Belter Health Measurement and Analysis Technology EPA46B sphygmomanometer User Manual

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. sphygmomanometer

User Manual

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd ePA-46B sphygmomanometer user m anua l shenzhen belter health measurement and analysis technology co.,ltd
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Tha nk you for purchasing t he BELTER e lect ronic sphygm om anom et e r This product is a sphygm om anom et er w hich uses noninva sive m et hod t o m e asure hum a n blood pre ssure .Plea se be sure to re ad t he inst ruct ions befor e use.Aft er rea ding, please safe keeping for inspect ion a t any tim e, reference. Scope of applicat ion: used for blood pressure and pulse m ea sur em ent of hum an body. The sphygm om a nom ete r is a ble t o store up t o 1 0 0 m ea sur em ents per user ( m a xim um 2 user s) an d equipped w ith the Blue toot h Sm a rt t echnology t o achieve r eliable t ransm ission link age w it h a m obile device or t ablet PC tha t is w it h t h e logo and corr esponding a pplica tion. Fr om now on, you ca n ea sily t ra ck your he alth on a daily basis. Referent Standards and Documents No Standard Name Reference No. 1 Standard Name Reference No. 2 Medical Device Quality System for the regulation requirement EN ISO13485: 2012 3 Medical device risk management to medical devices application EN ISO14971: 2012 4 Symbol for the label of medical devices EN 980: 2008 5 Term, symbol and information of medical device— information of medical device manufacturer offering EN 1041: 2008 6 Medical electrical equipment – Part 1: General requirements for safety EN60601-1: 2006/AC:2010 7 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests EN 60601-1-2: 2007 8 Clinical investigation of medical devices for human subjects. General requirements EN ISO 14155-1:2009 9 Clinical investigation of medical devices for human subjects. Clinical investigation plans EN ISO 14155-2:2009 10 Medical device software – Software life-cycle processes EN 62304: 2006/AC: 2008 11 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability EN 60601-1-6: 2010 12 Medical electrical equipment. Part 1-11:General requirements for basic safety and essential performance. Collateral standard:Requirements for medical electrical equipment and medical electrical EN 60601-1-11
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd systems used in the home healthcare environment 13 Medical devices – Application of usability engineering to medical devices EN62366: 2008 14 Council Directive 93/42/EECof 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 (including Directive 2007/47/EC ) MDD 93/42/EEC 15 Non- invasive sphygm om anom et ers —Part 1: General requirem ents EN 1060-1 16 Non- invasive sphygm om anom et ers.Part 3: Supplem entary requirem ents for elect ro- m echanical blood pressure m easuring syst em s EN 1060-3 17 Manual, elect ronic, or autom at ed sphygm om anom et ers SP10 18 User Manual Version:1.0 I m port ant safe t y not e s SI GN S AND SYMBOLS The following signs appear in this m anual. READ THE SAFETY SECTI ON AND ALL I NSTRUCTI ONS AND WARNI NGS COMPLETELY AND CAREFULLY BEFORE USI NG THI S PRODUCT. FOLLOW ALL SAFETY I NSTRUCTI ONS AND WARNI NGS TO AVOI D HAZARDOUS SI TUATI ONS AND TO MAKE CORRECT USE OF THI S PRODUCT. sym bol Description WARNING WARNING indicates a hazardous situation which, if not avoided, could Result in death or serious injury CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury NOTICE addresses practices not related to personal injury, such as product and/or property damage Type BF Bluetooth function Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is DI SPOSAL NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd necessary This item is compliant with Medical Device Directive 93/42/EEC of June 14,1993, a directive of the European Economic community Refer to instruction manual / booklet IP22 Degree of protection against harmful ingress of particulate matter and water Manufacturer Authorized representative in the European Community Date of manufacture Serial number SYS systolic DIA diastolic PUL pulse w a rning Do not use t h is product in the m ixed gas of flam m a ble gas w it h air or w ih oxygen or w it h nit rous oxide conditions. Do not dispose of ele ct rical appliance s as unsorte d m unicipal w aste , use separ a t e collect ion fa cilit ie s. Cont act you loca l governm ent for infor m at ion regarding the colle ct ion syst em s available. I f ele ct rica l appliance s a re dispose d of in landfills or dum ps, hazar dous subst a nces ca n lea k in t o the groundw at er a nd get int o t he food chain , dam a ging your he alt h a nd w e ll- being. The device is not suit able for use in the presence of flam m able ane sthe tic m ix ture s w it h air or w ith ox ygen or nitrous oxide. The device requires no calibra tion. The de vice is not repair able and cont ains no user servicea ble part s. N o m odificat ion of this e quipm e nt is allow e d. Rem ove batt er ies if e quipm ent is not lik ely to be used for som e tim e .
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd The user m u st check t hat t he equipm e nt funct ions safely and see that it is in pr oper w or king condit ion be fore being use d. The m a nufa ct urer does not require such pre ventive inspections by oth er pe rsons. . I t is dangerous t o car ry on self j u dgm e nt a nd self t rea t m ent by t he sufferer him se lf,so please follow doctor’s inst ruct ion. Self j udgm ent m a y lea d to exa cerbat ion of disease . Get a serious blood circulat ion obst acle, blood paroxysm sufferer, please use under the doct or's inst ruct ion, while m easuring because the arm is squeezed m ay cause im patient internal bleeding . I nfant and person not be able to express him self,please do not use . Please control t he add pressue to t he arm band in the range of 300 m m Hgs( 40 kpas) , otherwise the arm m ay appear blood clot, benumbed sym pt om . This product is only used for hum an body blood pressure m easurem ent and used out side t he purpose of m easuring hum an body blood pressure, m ay take place accident . Please don't use a cell phone in the neighborhood of this product and have the danger t o m ake product m ist ake act ion . Please don't dism ant le to unload or fix by yourself, reform ation of t he blood pressure account of essence or arm band, ot herwise can not m easure correct ly . Please use AA alkaline batt ery, don't use other bat teries, ot herwise m ay arouse breakdown . I f the elect rolyte in t he bat tery get s into your eye, please im m ediately flush with a great deal of clear water, will result into to blindness or other harm ful danger, need to im m ediately arrive hospit al nearby t o cure . I f the elect rolyt e in the bat tery glues on t he skin or the clothes, please im m ediat ely flush wit h a great deal of clear wat er, otherwise m ay hurt skin Please use special arm band, ot herwise m ay not be able t o m easure correct ly. I f t he abnorm al sit uation of adding pressure cannot st op or abnorm al air exhaustion occurs while m easuring,please rem ove t he arm band or pull out t he air pipe,ot herwise m ay suffer peripheral nerve disorder. CAUTION .Please be sure t o use the appropriate cuffs band, ot herwise you can't get correct m easurem ent .Please don't pack a plus or m inus pole of battery to pack anti-. After t he bat tery is used up, please replace it with new batt ery at t he sam e tim e, long tim e no need t o use ,please t ake out t he batt ery . The m et hod to abandon t he bat t ery aft er use please deal with it according t o cit y environm ental protect ion regulat ions. Please do not m ix use new and old bat t eries,otherwise m ay cause leakage, fever, fract ure of the bat tery to dam age the product . Please use according t o the st orage t em perature and hum idit y st andard recored in the user m anual.
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd When arrhythm ia situat ion occurs,the m easurem ent value m ay be incorrect or can not be m easured. .Please don't m ake an effort to curve arm band and arm band windpipe .While dism antling an air t ube, please take t he forepart of t he air tube plug t o pull out .Please don't bum p shot or drop t he product , this m ay lead t o t he m easurem ent value of t he product incorrect. Please do not add pressue before t he arm band wraps around t he upper arm ,or you can not get correct m easurem ent value. When the plug or wire of the power adapter is dam aged,please im m ediately drawn it out of the socket,ot herwise m ay cause the danger of fire or elect ric shock. Please do not use wet hand t o pull the power adapter from t he socket ,ot herwise m ay cause elect ric shock or fire burn. Operating instructions: How t o inst all and replace t he bat t e ry 1. Downward push the bat tery cover, rem ove the bat tery cover from ontology 2. I nst all or replace the 4 AA bat teries,Make t he bat tery positive ( + ) and negat ive ( - ) ext rem ely consist ent wit h the m arks in t he battery box,and then close t he batt ery cover. Please replace t he bat tery in the st at e of the body cut off power. I f you rem ove t he batt ery in the boot state, then count t im e to st op. When the low bat tery icon () appears on the screen please replace 4 batt eries. Recom m end alkaline bat tery wit h longer service life. When 3 m ont h or longer tim e wit hout t he use of the blood pressure please t ake out the batt ery. After replacing t he bat tery, you m ay need t o reset t he date / tim e. The m ethod to abandon the bat t ery after use please deal with it according to city NOTICE NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd environm ental protect ion regulat ions. How to sele ct th e adapt er a nd use Please choose t he output volt age is DC6V, out put current is 1A dedicated to m edical treat m ent power supply adapter. Please insert t he plug of the power adapt er into t he power adapter int erface of the product . Please insert t he power adapt er into t he socket. Please do not use nondedicated power adapt er. Even if you use the power adapter, please st all batt eries into t he product . The installat ion of bat teries is t o protect t he tim e sett ings. I f you do not inst all bat t eries, unplug the power adapter from the socket ,t he m achine will autom at ically st op count ing t im e, t he hist ory dat a will be delet ed. Se t custom er , dat e and t im e Please carry on enact m ent according to t he sequence of cust om er, age, m ont h and date, hour and m inute Shut down st at us bot tom , double-click SET butt on to get into a cust om er to choose m ode. Show a cust om er at t his t im e 1, press MEM button to chose cust om er 2: Press  SET  butt on, setage value  Press one tim e[ m em ory] butt on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but ton NOTICE power plug
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd The enactm ent scope of year is 2000-2040.I f the year at tains 2040, it will ret urn 2000 Press  SET button, set the m onth be worth  Press one tim e[ MEM] butt on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but ton Press SETbut ton, set dat e  Press one tim e[ MEM] butt on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a butt on Press SET butt on, sethour& m inute  Press one tim e[ MEM] butt on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but ton Set unit At shut down status, press SET but ton, then press MEM butt on t o carry on the conversion of t he blood pressure unit "m m Hg" and"kPa" . NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd The use of m e m ory funct ion Press MEM butt on, t he device shows user's group.Press SETbutt on again, it shows the latest diagraph result .(Press SETbutton up to change user) During the process of reading m easuring m em ory, When long press MEM but ton, all the m em ory value will be delet ed. I f show "-- -", m eans delet e finished. This blood pressure is autom at ically save t est value and pulse wit h m easurem ent date and tim e, 60 sets of diagraphs are kept. I f saved dat a is over than 60 sets, t he oldest diagraph result will be delet ed, newest one will be saved. Using st eps 1、 Tie up arm t o t ake A、plug the air tube of t he arm band into the joint of the product. B、open the arm band,put arm band air t ube toward the palm inside.(as below pict ures) NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd C, fix the armband in position, as position shown in below pictures . C、fix t he arm band t ight ly. Correct diagraph post ure I f you use it out of the indicated t em perat ure and hum idit y range,it m ay not be able t o achieve claim ed perform ance requirem ent. While m easuring you m ust ensure t he correct post ure t o obtain accurat e results. NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Even forget to t urn off t he power ,after about 2 m inut es it will shut down aut om at ically . Please m easure and control blood pressure at the sam e tim e every day. Measurem ent should be taken in quiet places ,the m easured person should be in a relaxed sit ting posit ion. You'd bet ter have a rest of 15 m inutes before m easurem ent. dat a transfe r The dat a uploads t o cellular phone or com puter via blue t oot h. Key of sym bols signal W ar ning- see use r m a nual Tr e at m ent The arm band fix t oo loose Check whet her arm band is loose t o m ove, re- fast en t ight again for m easuring. Speaking during m easurem ent or m ove the arm Keep body and arm st able and m easure again There's interference or work not correct ly during m easurem ent . Shut down, re- m easure once. The product leaks air or arm 's taking don't put good enough. Please check arm t o t ake whether already put like. Bat tery energy shortage Please replace bat tery Ex cr esce nt check
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Ex cre sce nt cir cu m st a nce Rea son Tr e at m ent Measured result is big deviation from norm al Arm band doesn't t ake correct ly The exact itude t ies up good arm to t ake t alks or m oves arm during the m easuring Keep quiet and m easure The clot hes of curling up oppressed arm take off t he clot hes and m easure again Don't add to press Air plug do not plug in the ontology of air tube correct Connect t he t ube correct ly The arm t akes to leak air Purchase new arm to take. The arm t akes in t he in a short t im e to carry on exhaust ion The arm takes t o t ie up too loosely Please t ie up t ight arm to take Add t o ran over dist ance in suddenly t he power failure reset clock Bat tery energy exhaust ion Replace new batt ery After pressing butt on, don't show Bat tery energy exhaust ion Replace new batt ery The power get s in touch with bad or pack anti- The exact it ude put s into batt ery Ot her phenom ena Show the appearance trem bles Can not m easure Please press ON/ OFFbutton, re-operat e 1 t im e. Please replace bat tery t o try. I n addition st ill can not m easure, please consult room contact wit h BELTER healt hily This product has ca r ried on ch e ck in t he fa ctor y,please ex ecut e strict ly in accordance w it h t he in struct ion m a nual. funct ion spe cification NOTICE
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Nam e Sphygmomanometer Model num ber ePA- 4 6B Display m ode Display m ode Bluetoot h Support ed Bluet oot h V2.0 Measurem ent scope The pressure m easurem ent scope: 0-280 m m Hg(0-37.3 kPa) Pulse scope: 40- 200 Tim e/ m inut e Accuracy Pressure: ± 3 m m Hg Pulse accuracy : ± 5% Power DC6v/ ” AA* 4” Weight 196g Shape size W74 m m * L152 m m * H33 m m Arm band size: W154 m m * L 486 m m ,air t ube to grow 600 m m Apply arm t he scope22cm - 36cm  operating environment a) temperature : +5℃-+40℃ a) relative humidity：15%-80% b) atmospheric pressure :700hpa-1060hpa Transportation and storage environment a)temperature :-20℃-+50℃ b)relative humidity：15%-90% c)atmospheric pressure :500hpa-1060hpa Protection against electric shock internal electric source,.BF application part clinical allow maximum error margin This product pass clinical verification, the clinical maximum allowable error is ≤±5mmHg/±0.67kPa Bat tery service life 300times(alkaline dry bat t ery can use ) product expects life span 2years CLASSIFICATION 1. Internally powered equipment; 2. Type BF applied part: cuff; 3. IP22; 4. Not category AP / APG equipment; 5. Mode of operation: continuous operation. Cleaning, maintenance and Storage Please always clean sphygmomanometer. Please use clean soft cloth ,gently wipe the LCD and shell, do not use solvents, and do not be soak it in water or other liquids. Please do not wash the arm band of the product. If the product is especially dirty you can use a soft cloth with water or neutral detergent, fully wring dry to wipe the product. Please do not use gasoline, thinner or similar solvent to clean arm band. When you do not use, please storage the sphygmomanometer and accessories in the collection bag.
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Please do not place the sphygmomanometer and arm band in high temperature, damp, full of water vapor or direct sunlight conditions. Please do not let the blood pressure cuff suffer strong shock or vibration (e.g., fell on the ground). Please do not put the blood pressure at easy splashing places. Please don't put this product where there is chemical or corrosive gas. Please do not dismantle the blood pressure. Please storage the product in requied environment. Calibration and repair This product has been calibrated and tested when delivered from the factory. If you have doubt about the measurement result of the product , please contact us and give the product to specialized person to repair Warranty: If you use the device according to the manual, replace it within 3 months and guarantee for free a year. The following situations are not included in warranty time: 1 problem caused by self dismounting 2 problem caused by shocking during use or delivery. 3 problem caused by incorrect maintenance 4 problem caused by incorrect operating, problems caused by unprofessional repair. Product Composition A piece of the product Cuff band and air pipe linemodel:BEARM-011PCS Probation dry cell4 AA batteries Collect soft band 1 piece A copy of instruction for use Adverse events :non ShenZhen Belter Health Measurement and Analysis Technology Co.,ltd 702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd 2012-09 FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct The interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation. Note: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. such modifications could void the user’s authority to operate this equipment.

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