safety care accuracy test and disposal Safety and protection Observe the storage and operating conditions described This device may be used only for the purpose described in the Technical specifications section of this manual in this booklet The device comprises of sensitive components and must be treated with caution The A Protect the device from water and moisture manufacturer cannot be held liable for damage caused by incorrect application Protect the device from direct sunlight Protect the device from extreme heat and cold A Ensure that children do not use the device unsupervised Avoid proximity to electromagnetic fields such as those produced by mobile phones Only activate the pump when cuff is installed Donotuse the device if you think it is damaged or if anything appears unusual eit some parts are small enough to be swallowed Never open device TOT eee Protect device from impact and drops e Read the further safety instructions in the individual P P sections of the instruction manual Do not connect the device to a computer until prompted to do so by the computer software 30 microlife Device care Clean the device with a soft dry cloth Accuracy test We recommend the WatchBP Home A device be tested for accuracy every 2 years or after mechanical impact e g being dropped Please contact Microl
14. llation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode the Afib icon is displayed If the Afib icon is displayed after a blood pressure measurement follow the instructions on page Zi Joseph Wiesel et al Detection of Atrial Fibrillation Using a Modified Microlife Blood Pressure Monitor American Journal of Hypertension 2009 22 8 848 852 aq ZJ ee x om Z R e g 7 gt m a om E wr at m T Tar om See TLN mC JE Atrial fibrillation a major cause of stroke can be detected by this device However not all risk factors for stroke including atrial flutter may be detected by this device This device may not detect atrial fibrillation in people with pacemakers or defibrillators People with pacemakers or defibrillators should therefore not use this device to detect atrial fibrillation 18 microlife WatchBP homem About Atrial Fibrillation Atrial fibrillation is a common heart rhythm problem A doctor can confirm the presence of atrial and a common cause of major strokes It affects more fibrillation by using an EKG Atrial fibrillation can than 2 million people in North America It is more sometimes come and go So a doctor may not see it common with older age and found in 10 of people on regularly scheduled visits over 80 years old About 20 of all strokes are caused One sign of atrial fibrilla
15. n might be present In sucha case it is still recommended to pay a visit to the doctor For people with pacemakers or defibrillators it is not recommended to use the WatchBP Home A Measurement If atrial fibrillation is detected during all readings of the triple measurements in USUAL Mode or all four readings of one day in DIAG Mode then atrial fibrillation is most likely present Since atrial fibrillation sometimes lasts for only a few minutes It is recommended to perform another measurement session one hour later If this also shows the presence of atrial fibrillation then a doctor should be seen It is recommended to take the device when visiting the doctor 20 microlife Atrial fibrillation detection instructions e Use this device regularly once per week or once per month to screen for atrial fibrillation e If atrial fibrillation is detected during all readings of the triple measurements another measurement session should be done approximately one hour later e If this last reading shows atrial fibrillation contact your doctor e Take this device with you when you see the doctor WatchBP homem Information for the doctor This device is designed to detect atrial fibrillation and false negative readings are very rare Though it is programmed to specifically detect atrial fibrillation frequent premature beats marked sinus arrhythmia or other rhythm abnormalities might cause false positive readings If
16. nts safely stored The WatchBP Home A device can store up to 250 averaged measurement readings in USUAL mode 250 Measurements When memory is full each new reading will automatically overwrite the earliest measurement To review the last three individual measurements press and hold the M button until a 1 is displayed on the screen The values of the last three individual measurements are displayed sequentially 3 GH Eight steps for measure blood pressure properly Step 1 Step 2 Avoid taking measurements directly after eating Prepare a chair and table for the measurement The drinking or smoking Allow at least one hour between chair should have a vertical back rest and the table these activities and measurement of your blood pressure should allow your upper arm to rest at the same height a as your heart N KS LL m TT 1 Hour Before 14 microlife Step 3 Remove all clothing covering or constricting the arm to be measured Apply the cuff Make sure the lower edge of the cuff is exactly 2 3cm from the inner fold of your arm The tube connecting the cuff to the device should be placed on the inside of the arm Additional visual instruction can be found on the cuff WatchBP home Step 4 Sit down and relax for at least five minutes prior to the measurement oF Relax 5 mins Eight steps for measure blood pressure properly cont Step 5 Step 6 in D
17. tion is palpitations But by atrial fibrillation The elderly or those with high blood many people don t feel anything These people can pressure diabetes or heart disease are more likely to get still get a stroke and should be checked for atrial a stroke if they have atrial fibrillation fibrillation regularly Finding atrial fibrillation earlier Atrial fibrillation is a rhythm problem that can last from and followed by treatment can lower the chances of a few minutes to days or weeks and even years Atrial getting a stroke fibrillation can lead to the formation of blood clots in the upper chambers of the heart the atria These clots can break off and flow to the brain causing stroke The use of blood thinners such as warfarin can lower the risk of stroke in patients with atrial fibrillation Atrial Fibrillation Detector The WatchBP home can screen for atrial fibrillation during blood pressure measurement Some people may have atrial fibrillation occasionally that lasts longer than a day In this situation the WatchBP Home A allows frequent screening on multiple days for optimal diagnosis of atrial fibrillation Sometimes the device might falsely detect atrial fibrillation which can have two causes 1 The arm has moved during blood pressure measurement For this reason it is of essential importance that the arm is kept still during the measurement 2 Some other arrhythmia irregular heart beat than atrial fibrillatio
18. will flash Complete the process as described above WatchBP home Selecting the correct cuff The WatchBP Home A device is available with different cuff sizes If the cuff provided with the device is an unsuitable size please consult your doctor please use only Microlife cuffs M Medium size 22 32 cm 8 7 12 6 inches Mis the correct size for most people L Large size 32 42 cm 12 6 16 5 inches 1 Taking measurements using WatchBP Home A Prior to each measurement use the Mode Switchonthe DIAG Mode The DIAG mode should be selected as requested right side of the device to select the proper measurement mode The two options include by your doctor when blood pressure is measured in DIAG Diagnostic or USUAL Usual mode accordance with the measurement guidelines of the European Society of Hypertension ESH Protocol Embedded e 3 Ss SS 10 microlife No measurements on non work days In DIAG mode blood pressure measurements are taken on 7 consecutive working days or normal week days No readings should be taken on non working days or particularly relaxing days in this mode ays z y WatchBP homem Two sets of measurements per day ESH guidelines recommend one double measurement taken in the morning between 06 00 09 00 and one in the evening between 18 00 21 00 Always perform measurements before taking
19. within 3 mmHg Pulse accuracy 5 of the readout value 4x 1 5 V Batteries size AA Mains adapter DC 6V 600 mA optional Reference to standards Electromagnetic compatibility C 0044 Type BF applied part SN Serial number Device standard Device corresponds to the requirements of the standard for noninvasive blood pressure monitor EN 1060 1 EN 1060 3 EN 1060 4 IEC 60601 1 IEC 60601 1 2 Device fulfills the stipulations of the standard IEC 60601 1 2 The stipulations of the EU Directive 93 42 EEC for Medical Devices Class Ila have been fulfilled Reference number aal Manufacturer 36 microlife Guarantee card This device is covered by a five year guarantee from the date of purchase This guarantee is valid only on presentation of the guarantee card completed by the owner confirming date of purchase or purchase receipt Batteries cuff and wearing parts are not covered by this guarantee Product WatchBP Home A Product Number BP 3MX1 3 Date WatchBP home Name Address Date Telephone Email Europe Middle East Africa Microlife WatchBP AG Espenstrasse 139 9443 Widnau Switzerland Tel 41 71 727 7000 Fax 41 717277011 Email watchbp microlife ch www watchbp com Asia Microlife Corporation 9F 431 RuiGang Road NeiHu Taipei 114 Taiwan R O C Tel 886 2 8797 1288 Fax 886 2 8797 1283 Email watchbp microlife com tw www watchbp com
20. your medication unless otherwise directed by your doctor SOE X1 06 00 09 00 ESH Guidelines 1 Taking measurements using WatchBP Home A cont Extended measurement period WatchBP Home A has an extended measurement period and allows morning measurements between 04 00 12 00 and evening measurements between 18 00 24 00 LAL N USUAL aoe f 2Ex1 DIAG TERETE fy An aa ne wy 0 f _04 00 12 00__ T i Ti 2 Peh L DT N m al Extended Time w H Outside these times measurements cannot be taken and the symbol on the right will be displayed on the screen Evaluation After measurements have been carried out for a total of 7 working days take the device to your doctor for evaluation of your home blood pressure data Q Ea e 2 When measurements Mm have been carried out for the full 7 days the doctor symbol will flash on the screen gt F a 5 vos T RK e jao a Jaa Nata bm tl Z TAY Ww poa mm r han onl 12 microlife USUAL Mode The USUAL mode is selected for regular blood pressure measurement with Afib detection In USUAL mode three consecutive measurements are taken automatically at 15 second intervals The results are averaged and displayed The averaged readings are automatically stored for later evaluation by your doctor ji G G C 15 sec 15 sec 15 sec WatchBP homem 250 measureme
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