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
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- 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 PAGE About the Blood Glucose Monitoring System 2 The iGlucose Blood Glucose System 7 The iGlucose Blood Glucose Meter 8 The iGlucose Test strip 9 Meter Activation and Battery Charging 9 Setting Up Your Meter - Setting the Date, Time 10 Turning On/Off the meter 11 Handling the Blood Glucose Test Strip 11 Getting Ready for Testing 12 Performing a Blood Glucose Test 14 View Appearance of Blood on the Test Strip 16 Understanding Test Results and Messages 16 Setting Meal Markers 17 About Quality Control 18 Performing a quality Control Test 19 Understanding Control Test Results 21 Recalling Test Results 21 Obtaining readings Averages 22 Obtaining Readings History 22 Caring for Your Meter 23 Cleaning and Disinfecting Procedures 23 Error Messages and Troubleshooting 25 FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 27 Specifications 28 Warranty 29 Customer Service 30 Expected Blood Glucose Values Without Diabetes 30 Component Manufacturer Information 30 Log Book 31 Warranty Card 32 Emergency Card 33
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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.
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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)
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inserted into the device. Strip was inserted incorrectly. Wrong strip was inserted. Device is damaged. Insert the test strip in the correct way. Insert the right test strip. Contact customer support. 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. Repeat the test with a sufficient blood sample. Repeat the test with a new strip. Check the device with a Control Solution test. Cannot send data Weak signal or network error Retry later or in different location. All unsent data will be sent together with data for next test Cannot synchronize time Network error 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 Description Action to Take HI Blood glucose result may be higher than 600 mg/dL. 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. LO Blood glucose result may be lower than 20 mg/dL. 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. Temperature out of range Temperature is above or below the operating range of test strips or the device. 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. Low Battery Battery is low on charge. Charge the battery. Unknown strip Test strip unknown or may be damaged. Perform the test with new test strip. Discarded strip Test strip is used or test was not performed correctly. 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.
SamplinPlease ddrop of use the Er1- TheEr2- Themeter wEr3- TheEr4- The Er5- An (1) Remo(2) Turn (3) PressIf after tperformIf one ofat 1-55-5Meter MIf the iG1. Open 2. Wait fActivatioThe metplease cCAUTIOA blood correctlysymbol. ng Error do not apply blood”. Othenew one. e inserted tese meter has mworks propere signal transe blood sampissue calibraove the test off the metes the main bturning on thm a test. f the above e555-5555. Malfunction lucose Bloodthe battery for 5 minuteon and Chanter should wcontact iGlucN sample shouy and the MeIf the blood the blood toerwise, the mst strip has bmalfunctionerly. smission is diple volume isting the Metstrip from ther (press andutton to turnhe Meter, yoerror messagd Glucose Mecover and rees and reinseging the Batork normallycose Diabeteuld ONLY be eter's screendrop flashino the sample meter will disbeen used ored. Do a Quaisrupted. Reps insufficient ter has occurhe meter. d hold the Mn ON the meu do not seeges still appeeter will not emove the brt the battertery). y after finishs Customer Sapplied to thn is showing tng symbol is port of the tsplay an error damaged. Pality Control peat the testt. Repeat therred. Please Main button feter. e Er5, your mears, please cturn on, pleatteries. ries as descring the abovSupport Cenhe test strip the image ofNOT showintest strip befor message. Please use a Test or reinst using a newe test using afollow the stfor 3 secondsmeter is functcontact iGlucease follow thibed as instrve steps. If thter. after the tesf the test strg on the screfore the metPlease discarnew test stristall the battw test strip. new test strteps below: s). tioning propecose Diabetehe steps beloucted on paghe meter stillst strip has bip and a blooeen, do not ater displays: rd the test stip. teries to checrip. erly and ablees Customer ow: ge 19, (Metel does not wbeen insertedod drop flashapply a samp“apply a trip and ck if the e to Service er ork, d hing 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 GSM Platform MT6260 Mode GSM+GPRS Frequency GSM 850/900/1800/1900 Antenna Interior on the bottom Glucose Type Module mounted IC Fujitsu MB95F378E
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℃, General LCM Size - 2.4" QVGA Hi contrast TFT Colors 260K Resolution - 320 * 240 pixels Button pad (3 Buttons) Left - Menu, information menu Middle - ON/OFF; Enter, test mode change Right - Averages, readings history 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 Battery 3.7V, 1,000mAh Li-Ion 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 1-555-555-5555 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 Range (mg/dL) Fasting < 100 mg/dL Two hours after meals < 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: Work Phone: Doctor: Doctor’s Phone: Pharmacy: Pharmacy Phone: Insulin/Pills: Log book date From: To: In case of emergency contact: Date M T W T F S S Breakfast Blood Glucose Insulin/ Medication Lunch Blood Glucose Insulin/ Medication Dinner Blood Glucose Insulin/ Medication Bedtime Blood Glucose Insulin/ Medication Other Blood Glucose Insulin/ Medication Comments
Warranty Card Distributor name and address PLACE STAMP HERE Warranty Card Name: Tel: Distributor name and address Address: Serial No.: Model Date of Purchase: (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.
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