Boneco 2in1.STEP User Manual Download Page 42

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Specifikace

Model

PG-201 (

2in1. STEP

Blood Glucose

Monitoring Systém)

Testovací metoda

Elektrochemické senzory

Kalibrační metoda

Plazma

Vzorek

Plná kapilární krev

Velikost vzorku

0,5

Doba testu

5 vteřin

Paměť

500 výsledků krevního cukru a kroků

Rozsah výsledku

0,6~ 33,3 mmol/L (10~600 mg/dL)

Maxim kroků

99.999 kroků (dostupné pouze
u

2in1. STEP

)

Hematokrit

20 - 60%

Pracovní teplota

10~40˚ C

Operační relativní vlhkost

10 – 90%

Nadmořská výška

Do 3 048 m (10 000 stop)

Zdroj

Baterie CR2032, 3 V, lithiová baterie,
vyměnitelná

Velikost

36,7 mm x 61,7 mm x 15,8 mm

Váha

30 g

Summary of Contents for 2in1.STEP

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 87: ...glucose 2in1 step...

Page 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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