User Manual
Contents
1. Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE Symbol for ENVIRONMENT PROTECTION Waste electrical products should not be disposed of with household waste Please recycle where facilities exist Check with your local authority or retailer for recycling advice The device is contraindicated for any inaccurate readings the effects of this device on the fetus are unknown When using this device please pay ai emale subject who may be suspected tention to the following situation which blood circulation of the patient thus cause harmful injury to the patient Too measurements The application of the cuff and its pressurization on any arm or an arterio venous A V shunt is present Inflating the cuff on the arm on Do not apply the cuff over a wound o Do not inflate the cuff on the same lim because this could cause temporary loss of function of those simultaneously mpairment of the circulation of the blood of the PATIENT Using it in case to result in prolonged i herwise it can cause further injury b which other monitoring ME EQUIPM of or is pregnant Besides provided may interrupt blood flow and influence requent and consecutive multiple where intravascular access or therapy he side of a mastectomy ENT is applied around simultaneously used monitoring ME EQUIPMENT Don t kink the connection tube otherwise the2. to show the average l Lo SYS M user ID when it displays your desired user ID press START STOP button to value of the latest three records for Lt gt Emma confirm the LCD will turn off Then press MEM button to review the selected the selected user rl DIA user s records Take User 1 for example A T E po m E q pa T Pul min im sys AUG leis IE DIA 2 Press MEM button or SET button to rotate the history records Press Lt gt Emms MEM button to review the record from the latest to the oldest Press 4nr V SET button to review the record from the oldest to the latest Wit uP AUS IME sys m HILI sys Leo 2 LOLS 2 im re DIA L DIA DOWN 4 If there is no record the following display will be shown Lt _ cs ae eo Take User 1 for example T47 2 ar x 2 b Da l i vo q f i Pul min _ or oa a The date and time z a ae rer ore DIA of the record oi pu ULI poeta will be shown 4 v alternately The current No is No 2 The corresponding The corresponding ii date is January st time is P M 10 08 EJ N EEO a E E J eee The most recent record 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed back one digit e g 2 becomes 3 and so on and the last record 60 is dropped from the list 12 13 DATA MANA
3. D 3 4xAAA batteries SET BUTTON START STOP BUTTON BATTERY COMPARTMENT 4 User manual BEFORE YOU START v The Choice of Power Supply 1 Battery powered mode 6VDC 4xAAA batteries 2 AC adaptor powered mode 6V 1A Please use the recommended AC adaptor model Not Included Please unplug the adaptor when not in use AC adaptor Not Included CAUTION In order to get the best effect and protect your monitor please use the right battery and special power adapter which complies with U S safety standard v Installing and Replacing the Batteries e Open the battery cover e Install the batteries by matching the correct polarity as shown e Replace the cover Replace the batteries when See Below The g shows e The display dims e The display does not light up CAUTION e Remove batteries if the device is not likely to be used for some time e The old batteries are harmful to the environment so please DO NOT dispose with other daily trash e Remove the old batteries from the device and follow your local recycling guidelines e Do not dispose of batteries in fire Batteries may explode or leak v Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure Before every measurement the unit establishes a zero pressure equivalent to the air pressure Then it starts inflating the arm cuff meanwhile the
4. cuff pressure may continuous and result in harmful injury to the PATI ENT y increase which can prevent blood flow The device has been evaluated clinically used manual cuff stethoscope auscultations the reference Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultatory method within the limits prescribed INTRODUCTION v LCD display signal I ZI sys t O 2 CII DIA ee 2 Aa wll AA AM LO at A Dat Dal SYMBOL SYS DIA Pulimin DESCRIPTION Pulse per minute Deflating Memory kPa mmHg Low battery Arrhythmia Grade Current Time User 1 User 2 Systolic blood pressure Diastolic blood pressure EXPLANATION High pressure result Low pressure result Beats per minute BPM Air in cuff is deflating The displayed measurement values stored in the memory Measurement Unit of the blood pressure Measurement Unit of the blood pressure Batteries are low and need to be replaced Irregular heartbeat The grade of the blood pressure Month Day Year Hour Minute Start measurement and save the results for User 1 Start measurement and save the results for User 2 INTRODUCTION v Monitor Components CUFF LCD DISPLAY Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve v List 1 Blood Pressure Monitor TMB 1491
5. 00mA Output 6V 1A Conforms to UL certificate Contact Information AUTHORIZED COMPONENT For more information about our products please visit www vivehealth com You can get customer service usual problems and customer download VIVE will serve you anytime Distributed by Copyright and Distributed by VIVE Health 5650 Yahl Street Unit 1 Naples FL 34109 All Rights Reserved Made in China vivehealth com Email service vivehealth com 21 COMPLIED STANDARDS LIST v Complied Standards List Risk management ISO EN 14971 2012 Medical devices Application of risk management to medical devices Labeling ISO EN 15223 1 2012 Medical devices Symbols to be used with medical device labels labelling and information to be supplied General requirements User manual EN 1041 2008 Medical equipment manufacturers to provide information General Requirements for Safety IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Electromagnetic compatibility IEC EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Performance requirements and Clinical Investigation IEC 80601 2 30 2009 Medical electrical equipment Part 2 30 Particular requirements for the b
6. GEMENT v Delete the Records If you did not get the correct measurement you can delete all results by following the steps below 1 Hold pressing MEM and SET button for 3 seconds when the monitor is in the memory recall mode the flash display dEL ALL will be shown Sys mkPa m mmHg DIA kPa m mmHg la Ne Pul min ml p Ns 2 Press SET button to confirm deleting and the LCD will display AEL dOnE and then turn off s AZ sys Q D E gt he Pul min 3 If you don t want to delete the records press START STOP button to escape INFORMATION FOR USER v Tips for Measurement It can cause inaccuracy if the measurement is taken in the following circumstances Within 1 hour Immediate measurement after dinner or drinking after tea coffee smoking Within 20 minutes ba X lt after taking a bath When talking or moving your fingers In a very cold environment xX When you need to urinate INFORMATION FOR USER v Maintenance In order to get the best performance please follow the instructions below Keep monitor in a dry place and avoid direct sunlight Avoid intense shaking collision and shock Use a damp cloth to wipe down monitor Do not attempt to clean the reusable cuff DO NOT use corrosive cleaning chemicals with water and never immerse the cuff in as they may damage device water CAUTION ease u
7. User 1 When the monitor is off press SET button to turn on the monitor Press SET button again to select the User ID between User 1 and User 2 ou HOD SYS mkPa m mmHg DIA B kP S m mmHg Pul min 2 When the desired User ID is shown press START STOP button to confirm and the monitor will turn off Take User 1 for example 10 erir PM HEIE SYS mkPa m mmHg DIA Pul min MEASUREMENT v Start the Measurement 1 After correctly positioning the cuff and selecting the User ID press the START STOP button to turn on the monitor when the LCD is off and it will finish the whole measurement Take User 1 for example LCD display Adjust the zero Z sys mM sys LJ LULG 23 E ee MI DIA DIA ll Lit Ee Eg 4 4100 9 z S wii gon 4 288 88 a 400 Display and save the results o y CM sys Mit sys bal Se LOLS 2 DIA 77 DIA aa fF tems Ae em A Cay v 4 d ee aox PEH a 400 2 Press the START STOP to power off otherwise it will turn off within 1 minute 11 DATA MANAGEMENT DATA MANAGEMENT v Recall the Records 3 If you want to check another user s records press START STOP button to turn off the monitor when it is in the memory recall mode Then press SET 4 When the monitor is off button to turn on the monitor press SET button again to select the desired press the MEM
8. VIVE WWW VIVEHEALTH COM Contact us 24 7 at www vivehealth com VIVE User Manual Digital Blood Pressure Monitor DMD1001 version 1 0 Arm Type Thank you very much for selecting VIVE Digital Blood Pressure Monitor DMD1001 a Please read the user manual carefully and thoroughly to ensure the safe usage of this product and retain the manual for reference in case you have problems CATALOG CATALOG Table of Contents INTRODUCTION bi cicta evsessegvececnatadere diecast vevencevs exestcenneestinineth catensend cust vavedy a ia iarna aiaa 2 e General Description e Safety Information e LCD Display Signal e Monitor Components BEFORE YOU START ccstetiuesecciess av a ar i aa i r aai aa rA Ea 6 e The Choice of Power Supply e Installing and Replacing the Batteries e Measurement Principle e Setting Date Time and Measurement Unit MEASUREMENT stones oerna a aaa a aia aasia eat alana 9 e Tie the Cuff e Select the User e Start the Measurement DATA MANAGEMEN Terrori araire eNotes ca deta eo E 12 e Recall the Records e Delete the Records INFORMATION FOR USE Reve iicsescveceteseedaceuscietyeredyceeelseusttuatninoctedl aaa ia en 15 e Tips for measurement e Maintenances ABOUT BLOOD PRESSURE viriito ia eead H deeb ecdectieetine dats 17 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Why does my blood pressure fluctuate throughout the day Why
9. asic safety and essential performance of automated non invasive sphygmomanometers ANSI AAMI SP10 2002 A2 2008 Manual electronic or automated sphygmomanometers Software life cycle processes IEC EN 62304 2006 AC 2008 Medical device software Software life cycle processes v FCC Statement This device complies with Part 15 of the FCC Rules Operation is subject to the following 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 22 EMC GUIDANCE v EMC Guidance 1 MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS 2 Wireless communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations walkie talkies can affect this equipment and should be kept at least a distance d 3 3m away from the equipment Note As indicated in Table 6 of IEC 60601 1 2 2007 for ME EQUIPMENT a typical cell phone with a maximum output power of 2 W yields d 3 3m at an IMMUNITY LEVEL of 3V m 23
10. ist etc This unit is not suitable for continuous monitoring during medical emergencies or operations Otherwise the patient s arm and fingers will become anesthetic swollen and even purple due to a lack of blood Please use the device under the environment which was provided in the user manual Otherwise the performance and lifetime of the device will be impacted and reduced During using the patient will contact with the cuff The materials of the cuff have been tested and found to comply with requirements of ISO 10993 5 2009 and ISO 10993 10 2010 It will not cause any potential allergic reaction or contact injury The device doesn t need to be calibrated in two years of reliable service Please dispose of ACCESSORIES detachable parts and the ME EQUIPMENT according to the local guidelines When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or arterial fibrillation the best result may occur deviation Please consult your physician about the result Maximum 60 records per each user 3rd technology Measuring during inflation Most up to date technology in the world Safety Information The below signs might be in the user manual labeling or other component They are the requirement of standard and using Symbol for THE OPERATION Symbol for TYPE BF APPLIED GUIDE MUST BE READ PARTS Symbol for MANUFACTURER
11. it of Normal BP nomal Prehypertension 120 139 80 89 Blood Pressure Category Systolic Diastolic mmHg upper mmHg lower less than 120 less than 80 High Blood Pressure 140 159 90 99 Hypertension Stage 1 High Blood Pressure 2 160 or higher Hypertension Stage 2 100 or higher Hypertensive Crisis Higher than 180 Emergency care needed TRANEN Higher than 110 CAUTION Only a physician can tell your normal BP range Please contact a physician if your measuring result falls out of the range Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat IHB Detector During each measurement this equipment records the heartbeat intervals and works out the standard deviation If the calculated value is larger than or equal to 15 this equipment will light up the IHB symbol on the screen when displaying the measuring result CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart beat was detected during measurement Usually this is NOT a cause for concern However if the symbol appears often we recommend you seek medical advice Please note that the device does not replace a cardiac examination but serves to detect pulse irregularities at an ear
12. ly stage 17 ABOUT BLOOD PRESSUR 18 v Why does my blood pressure fluctuate throughout the day 1 Individual blood pressure can change on a daily basis It is also affected by the way you apply the cuff and the measurement position Please take measurements using the same method to ensure accuracy 2 The variations in the pressure can be greater or smaller depending on the actual medicine taken 3 Waiting at least 3 minutes for another measurement When you take your blood pressure v Why the blood pressure at home make sure to pay close l get from the hospital attention to the following is different from home If the cuff is secured properly If the cuff is too tight or too loose If the cuff is secured on the upper arm If you feel anxious You had better take 2 3 deep breaths Advice Wait at least 4 5 minutes until you calm down Blood pressure can fluctuate over a period of 24 hours based on weather emotions exercise stress etc v Can the results be different while taking measurement from right arm You may choose to measure both arms and then average the two readings to get your blood pressure result The norm is to measure the left arm closest to your heart For accuracy use the same method each time TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor If the product is n
13. mation and return instructions SPECIFICATIONS Power supply Battery powered mode 6VDC 4xAAA batteries AC adaptor powered mode 6V 1A Please use the recommended AC adaptor model Not Included Display mode Digital LCD 2 4x1 6in Digital LCD display Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure Okpa 40kpa OmmHg 300mmHg Measurement pressure 5 3kPa 30 7kPa 40mmHg 230mmHg pulse value 40 199 beat minute Accuracy Pressure Pressure 40 F to 104 F withint0 4kpa 3mmHg pulse value t5 Normal working condition Temperature 40 to 104 F Relative humidity lt 85 Atmospheric pressure 86kPa to 106kPa Storage amp transportation condition Measurement perimeter of the upper arm Temperature 4 F to 140 F Relative Humidity 10 93 Atmospheric Pressure 50 106 kPa About 8 3 4 16 1 2 22 42 cm Net Weight Approx 0 63lbs Excluding the dry cells External dimensions Approx 4 3 4 3 1 6in Attachment Mode of operation 4xAAA batteries user manual Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP21 Software Version vo1 20 WARNING No modification of this equipment is allowed v Authorized Component 1 Use the VIVE authorized adaptor Not Included Adaptor Type UEO8WCP 060100SPA Input 100 240V 50 60Hz 4
14. nd 3 to set the HOUR v Applying the cuff the MONTH and DAY and MINUTE 1 Apply the cuff on your upper arm Make sure the position of the tube SYS M sys M is off center toward the inner side of arm sits aia in line with the little finger DIA DIA a mkPa meP m mmHg m mmHg Pul min Pul imin i 2 The cuff should be snug but not ely oe too tight You should be able to insert one finger between the cuff and your arm 6 Repeat step 2 and 3 to set the UNIT 3 Sit comfortably with your test YS M SYS mM arm resting on a flat surface DIA D DIA o 4 Patients with Hypertension tinny srt The middle of the cuff should be NW at the level of the right atrium of the heart Hi j S Before starting measurement please sit comfortably with legs uncrossed feet flat on the floor back and arm supported Mtt 4 r r lt r C Z Noa e Resting For 5 minutes before measuring 7 After the unit is set the LCD will display SYS e Wait at least 3 minutes between done first then display all the settings you EO measurements This allows your E have done and then it will turn off l DIA blood circulation to recover LEY e For a meaningful comparison try to measure under similar Pulmin conditions For example take daily measurements at approximately the same time position of upper arm or as directed by a physician kP m mmHg MEASUREMENT v Select the
15. ot operating as you think it should please check troubleshooting below before arranging for service PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will not light up Batteries are exhausted Batteries are inserted incorrectly Replace with new batteries Insert the batteries correctly AC adaptor is inserted incorrectly Insert the AC adaptor tightly Low batteries Display is dim or showe 0 Batteries are low Replace with new batteries Error message E 1 shows E 2 shows The cuff is not secure The cuff is very tight Refasten the cuff and then measure again Readjust the cuff not too loose or too tight and then measure again E 3 shows The pressure of the cuff is excess Relax for a moment and then measure again E10 or E11 shows The monitor detected motion talking or the pulse is too poor while measuring Relax for a moment and then measure again E20 shows The measurement process does not detect the pulse signal Loosen the clothing on the arm and then measure again E21 shows The treatment of the measurement failed Relax for a moment and then measure again EExx shows on the display A calibration error occurred Retake the measurement If the problem persists contact the retailer or our customer service department for further assistance Refer to the warranty for contact infor
16. se ACCESSORIES and detachable parts specified authorized by MANUFACTURE therwise it may cause damage to the unit or danger to the user patients he device doesn t need to be calibrated in two years of reliable service ease dispose of ACCESSORIES detachable parts and the ME EQUIPMENT according to the cal guidelines you have any problems with this device such as setting up maintaining or using please ontact service vivehealth com Don t open or repair the device by yourself ease report to vivehealth com if any unexpected operation or events occur ease use a soft cloth to clean the whole unit Don t use any abrasive or volatile cleaners vao T lo If Q Ud 16 ABOUT BLOOD PRESSURE What is systolic pressure and diastolic pressure When ventricles contract and pump blood out of the heart the blood pressure reaches its maximum value in the cycle which is called systolic pressure When ay S amp S the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic p relax TARS e Aol pressure What is the standard blood pressure classification The chart on the right is the standard blood pressure classification published by American Heart Association AHA Diastolic blood entering Systolic blood discharging AHA Home Gu ideline for This chart reflects blood pressure categories defined by American Heart Association Upper Lim
17. the blood pressure get from the hospital is different from home If the result is the same if measuring on the right arm TROUBLESHOOTING is sic celts cee a i re alata eu aaa 19 SPECIFICATIONS ai AUTHORIZED COMPONENT deiss iineoa esaea esi ese a aaea aa a aSa eieaa etaa 21 CONTACT INFORMATION sessi Kassen dedaro aesae AE ERES NES SS EEEE EIS EE EES 21 COMPLIED STANDARDS LIST 1 22 FCC STATEMENT irere at eaea Aa Ee aA EE de E EE a E EAE 22 EMC GUIDAING Beet everett es eae ee a es ta te ONG Dat E Se 23 1 INTRODUCTION INTRODUCTION v General Description CAUTION This device is intended for adult use only This device is intended for non invasive measuring and monitoring of arterial blood pressure It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement Do not confuse self monitoring with self diagnosis This unit allows you to monitor your blood pressure Do not begin or end medical treatment Consult your physician for treatment or advice If you are taking medication consult your physician to determine the most appropriate time to measure your blood pressure Readings taken by the DMD1001 are equivalent to those obtained by Never change a prescribed medication without consulting your physician If the cuff pressure exceeds 40kPa 300 mmHg the unit will automatically deflate Should the cuff not deflate when a trained observer using the cuff and ste
18. thoscope auscultation method pressure exceeds 40 kPa 300 mmHg detach the cuff from the arm and press the START STOP button to stop This manual contains important safety and care information inflation 2 x i o avoid measurement errors carefully read this manual before using the product and provides step by step instructions for using the product The equipment is not AP APG equipment and not suitable for use in the presence of a flammable anesthetic mixture Read the manual thoroughly before using the product Thank you for selecting VIVE upper arm Blood Pressure Monitor DMD1001 The monitor features blood pressure measurement pulse measurement and result storage The design provides you with two years of reliable service with air of with oxygen or nitrous oxide The operator shall not touch output of batteries and the patient simultaneously To avoid measurement errors please avoid the condition of strong electromagnetic field radiated interference signal Features or electrical fast transient burst signal when using the AC adaptor eatures The user must check that the equipment functions safely and see that it is in proper working condition before being 2 4x1 6in Digital LCD display used Please use ACCESSORIES and detachable parts specified authorized by MANUFACTURE Otherwise it may cause damage to the unit or danger to the user patients Manufacturer will make available on request circuit diagrams component parts l
19. unit detects pressure oscillations generated by beat to beat pulsatile which is used to determine the systolic and diastolic pressure and also pulse rate The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25 v Setting Date Time and Measurement Unit It is important to set the clock before using your blood pressure monitor so that a time stamp can be assigned to each record that is stored in the memory The setting range of the year 2014 2054 time format 12 H year press SET to set down and turn to next s step DIA e Pulimin 1 When the monitor is off SYS hold pressing SET De for 3 seconds to enter DIA S the mode for year eae Q setting pumin Or when the monitor is off p press SET button shortly cu th it will display the time Then hold pressing SET button SYS m to enter the mode for year TON setting DIA 2 Press the MEM to change maha the YEAR Each press will increase the numeral by one a in a cycling manner any a y ears k jaht A A E 3 When you get the right Z SYS mkPa m mmHg BEFORE YOU START MEASUREMENT 4 Repeat step 2 and 3 to set 5 Repeat step 2 a
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