EN Version:1.0 User Manual ARCHOS Blood Pressure Monitor
Contents
1. 0123 Version 1 0 ARCHOS User Manual ARCHOS Blood Pressure Monitor Wrist Type Thank you very much for selecting ARCHOS Blood Pressure Monitor Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product and keep the manual well for your further reference in case you have problems C 0123 Bluetooth ONG TRANSTEK MEDICAL ELECTRONICS CO LTO A SF mesinent Budding Ne 12 Hutrhen East Rd Torch Zaongshas Guangdong 528437 Chine SehiSgraban 41 20175 Harrewar Garmany CATALOGUE Table of Contents INTRO DUG ON ects oeccasesscesscctbaavsceassceeattescrssasetatytocra actsayenesaveztostcnscassesttssczertsseecsayasvesesesaiyeceawedeesivseraa ectvatsedussgetberesceavsareatnenee 2 Safety Information LCD Display Signal Monitor Components BEFORE YOU START isssssesssssaseveschsscssssavessasscasdsesesazverteissSevayaedbevsveevuitetbsyacuaittaostrndest R R AE 6 Installing and Replacing the Batteries Setting Date and Time MEASUREMENT icii E sipsseesqnsisiaivstbansvigaisedbesivebanse toasts tbandehauiiatigiueesaisevbesseteies 11 Tie the Cuff Start Measurement DATA MANAGEMEN Tessexdesstcctsseseats sceatsscaceissceasisvadssyucnaaseSoossyvecsssysnevosstosssutecbsscedtsbeseasssdeansunbanaisceasivinautusevsagvtesanivevasteteaassieites 13 Recalling the Records Deleting the Records INFORMATION FOR USER sssssssecets sisccssetsaiss EE AA EE SR 15 Tips for Measurement Maintenance2. ABOUT BLOOD PRESSURE vsssissssonss ssssssscoovacsensvsssnnvivsonsvesensvicsnavedsenvdvstonwdshavedeesostdsuatesostadesessvvessescsevovbcesustdseveudbesstdvivesceevets 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 the blood pressure get from the hospital is different from home If the result is the same if measuring on the right wrist TROUBLES FOO MUN G asasena aiee esenea apane aasia Eara aitaren ease caseustencadscosstadassteitustes aeassteatesasaassucuctesccssresasestolsertastee 19 SPECIFICATIONS cscsscessessicsnesvisvciasveeitauessecsssdeasgcsssconnssacSuendsuuhetausie adarasveyvesbasveviudacsstsesousbunebessqssoiachaiuussiniasVestadsrausbnidbesteesioncsd 20 CONTACT INFORMATION esis seceasicssessnaseiedsstaaasectvebssedzossadvenvssuansssisstntenasvceaaisucssiesvaststadaasvdgeshv aatadhchatuldsaisasaat hacdeauseasasioisste 21 COMPLIED EUROPEAN STANDARD LIST sssessssssssseesssescsssessssessssesssecssscessncesseasssesssseassseessseessuecssncessneeesseesssessnsessnsasens 21 EMG GUIDAINGE A E T tint cativay cua aheasietsa E T 22 x INTRODUCTION General Description Thank you for selecting ARCHOS Blood Pressure Monitor The monitor features blood pressure measurement pulse rate measurement and the result storage The design provides you with two years of reliable service Reading taken by the Blood Pressure Monitor ar
3. danger to the user patient Manufacturer will make available on request circuit diagrams component parts listed Sensitive people including pregnant women and those who implanted medical electronic Instrument should avoid using the unit whenever possible This unit is not suitable for continuous monitoring during medical emergencies or operations After the cuff inflated long time the patient s wrist and fingers will is insufficient anesthesia distending pain and ecchymosis Please use the device under the environment which was provided in the user manual Otherwise the performance and lifetime of the device will been 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 has been evaluated clinically used manual cuff stethoscope auscultation as the reference The device doesn t need to be calibrated in two years of reliable service When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation the test result may occur deviation Please consult your physician about the result This device is contraindicated for any female subject who may be suspected of or is pregnant Besides provided inaccurate readings the effects of
4. dim Batteries are low Replace with new batteries batteries or Display Error 2 shows The cuff is very tight Readjust the cuff not too loose or too tight and then measure again Error re E Data communication Check if the APP is on or not try massage shows has failed data transmission again Error 1 shows Inflation is slow or the Refasten the cuff and then cuff is not secure measure again Error 3 shows The pressure of the cuff Refasten the cuff and then is excess measure again Error Error 5 or Error 6 shows System error Retake the measurement massage occurred If the problem persists contact the retailer or our customer service department for further assistance Refer to the warranty for contact information and return instructions Error 10 or Error 11 The monitor detected Relax for a moment and then shows motion talking or measure again the pulse is too poor while measuring Error Error 20 shows The measurement Loosen the clothing on the massage process does not wrist and then measure again detect the pulse signal Error 21shows on the The treatment of the Relax for a moment and then display measurement failed measure again SPECIFICATIONS Power supply 2 AAA batteries Display mode Digital LCD V A 36x41mm 21 22 Measurement range Pressure 0kpa 40kpaXO0mmHg 300mmHgX pulse value 40 199 beat minute Accuracy Pressure 5X 40Xwithin 0 4kpa 3mmHg OX 45X out of 5X 40X within 0 7kpa 5mmHg pulse va
5. the measurement will not be accurate Resting for 5 minutes before measuring Wait at least 3 minutes between measurements This allows your blood circulation to recover For a meaningful comparison try to measure under similar conditions For example take daily measurements at approximately the same time on the same wrist or as directed by a physician Pair up the Blood Pressure Monitor with Your Device f s 1 Turn on Bluetooth and the app Make sure both are ON Oo 0 when pair up is proceeding 2 When the monitor is OFF press and hold the START button for 2 seconds to start pair up The symbol and the symbol will be shown on the LCD alternatively indicating pair up is proceeding If SUCCEED symbol willbe shown onthe LCD 3 11 12 mq Be If FAIL symbol will be shown on the LCD i 3 The monitor will shut off automatically after Pair up process is complete MEASUREMENT Start Measurement 1 After correctly positioning the cuff press START button to turn on the monitor and it will complete the measurement process automatically Adjust to zero 8 sa OAH Inflating and measuring 30 y 4 8 20 S ivie Display and save the measuring result 2 This device will proceed to data transmission automatically after measurement The Bluetooth symbol blinks Lies xX Ws 68 3 If the data is successfully transmitted the LCD will display as pictured to the right ao ne
6. If the data transmission fails the LCD will display ERROR instead 4 Press STOP button to turn off the monitor Otherwise it will power off automatically 14 The mobile or portable equipment which are equipped with Bluetooth function in line with BLE Technical Specifications as well as BLP Protocol established by global organization Bluetooth SIG are capable to receive the health data including measurement time systolic pressure diastolic pressure etc DATA MANAGEMENT Recalling the Records 1 Press MEM button to access the memory i 19 a Be pi B 2 Press MEM UP button or SET DOWN button to rotate the history records MEM UP to go forward SET DOWN to go backward iig R ICa v Deleting the Records When you did not obtain the accurate measurement you can clear all the measuring results by following below steps i i8 1 Under Memory Recalling Mode press and hold both the MEM 79 button and the SET button for 3 seconds 18 2 The LCD will display QEL dONE indicating that memory clearing is JEL a complete 3 If you wish to give up clearing press START STOP to turn off the aane monitor 4 When there is no memory in the monitor if you press the MEM button to look up History the LCD will display as pictured to the right INFORMATION FOR USER meee Tips for Measurement It can cause inaccuracy if the measuremen
7. blood pressure classification The blood pressure classification published by World Health Organization WHO and International Society of Hypertension ISH in 1999 is as follows CAUTION aan 1m wm 1s Only a ph cian can tell your normal BP range Please contact a physician if your ily a physician could tell whether your blood pressure value has reached a dangerous point 17 18 huis lal Irregular Heartbeat Detector This Wrist 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 heartbeat intervals compare with the average intervals the deviation more than 3 is over 25 or more than 5 is over 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 thisis NOT a cause for concer 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 Why does my blood pressure fluctuate throughout the day 1 Individual blood pressure varies every in one day it also affected by the way you t i e your cuff and your measurem
8. e 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 Read the manual thoroughly before using the product FEATURES Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Memory Up to 60 pieces of records Safety Information The below signs might be in the user manual labeling or other components They are the requirement of standard and using Symbol for THE OPERATION GUIDE Symbol for MANUFACTURER MUST BE READ C 0123 Symbol for COMPLIES WITH Symbol for Authorized Representative MDD93 42 ECC REQUIREMENTS in the European Community The Bluetooth Combination Mark Symbol for TYPE BF APPLIED advice Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE Symbol for SERIAL NUMBER 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 CAUTION Please do read this user manual carefully and thoroughly before use 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 wrist or for functions other tha
9. ent position so please take the measurement at the same condition 2 The varies of the pressure is greater if the person take medicine 3 Waiting at least 3 minutes for another measurement K 3 Why the blood pressure I get from the hospital is different from home The blood pressure is different even during 24 hour because of the weather emotion exercise etc especially the white coat in hospital which makes the results are higher than the ones at home If the result is the same if measuring on the right wrist It is ok for both wrists but there will be some different results for different person so suggest you measure the same wrist every time The attention need to pay when you measure you blood pressure at home If the cuff is tied properly If the cuff is too tight or too loose If the cuff is tied on the wrist If you feel anxious pressured You had better take deep breath 2 3 times before beginning 19 Advice adjust yourself for 4 5 minutes until you calm down TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your wrist blood pressure monitor If the products not operating as you think it should check here before arranging for servicing PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will Replace with new batteries not light up Batteries are inserted Insert the batteries correctly incorrectly Low Display is
10. lines Do not dispose of batteries in fire Batteries may explode or leak Setting Date and Time Please proceed to time setting before your initial use so as to ensure each piece of record is labeled with a time stamp Year Range 2012 2052 Time Format 12 Hours 1 When the monitor is OFF press and hold SET button for 3 seconds to enter Time Setting Mode 8 8 tin By 2 As pictured in the right the blinking numeral 6 representing HOUR Press MEM button to change the numeral Each press will increase the numeral by one ina cycling manner a a tn B 3 Press SET button again to confirm HOUR Then the numeral representing MINUTE blinks 4 Repeat step 2 and 3 to confirm MINUTE R 8 36 so y Fr ao 5 Repeat step 2 and 3 to confirm MONTH DAY and YEAR 8 36 836 8 36 i B 27 18 18 B d FE TE ry 7Y 6 After confirming YEAR the LCD will display DONE and the monitor will shut off 10 Tie the Cuff 1 Remove all accessories watch bracelet etc from your wrist If your physician has diagnosed you with poor circulation in your wrist use the other wrist 2 Roll or push up your sleeve to expose the skin 3 Apply the cuff to your wrist with your palm facing up A 4 Position the edge of the cuff about 1 1 5 cm A 5 Fasten the wrist cuff around your wrist leaving no extra room Rs between the cuff and your skin If the cuff is too loose
11. lue 5 Normal working condition Temperature 5X 40X Relative humidity lt 80 Atmospheric pressure 86kPa to 106kPa Storage amp transportation condition Temperature 20X to 60X Relative Humidity 10 to 93 RH Degree of protection Type BF applied part Protection against ingress of water IP22 Device classification Internally Powered ME Equipment WARNING No modification of this equipment is allowed CONTACT INFORMATION Contact Information For more information about our products please visit www archos com you can get customer service usual problems and customer download ARCHOS will serve you anytime Manufactured by GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD Company GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD Address Zone A 5 F Investment Building No 12 Huizhan East Rd Torch Development District Zhongshan Guangdong 528437 China Authorized European Representative Company MDSS Medical Device Safety Service GmbH Address Schiffgraben 41 30175 Hannover Germany 23 24 Complied European Standards List Risk Management EN ISO 14971 2007 Labeling EN 15223 2012 General Requirements EN 60601 1 2006 AC2010 for Safety EN 60601 1 11 2010 Non invasive EN 1060 1 1995 A2 2009 Sphygmomanometers EN 1060 3 1997 A2 2009 General EN 1060 4 2004 Requirements Electromagnetic EN 60601 1 2 2007 AC 2010 Compatibility Software Lifetime EN 62304 2006 AC 2008 Usability EN 60601 1 6 2010 EMC Guida
12. m structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m 30 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment at the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum out
13. n obtaining a blood pressure measurement Do not confuse self monitoring with self diagnosis This unit allows you to monitor your blood pressure Please start or end medical treatment basing solely on 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 If the pressure of the cuff exceeds 40 kPa 300 mmHg the unit will automatically deflate Should the cuff not 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 the conditions of strong electromagnetic field e g medical RF equipment that radiates interference signal or electrical fast transient burst signal The maximum temperature that the applied part can be achieved is 42 5X while the environmental temperature is 40X 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 keep the unit out of reach of infants or children since inhalation or swallowing of small parts is dangerous or even fata Please use ACCESSORIES and detachable parts specified authorized by MANUFACTURER Otherwise it may cause damage to the unit or
14. nce Table 1 Guidance and MANUFACTURER S declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEM Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 The device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected Harmonic emissions IEC Not applicable 61000 3 2 Voltage fluctuations flicker Not applicable emissions IEC 61000 3 3 25 26 Table 2 Guidance and MANUFACTURER S declaration electromagnetic IMMUNITY for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level f Electromagnetic environment guidance 6 kV contact 6 kV contact Floors should be wood Electrostatic 8 kV air 8 kV air concrete or ceramic tile discharge ESD If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for po
15. put power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter w 150 kHz to 80 MHz 80 MHz to 800 MHz 3 57 ps 3 5 r v JYP d LV 4 d 25 yp a 3 vP d Lv Not applicable Not applicable For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency 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 31
16. r or the user of the device should assure that it is used in such an environment IMMUNITY IEC 60601 test Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance Conducted RF 3 Vrms Not IEC 61000 4 6 150 kHz to 80 applicable MHz 800 MHz 2 5 GHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 LE zh a MH25 Gis hes Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occurin the vicinity of equipment marked with the following symbol p NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fro
17. t is taken in the following circumstances 15 16 Maintenance To obtain the best performance please follow below instructions 4 OA Se Put in a diy place and Avoid immersing It in the water ka Ciean R wtth a dry doth In case Avoid dusty environment and unstable temperature surrounding Avold shating and collision A Use fhe slightly damp cioth to remove the dirt Avoid washing the cut Cleaning Dust environment may affect the performance of the unit Please use the soft cloth to remove the dirt before use Please make sure the unit functions safely and it is in proper working conditions before use Please follow the instructions for correct replacement of interchangeable or detachable parts specified by SERVICE PERSONNEL of MANUFACTURER as Replaceable Disposal Degraded sensors or loosened electrodes may degrade the unit s performance or even cause other problems Please dispose of ACCESSORIES detachable parts and the ME EQUIPMENT according to the local guidelines 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 Systolic Diastolic boad discharging blood entering What is the standard
18. this device on the fetus are unknown LCD Display Signal 888 DESCRIPTION EXPLANATION Systolic Blood Pressure High blood pressure Diastolic Blood Pressure Low blood pressure Low Battery Low battery and please replace the batteries Monitor Components Component List 1 PCBA 2 Air Pipe 3 Pump 4 Valve 5 Cuff MEMIUP SYSTOLIC BUTTON DIASTOLIC START STOP BUTTON PULSE RATE LCD DISPLAY TIME SETIOOWN SUTTON List 1 Wrist Blood Pressure Monitor 2 Two AAA size batteries 3 User Manual BEFORE YOU START Installing and Replacing the Batteries Open the battery door Insert the batteries according to the polarity indications Always select the authorized specified battery Two LRO3 AAA size batteries Close the battery door Battery Life Approx 57 days Battery capacity 600 mAH If measured 3 times per day each measurement takes 30s and memory checked once per day each checking takes 60s The current for measurement is 350 mA and that for records display is 50 mA while the current when shutdown is 25 uA Charging the power under following circumstances displays on the LCD The LCD display dims When powering on the monitor the LCD doesn t light up CAUTION Remove batteries if the device 1s not likely to be used for some time Worn batteries are harmful to the environment Do not dispose with daily garbage Remove the old battery from the device following your local recycling guide
19. wer Not applicable Mains power quality transient burst supply lines should be that of a IEC 61000 4 4 1 kV for input typical commercial or output lines hospital environment Surge 1 kV line s to line s Not applicable Mains power quality IEC 61000 4 5 2 kV line s to earth should be that of a typical commercial or hospital environment Voltage dips short X5 UT K95 dip in Not applicable Mains power quality interruptions and UT for 0 5 cycle should be that of a voltage variations on 40 UT 60 dip in typical commercial or power supply input UT for 5 cycles hospital environment lines IEC 61000 4 11 70 UT 30 dip in If the user of device UT for 25 cycles requires continued X5 UT K95 dip in operation during power UT for 5s mains interruptions it is recommended that device be powered from an interruptible power supply or a battery Power frequency Power frequency 50 60 Hz magnetic fields should magnetic field be at levels characteristic IEC 61000 4 8 of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 27 28 Table 3 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 device is intended for use in the electromagnetic environment specified below The custome
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