Andon Health GMM0001 Blood Glucose Meter User Manual FCC

Andon Health Co., Ltd Blood Glucose Meter FCC

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GMM0001 User Manual

FCC User Manual

IDEAL LIFE Gluco-Manager TMBlood Glucose Management SystemModel GMM00010001Products may vary from images shown*NOTE: The IDEAL LIFE Gluco-Manager™ is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the nger and the following alternative sites: the palm, the forearm, the upper-arm,the calf and the thigh. It is intended for use by adults with diabetes mellitus in a non-clinical environment such as in the home, as an aid to monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of, or screening for, diabetes mellitus and not in-tended for use on neonates. The alternative site testing can be used only during steady state blood glucose conditions. The system is intended for information purposes only, for expert advice make sure to consult a healthcare professional. Any instructions for change in treatment and health related information or advice should only be made directly with a healthcare professional.Version 7.0 Jun 2013INSTRUCTION MANUALRead before useMay be used with IDEAL LIFE Pod™(sold separately) for use with IDEAL LIFE Health Management System™

2IDEAL LIFE Gluco-Manager™Table of ContentsTable of Contents......................................2Introduction.................................................3Preface..........................................................3Contraindications......................................3Precautions..................................................4Important Information..............................4About Alternative Site Testing (AST)....6Package Contents......................................7Additional Items ........................................8IDEAL LIFE Pod™Location/Interference................................................ 9Before You Start Your IDEAL LIFE Gluco-Manager™....................................10Your IDEAL LIFE Pod™..........................11Test Strip Description ............................12Important Test Strip Information..........12Powering Up Your IDEAL LIFE Gluco-Manager............................................13First Time Power Up and Activation When Using a Pod..................................14About Control Solution........................15Important Control Solution TestInformation...............................................15How to do a Control Solution Test.....16Functions...................................................18Table of ContentsTaking Your Blood GlucoseReading.....................................................19Getting a drop of blood ......................19When obtaining blood from sites other than the ngertip.........................19Taking a reading......................................20Looking at Previously Taken Readings...................................................21Looking at Messages..............................22Looking at Graphics...............................23Comparing Meter and Laboratory Results......................................................24Care and Maintenance..........................25Cleaning and Desinfecting....................26A List of the Signs of Potential Deterioration..........................................27Specications...........................................28Limitations of Use..................................29Problem Solving Guide..........................30Error Message.........................................31Summary of Operation.........................32FCC Statement ......................................33Customer Information..........................34Service Requirements............................35

3Instruction ManualIntroductionPrefaceThank you for purchasing the IDEAL LIFE Gluco-Manager™, or GMM 0001 and IDEAL LIFE Pod™, or ILP 0001. This completely automatic system measures your blood glucose, captures subjective information and manages information automatically so that you can better manage your blood glucose with your care provider. Your measurement reading is clearly displayed on a large screen on the IDEAL LIFE Gluco-Manager™ after each measurement, and later stored for a more detailed analysis in the form of tables for easy viewing and graphs for easy interpretation. Your new IDEAL LIFE Gluco-Manager™ provides you with accurate, whole blood test results for blood glucose. The system is compact with convenient operation so it is simple to use.Intended UseIDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the ngertip and alternative sites for self-testing by persons with diabetes in the home, or by healthcare professionals in healthcare facilities.Testing is done outside the body (in vitro diagnostic use). The IDEAL LIFE Gluco-Manager™ is not intended for the diagnosis of, or screening for, diabetes mellitus and not intended for use on neonates. The alternative site testing (the palm, forearm, upper arm, calf and thigh) using this system can be used only during steady-state blood glucose conditions.You do not need to calibrate your meter, making it easier for the user to monitor blood glucose at home.The IDEAL LIFE Gluco-Manager™ can wirelessly communicate to a communication gateway or an access point. CAUTION: Before using any product to test your blood glucose, read all instructions thoroughly and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. For proper interpretation of blood glucose measurements, make sure to consult a physician.Contraindications**Warning: This system is designed for use outside the human body. It is not recommended for use on infants and is not intended for and should not be used to try and measure the blood glucose of infants as it may not be accurate and/or relied upon.Do NOT use the device for purposes other than measuring blood glucose. This unit does not serve as a cure of any symptoms or disease. The data measured are only for reference. Always consult your physician to have the results interpreted.Introduction

4IDEAL LIFE Gluco-Manager™Precautions• Do not drop this unit. Please avoid strong impact. Disassembly or modication of the unit may lead to permanent reading error.• The device might not meet its performance specications if stored or used beyond the specied temperature and humidity ranges.• Operating conditions: 50°F to 104°F (10°C to 40°C), below 80% RH.• System storage: 39.2°F to 86°F (4°C to 30°C), below 80% RH.• Be sure to keep this manual for future reference.• NOTE: Before using any product to test your blood sugar (blood glucose), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional.• Do not place the device in liquid, nor put it where it could fall into liquid.• Close supervision is necessary when the device is used by, on, or near children, handicapped people or invalids.• Do not use the device come into contact with surfaces which are too hot to touch.• Do not use the device where aerosol sprays are being used.• Do not use the device if it is not working properly, or if it has been damaged.Precautions

5Instruction ManualImportant Information• Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.• Test results below 60 mg/dL (3.3 mmol/L) indicate hypoglycemia, or low glucose. Test results higher than 240 mg/dL (13.3 mmol/L) indicate hyperglycemia, or high glucose. Consult your physician when one of these results is shown repetitively.• If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this owner’s manual, call your healthcare professional.• Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with blood glucose meters.• Please refer to your test strip package insert for additional important information.• Always follow the operation procedures described in the manual in order to obtain correct results.The meter and lancing device are for single individual use. Do not share them with anyone including other family members! Do not use on multiple individuals!All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.You should refer to the following linkages for more information: “FDA Public Health Notication: 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“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.htmlFor any questions or comments, please call an IDEAL LIFE customer representative at 1-866-IDEAL-41 (866-433-2541)Important Information

6IDEAL LIFE Gluco-Manager™About Alternative Site Testing (AST)IMPORTANT: There are limitations for doing alternative site testing (AST).Please consult your healthcare professional before you do AST.What is AST?Alternative site testing (AST) means that people use parts of the body other than ngertips to checktheir blood glucose levels. This system provides you to test on your forearm, upper arm, calf, or thighwith the equivalent results to ngertip testing when used at appropriate times.What is the advantage?Fingertips feel pain more readily because they are full ofnerve endings (receptors). At other body sites, since nerveendings weren’t so condensed, you won’t feel as muchpain as at the ngertip.When to use AST?Food, medication, illness, stress and exercise can affect ablood glucose levels. Capillary blood at ngertip reectsthese changes faster than capillary blood at other sites.Therefore when testing blood glucose during orimmediately after meal, physical exercise, or any otherevent, take blood sample from your nger only.We strongly recommend you do AST in the following intervals:• In a pre-meal or fasting state (more than 2 hours since the last meal).• 2 hours or more after taking insulin.• 2 hours or more after exercise.Do NOT use AST if:• You think your blood glucose is low.• You are unaware of hypoglycemia.• Your AST results do not match the way you feel.• You are testing for hyperglycemia.• Your routine glucose results are often uctuating.• You are pregnant.About Alternative Site Testing (AST)

8IDEAL LIFE Gluco-Manager™Additional Items (*sold separately) There are 3 levels for control solutions. Please call 1-866-IDEAL-41 (866-433-2541) for availability. Additional ItemsILP 0001 IDEAL LIFE POD™25 STERILELANCETS25 TEST STRIPSCONTROLSOLUTION1 CLEAR CAP LANCINGDEVICENOTE: Check your system to be sure that it is unopened prior to use and that it contains all parts listed above. If either of these conditions occurred, please return your system to the place of purchase.AC ADAPTER

9Instruction ManualLocation/InterferenceThe IDEAL LIFE Manager™ may be used with a communication gateway such as the IDEAL LIFE Pod™ or access point such as a cellular phone or computing device.The IDEAL LIFE Pod™ uses wireless radio waves to transfer information from your IDEAL LIFE Manager™. For the best distance and least interference, the recommended IDEAL LIFE Pod™location is:NOTE:While using an IDEAL LIFE Pod™ with telephone line connectivity, the telephone line will be in use. If the telephone line is in use while trying to use your IDEAL LIFE Pod™, the information will be stored in your IDEAL LIFE Manager™ and will be sent later.• Away from electrical appliances such as aTV, personal computer or a cordless phone• In a HIGH and CENTRALlocation with no obstructionssuch as wallsLocation/Interference

10 IDEAL LIFE Gluco-Manager™Before You StartBefore You StartYour IDEAL LIFE Gluco-ManagerTMTest PortLCD DisplayBlue LEDLeft “Soft”ButtonSTART/ESCAPE ButtonRight “Soft”ButtonBattery CoverBattery CoverAAA Batteries

11Instruction ManualYour IDEAL LIFE PODTM* Note: There is only a battery compartment for telephone line connectivityLED DisplayAC Adapter JackUSB PortEthernet Cable RJ45 Jack Connection Battery CoverTelephone Cord RJ11 Jack For Telephone ConnectionYour IDEAL LIFE Pod ™(*An optional accessory sold separately)(Sealed with an antenna for cellular Internet connectivity)Telephone Connection Telephone Cord RJ11 Jack For Line Connection(sealed for cellular internet connectivity)

12 IDEAL LIFE Gluco-Manager™Test Strip DescriptionTest Strip Description • Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction cell where the reaction takes place.• The test strip consists of the following parts:Contact BarsInsert this end of the test strip into the meter.Push it in rmly until it will go no furtherTest Strip Handle Hold this part to insert the test strip into the slot.Conrmation WindowThis is where you conrm if enough blood has beenapplied to the Absorbent Hole of the strip.Absorbent HoleApply a drop of blood here; the blood will be sucked automatically.• Refer to the section below: “Taking Your Blood Glucose Reading,” for complete instructions.Important Test Strip Information• Store test strip packages in a cool, dry place from 39.2°F to 86°F (4°C to 30°C) . Keep away from direct sunlight and heat. Do not freeze.• Store your test strips in their original vial only; do not transfer them to a new bottle or anyother container.• After removing a test strip from the vial, immediately replace the vial cap and close it tightly.• With clean, dry hands, you may touch the test strip anywhere on its surface when removing it from the vial or inserting it into the meter.• Use each test strip immediately after removing it from the vial.• Write the discard date on the vial label when you rst open it. Discard remaining test strips and the vial 90 days after rst opening date.• Apply only blood sample or control solution to the absorbent hole. Applying other substances to the absorbent hole will cause inaccurate results.• Do not use test strips beyond the expiration date printed on the package since they may cause inaccurate results.• Do not bend, cut or alter a test strip in any way.(Model: AGS-1112)

14 IDEAL LIFE Gluco-Manager™First Time Power Up And Activation When Using An IDEAL LIFE POD™First Time Power Up And Activation When Using An IDEAL LIFE POD™(*an optional accessory, sold separately)To use the IDEAL LIFE Gluco-Manager™with your IDEAL LIFE Pod™you must call an IDEAL LIFEcustomer representative to activate. Make sure to call IDEAL LIFE before you begin. Then make surethat the IDEAL LIFE Pod™ is connected to a telephone line cord and RJ11 jack (or an Ethernet cordand RJ45 jack), “Powered ON”!Hold down any button on your IDEAL LIFE Gluco-Manager™for 3 seconds to Power up.READ THROUGH THE IDEAL LIFE INC. TERMS AND CONDITIONS FIRST, THEN PROCEED AND FOLLOW THE PROMPTS ON THE SCREEN AS SHOWN HERE:First select the appropriate language using the buttons labeled and OK.Then Answer the question on the following screen regardingterms and conditions using the YES and NO labeled buttons.To gain full advantage of all the features your IDEAL LIFE Gluco-Manager™ has to offer, using an IDEAL LIFE Pod™is recommended. To ensure that your IDEAL LIFE Gluco-Manager™ and IDEAL LIFE Pod™ are setup properly you will need to call IDEAL LIFE directly to activate your system. You should ensure that the steps are followed correctly, you should rst setup your IDEAL LIFE Pod™, power it up, and then begin the steps of powering up your IDEAL LIFE Gluco-Manager™. During your activation call with IDEAL LIFE, an IDEAL LIFE customer representative will verify your IDEAL LIFE Gluco-Manager™and IDEAL LIFE Pod™ID numbers and you will be ready to take full advantage of all your IDEAL LIFE Gluco-Manager™ has to offer. For a detailed description of all the features and functions continue to the FUNCTIONS section of this manual.

15Instruction ManualAbout Control Solution (sold separately)Control solutions contain a known amount of glucose that reacts with test strips. By comparing yourcontrol solution test results with the expected range printed on the test strip vial label, it is able to checkthat the meter and the test strips are working together as a system and that you are performing the testcorrectly. It is very important that you do this simple check routinely to make sure you get accurate results.How often should the control solution test be performed?• When you use this system to test your blood for the rst time, practice the procedure usingcontrol solution. When you can do three tests in a row that are within the expected range, you areready to test your blood.• Routinely check the meter and test strips, so perform a single test for each level of control solution at least once a weekWhen should the control solution test be performed?• When you rst get your IDEAL LIFE Gluco-Manager™.• When you begin using a new vial of test strips.• Whenever you suspect that the meter or test strips are not working properly.• When your blood glucose test results are not consistent with how you feel, or when you think yourresults are inaccurate.• When your test strips are exposed to extreme environmental conditions (See “Important Test StripInformation” below).• When you want to practice running the test.• If you drop the meter.Important Control Solution Test Information• Use the same branded control solutions as the test strips.• Check the expiry date on the control solution vial. Do not use if expired.• Control solution, meter, and test strips should come to room temperature (20°C to 25°C/ 68°F to 77°F)before testing.• Shake the vial before use. Discard the rst drop of control solution. After squeezing, wipe off the dispenser tip to avoid contamination. The above tips ensure you get a good sample and an accurate result.• Use a period of 90 days from the date that you rst open it. Record the discard date (date opened plus 90 days) on the control solution vial. Discard after 90 days.• Store the control solution tightly closed at temperature from 36°F to 86°F (2 to 30°C) and do not freeze.NOTE! The control solution range printed on the test strip vial is for appropriately branded control solution only. It is used to test meter and test strip performance. It is not the recommended range for your blood glucose level.About Control Solution

16 IDEAL LIFE Gluco-Manager™How To Do A Control Solution Test?Step 1. Power up DeviceFrom the off position, press the power button to turn on the display. From the default screen, pressthe power button once more. The display will instruct you to insert a strip at this time. Insert a teststrip with contact bars end rst and facing up into the test slot. (Contact bars must be inserted allthe way into the meter or you may get an inaccurate test result.)After the “ ” symbol appears on the display, you may now move to the STEP 2 and add the controlsolution to the test strip. If you decide not to perform a control solution test, press Soft Buttonlabeled EXIT to return to the default screen.Step 2. Apply Control SolutionShake the control solution vial well. Remove the cap from the control solution bottle. Place cap on at surface. Squeeze the vial, discard the rst drop, and wipe off the dispenser tip to prevent contamination. Squeeze the vial again to get another drop and apply the drop to the top of cap.How To Do A Control Solution Test?

17Instruction ManualHow To Do A Control Solution Test?CAUTION! To avoid contaminating the control solution with the content of the test strip, you have to place a drop of control solution on a clean surface or on your nger tip rst. Do not directly apply control solution into a strip.Step 3. Display test resultCompare the result with the range printed on the test strip vial.The result should fall within this range.Out of Range ResultsIf test results fall outside the range printed on the test strip vial, check the “Problem Solving Guide,” below and repeat the test. If you continue to get out of range results, it means that the system may not be work-ing properly. Do NOT test your blood. Contact an IDEAL LIFE customer representative at 1-866-IDEAL-41 (866-433-2541) to resolve the issue.

18 IDEAL LIFE Gluco-Manager™Functions(when using the IDEAL LIFE POD™, an optional accessory sold separately)Main ScreenThe Main Screen is your default screen. This is where you will be directed to after completing functions and where you will nd status indicators for the functioning of your IDEAL LIFE Gluco-Manager™.In the upper middle portion of the display you will nd a battery icon, displaying power status of your IDEAL LIFE Gluco-Manager™Indicates full powerIndicates power is getting low, you should change your batteriesIndicates that your blood pressure measuring function has been turned off.Replace your batteries immediately. If you have unread messages, you will see an envelope icon on the upper left corner of the display.Functions

19Instruction ManualTaking Your Blood Glucose ReadingBe sure to read this section and any inserts found in the test strip box carefully before taking areading. Wash and dry your hands before starting.Getting a Drop of BloodStep 1. Use your lancing device (sold separately) to obtain a blood sample. Follow the instructions included in your lancing device.WARNING! To reduce the chance of infection:• Never share a lancet or the lancing device with anyone.• Always use a new, sterile lancet. Lancets are for single use only.• Avoid getting hand lotion, oils, or debris in or on the lancets and the lancing device.WHEN OBTAINING BLOOD FROM SITES OTHER THAN THE FINGERTIPA clear cap, often provided, makes it easier to get a drop of blood from AST.Step 2. Wash your hands and the Puncture SiteSelect the puncture site either in nger or in other parts (AST). Clean the puncture site with 70% using cotton moistened with 70% alcohol and let it air-dry.Step 3. Spuncturevure Site• FingertipHold the lancing device rmly against the side of your nger.• Sites other than a ngertipPlease refer to the section of “About Alternative Site Testing” above. Please consult your health professional before obtaining blood from sites other than a ngertip.WARNING! The system requires a very small blood drop to perform a test. You can obtain it from a ngertip. Choose a different spot each time you test. Repeated punctures in the same spot may cause soreness and calluses. Before you decide to do palm testing, please consult your health professional rst.Step 4. Gently Massage the Area. Do NOT Smear the Blood SampleTo obtain correct results, it is recommended that the rst drop of bloodshould be discarded with a clean tissue paper or cotton. Use the seconddrop of blood for testing. The required blood sample is 0.7 microlitre in avolume.WARNING! The rst drop of blood usually containstissue uid and serum, which may affect the testresult. It should be discarded.Taking Your Blood Glucose Reading

20 IDEAL LIFE Gluco-Manager™Taking a ReadingStep 1. Insert the Test StripInsert a test strip with contact bars end rst and facing up into the testslot. (Contact bars must be inserted all the way into the meter or you may get an inaccurate test result.) The meter turns on automatically and shows the following messages:Step 2. Apply SampleObtain a drop of blood using the adjustable lancing device. The blood asample must be at least 0.7 microliter in volume or you may get aninaccurate test result. When “ ” appears on the display, apply the bloodto the absorbent hole of the test strip where it meets the narrow channel.Do not push your nger against the test strip or try to apply a smearedsample. The blood should completely ll the conrmation windowbefore the meter begins to count down. If not, do not try to add moreblood to the test strip. Discard the test strip and retest with a new one.If you have trouble lling the test strip, please contact the dealer forassistance.Step 3. Display a Glucose ResultYour blood glucose test result will appear. After the reading is displayed you may remove the test strip. Discard the used test strip carefully to avoid contamination.When the measurement is complete, your IDEAL LIFE Gluco-Manager™will then display your reading automatically and begin to communicate when you are using a communication gateway or access point such as a cellular phone, computing device or the IDEAL LIFE Pod™.When the measurement is complete, your IDEAL LIFE Gluco-Manager™will then display your reading automatically and begin to communicate when you are using a communication gateway or access point such as a cellular phone, computing device or the IDEAL LIFE Pod™.Connection times may vary depending on many factors. Your reading will always be stored in your meter memory for local lookup. After displaying your reading and automatically communicating the information, your meter will automatically return to the default screen before going to sleep mode. Each time your IDEAL LIFE Gluco-Manager™communicates successfully to IDEAL LIFE through your IDEAL LIFE Pod™ the time and date are set to ensure reliable date and time stamping of all readings.NOTE! If you do not apply a blood sample within 2 minutes, the meter will automatically turn off. You must remove the test strip and insert it back again to restart the test procedure.Taking a Reading

21Instruction ManualLooking At Previously Taken ReadingsYour IDEAL LIFE Gluco-Manager™ will store up to 575 of your latest readings.Press Menu to view the feature list.SCROLL to highlight READINGS (it should already be highlighted asit is the rst line item in the list).Press SELECT to enter your selection.You can now scroll through your readings, screen by screenusing the SCROLL button.If you have less than one page full of readings or have reached your nal screen you can press the button labeled EXIT to return to the READINGS section (Remember you can always press the START/ESCAPE button to return to the default screen).NOTE! Your meter can display test results in milligrams per deciliter (mg/dL). The mg/dL unit is standard in the United States. Looking At Previously Taken Readings

22 IDEAL LIFE Gluco-Manager™Looking at MessagesYour IDEAL LIFE Gluco-Manager™ is equipped for 2-way, interactive communication when using a communication gateway or access point such as a cellular phone, computing device or the IDEAL LIFE Pod™. Messages can be sent remotely to your IDEAL LIFE Gluco-Manager™ and responded to directly. When messages are transmitted to your IDEAL LIFEGluco-Manager™, they are stored for automatic display before your next blood glucose measurement. If you have unread messages in memory, there will be an ENVELOPE icon located on the upper left corner of the default screen. You can also read any unread messages in the MESSAGES section for later response.• Press Menu to view the feature list.• SCROLL to highlight MESSAGES.• Press SELECT to enter your selection.Messages will be displayed in order of time received (oldest rst). Responding tomessages automatically stores them for later transmission and automatically scrolls to the next message if there is more than one un read message in your IDEAL LIFE Gluco-Manager™.Free text messages allow for 2 possible responses, and are displayed on one screen and may look like this:For Example:There are 2 types of messages. The type of question will dictate the button labels. Simply press the desired button shown on the screen.Multiple Choice messages allowing for up to 6 possible responses are displayed on 2 screens, and may look like this:Looking At Messages

23Instruction ManualLooking at GraphicsWhen using a communication gateway or access point such as a cellular phone, computing device or the IDEAL LIFE Pod™ your IDEAL LIFE Gluco-Manager™will store different types of graphicsdownloaded from the IDEAL LIFE website. (All the graphics can be altered through the IDEAL LIFEwebsite, refer to www.ideallifeonline.com for details).Press Menu to view the feature list.• SCROLL to highlight GRAPHICS.• Press SELECT to enter your selection. • You can now scroll through your graphics screen by screen using the button labeled NEXT. While scrolling through screens, you can always go to the previous screen by pressing the button labeled BACK. If you have only one graphic in memory, or have reached your nal screen you can press the button labeled EXIT to return to the MENU section (Remember you can always press the START/ESCAPE button to return to the default screen).Looking at Graphics

24 IDEAL LIFE Gluco-Manager™Comparing Meter And Laboratory ResultsThe meter provides you with whole blood equivalent results.The result you obtain from your metermay different somewhat from your laboratory result due to normal variation. Meter results can beaffected by factors and conditions that do not affect laboratory results in the same way (see test strippackage insert for typical accuracy and precision data and for important information on limitations).To make an accurate comparison between meter and laboratory results, follow the guidelines below.Before you go to the lab:• Perform a control solution test to make sure that the meter is working properly.• It is best to fast for at least eight hours before doing comparison tests.• Take your meter with you to the lab.While at the lab:• Make sure that the samples for both tests (the meter test and the lab test) are taken and tested within 15 minutes of each other.• Wash your hands before obtaining a blood sample.• Never use your meter with blood that has been collected in a gray-top test tube.• Use fresh capillary blood only.You may still have variation from the result because blood glucose levels can change signicantly overshort periods, especially if you have recently eaten, exercised, taken medication, or experiencedstress1. In addition, if you have eaten recently, the blood glucose level from a nger stick can be upto 70mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test2.Therefore, it is best to fast for eight hours before doing comparison tests. Factors such as the amountof red blood cells in the blood (a high or low hematocrit) or the loss of body uid (severe dehydration) may also cause a meter result to be different froma laboratory result.References1. Surwit, R.S., and Feinglos,M.N.: Diabetes Forecast (1988), April, 49-512. Sacks, D.B.: “Carbohydrates.“Burtis, S.A., and Ashwood, E.R. (ed.),Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.Comparing Meter And Laboratory Results

25Instruction ManualCare and Maintenance• Handle the meter with care. Dropping or throwing the meter may cause damage to the device.• Don’t expose the Blood Glucose Monitoring system, Test strip, and Control solution, to extreme conditions, such as high humidity, heat, freezing cold or dust. Storage conditions for the blood glucose Monitoring system (meter and test strips) are 39.2°F ~86°F Humidity <80% RH. Storage conditions for the meter are -4°F ~131°F, Humidity <80%RH.• Always wash your hands with soap and water and rinse and dry completely before handling the Blood Glucose Monitoring system and Test strip.• Use surface desinfectant wipes to clean the Blood Glucose Monitoring System.• Discard the used lancet into a container for sharp objects.Care and Maintenace

26 IDEAL LIFE Gluco-Manager™Cleaning and DisinfectionThe cleaning and disinfection is absolutely necessary for the test procedure. Cleaning can insure that the meter works well (for example, the display will be clear to see after cleaning); and disinfection can avoid infection. We strongly advise that the glucometer and the lancing device be cleaned and disinfected following every use. We suggest you use the following product: CaviWipes (EPA registration number: 46781-8). You can purchase this product by visititing the web site: www.metrex.com.Alternatively, you may clean, wipe meter down with soap and water or 70-80% isopropyl alcohol. To disinfect, use a 1:10 concentration of sodium hypochlorite (bleach) solution.Cleaning and desinfectingStep 1Dispose of used test strip.Step 2Remove a wipe from package or container. Follow instructions on package. If wipe is very wet, wring wipe slightly to discard excess liquid.If blood is visibly present on the meter, two wipes must be used, one wipe to clean and a second wipe to disinfect. Step 3Wipe down the meter on front, back and sides. DO NOT WRAP THE METER IN A WIPE.Take extreme care not to get liquid in the test strip and key code ports of the meter.Step 4Let meter dry. Dispose of the wipe.With all the recommended glucose meter cleaning methods, it is crucial that the IDEAL LIFE Gluco-Manager™ is completely dry before taking a reading. Please follow the disinfectant’s product label instructions to ensure proper drying time.Cleaning and Disinfection

27Instruction ManualNote:1. Each disinfection step requires a pre-cleaning step.2. The users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.3. If you have any questions you can contact an IDEAL LIFE customer representative at 1-866-IDEAL-41 (866-433-2541) to resolve the issue.4. Please refer to the following linkage for detail information: “FDA Public Health Notication: 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“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.htmlA List of the Signs of Potential Deterioration (Physical and in Performance)What do you see? What to do?The buttons do not work. For example; when pressing the buttons, the screen does not activate. Replace the batteries. If this does not work, contact local customer services or place of purchase for assistance, or toll free service hotline: 1-866-IDEAL-41 (866-433-2541)The device does not work. For example; if a strip is inserted and the reading values are not displayed.Stop using and contact local customer services or place of purchase for assistance, or toll free service hotline: 1-866-IDEAL-41 (866-433-2541)Corrosion, crazing, embrittlement, cracking of the buttons, meter casing, display or lancing device Stop using and contact local customer services or place of purchase for assistance, or toll free service hotline: 1-866-IDEAL-41 (866-433-2541)Cloudiness of the screen Stop using and contact local customer services or place of purchase for assistance, or toll free service hotline: 1-866-IDEAL-41 (866-433-2541) Cleaning and Disinfection

28 IDEAL LIFE Gluco-Manager™SpecicationsIDEAL LIFE Gluco-Manager™Model: GMM0001 IDEAL LIFE Gluco-Manager™Display: LCD Digital DisplayPower Source: Two 1.5V AAA alkaline batteriesBattery Life: Over 200 determinantsOperatingTemperature/Humidity: 50°F to 104°F (10°C to 40°C), below 80%R.H. (non-condensing)Meter Storage Temperature/Humidity: -4°F to 131°F (-20°C to 55°C), below 80%R.H.Weight: Dimension: 77.3 mm(l) x 60.2 mm(w) x 25 mm(h)Auto Electrode Inserting Detection: YESAuto Sample Loading Detection: YESSleeping Mode Power Consumption: Less than 500uAAuto Shut Off: After 2 minutes without actionMeasurement Units: Mg/dLNote: These specications, to improve performance, are subject to change without notice.IDEAL LIFE Pod™Model: ILP 0001 IDEAL LIFE Pod™Display: LED’sPower Source: AC adapterOperatingTemperature/Humidity: 50°F to 104°F (10°Cto 40°C)/Below 85% relative humidityStorage Temperature/Humidity 23°F to 122°F (-5°C to 50°C)/Below 90% relative humidityConsole Weight: Approx. 142g without batteriesOuter Dimensions: Approx. 120mm Width x 105mm Depth x 30mm HeightNote: These specications are subject to change without notice.Specications

29Instruction ManualLimitations of Use• The blood glucose monitoring system is not intended for use on neonates.• The blood glucose monitoring system is not intended for use on artery blood, neonates’ serum and plasma.• IDEAL LIFE Gluco-Manager™ should be used with IDEAL LIFE test strip.• The system can be used up to an altitude of 10744 feet.• The following substances at levels greater than normal or therapeutic levels may cause signicant interference (affect the result by greater than 10%) resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, Dopamine, L-dopa, L-dopa and Tolbutamide etc. These substances do not affect test results in normal concentration but may affect test results in high concentration. Do not use haemolysis sample, icterus sample or high lipemia samples.• The following compounds, when determined to in excess of their limitation, may produce inaccurate results:Compound LimitationAscorbic acid > 2mg/dLUric acid > 10mg/dLAcetaminophen > 5mg/dLBilirubin > 15mg/dLDopamine > 0.03mg/dLL-dopa > 0.45mg/dLMethyldopa > 0.75mg/dLTolbutamide > 24mg/dLTriglycerides > 2000mg/dL• Users undergoing oxygen therapy may yield falsely lower results.• Not for use for users in a hyperglycemic-hyperosmolar state, with or without ketosis.• Not for use on critically ill individuals.• Not to be used for individuals who are dehydrated, hypertensive, hypotensive or in shock.• Very low (less than 20%) or very high (more than 60%) red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hemarocrit level, please consult your health care provider.Limitations of Use

30 IDEAL LIFE Gluco-Manager™Problem Solving GuideThe following is a summary of potential problems in operation to help troubleshoot various issues.Improper use may cause an inaccurate result without producing an error message or a symbol. In theevent of a problem, refer to the information under action.If you follow the recommended instructions but a problem still exists, please contact an IDEAL LIFE™customer representative at 1-866-IDEAL-41 (866-433-2541) to resolve the issue.Trouble ShootingSituation: The meter does not display a message after inserting a test strip.PROBABLE CAUSE WHAT TO DOBattery exhausted. Replace the battery.Battery incorrectly installed or absent. Check that the battery is correctly installed.Test strip inserted upside-down Insert the test strip correctly with the contact bars end rst and facing up.Defective meter. Please call an IDEAL LIFE customer representative.Situation: The test does not start after applying the sample.PROBABLE CAUSE WHAT TO DOInsufcient blood sample. Repeat the test using a newtest strip with larger volume of blood sample.Defective test strip. Repeat the test with a newtest strip.Sample applied after automatic Repeat the test with a new test strip.shut off (3minutes after last user action) Apply sample only when “ ” appears on the display.Defective meter. Please call an IDEAL LIFE customer representative.Situation: If the control solution test result is out of range.PROBABLE CAUSE WHAT TO DOError in performing the test. Read the instruction thoroughly and repeat the test again.Do not shake the control solution vial Shake the control solution vigorouslyvery well. and repeat the test again.Expired or contaminated control solution. Check the expiry date or the discarded date of the control solution.Control solution that is too warm Control solution, monitor, and test strips shouldor too cold. come to room temperature (68 to 77°F / 20 to 25 °C) before testing.Test strip deterioration. Repeat the test with a newtest strip.Meter malfunction. Please call an IDEAL LIFE customer representative.Problem Solving Guide

31Instruction ManualError MessageMESSAGE WHAT IT MEANS ACTIONProblem Solving GuideAppears when inserting aused test strip.Appears when the batteriescan not provide enoughpower for a test.Problem with the meter.Replace the batteries immediately.Test with a newtest strip.Re-test with a new test strip.Review the instructions and re-test witha newtest strip. If the above steps donot work, please contact the CustomerCare Service for help.Remove the strip afterapplying blood to theabsorbent hole.LOW BATTERYUSED TEST STRIPTEST STRIP REMOVED PRIORTO READINGTECHNICALERRORREADINGERROR

32 IDEAL LIFE Gluco-Manager™Summary of OperationThis summary is intended only for quick reference and not as a substitute for the instruction manual.Please read the entire manual before you begin testing.Step 1. Insert test stripThe meter is automatically turned on and displays the “ ” symbolStep 2. Apply sampleSelect and clean the puncture site. Obtain a drop of blood by lancing the puncture site. Apply a drop of blood to the absorbent hole of test strip until the conrmation window is completely lled.Step 3. Obtain accurate resultsThe meter will display an hour glass and then display the test result.The IDEAL LIFE Gluco-Manager™ will automatically return to sleep mode once the reading has been transmitted.Summary of Operation

33Instruction ManualFederal Communications Commission (FCC) Statement15.21You are cautioned that changes or modications not expressly approved by the part responsible forcompliance 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 protectionagainst harmful interference in a residential installation. This equipment generates, uses and canradiate radio frequency energy and, if not installed and used in accordance with the instructions, maycause harmful interference to radio communications. However, there is no guarantee that interferencewill not occur in a particular installation. If this equipment does cause harmful interference to radioor television reception, which can be determined by turning the equipment off and on, the user isencouraged 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.OPERATION IS SUBJECT TO THE FOLLOWING TWO CONDITIONS:1) this device may not cause interference and2) this device must accept any interference, including interference that may cause undesiredoperation of the device.FCC RF RADIATION EXPOSURE STATEMENT:This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.End users must follow the specic operating instructions for satisfying RF exposure compliance. Thistransmitter must not be co-located or operating in conjunction with any other antenna or transmitter.Federal Communications Commission (FCC) Statement

34 IDEAL LIFE Gluco-Manager™Customer InformationThis equipment complies with Part 68 of the FCC rules and the requirements adopted by the ACTA.On the bottom of this equipment is a label that contains, among other information, a productidentier of [US: 5CQMM00BILP0001]. If requested, this number must be provided to the telephonecompany. If this equipment [ILP 0001] caused harm to the telephone network, the telephonecompany will notify you in advance that temporary discontinuance of service may be required. But ifadvance notice isn’t practical, the telephone company will notify the customer as soon as possible.Also, you will be advised of your right to le a complaint with the FCC if you believer it is necessary.The telephone company may make changes in its facilities, equipment, operations or procedures thatcould affect the operation of the equipment. If this happens the telephone company will provideadvance notice in order for you to make necessary modications to maintain uninterrupted service. Ifyou experience trouble with this equipment, you disconnect if from the network until the problem hasbeen corrected or until you are sure that the equipment is not malfunctioning. Please followinstruction for repairing if any (e.g. battery replacement section) other wise do not alternate or repairany parts of the device except specied. Connection to party line service is subject to state tariffs.Contact the state public utility commission, public service commission or corporation commission forinformation. If the telephone company requests information on what equipment is connected to theirlines, inform them of:a) The telephone number that this unit is connected to,b) The ringer equivalence number [0.0B]c) The USOC jack required [RJ11C], andd) The FCC Registration Number [US:5CQMM00BILP0001]Items (b) and (d) are indicated on the label. The ringer equivalence number (REN) is used todetermine how many devices can be connected to your telephone line. In most areas, the sum of theRENs of all devices on any one line should not exceed ve (5.0). If too many devices are attached,they may not ring properly.Customer Information

35Instruction ManualService RequirementsService RequirementsIn the event of equipment malfunction, all repairs should be performed by our Company or anauthorized agent. It is the responsibility of users requiring service to report the need for service toour Company or to one of our authorized agents. Please refer to the location you purchased orreceived your equipment for details of where service can be facilitated through.

IDEAL LIFE US INC.Between 9:00 am and 8:00 pm (EST)Tel 1-866-IDEAL-41 1-866-433-2541 www.IDEALLIFEonline.comAt all other times, you should contact your healthcare professional for assistance.© 2011 - V1 IDEAL LIFE INC. All rights reserved. IDEAL LIFE is a registered trademark in the United States for weight scales, blood glucose me-ters, blood pressure cuffs and meters, heart monitors. IDEAL LIFE SpO2 MANAGER, IDEAL LIFE STEP MANAGER, IDEAL LIFE BREATH MANAGER, IDEAL LIFE MESSAGE MANAGER, IDEAL LIFE BODY MANAGER, IDEAL LIFE BODY MANAGER PLUS, IDEAL LIFE BP MANAGER, IDEAL LIFE GLUCO MANAGER, IDEAL LIFE POD, IDEAL LIFE MEDICATION MANAGER, REALIZING THE VISION OF A BETTER TOMORROW, Leveraging the Power of Communication, Real time health and wellness information on demand, wireless remote health and wellness management, and Solutions for better healthcare through advanced communication technology, The IDEAL LIFE Interactive Communication Technology Platform, the IDEAL LIFE Information Management System, and the IDEAL LIFE Health & Wellness Solution are all proprietary trademarks of IDEAL LIFE INC. Contents are covered by two issued U.S. patents and one or more U.S. patents pending.Manufactured for and Distributed by IDEAL LIFE INC., Toronto ON M4P 1G8, and made in China.Products may vary from pictures shown.

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