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2   

Warnings   

•

 

Do not use with pregnant or pre-eclamptic patients 

•

 

Regarding the effect of blood flow interference and resulting harmful 

injury to the patient caused by continuous cuff pressure due to 

connection tubing kinking. 

•

 

Regarding the information that pressurization of the cuff can 

temporarily cause loss of function of simultaneously used monitoring 

ME equipment on the same limb. 

•

 

Regarding the need to check that operation of the automated 

sphygmomanometer does not result in prolonged impairment of 

patient blood circulation. 

•

 

An explanation that any reading can be affected by the measurement 

site, the position of the patient, exercise, or the patient's physiologic 

condition. 

•

 

Details of what the operator should do if unexpected readings are 

obtained. 

•

 

An explanation of the need to avoid compression or restriction of the 

Содержание BPM19B

Страница 1: ... Pressure Monitor BPM19B EN RoHS REACH MDSS GmbH Schiffgraben 41 30175 Hannover Germany AViTA Corporation 9F No 78 Sec 1 Kwang Fu Rd San Chung Dist New Taipei City 24158 Taiwan China AViTA WUJIANG Importer Distributor ...

Страница 2: ...e Use 4 Product Identification 8 Description of LCD Display 9 Battery Installation 11 Setting the Date and Time 13 Applying Your Cuff 14 Measurement of Pulse Rate and Blood Pressure 16 Hypertension Indicator World Health Organization WHO 18 Heartbeat Remind Irregular Heartbeat Detector 20 Memory Function 22 Data Transferring 24 Error Codes 28 ...

Страница 3: ...Troubleshooting 30 Cleaning and Disinfecting 33 Technical Specification 34 EMC Tables 36 Explanation of Symbols 40 ...

Страница 4: ...cumference ranging from 125 mm to 210 mm Approx 4 9 8 3 inches and for home use When the device detects the appearance of irregular heartbeats during measurement an indicated symbol will appear with measuring readings This device is designed only for adults Contra indications Do not use in this case e g common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation arteria...

Страница 5: ...function of simultaneously used monitoring ME equipment on the same limb Regarding the need to check that operation of the automated sphygmomanometer does not result in prolonged impairment of patient blood circulation An explanation that any reading can be affected by the measurement site the position of the patient exercise or the patient s physiologic condition Details of what the operator shou...

Страница 6: ...mastectomy Do not too frequent measurements can cause injury to the patient due to blood flow interference Do not application of the cuff over a wound as this can cause further injury Cuff pressure 0 300 mmHg CAUTION automated sphygmomanometer can be affected by extremes of temperature humidity and altitude Reduction rate Refer to IEC 80601 2 30 30S This product is not suitable for use with pregna...

Страница 7: ... your blood pressure 2 Perform your measurement in a quiet place You should be seated in a relaxed position 3 Avoid smoking eating taking medication alcohol consumption or physical activity 30 minutes prior to taking a reading If you are exhibiting signs of stress avoid taking your measurement until the feeling subsides 4 Rest 15 minutes prior to taking a reading 5 Remove any constrictive clothing...

Страница 8: ...llow for the blood vessels to return to normal The wait time may vary depending on your individual physiological characteristics 10 Although such cases are rare for those with an extremely weak pulse or irregular pulse errors may result which prevent proper measurement If abnormal variations are noticed consult with your physician or trained healthcare professional 11 This device is intended for a...

Страница 9: ... with your name address phone number and description of the specific problem Pack the product carefully to prevent damage in transit Because of possible loss in transit we recommend insuring the product with return receipt requested If in need of assistance of setting up using maintaining or to report unexpected operation events please contact manufacturer or local representative for further infor...

Страница 10: ...e affected by extremes of temperature humidity and altitude Please refer to the instructions for use CAUTION Keep this device out of the reach of children Strangulation resulting from baby or child entanglement in cables Please keep this device away from pets pests and children Avoid potential allergic reactions please avoid the device in direct contact to patient s wound No modification of this e...

Страница 11: ...8 Product Identification ...

Страница 12: ...9 Description of LCD Display Memory sets Memory Symbol Average Measurement Symbol Low Battery Symbol Inflation Symbol Deflation Symbol Date ...

Страница 13: ...10 Time Digital Display Pulse Rate Heartbeat Symbol Hypertension Indicator Irregular Heart Beat Symbol ...

Страница 14: ...n is pressed Replacing the Battery Open the battery cover on the bottom of the monitor Insert or replace 2 x 1 5 V AAA batteries into the battery compartment ensuring to match the indicated polarity symbols Always use new batteries Close the battery cover Battery operated Always use NEW batteries never mix old and new batteries Do not use rechargeable batteries rechargeable batteries can vary ...

Страница 15: ...ase properly dispose of the batteries away from small children and heat It is recommended to remove the batteries if the unit will not be used for an extended period of time Batteries must be disposed of in accordance with local environmental and institutional policies Remove the battery during extended storage ...

Страница 16: ...the Date and Time button the Year will begin to flash on the display 2 Press the MEMORY button to advance the display to the desired Year press POWER button to confirm the Year 3 Next the Month will blink Repeat steps 1 and 2 to set the Month and Day then hour then Minute 4 After setting the minute the unit will automatically exit out or press power button the date time setting mode and briefly sh...

Страница 17: ...ption or physical activity 30 minutes prior to taking a reading If for any reason you are unable to or should not use your left wrist please modify the instructions for cuff application to your right wrist Your physician can help you identify which wrist is best for you to take measurements from ...

Страница 18: ...pward Apply the preformed cuff to your wrist so that the digital display face is positioned on the inside area of your wrist facing you Adjust the cuff 0 5 1 cm from the edge of the head of the ulna bone The cuff should fit comfortably yet snugly around your wrist Blood pressure naturally varies from one wrist to the other therefore measure your blood pressure on the same wrist to ensure comparabi...

Страница 19: ...ter the self test the values for the last reading will appear on the display The blood pressure monitor start to measure Do not move or speak while the measurement is in progress 4 The cuff will automatically begin to inflate with the display showing the increasing pressure in the cuff As the pressure increases an arrow pointing up will appear on the display 5 When the inflation has reached optimu...

Страница 20: ...easurement and pulse will display simultaneously on the screen 8 The Hypertension Indicator will indicate your reading range on the display separately 9 The reading will automatically be stored in memory 10 Select POWER to turn the unit off and conserve energy and battery life The unit will automatically shut off approximately 2 minutes ...

Страница 21: ... the stages that could potentially indicate increased risk Please note that cues provided by this monitor are only intended to assist you in using this table The table and cues are only provided for convenience to help you understand to the level information They are not a substitute for a medical examination by your physician It is important for you to consult with your physician regularly Your r...

Страница 22: ...19 ...

Страница 23: ...ement values You can take another measurement to make sure the values are not influenced by moving during measurement or Irregular Heartbeat The appearance of the 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 ...

Страница 24: ...ythmias nor for diagnosing or treating an arrhythmia problem As a safeguard we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your blood pressure monitor ...

Страница 25: ...ments Measurements will appear on the display from most current to oldest the memory number will appear on the lower left corner 3 All results for a given measurement will display including measurement results pulse rate Hypertension Indicator and date time stamp 4 When the number of readings exceeds 60 the oldest data will be replaced with the new record 5 Press the Power button to turn the monit...

Страница 26: ...23 Clearing Measurements from Memory From power display off press and hold down the MEMORY button until the display shows CLr This indicates that all measurements have been erased ...

Страница 27: ...n process The firmware and software of the product have been programmed in the production process and the programming interface is different from the data transmission interface When programming to the microcontroller use an encrypted programmer so there is no need to worry about the software being tampered with during transmission Bluetooth function What You Need An Android device with Android ve...

Страница 28: ...ownload an app which supports Bluetooth 4 0 from the iTune App Store or Google Play 2 Enable Bluetooth on your mobile device 3 Open the app and activate the function 4 Turn on the BPM19B 5 The app should automatically detect your BPM19B Tap the BPM19B that is showed in the device list 6 Your BPM19B is now successfully connected to your mobile device Every measure reading will be transfer to your m...

Страница 29: ...g to the mobile phone for the first time make sure that the pairing password is not leaked You can send results in memory zone as following step 1 Press Memory recall button of blood pressure monitor to enter memory mode The symbol AVG and M will appear on the display and the number of memory index is A3 2 Turn on the Bluetooth function of device to search the blood pressure monitor Then the blood...

Страница 30: ...27 3 After the connection is completed you can press memory recall button to display the memory result on LCD Each result showed on LCD the result will be transmitted by Bluetooth immediately ...

Страница 31: ...Inflation too low The wrist cuff is not fastened properly Reapply the cuff and take a measurement again Err 02 Measured abnormal values Take a rest for 3 5 minutes Re apply the cuff and take a measurement again Err 03 Deflation fault Re apply the cuff and take a measurement again Err Memory error Take off batteries to reboot the device then take another measurement ...

Страница 32: ...29 Error Code Cause Corrective Action Low batteries Replace all batteries with new ones ...

Страница 33: ...is not at heart level Measure while in the correct posture The cuff is not wrapped snugly around the wrist Wrap the cuff correctly The arms and shoulders are tense Relax and try taking the measurement again Movement or talking during measurement Remain still and do not talk during measurement ...

Страница 34: ... and how relaxed you are Take several deep breaths and try to remain relaxed before taking a measurement Nothing happens when you press the buttons The batteries have been inserted incorrectly Insert the batteries with the correct polarity Overpressure protection The machine must be adjusted according to the instruction manual and with professional equipment ...

Страница 35: ...32 Problem Cause Remedy Errors with wrist positional The machine must be adjusted according to the instruction manual and with professional ...

Страница 36: ...t use any detergents or solvents Never hold the instrument under water as otherwise liquid can penetrate and damage the instrument Never place any heavy objects on the instrument Please note For home use device disinfection 75 Ethanol or Isopropyl alcohol available in the phWristacy can be used receipt requested ...

Страница 37: ...sure 3 mmHg Pulse rate 4 of reading Operating environment 10 40 50 104 with relative humidity up to 85 non condensing Atmospheric Pressure 700 1060 hPa Storage Transportation environment 20 50 4 122 with relative humidity up to 85 non condensing Atmospheric Pressure 700 1060 hPa Power Source 2 x 1 5 V AAA batteries alkaline ...

Страница 38: ...ight approx 94 5g exclude batteries Dimensions approx 94 5mm 68mm 15mm L W D Cuff circumference approx 12 5 21 cm Frequency 2402 2480GHz Output power range 4dBm Life time 3 years Battery life above 300 times ...

Страница 39: ...r s declaration Electromagnetic emissions Phenomenon Professional healthcare facility environment a HOME HEALTHCARE ENVIRONMENT a Conducted and radiated RF EMISSIONS a CISPR 11 Group 1 Class B Harmonic distortion Not applicable Voltage fluctuations and flickering Not applicable a The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to pati...

Страница 40: ...ironment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard Guidance and manufacturer s declaration Electromagnetic immunity Enclosure port Phenomenon Basic EMC standard or test method Immunity test levels Professional healthcare facility environment HOME HEALTHCARE ENVIRONMENT ELECTRO...

Страница 41: ...tions equipment transmitters and the BPM19B can be requested from supplier using the contact information provided in this manual However it is advisable to keep the electromechanical aerosol equipment at an adequate distance of at least 0 5 m from mobile phones or other RF communications transmitters to minimise possible interference RATED power frequency magnetic fields IEC 61000 4 8 30 A m c 50 ...

Страница 42: ...t rooms and respiratory treatment facilities in hospital or clinics The more restrictive IMMUNITY acceptance limits have been considered and applied b Before modulation is applied c This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields ...

Страница 43: ...40 Explanation of Symbols The CE marking with the Registration Number of the Notified Body This denotes the compliance of European Medical Device Directive 93 42 EEC Medical Device Manufacturer ...

Страница 44: ...41 Authorized representative in the European Community Date of manufacture YYYY MM DD or YYYY MM Batch code YYMMWWWW Serial number YYMWWWXXXXX ...

Страница 45: ...42 Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation ...

Страница 46: ... information Should you wish to dispose of the article do so in accordance with current regulations Details are available from your local authority WEEE 2012 19 EU Directives RoHS This product fulfilling the requirements of the RoHS Directive 2011 65 EU ...

Страница 47: ...e EC 1907 2006 and its amendments do not contain Substances of Very High Concern in concentration above the limit of 0 1 No substance s is are present in the parts of the product above the concentration of 0 1 weight by weight ON OFF push push Device classification type BF ...

Страница 48: ...against solid foreign objects of 12 5mm and greater and against vertically falling water drops when enclosure tiled up to 15 The empty completely flat batteries must be disposed of through specially designated collection boxes recycling points or electronics retailers You are legally required to dispose of the batteries Importer ...

Страница 49: ...46 Distributor Model Number Country of Manufacturer Unique Device Identifier BPM19BP 22002AV 2022 06 29 ...

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