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References

1. Caraway R.I.; Fundamentals of Clinical

Chemistry: “Carbohydrates”, Tietz N.W Editor,
Philadelphia PA, Saunders, pp. 242-243 (1976).

2. American Diabetes Association Clinical Practice

Recommendations. Diabetes Care 23 (Suppl. 1):
S32-S60, 2000

3. Hackett, J., Aziz, K., Review Criteria Assessment

of Portable Blood Glucose Monitoring in Vitro
Diagnostic Devices using Glucose Oxidase,
Dehydrogenase or Hexokinase Methodology;
FDA Draft Document, p. 6 (1997).

38

Summary of Contents for IQ

Page 1: ...Owner s Booklet Blood Glucose SYSTEM Blood Glucose SYSTEM IQ IQ Owner s Booklet ...

Page 2: ...icated customer service If you have any questions about the use of our P Pr re es st ti ig ge e S Sm ma ar rt t S Sy ys st te em m products visit our web site at www homediagnostics com or please call 1 800 803 6025 For Medical Assistance call your Doctor or Diabetes Healthcare Professional ...

Page 3: ...such as kidney problems and blindness Regular testing lets you know if your sugar is too high too low or just right depending on what you and your Healthcare Professional decide is just right for you Do not use the Prestige Smart System IQ Meter in any way not recommended in this Booklet 1 For assistance call Use By date Lot number For in vitro diagnostic testing only Authorized Representative Ste...

Page 4: ...wrong Repeat the test if your results seem much higher or lower than you think they should be 5 Work with your Diabetes Healthcare Professional Discuss your results with your Diabetes Healthcare Professional 6 Use only W Wh ho ol le e B Bl lo oo od d when testing with the Prestige Smart System If you choose to display results as plasma the Meter uses the whole blood value to calculate and then dis...

Page 5: ...13 14 Glucose Control Test 15 18 Section 4 TEST WHOLE BLOOD 19 21 Section 5 IMPORTANCE OF TESTING 22 Section 6 METER MEMORY 23 25 Recalling Blood Test Results 23 24 Recalling Morning Average Value 25 Section 7 CLEANING MAINTENANCE 26 27 Section 8 CHANGE METER BATTERY 28 29 Section 9 DISPLAY MESSAGES 30 34 Section 10 TROUBLESHOOTING 35 36 Section 11 METER SPECIFICATIONS 37 References 38 Warranty 39...

Page 6: ...er Button Turns Meter on and off Meter turns off after 3 minutes of non use Test Strip Platform Holds Test Strip or Standard Strip in place during a test Test Window Area under Test Strip Platform that contains Meter optics Î Battery Compartment Holds one replaceable AAA 1 5 volt alkaline battery Ï Meter Label Provides Meter name serial number and toll free number for assistance ...

Page 7: ...est Î Communication Port Use to attach Prestige Smart System serial cable to Meter WARNING U Us se e o on nl ly y Prestige Smart System s se er ri ia al l c ca ab bl le e i in n p po or rt t P Pu ut tt ti in ng g a an ny yt th hi in ng g e el ls se e i in nt to o p po or rt t m ma ay y d da am ma ag ge e M Me et te er r P Pl le ea as se e c ca al ll l f fo or r m mo or re e i in nf fo or rm ma at ...

Page 8: ...ration Date Date after which Test Strips cannot be used Control Range Range of numbers in which Glucose Control test results must fall to be sure that System is working correctly À for Low Á for High Prestige Smart System Test Strip Test Spot Apply blood or Glucose Control solution here Î Color Spot Changes color after blood or Control solution is applied to the Test Spot 6 ...

Page 9: ...testing Plasma results are about 12 higher than whole blood results 1 When selecting this option Meter uses the whole blood value to calculate and display the plasma result N NE EV VE ER R u us se e p pl la as sm ma a f fo or r t te es st ti in ng g w wi it th h Prestige Smart System mg dL Glucose unit of measure expressed as milligrams per deciliter used in U S mmol L Glucose unit of measure expr...

Page 10: ...ased on 12 hour clock am pm 24 hr Time based on 24 hour clock m d y Date displayed as month day year 03 11 2009 d m y Date displayed as day month year 11 03 2009 I If f y yo ou u h ha av ve e a an ny y q qu ue es st ti io on ns s r re eg ga ar rd di in ng g t th he es se e O Op pt ti io on ns s p pl le ea as se e c ca al ll l f fo or r a as ss si is st ta an nc ce e 8 ...

Page 11: ...ype 2 Set the options Press top or bottom of the U Up p D Do ow wn n Button to switch between the selections available Press S Se el le ec ct t S S Button to set the option Meter Options Results as Blood or Plasma mg dL or mmol L unit of glucose measure Period or Comma delimiter mmol L only 14 or 30 day Morning Average 12 or 24 hour clock 9 or or or or or Up Down Select S ...

Page 12: ...Se el le ec ct t S to set 5 Set Date Press U Up p D Do ow wn n Button to change the flashing number Press S Se el le ec ct t S to set Turn Meter off Meter is now ready to use for testing N NO OT TE E C Ch he ec ck k T Ti im me e a an nd d D Da at te e a af ft te er r e ea ac ch h b ba at tt te er ry y c ch ha an ng ge e R Re es se et t i if f n ne ec ce es ss sa ar ry y A Al ll l o ot th he er r M...

Page 13: ... in Display to Code printed on Strip vial being used Codes must match If Codes DO NOT match go to Step 4 C Ca al li ib br ra at ti io on n C Co od de e N Nu um mb be er rs s r ra an ng ge e f fr ro om m 0 0 2 23 3 4 Code Meter Press top of U Up p D Do ow wn n Button to increase number press bottom of Button to decrease number Meter stores Code automatically 11 ...

Page 14: ... When using a new vial of Test Strips When results do not agree with how you feel When you suspect that results are incorrect To practice using the System After cleaning the Meter or replacing the Test Strip Platform A AL LW WA AY YS S p pe er rf fo or rm m t th he e S St ta an nd da ar rd d S St tr ri ip p t te es st t W WA AR RN NI IN NG G B Bo ot th h t th he e S St ta an nd da ar rd d S St tr ...

Page 15: ...nd release P Po ow we er r Button 4 Perform test Slide Standard Strip all the way into Test Strip Platform with Range Label facing up N NO OT TE E D Do o n no ot t m mo ov ve e S St ta an nd da ar rd d S St tr ri ip p o or r M Me et te er r d du ur ri in ng g t te es st ti in ng g o or r a an n e er rr ro or r m me es ss sa ag ge e m ma ay y a ap pp pe ea ar r Meter detects Strip and begins test W...

Page 16: ...ar rd d S St tr ri ip p s se ee e S Se ec c 7 7 C Cl le ea an ni in ng g M Ma ai in nt te en na an nc ce e d dr ry y t th ho or ro ou ug gh hl ly y a an nd d r re ep pe ea at t t te es st t I If f r re es su ul lt t i is s s st ti il ll l o ou ut ts si id de e o of f r ra an ng ge e c ca al ll l f fo or r a as ss si is st ta an nc ce e 6 Replace Standard Strip Remove Strip from Test Platform and p...

Page 17: ...ntrol bottle If your bottle of Control is being used for first time write date opened on bottle 3 Turn Meter on Press and release P Po ow we er r Button N NO OT TE E U Us se e e ex xp pi ir ra at ti io on n d da at te e p pr ri in nt te ed d o on n u un no op pe en ne ed d C Co on nt tr ro ol l b bo ot tt tl le e l la ab be el l O On nc ce e C Co on nt tr ro ol l b bo ot tt tl le e i is s o op pe ...

Page 18: ... o or r d di ir rt ty y s su ur rf fa ac ce e D Do o n no ot t c cu ut t o or r a al lt te er r S St tr ri ip ps s i in n a an ny y w wa ay y Gently swirl bottle several times D DO O N NO OT T S SH HA AK KE E Remove cap from bottle Hold bottle upside down and squeeze one full drop onto a tissue While holding Control bottle upside down place bottle over Test Spot of Test Strip Squeeze one drop onto...

Page 19: ... white areas t th he er re e i is s n no ot t e en no ou ug gh h C Co on nt tr ro ol l o on n t th he e T Te es st t S St tr ri ip p D DO O N NO OT T a ad dd d m mo or re e C Co on nt tr ro ol l t to o T Te es st t S Sp po ot t D Di is sc ca ar rd d S St tr ri ip p a an nd d r re ep pe ea at t t te es st t u us si in ng g n ne ew w S St tr ri ip p I If f C Co ol lo or r S Sp po ot t a ap pp pe ea ...

Page 20: ...d Strip Slide Strip out of Meter 8 Wipe tip of Bottle with tissue Recap bottle Store bottle in a cool dry place at 59º 86ºF or 15º 30ºC N NO OT TE E I If f C Co on nt tr ro ol l r re es su ul lt t i is s o ou ut t o of f r ra an ng ge e r re ep pe ea at t t te es st t w wi it th h n ne ew w S St tr ri ip p C Ch he ec ck k C Co ol lo or r S Sp po ot t a an nd d i in ns se er rt t S St tr ri ip p i ...

Page 21: ...damaged or cracked display missing or damaged buttons If any damage is seen do not use Meter Call for assistance Check Strip vials for damage Discard any vials that appear cracked 3 Check expiration date Check expiration date on Strip vial Do not use if expiration date has passed 4 Turn Meter on Press and release P Po ow we er r Button 5 Match Code Meter Code must match to Code number on Strip via...

Page 22: ...ull color development N NO OT TE E I If f C Co ol lo or r S Sp po ot t l lo oo ok ks s l li ik ke e t th hi is s o or r large white spots white areas t th he er re e i is s n no ot t e en no ou ug gh h b bl lo oo od d o on n t th he e T Te es st t S St tr ri ip p D DO O N NO OT T a ad dd d m mo or re e b bl lo oo od d t to o S St tr ri ip p D Di is sc ca ar rd d S St tr ri ip p a an nd d r re ep p...

Page 23: ...oi id d e er rr ro or r m me es ss sa ag ge e o or r a a f fa al ls se e r re es su ul lt t Meter is counting seconds Test normally takes 10 to 50 seconds Test is complete Result is displayed If result is higher or lower than you expected see Sec 10 Troubleshooting Guide 7 Record result in Daily Log Book 8 Discard Strip Slide Strip out of Meter Blood is a biohazard material that may contain bloodb...

Page 24: ...Values For Non Diabetics W Wh ho ol le e b bl lo oo od d P Pl la as sm ma a Preprandial goal 80 120 mg dL 90 130 mg dL Bedtime goal 100 140 mg dL 110 150 mg dL If your results are outside your personal target glucose range as determined by your Diabetes Healthcare Professional and you are sure that the System is working properly consult with your Diabetes Healthcare professional Severe dehydration...

Page 25: ...result is added When you recall results from Memory the results are displayed in order beginning with the most recent result N NO OT TE E R Re em me em mb be er r t to o s se et t d da at te e a an nd d t ti im me e c co or rr re ec ct tl ly y s se ee e S Se ec c 1 1 S Se et t M Me et te er r O Op pt ti io on ns s To recall results 1 Turn Meter on Press and release P Po ow we er r Button 2 Display...

Page 26: ... t to o t th he e o op pt ti io on ns s s se et t i in n t th he e M Me et te er r a at t t th ha at t t ti im me e F Fo or r e ex xa am mp pl le e i if f a a g gl lu uc co os se e t te es st t i is s p pe er rf fo or rm me ed d w wh he en n t th he e p pl la as sm ma a o op pt ti io on n i is s s se et t b bu ut t t th he e r re es su ul lt t i is s a ac cc ce es ss se ed d f fr ro om m M Me em m...

Page 27: ... A AM M t to o d di is sp pl la ay y a a M Mo or rn ni in ng g A Av ve er ra ag ge e v va al lu ue e I If f t th he er re e i is s n no o M Mo or rn ni in ng g A Av ve er ra ag ge e v va al lu ue e M Me et te er r d di is sp pl la ay ys s t th hr re ee e d da as sh he es s To display Morning Average 1 With Meter Off Press and hold the center of U Up p D Do ow wn n Button with one hand Press and re...

Page 28: ...ter Test Strips and Control as directed take Meter apart CLEAN METER WITH ALCOHOL Clean the Meter 1 Gather supplies Clean dry work surface Meter Dry cotton swab or tissue Water mild detergent mild soap and water or 10 household bleach Clean dry lint free cloth 2 Remove Test Strip Platform Lift up bottom end of Platform and gently pull up 3 Clean Test Strip Platform Rinse Platform with water mild d...

Page 29: ...f fo or rm m C Co on nt tr ro ol l o or r b bl lo oo od d t te es st ts s u un nt ti il l S St ta an nd da ar rd d S St tr ri ip p t te es st t h ha as s g gi iv ve en n g go oo od d r re es su ul lt ts s N NO OT TE E T Th he e M Me et te er r d do oe es s n no ot t c co on nt ta ai in n a an ny y s se er rv vi ic ce ea ab bl le e p pa ar rt ts s o ot th he er r t th ha an n t th he e r re ep pl l...

Page 30: ...ange Battery 1 Gather supplies Meter 1 new AAA 1 5 volt alkaline battery 2 Remove Battery Door Turn Meter over slide Battery Compartment Door up with thumb and lift Door up to remove 3 Remove Old Battery Gently pull up ribbon that is placed under battery or hold Meter with one hand and gently tap Meter with other hand to loosen battery 28 Ribbon or ...

Page 31: ...see Sec 1 Set Meter Options N NO OT TE E B Ba at tt te er ri ie es s m mi ig gh ht t e ex xp pl lo od de e i if f m mi is sh ha an nd dl le ed d D Do o n no ot t d di is sp po os se e o of f b ba at tt te er ry y i in n f fi ir re e D Do o n no ot t d di is sa as ss se em mb bl le e o or r t tr ry y t to o r re ec ch ha ar rg ge e b ba at tt te er ry y D Di is sp po os se e a ac cc co or rd di in ...

Page 32: ...lay during a Standard Strip test If any part of number or symbols in Display are missing call for assistance If symbol remains in Display after Strip is inserted turn Meter off discard Strip and clean Meter see Sec 7 Repeat test If numbers do not count up after Strip is inserted turn Meter off discard Strip and clean Meter see Sec 7 Repeat test If result does not appear in Display after 10 seconds...

Page 33: ...eter is hot May not give correct result Turn Meter off Repeat test see Sec 3 without moving Strip or Meter Move Meter and Strips to warmer place 59º 98ºF or 15º 37ºC Allow Meter and Strips to adjust to temperature Run Standard Strip test before using Meter see Sec 3 Move Meter and Strips to cooler place 59º 98ºF or 15º 37ºC Allow Meter and Strips to adjust to temperature Run Standard Strip test be...

Page 34: ...laced Battery must be replaced Repeat test immediately If result is still high review Section 10 to troubleshoot If no error is found call your Diabetes Healthcare Professional immediately Remove old battery and install new one see Sec 8 Remove old battery and install new one see Sec 8 If there still is no Display call for assistance Blank or No Display ...

Page 35: ...may be defective 3 Strip was not inserted properly 4 Result is 25 mg dL 1 4 mmol L or lower Discard Strip Repeat test with new Strip Check Color Spot If error message persists call for assistance Call for assistance Meter must be replaced Remove Strip and check Color Spot Turn Meter off Discard Strip Clean Meter see Sec 7 Repeat test with new Strip If error message persists call your Diabetes Prof...

Page 36: ...p or Meter was moved during test Sun error too much light for Meter to perform properly Turn Meter off Discard Strip Repeat test with new Strip Turn Meter off Place Meter on flat surface and repeat test Do not move Standard Strip or Meter during test Take Meter to area where light is less bright Call for assistance Any Other Error Message or Warnings ...

Page 37: ...much blood go to Step 5 2 Check to see that vial of Strips or Control has NOT expired 3 Check to see that the Meter Code matches Code printed on vial of Test Strips being used Change Meter Code if needed 4 Clean Meter Test Window see Sec 7 After cleaning carefully replace Test Strip Platform and perform Standard Strip test 5 Repeat blood test with new Strip Follow all instructions exactly see Sec ...

Page 38: ...not within range call for assistance 7 Perform Control test to assure that System Meter Test Strips and testing technique is working properly see Sec 3 8 If both Steps 6 and 7 give acceptable results then blood glucose results are correct 9 If you still feel that your results are not correct contact your Diabetes Healthcare Professional or call Technical Service for assistance 10 If Meter displays...

Page 39: ... Any non condensing atmosphere Size 2 75 x 4 0 x 0 8 7 0 x 10 2 x 2 0 cm Weight Approximately 3 6 oz or 102 gms with battery Blood Source Fresh Whole Blood Test Time Typically 10 to 50 seconds Memory 365 most recent results Glucose Control and Standard Strip results are not stored in Memory Code Numbers 24 total Code 0 through Code 23 Accuracy Precision See Prestige Smart System Blood Glucose Test...

Page 40: ...242 243 1976 2 American Diabetes Association Clinical Practice Recommendations Diabetes Care 23 Suppl 1 S32 S60 2000 3 Hackett J Aziz K Review Criteria Assessment of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices using Glucose Oxidase Dehydrogenase or Hexokinase Methodology FDA Draft Document p 6 1997 38 ...

Page 41: ...lent Meter at its option at no cost to the purchaser Failure of the Meter due to abuse or use not in accordance with the instructions for use is not covered by this Warranty 2 This Warranty does not include the battery supplied with the Meter 3 Do not take the Meter apart This action will void the Warranty and cause the Meter to display false results 4 The duration of any implied Warranty includin...

Page 42: ...ar use with respect to the Meter Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitations or exclusion may not apply 6 This Warranty gives the user specific legal rights and the user may also have other rights which vary from state to state Your Prestige Smart System Technical Service Representative will be able to provide detailed inform...

Page 43: ..._________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ _____________________________________ ________________________________...

Page 44: ... Lauderdale FL 33309 U S A Printed in U S A HDI 2007 IQQ603 Rev 7 0197 Authorized Representative AR MED Ltd Runnymede Malthouse Egham TW20 9BD United Kingdom 24 Hour Toll Free Assistance Available in English Spanish 7 days per week Call 1 800 803 6025 www homediagnostics com ...

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