Smart Meter GM291 Glucose Meter with data transfer capability User Manual Manual Version 0330
Smart Meter Corporation Glucose Meter with data transfer capability Manual Version 0330
Manual-0331
Version 2 Date: 3.17.2016 iGlucose™ Blood Glucose Monitoring System GM291 User Manual Version 2 Date: 3.17.2016 iGlucose™ Blood Glucose Monitoring System User Manual iGlucose™ is a trademark of Smart Meter Corporation iGlucose Blood Glucose Monitoring System is manufactured by Bionime Corporation, No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C) Preface Thank you for selecting the iGlucose Blood Glucose Monitoring System. This manual provides all the information you need to operate this product for accurate test results. Please read this entire manual before you start any testing. For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively reduce complications from the disease. The easy-to-use iGlucose Blood Glucose Monitoring System provides accurate, reliable test results. It can be connected to web portals by GSM technology to help you better manage your diabetes. The iGlucose Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The iGlucose Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iGlucose Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. The iGlucose Blood Glucose Test Strips are for use with the iGlucose Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The iGlucose Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation. If you have any questions or concerns, please contact the iGlucose Diabetes Customer Support Center toll free at 1-555-555-5555 (Monday through Friday 8:00 AM to 5:00 PM PST).. We will make every effort to assist you. The iGlucose Blood Glucose Monitoring System is a personal blood glucose monitoring system to be used for self-testing only. The glucose meter and lancing device are for single patient use. Do not use on multiple patients. Do not share meter or lancing device with anyone including other family members. A healthcare professional should be contacted when Customer Service is not available. Please forward your warranty card to iGlucose Diabetes Customer Support Center. iGlucose Diabetes Customer Support Center 12345 Main Street Any town AA, 12345 Caution - Before using the iG Glucose Blood d Glucose M Monitoring Syystem to testt your blood glucose, please read all of thee instruction ns and condu uct all of the tests includiing the quality control teest (Refer to page XX). - Please perform thee quality control test reguularly to makke sure the test results aare accurate. d Glucose Me eter can be uused with iGlucose Blood d Glucose Tesst Strips. Oth her test - The iGllucose Blood strips sh hould not be used under any circumsttances. The use of other test strips m may give inacccurate results. - The iGllucose Blood d Glucose Mo onitoring Sysstem is inten nded for in vitro diagnosttic use only. The Blood Glucose test results using fresh capillaary whole blo ood samples from the finngertip are ca alibrated to be eq quivalent to that of plasm ma samples.. - The iGllucose Blood d Glucose Mo onitoring Sysstem is inten nded for self--testing. It shhould not be used to screen for or diagno ose diabetes mellitus. Glucose Bloo od Glucose meter and Teest Strips are e exposed to a substantiaal change in - If the iG temperaature, pleasee wait 45 min nutes beforee measureme ent. - Follow all environm mental protection regulattions when disposing of batteries. d Glucose me eter will be sset as mg/dL by default when sold in United State es. If - The iGllucose Blood meter display showss “mmol/L” during settin g or test, ple ease contact iGlucose Diaabetes Custo omer Support Center. Usee of the wron ng unit of meeasurement may cause in ncorrect treaatment. d Glucose Mo onitoring Sysstem is not fo or use on neonates and sshould not be b used - The iGllucose Blood in the crritically ill. - The miinimum bloo od sample sizze to test usi ng the iGluco ose Blood Gllucose Monittoring System m is 0.75µL: Blood saample size ab bove 3.0µL might contam minate the te est strip portt and the meeter. Blood saample size beelow 0.75µL may cause aan inaccurate e result or may m prevent a meter read ding. An Er4 read ding will be displayed if th he sample siize is too small. In this case, repeat thhe test with a new test strip p. Importaant Safety No otes: - The iGllucose Blood d Glucose me eter and iGluucose Lancingg Device are for single paatient use. Do D not share th hem with anyyone includin ng other fam mily memberss. - All partts of the kit are a considered biohazarddous and can n potentiallyy transmit inffectious diseases, even aftter followingg the cleaningg and disinfeecting proced dures. Please e refer to thee section "Cleaning and Disinfecting Procedures" on page XX. - Users should wash their hands thoroughly with soap and water before and after handling the meter, lancing device, or test strips. Please see the following references for further information. 1."FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication" (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm 2."CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk or Transmitting Bloodborne Pathogens" (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html Limitations - Blood glucose meter readings may be significantly lower than "true glucose levels" in a hyperglycemic- hyperosmolar state, with or without ketosis. - Caution is advised when glucose values are below 50 mg/dL or above 250 mg/dL. Consult a Physician as soon as possible, if values in this range are obtained. - Healthcare professionals should evaluate their patients' technique regarding the use of the iGlucose Blood Glucose Monitoring System regularly. To accomplish this, it is recommended that blood glucose monitoring results be compared with a concurrently obtained laboratory measurement on the same blood sample. A proven clinical laboratory method employing hexokinase or glucose oxidase should be used as the comparative method. - Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated results. - The results of blood glucose measurements are different for measurements with whole blood and plasma. - Storage of strips near bleach as well as bleach containing products will affect the results of the iGlucose Blood Glucose Test Strips. - Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3,048 meters) above sea level. - Hematocrits below 20% may cause higher results. Hematocrits above 60% may cause lower results. - High concentrations of Uric acid ≥10 mg/dL, Cholesterol ≥600 mg/dL, and Ascorbic acid (Vitamin C) ≥5 mg/dL may interfere with the glucose test causing inaccurate test results. - Do not perform the blood glucose test at temperatures below 10°C (50°F) or above 40°C (104°F), nor below 10% or above 90% relative humidity. - iGlucose Blood Glucose Test Strips are designed for use with capillary whole blood samples. Do not use serum or plasma samples. - Not for screening or diagnosis of diabetes mellitus. - Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients. - Not for neonatal use. Table of Contents About the Blood Glucose Monitoring System The iGlucose Blood Glucose System The iGlucose Blood Glucose Meter The iGlucose Test strip Meter Activation and Battery Charging Setting Up Your Meter - Setting the Date, Time Turning On/Off the meter Handling the Blood Glucose Test Strip Getting Ready for Testing Performing a Blood Glucose Test View Appearance of Blood on the Test Strip Understanding Test Results and Messages Setting Meal Markers About Quality Control Performing a quality Control Test Understanding Control Test Results Recalling Test Results Obtaining readings Averages Obtaining Readings History Caring for Your Meter Cleaning and Disinfecting Procedures Error Messages and Troubleshooting FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT Specifications Warranty Customer Service Expected Blood Glucose Values Without Diabetes Component Manufacturer Information Log Book Warranty Card Emergency Card PAGE 10 11 11 12 14 16 16 17 18 19 21 21 22 22 23 23 25 27 28 29 30 30 30 31 32 33 The iGlu ucose Blood Glucose Mo onitoring Sysstem Your iGlucose Blood Glucose Mo onitoring Sysstem consistss of several ittems. Pleasee identify eacch item, learn its name and how h it is used d. Below are the items included in your iGlucosse Blood Glucose Monito oring System : 1. 2. 3. 4. 5. 6. 7. iGlucose Blood Glucose meter (with a Li rechargeable battery insstalled) User's Manual (iincludes Log Book, Warraanty Card, Em mergency Ca ard)* iGlucose Blood Glucose Testt Strip Packagge Insert* Righ htest® Contro ol Solution GC550 Packagge Insert* Gettting Started Guide* iGlucose Blood Glucose Testt strips (10/225 pcs)* Leveel 2 of Righteest Control Solution GC5550* (Levvel 2 and Level 4 of Rightest Control SSolution GC5 550 are availa able for the iGlucose Blo ood Gluccose Monitoring System but must bee purchased separately.) 8. iGlucose Lancingg Device* 9. Cleaar Cap* 10. Disp posable Sterile Lancets (1 10 pcs)* 11.Meteer charger an nd Meter cab ble (Input: D DV5V, 0.5A ;Output:DC5V V, 0,5A) me of package es might nott include * ite ems) (* Differrent packagees have differrent bundledd items. Som (By the n need to use the product specification ns for the inpu ut and authe entication iec6 c60950-1 AC100-2 240V, 50 / 60 0Hz 0.2A, ou utput DC5V, 0.5A of charrging transforrmer ) (IEC621 133 certified d by the nee ed to use th he product, specificatio ons for DC33.7V, 1000m mAh Lilon batttery of lithium) The iGlu ucose Blood Glucose Meter The iGlu ucose Blood Glucose Meter Icons Spelled o out on display Average result In ndicates a co ontrol solutioon test resultt mg/dL Unit of test re esult T result Test Warns when the batteriess are low or must be recharged In ndicates a meal marker w with test resu ults In ndicates thatt the GSM is turned on In ndicates whe en to apply t he blood sam mple “Strip In nserted” “Er # (Nu umber)” Spelled o out on display Appears afterr you insert ttest strip into o meter Appears when an error occcurs Current date and time Warns when the operatioonal temperaature limit is exceeded duuring testingg The iGlu ucose Blood Glucose Test Strip The iGlu ucose Blood Glucose metter can only bbe used with h the iGlucosse Blood Gluccose Test Strrips and Rightestt® Control So olution GC550. The use oof other test strips or control solutionns can lead to incorrecct results. The iGlu ucose Blood Glucose Test Strip PRECAU UTION - Close tthe iGlucose Blood Gluco ose Test Stripp vial immediately after removing a teest strip. - Do nott reuse iGluco ose Blood Gllucose Test SStrips - Do nott use expired d Blood Gluco ose Test Stripps. - When yyou open a new n vial of iG Glucose Bloood Glucose Test Strips, re ecord the datte on the via al. Discard the vial of teest strips afte er 3 months from openin ng. ose Test Stripps, between 39-86°F (or 4-30°C) and iin a location 10-90% - Store tthe iGlucose Blood Gluco o not expose e to direct suunlight or heat. relative humidity. Do Glucose Metter and test Strips are ex posed to a substantial ch hange in tem mperature, please - If the iG wait 45 minutes before measure ement. mation, pleasse refer to thhe iGlucose Blood Glucose Test Strip, Package Insert. - For dettailed inform -The usee of other tesst strips mayy cause strip error. Please e refer to page XX for trooubleshootin ng. Meter A Activation an nd Battery Ch harge Your iGlucose Blood Glucose me eter comes w with an installed Li recharrgeable batteery. When fu ully charged this batteryy will provide e power to peerform approximately 50 00 tests undeer normal usse. Press the main n button to activate yourr meter or innsert a strip. Connectt the charging adapter an nd the cable.. Insert the battery 1. Take the battery out of the plastic bag. 2. Open the back cover of the device by inserting your thumbnail into the small groove on the right-hand side near the bottom of the back cover and lifting up the cover. 3. Remove the old battery 4. Install a new battery inside the battery compartment so that the small metal contacts on the bottom of the battery touch the small metal pins in the battery compartment. 5. Replace the back cover of the device. Charge the battery 1. Connect the Meter Charger to its adapter cable 2. Plug the pin into the port at the bottom of unit 3. Plug the Charger into a power outlet. When the unit begins charging, the charging light illuminates and a charging battery icon flashes on the screen for a short while. Charging takes between 2-3 hours to complete. 4. When charging is complete, the battery icon on the device screen appears solid green. 5. Unplug the adapter from the socket. CAUTION - Please follow the local regulation to properly recycle rechargeable battery. - Risk of explosion if battery is replaced by an incorrect type. Setting Up Your Meter - Setting the Date, Time. Synchronizing the date and time To synchronize the date and time manually: 1. Press the “up” (Menu) button on the device. The Menu appears. 2. Select the “Date and Time” option. The “Date and Time” menu appears. 3. Select the “Synch Time” option. A confirmation message appears after a few seconds. Setting the Time and Date Manually To set the time and date manually: 1. Press the “up” (Menu) button on the device. The Menu appears. 2. Select the “Date and time” option. The “Date and time” menu appears. 3. Select the “Set Date” option. The year appears. Use the up or down buttons to change the year as needed. Press the “home” button to move on to the month. 4. Press the up or down buttons to change the month as needed. Press the “home” button to move to the day. 5. Press the up or down buttons to change the day as needed. Press the “home” button finish and return to the “Date and time” menu. 6. To exit the menu, press the up or down button to scroll to the “Back” option. Select the “Back” option to exit the menu. Settting the Date e or Time forrmat To selecct your formaat for date or time: 1. Press the “up” (M Menu) buttonn on the device. The Menu appears. 2. Selectt the “Date and a Time” opption. The “D Date and Tim me” menu apppears. 3. Selectt the “Date Format” opti on. Press the e up or down n button to sscroll to the desired datee format. Pre ess the homee button to select. A conffirmation meessage appears. 4. Selectt the “Time Format” optiion. Press the up or down button to sscroll to the desired timee format. Pre ess the homee button to select. A confirmation meessage appears. 5. To exit the menu, press the upp or down bu utton to scro oll to the “Baack” option. Select the “Back” optio on to exit thee menu. Turn ning On / Offf the Meter 1. How to t turn on th he iGlucose B Blood Glucosse Meter Press the Main butto on or Insert a test strip. 2. Manu ual Power offf To poweer off the iGlucose Bloodd Glucose Me eter, press an nd hold the M Main button for 3 seco onds. 3. Auto Power off The iGlu ucose Blood Glucose Metter will powe er off automatically afterr 2 minutes iff no butttons are presssed or no sttrip is inserte ed. Handlingg the iGluco ose Blood Glu ucose Test Sttrip Insertingg the iGlucosse Blood Glucose Test Strrip 1. Hold the Blo ood Glucose Test Strip beetween your thumb and middle fingeer with the view facing up. window 2. Put your forrefinger on th he side of th e strip as sho own. 3. Insert the iG Glucose Blood d Glucose Teest Strip into o test strip po ort until it cliicks and firm mly stops. ng the iGluco ose Blood Glucose Test SStrip Removin 1. Hold the iGlucose Blood Glucose Tesst Strip as shown. Glucose Bloo od Glucose TTest Strip cou unterclockwise and pull uup simultane eously. 2. Rotate the iG 3. Take the iGlucose Blood Glucose Tesst Strip out of o the test strrip port. Please fo ollow your healthcare prrofessional's instructionss and discard used strips properly. esting Getting Ready for Te performing a blood gluco ose test, preppare the item ms below: Before p - iGlucosse Blood Glucose Meter - iGlucosse Blood Glucose Test Strips (Please ccheck the exxpiration date on the testt strip vial. Do D not use exxpired test sttrips) - iGlucosse Lancing deevice - Sterile lancet 1. Hold tthe adjustab ble depth cap p of the lanciing device in one hand while holding the base in the other haand. Slightly force downw ward. 2. Pull th he two partss in opposite directions too remove the adjustable depth cap. 3. Insertt a new dispo osable lancett firmly into lancet carrie er. 4. Twist off and set aside the pro otective coveer of the disp posable lance et. h adjustable cap. 5. Replace the depth n by rotatingg the top porrtion of the depth adjust able cap unttil your 6. Choosse a depth off penetration desired setting is vissible in the window. Settiings are base ed on skin type " " for averagee skin; " " for thickk or calloused d skin. hin skin; " ffor soft or th Perform ming a Blood Glucose Tesst 1. Wash h your handss thoroughly with soap a nd water and dry well 2. Hold the base of the lancing device in onee hand and pull p on the pllunger with tthe other hand. The devicce will be coccked. Release e the plungeer and it will automatically move backk to its origin nal position near thee base. 3. Take one iGlucose Blood Gluccose Test Strrip from the vial. v Close th he vial cap im mmediately. 4. Insert the strip in nto the test strip port of tthe iGlucose Blood Gluco ose meter wiith the view window facingg up. Once the strip is inserted, yourr meter will be b automaticcally turn on.. 5. A blo ood drop icon n will appearr on the dispplay window. Apply the blood samplee within 2 minutes. 6. Placee the lancing device again nst your fing ertip and pre ess the relea ase button. 7. Touch and hold the blood dro op to the edgge of sample e port until th he view winddow is filled with blood d. If the view w window is not n completeely filled with blood the test t will not start. If the blood samp ple was insuffficient, disca ard the test sstrip and rep peat with a new iGlucosee Blood Gluco ose Test Strip.. 8. Coun ntdown Mode will begin on o the displaay window. After 5 secon nds, your tesst result will appear. 9. Pull o off the depth h adjustable cap. Withou t touching th he used disposable lanceet, insert the lancet tip into the proteective lancet cover. 10. Hold d the releasee button in one hand andd pull on the plunger with h the other hhand to safely eject the used disposaable lancet. 11. Disccard the used d disposable lancet into aan appropriaate puncture-proof or bioohazard conttainer. 12. Replace the dep pth adjustable cap after ffinishing the test. CAUTION drop to t the samplee port on the e strip until you y see the ""Apply a dro op of - Do nott apply your blood blood " aappear. The iGlu ucose Blood Glucose Metter is perform ming an interrnal test and d will display an error me essage if you apply blood too soon. If this occurs, pleaase repeat th he test with a new test sttrip. d the openingg date of a new test stripp vial. Discard the vial of test strips 3 months afte er - Record openingg. - Alwayss keep the metal contacts of the test strip port cle ean. If any dust or impurrities are pre esent, please cclean with a small, soft brrush. - The iGllucose Blood d Glucose Mo onitoring Sysstem and iGlucose Lancin ng Device aree intended fo or a single usser only. Do not share these devices with anyone e, including other family members. - All partts of this kit are considerred biohazar ds and can potentially transmit infecctious diseases, even after you have perfo ormed the cle eaning and ddisinfecting procedure. oughly with ssoap and water after han ndling the meeter, lancingg device, - Users sshould wash hands thoro and testt strips. - For cleaning and diisinfecting pllease refer too the section n "Cleaning and a Disinfectting Procedures" on page XX. View Ap ppearance off Blood on th he strip Make su ure your bloo od sample co overs the whhole area of the t view window to get aan accurate test result. A An insufficien nt blood sam mple will resuult in an error message ("Er4"). If this occurs, repe eat the test with h a new test strip. CAUTION on date printted on the sttrip vial every time you use a test striip. Do not usse - Check tthe expiratio expired iGlucose Blo ood Glucose Test Strips. - Use each iGlucose Blood Glucose Test Stripp immediately after remo oving it from the vial. ose Blood Gllucose Test SStrips. - Do nott reuse iGluco - Do nott perform tessting immediately after m moving from one ambien nt temperatuure to anothe er (e.g. after com ming indoors from the outside). Allow es for the tem mperature off the meter and a the w 45 minute test strip ps to equilibrate. - Apply tthe blood sample only on n the samplee port of the test strip. Understtanding Test Results and d Messages Blood glucose test reesults are shown on the iGlucose Blo ood Glucose meter as mgg/dL. If your b blood glucosee result is un nusually highh or low, or iff you questio on your test rresults, repe eat the test with h a new iGlucose Blood Glucose Testt Strip. You can also run a Quality Control Test with the Rightestt® Control So olution GC5550 to check your iGlucosee Blood Gluco ose meter an nd iGlucose Blood Glucose Test Strip (Refer to “PPerforming a Quality Control Test” on pagge XX) . usually high or low, contact your hea althcare proffessional If the test result still remains unu immediaately. If you arre experienciing symptom ms that are n ot consisten nt with your blood glucosse test resultts and you havee made suree to follow all instructionss in this man nual, contact your health care professsional immediaately. Consult your healthccare provider for approppriate disposaal of used test strips and lancets. ucose Blood Glucose metter displays rresults betwe een 20 and 600 6 mg/dL. The iGlu If the test result is below 20 mg//dL , “LO ” w will appear on n the screen. Please repeeat your test with by a new teest strip. If you still get a “LO ” result, contact your heealthcare pro ofessional. bove 600 mgg/dL, “HI” wiill appear on the screen. Please repeaat your test again If the test result is ab p. with a new test strip If you still get a “HI ” result, conttact your heaalthcare proffessional. Meal Marke ers: Setting M Press the main butto on to choose e among befoore meal and after meal, Before meal: You execute e this blood gglucose test before a me eal. Affter meal: Yo ou execute this blood gluucose test after a meal. Select th he appropriaate test mode e: “Before M Meal” or “After Meal” in one o of the foollowing wayys: Using the menu: a. b. c. d. Menu) buttoon on the devvice. The Me enu appears.. Presss the “up” (M Seleect the “Test Mode” optioon. Scro oll to the “Be efore Meal” oor “After Me eal” option as required. Presss the middle e button. A cconfirmation message ap ppears. Using the middle button n from the hoome screen (when no me enu is selecteed): a. Presss the “middle button onn the device to t toggle the e Test Mode icon (#8 in Figure abovve) on the display. b. For “Before Mea al” toggle to the whole apple icon; fo or “After Meaal” toggle to the parttially eaten apple icon. c. Notee: Do not use e the “Contrrol Solution” setting (represented by the solution n bottle icon ) for a blood test, aas the result will not be calculated intto averages. About Q Quality Contrrol Testing What is a Quality Co ontrol Test? onitoring fun nction, it is nnecessary to regularly perform a quallity control test. To ensure proper mo your iGlucose Blo od Glucose Use onee of the Righttest® Control Solution GCC550 when testing Monitorring System in i the Contro ol Solution M Mode. If the test t result is within the CControl Soluttion Range printed on the strip vial la abel, the iGluucose Blood Glucose Monitoring Systtem passes the Quality C Control Test and your iGlucose Bloodd Glucose Monitoring Sysstem is workking properlyy. Control Solution Ran nge: Ran nge printed oon your test strip vial labe el. Examplee of Control Solution NOTE ® Control Sollution GC550 0 are available for iGlucoose Blood Glu ucose - Level 2 and Level 4 of Rightest® Monitorring System but b must be purchased sseparately. Iff you want to o purchase Leevel 2 or Levvel 4, please ccontact the iG Glucose Diab betes Custom mer Support Center. hould a quallity control test t be perfoormed? When sh - To ensure that you ur iGlucose Blood Glucosee meter and iGlucose Blo ood Glucose Test Strip arre workingg properly. - To confirm that you u are followiing the correect testing prrocedures. pare for your initial blood glucose te st. - To prep - To check the iGluco ose Blood Glucose Test SStrip or when n you open a new vial of strips. meteer after it has been dropped, damageed or expose ed to - To check your iGluccose Blood Glucose liquids. esults are noot consistent with the - If you ssuspect that your test results are inacccurate, or iff your test re way you u feel. - To pracctice testing. equired Items for Quality Control Tests orm a qualityy control testt, prepare thhe items belo ow: To perfo - iGlucosse Blood Glucose Meter - iGlucosse Blood Glucose Test Strips - Rightesst® Control Solution GC5 550 CAUTION the expiration date oon the label.. The - Each time you open a new botttle of contro l solution, write Rightestt® Control So olution GC550 is good forr 3 months after opening g the bottle, or until the expiratio on date printted on the la abel, whichevver comes first. Examplee - Wipe the bottle cap with a clea an tissue befoore tightly cllosing the bo ottle of contrrol solution. - Close tthe bottle of control solution tightly iimmediatelyy after using. - Check tthe expiratio on date before use. (Refeer to the Righ htest® Contrrol Solution G GC550 Packa age Insert). - Keep control solutiion bottles out of reach oof children. ming a Qualitty Control Te est Perform 1. Take o one iGlucosee Blood Glucose Test Stri p from the vial v and close e the vial capp immediately. 2. Insertt the iGlucose Blood Gluccose Test Strrip horizontally (not vertically) with thhe colored view window facing up into the test strip port. 3. Press the “up” (M Menu) button on the devicce and the Menu will appear. . option n. The “Test Mode” menu appears. 4. Selectt the “Test Mode” 5. Selectt the “Contro ol Solution” option. A connfirmation message appears. Note: W When a test mode is set fo or a Control Solution, the e result will not n be calcullated into avverages. It is important to sett the Test Mo ode to “Conttrol Solution” to ensure this t when peerforming a control test. 5. Shakee the bottle of o Rightest® Control Soluution GC550 well before opening the cap. Place th he cap on a flatt surface. 6. Place a drop of co ontrol solutio on onto the ttop of the cap. port of the strip w with the con ntrol solution n from the toop of the cap p. 7. Gentlyy touch the sample 8. The sccreen will dissplay the cou unt time starrting from 5.. ottle. 9. Tightly replace thee cap on the Rightest® Coontrol Solutiion GC550 bo w appear. CCompare you ur Quality Control Test reesult to the Control 10. The control soluttion result will n Range printted on the Blood Glucosee Test Strip vial v label. Solution CAUTION ontrol Solutiion Test resu ults will not bbe included in the averag ge calculationns, however, they - Your Co can still can be recalled and view wed. The Conntrol Solution n Test result will be show wn with the control ssolution icon n on the scre een. - The Co ontrol Solutio on Test should be conduccted betwee en 59-104°F (15-40°C) andd in a locatio on with 10-90% RH. op of blood ", " do not touuch the contrrol solution to t the sampl e port on the strip. - Before "Apply a dro The iGlu ucose Blood Glucose metter is perform ming an interrnal check. Touching the control solu ution to the sample port befo ore prompte ed will result in an error message. ntrol solution n on to the ssample port of o the test sttrip directly. The reagentt on the - Do nott drip the con strip migght leak into the bottle of o control sollution and may m cause the e degeneratiion of the control solution. This could contaminate e the meter vvia the test strip port. - Keep th he test strip port clean and dry. Clea n immediate ely if the testt strip port iss stained or is overly exposed d to moisturee. - Do nott touch the tiip of the control solutionn bottle. If the tip is touch hed, clean w with water an nd pour out 2 drops of control solution. Understtanding quallity Control Test T Results Your con ntrol solution n test resultss should fall within the co ontrol solution range priinted on the test strip vial label. If thee results are within the raange, the Blo ood Glucose Monitoring System is wo orking correctlyy. Examplee of control solution rangge printed onn your test sttrip vial label. Control Solution Ran nge Level 2 888-120 mg/dLL LLevel 4 250-3340 mg/dL Possiblee reasons you ur Control So olution resultts being out of the range e: - Your Rightest® Con ntrol Solution n GC550 is exxpired or waas first opene ed more thann 3 months ago. h expired. - Your Blood Glucosee Test Strip has e Blood Glucoose Test Strip vial or the control soluution off for a period - You lefft the cap of the iGlucose of time. d not perform m the test prrocedure corrrectly. - You did - The iGllucose Blood d Glucose me eter or Bloodd Glucose Test Strip have e malfunctionned. If Righteest® Control Solution GC5 550 results aare out of ran nge, your iGlucose Bloodd Glucose Mo onitoring may not be working System m prop perly. Repeaat the Qualityy Control Tesst. If your conntrol solution results are still o out of rangee, do not use Blood Glucoose Meter to o test your blood glucose . Please conttact the iGlucosee Diabetes Cu ustomer Sup pport Center . Recalling Test Results ucose Blood Glucose metter is able to automaticallly store a maximum of 5500 test results with The iGlu time and d date. If you ur meter hass stored 500 results, the newest test result will reeplace the oldest one. Obtainin ng Readings Averages iGlucosee maintains the t averagess of your bloood glucose re eadings for the t last 7, 144, 30 and 90 days in memoryy on the deviice. To obtaiin glucose reeading averagges: 1. Presss the “down n” button on the right sidde of the devvice. The “Avverages” mennu appears. 2. Seleect the desireed option: a. Last 7 Days b. Last 14 Days c. Last 30 Days d. Last 90 Days 3. The average blood glucose reading for thhe selected period appea ars. Press thee middle buttton to retu urn to the “Averages” me enu. Select a nother item from the me enu that youu wish to view w, or select the “Backk” button to exit e the mennu. Please no ote “control solution” reaadings do not count in caalculating thee averages. Obtainin ng Readings History iGlucosee maintains a record in memory on thhe device of each blood glucose readding for up to o 500 readingss. To obtaiin the list of previous blo ood glucose rreadings: 1. Presss and hold (“long press”) the “down ” button on the right side of the deviice OR From m the “Averaages” menu (see above), select the “Previous Rea adings” optioon. The “Hisstory” list appears showing previous readings. Press the “up” or “down” bbuttons to sccroll through the list. Press the middle button to eexit the list. Caring for Your Meter Maintenance Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If your meter is dropped or damaged, perform a quality control test with the control solution before performing a blood glucose test. Cleaning Meter Clean the outside of the meter with disinfecting wipes listed on next page. Do not get the test strip port wet. Cleaning Test Strip Port If your test strip port is stained with blood, control solution or any liquid, please use disinfecting wipes listed on next page to clean it immediately. Do not immerse in water. Perform a quality control test to ensure the iGlucose Blood Glucose meter is working properly. Cleaning and Disinfecting Procedures Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) during the delivery of healthcare services has been increasingly reported. Persons using blood glucose monitoring systems have been identified as one risk group due to the shared use of fingerstick (lancing) devices and point of care blood testing devices. The cleaning procedure is to remove dust, blood and body fluid from the surface and should be performed whenever the meter or lancing device is visibly dirty. Performing the cleaning procedure once per week is recommended. The disinfecting procedure is necessary to kill pathogens such as HBV on the housing materials of the device. The cleaning and disinfecting procedure should be performed at least once per week. The meter and lancing device should be cleaned before being disinfected. If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person. NOTE: the cleaning procedure can only remove visible contaminates from surfaces. Only the disinfecting procedure can eliminate non-visible pathogens. CaviWipes Disinfecting Towelettes has been tested and may be used to clean and disinfect the meter and lancing device. Users may purchase the disinfecting wipes from the manufacturer (Metrex), distributors or major on line Users may purchase the disinfecting wipes from the manufacturer (Metrex), distributors or major on line retail sites such as www.amazon.com and www.ebay.com. You can contact Metrex customer service at 1-800-841-1428 and info@metrex.com. (Monday through Friday, between 6 AM and 4 PM PST) Please see the following references for further information: -FDA Public Health Notification: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010). http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm - CDC Clinical Reminder: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://w www.cdc.govv/injectionsafety/Fingersstick-DevicesBGM.html NOTE e of the devicce only. Do not n remove battery coverr when clean ning and - Clean aand disinfectt the outside disinfectting. To clean n the meter: 1. Thoro oughly wipe the t entire su urface of the meter, espe ecially port, face/display, , housing and buttons with disinfecting wipes listed above to clean anyy possible dirrt, dust, bloood and otherr body fluids. To disinffect the meter: 2. Take aanother disin nfecting wipe and wipe tthe meter thoroughly. (N Note: All bloood and body fluids should b be cleaned frrom surface before perfoorming the disinfecting procedure) 3. Allow w the surface to remain wet w for 2 min utes. 4. Allow w to air dry. NOTE Glucose Bloo od Glucose meter has beeen tested to ensure that there is no cchange in the - Your iG perform mance or exteernal materia als of the devvice after 55 50 cleaning cycles and 5550 disinfectin ng cycles. The testting simulatees 2 cleaning and disinfeccting cycles per p week ove er the typica l life of the meter (5 years). n the iGlucosse lancing device: To clean 1. Thoro oughly wipe the t entire su urface of the iGlucose lan ncing device with disinfeccting wipes listed above to o clean any possible dirt, dust, blood and other body fluids. To disinffect the iGlucose lancingg device: 2. Take aanother disin nfecting wipe and wipe tthe iGlucose Lancing device thoroughhly. (Note: All blood and bod dy fluids shou uld be cleane ed from surfaace before performing disinfecting pprocedure) 3. Allow w the surface to remain wet w for 2 min utes. NOTE Glucose Lanccing Device has been testted to ensure e that there is no changee in the perfo ormance - Your iG of the deevice after 550 5 cleaning cycles and 5550 disinfectiing cycles. Th he testing sim mulates 2 cle eaning and disin nfecting cyclles per weekk over the typpical life of the meter (5 years).CAUTTION - Users sshould wash their hands thoroughly w with soap an nd water afte er handling tthe meter, la ancing device o or test strips.. - Please examine you ur LCD scree en, test strip port, button ns and surfacce of your meeter and lanccing device aafter cleaningg and disinfe ecting cycles.. Stop using the t meter an nd/or lancingg device if an ny of the following occur: - Thin, sliver streaks appear on the screen, dissolveed, brittle or swollen. - The scrreen becomees cracked, soft, - You aree unable to turn on/off your meter, ooperate the left/ right bu utton, the lanncing device release button o or depth adju ustable cap. - You aree unable to enter meter settings, funnction modess or recall yo our testing reesults. If you haave any quesstions or con ncerns, pleas e contact yo our Blood Glu ucose Monitooring System authorizzed represen ntative or call the GE Diabbetes Support Center. Error Meessages and Troublesho ooting Trouble Shooting Potentiaal problems and a the reco ommended s olution(s) arre listed belo ow: Problem Cannot turn on devicce Cannot turn off devicce by pressingg middle button Part of tthe display is not working Cannot insert strips No resp ponse when sttrip is PPossible reaso on No batteryy Battery noot charged or Battery co nnection erro Software eerror Device is ddamaged Strip insertted incorrectly. Damaged sstrip. Incorrect m make of strip. Damaged sstrip slot. Battery is ddead. SSolution(s) Check batterry is inserted correctly. Recharge batttery. Replace batttery. Press and hoold “up” butto on, select “Shutdown”.. Contact custtomer supportt at 15-5555) 844-IGLUCOSSE (1-555-555 Insert the strrip in the corrrect way. Use a differeent strip. Use correct m make of strip.. Repair or repplace device. Charge the bbattery. inserted into the device. Strip was inserted incorrectly. Wrong strip was inserted. Device is damaged. No response when blood sample is applied to the strip Blood sample is not sufficient. Strip is has been used or is damaged. Device is damaged. Cannot send data Weak signal or network error Cannot synchronize time Network error Insert the test strip in the correct way. Insert the right test strip. Contact customer support. Repeat the test with a sufficient blood sample. Repeat the test with a new strip. Check the device with a Control Solution test. Retry later or in different location. All unsent data will be sent together with data for next test Set manually from device menu: Date & Time Contact customer support at (1-555-555-5555) for any unresolved issues. Display Messages and Problem-Solving Guide When any of the following messages appears, there is a problem that requires your attention. Display HI Description Blood glucose result may be higher than 600 mg/dL. LO Blood glucose result may be lower than 20 mg/dL. Temperature out of range Temperature is above or below the operating range of test strips or the device. Low Battery Unknown strip Battery is low on charge. Test strip unknown or may be damaged. Test strip is used or test was not performed correctly. Discarded strip Action to Take Review proper testing procedure and perform a quality check with control solution. Repeat blood test; if “HI” still appears, call your doctor or seek medical attention immediately. Review proper testing procedure and perform a quality check with control solution. Repeat test; if “LO” still appears, call your doctor or seek medical attention immediately. The result you have obtained may not be accurate. Move to an area with temperature between 50ºF - 104ºF (10ºC to 40ºC). Do not artificially heat or cool the device. Repeat the test with a new test strip. Charge the battery. Perform the test with new test strip. Discard the strip and repeat the procedure with a new strip from the vial or package Perform the test with a new test strip and follow the test procedure correctly. If error messages appear that are not listed above, or for any unresolved issues, contact customer support at (1-555 555 5555). 1. In order to get accurate testing results, please test between 50-104 °F (10-40 °C). 2. When the temperature is below 50 °F (10 °C) or over 104 °F (40 °C), the meter will not function and the " " symbol will blink. 3. If the iGlucose Blood Glucose meter and Test Strips are exposed to a substantial change in temperature, please wait 45 minutes before measurement. Samplin ng Error Please d do not apply the blood to o the sample port of the test t strip beffore the metter displays: “apply a drop of blood”. Otheerwise, the meter will dissplay an erro or message. Please discarrd the test sttrip and use the new one. used orr damaged. Please use a new test striip. Er1- Thee inserted tesst strip has been Er2- Thee meter has malfunctione ed. Do a Quaality Control Test or reinsstall the battteries to checck if the meter w works properrly. Er3- Thee signal transsmission is diisrupted. Reppeat the testt using a new w test strip. Er4- Thee blood samp ple volume iss insufficientt. Repeat the e test using a new test strrip. Er5- An issue calibrating the Metter has occurrred. Please follow the stteps below: ove the test strip from th he meter. (1) Remo (2) Turn off the meteer (press and d hold the M Main button for f 3 secondss). n ON the meeter. (3) Presss the main button to turn If after tturning on th he Meter, you do not seee Er5, your meter is functtioning propeerly and able e to perform m a test. If one off the above error messagges still appeears, please contact iGluccose Diabetees Customer Service at 1-55-5555-5555. Meter M Malfunction If the iGlucose Blood d Glucose Me eter will not turn on, ple ease follow th he steps beloow: emove the b atteries. 1. Open the battery cover and re er 2. Wait ffor 5 minutees and reinsert the batterries as described as instructed on pagge 19, (Mete Activatio on and Changing the Battery). The metter should work normallyy after finish ing the abovve steps. If th he meter stilll does not work, please ccontact iGluccose Diabetes Customer SSupport Center. CAUTION uld ONLY be applied to thhe test strip after the tesst strip has bbeen inserted A blood sample shou correctlyy and the Meeter's screen n is showing tthe image off the test strip and a bloood drop flash hing symbol. If the blood drop flashin ng symbol is NOT showing on the scre een, do not aapply a samp ple to the test strip. Please re-insert the unused test strip correctly. The screen MUST show the image of the test strip accompanied by the blood drop symbol flashing (this symbol take 3 seconds to show after correctly inserting the test strip) in order for a sample to be applied. Please consult your User Manual and/or contact Customer Service for support on how to correctly insert a Blood Glucose Test strip. FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user's authority to operate the equipment. 15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference and 2) this device must accept any interference received, including interference that may cause undesired operation of the device. Specifications GSM Platform MT6260 Mode GSM+GPRS Frequency GSM 850/900/1800/1900 Antenna Interior on the bottom Type Module mounted IC Fujitsu MB95F378E GSM Glucose Test Sample Fresh capillary whole blood Test Result Plasma / Serum glucose Sample Size Less than 0.5 μL Measuring Time Less than 5 seconds Measuring Range 20mg/dL~600mg/dL Hematocrit Range 20% ~ 60% Working temp 10℃ ~ 40℃, Size - 2.4" QVGA Hi contrast TFT LCM Colors 260K Resolution - 320 * 240 pixels Left - Menu, information menu Button pad (3 Buttons) Middle - ON/OFF; Enter, test mode change Right - Averages, readings history General Meter Dimension 100* 49.8 * 16.5mm Meter weight 85g+/-5g With battery meter input DC5V, 0.5A Port Micro USB - Charging, software download Speaker 15MM mini-speaker as buzzer or vocal reminding Battery Capacity 3.7V, 1,000mAh Li-Ion Battery Life - 25-30 days for normal use (2-3 tests per day) Data entry 500 Entries Main standby page GSM signal strength, battery level, carrier name, date/time Languages English software name and version Bionime X.X Warranty Smart Meter Corporation warrants that this product will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of an iGlucose Blood Glucose meter that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the iGlucose Blood Glucose Monitoring System. Please complete and return the enclosed warranty card. Different models have different specifications. This warranty applies only to the iGlucose Blood Glucose Monitoring System; other models are not covered with this warranty card. iGlucose is a trademark of Smart Meter Corporation. NOTE - During blood glucose measurement, the iGlucose Blood Glucose meter itself may come into contact with blood. All parts of the iGlucose Blood Glucose Monitoring System are considered biohazardous and can potentially transmit infectious diseases. Please follow your healthcare professional's direction to properly dispose of the used iGlucose Blood Glucose Monitoring System after removing the batteries. Customer Service Please review all of the instructions to make sure you are performing the steps correctly. If you have any questions or concerns, please contact the iGlucose Diabetes Support Center toll free at 1-555555-5555 or visit our web site: www.gediabetes.com. (Monday through Friday 8:00 AM to 5:00 PM PST. If you have questions or need assistance outside the operational days and times, please contact your healthcare provider.) Expected glucose values for persons without diabetes ⁽¹⁾ Status Fasting Two hours after meals Range (mg/dL) < 100 mg/dL < 140 mg/dL References 1) American Diabetes Association: Diabetes Care, January 2015, volume 38 (Suppl. 1) S8-S16. Component Manufacturer Information iGlucose Blood Glucose Meter, Test Strip, Control Solution Manufacturer: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Lancing Device Manufacturer: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Disposable Sterile Lancets Manufacturer: SteriLance Medical (SuZhou) Inc. No.68 LiTangHe RD, XiangCheng, SuZhou, JiangSu 215133, P.R. China General Electric Company and is under license by Bionime Corporation, No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C) Log Book Name: Address: Home Phone: Doctor: Pharmacy: Insulin/Pills: In case of emergency contact: Date Blood Glucose Breakfast Insulin/ Medication Blood Glucose Lunch Insulin/ Medication Blood Glucose Dinner Insulin/ Medication Blood Glucose Bedtime Insulin/ Medication Blood Glucose Other Comments Insulin/ Medication Work Phone: Doctor’s Phone: Pharmacy Phone: Log book date From: To: Warranty Card Distributor name and address PLACE STAMP HERE Warranty Card Name: Address: Serial No.: Date of Purchase: Tel: Distributor name and address Model (Please present this card for product replacement) Limited warranty: 1. Bionime warrants to the original purchaser only, that the iGlucose Blood Glucose meter shall be free of any defects in materials or workmanship and, provided it is not modified, altered or misused, will perform in accordance with specifications for a period of five (5) years from the original date of purchase. 2. Bionime guarantees the performance of the iGlucose Blood Glucose meter only if used as directed and provided that the failure to perform has not been caused in whole or in part by the use of test strips that are not iGlucose Blood Glucose Test Strips manufactured by Bionime. Use only iGlucose Blood Glucose Test Strips in your iGlucose Blood Glucose Meter. 3. The sole obligation of Bionime under this warranty shall be to replace any defective iGlucose Blood Glucose Meter. No other warranties, express or implied, are made. Bionime shall not be responsible for any incidental or consequential damages. 4. You must contact your distributor for assistance and/or instructions for obtaining a replacement iGlucose Blood Glucose meter is a trademark of Smart Meter Corporation. Emergen ncy Card ose Monitorring System iGlucosee Blood Gluco • User N Name: • Emerggency Contacct Phone No.: • Blood Type: • Doctorr/Hospital: If yo ou find me inn a coma or stupor, please contact nearest emerrgency I am a person with diabetes. services immediatelyy. Or call: *Pleasee fill out this card and carry with youu at all times..
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