Lifescan SureStep Pro manual

Be dsid e Un it Ope r ato r’ s Guid e BU .boo k Page 1 M on d ay, Oct o ber 28 , 2 002 1 1: 14 PM[...]

BU .boo k Page 2 M on d ay, Oct o ber 28 , 2 002 1 1: 14 PM[...]

i The SureSt ep ® Pr o Be dside Unit is for in vitr o diagn ostic use f or th e qua ntitat ive measurem ent o f glucose in venous, ca pilla ry , arter ial, and n eonat al whole blo od s am ples. It sh oul d not be used for the diagnosis of diabetes. BU.book Page i Monda y, O ct o ber 28, 2002 11: 14 P M[...]

ii ▲ CA UTION This product contain s a b arcod e scanne r . It is a cl as s II las er wh ich ope rat es a t 68 0 n m and use s 0. 88 mW of en er gy . This pr odu ct m eets 21 CF R (Code of Fed er al R egulat ions ) 10 40.10* la ser l ight wh en acti vated. Do not sta re into the laser beam . Refer to page 8 of th is guid e for in fo rma t i on a [...]

iii T able o f Co n ten ts Prefa ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Abou t This Guide . . . . . . . . . . . . . . . . . . . vi What Y ou’ll Find i n Th is Guid e . . . . . . . vi Convent ions Us ed in This Gui de . . . . . . . viii Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i x CHAPTER 1– Introducti[...]

Table of Cont e nts iv CHAPTER 4– Data M anagem ent . . . . . . . 41 Transf erri ng Data to t he Workstati on . . . . 41 Using a Dir ect In frared P ort Con n ectio n 42 Using the Conn ection M odule . . . . . . . . 44 Bedsi de Un it Me mory . . . . . . . . . . . . . . . . 49 Acces sing Memor y to Re view Data . . . . 49 CHAPTER 5– Ca re an d M[...]

v Pref ace Sur eStep Pro i s Life Scan’ s integr ated blood gluco se ma nagem ent syste m for t esting, tracki ng, and managing pa tie nt and qua lity contr ol da ta. The SureSt epPro Sys tem o ff e rs dia betes care giver s and patients off-m eter bl ood d o sing of the t est strip. Th is design can hel p reduce the ri sk of trans missi o n of b[...]

Prefac e vi About Thi s Guide The Sur e StepPr o Bed side U nit O pera to r’ s Gui de prov ides det aile d in structi ons on us ing and mainta inin g t he Sure St epPro Beds ide Unit. Becaus e b edside unit setting s wi ll vary depending on h ow the unit is conf igured, yo u will benefit by becomi ng fami liar wit h the confi gurat ion o ption s.[...]

vii Chapter 5, Care and M aintenance, instructs you o n how to clean the bedside uni t and t est strip holde r and change t he batte rie s. Chapt er 6, Sp ecial T ests , provi de s inst ru ction s for per forming a line arity test and an unknown soluti on te st. Als o inclu ded ar e in structi ons on in-ser vice training , when teach ing new operat[...]

Prefac e viii Co n v e ntio n s U se d in T his G u id e ■ NO TE Poi nts out additi onal informa tion th at may be helpful . ◆ IMP ORT ANT Contai ns in form ation necessary to s uccessf ully pe rfor m t h e te st. ▲ CA UTION Aler ts you to situations that could r esu lt in instr ume nt damage, f ailure in a pr oce dure, o r possib le i naccu [...]

ix Hel p 1. Read t hrough the section of the guide speci fic to the operat ion y ou are perf orming. Refer to th e tabl e of co ntents and inde x t o lo c at e i nfo rma t io n. 2. Se e Cha pter 7 for er ror messa ges and troubl eshoo ti ng informati on. 3 . Cal l Life S c an Hea lth ca re Pr of ess i on al Lin e at: 1 800 524-7226 (USA) 1 888 353-[...]

Prefac e x BU .boo k Page x M on d ay, Oct o ber 28 , 2 002 1 1: 14 PM[...]

1 CHAP T ER 1 Intr od uctio n The SureStepPr o Bedsi de Unit is one component of L ifeScan ’ s prof essiona l blood glucose monitor ing system. When u sed with SureStepPro T est Strip s, the bedsi de unit measures a patient’ s blood glucose l evel from a who le bloo d sa mp le ta ken at the be dsid e. Bloo d is a pplie d dir ectly to the te st [...]

Intr oducti on 2 The beds ide unit store s patient and quality control data in internal memory . A bi-direct ional da ta t ran sfe r , perf or me d with th e wor k stat i on, sen ds te st resu lts f ro m the beds id e unit to th e worksta tion and the lates t configur ation in for - mati o n fr om t he wo rk stat ion to t he be dsi de unit. LifeSca[...]

3 The B eds i de U ni t ▲ CA UTION Do not stare into the b arcode scanner or point it towards anyone’ s eyes while the laser lig ht is on. P ower but ton turns the uni t on and o ff . T est st rip h older cov ers th e lens area and holds t he t est st rip . T he holder s lides out of the uni t for e as y cl ea ning . Th e le ns ar ea , located [...]

Intr oducti on 4 T h e inse rtion point is the are a where the test stri p is insert ed. T he base hold s the te st st ri p i n pl ace . The cove r protec ts the lens. TEST S TRIP HO LD ER Op e ne d The test strip h older is i nterchangeable—the same holder may be used in any SureStep brand meter . Close d BAC K Batte ry Compart men t ho lds two [...]

5 General Op erati ng Inf or mati on LifeS can reco mme nds tha t on ly certi f ied oper ators in the hospital or clin ic perform blood gluc ose testin g u si ng the SureStepPro Sys tem. B efo re yo u can o p e rat e t h e b ed si d e u ni t, it mu s t be con figur ed. Y our sy stem adm ini strator w ill per form this f uncti on afte r com pleti ng[...]

Intr oducti on 6 A Main M en u lets you s elect fro m six di fferent funct ions. Enter ing Info rmatio n Sele ct an item from a list by t ouchi ng the appr opria te a re a of t he s cr een. If a list is too long to fit on one s creen , a rro w buttons allow yo u to scr oll th rough the lis t. P atient T es t allo ws yo u t o ru n a patien t t es t.[...]

7 Manu ally ent er ID s or lot numbers b y pres s in g the app ropriate ch aract ers on th e scree n. Both alpha a nd num eric ch ar acters ar e available for data ent r y. Use the A–Z and 0–9 buttons to swi tch b etween al pha an d numeric mode s. Press Ok w hen you have compl eted the en try. T o del ete th e l ast char acter or ch aract ers [...]

Intr oducti on 8 Scann ing a Bar cod e T o scan a ba rcode, hold t he barcode label paral lel to and appro ximat ely 6 t o 1 0 inches from the u nit’ s sca nne r. Pres s and rel ease the Scan butt on on the scr een. Scann ing begins whe n y ou r t humb is li ft e d fro m th e sc r ee n. After a su cce ssfu l scan , t he infor mati on appea rs in [...]

9 Syst em Bee p Signals The S ureS tepPro Beds id e Uni t uses be eping signa ls to indicate various stag es i n the testing procedur e. Th es e signals do not indi cate that the proc edure is bei ng p erform ed corr ectly . The unit can d etect so me, bu t not all , error s in the te st procedu re. • A single short beep sound s each time a selec[...]

Intr oducti on 10 sam ple was applied. The in tensity of the blue is rea d by t he be ds id e uni t—t he d arke r the blue , the hi gh er the gluco se le ve l . Whit e T i p fa c es u p as the tes t s t r ip is i nserte d into the test strip holde r. Pi nk T e st Sq ua re i s the ar ea where the blood must be appl ied. For deta iled inf ormati on[...]

11 ◆ IM POR T ANT T est St rip Infor ma tio n For de tailed inf ormati on regardin g SureS tepPro T est Strips, r ead the package i n se rt . • Use o n ly S u re S t epP r o Test St ri ps w it h t he Su reS tepP ro B lo od Gl uc ose B ed s ide U ni t. • S ureSte pPro T est Stri ps are s ens itiv e to he at, li ght, and mois ture. Ke ep the m [...]

Intr oducti on 12 • Use ea ch tes t strip i m mediate ly a fter removi ng i t fro m the bot tle. • Do not use t est s trip s that a re bent, t orn, cu t, or dama ged in any way . • Co mpare t he col or of the co nfirm ati on do t from a n u n used test st ri p t o the “Unus ed ” color dot sho wn o n th e Co lor Ch art on th e tes t stri p[...]

13 – If the confi rmat ion d ot is comp letel y blue, com par e it to the sample color dots on th e te s t str ip bo ttl e Colo r C ha rt. I f th e colo r c ompar ison indicat es v ery l ow blood gluco se, repeat the t est. If t he resul t is still low er than e xpected , perfor m a quali ty contro l test. A pa ssin g cont rol r esu lt indicat es[...]

Intr oducti on 14 Infec tio n Co nt rol Us e un i v e rs a l bl o o d p recau ti o n s. * Al l p at i en t sample s and materia ls w ith whi ch they come i n contact are consider ed b ioha zards a nd should be han dled as i f c apable o f transm itting infect ion. Foll ow proper prec aut ions in acco rdance w ith you r inst itut ion’ s poli cies [...]

15 CHA PT ER 2 Qua lity Contro l T e st Thre e levels of SureSte pPr o Gl ucos e Contro l Solut ion a re available to check tha t the SureSt epP ro Beds ide Unit and SureS te pPro T e st S tri ps are func tioni ng prope rl y. The SureStep Pro bedside uni ts are cali brate d at the factory . Alt hough an inter nal v erifica ti on is perf orme d each[...]

Qual ity Co ntrol Te st 16 When to Perf or m a Q ual i ty Contro l Test • As r e qu ire d b y y o u r i ns tit u t i o n ’ s q uality con t ro l po li cy or lo cal r eg ul atory req ui rements. • When you open a new bottl e of test strips . • I f a pati ent test ha s been repe ate d and the bloo d gl ucose resul ts are still l ower o r high[...]

17 Glucose Control Sol uti ons Use S ure StepPr o Glu cose C ontro l Soluti ons with th e SureS tepPro Bed side Unit a nd SureSt epP ro T est S trips o n ly . ◆ IMP ORT AN T C o nt ro l Sol u tio n I nfo rm at i on Read th e Su reStep Pro Con trol Sol uti ons package ins ert f or mo re inform at ion. • Gently sh ake ea ch v ial o f control s ol[...]

Qual ity Co ntrol Te st 18 Perf orming a Quali t y Control Te st Press the power but ton to turn on the uni t. A start -up scree n ap pear s... ...f oll owed by the Status screen. Check the batt ery status to ensur e adequate powe r . The battery and memory bar s provide the approximate status of battery power and bedsi de unit memo ry . (If the re[...]

19 Select QC T est from th e Main Menu. Enter you r ope rato r I D, eith er by p ressing the touch sc reen or usi ng the barcode s canne r . Refer to page 8 for i nfo rmatio n o n scann ing a b arcode. Depe nd ing on the config urati on option settin g, you may or m ay not be re quired to enter your op erat or ID. If your operat or ID is re quired,[...]

Qual ity Co ntrol Te st 20 Sele ct the contro l lev el you wish to run; for exa mp le, High. Sele ct the contro l lot number fr om th e l ist disp layed. The l ast control lot selected appe ars at the top of the list. Us e the arro ws to s cr oll through the list , if n ece ssary . Alt ernat ively , scan the barco de on t he co ntrol vial . The con[...]

21 Sele ct the te st s trip lot number (and co de) from the list d ispl ayed. Th e l ast test strip lo t numb er sele cte d appea rs at t he top of the list . Use t he arrows to scr ol l thro ugh the li st, if neces sary . Alt ernat ively , scan the barc ode on the te st strip bott le label. ▲ CA UTION T o ob tain accu rate r e sult s, you must e[...]

Qual ity Co ntrol Te st 22 The QC T est screen app ears with m essages promp tin g you to apply the contro l t o the test strip and th en ins ert t he test s t rip. Ap pl yi ng Con tr ol Sol ut io n to T e st St rip ▲ CA UTION Appl ying to o much or too li ttle con trol soluti on may cause out-o f-ra nge resul ts. Appl y the cont r ol s olutio n [...]

23 If th e white pad b ec o me s c om pl e tel y s a tur a ted , you have applied too much control solution. Re pea t the a ppl icat io n w i th a new test strip . • Check the co nfirmat ion d ot on the b ack of the test strip to verify it has turned comple tely blu e, indicat ing an adequate amount of contr ol was appl ied. If white patches or s[...]

Qual ity Co ntrol Te st 24 ◆ IMP ORT ANT If you fail to co mpletely insert the test strip, the test may start; however , you may receive an out-of-r ange result . ◆ IMP ORT ANT Y ou have up to 2 mi nutes to i nsert t he tes t strip after th e con trol s oluti on i s a pplied. If yo u inse rt the tes t strip a fter 2 minut e s, you may g et a n [...]

25 ◆ IMP ORT ANT Do not r emove the t est s tri p until t he countdo wn is com plete. • I f the resu lt is P ASSE D, pr e ss O k , r em o ve th e st r ip , and continue with th e remai ning required co ntrol levels . Or , if you wish to record additional i nfo rmatio n wi th the t est re sult , p res s En ter Not es an d c hoos e 1 to 3 comm en[...]

Qual ity Co ntrol Te st 26 • If the result i s F AILED, press Ente r Notes and choos e f rom 1 to 3 com men ts . This will be recorded with the failed result. Press Ok, remove the t est stri p, a nd rep eat the QC te st. Or , if the Me nu button is disp la yed at the Fai led Q C screen, you may p ress Menu to repeat t he te st without recordi ng [...]

27 ■ NO TE Results tagge d wi th the comment “Pr ocedure Err ” a re not in cluded in t he statist ica l c alcul ati ons fo r a ny QC repor ts genera ted by the syst em admi nist rator . If yo u have proble ms using the bed side un i t to test the contr ol s oluti ons, or if th e be dside un it malfun ctions, c all the LifeScan Healthcare Prof[...]

Qual ity Co ntrol Te st 28 BU .boo k Page 2 8 Monda y , Oc to ber 28, 2002 11: 14 P M[...]

29 CHAP T ER 3 Pa tient T est LifeS can reco mme nds tha t on ly certi f ied operat ors perfo rm patient bl ood gluco se testin g usin g the SureStep Pro System . Foll ow your i nstitu tion’ s poli cies fo r in-serv ice traini ng to be co me a c ertified o perator . Pe rform i ng a P a tien t T e st Press the power but ton to turn on the uni t. 1[...]

Pat ien t Test 30 A start -up scree n ap pear s... ...f oll owed by the Status screen. Check the batt ery status to ensur e adequate powe r . The battery and memory bar s provide the approximate status of battery power and bedsi de unit memo ry . (If the re is ins uff icien t ba tter y p o we r or me mory to per fo rm a tes t, a warnin g me ssage a[...]

31 Enter you r operator ID ei ther by pressi ng the touc h screen or usi ng the barcode scanner . Re fe r to page 8 for inf o rm at io n on sc an ning a ba rco de. Enter the patien t’ s ID, ei the r by pre ssing t he touch s creen or using the barco de scanner . ■ NO TE Carefully enter the ID. An accura te patient ID is imp er at ive for tr ans[...]

Pat ien t Test 32 Se le c t th e te st stri p l ot numb er (and co d e) fro m th e list di splayed. The l ast test strip lot num ber se lecte d appears at the top of the list. Use th e arrows to scroll through th e li st, if necessary . Alt ernat ively , scan the barc ode on the te st strip bott le label. ▲ CA UTION T o ob tain accu rate r e sult[...]

33 The Pati ent T est scre en appe ars w ith me ssage s prompt ing you t o app ly blo od to t he s trip an d then in sert th e test s t rip. Appl ying Bl ood Sam pl e to T es t Stri p Obtai n a drop of b lood. Capillar y blo od can be obtaine d fro m puncturing the finger or heel using a lanc ing de vice. The puncture site shoul d b e clea ne d a n[...]

Pat ien t Test 34 Apply the bl ood to the te st st rip as follo ws: Finge r St ic k Careful ly t ouch the ce nter of th e pin k t e st squa re to the dr op o f b lood o n th e pa tien t’ s finge r . The te st area will qu ickly abso rb t he blood. Hee l S tic k Careful ly t ouch the ce nter of th e pin k t e st square t o the drop of bl ood on th[...]

35 S yringe T ouch the ti p of the syr inge to th e cent er of the pin k t es t s quare . G en t ly a pp ly pressure to th e plunger . As the bl ood eme rge s from the tip of th e s y ri n ge , i t is a b sor be d by t he te st s quare . ▲ CA UTION A v oid applying to o much bl ood when using a syring e o r y ou may get a n i naccu rate, hi gh re[...]

Pat ien t Test 36 Check t he w hite p ad on the f ront o f the te st strip and th e con firm at ion dot o n the ba ck o f the te st strip. • If the wh ite pa d b eco mes completel y saturated , you have appl i ed t oo much b lood for an accurat e resul t. Repeat the ap plicat ion wi th a n ew test strip. • The conf ir matio n dot on the back of[...]

37 ▲ CA UTION Do not ap ply add iti onal b lood to the test str ip or y ou m ay get an inaccura te result. If white patches or strea ks co ntinue to appe ar afte r you have re peated the t es t with a n ew test strip and a large r sa m pl e volume, cal l the LifeS can Hea lthcar e Profess ional Line a t 1 800 524 -7226. Firmly insert the test str[...]

Pat ien t Test 38 The test result app ears in ap proxima tely 30 seconds . ◆ IMP ORT ANT Do not remo ve the test st rip until the c ountdown is comp let e. If an er ro r m e ssa ge ap pe a rs, refer to Ch apte r 7, T r oubles hooting, f or in format ion. A gluco se r a nge ma y h av e bee n d ef ined by y ou r system ad ministrato r . Results tha[...]

39 • CRITICAL LOW indicat es a res ult be lo w the rang e. • HIGH i ndicates a result greater than 500 m g/dL . ◆ IMP ORT ANT When the result is greater th an 500 mg/dL and p rop er pro ce dures ar e fo ll owe d, t h e beds ide u nit wil l dis p la y H IG H in virt ual ly al l ca ses . Addi tio na ll y , th e con fir mati o n dot will be dark[...]

Pat ien t Test 40 Press E nter Notes and choose 1 to 3 com ments that correspond to the patient’ s current sit uation. Press O k. Or p ress Menu an d contin ue testing. ■ NO TE Res ults tagged with the c omm ent “Proce d ure Err ” a re no t includ ed in any pati ent re por ts generate d by the sys tem admin istra tor . If yo u have proble m[...]

41 CHAP T ER 4 Data Ma nag emen t T r an sfe rrin g D a ta to the W or ks ta tion Dat a transf er is requir ed period ically to exch ange i nformat ion be twe en th e workst ation and th e be dsid e un it. Confi gur ati on inf or ma tio n is t ransfe rred from t he w orksta tion to the bedsi de uni t, and QC an d patient te st results are tran sfer[...]

Da ta Ma na g eme nt 42 Y ou may t ransfer d ata using : • a d irect i nfrar ed link with th e work station’ s infrared p ort • a conn ectio n m odule tha t is directly conn ecte d to the work stati on’ s serial po rt • a conn ectio n m odule tha t is con nected to a se ri a l se rv e r or mo d em. Using a Direc t Infrar ed P o rt Conne c[...]

43 The bed s ide u nit is ready for the communica t ion link to be e stabl ished. I f the bedside uni t has been confi gured to com municat e directl y with the worksta tion infrare d port, the message at the ri ght appea rs. Place the bedside uni t’ s infra red comm unic ation port appro ximatel y 6 to 10 i nches (15 to 25 c entim eters) from th[...]

Da ta Ma na g eme nt 44 A series o f messages are displ ayed on t he b edside unit s creen indi cating the status of t he transf er . Whe n the transf er i s comple te, th e bedsi de unit beeps an d a message appears. Usi ng th e Conne ct ion Mo du le The connec ti on module, used with a m odem, provi des a remot e commun ica tion link betwee n the[...]

45 Sele ct T ransf er Dat a from the Ma in Me nu. The beds ide unit is ready fo r the co mm uni catio n link t o be es tabli shed. A me ssage appears i nstruc ting you to dock the b eds ide unit. Place the bed side uni t in t he conne cti on m odul e. Su reStepPro 1 .2 Users Enter th e works tatio n mode m phone n umber , then press Di al. (Onc e t[...]

Da ta Ma na g eme nt 46 up to 20 ti mes a t 30-sec ond i nterva ls befor e it times out. Messag es ap pea r on th e screen indi cating t he status of the c onne ction. The indicat or light on the conne ction modul e bl inks durin g tr ansfer . A message ap pears when data tr an sfer is comp let e. Remo ve t he bedsid e un it from t he c onnect ion [...]

47 Eth erne t If yo u a re t ran sferri ng da ta over an Ethernet network usin g a serial serv er , the trans fer begi ns i mm ediatel y . A series o f messages are displ ayed on t he b edside unit s creen indi cating the status of t he transf er . Whe n the tra nsfer is comple te , t he bedsi de unit beeps an d a message appears. Modem If a m odem[...]

Da ta Ma na g eme nt 48 If th e workstation modem phone n umber was not pre- programmed, ente r the p hone nu mb er , then p res s Di al. If th e phone n um ber appears on the screen, simply press D ial. A series o f messages are disp layed on the screen indicat in g the s tatus of the transf er . Whe n the tran sfer is compl ete, the beds ide unit[...]

49 Be d sid e U n it M em o r y The bedsid e unit s tores up to 2500 QC and patien t test resu lts in its m emory . Addit ional ly , th e l ot I D s fo r t e s t stri ps a nd c ont r o l , l in eari ty, and unknown solutions ar e also stored in memo ry . Th is info rm atio n can b e accesse d by sel ecti ng Revi ew Data fr om the M ain Menu. Wh en [...]

Da ta Ma na g eme nt 50 Pres s Re view Data from the Ma in Me nu. Select Pati ent Resu lts, QC/ Lin/Unkn, T est Strip Lots, or Reagent Lots. Li n a nd Un k n r ef er to Li ne ari t y and Un k no w n Sol ut i ons . Fo r more information, s ee Chapter 6, Special T ests. • If yo u s el ec t P ati e nt Results, y ou may specify a part icula r patien [...]

51 res ults marked with the Pr oce dure Er r comme nt will appea r as Pr oc Err . • I f you select QC/L in/Unkn, you may enter an operator ID a n d s e e the r esu lt s fo r the QC, linearity , and unknown t ests a particular operato r has run, or leave the operat or ID field blank and s ee th e r esu lt s fo r all QC, li ne arity , and un kn own[...]

Da ta Ma na g eme nt 52 • S elect T est S trip Lots to s ee all test str ip lot numb ers wi th exp irati on dates curre ntly en tered in th e sy st em. Th e l ast lo t number used appears at the top of the li st. • Select Reag ent Lot s to see all control, linea ri ty , a nd unknown solut ion lo t numbers with expir ation date s curre ntly e nt[...]

53 CHAP T ER 5 Ca re a nd M ai ntenanc e Genera l Care T o ke ep t he b e ds i de un it in go od op erat ing condi tion, you must keep i t cle an a nd handle it wi th care. Foll ow thes e simpl e rul es: • Keep the t est s tri p hol der a nd lens area clean . • Keep the un it dry an d av oid exposing it to extrem es in temp er ature and hum idi[...]

Care and Main tenance 54 Cl eanin g th e Outsi de of th e Unit Clean t he outsi de of th e un it wi th a clot h moi stened wi th a 10% ble ach so lution . Follow with a clo th m oisten ed w ith wate r to remo ve residua l b leach . Dry the uni t tho roughl y . ▲ CA UTION Do not ge t water in side the uni t. Never i m- mer se the unit or h o ld it[...]

55 W ipe the te st strip holder cover and b ase with a co tton swab or soft cl oth m oistene d w ith a 10% bl each s ol ution . Be sure to thoro ughly wipe the a re a on th e insi de cove r. Clean both sides of the ba se. F ollow with a swab moiste ned with wate r to remove re sid ual bleach. ▲ CA UTION Bleach re sidue left on the test strip hold[...]

Care and Main tenance 56 Dry the len s a rea gent ly wit h a clean, soft, l int- free cloth or ti ssue. Remove an y li nt. Sli de the clos ed t e st str ip holde r into the unit . Push th e hol de r unti l it clic ks in to place. T urn on the beds id e uni t. If an err or appea rs, check t o ma ke su re you inst a lled th e t est s trip holde r cor[...]

57 Ch a ng ing th e Batte rie s The SureStepPro Bedside Unit is powered by two size C alkaline batteries. Change the batteries when the LO W BA TTE R Y message appears on the screen. Y o u may want to change the batteries if the bat tery bar o n the Stat us scre en is lo w . Howev er , the u nit will co ntinue to function properly until t he LO W B[...]

Care and Main tenance 58 Pr ess the powe r bu tt on to turn off the bedsi de unit. T u rn th e uni t over . Use a coi n or screwdri v er to loosen the sc rew fro m the ba ttery compartm en t door . Lift ope n t he door. R em o v e b o t h ba tter i e s f r om the battery comp artm ent and dispo se of the m acco rding t o your in stituti on’ s gui[...]

59 Inser t tw o new size C ba tteries, matchi ng the positive (+) end o f each b attery with the + sign s insi de th e b atter y c ompa rtmen t. ■ NO TE The batt ery li fe depend s on h ow quickl y the bedsi de unit is powered o ff after e ach test. Under opti mal conditi ons—usin g the barco de scanner to enter in formation an d tu rning off t[...]

Care and Main tenance 60 Adj ust in g t he Sc reen C ontra st Y ou ca n incr ease or decr ease th e LCD scr een contra st. Select Se tup from the Mai n Menu . Pr ess the arrows to increase or decrease th e LCD contr ast. A change occurs each t i me you press the arro w . The g a uge in the Low/ Hig h bar give s you an ap proxima te ind icat ion of [...]

61 CHAP T ER 6 Specia l T ests The Special T ests function allows you to perform tests that ar e not routinel y performed, suc h as a l in ea rit y te st and a n unkn ow n s o lut i on test. Sp ecial T ests a lso features an In-Service mod e, wh ic h al lo w s yo u to us e th e bed s ide un it for training new operators. T e st results obtained whi[...]

Spe cia l T es t s 62 Select S peci al T ests fro m the Main Menu. Sele ct Lin /Unkn T est fro m the Sp ecial T est s menu. Enter you r oper ato r I D. 1 2 3 BU .boo k Page 6 2 Monda y , Oc to ber 28, 2002 11: 14 P M[...]

63 Star t by sele cting Lin 1. Sele ct the Line arit y Soluti on lot nu mbe r fro m the l ist display ed. Alt ernat ively , scan the barcod e on t he linear ity soluti on vi al. Depe nd ing on the config urati on option settin g, you may or m ay not be re quired to enter your op erat or ID. If your operat or ID is re quired, a conf iguration op tio[...]

Spe cia l T es t s 64 Sele ct the te st s trip lot number (and co de) from the list d ispl ayed. Th e l ast test strip lo t numb er sele cte d appea rs at t he top of t he lis t. Use t he arrows to scr ol l thro ugh the l ist, if nece ssar y . Alt ernat ively , scan the barc ode on the te st strip bott le label. Depending on the con figuratio n opt[...]

65 ▲ CA UTION T o ob tain accu rate r e sult s, you must en ter the corr ect te st strip lot numb er (and co de) for each ne w te st . S ur e S te p Pr o 2 . 0 user s , press Ok to pe rform th e test fo r the linear ity leve l and repl icate indicat ed. Apply th e linea rity sol uti on to th e test st rip. ▲ CA UTION Appl ying to o much or too [...]

Spe cia l T es t s 66 • T ouch a drop o f line ari ty soluti on to the cen ter of the p ink t est squar e . If t he white pa d be co mes completel y saturated , you have appl i ed t oo much li nearity so lut ion . Re peat the ap plicat ion wi th a n ew test strip. • Check the co nfirmat ion d ot on the b ack of the test strip to verify it has t[...]

67 ◆ IMP ORT ANT If you fail to co mpletely insert t he test strip, the test may start; however , you may receive an out-of-rang e result. ◆ IMP ORT ANT Y ou ha ve up to 2 mi n u te s to insert th e test strip af ter t he linearity soluti on is applied. If you in sert the te st s t r ip after 2 mi nute s, you may get an o ut-of-ran ge result o [...]

Spe cia l T es t s 68 If you wish to rec ord additional i nfor mation with th e test resu lt, pres s Enter No tes and choose a commen t from the list. Press Ok. Sure Ste pPro 2.0 – Press Ok at the Linea rity Level Result screen to dis play the Lin L evel screen. Press Ok to proceed with th e remaining replicates of level 1. SureStepPro 1.2 – Pr[...]

69 Unknown Solution T est Per iodical ly , you ma y be asked to perfor m a profic iency test on a soluti on for w hich y ou do not kn ow the gluc ose value. Thi s typ e of test ing may be r equ ired b y your ins tituti on’ s accr editat ion o r ganiz ation . Sele ct Speci al T ests from the Ma in Me nu. Sele ct Lin /Unkn T est fro m the Sp ecial [...]

Spe cia l T es t s 70 Enter you r oper ato r I D. Depe nd ing on the config urati on option settin g, you may or m ay not be re quired to enter your op erat or ID. If your operat or ID is requi red, a confi gura tion op tion ma y be set t o r emembe r your ID for up to 1 hour after the bedside unit is turned of f. If your ID appears at the operator[...]

71 Sele ct an o ption to ide ntify your unknow n solut ion, for exam ple Unkn A. Sel ect the so lutio n lot (or ident ifi catio n) number from the list di splaye d. Depending on the con figuratio n opti on setting, you may b e r equire d to en ter the u nkno wn solution lo t number . If you are not required t o enter the lot numbe r, the Select Lot[...]

Spe cia l T es t s 72 Selec t th e tes t strip lot numbe r ( and code ) fr om th e list d ispl ayed. The last tes t stri p lot n umb er selected appe ars at the top of th e list. Use the arrows to scroll throu gh th e list i f nec essa ry . Alt ernat ively , scan the barc ode on the te st strip bott le label. If you ar e required to ent er the unkn[...]

73 ▲ CA UTION T o ob tain accu rate r e sult s, you must en ter the corr ect te st strip lot numb er (and co de) for each ne w te st . Apply the unkno w n solut ion to t he tes t strip. • T ouch t h e drop of so lutio n to the ce nter of th e p ink tes t squ are . If t he white pa d be co mes completel y satura ted, you have appl i ed t oo much[...]

Spe cia l T es t s 74 Firmly i nsert th e test str ip all th e w a y into the test strip holder un til it stop s (the confi rmat ion d ot shou ld be facing down) . ◆ IMP ORT ANT If you fail to co mpletely insert the test strip, the test may start; however , you may receive an inaccurate, l ow result. ◆ IMP ORT ANT Y ou ha ve up to 2 mi n u te s[...]

75 Press O k to d isplay the Lin/ Unkn T e st screen . Or , if y ou w ish to rec ord a dditio nal infor mation with the te st result , press Enter Notes an d ch oo se a co mment fr om th e li st. Pres s Ok . In -Ser vi ce T est Use th e In- Servi ce m ode t o train and cer tify oper ators. Thi s mode is ident ica l to th e QC T e st m ode . Howeve [...]

Spe cia l T es t s 76 Sele ct In-S ervi ce Mo de fro m the Sp ecial T est s menu. Follo w the instruc tions in Chap ter 2, Qua lit y Contro l T e st, beginnin g with step 4. Use the SureS tepPro H igh, Lo w , and Nor mal Gluc ose Contro l Soluti ons . The QC warnin g or locko ut mo de does no t affec t t ests perfo rmed in the In-S ervi ce mo de. M[...]

77 CHAP T ER 7 Tr o u b l e s h o o t i n g The SureSt e pPro Bedsi de Unit display s prompt s a nd erro r message s to indicate the syst em has dete cte d a probl em with its i ntern al funct ion, the test strip , o r th e testing procedur e. Th ese m essages hel p i n res olving some c om mon prob lems t hat m ay occur dur ing testing. H owever ,[...]

Troub leshoot ing 78 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) ▲ CA UTION While t rying t o re solve an erro r m essa ge using the T ro ublesho oting se ction, keep in mind the foll owing: • I f patient symptoms indicate the need fo r treatm ent, provid e a[...]

79 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) Erro r Mess a ges ERROR POSSI BLE CAUSE SO LUT ION Error 1 Samp le Applicat ion T h e beds ide u nit de te ct e d a p r ob l em with th e color of th e te st strip . 1. Re pea t tes t wi th n ew te st str ip and:[...]

Troub leshoot ing 80 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Error 2 Te s t S t r i p T h e beds ide u nit de te ct e d a p r ob l em wi th th e te st st rip . 1. Repeat tes t w ith ne w t est strip a nd: • Chec k test s trip exp ira - tion dat e . Do n ot [...]

81 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) Error 3 Te s t S t r i p T h e beds ide u nit de te ct e d a p r ob l em with the po sitio n of th e te st strip . 1. C lean beds ide unit, espec ially contact points in lens area, but NOT E: Befor e cleaning, co[...]

Troub leshoot ing 82 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Erro r 4 T emperatur e Range T h e beds ide u nit de te ct e d a temper atur e pr ob le m. 1. Repeat tes t w ith ne w t est str ip . M ak e su re be d sid e unit a nd tes t strip a r e at r oom te m[...]

83 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) Error 5 Meter Optics T h e beds ide u nit de te ct e d a p r ob l em with th e opt ica l sys te m. 1. C lean beds ide unit, especially gray area inside test st rip hold e r , bu t NOT E: Befor e cleaning, compar [...]

Troub leshoot ing 84 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Error 6 Sys t em E rro r T he be dsi de un it detec ted a pr obl em with the electron ic s . 1. Wip e contact points in lens ar ea wi t h c lo t h moi s te ne d with w ater to r emo ve re s i dua l [...]

85 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) U nex pec ted M e ss a ges and O b se rva tio n s MES SA GE POSSI BLE CAUSE SO LUT ION App ly Bloo d Beds ide u nit is read y for bl ood applic ation. Obta in a dr op of cap illary blood a n d apply it to ce nter[...]

Troub leshoot ing 86 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Check Conne ction s at Be dside Unit 1. Be dside unit was rem ove d from con nect ion m odu le before con nect ion w as est ablishe d. 2. Bad c onne ction between mo dem and c onnect ion modu le. 3.[...]

87 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) Data Memo ry Low Les s t han 10 0 tes t records can be ge ne ra t ed . T ransfer data t o f ree me mory spa ce . Data T ran sfer Error Beds ide u nit/ work st at ion com mun ication erro r . Retry d ata tra nsf e[...]

Troub leshoot ing 88 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Inv alid Oper ator ID Operator ID fo rmat no t co rre ct. Re -e nt er yo u r I D us ing barcod e scan ne r or alphanumeric touch sc re en. Inv alid Pa t i e n t I D P atient ID f o rmat no t co rre [...]

89 If y ou cannot re solv e a problem, ca ll Life Scan Healthca re Prof essional Line : 1 800 524 -722 6 (USA) 1 888 3 5 3-0800 (Canad a) No R o om for New T es t Data Beds ide u nit me mo r y f u ll . T ransfer data t o f ree me mory spa ce . No R o om for New T es t Strip Lo t T h ere a re f iv e n e w (non-va lidated) tes t str ip lots in bed si[...]

Troub leshoot ing 90 If you cannot r esolve a problem, call Li feScan He althcare Prof essional L ine: 1 800 524-7226 (US A) 1 888 3 5 3-0800 ( Canada) Shake vial and apply (High, Norma l, Low) co ntro l Beds ide unit is read y for con trol solut ion applic ation. Gently shak e vial. T ouch a dr op of so lu ti o n t o c ent er of pink t est sq uare[...]

91 APPEN DIX A Bedside Un it Configurat ion Optio ns Follo wing is a lis t of work station opti ons conf igure d by y our Syst em Admi nistrat o r. These options appl y to all b edside uni ts w ithin a nursing uni t and direct ly aff ect how t hese bedsi de units fun ction. P a tie nt R e sults Configuration Option Meaning Gluc ose units ❍ mg/ dL[...]

Beds id e Unit Conf igur ati on Opt ions 92 Be d sid e U n it Cr iti c al W a rn in g M es s ag es Lower L im it ____ Upper Limit ___ _ Notes t hat appear at the patien t test result scre e n whe n th e tes t re sult f all s outsid e the critica l limi ts. The notes ar e in tended to offe r s u g ge sti o ns fo r abnormal resu lts. The uppe r and l[...]

93 Nursi ng unit to which bedsi de un it is assi gned Each bedside unit is assigne d to a parti cular nursing u nit . Do n ot use the bedsi de unit outside the desig nated nu rsing unit. ❑ Reagent Entr y at W orkst ation Onl y If sel ected, yo u m ust choose an existing test strip or contro l lot numbe r from th e list displayed. If not selected [...]

Beds id e Unit Conf igur ati on Opt ions 94 Operator and IDs Configuration Option Meaning ❑ ID required f or all tests ❑ Maintai n ID for _ ___ minutes a fter power o ff If sele cted, all operators are require d to enter t heir IDs for each test. If M ain tain ID is s ele cted, the last ID entere d remai ns in m emo ry f or 1 t o 60 mi nu t es [...]

95 Qu a lity Co nt r ol Configuration Option Meaning Gluc ose units ❍ mg /d L ❍ mm o l/L The units selected f or display ing a nd re porting control and bl ood g luco se results. Req uired QC tests ❑ High ❑ Low ❑ Nor mal Three gl ucose c ontrols are av ai lab le. A n y c o mb in a t ion may be select ed. Con trol s olutio n ra ng es ( h i[...]

Beds id e Unit Conf igur ati on Opt ions 96 QC T est Peri od ❍ T ime of day_ ___ ❍ Elap sed ti me ____ h o urs Fr eq uenc y of p er for mi ng a QC te st is defi ned as a set time e ach d ay o r an elap sed time be tween 6 and 24 hours. QC A c tion M essages Messages di splayed in th e bedside u nit following a failed Q C test. T hese messages a[...]

97 Specif ications The perf ormance of the s ystem has been eval uated u nder the condit ion s lis te d be low. R ef er to th e Sur eS tepPr o T est Stri ps package inse rt for typical acc uracy and precis ion data. Be d sid e U n it Spe c ific at ion s power supply : two siz e C, 1 .5-V alkal ine batte ries result range: 0–500 mg/dL displ ay: li[...]

Spe cif i ca t io n s 98 operat ing h umidi ty: 30%–70% relativ e humid ity (no ncondens ing) alt itu de: up to 10,00 0 ft (3 048 m ) [For more i nformation , read the SureStepPro T est Strip pa ckage i nsert.] class II laser: 680 nm barcodes : Barcode 39 Barcode 128 Barcod e Spec if i c ati o ns • Black and wh ite o nly; no color backgro und. [...]

99 The SureStepPro Blood Glucose Bedside Unit co mp li es w ith the foll o w in g stan da r ds: • CAN/CSA - C22.2 No. 601.1-94 Medi cal Electri cal Eq uipmen t - Part 1 : G eneral Req uiremen ts fo r Safety (Co m plies wit h UL 2601-1 and IEC 6 01-1) • CAN/CSA - C108 .6-M91 ( CISPR 11 :19 90) Limits and Method s o f Measuremen t of Electrom agn[...]

Spe cif i ca t io n s 100 Cl eanin g Agent s Th e foll owin g co mpoun ds can b e used t o clean the exte rio r only of the beds ide unit. Follow the instructi ons for u se on the prod uct’ s pa cka ging. Refer t o Ch apte r 5, Care and Main tenan ce, fo r cleanin g p re c auti ons and d etailed informat ion on clean ing the be dside unit a nd te[...]

101 a ap ply i ng b l o od 3 3–3 6 contro l solu tion 22– 23 b ba rco de sca nn er 3 cle aning 56 usi n g 8 ba rco de sp eci fic a tio ns 9 8 ba rco de sp ecs 9 8 bat te r ies c h a n gi n g 5 7–59 sta tus 18, 30, 57 bed sid e un it b a t te r ie s 4, 57 dat a transfer 41– 48 des cript ion 1, 3–4 mem ory 4 9 operatio n 5– 9 scr een c on[...]

Inde x 102 i ID operator 7 pat ient 31 infection cont rol 1 4 insert test stri p 23 , 37, 66, 74 in -se rv i ce te st 75 –76 l laser infor mation i i , 4 LCD scr een 3 contra st 60 lens are a 3 cleaning 55 – 5 6 li nea rity te st 6 1–6 8 res ult 67 uppe r limit 6 7 lockout dat a transfer 41 operator 1 5 QC 15 lot number s review i ng 52 m mai[...]

103 t tes t i n - s e r vi c e 75–7 6 l i n ear i ty 6 1–68 p a t ie n t 2 9–4 0 q u a li t y c on t r o l 18 –2 7 unkno wn so lutio n 69– 75 te st st rip b l o od a pp li ca t io n 33–36 control ap plication 22 – 23 g en er al inf or ma ti on 9–12 insert i ng 23, 37 , 6 6, 74 lo t nu m be r 2 1, 32, 6 4, 72 te st st rip ho ld er 3,[...]

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AW 061-296-01A ©2002 LifeScan, In c. For use with bedsid e units , versio ns 1. 2 and 2.0. 09/02 BU .boo k Page 105 M on d ay, Oct o ber 28, 2 002 11:1 4 P M[...]