Belter Health Measurement and Analysis Technology EPA46B sphygmomanometer User Manual
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. sphygmomanometer
User Manual
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 2215520 |
| Application ID | lHvUklEf2LeHV3c43EG57Q== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 29.74kB (371780 bits) |
| Date Submitted | 2014-03-14 00:00:00 |
| Date Available | 2014-03-17 00:00:00 |
| Creation Date | 2017-10-23 15:13:55 |
| Producing Software | GPL Ghostscript 9.18 |
| Document Lastmod | 2017-10-23 15:13:55 |
| Document Title | Microsoft Word - 血压计说明书ePA-46B _Final_ |
| Document Creator | PScript5.dll Version 5.2.2 |
| Document Author: | 0111 |
Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd ePA-46B sphygmomanometer u se r m a n u a l shenzhen belter health measurement and analysis technology co.,ltd Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Th a n k you for pu r ch a sin g t h e BELTER e le ct r on ic sph ygm om a n om e t e r Th is pr odu ct is a sph ygm om a n om e t e r w h ich u se s n on in va sive m e t h od t o m e a su r e h u m a n blood pr e ssu r e .Ple a se be sur e t o r e a d t he inst r uct ions be for e u se .Aft e r r e a din g, ple a se sa fe k e e pin g for in spe ct ion a t a n y t im e , r e fe r e n ce . Scope of a pplica t ion : u se d for blood pr e ssu r e a n d pu lse m e a su r e m e n t of h u m a n body. Th e sph ygm om a nom e t e r is a ble t o st or e u p t o 1 0 0 m e a su r e m e n t s pe r u se r ( m a x im u m 2 u se r s) a n d e qu ippe d w it h t h e Blu e t oot h Sm a r t t e ch n ology t o a ch ie ve r e lia ble t r a n sm ission lin k a ge w it h a m obile de vice or t a ble t PC t h a t is w it h t h e logo a nd cor r e spon din g a pplica t ion . Fr om n ow on, you ca n e a sily t r a ck you r h e a lt h on a da ily ba sis. Referent Standards and Documents No Standard Name Standard Name Medical Device Quality System for the regulation requirement Medical device risk management to medical devices application Reference No. Reference No. EN ISO13485: 2012 EN ISO14971: 2012 Symbol for the label of medical devices EN 980: 2008 Term, symbol and information of medical device— information of medical device manufacturer offering Medical electrical equipment – Part 1: General requirements for safety Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests Clinical investigation of medical devices for human subjects. General requirements Clinical investigation of medical devices for human subjects. Clinical investigation plans Medical device software – Software life-cycle processes Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability 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 1041: 2008 10 11 12 EN60601-1: 2006/AC:2010 EN 60601-1-2: 2007 EN ISO 14155-1:2009 EN ISO 14155-2:2009 EN 62304: 2006/AC: 2008 EN 60601-1-6: 2010 EN 60601-1-11 Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd 13 14 15 16 systems used in the home healthcare environment Medical devices – Application of usability engineering to medical devices Council Directive 93/42/EECof 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 (including Directive 2007/47/EC ) Non- invasive sphygm om anom et ers —Part 1: General requirem ent s EN62366: 2008 MDD 93/42/EEC EN 1060-1 EN 1060-3 Non- invasive sphygm om anom et ers.Part 3: Supplem ent ary requirem ent s for elect ro- m echanical blood pressure m easuring syst em s 17 Manual, elect ronic, or aut om at ed SP10 18 sphygm om anom et ers User Manual Version:1.0 I m por t a n t sa fe t y n ot e s SI GN S AN D SYM BOLS The following signs appear in t his 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 indicates a hazardous situation which, if not avoided, CAUTION may result in minor or moderate injury NOTICE addresses practices not related to personal injury, such NOTICE 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 D I SPOSAL 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 r n in g D o n ot use t his pr oduct in t he m ix e d ga s of fla m m a ble ga s w it h a ir or w ih ox yge n or w it h nit r ous ox ide con dit ion s. D o not dispose of e le ct r ica l a pplian ce s a s u n sor t e d m un icipa l w a st e , u se se pa r a t e colle ct ion fa cilit ie s. Con t a ct you loca l gove r nm e nt for in for m a t ion r e ga r din g t h e colle ct ion syst e m s a va ila ble . I f e le ct r ica l a pplia nce s a r e dispose d of in la n dfills or dum ps, h a za r dou s su bst a n ce s ca n le a k in t o t he gr oundw a t e r a nd ge t in t o t h e food ch a in , da m a gin g you r h e a lt h a nd w e ll- be in g. The de vice is not su it a ble for u se in t h e pr e se n ce of fla m m a ble a n e st h e t ic m ix t u r e s w it h a ir or w it h ox yge n or n it r ous ox ide . The de vice r e quir e s n o ca libr a t ion . Th e de vice is not r e pa ir a ble a n d con t a in s no u se r se r vice a ble pa r t s. N o m odifica t ion of t h is e quipm e n t is a llow e d. Re m ove ba t t e r ie s if e qu ipm e n t is not lik e ly t o be u se d for som e t im e . Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd The use r m u st che ck t h a t t he e quipm e n t fu nct ions sa fe ly a n d se e t h a t it is in pr ope r w or k in g con dit ion be for e be in g use d. The m a nu fa ct u r e r doe s n ot r e quir e such pr e ve nt ive inspe ct ions by ot h e r pe r son s. . I t is da nge r ous t o ca r r y on se lf j u dgm e nt a nd se lf t r e a t m e nt by t he su ffe r e r h im se lf,so ple a se follow doct or ’s in st r u ct ion . Se lf j u dgm e n t m a y le a d t o e x a ce r ba t ion of dise a se . Get a serious blood circulat ion obst acle, blood paroxysm sufferer, please use under t he doct or's inst ruct ion, while m easuring because t he arm is squeezed m ay cause im pat ient int ernal bleeding . I nfant and person not be able t o express him self,please do not use . Please cont rol t he add pressue t o t he arm band in t he range of 300 m m Hgs( 40 kpas) , ot herwise t he arm m ay appear blood clot , benum bed 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 t ake place accident . Please don't use a cell phone in t he neighborhood of t his product and have t he danger t o m ake product m ist ake act ion . Please don't dism ant le t o unload or fix by yourself, reform at ion of t he blood pressure account of essence or arm band, ot herwise can not m easure correct ly . Please use AA alkaline bat t ery, don't use ot her bat t eries, ot herwise m ay arouse breakdown . I f t he elect rolyt e in t he bat t ery get s int o your eye, please im m ediat ely flush wit h a great deal of clear wat er, will result int o t o blindness or ot her harm ful danger, need t o im m ediat ely arrive hospit al nearby t o cure . I f t he elect rolyt e in t he bat t ery glues on t he skin or t he clot hes, please im m ediat ely flush wit h a great deal of clear wat er, ot herwise 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 uat ion of adding pressure cannot st op or abnorm al air exhaust ion 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 t he appropriat e cuffs band, ot herwise you can't get correct m easurem ent .Please don't pack a plus or m inus pole of bat t ery t o pack ant i- . Aft er t he bat t ery is used up, please replace it wit h new bat t ery at t he sam e t im e, long t im e no need t o use ,please t ake out t he bat t ery . The m et hod t o abandon t he bat t ery aft er use please deal wit h it according t o cit y environm ent al prot ect ion regulat ions. Please do not m ix use new and old bat t eries,ot herwise m ay cause leakage, fever, fract ure of t he bat t ery t o dam age t he product . Please use according t o t he st orage t em perat ure and hum idit y st andard recored in t he user m anual. Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd When arrhyt hm ia sit uat ion occurs,t he m easurem ent value m ay be incorrect or can not be m easured. NOTICE .Please don't m ake an effort t o curve arm band and arm band windpipe .While dism ant ling an air t ube, please t ake t he forepart of t he air t ube plug t o pull out .Please don't bum p shot or drop t he product , t his 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 t he plug or wire of t he power adapt er is dam aged,please im m ediat ely drawn it out of t he socket ,ot herwise m ay cause t he danger of fire or elect ric shock. Please do not use wet hand t o pull t he power adapt er from t he socket ,ot herwise m ay cause elect ric shock or fire burn. Operating instructions: H ow t o inst a ll a nd r e pla ce t he ba t t e r y 1. Downward push t he bat t ery cover, rem ove t he bat t ery cover from ont ology 2. I nst all or replace t he 4 AA bat t eries,Make t he bat t ery posit ive ( + ) and negat ive ( - ) ext rem ely consist ent wit h t he m arks in t he bat t ery box,and t hen close t he bat t ery cover. NOTICE Please replace t he bat t ery in t he st at e of t he body cut off power. I f you rem ove t he bat t ery in t he boot st at e, t hen count t im e t o st op. When t he low bat t ery icon ( ) appears on t he screen please replace 4 bat t eries. Recom m end alkaline bat t ery wit h longer service life. When 3 m ont h or longer t im e wit hout t he use of t he blood pressure please t ake out t he bat t ery. Aft er replacing t he bat t ery, you m ay need t o reset t he dat e / t im e. The m et hod t o abandon t he bat t ery aft er use please deal wit h it according t o cit y Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd environm ent al prot ect ion regulat ions. H ow t o se le ct t h e a da pt e r a nd use Please choose t he out put volt age is DC6V, out put current is 1A dedicat ed t o m edical t reat m ent power supply adapt er. Please insert t he plug of t he power adapt er int o t he power adapt er int erface of t he product . Please insert t he power adapt er int o t he socket . power plug NOTICE Please do not use nondedicat ed power adapt er. Even if you use t he power adapt er, please st all bat t eries int o t he product . The inst allat ion of bat t eries is t o prot ect t he t im e set t ings. I f you do not inst all bat t eries, unplug t he power adapt er from t he socket ,t he m achine will aut om at ically st op count ing t im e, t he hist ory dat a will be delet ed. Se t cust om e r , da t e a n d t im e Please carry on enact m ent according t o t he sequence of cust om er, age, m ont h and dat e, hour and m inut e Shut down st at us bot t om , double- click SET but t on t o get int o a cust om er t o MEM but t on t o chose cust om er 2: choose m ode. Show a cust om er at t his t im e 1, press Press SET but t on, set age value Press one t im e[ m em ory] but t on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but t on Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd NOTICE The enact m ent scope of year is 2000- 2040.I f t he year at t ains 2040, it will ret urn 2000 Press SET but t on, set t he m ont h be wort h Press one t im e[ MEM] but t on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but t on Press SET but t on, set dat e Press one t im e[ MEM] but t on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but t on Press SET but t on, set hour& m inut e Press one t im e[ MEM] but t on, prom ot e 1. I t can quickly change dat a while cont inuously pressing down a but t on Se t u n it At shut down st at us, press SET but t on, t hen press MEM t he conversion of t he blood pressure unit " m m Hg" and"kPa" . but t on t o carry on Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Th e u se of m e m or y fu n ct ion Press MEM but t on, t he device shows user's group.Press SET but t on again, it shows t he lat est diagraph result .( Press SET but t on up t o change user) During t he process of reading m easuring m em ory, When long press MEM but t on, all t he m em ory value will be delet ed. I f show " - - - " , m eans delet e finished. NOTICE This blood pressure is aut om at ically save t est value and pulse wit h m easurem ent dat e and t im e, 60 set s of diagraphs are kept . I f saved dat a is over t han 60 set s, t he oldest diagraph result will be delet ed, newest one will be saved. Usin g st e ps 1、 Tie up arm t o t ake A、plug t he air t ube of t he arm band int o t he j oint of t he product . B、open t he arm band,put arm band air t ube t oward t he palm inside.( as below pict ures) 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 NOTICE I f you use it out of t he indicat ed 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 obt ain accurat e result s. Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Even forget t o t urn off t he power ,aft er aut om at ically . Please m easure and cont rol blood pressure at Measurem ent should be t aken in quiet places relaxed sit t ing posit ion. You'd bet t er have a rest of 15 m inut es before about 2 m inut es it will shut down t he sam e t im e every day. ,t he m easured person should be in a m easurem ent . da t a t r a n sfe r The dat a uploads t o cellular phone or com put er via blue t oot h. Ke y of sym bols sign a l W a r n in g- se e u se r m a n u a l The arm band fix t oo loose Tr e a t m e n t Speaking during m easurem ent or m ove t he arm Check whet her arm band is loose t o m ove, refast en t ight again for m easuring. Keep body and arm st able and m easure again There's int erference or work not correct ly during m easurem ent . Shut down, re- m easure once. The product leaks air or arm 's Please check arm t o t ake t aking don't put good enough. whet her already put like. Bat t ery energy short age Ex cr e sce n t ch e ck Please replace bat t ery Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Ex cr e sce nt cir cu m st a n ce Measured result is big deviat ion from norm al Don't add t o press Re a son Tr e a t m e nt Arm band doesn't t ake correct ly The exact it ude t ies up good arm t o t ake t alks or m oves arm during t he m easuring Keep quiet and m easure The clot hes of curling up oppressed arm t ake off t he clot hes and m easure again Air plug do not plug in the ontology of air tube correct Connect t he t ube correct ly The arm t akes t o leak air Purchase new arm t o t ake. The arm t akes in t he in a The arm t akes t o t ie up t oo Please t ie up t ight arm t o short t im e t o carry on loosely t ake exhaust ion Add t o ran over dist ance in suddenly t he power failure Bat t ery energy exhaust ion Replace new bat t ery Bat t ery energy exhaust ion Replace new bat t ery reset clock Aft er pressing but t on, don't show The exact it ude put s int o The power get s in t ouch wit h bad or pack ant i- bat t ery Please press ON/ OFF but t on, re- operat e 1 t im e. Ot her phenom ena Show t he appearance Please replace bat t ery t o t rem bles Can not m easure t ry. I n addit ion st ill can not m easure, please consult room cont act wit h BELTER healt hily NOTICE Th is pr odu ct h a s ca r r ie d on ch e ck in t h e fa ct or y,ple a se e x e cu t e st r ict ly in a ccor da n ce w it h t h e in st r u ct ion m a n u a l. fu n ct ion spe cifica t ion Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd Nam e Sphygmomanometer Model num ber Display m ode ePA- 46B Bluet oot h Support ed Bluet oot h V2.0 The pressure m easurem ent scope: 0- 280 m m Hg( 0- 37.3 kPa) 40- 200 Tim e/ m inut e Pressure: ± 3 m m Hg : ± 5% DC6v/ ” AA* 4” 196g W74 m m * L152 m m * H33 m m W154 m m * L 486 m m ,air t ube t o grow 600 m m Apply arm t he scope22cm - 36cm a) temperature : +5℃-+40℃ a) relative humidity：15%-80% b) atmospheric pressure :700hpa-1060hpa a)temperature :-20℃-+50℃ b)relative humidity：15%-90% c)atmospheric pressure :500hpa-1060hpa Measurem ent scope Pulse scope: Accuracy Pulse accuracy Power Weight Shape size Arm band size: operating environment Transportation and storage environment Display m ode 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 t ery service life product expect s life span 300times(alkaline dry bat t ery can use ) 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: problem caused by self dismounting problem caused by shocking during use or delivery. problem caused by incorrect maintenance 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.
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : No Encryption : Standard V4.4 (128-bit) User Access : Print, Extract, Print high-res Author : 0111 Create Date : 2014:03:12 15:45:34+08:00 Modify Date : 2014:03:12 15:45:45+08:00 XMP Toolkit : Adobe XMP Core 4.2.1-c041 52.342996, 2008/05/07-20:48:00 Creator Tool : PScript5.dll Version 5.2.2 Metadata Date : 2014:03:12 15:45:45+08:00 Format : application/pdf Title : Microsoft Word - 血压计说明书ePA-46B _Final_ Creator : 0111 Producer : Acrobat Distiller 9.0.0 (Windows) Document ID : uuid:f667f4c9-62e6-4b00-b273-d74c8916376a Instance ID : uuid:e778e454-1e97-4b5b-99ea-569e35e8ef88 Page Count : 15EXIF Metadata provided by EXIF.tools