Boneco 2in1.STEP Скачать руководство пользователя

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Before Starting

Symbols:

Caution, see instructions for use

Single use only

Expiration date

Serial number

Lot number

In Vitro Diagnostic medical device

Manufacturer

Authorised representative

Symbol for temperature limitation

Consult instructions for use

Biological risks

Contains sufficient for <n> tests

Direct current

Separate disposal from other household waste

Содержание 2in1.STEP

Страница 1: ...SELF TESTING IVD CZ ENG N VOD K OBSLUZE USER GUIDE Glukometr s krokom rem Blood glucose monitoring system for self testing use...

Страница 2: ...kujeme V m za n kup glukometru 2in1 STEP Abyste mohli syst m 2in1 spr vn pou vat tak si p ed prvn m pou it m pe liv p e t te tuto p ru ku Schovejte si ji i pro budouc pou it Text kter je v n vodu ozn...

Страница 3: ...rolu doma a v klinick praxi Nem l by b t pou v n pro diagn zu diabetes nebo testov n novorozenc Funkce 1 2in1 STEP m pouze jedno tla tko kter m se lehce a snadno ovl daj v echny funkce 2 Je mal m styl...

Страница 4: ...krve 16 O alternativn m m st testov n 19 Testov n Va hladiny cukru v krvi 21 Kontroln testovac roztok 25 Kontrola v sledk 28 Nastaven m i e 31 V m na bateri 34 Chybov hl en 35 e en probl m 37 Funk n...

Страница 5: ...2in1 STEP m i 2 Pouzdro 3 Lancetov pero 4 Lithiov baterie CR2032 5 Z v snou rku na krk dostupn pouze u p stroje 2in1 STEP 6 2in1 STEP testovac prou ky 7 Lancety Dokumenty k p stroji zahrnuj tuto u iv...

Страница 6: ...y S riov slo Lot slo Zdravotnick prost edek In Vitro V robce Autorizovan prodejce distributor Symbol pro teplotn omezen Viz n vod k pou it Biologick riziko Obsahuje uveden po et p slu enstv k proveden...

Страница 7: ...inidly na prou ku Tento proud m n stice cukru ve vzorku krvi Koncentrace cukru v krevn m vzorku je vypo t v na na z klad elektrick ho proudu a zobraz se na displeji m i e Nastaven data a asu V 2in1 ST...

Страница 8: ...na 3 sekundy p stroj vypnete Port pro testovac prou ky Vlo te do portu konec 2in1 STEP tes tovac ho prou ku P stroj se zapne jakmile prou ek vlo te dovnit St brn elektrody Konec testovac ho prou ku s...

Страница 9: ...a funkce st Otvor na rku Pro rku na ruku nebo na krk Bo n pohled Zadn strana Kryt baterie Vysu te kryt p i v m n bateri Tla tko SET Pou v se p i vstupu do re imu nastaven pro zm nu data asu a jednotk...

Страница 10: ...stav baterie Zobrazuje v sledky po et krok stav m en chybov hl en a dal informace V sledky jsou zobrazeny spolu s jed notkami m en Displej Popis lancetov ho pera Pr hledn krytka Nastaviteln krytka Vy...

Страница 11: ...jte 2in1 STEP p stroj pro diagnostikov n diabetes testov n novorozenc a testov n arteri ln krve 2in1 STEP obsahuje mal sti kter mohou b t po spolknut nebezpe n P ed za tkem m en zkontrolujte balen P e...

Страница 12: ...neupravujte Nevystavujte m i r zn m ok m zabra te p du a po lap n M i nen vod odoln Neom vejte ho nebo se ho nedot kejte mokr ma rukama Neot rejte p stroj edidly nebo abrazivn mi istidly Vyhn te se v...

Страница 13: ...M ete zp sobit nep esnost Nepou vejte testovac prou ek kter se zd po kozen nebo byl u pou it Prou ek je ur en pouze na jedno pou it Skladujte prou ky pouze v origin ln krabi ce Po vyjmut testovac ho p...

Страница 14: ...ho um st te nat sno nebo si ho pov ste kolem krku pomoc rky Um st n krokom ru do Va kapsy Neumis ujte m i do zadn kapsy Va ich kalhot Um st te ho do kapsy kde bude um st n nat sno Um st n krokom ru v...

Страница 15: ...zem Kdy je m i um st n v ba ohu kter se pohybuje nepravideln proto e je zasa en va nohou opaskem nebo horn st va ich kalhot Kdy p stroj vis za V p sek kalhoty nebo ba oh Kdy chod te nepravideln m temp...

Страница 16: ...ROK 1 Umyjte si ruce v tepl vod Zv te cirkulaci krve ve Va ich prstech Usu te si ruce d kladn tak aby byly prsty such KROK 2 Od roubujte v ko lancetov ho pera ot en m proti sm ru hodinov ch ru i ek za...

Страница 17: ...a dno nosi e na lancety KROK 4 Oto en m odstra te kryt lancety KROK 5 Vra te zp tky v ko na lancetov pero a oto te ve sm ru hodinov ch ru i ek KROK 6 Dr te pevn posunovac v lec v jedn ruce Dr te pero...

Страница 18: ...st te lancetov pero na p slu n m sto Dr te lancetov pero pevn kol mo proti prstu Zm kn te uvol ovac tla tko pro odebr n vzorku Upozorn n Sni te riziko infekce P ed odebr n m vzorku se ujist te e m te...

Страница 19: ...ky krve z t chto alternativn ch m st m en by m lo b t m n bolestiv ne ze pi ek prst N sleduj c obr zek ukazuje na kter ch m stech mohou b t pomoc 2in1 STEP p stroje prov d ny testy Vyh bejte se mate s...

Страница 20: ...krevn ho vzorku dokud nen dosa eno dosta te n mno stv Pokud zde nen dost krve jemn mas rujte m sto dokud nen dostate n vzorek posb r n Upozorn n Netestujte se na alternativn ch m stech kdy si mysl te...

Страница 21: ...u ku se p stroj se zapne KROK 2 Na chv li se zobraz as Potom se zob raz k dovac slo a symbol prou ku Symbol prou ku signalizuje p iprave nost p stroje k m en KROK 3 Ujist te se e k dovac slo zobrazen...

Страница 22: ...kud p stroj nezap p Krev se automa ticky nasaje do testovac ho prou ku KROK 4 M i zobraz v sledek b hem 5 sekund KROK 4 V sledek testu je zobrazen v okam iku kdy p stroj zvukem ozn m ukon en m en Hlad...

Страница 23: ...m en D le it Pokud je test okolo 33 3 mmol L 600 mg dL objev se na displeji slovo HIGH vysok Pokud je test ni ne 0 6 mmol L 10 mg dL zobraz se na displeji slovo LOW n zk D le it P stroj se vypne autom...

Страница 24: ...Pokud budou neo ek van v sledky pokra ovat zkontrolujte syst m m i e kontroln m roztokem Viz Kontroln testovac roztok str 68 Rozsah o ek van ch v sledk Hladina cukru v krvi se li podle p jmu potravy...

Страница 25: ...ou ku Symbol prou ku signalizuje p iprave nost p stroje k m en 2in1 STEP kontroln roztok obsahuje p esn definovan mno stv gluk zy a je pou van ke kontrole zda m i a testo vac prou ky pracuj spr vn Kon...

Страница 26: ...tovac mi prou ky Pokud je k dovac slo na displeji jin ne slo natisknut na krabi ce s prou ky zkuste vlo it nov prou ek KROK 4 Prot epejte lahvi kou s kontroln m roztokem a sundejte v ko Jemn se dotkn...

Страница 27: ...t testovac prou ek Zopakujte test kontroln ho roztoku V sledky mimo testovac rozsah mohou zp sobit nedodr en instrukc v u ivatelsk p ru ce pro l kontaminovan nebo z ed n kontroln roztok pro l nebo po...

Страница 28: ...tup do re imu gluk za V re imu krokom r stiskn te a podr te tla tko M Zobraz se posledn v sle dek m en hladiny cukru v krvi Uvol n te tla tko M Zobraz se posledn v sledek m en hladiny cukru v krvi Vyh...

Страница 29: ...Stiskn te a podr te tla tko M Zobraz se v sledek n sleduj c ho m en cukru v krvi Uvoln te tla tko M Zobraz se n sleduj c v sledek nam en ho cukru v krvi Poka d kdy stisknete a uvoln te tla tko M p str...

Страница 30: ...p ezkoum n P stroj zobraz 7 denn pr m rn v sledek Zat esen m p stroje znovu m ete posouvat vp ed 14 ti denn a 30 ti denn pr m ry s p pnut m Pokra ujte stisknut m tla tka M pro zobrazen ulo en ch v sle...

Страница 31: ...u nastaven M ete za t s nastaven m p stroje KROK 3 Prvn se objev nastaven roku Stisk n te tla tko M dokud nenastav te spr vn rok Stiskn te tla tko ET k p ejit na nastaven form tu data KROK 4 P i blik...

Страница 32: ...o M dokud se neobjev spr vn den Stiskn te tla tko Set a p ejd te na nastaven hodin KROK 7 P i blik n hodin stiskn te tla tko M doku se neobjev spr vn hodina P stroj zobrazuje as pouze ve 24 hodinov m...

Страница 33: ...33 Nastaven p stroje KROK 9 Kdy blik jednotka stiskn te tla tko M a vyberte mg dL nebo mmol L Stiskn te tla tko SET pro dokon en kompletn ho nastaven p stroje a p stroj vypn te...

Страница 34: ...terie nahoru KROK 1 Um st te kryt baterie zp t na m sto a pevn zav ete D le it Zlikvidujte baterii podle p edpis o ivotn m prost ed odevzdejte ji do t d n ho odpadu D le it Pokud nevym n te novou bate...

Страница 35: ...stroj a testovac prou ky dos hnou teplotn ho rozsahu Zobraz se kdy je teplota prost ed vy ne je pracov n teplotn rozsah Pracovn teplotn rozsah je 10 40 C 50 104 F Opakujte test pot a p stroj a testova...

Страница 36: ...pakujte vyjmut a vlo en testovac ho prou ku nebo opakujte test s nov m testovac m prou kem Tato zpr va Err3 zna e je probl m s p strojem P ezkoumejte instrukce a prove te test s nov m testovac m prou...

Страница 37: ...te sv ho m stn ho prodej ce nebo distributora Krev nebo ciz p edm ty byly vlo e ny do testovac ho portu Kontaktujte sv ho m stn ho prodej ce nebo distributora P stroj neprov d test po aplikaci krevn h...

Страница 38: ...ce gluk zy 4 2 mmol l 75mg dl V sledky p esnosti syst mu p i koncentraci gluk zy 4 2 mmol L 75mg dl Regresn statistiky 2in1 STEP System 0 28 mmol L 5 mg dL 87 26 30 0 56 mmol L 10 mg dL 100 30 30 0 83...

Страница 39: ...ardn odchylka mmol l mg dl Koeficient kol s n 2 3 mmol L 41 mg dL 0 07 1 2 3 0 5 7 mmol L 102 mg dL 0 15 2 8 2 7 8 2 mmol L 147 mg dL 0 17 2 9 2 0 13 2mmol L 237mg dL 0 24 4 3 1 8 21 9mmol L 394mg dL...

Страница 40: ...eby testovac ch prou k a kontroln ho roztoku Testovac prou ky a kontroln roztok maj vytisknutou dobu spot eby na jejich krabi k ch Kdy poprv otev ete krabi ku s testovac mi prou ky nebo lahvi ku s kon...

Страница 41: ...a Ned vejte dnou kapalinu p nu prach krev nebo kontroln roztok do p stroje skrz testovac port i t n lancetov ho pera a i t n AST v ka Vy ist te vn j stranu lancetov ho pera navlh en m jemn m had kem n...

Страница 42: ...rku 0 5 L Doba testu 5 vte in Pam 500 v sledk krevn ho cukru a krok Rozsah v sledku 0 6 33 3 mmol L 10 600 mg dL Maxim krok 99 999 krok dostupn pouze u 2in1 STEP Hematokrit 20 60 Pracovn teplota 10 40...

Страница 43: ...bn rovn specifikovan v IEC 61000 4 3 P stroj byl tes tov n na elektromagnetick emise specifikovan v IEC 61326 Z ruka BONECO CR s r o zaru uje e v 2in1 STEP nebude m t z vady na materi lu a zpracov n p...

Страница 44: ...GLUKOMETR 2in1 STEP Distributor Husovo n m st 42 588 13 Poln Tel 774 162 396 www boneco cr cz...

Страница 45: ...ng the 2in1 STEP Please read this User Guide carefully before using to ensure correct use Please keep this User s Guide for your future reference indicates Available only in 2in1 STEP Blood glucose mo...

Страница 46: ...rsons with use in the home and in clinical settings It should not be used for the diagnosis of diabetes or the testing of newborn Features 1 2 3 4 5 6 2in1 STEP has only one button to navigate all fun...

Страница 47: ...ternate Site Testing Testing Your Blood Glucose Control Solution Testing Reviewing Results Setting the Meter Replacing the Battery Error Messages Troubleshooting Performance Characteristics System Car...

Страница 48: ...with 2in1 STEP 1 pcs 6 2in1 STEP Blood glucose test strips 10 pcs 7 Lancets 10 pcs The address and related CE marks of lancets manufacturer and the address of lancing device manufacturer are mentione...

Страница 49: ...ation date Serial number Lot number In Vitro Diagnostic medical device Manufacturer Authorised representative Symbol for temperature limitation Consult instructions for use Biological risks Contains s...

Страница 50: ...agents on the strip This current changes with the amount of glucose in the blood sample The glucose concentration in the sample is calculated based on the electrical current and displayed on the meter...

Страница 51: ...You can turn the meter off by pressing and holding the M button for 3 seconds Test Strip Port Insert the end of a 2in1 STEP test strip here The meter will turn on when you insert the test strip Silve...

Страница 52: ...of the Parts Strap Hole It is for hand strap or neck strap Battery Cover Slide cover off to replace batteries SET Button Used to enter the setup mode for changing the date and time and unit of measur...

Страница 53: ...Adjustable cap Lancet holder Release button Display Lancing Device Displays the mode of meter Warns when the battery is low or must be replaced Display test results steps measuring status error messag...

Страница 54: ...the 2in1 STEP System for the diagnosis of diabetes testing on newborns and testing of arterial blood The 2in1 STEP System contains small parts that may be dangerous if swallowed Check the package befo...

Страница 55: ...odify the meter Do not subject the meter to severe shock drop or step on meter The meter is not waterproof Do not wash it or touch it with wet hands Do not wipe the meter with thinner or abrasive clea...

Страница 56: ...st strip against your finger This may affect inaccurate aspiration of blood Do not use a test strip that appears damaged or has been used Test strips are for single use only Store test strips in their...

Страница 57: ...the meter with neck strap around your neck Place the meter in your pocket Do not place the meter in the back pocket of your pants Place the meter in the pocket you hold tightly Place the meter in you...

Страница 58: ...e meter is placed in the bag that moves irregularly because it hits your foot your belt or the top of your pants When the unit hangs from your belt the top of your pants or a bag When you walk at an i...

Страница 59: ...increase the circulation of the blood into the fingers Dry hands thoroughly until the finger to be pricked is completely dry STEP 2 Unscrew the cap of the lancing device by turning it counter clockwi...

Страница 60: ...ile lancet into the bottom of lancet carrier STEP 4 Twist the cap of the lancet off STEP 5 Put the cap of the lancing device back on and turn it clockwise STEP 6 Hold the tip firmly in one hand then p...

Страница 61: ...g device firmly against the side of the finger with the cap resting on the finger The harder it is pressed the deeper the puncture Press the release button to take a sample Caution To reduce the chanc...

Страница 62: ...ng a drop of blood from these alternate site testing may be less painful than a fingertip sample Following figure shows the areas where you can test with the 2in1 STEP System Avoid moles veins bones a...

Страница 63: ...elease button to take a sample Watch through the clear cap until a sufficient blood sample is taken If there is not enough blood gently massage the area until a sufficient sample has been collected Ab...

Страница 64: ...on STEP 2 Time will be displayed for a moment Then Code number and strip symbol will be displayed A strip symbol with filling blood will appear letting you know the meter is ready to test STEP 3 Make...

Страница 65: ...ter beeps Blood is automatically pulled into the test strip STEP 5 The Meter will now show counting progress of 5 seconds STEP 6 The test result is complete when you hear beeps Your blood glucose test...

Страница 66: ...our area Be sure to follow your local regulations for proper disposal If your test is above 600 mg dL 33 3 mmol L HIGH will appear on the display screen If your test result is lower than 10 mg dL 0 6...

Страница 67: ...pected results check your system with control solution See Control Solution Testing page 24 Range of expected results Blood glucose levels will vary depending on food intake medication dosages health...

Страница 68: ...ess VPD Bled Pot na Lisice 4 SI 4260 Bled Slovenia Customer Service Tel 386 457 45 070 Do a control solution test to practice the test process instead of using blood whenever you open a new vial of te...

Страница 69: ...vial If the code number on the screen is different from the code number printed on the strip vial try to insert new strip STEP 4 Shake the control solution vial and remove the cap Gently touch a drop...

Страница 70: ...ntrol solution test STEP 8 To turn your meter off remove the used test strip Control Test Range 0 6 33 3 mmol dL not following the instructions on this USER GUIDE expired contaminated or watered down...

Страница 71: ...f your step STEP 2 To enter review mode In the STEP meter mode Press and hold the M button The number of last glucose result will be displayed Release the M button The last glucose result will be disp...

Страница 72: ...EP 3 Press and release the M button The counts of steps between previous and next glucose results will be displayed STEP 4 Press and hold the M button The number of next glucose result will be display...

Страница 73: ...day average shake the meter slowly in the review mode The meter will display 7 day average and 7DAY alternatively Shaking the meter again allows you to scroll forward to 14 and 30 day averages with be...

Страница 74: ...in the setting mode You can start setting up the meter STEP 3 The year will appear first with the year flashing Press the M button until the correct year appears Press the SET button to move to the d...

Страница 75: ...ton until the correct day appears Press the SET button to move to the hour setting STEP 7 With the hour flashing press the M button until the correct hour appears The meter displays only the 24 hour t...

Страница 76: ...76 Setting the Meter STEP 5 With the unit flashing press the M button to select mg dL or mmol L Press the SET button to complete meter set up and turn off the meter...

Страница 77: ...lace the new one in the tray with the side facing up STEP 3 Slide the battery cover back into place and close firmly Caution Dispose of battery according to your local environmental regulations Import...

Страница 78: ...t after the meter and test strip have reached the above temperature range Appears when environmental temperature is ABOVE system operation range System operation range is 10 40 C 50 104 F Repeat the t...

Страница 79: ...ith a new test strip This error message indicates the meter has a problem Review the instructions and re test with a new test strip If this message appears again contact the local dealer Battery is lo...

Страница 80: ...ted side up and the silver end of the strip into the test strip port on the meter Defective meter or test strips Contact your local distributor Blood or foreign objects put into the test strip port Co...

Страница 81: ...ons 75 mg dL 4 2 mmol L System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L Regression statistics 2in1 STEP System within 5 mg dL 0 28 mmol L 87 26 30 within 10 mg dL 0 56 mmol L 100...

Страница 82: ...mg dL 13 2 mmol L 4 3 1 8 394 mg dL 21 9 mmol L 9 9 2 5 2in1 STEP System Mean glucose Standard deviation mg dL Coefficient of variation 40 mg dL 2 2 mmol L 0 8 2 1 106 mg dL 5 9 mmol L 2 5 2 4 322 mg...

Страница 83: ...inal vial Checking for expiration to strips and control solution Test strips and control solution have expiration dates printed on their vials When you first open a test strip or control solution vial...

Страница 84: ...lvent to clean your meter Do not get any liquids dirt dust blood or control solution inside the meter through the test port Cleaning your lancing device and clear AST cap Clean and wipe the outside of...

Страница 85: ...e Size Weight PG 201 2in1 STEP Blood Glucose Monitoring System Electrochemical sensor Plasma Whole blood capillary 0 5 L 5 seconds 2in1 STEP 500 Blood glucose tests and steps 10 600 mg dL 0 6 33 3 mmo...

Страница 86: ...frequency interference at the frequency range and test levels specified in IEC 61000 4 3 The meter has been tested for electromagnetic emissions specified in IEC 61326 Warranty VPD Bled d o o warrants...

Страница 87: ...glucose 2in1 step...

Страница 88: ...Distributor Husovo n m st 42 588 13 Poln tel 420 774 162 396 web www boneco cr cz V robce DATUM VYD N EDITION DATE 21 11 2012 DATUM POSLEDN REVIZE LAST REVISION DATE 21 11 2012...

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