Microlife WatchB Home T. Instruction Manual Download Page 43 | Manualshive

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43

EN

Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME
SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The WatchBP Home T(BP3MX1-3T) is intended for use in the electromagnetic environment specified

below. The customer or the user of the WatchBP Home T(BP3MX1-3T) should assure that it is used

in such an environment.

Immunity test IEC 60601

Compliance Electromagnetic environment - guidance

test level

level

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Summary of Contents for WatchB Home T.

Page 1: ...Accu mea with Instruc EN rate home b surements the WatchB ction Manual 3 blood pressur P Home T re ...

Page 2: ...n radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is...

Page 3: ...tolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 42 cm by using a non invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm The memory data can be transferred to the PC personal computer running the WatchBP Analyzer Home software by connecting the monitor via cable The device can also be ...

Page 4: ...l Function Atrial Fibrillation Detection 17 About Atrial Fibrillation 18 Atrial Fibrillation Detector 19 Atrial fibrillationdetection instructions 20 Information forthe doctor 20 Viewing deleting and transferring measurements Viewing measurements 21 22 Deleting measurements 23 24 Installation of the software program 25 Bluetooth connectivity 26 27 Batteries andpower adaptor 29 30 Safety care accur...

Page 5: ...5 EN USUAL DIAG NOCTURNAL Bluetooth symbol SYS mmHg DIA mmHg PUL min Serial Port Mode Switch PowerSocket Display ON OFF Button M Button Memory Battery Compartment Cuff Socket ...

Page 6: ... Symbo Fibrillation Detectio e Measurement Tim Rela Battery Displa Delete Memory Da Stored Valu n ol on me ax ay ta ue Morning Data Evening Data Date Time Systolic Value Diastolic Value Pulse Indicator Pulse Rate Number of Sto EN e r ored Data ...

Page 7: ...he M Button to se Button to confirm you BP Home T f battery protective strip or number flashes in elect the Year Press ur selection for the first 2 Set the month Press the ON O 3 Set the day Pr Press the ON OF time Press M Butto Press ON O Press the M Button OFF Button to confirm ess the M Button to se FF Button to confirm 7 EN ton to make selection OFF Button to confirm to set the Month et the Da...

Page 8: ...bed above the Hour and utton the date and displayed time take out one ment briefly and sh Complete the Selecting the The WatchBP Hom cuffsizes Ifthe cu unsuitable size p please use only M M Med 22 32 M is the L Large 32 42 correct cuff me T device is availab ff provided with the d lease consult your do Microlife cuffs diumsize cm 8 7 12 6 inche correct size for most pe e size cm 12 6 16 5 inch ble...

Page 9: ...ions include nostic or USUAL U nts using Wa Mode Switch on the proper measurement Usual mode USUAL atchBP Hom t DIAG Mode The DIAG mod by your doctor wh accordance with t European Society DI me T e e should be selected hen blood pressure is he measurement gui of Hypertension ESH IAG 9 EN as requested s measured in delines of the H ...

Page 10: ... 0 7 ays surements are ays or normal aken on relaxing days working ays Two sets of measu ESH guidelines reco taken in the mornin the evening betwee measurements be unless otherwise d E urements per day ommend one double ng between 06 00 09 en 18 00 21 00 Alw efore taking your m directed by your doc ESH Guidelines X1 06 00 09 00 X1 18 00 21 00 e measurement 9 00 and one in ways perform medication c...

Page 11: ...een me e times measuremen e symbol on the right w chBP Home T cont measurement period between04 00 12 00 n18 00 24 00 nts cannot be will be displayed d 0 Evaluation After measurem of 7 working da evaluation of y ments have been carr ays take the device to your home blood pres When have for th docto flash 11 EN ried out for a total o your doctor for sure data n measurements e been carried out he fu...

Page 12: ...ed and if at ib icon is displayed T ored for later evaluat USUAL egular blood ection In USUAL he results of the rial fibrillation is The readings are tion by your 2 M 250 measuremen The WatchBP Home measurement read When memory is fu overwrite the earlie 250 Measurements ts safely stored e T device can store up ings in USUAL mod ull each new reading wi iest measurement p to 250 de will automatical...

Page 13: ... least andmeasurement of 1 Hour Before sure blood p y after eating one hour between fyour blood pressure pressure pro Step 2 Prepare a chair an chair should have should allow your as yourheart operly nd table for the mea e a vertical back rest upper arm to rest at t 13 EN surement The and the table the same height ...

Page 14: ...an be ing covering or constr ply the cuff Make sur ctly 2 3cm from the in nnecting the cuff to th e inside of the arm A be found on the cuff ricting the arm to re the lower edge nner fold of your he device should Additional visual Step 4 Sit down and relax measurement x for at least five minu utes prior to the ...

Page 15: ...oss yo es Breath normally a essure properly co ainst the chair s e device will DIAG mode or a mode During the our legs or tense and do not talk nt Step 6 in DIA One measuremen Once the first mea relax as you wait second measurem this time avoid any 1 AG mode nt cycle includes two asurement is comple for the second meas ment will start after 60 y movement 60 sec 15 EN measurements ete continue to s...

Page 16: ...ps once again utomatically stored measurement reference by your eadings please d Step 8 in DIA Whenseven days o the Doctor Symbol to take your Watch next visit to the do displayed for meas AG mode of measurements hav will flash on the disp hBP Home T device w ctor Note the docto asurements in DIAG ve been collected lay Do not forget with you on your or symbol is only Mode ...

Page 17: ...nal of Hypertension 20 atrial fibrillation ts ng blood on is al Fibrillation Using a onitor 009 22 8 848 852 Atrialfibrillation a this device Howev atrial flutter may This device may no pacemakers or de defibrillatorsshou atrial fibrillation a major cause of stroke c ever not all risk factors fo y be detected by this de not detect atrial fibrillatio efibrillators People with uld therefore not use ...

Page 18: ...rs can lo rhythm problem es It affects more ica It is more of people over es are caused by e with high blood are more likely to ation m that can last ks and even years mation of blood eart the low to the brain nners such as ower the risk of stroke in patie A doctor can co fibrillation by u sometimes com it on regularly One sign of atr many people d still get a strok episode of atri increased risk ...

Page 19: ...ation If the device detects atrial fibrillation in someone who is not on a blood thinner that person should contact their doctor to determine if they need to be on a blood thinner Sometimes the device might detect atrial fibrillation when it is not there This is usually caused by other rhythm abnormalities Occasionally the device might not detect atrial fibrillation even when it is there On a repe...

Page 20: ... appropriate eva instructions rack of the t risk of stroke ticoagulation omeone who is n should be aluation and Information This device is de patients previous Though it is prog fibrillation frequ arrhythmia or ot false positive rea occur infrequent for the doctor signed to detect atri sly diagnosed with a grammed to specifica uent premature beats her rhythm abnorma adings False negativ ly al fibr...

Page 21: ...rr the type of USUAL ring measur In DIAG Mode 1 When the M But total number of then switches to A is displaye the number sh the average of rements e tton is pressed it brie f measurements store o the average of all re ed when hown is f all data w numbe is less 21 EN efly displays the ed e g N 20 and eadings will display when the ber of measurements s than 12 ...

Page 22: ...e day the average of all once again to show view all the the individual In USUAL Mode 1 When the M Butt detected with Af 2 Press M Button a stored e g N 63 by the average of 3 All individual rea pressing the M Bu on is pressed the num ib are displayed again the number of 3 is displayed followe f all measurements st dings can be viewed utton Individual Reading mber of readings f total readings ed i...

Page 23: ...ta from DIA independent of DIA tingandtransfering easurements AG and USUAL can f each other G measurements con n be deleted USUAL nt Only delete the that you no long e stored measurements nger need the data 23 EN when you are sure ...

Page 24: ... you want to delete tton and hold it for 7 s mbol flashes ess and hold for 7 s mode of 3 seconds until econds USUAL Release the M Butto Delete symbol flashe beep sound Only measurements in n and press it once m es The deleting is con in the selected mode w ore while the nfirmed by the will be deleted ...

Page 25: ...are is available from the Microlife website https www microlife com support softwareprofessional products Double click the download installer and simply follow the instructions provided in the installation window on the PC screen System Requirements for Software 1GHz CPU 512MB Memory 4 5GBfreeharddiskspace MicrosoftWindows7 SP1 8 10 ...

Page 26: ...ce to a PC See instruction m data to the com are program and conn using the cable suppli ime on the device a ith the date and time nnectedwithWatchB ad button in the Wat er the measurement d manual of the WatchBP A mputer nect the device to ed utomatically on the PC when BPAnalyzerHomePC tchBP Analyzer data on the Analyzer Home for deta tails ...

Page 27: ...y SYS mmHg DIA mmHg PUL min Press and hold the M 6 digit device ID of th WatchBP Home app Click Sync data icon The measurement data automatically when th WatchBP Home A iPhone 6 or above r running Android 8 S g A g L button for around 5 sec e unit is displayed Ope on your smartphone Go n Connect the device an a on the device will uplo he connection is establi App Compatibility running iOS 12 0 or ...

Page 28: ...etooth Bonding button of the devic again Bluetooth is not act device is recording d will not sound any a Bluetooth is used on USUAL DIAG NOCTURNAL onnection keeps failing p gby pressingand holding ice for 7 seconds and star tive when the blood pre data The blood pressu alarm with or without B nly to transfer data from SYS mmHg DIA mmHg PUL min please reset the ngthe Start Stop art the connection r...

Page 29: ... on 1 Open the batter the device 2 Replace the bat shown by the sy Use 4 new 1 5V s Do not use batter Remove batteries prolonged period w batteries es need to be replac ill flash each time the ry compartment at th teries ensure correc ymbols in the compar size AA alkaline batterie ries beyond their date of es if the device will not b d 29 EN ed the e device is e back of ct polarity as rtment es of...

Page 30: ...sumed Externalpoweradap requirements of IEC 6 er adaptor me T device can also b power adaptor DC 6V ife branded power adap or cable into the Pow e T device tor plug into the wal ptor is connected no ptor shall be fulfilled in compl C 60601 1 2005 be operated V 600mA ptors er Plug in the l socket When battery power is liance with the ...

Page 31: ...mum distance of 3 3m from such devices when using this unit Never open device Protect device from impact and drops Protected against solid foreign objects of 12 5 mm diameter and greater Protected against the ingress of vertically falling water drops with the device positioned on a turntable Protectthedevicefromwaterandmoisture Protect the device from direct sunlight Protect the device from extrem...

Page 32: ...15 luted 1 500 provides chlorine t the WatchBP Home T acy every 2 years or a g dropped Please co curacy test W i T device be after mechanical ontact Microlife to Cuff cleaning DO NOT wash the cu Wipe the cuff with 7 immerse hose Allow Disposal Batteries and elec disposed of in acco regulations and n and disinfecting ff DO NOT iron the c 0 ethyl or isopropy w to air dry thorough ctronic instruments...

Page 33: ...lts are unusual please read through the information in this instruction manual carefully Error Description Potential cause and remedy Er 1 Signal too weak The pulse signals on the cuff are too weak Re position the cuff and repeat the measurement Er 2 Error signal During the measurement error signals were detected by the cuff caused for instance by movement or muscle tension Repeat the measurement ...

Page 34: ...place the f necessary e measurement uring signals are e and no result fore be displayed ugh the checklist ming reliable ments and then e measurement HI Pulse o pressur high LO Pulse to low r cuff re too The pressure is too high o mmHg OR t too high ov per minute minutes and measuremen oo The pulse is than 40 beat Repeat the m e in the cuff over 300 the pulse is er 200 beats Relax for 5 d repeat th...

Page 35: ...pressure Your and offer treatm Blood pressure i day progresses physical exertio home meas r value are always s the number of time ghbloodpressureca refore must be treat your home blood pre data with your doctor iced anything unusua single blood pressu causes of excessively doctor will explain th ment when appropria s subject to wide fluc and can be impacted n and other condition 35 EN surements me...

Page 36: ...ESH Data in e is the one that dete mple a readout value g indicates Grade 1 pressure data for s of the European n mmHg ermines the between150 85 Hypertension Category Optimal Normal High normal Grade 1 Hyperten Grade 2 Hyperten Grade 3 Hyperten lsolated Systolic Hypertension Systolic 120 120 12 130 13 sion 140 15 sion 160 17 sion 180 140 Diastolic 80 9 80 84 9 85 89 9 90 99 79 100 109 110 90 ...

Page 37: ...ons of the standard Measuring procedure Oscillometric corresponding to Korotkoff compatibility Expected service IEC 60601 1 2 5 years or 10 000 measurements batteries Method Phase I systolic Phase V diastolic life and cuff are not included Measurement range Cuff pressure display 30 280 mmHg blood pressure 40 200 beats per minute pulse Range 0 299 mmHg Resolution 1mmHg Static accuracy pressure with...

Page 38: ...this ecard Model W ERP Mode Date overedbyafive year chase This guarantee of the guarantee card firming date of purcha ies cuff and wearing s guarantee WatchBP Home T el Number BP3MX1 3 guaranteefrom e is valid only on d completed by ase or purchase g parts are not Name Address 3T Date Telephone Email ...

Page 39: ...39 EN Distributed by 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 Made in China ...

Page 40: ...ded customer or the user such an environment mpliance up 1 ss B mplies ges emission for all EQU ectromagnetic em d for use in the electrom of the model BP3MX1 Electromagnetic e The Model WatchB energy only for its emissions are ver interference in ne The Model WatchB for use in all estab establishments an public low voltage buildings used for UIPMENT mission magnetic 1 3T WatchBP Home environment ...

Page 41: ...ic 8 kV contact 8 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 discharge ESD 2 kV 4 kV 8 kV 2 kV 4 kV 8 kV IEC 61000 4 2 15 kV air 15 kV air Electrostatic 2 kV for power 2 kV for power Mains power quality should be that transient burst supply lines 100 supply lines100 kHz of a typical commercial ...

Page 42: ...cles at 0 UT 100 UT for 25 cycle at 0 60Hz 30 A m 5 age prior to applicat 00 dip 0 5 cycle 90 225 315 0 dip in cycle at UT 30 for 25 30 0 0 dip in 0 300 Mains p typical c environ WatchB name re during p recomm Home T uninterr battery 50 60Hz Power be at le locatio hospita tion of the test leve ower quality should commercial or hosp ment If the user o P Home T BP3MX1 equires continued o power mains...

Page 43: ...nufacturer s declaration electromagnetic immunity The WatchBP Home T BP3MX1 3T is intended for use in the electromagnetic environment specified below The customer or the user of the WatchBP Home T BP3MX1 3T should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level ...

Page 44: ...smitter in watts manufacturer and d i in metres m Field strengths from f by an electromagneti compliance level in ea Interference may occ with the following sym RF communications eq y part of the Models W ding cables than the r alculated from the eq transmitter on distance 800MHz 2 7GHz mum output power rati W according to the t s the recommended s fixed RF transmitters c site survey a should ach ...

Page 45: ...e communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges C Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mo...

Page 46: ...tweenportableandmo 3MX1 3T is intende s are controlled Th revent electromagn mobile RF communic 1 3T as recommen uipment tion distance accordin Hz to 80 MHz F communications equipm bileRFcommunication ed for use in an elec e customer or the u netic interference by cations equipment ded below accordin g to frequency of trans 80 MHz to 800 MH 0 12 0 38 1 2 3 8 12 ment and the EQUIPMEN sequipmentandt...

Page 47: ... 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 ...

Page 48: ... prevent electrom ommunications equi t power of the comm ance Electromagne Environment RF wireless c be used no c including cab separation di equation app transmitter Recommend Where P is th of the ransm the transmitt recommende m munications equip radiated RF disturban magnetic interferenc pment and the devic munications equipme etic Guidance communications equ loser to any part of bles than the ...

Page 49: ... by absorption and reflection from structures objects and people WARNINGS This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone transceiver or radio control products If you have to do so the device should be observed to verify normal operation The use of accessories and power cord other than those specified with the exception of cables sold b...

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