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Complied Standards List

Risk management

EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk 

management to medical devices

Labeling

EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.

Symbols to be used with medical device labels, labelling and information to 

be supplied. Part 1 : General requirements

User manual

EN 1041:2008 +A1:2013 Information supplied by the manufacturer of 

medical devices

General 

Requirements

for Safety

EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical 

equipment - Part 1: General requirements for basic safety and essential 

performance

EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - 

Part 1-11: General requirements for basic safety and essential performance 

- Collateral standard: Requirements for medical electrical equipment and 

medical electrical systems used in the home healthcare environment

Electromagnetic

compatibility

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 

1-2: General requirements for basic safety and essential performance - 

Collateral standard: Electromagnetic disturbances - Requirements and tests

Performance

requirements

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:

Requirements and test methods for non-automated measurement type 

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 

3: Supplementary requirements for electro-mechanical blood pressure 

measuring systems

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: 

Particular requirements for the basic safety and essential performance of 

automated non-invasive sphygmomanometers

Clinical investigation

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test 

procedures to determine the overall system accuracy of automated non-

invasive sphygmomanometers

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical 

validation of automated measurement type

Usability

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical 

electrical equipment - Part 1-6: General requirements for basic safety and 

essential performance - Collateral standard: Usability IEC 62366-1:2015 

Medical devices - Part 1: Application of usability engineering to medical 

devices

Software life-cycle

processes

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device 

software - Software life-cycle processes

Bio-compatibility

ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: 

Evaluation and testing within a risk management process ISO 10993-5:2009 

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 

ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests 

for irritation and skin sensitization

EMC GUIDANCE

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments

Warning

: Don’t near active HF surgical equipment and the RF shielded room of an ME 

system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning

: Use of this equipment adjacent to or stacked with other equipment should 

be avoided because it could result in improper operation. If such use is necessary, this 

equipment and the other equipment should be observed to verify that they are operating 

normally.

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Summary of Contents for Compact 2297 90000

Page 1: ...3 18 CZ M i krevn ho tlaku na pa i N VOD K OBSLUZE 19 33 SK Automatick mera krvn ho tlaku na pa i N VOD NA OBSLUHU 34 47 GB Automatic blood pressure monitor on arm INSTRUCTIONS FOR USE Model ETA2297 T...

Page 2: ...S TA R T S TO P 2 3cm A A1 A2 A3 A4 A6 A5 B C A5 1 2 3 1 2 3 4...

Page 3: ...t i t n a dr bu prov d nou u ivatelem nesm j prov d t d ti pokud nejsou star 8 let a pod dozorem Nikdy spot ebi nepou vejte pokud nepracuje spr vn pokud upadl na zem a po kodil se nebo pokud spadl do...

Page 4: ...et jen by mohl br nit pr toku krve a v st ke zran n PACIENTA P i pou v n p stroje dejte pozor aby nedo lo k uveden m situac m je mohou naru it pr tok krve ovlivnit krevn ob h u pacient a t m jim zp s...

Page 5: ...pn m stavu P stroj zkontrolujte a v p pad po kozen jak hokoli druhu jej nepou vejte Dal pou v n po kozen ho p stroje m e v st k razu nep esn m v sledk m nebo v n mu nebezpe Man etu neperte v pra ce an...

Page 6: ...organizace WHO a Mezin rodn spole nost pro hypertenzi ISH stanovily v roce 1999 n sleduj c klasifikaci krevn ho tlaku Tlak mm Hg Optim ln Norm ln Mezn oblast hypertenze m rn hypertenze st edn hyperte...

Page 7: ...ku p i r zn ch ka dodenn ch situac ch Pravideln dom c m en krevn ho tlaku m e l ka i poskytnout cenn informace o skute n ch ka dodenn ch hodnot ch tlaku emu je t eba v novat pozornost p i dom c m m en...

Page 8: ...r A1 tla tko START STOP A2 tla tko SET A3 tla tko MEM A4 LCD displej A5 otvor pro p ipojen hadi ky A6 prostor pro baterie B man eta C hadi ka POPIS DISPLEJE TIP A koliv tento spot ebi nepodporuje p m...

Page 9: ...hem m en srde n tep U ivatel 1 U ivatel 2 Zah jit m en u U ivatele 1 U ivatele 2 Pam as datum Zobrazuje slo pam ti as datum IV POKYNY K OBSLUZE Pro spr vnou funkci spot ebi e dbejte na pe liv dodr en...

Page 10: ...Pozn mka Hlavn tepnu najdete tak e dv ma prsty zatla te na m sto asi 2 cm nad vnit n m ohybem lokte Tam kde je tep nejv ce hmatateln se nach z hlavn tepna Obr 3 4 Man eta by m la pa i obep nat ne v a...

Page 11: ...e V m pr m rn hodnota posledn ch t z znam Pokud je soubor z znam ni ne t i nejprve se zobraz posledn ulo en hodnota 2 Stisknut m MEM nebo SET si zobraz te hodnotu kterou chcete Aktu ln je 2 Odpov daj...

Page 12: ...lo en Vlo te baterie spr vn Baterie jsou vybit Displej je ztemn l p padn se na n m zobrazuje Zda nejsou baterie vybit Vlo te nov baterie Chybov hl en Zobrazuje se E 1 Man eta nen zaji t na Znovu upevn...

Page 13: ...jejich recyklace Uveden symboly na v robku nebo v pr vodn dokumentaci znamenaj e pou it elektrick nebo elektronick v robky nesm b t likvidov ny spole n s komun ln m odpadem Za elem jejich spr vn likv...

Page 14: ...ypu BF Verze software A01 UPOZORN N A SYMBOLY POU IT NA SPOT EBI I OBALECH NEBO V N VODU HOUSEHOLD USE ONLY Pouze pro pou it v dom cnosti DO NOT IMMERSE IN WATER OR OTHER LIQUIDS Nepono ovat do vody n...

Page 15: ...obcem medic nsk ch za zen Obecn bezpe nostn po adavky EN 60601 1 2006 A1 2013 IEC 60601 1 2005 A1 2012 Zdravotnick elektrick za zen st 1 Obecn po adavky na z kladn bezpe nost a funk nost EN 60601 1 11...

Page 16: ...ZA ZEN ME nebo SYST MY ME jsou vhodn mi p stroji pro pou it v r mci dom c p e v dom c m prost ed Varov n Nep ibli ujte se k aktivn mu vysokofrekven n mu chirurgick mu vybaven a RF st n n m stnosti ME...

Page 17: ...2 kV 4kV 8 kV 15 kV vzduchu 8 kV kontakt 2 kV 4kV 8 kV 15 kV vzduchu 31 5000 Elektrick rychl p echod roztr en IEC 61000 4 4 Neuplat uje se Neuplat uje se P ep t IEC61000 4 5 Neuplat uje se Neuplat uje...

Page 18: ...30 470 GMRS 460 FRS 460 FM c 5kHz odchylka 1kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulzn modu lace b 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE roz 5 Pulzn m...

Page 19: ...jov Tento spotrebi nesmie by pou van de mi Spotrebi m u pou va osoby so zn en mi fyzick mi alebo ment lnymi schopnos ami alebo nedostatkom sk senost a znalost pokia s pod dozorom alebo boli pou en o p...

Page 20: ...na meranie krvn ho tlaku Nikdy neme te predp san lieky bez porady s lek rom Nepodnikajte iadne lie ebn opatrenia na z klade vlastn ho merania Nikdy neme te lek rom stanoven d vkovanie liekov V pr pade...

Page 21: ...a te tla idlo START STOP k okam it mu vypusteniu vzduchu z man ety Man etu uvo nite a dajte dole z ruky Hne ako tlak v man ete dosiahne 40 kPa 300 mmHg vzduch sa za ne automaticky vyp a V pr pade e sa...

Page 22: ...ka organiz cia WHO a Medzin rodn spolo nos pre hypertenziu ISH stanovili v roku 1999 nasleduj cu klasifik ciu krvn ho tlaku Tlak mm Hg Optim lny Norm lny Medzn oblas hypertenzia mierna hypertenzia str...

Page 23: ...ri na spodnej strane vlo te bat rie spr vnou polaritou a kryt opa n m sp sobom zavrite V mena bat rie Otvorte kryt bat ri na spodnej strane tlakomeru Vlo te bat rie pozor na spr vnu polaritu a kryt u...

Page 24: ...Mesiac De Hodiny Min ty Srdcov tep Monitor krvn ho tlaku zis uje behom merania srdcov tep U vate 1 U vate 2 Zah ji meranie u U vate a 1 U vate a 2 IV N VOD NA OBSLUHU Pre spr vnu funkciu spotrebi a db...

Page 25: ...e te na ruku man etu Hadi ka m vies vn tornou stranou ruky s be ne s mal kom Alebo umiestnite zna ku tepny na hlavn tepnu na vn tornej strane ruky Obr 2 Pozn mka Hlavn tepnu n jdete tak e dvoma prstam...

Page 26: ...emern hodnota posledn ch troch z znamov Pokia je skup n z znamov menej ako tri najprv sa zobraz posledn ulo en hodnota 2 Stla en m MEM alebo SET si zobraz te hodnotu ktor chcete Aktu lny je 2 Odpoveda...

Page 27: ...bezpe en Znovu upevnite man etu a vysk ajte znovu Zobrazuje sa E 2 Man eta je pr li pritiahnut Znovu upevnite man etu a vysk ajte znovu Zobrazuje sa E 3 Tlak v man ete je pr li vysok Chv u si odd chni...

Page 28: ...v ktor s pou it na obalov materi l komponenty a pr slu enstvo ako aj na ich recyklovanie Uveden symboly na v robku alebo v sprievodnej dokument cii znamenaj e pou it elektrick alebo elektronick v robk...

Page 29: ...110 x 41 Stupe ochrany V robok typu BF Verzia software A01 UPOZORNENIA A SYMBOLY POU IT NA SPOTREBI I OBALOCH ALEBO V N VODE HOUSEHOLD USE ONLY Len na pou itie v dom cnosti DO NOT IMMERSE IN WATER OR...

Page 30: ...013 Inform cie dod van v robcom medic nskych zariaden Obecn bezpe nostn po iadavky EN 60601 1 2006 A1 2013 IEC 60601 1 2005 A1 2012 Zdravotn cke elektrick zariadenia as 1 Obecn po iadavky na z kladn b...

Page 31: ...i pr strojmi pre pou itie v r mci dom cej starostlivosti v dom com prostred Varovanie Nepribli ujte sa k akt vnemu vysokofrekven n mu chirurgick mu vybaveniu a RF tienenej miestnosti ME syst mu pre zo...

Page 32: ...kV 8 kV 15 kV vzduchu 8 kV kontakt 2 kV 4kV 8 kV 15 kV vzduchu 31 5000 Elektrick r chly prechod roztrhnutie IEC 61000 4 4 Neuplat uje sa Neuplat uje sa Prep tie IEC61000 4 5 Neuplat uje sa Neuplat uje...

Page 33: ...0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5kHz odch lka 1kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulzn modul cia b 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE r...

Page 34: ...safe way and understand the hazards involved Children shall not play with the appliance Cleaning and user maintenance shall not be made by children without supervision Never use the appliance if it m...

Page 35: ...lood flow and result in harmful injury to the PATIENT When using this device please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patie...

Page 36: ...tion Before use make sure the device functions safely and is in proper working condition Check the device do not use the device if it is damaged in any way The continuous use of a damaged unit may cau...

Page 37: ...blood pressure mmHg Diastolic blood pressure mmHg The blood pressure classification published by World Health Organization WHO and International Society of Hypertension ISH in 1999 is as follows Blood...

Page 38: ...olarity and close the cover Use AAA batteries 4 pcs for this appliance If you are not using the appliance for some time take the batteries out Note Do not use different type of batteries Do not use us...

Page 39: ...STRUCTIONS FOR USE A SETTING DATE TIME AND MEASUREMENT UNIT It is important to set the clock before using your blood pressure monitor so that a time stamp can be assigned to each record that is stored...

Page 40: ...ff should be snug but not too tight You should be able to insert one finger between the cuff and your arm 5 Sit comfortably with your tested arm resting on a flat surface Place your elbow on a table s...

Page 41: ...w 1 Hold pressing MEM and SET at the same time for 3 seconds when the monitor is in the memory recall mode the flash display will show dEL ALL 2 Press SET to confirm deleting the monitor will display...

Page 42: ...r contact information and return Warning message out shows Out of measurement range Relax for a moment Refasten the cuff and then measure again If the problem persists contact your physician VI MAINTE...

Page 43: ...tworks Never dispose of the battery by burning VIII TECHNICAL DATA Parameter Description Measurement mode Oscillographic testing mode Protection against Measurement range Rated cuff pressure 0 mm Hg 2...

Page 44: ...D CHILDREN DO NOT USE THIS BAG IN CRIBS BEDS CARRIAGES OR PLAYPENS THIS BAG IS NOT A TOY Manufactured by Guangdong Transtek Medical Electronics Co Ltd Zone A No 105 Dongli Road Torch Development Distr...

Page 45: ...requirements for the basic safety and essential performance of automated non invasive sphygmomanometers Clinical investigation EN 1060 4 2004 Non invasive sphygmomanometers Part 4 Test procedures to d...

Page 46: ...e life 2 Guidance and manufacturer s declaration electromagnetic emissions and Immunity Table 1 Guidance and manufacturer s declaration electromagnetic emissions Emissions test Compliance RF emissions...

Page 47: ...Frequency MHz Band MHz Service Modulation Modulation W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse modulation b 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1kHz...

Page 48: ...u nespr vn nebo neodborn mont e v robku po kozen p stroje vlivem iveln pohromy pou v n v robku pro jin ely ne je obvykl pou v n v robku k profesion ln i jin v d le n innosti pou v n v robku s jin m ne...

Page 49: ...kona mo n alebou osoby opr vnenej v robcom v robku na vykon vanie z ru n ch opr v Pri reklam cii je nutn predlo i reklamovan v robok origin l n kupn ho dokladu v ktorom je zrete ne uveden typ v robku...

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Page 52: ...e 03 2020 DATE 18 3 2020...

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