ACMMD001 Blood Pressure Monitor Wrist MAN
Contents
1. shows Data communication has failed Make sure that phone s Bluetooth is on or within the distance range E 2 shows The cuff is very tight Refasten the cuff and then measure again E 3 shows The pressure of the cuff is in excess Relax for a moment and then measure again E 9 shows Product has not been activated Reactivated E10or E 11 shows The monitor detected motion while measuring Movement can affect the measurement Relax for a moment and then measure again E 20 shows The measurement process does not detect the pulse signal Loosen the clothing on the arm and then measure again E 21 shows EExx shows on the display Measured incorrectly A calibration error occurred Relax for a moment and then measure again Retake the measurement If the problem persists contact the retailer or our customer service department for further assistance SPECIFICATIONS Power supply Display 3 7V 420mAH Built in rechargeable lithium ion battery 5V 1A USB Digital LCD V A 46 5x36 5mm Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure Okpa 40kpa OmmHg 300mmHg Measurement pressure 4kPa 34kPa 80mmHg 255mmHg pulse value 40 199 beat minute Accuracy Pressure 5 C 40 C within 0 4kpa 3mmHg 0 C 45 C out of 5 C 40 C within 0 7kpa 6mmHg pulse value 5 Normal w2. Error Error MEMORY REVIEW Memory Recalling the history records 8 33 PM 18 8 38 Time Hour Minute Month Day Year INTRODUCTION v Monitor Components PULSE RATE TIME MEM UP START STOP BUTTON BUTTON SET DOWN BUTTON CUFF Type BF applied part USB Interface v List 1 Blood Pressure Monitor 2 USB Cable ACMMD001 3 User Manual BEFORE YOU START BEFORE YOU START v Power Supply and Charge Power 1 The battery for ACMMD0071 is a built in rechargeable lithium ion battery with a current of 420 mAh 2 Please use the USB cable provided to charge the battery just like the picture below v Setting Date and Time Please proceed to set the time before your initial use to ensure each record is labelled with a time stamp Year Range 2012 2052 Time Format 12 Hours 1 When the monitor is OFF press and hold the SET button for 3 seconds to enter Time Setting Mode Your device will require charging under the following circumstances 3 A i 1 ie A Lo displays on the LCD e The LCD display dims e When powering on the monitor the LCD doesn t light up 2 As pictured in the right the blinking number 12 representing ED cauTION HOUR Press MEM button to 1 The battery used is a built in rechargeable lithium ion battery change the number Each press please do not disassemble it by an unauthorized maintenance personel will increase the n
3. labelling and information to be according to the EMC information provided in the lied Gi ii t E ACCOMPANYING DOCUMENTS User manual 1041 2008 Medical equipment manufacturers to provide 2 Wireless communications equipment such as wireless home information g P network devices mobile phones cordless telephones and their General Requirements 0 EN 60601 1 2006 A1 2012 Medical electrical base stations walkie talkies can affect this equipment and should for Safety eo requirements for basic safety and be kept at least a distance d 3 3 m away from the equipment IEC EN 60601 1 11 2010 Medical electrical equipment Note As indicated in Table 6 of IEC 60601 1 2 2007 for ME Part 1 11 General requirements for basic safety and essential i f performance Collateral standard Requirements for medical EQUIPMENT a typical cell phone with a maximum output power electrical equipment and medical electrical systems used in of 2 WwW yields d 3 3 matan IMMUNITY LEVEL of 3 V m the home healthcare environment IEC EN 80601 2 30 2009 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers Electromag netic IIEC EN 60601 1 2 2007 Medical electrical equipment Part compatibility 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Performance
4. normal BP range Please contact your doctor if your measuring result falls out of the range Kindly note that only a doctor can tell whether your blood pressure value has reached a dangerous point High normal Blood Pressure Normal Blood Pressure Optimal Blood Pressure 120 130 140 150 160 180 Systolic blood pressure mmHg Level Blood Optimal Normal High normal Mild Moderate Severe Pressure mm Hg SYS lt 120 120 129 130 139 140 159 160 179 2180 DIA lt 80 80 84 85 89 90 99 100 109 2110 v Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent Irregular Heartbeat IHB Detector function 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 heartbeat 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 early stage ABOUT BLOOD PRESSURE Why does my blood pressure vary even in one day 1 In
5. which is used to deter mine the systolic pressure and diastolic pressure as well as pulse rate The device also compares the longest and the shortest intervals of detected pulse wave with the average value and then calculates the standard deviation The monitor will light up a warning symbol when the calculated standard deviation is larger than or equal to 15 v Safety information The below signs might appear in the user manual labeling or other components Symbol for THE OPERATION GUIDE MUST BE READ Symbol for TYPE BF APPLIED PARTS For indoor use only Symbol for DIRECT CURRENT The Bluetooth Combination T1A 250V 3 6 10CCC 8 Bluetooth Mark INTRODUCTION v Indications for use The Actiiv Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13 5 cm to 21 5 cm about 5 8 5 inches It is intended for adult indoor use only caution It is intended for adult indoor use only Pregnant women pre eclamptic patients and patients with severe obesity should not use this device If required please consult a professional doctor 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 wrist or for functions other than obtaining a blood pressure measurement Please use the device under the specified
6. 1 Turn on Bluetooth and the app Make sure both are ON when pair up is proceeding 2 When the monitor is OFF press and hold the START button to start 6 30 pm pair up The symbol and the 0 15 13 symbol o will be shown on the LCD alternatively indicating pair up is proceeding IF SUCCESSFULL symbol Inflating and measuring Display and save the will be shown on the LCD measuring result IF FAILED symbol 6 will be shown on the LCD ERROR 3 The monitor wil shut off after pair up process is complete g T o DUA Pan A oes ss Bluetooth Module No AW2540MV1 RF Frequency Range 2 4 GHz Output Power Range 1 dBm 2 w Cajon Supply Voltage 2Vto3 6V Transmitting Distance 10 meters 11 MEASUREMENT 2 The device will proceed to transmit data after taking the measurement The Bluetooth symbol blinks on the LCD to indicate data is transmitting to your phone 3 If the data is successfully transmitted the LCD will then display dONE If the data transmission fails the LCD will display 8 instead 8 4 Press STOP button to turn off the monitor cautio 1 When using this device please pay attention to the following situations which may interrupt blood flow and influence blood circulation of the patient thus causing harm or injury to the patient too frequent and consecutive multiple measurements the application of the CUFF and it s pressu
7. EN 1060 1 1995 A2 2009 Non invasive blood pressure Part 1 General requirements requirements EN 1060 3 1997 A2 2009 Non invasive blood pressure Part 3 Supplementary requirements for electromechanical blood pressure measuring system EN 1060 4 2004 Automatic Blood Pressure Monitor overall Clinical investigtion 3 system Interventional accuracy of the testing process IEC EN 60601 1 6 2010 Medical electrical equipment se Part 1 6 General requirements for basic safety and essential Usability performance Collateral Standard Usability IEC EN 62366 2007 Medical devices Application of usability engineering to medical devices IEC EN 62304 2006 AC 2008 Medical device software Software life cycle processes Software life cycle processes 23 APPENDIX 24 Installing App and Pairing The following steps are for use with iPhone The App is also available for Android through Google Play b Search for the App in the App Store The App name is Lifesense International Download and install the App onto your phone Ensure Bluetooth is turned ON on your phone Run the App the following screen romene should appear Create a new account or sign in The following screen will _ appear after you have signed in Press Edit at the bottom right corner untick Weight press the back button and Yes to save Data this will remove the weight measurement and ret
8. Kdahiaece cnduainiidiuminteecaie 19 SPECIFICATIONS z csscstcsscsccitssstcestessnssisstnesdvcsoeeseeseasedzssescedticetsevevouzsutessexorsentsusteattestiaeer 20 THE MATCHED COMPONENTS CONTACT INFORMATION COMPLIED EUROPEAN STANDARDS LIST cscssssssesssssescseseseeseessescsescssseseenensssecaseneees 22 EMG GUIDANCE araicis catscasscscactuasacsetea aistiscssivsncsevssbansintsindececncvtecedncesecnteseuaseeseecestins 23 APRENDIXG ENE OEN AEA TEE ER TAA E T 24 INTRODUCTION v General Description Thank you for selecting the Actiiv blood pressure Monitor ACMMD001 The monitor features blood pressure measurement pulse rate measurement and storage of results Readings taken by the device are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method This manual contains important safety and care information and provides step by step instructions for using the product Please read this user manual carefully and thoroughly before use FEATURES Systolic Blood Pressure Pulse Rate Diastolic Blood Pressure Memory Up to 60 readings can be recorded v Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure Before every measurement the unit establishes a zero point equivalent to the atmospheric pressure Then it starts inflating the cuff Meanwhile the unit detects pressure oscillation generated by beat to beat pulsatile
9. S Actiiv WRIST BLOOD PRESSURE MONITOR User Manual Thank you very much for selecting the Actiiv Wrist Blood Pressure Monitor ACMMDO01 a Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product and keep the manual for further reference in case you have problems MODEL ACMMDO01 Table of Contents Table of Contents INTRODUCTION cnanbne nki 2 e General Description Measurement Principle Safety Information Indications for Use LCD Display Signal Monitor Components BEFORE YOU STARU aeinn anpa aa aeaa KE anea ainei Ea SENAR 6 e Charging your Device e Setting Date and Time MEASUREMENT saistiisacd onthe cack dicks eich eeaniniwainiiencdendaandedds 9 e Positioning the Cuff e Pair up the Blood Pressure Monitor with your Device e Start Measurement DATA MANAGEMENT 0 s c0ssccssssocovssscesseszsedicasdeezscosstessevbescsstesetceptesetscesssas ecoseesidecsdiesds 13 e Recall the Records e Delete the Records INFORMATION FOR USER nonna 15 e Tips for Measurement e Maintenance ABOUT BLOOD PRESUNE i si ranie ranra an a aiai A a aaea einas a ah AEAEE 17 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Why does my blood pressure vary even in one day Why is the blood pressure get from the hospital different from home Will get the same result if measure on the right wrist TROUBLESHOOTING vsiiciiisncniniinnces
10. dividual blood pressure varies every day It is also affected by the way you tie your cuff and your measurement position so please take the measure ment in the same conditions 2 Blood pressure variation is greater if the person takes medication 3 Make sure you wait at least 3 minutes before taking another measurement Why is the blood pressure Will get the same result if 18 get from the hospital different from home Blood pressure can vary even during a 24 hour period due to influences like the weather emotions exercise etc You may experience different environmental and emotional conditions at a hospital compared to at home which can affect your blood pressure measurements measure on the right wrist It is ok to use the device on both wrists but the results may differ depending on the person It is recommended that you measure on the same wrist every time to maintain an accurate record of measurements 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 not operating as you think it should check here before contacting support PROBLEM SYMPTOM CHECK THIS REMEDY No power Low batteries Display is dim or will not light up Show on ase the display Power is exhausted Power is low Charge the power Charge the power Error message 8
11. eep the unit out of reach of infants children or pets since inhalation or swallowing of small parts is dangerous or even fatal Please use the accessories and detachable parts as specified and authorised by the manufacturer Otherwise it may cause damage to the unit or danger to the user patient The patient is an intended operator The patient can measure transmit data and charge the batte under normal circumstances and maintain the device and its accessories according to the user manual The blood pressure monitor its adaptor and the cuff are suitable for use within the patient environment If you are allergic to dacron or plastic please don t use this device This device cannot be used with HF surgical equipment at the same time There is a PTC current limiter in the monitor with a specification of 8V and 0 5A When the voltag and current exceed the limiting value the monitor will stop working The device is not suitable for public use INTRODUCTION v LCD Display Signal log MEMORY REVIEW DESCRIPTION lt D EXPLANATION Systolic Blood Pressure High blood pressure Diastolic Blood Pressure Low blood pressure Pulse beat minute Low Battery Please use the USB cable provided to recharge the battery Unit IHB Detector Measurement unit of blood pressure Irregular Heartbeat Detector Bluetooth Successful Bluetooth Connection ERROR
12. environment as instructed in this user manual otherwise the accuracy of the device will be influenced Do not confuse self monitoring with self diagnosis This unit allows you to monitor your blood pressure Please only start or end any medical treatments based solely on a physician s treatment advice If you are taking medication consult your physician to determine the most appropriate time for your measurement Never change a prescribed medication without your physician s consent This unit is not suitable for continuous monitoring during medical emergencies or operations After the cuff has been inflated for a long time the patient s wrist and fingers blood supply will become insufficient and could result in distending pain and ecchymosis If the pressure of the cuff exceeds 40 kPa 300 mmHg the unit will automatically deflate If the cuff doesn t deflate when its pressure exceeds 40 kPa 300 mmHg detach the cuff from the wrist and press the START STOP button to stop inflation Do not use the monitor under strong electromagnetic field conditions e g medical RF equipment that radiate an interference signal or electrial fast transient burst signal The maximum temperature that the applied part can achieve is 42 8C while the environmental temperature is 40 C The device is not AP APG equipment It is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen nitrous oxide Please k
13. environments and Avoid washing the cuff remove any dirt cauTIon 1 Please make sure the unit functions safely and that it is in proper working condition before use Don t service or maintain while the device is in use 2 If you have any problems with this device such as setting up maintaining or using please go to www actiivfitness com Don t open or repair the device by yourself 3 Please report to Actiiv if any unexpected operation or events occur 4 Cleaning Dusty environments may affect the performance of the unit Please use a soft cloth to remove any dirt from the device and cuff before and after use 16 unstable surrounding temperatures ABOUT BLOOD PRESSURE What are 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 the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic pressure What is the standard blood pressure classification A Diastolic blood entering vein Systolic blood discharging artery The blood pressure classification published by the World Health Organization WHO and the Grade 3 hypertension severe B110 Grade 2 hypertension moderate International Society of Hypertension ISH in 1999 is as follows CAUTION Only a doctor can tell your
14. orking condition Temperature 5 C to 40 C Relative humidity lt 85 Atmospheric pressure 86kPa to 106kPa Storage amp transportation condition Temperature 20 C to 60 C RH 10 to 93 Atmospheric pressure 50kPa to 106kPa Measurement perimeter of the wrist About 13 5cm 21 5cm Net Weight Approx 110g External dimensions Approx 79 8x72 5x13 2mm Attachment USB cable User manual Mode of operation Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP22 It means the device could be protected against solid foreign objects of 12 5 mm and greater and against vertically falling water drops when ENCLOSURE is tilted up to 15 Software version voi Device classification Battery Powered Mode Internally Powered ME Equipment WARNING No modification of this equipment is allowed 20 v Contact Information CONTACT INFORMATION For customer support please visit www actiivfitness com 21 COMPLIED EUROPEAN EMC GUIDANCE STANDARDS LIST v Complied European Standards List v EMC Guidance ISO EN 14971 2012 Medical devices Application of risk Risk management management to medical devices 1 The Blood Pressure Monitor needs special precautions i ISO EN 15223 1 2012 Medical devices Symbols to be used regarding EMC and needs to be installed and put into service Labeling with medical device labels
15. rization on any wrist where intravascular access or therapy or an arterio venous A V shunt is present Inflating the cuff on the wrist on the side of a mastectomy 2 Do not apply the cuff over a wound otherwise it can cause further injury 3 Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied simultaneously because this could cause temporary loss of function of those simultaneously used monitoring ME EQUIPMENT 4 Do not use the device in such a way as to cause prolonged impairment of blood circulation in the patient 12 v Recall the Records CAUTION 5 The cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT Sensitive people including pregnant women pre eclamptic patients patients with implanted medical electronic instruments and have atrial fibrillation AF premature ventricular beats and peripheral arterial disease PAD should avoid using the unit whenever possible 1 Press the MEM button to access the memory The monitor will display the calculated average of the last three readings first 2 Press MEM UP button or SET DOWN button to rotate the history records MEM UP to go forward SET DOWN to go backward 4 us 2 wn S E ri aal ISI wl CAUTION The most recent record 1 is shown first Each new measurement is assigned to the firs
16. t 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 13 DATA MANAGEMENT v Delete the Records When you have not obtained an accurate measurement you can clear all the measuring results by following the below steps 1 Under Memory Recalling Mode press and hold both the MEM button and the SET button for 3 seconds 2 The LCD will display dEL dONE indicating that memory clearing is complete It will then shutdown CAUTION Under Memory Recalling Mode if you wish to give up clearing press START STOP to turn off the monitor 3 When there is no memory in the monitor if you press the MEM button to look up the history the LCD will display as pictured to the right 14 INFORMATION FOR USER v Tips for Measurement Measurements could be inaccurate if taken in the following circumstances lt T I E Within 1 hour Immediate measurement after eating or drinking after tea coffee smokin Within 20 minutes X after taking a bath When talking or moving your fingers In a very cold are 4 When you want to discharge urine 15 INFORMATION FOR USER Maintenance To obtain the best performance please follow the below instructions Keep your device in a cool Avoid immersing your device dry place avoid direct sunlight in liquid and high temperatures Avoid dusty
17. tension DAY and YEAR The middle of the cuff should be at the same level as the right atrium of the heart Before starting the measurement please sit comfortably with legs uncrossed feet flat on the floor back and arm supported e Rest for 5 minutes before measuring e Wait at least 3 minutes between measurements This allows your blood c circulation to recover e For a meaningful comparison try to measure under similar conditions For example take daily measurements at approximatelythe same time on the same wrist 7 After confirming the YEAR the LCD will display GONE and the monitor will shut off dO ME MEASUREMENT MEASUREMENT v Install App and Pair Up Y Start Measurement Supports Bluetooth 4 0 only With the advanced Bluetooth 4 0 technology applied to this blood pressure monitor mobile phones which are equipped with Bluetooth functionality are able to receive your personal health data Just simply install the specially designed app and pair up your blood pressure monitor with your mobile phone by following the instructions below 1 After correctly positioning the cuff press the START button to turn on the monitor and it will complete the measurement process 1 The App is now available in the App Store and Google Play App name is LIFESENSE INTERNATIONAL aT You may search for the app then download and install the app on your iPhone or Android Phone Simple and convenient Adjust to zero
18. umber by one 2 Under normal use it can be charged about 300 times in a cycling manner If measured three times per day and the battery be is fully charged it can be used for about 20 days 3 Store and use the blood pressure monitor in a cool dry and ventilated environment Avoid close proximity to fire and heat sources or it 3 Press SET button again to may cause the battery explode confirm HOUR Then the 4 You cannot use the blood pressure monitor during the charging process number representing MINUTE 5 During the process of charging the blood pressure monitor will blinks display this symbol When charging is complete please remove plug before use 6 When charging do not touch the charging connector and the patient B i simultaneously BEFORE YOU START MEASUREMENT v Positioning the Cuff 4 Repeat step 2 and 3 to confirm MINUTE 1 Remove all accessories watch bracelet etc from your left wrist If your physician has diagnosed you with poor circulationin your left wrist use your right wrist 2 Roll or push up your sleeve to expose the skin 3 Apply the cuff to your left wrist with your palm facing up 6 35 pm 4 Position the edge of the cuff about 1 2 cm from bottom of hand 5 Fasten the wrist cuff around your wrist leaving no extra room between the cuff and your skin If the cuff is too loose the measurement will not be accurate 5 Repeat step 2 and 3 to confirm MONTH 6 Patients with Hyper
19. urn to the Start menu Press the Settings button p in the top right corner l Press the Add button to add a device Press the Bluetooth logo 10 Please ensure you pressand hold the Start button on the blood pressure monitor to initiate Pairing Mode 11 Once connected the device will show It is now ready to use 12 Your readings will be r recorded on the App you can find the readings by selecting Blood Pressure in the App as per the image shown here 13 The following screen will appear ie 14 To see records press the list button at the top of the screen 15 The following screen will appear an 16 To delete any unwanted readings slide to the left on the reading and the delete button will appear 25
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