Telcare Blood Glucose Monitoring System ®

® Telcare Blood Glucose Monitoring System ®

(All images are for reference only.) Telcare Blood Glucose Monitoring System User Manual

Thank you for choosing the Telcare Blood Glucose Monitoring System. The Telcare system is comprised of the Telcare meter and the online website. The meter provides accurate readings sent immediately to your online account to store, track and chart. Personalized messages are also sent from www.mytelcare.com to the meter. This manual will provide you with all you need to know to use your new meter. So let’s get started.

*Not intended for sale within the EU. ® ® Telcare Blood Glucose Monitoring System

Intended Use

The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Test results are plasma-calibrated for easy comparison to clinical laboratory methods. Testing is done outside the body (in vitro diagnostic use). The Telcare Blood Glucose Monitoring System consists of the Telcare BGM® Blood Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare Blood Glucose Monitoring system is not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. The Telcare BGM Blood Glucose Meter uses cellular data transmission to send test results to Telcare’s remote database, Telserve, and to receive messages from Telserve. The Telcare Blood Glucose Monitoring System is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.

(i) ® Telcare Blood Glucose Monitoring System ®

Table of Contents

Your Telcare Blood Glucose Meter Getting Started 1 The Telcare BGM® Device 2 Telcare Test Strips 3 The Display Screen 4 Setting Up Your Telcare BGM 5 Settings Options 6 Control Solution Testing Step-by-Step Guide to Control Testing 8 Testing Your Blood Sugar Preparation and Safety 14 Step-by-Step Blood Sugar Testing 16 Prepare Your Lancing Device 17 Understanding Your Blood Glucose Test Results 28 View Your History on the Meter or Online 29 Maintenance of Your Telcare BGM and Lancing Device Charging Your Telcare Blood Glucose Meter 30 Cleaning and Disinfecting Your Meter 32 Cleaning and Disinfecting Your Lancing Device 34 Storing Your Telcare BGM Meter and Test Strips 36 Troubleshooting 37 Terms of Warranty 40 Specifications 41 About Telcare 42 Contact Telcare 43 Display Icon Definitions Inside Back Cover

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Important Safety Instructions

The Telcare Blood Glucose Monitoring System and lancing device is for single patient use. Do not share it with anyone, including family members! Do not use on multiple patients! Because all parts of the kit may come in contact with your blood, all parts are considered biohazardous. Kit parts can potentially transmit infectious diseases, even after cleaning and disinfection.

Users should wash hands thoroughly with soap and water and dry thoroughly after handling the meter, test strips, and any lancing device. For Cleaning and Disinfecting procedures to prevent the spread of diseases such as Hepatitis B, see Cleaning and Disinfecting Your Meter (page. 32).

For Technical Support, contact Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International). Hours of Operation: Monday - Friday, 9AM - 9PM EST References “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 “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood- borne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html “Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline–Third Edition. Clinical and Laboratory Standards Institute (CLSI), document M29-A3, (ISBN 1-56238-567-4).

(iii) ® Telcare Blood Glucose Monitoring System ®

Important Safety Instructions Getting started

Unboxing the Telcare BGM® for the first time Before we begin, take a moment to go over the contents of your Telcare BGM kit. Your kit should include: n Telcare BGM (battery included) n Control Solution Levels 1 & 2 n AC Charger (2.5 mL) n Quick Start Guide n Lancing Device n Instruction Manual n Telcare Lancets (10 Count) n Test Strip Insert n Telcare Test Strips (10 Count)

Using your new meter BLOOD GLUCOSE METER Make sure you charge your glucose meter for at least 3 hours before first use. ® To charge your glucose meter, use the AC Charger included in your kit. IMPORTANT: Slight delays occur when meter powers on. If delay is greater than 20 seconds, do not use meter. Contact technical support at (888) 666-4530 (US) or (1) (978) 610-4688 (International). TELCARE YOUR

You should use the Telcare BGM for: n Testing blood glucose n Testing only with fresh capillary whole blood samples You should NOT use the Telcare BGM for: n The diagnosis of diabetes n Testing of arterial blood n Testing blood glucose on newborn infants n Testing of venous blood

1 ® ® Telcare Blood Glucose Monitoring System

The Telcare BGM®

1 Power Button 3 Enter Button 6 Charging Port 7 Wireless Signal 2 UP / DOWN 4 Display Screen (do not Indicator Keys to scroll attempt to (Other carrier 5 Insert Test Strip insert strip through the (white side up) names may menus here) appear here.)

2 1

2 4

left side right side

bottom

2 ® Telcare Blood Glucose Monitoring System ®

Telcare Test Strips

Blood Sample End

Contact End (put into device)

Important notes on test strips:

n Because of the autocoding feature of this meter, the strip insertion will be snug. This is to be expected and users find it easy after a few attempts.

n Check the expiration date printed on the test strip bottle and its package. Do Not use expired test strips.

n Use each test strip immediately after removing it from the bottle.

n Do not use wet or damaged test strips.

n Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool place.

n Record the “date opened” on the bottle label. Discard the bottle and any remaining test strips 6 months after the date of opening.

n Do not operate the meter outside the temperature range of 50˚F (10˚C) to 104˚F (40˚C).

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The Display Screen

3 2 On the Display Screen, you can see the following:

1 Wireless Signal Strength 1 2 Current Time 4 3 Battery Level

4 Last Test Reading

5 5 Date and Time of Last Reading

In this Display Screen, use the UP/ Up button DOWN buttons (located on the left of your meter) to access the meter’s options:

n Test Mode Down button n L1 Control Solution Mode (Low) n L2 Control Solution Mode (High) n History n Settings Menu left side

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Setting Up Your Telcare BGM®

Your Telcare BGM time is automatically updated with the local date and time when a cellular connection is established.

If you would like to view your meter’s preset settings, navigate to the Settings screen.

Getting to the Settings Screen 1 Power (PWR) your Telcare BGM device on. 2 Use the UP/DOWN buttons to reach the Settings Screen.

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Settings Options

Alarms Create up to 3 alarms to help remind yourself when to test next. Date and Time This page allows you to view the Date and Time settings of your device.

Volume This page allows you to select the volume of your meter. Use the UP/DOWN keys to select the appropriate volume. There are six possible volumes you may select from.

Brightness Change the brightness of your meter’s screen.

Language Settings Change the language displayed by your meter.

BG Tag Timeout BG tag timeout determines the duration of the tagging time before a new blood glucose reading is automatically sent to the server if no selection is made.

Airplane Mode Turning on Airplane Mode disables cellular network access. You will not be able to transmit your readings while Airplane Mode is turned on. Your meter’s clock will continue to work properly while in this mode.

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If a time zone change occurs, your meter will not automatically update to the new time until Airplane Mode has been disabled. The meter will reset the time from the new network.

About This screen provides a listing of current software and related information about your meter. This is helpful if you need technical support.

Personalize You may enter a Name on this screen that can help identify your meter and will be displayed on your screen in Test, L1 and L2 mode. Use the up and down arrow keys to choose a character and the Enter button to enter it. When you are done entering your Name, press the Enter button again after entering the last character.

7 ® Telcare® Blood Glucose Monitoring System

Control Solution Testing

Control solution testing will confirm that your Telcare BGM® and Test Strips are working properly. You should perform control solution testing when:

n Using the meter for the first time n Using a new bottle of Telcare Test Strips n You left the test strip bottle cap open n You dropped the meter n You suspect the meter and test strips are not working properly n The test results do not reflect how you feel n Practicing the testing n The test strips are exposed to environmental conditions outside the temperature requirements printed on the label Purchase additional control solution by calling Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International) (9AM – 9PM EST, M-F). CONTROL SOLUTION TESTING SOLUTION CONTROL Step-by-Step Guide to Control Testing

Power on the Telcare BGM with the PWR 1 button on the right side of the BGM.

The device will automatically start in Normal Test Mode, ready to check blood glucose. You will see the “Insert test strip” screen as shown.

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To access the main menu, use the 2 UP/DOWN keys on the left side of the BGM. Switch modes from Normal Test Mode to L1 Control Solution Mode. UP/ To test Level 1 (L1) control solution, use the DOWN UP/DOWN buttons to highlight L1 mode. Press the middle (ENTER) button to select Enter L1 mode.

Upon successful completion of Level 1 (L1), test Level 2 (L2) control solution:

Again use the UP/DOWN keys on the left side of the BGM to access the main menu. Switch modes from Normal Test Mode to L2 Control Solution Mode.

To test Level 2 (L2) control solution, use the UP/DOWN buttons to highlight L2 mode. Press the middle (ENTER) button to select L2 mode.

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You can select any Mode you want by 3 pushing the ENTER button.

Take out a Telcare Test Strip from the test 4 strip bottle. Close the bottle immediately.

IMPORTANT: n Firmly insert the test strip into your

5 ® Telcare BGM until it is fully seated. n The word “Telcare” should be facing up. n The sample tip should be facing up. n Continue to push the strip in until “Apply Level 1 (2) Control Solution” Sample Tip appears. n Do not touch the sample tip

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Squeeze a drop of control solution onto a clean, 6 dry, non-absorbing surface. Use Level 1 solution for L1 mode. Use Level 2 solution for L2 mode. Do not apply control solution to the test strip directly from the bottle. Immediately replace the bottle cap on the control solution bottle.

Gently touch the tip of the test strip to the drop 7 of control solution. You should see the sample end of the test strip fill.

The screen will start to count down. After 8 6 seconds, the control test result will appear on the meter’s display screen.

11 ® ® Telcare Blood Glucose Monitoring System

Compare the reading on the screen to the “L1 9 Control Solution” or “L2 Control Solution” range printed on the test strip bottle or package. If the reading on the meter falls within the appropriate range, select the YES tag. If not, select the NO tag. If the reading falls outside the level printed on the bottle or package that you used, please see “Control Solution Troubleshooting” on page 13. Control Solution Range (Images are Control Solution readings are stored on the meter for reference only. but are not transmitted and displayed in Telserve. Actual numbers may vary.)

Important tips about control solution:

1. Only use Telcare Glucose Control Solution with the Telcare Test Strips. Other brands of control solution or test strips may produce inaccurate results.

2. Always check the expiration date. DO NOT use expired control solution.

3. DO NOT FREEZE. Store the control solution at room temperature.

4. Never touch the tip of the control solution bottle to the test strip. It will damage all remaining solution in the bottle.

5. Record the “date opened” on the bottle label.

6. Do not use the control solution if more that 3 months since first opened.

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Control Solution Troubleshooting If your control solution testing is out of range (too high or too low), it may be caused by the following:

n Wrong brand of control solution

n Control solution not at room temperature

n Expired or contaminated control solution

n Damaged test strip

n Touched the tip of solution bottle to test strip

n Meter malfunction

n Testing outside of meter operating temperatures (50˚F – 104˚F) (10˚C – 40˚C) Check the expiration date and open bottle date on the control solution and on the test strips. Repeat testing using a new test strip. If the result is still out of range, use a new bottle of control solution and retest

If the problem persists, call Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International). Do not perform any blood glucose tests until you resolve this issue.

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Preparation and Safety

Before you begin, make sure to: n Set up your Telcare BGM® Blood Glucose Meter properly.

n Run a control test before first use. (See Step-by-Step Guide to Control Testing on page 8.)

n Wash your hands and testing site thoroughly with warm water and soap. Dry your hands well.

n Test in a place where the temperature range is between 50˚F (10˚C) and 104˚F (40˚C). (See “Troubleshooting” on page 37 for more information.)

You will need:

n Your Telcare BGM Blood Glucose Meter

n A new Telcare Test Strip

TESTING YOUR BLOOD GLUCOSE BLOOD YOUR TESTING n A lancing device with a clean, unused lancet (or safety lancets)

IMPORTANT WARNINGS ABOUT INACCURATE RESULTS: 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.

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FOLLOW THESE IMPORTANT SAFETY GUIDELINES n Please follow cleaning and disinfecting instructions for the meter (page 32) and lancing device (page 34) to prevent the risk of blood-borne pathogen transmission!

n Follow any cleaning/disinfection instructions that may come with the lancing device you use.

n The meter and lancing device are intended for a single user and should not be shared.

n Make sure you wash with soap and water and dry hands thoroughly before and after handling the meter, lancing device, or test strips.

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Step-by-Step Blood Glucose Testing

Power on the Telcare BGM® device with the 1 PWR button on right side of meter. The device will automatically start in Normal Test Mode. When ready to check blood, Insert test strip will be displayed.

Take out a Telcare Test Strip from the bottle, 2 and close the bottle immediately. (Some meters require the user to enter a code from the vial. Telcare’s strips do not require a code.)

Firmly insert the test strip into your Telcare 3 BGM until it is fully seated.

16 5 Depth Adjustable Inserting a Lancet Lancing Device 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the site with soap and warm water. Cover Lancet Carrier 5 Depth Adjustable Note: Rinse and dry thoroughly. The lancing device is intended for patient Inserting® a Lancet self-monitoring by a single person only. It Telcare Blood Glucose Monitoring System ® Lancing Device must not be used to collect blood from more 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the 5 Depth Adjustable than one person as this poses an infection site with soap and warm water. Cover Lancet Carrier risk. Note: Inserting a Lancet Rinse and dry thoroughly. A The lancing device is intended for patient Prepare Your Lancing Device This Lancing Device is used to obtain capillary whole self-monitoring by a single person only. It 1 Wash your hands and puncture 2 Twist4 off theLancing Lancing Device Device 3 Insert a new Lance firmly into the must not be used to collect blood fromblood more samples needed for blood glucose monitoringsite with soap and warm water. Cover 4LancetHold Carrier the Lancet Needle Cover 5 Replace the Lancing Device 6 The Adjustable Tip offers 5 levels of or for other tests requiring one or two drops of blood. A Twist off the lancing device cover. Note: than one person as this poses an infection Rinse and dry thoroughly. and gently twist off of the Lancet Cover skin penetration. To select the The Adjustable Tip on the Lancing Device allows you Insert a new lancet firmly into the The lancing device is intended for patient risk. desired depth, twist the Adjustable to choose the best depth of skin penetration. lancet carrier. self-monitoring by a single person only. It Tip in either direction until the number line up with the Arrow. must not be used to collect blood from moreThis Lancing Device is used to obtain capillary whole Use the CLEAR endcap for alternative site testing than one person as this poses an infection blood samples needed for blood glucose monitoring (AST) on the palm or forearm. Please see the blood 4 Hold theB Hold Lancet the lancet Needle needle Cover cover and 5 BReplace the Lancing Device 6 The Adjustable Tip offers 5 levels of risk. or for other tests requiring one or two drops of blood. glucose user guide before performing alternative site and gentlygently twist it off off of of thethe lancet.Lancet Cover skin penetration. To select the The Adjustable Tip on the Lancing Device allows you desired depth, twist the Adjustable testing as it provides important information about the Continued on next page to choose the best depth of skin penetration. This Lancing Device is used to obtain capillary whole best testing site for your system. AST Endcap (for palm or forearm) Tip in either direction until the blood samples needed for blood glucose monitoring 4 Hold the Lancet Needle Cover 5 Replace the Lancing Device 6 The Adjustable Tip offers 5 levels of number line up with the Arrow. or for other tests requiring one or two drops of blood.Use the CLEAR endcap for alternative site testing and gently twist off of the Lancet Cover skin penetration. To select the (AST) on the palm or forearm. Please see the blood To select the best depth: The Adjustable Tip on the Lancing Device allows you Note: desired depth, twist the Adjustable to choose the best depth of skin penetration. glucose user guide before performing alternative site Tip in either direction until the 1-2 for soft or think skin • Should not be used for assisted blood draws by healthcare providers or at healthcare provisionIMPORTANT sites*, and SAFETY PROCEDURES REGARDING LANCETS: testing as it provides important information about the number line up with the Arrow. 3 for average skin should never be shared with anyone else, even a family member.. n Use a new lancet every time you test, to avoid contamination. It is important Use the CLEAR endcap for alternative site testingbest testing site for your system. AST Endcap (for palm or forearm) 4-5 for thick or calloused skin • Always use a new lancet with each test. to discard the used lancet carefully after each use to avoid unintended lancet (AST) on the palm or forearm. Please see the blood • Keep your lancing device clean. glucose user guide before performing alternative site stick injuries. Used lancets may be considered biohazardous waste in your To select the best depth: testing as it provides important information aboutNote: the * Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, healtharea. fairs, Be sure shelters, to follow your local regulations forHold proper the disposal. Lancing Device Cover in Position the end of the Adjust- Place the Lancing Device aside detention facilities, senior centers, schools, and camps. 7 8 1-2 for soft or think skin 9 best testing site for your system. • Should not be used for assisted blood drawsAST Endcap by healthcare (for palm or forearm) providers or at healthcare provision sites*, and n one hand. Using the other hand, able Comfort Tip against the and wait a few seconds for a blood If alcohol wipes are used to clean your finger or palm, make sure your skin is 3 for average skin should never be shared with anyone else, even a family member.. slowly pull the Sliding Barrel side-tip of the finger. Press the drop to form. To help form a blood dry before the blood sample is obtained. 4-5 for thick or calloused skin • Always use a new lancet with each test. away from the Lancing Device Trigger Button, and then lift the drop, lower the hand to waist level To clean the Lancing Device: n Lancing devices should NEVER be used by moreTo select than one the person. best depth: • Keep your lancing device clean. Cover. You will hear a click, Lancing Device away from the and gently massage the finger from Note: 1-2 for soft or think skin • Should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and n If the seal is broken, discard the lancet. indicating that the Lancet Carrier finger after the puncture is palm to fingertip. * Any setting where fingerstick procedures are performed,Cleaning including assisted and living disinfection or residential care frequency facilities, skilled: The nursing lancing facilities, device clinics, healthshould fairs, be shelters, clean and disinfected after7 everyHold theuse Lancing by the individual Device Cover in 38 forPosition average the skin end of the Adjust- 9 Place the Lancing Device aside should never be shared with anyone else, evendetention a family facilities, member..senior centers, schools, and camps. is locked into position. Release complete. patient. one hand. Using the other hand, 4-5 forable thick Comfort or calloused Tip against skin the and wait a few seconds for a blood the Sliding Barrel to return it to its • Always use a new lancet with each test. slowly pull the Sliding Barrel 17 side-tip of the finger. Press the drop to form. To help form a blood • Keep your lancing device clean. original position. 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Cleaning and disinfection frequency: The lancing• Damp device cloth shouldor paper be towel clean and disinfected after every use by the individual 3. To clean the lancing device and endcap, blood/body fluids must be thoroughly cleaned from surface and objects before patient. • DISPATCH: DISPATCH Hospital Cleaner Disinfectant Towels With Bleach are pre-moistenedis disposablelocked into towelsposition. for Release use in complete. Removing and disposing of the used lancet disinfecting. Wipe surface with towel (DISPATCH) until completely wet. Allow to remain wet for one minute at room Note: healthcare and other areas where control of cross contamination is required. the Sliding Barrel to return it to its temperature (68-77˚F). original position. DO NOT re-use the Lancet Equipment Needed: 4. To disinfect the lancing device allow 2 minutes contact at room temperature. Wipe dry or allow to air dry. 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Gross soil must 10 To remove the used Lancet from the Lancing Device, first twist off the Lancing Device#7, Cover. Li Hsin WhileV Rd., Hsinchuholding Science Park, Hsinchu, Taiwan, R.O.C. be removed prior to disinfection. Note: the Sliding Barrel., leave the Lancet in the Lancet11 To disposeCarrier and the firmlyused Lancetstick the safety, Lancet discard TEL:Needle 1-877-979-5454 it intointo thethe appropriateLancet Website: sharps www.apexbio.com or biohazard container. P/N 65070000002 Rev.11/10 5. Wash hands with soap and water. • Keep Dispatch out of reach of children. Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. • User should wash hands thoroughly with soap and water after handling the lancing Pressdevice. the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover. • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Manufactured for: Note: lancing device. 11 To dispose the used Lancet safety, discardApex it into Biotechnology the appropriate Corporation sharps or biohazard container. • Keep Dispatch out of reach of children. #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. TEL: 1-877-979-5454 Website: www.apexbio.com • User should wash hands thoroughly with soap and water after handling the lancing device. P/N 65070000002 Rev.11/10 • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Manufactured for: lancing device. Apex Biotechnology Corporation #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. TEL: 1-877-979-5454 Website: www.apexbio.com P/N 65070000002 Rev.11/10 5 Depth Adjustable Inserting a Lancet Lancing Device 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the site with soap and warm water. Cover Lancet Carrier Note: Rinse and dry thoroughly. The lancing device is intended for patient self-monitoring by a single person only. It must not be used to collect blood from more 5 Depth Adjustable than one person as this poses an infection risk. Inserting a Lancet Lancing Device This Lancing Device is used to obtain capillary whole 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the blood samples needed for blood glucose monitoring site with soap and warm water. 4 HoldCover the Lancet Needle Cover 5 ReplaceLancet the Carrier Lancing Device 6 The Adjustable Tip offers 5 levels of 5 Depth Adjustable Note: or for other tests requiring one or two drops of blood. 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It This Lancing Device is used to obtain capillary whole best testing site for your system. AST Endcap (for palm or forearm) blood samples needed for blood glucose monitoring Hold the Lancet Needle Cover Replace the Lancing Device The Adjustable Tip offers 5 levels of must not be used to collect blood from more 4 5® 6 than one person as this poses an infection or for other tests requiring one or two drops of blood. and® gently twist off of the LancetTelcare BloodCover Glucose Monitoring System skin penetration. To select the risk. The Adjustable Tip on the Lancing Device allows you desired depth, twist the Adjustable To select the best depth: to choose the best depth of skin penetration.Note: Tip in either direction until the 1-2 for soft or think skin • Should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and This Lancing Device is used to obtain capillary whole number line up with the Arrow. 3 for average skin Use the CLEAR endcap for alternative siteshould testing never be shared with anyone else, even a family member.. blood samples needed for blood glucose monitoring Hold the Lancet Needle Cover ReplaceC Replace the the Lancing lancing deviceDevice cover. TheC Adjustable Tip offers 5 levels of 4-5 for thick or calloused skin (AST) on the palm or forearm. Please see• Always the blood use a new lancet with each test. 4 5 6 or for other tests requiring one or two drops of blood. and gently twist off of the Lancet CoverThe adjustable tip offers 5 levels of skin skin penetration. To select the glucose user guide before performing alternative• Keep your site lancing device clean. The Adjustable Tip on the Lancing Device allows you penetration. To select the desired depth, twist desired depth, twist the Adjustable testing as it provides important information* Anyabout setting the where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, to choose the best depth of skin penetration. the adjustable tip in either direction until the 7TipHold in either the Lancingdirection Device until the Cover in 8 Position the end of the Adjust- 9 Place the Lancing Device aside best testing site for your system. detention facilities, senior centers, schools, and camps. AST Endcap (for palm or forearm) number lines up with the arrow. numberone hand. line up Using with thethe otherArrow. hand, able Comfort Tip against the and wait a few seconds for a blood Use the CLEAR endcap for alternative site testing slowly pull the Sliding Barrel side-tip of the finger. Press the drop to form. To help form a blood To select the best depth: (AST) on the palm or forearm. Please see the blood To clean the Lancing Device: away from the Lancing Device TriggerTo select Button, the andbest thendepth: lift the drop, lower the hand to waist level 1-2 for soft or thin skin glucose user guide before performing alternativeNote: site Cover. You will hear a click, Lancing1-2 for Device soft or awaythink skinfrom the and gently massage the finger from • Should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and 3 for average skin indicating that the Lancet Carrier finger after the puncture is palm to fingertip. testing as it provides important information about the Cleaning and disinfection frequency: The lancing device should be clean and disinfected after every use by the individual 3 for average skin should never be shared with anyone else, even a family member.. 4-5 for thick or callused skin best testing site for your system. patient.AST Endcap (for palm or forearm) is locked into position. Release complete.4-5 for thick or calloused skin • Always use a new lancet with each test. the Sliding Barrel to return it to its D Hold the lancing device cover in one hand. • Keep your lancing device clean. original position. Equipment Needed: Using the other hand, slowly pull the sliding To select the best depth: Note: * Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, Hold the Lancing Device Cover in Position the end of the Adjust- Place the Lancing Device aside detention facilities, senior centers, schools, and camps.• Damp cloth or paper towel 7 barrel away from the lancing device cover. 1-28 D for soft or think skin 9 • Should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and one hand. Using the other hand, able Comfort Tip against the and wait a few seconds for a blood • DISPATCH: DISPATCH Hospital Cleaner Disinfectant Towels With Bleach are pre-moistened disposableYou will hear towels a click, for indicating use in that the 3 for average skin Note: should never be shared with anyone else, even a family member.. slowly pull the Sliding Barrel side-tip of the finger. Press the drop to form. To help form a blood healthcare and other areas where control of cross contamination is required. lancet carrier is locked into position. Release 4-5 for thick or calloused skin DO NOT re-use the Lancet • Always use a new lancet with each test. away from the Lancing Device Trigger Button, and then lift the drop, lower the hand to waist level To clean the Lancing Device: the sliding barrel to return it to its original • Keep your lancing device clean. Cover. You will hear a click, Lancing Device away from the and gently massage the finger from 1. Inspect for blood, debris, dust, or lint anywhere on the lancing device. position. indicating that the Lancet Carrier finger after the puncture is palm to fingertip. * Any setting where fingerstick procedures are performed, includingCleaning assisted living and or residential disinfection care facilities, frequency skilled nursing: The2. facilities, Clean lancing clinics, or disinfectdevice health fairs, should lancing shelters, be device. clean and disinfected Holdafter theevery Lancing use by Device the individual Cover in Position the end of the Adjust- Place the Lancing Device aside detention facilities, senior centers, schools, and camps. 7 8 is locked into position. Release 9 complete. patient. 3. To clean the lancing device and endcap, blood/bodyone fluidshand. must Using be the thoroughly other hand, cleaned fromable surface Comfort and Tipobjects against before the and wait a few seconds for a blood the Sliding Barrel to return it to its Removing and disposing of the used lancet disinfecting. Wipe surface with towel (DISPATCH)slowly until completelypull the Sliding wet. BarrelAllow to remain wet side-tipfor one ofminute the finger. at room Press the drop to form. To help form a blood original position. To clean the Lancing Device: Equipment Needed: temperature (68-77˚F). away from the Lancing Device Trigger Button, and then lift the drop, lower the hand to waist level • Damp cloth or paper towel 4. To disinfect the lancing device allow 2 minutes contactCover. at You room will temperature. hear a click, Wipe dry or allowLancing to airHow Device dry. to Gross choose away soil the from mustcap the 10andTo gently remove massage the used the Lancet finger fromfrom the Lancing Device, first twist off the Lancing Device Cover. While holding be removed prior to disinfection. indicating that the Lancet Carrier finger aftern For the fingertip puncture testing, is use the colored cap includedpalmthe to onSliding fingertip.the lancing Barrel., device. leave the Lancet in the Lancet Carrier and firmly stick the Lancet Needle into the Lancet Cleaning and disinfection frequency: The lancing• DISPATCH: device should DISPATCH be clean Hospital and disinfected Cleaner Disinfectant after every Towels use by With the individualBleach are pre-moistened disposable towels for use in Note: 5. Wash hands with soap and water. Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. patient. healthcare and other areas where control of cross contamination is required. is locked into position. Release complete.n For alternate site testing on your palm, use the clear cap. DO NOT re-use the Lancet the Sliding Barrel to return it to its Press the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover. 1. Inspect for blood, debris, dust, or lint anywhere on the lancing device. original position. Equipment Needed: Note: 2. Clean or disinfect lancing device. 18 11 To dispose the used Lancet safety, discard it into the appropriate sharps or biohazard container. • Damp cloth or paper towel • Keep Dispatch out of reach of children. 3. To clean the lancing device and endcap, blood/body fluids must be thoroughly cleaned from surface and objects before • DISPATCH: DISPATCH Hospital Cleaner Disinfectant Towels With Bleach are pre-moistened• User disposable should wash towels hands for use thoroughly in with soap and water after handling the lancing device.Removing and disposing of the used lancet disinfecting. Wipe surface with towel (DISPATCH) until completely wet. Allow to remain wet for one minute at room Note: healthcare and other areas where control of cross contamination is required. • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the temperature (68-77˚F). ManufacturedDO NOT for: re-use the Lancet lancing device. 4. To disinfect the lancing device allow 2 minutes contact at room temperature. Wipe dry or allow to air dry. Gross soil must To remove the used Lancet from theApex Lancing Biotechnology Device, first Corporationtwist off the Lancing Device Cover. While holding 1. Inspect for blood, debris, dust, or lint anywhere on the lancing device. 10 #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. be removed prior to disinfection. the Sliding Barrel., leave the Lancet in the Lancet Carrier and firmly stick the Lancet Needle into the Lancet 2. Clean or disinfect lancing device. TEL: 1-877-979-5454 Website: www.apexbio.com 5. Wash hands with soap and water. Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. P/N 65070000002 Rev.11/10 3. To clean the lancing device and endcap, blood/body fluids must be thoroughly cleaned from surface and objects before Removing and disposing of the usedPress lancet the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover. disinfecting. Wipe surface with towel (DISPATCH) until completely wet. Allow to remain wet for one minute at room temperature (68-77˚F). Note: 4. To disinfect the lancing device allow 2 minutes contact at room temperature. Wipe dry or allow to air dry. Gross soil must To remove the used Lancet from the Lancing11 Device,To dispose first twist the usedoff the Lancet Lancing safety, Device discard Cover. it into While the holding appropriate sharps or biohazard container. • Keep Dispatch out of reach of children. 10 be removed prior to disinfection. the Sliding Barrel., leave the Lancet in the Lancet Carrier and firmly stick the Lancet Needle into the Lancet • User should wash hands thoroughly with soap and water after handling the lancing device. 5. Wash hands with soap and water. Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Press the Trigger Button to release the LancetManufactured Carrier. Replacefor: the Lancing Device Cover. lancing device. Apex Biotechnology Corporation #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. Note: 11 To dispose the used Lancet safety, discard TEL:it into 1-877-979-5454 the appropriate sharpsWebsite: or www.apexbio.com biohazard container. • Keep Dispatch out of reach of children. P/N 65070000002 Rev.11/10 • User should wash hands thoroughly with soap and water after handling the lancing device. • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Manufactured for: lancing device. Apex Biotechnology Corporation #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. TEL: 1-877-979-5454 Website: www.apexbio.com P/N 65070000002 Rev.11/10 5 Depth Adjustable Inserting a Lancet Lancing Device 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the 5 Depth Adjustable site with soap and warm water. Cover Lancet Carrier Note: Inserting a LancetRinse and dry thoroughly. LancingThe Device lancing device is intended for patient self-monitoring by a single person only. It 1 Wash your hands and puncture 2 Twist off the Lancing Device 3 Insert a new Lance firmly into the must not be used to collect blood from more site with soap and warm water. Cover Lancet Carrier Note: than one person as this poses an infection Rinse and dry thoroughly. The lancing devicerisk. is intended for patient self-monitoring by a single person only. It must not be used Thisto collect Lancing blood Device from is moreused to obtain capillary whole than one person asblood this samples poses an needed infection for blood glucose monitoring 4 Hold the Lancet Needle Cover 5 Replace the Lancing Device 6 The Adjustable Tip offers 5 levels of risk. or for other tests requiring one or two drops of blood. and gently twist off of the Lancet Cover skin penetration. To select the The Adjustable Tip on the Lancing Device allows you desired depth, twist the Adjustable This Lancing Deviceto ischoose used to the obtain best capillarydepth of skinwhole penetration. Tip in either direction until the blood samples needed for blood glucose monitoring 4 Hold the Lancet Needle Cover 5 Replace the Lancing Device 6 The Adjustable Tip numberoffers 5 levelsline up of with the Arrow. or for other tests requiringUse the one CLEAR or two endcap drops forof blood.alternative site testing and gently twist off of the Lancet Cover skin penetration. To select the The Adjustable Tip (AST)on the onLancing the palm Device or forearm. allows youPlease see the blood desired depth, twist the Adjustable to choose the best glucosedepth of userskin guidepenetration. before performing alternative site Tip in either direction until the testing as it provides important information about the number line up with the Arrow. Use the CLEAR endcapbest testing for alternative site for yoursite testingsystem. AST Endcap (for palm or forearm) (AST) on the palm or forearm. Please see the blood glucose user guide before performing alternative site To select the best depth: testing as it providesNote: important information about the ® 1-2 for soft or think skin • Should not be used for assisted blood draws by healthcare providersAST Endcapor at healthcare(for palm or forearm) provision sites*, and Telcare Blood Glucose Monitoring System ® best testing site for your system. 3 for average skin should never be shared with anyone else, even a family member.. 4-5 for thick or calloused skin • Always use a new lancet with each test. To select the best depth: • Keep your lancing device clean. Note: 1-2 for soft or think skin • Should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and * Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, 7 Hold the Lancing Device Cover in 8 Position the end of the Adjust3 for average- skin9 Place the Lancing Device aside should never be shareddetention withfacilities, anyone senior centers, else, schools, even and a camps.family member.. Tips for fingertip testing one hand. Using the other hand, able Comfort Tip against4-5 the for thick or callousedand wait skin a few seconds for a blood • Always use a new lancet with each test. slowlyn Gently pull massagethe Sliding your hand Barrel and finger toward theside-tip puncture ofsite theto form finger. a Press the drop to form. To help form a blood • Keep your lancing device clean. To clean the Lancing Device: away dropfrom of theblood. Lancing Do not “milk” Device or squeeze around theTrigger puncture Button, site. and then lift the drop, lower the hand to waist level n Lance the side of your fingertip to avoid soreness. To avoid calluses, choose * Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, 7 Hold the Lancing DeviceCover. Cover You will in hear8 a click,Position the end of Lancingthe Adjust Device- away9 fromPlace the the Lancing Deviceand gently aside massage the finger from detention facilities, senior centers, schools, and camps. indicatinga different that lancing the Lancet site each Carrier time. finger after the puncture is palm to fingertip. Cleaning and disinfection frequency: The lancing device should be clean and disinfected after every use by the individualone hand. Using the other hand, able Comfort Tip against the and wait a few seconds for a blood patient. slowly pull the Slidingis locked Barrel into position. Releaseside-tip of the finger.complete. Press the drop to form. To help form a blood To clean the Lancing Device: away from the Lancingthe SlidingDevice Barrel to returnTrigger it to Button,its and then lift the drop, lower the hand to waist level original position. Equipment Needed: Cover. You will hear a click, Lancing Device away from the and gently massage the finger from indicating that the Lancet Carrier finger after the puncture is palm to fingertip. Cleaning and disinfection• Damp cloth frequency or paper: The towel lancing device should be clean and disinfected after every use by the individual Fingertip Testing is locked into position. Release complete. patient. • DISPATCH: DISPATCH Hospital Cleaner Disinfectant Towels With Bleach are pre-moistened disposable towels for use in 5 Position the end of the adjustable the Sliding Barrel to return it to its Note: healthcare and other areas where control of cross contamination is required. comfort tip against the side of the original position. DO NOT re-use the Lancet Equipment Needed: fingertip. Press the trigger button, • Damp cloth or paper1. Inspect towel for blood, debris, dust, or lint anywhere on the lancing device. and then lift the lancing device away • DISPATCH: DISPATCH2. Clean Hospital or disinfect Cleaner lancing Disinfectant device. Towels With Bleach are pre-moistened disposable towels for use in from the finger after the puncture is Note: healthcare and other3. To areas clean where the lancing control device of cross and contamination endcap, blood/body is required. fluids must be thoroughly cleaned from surface and objects before Removingcomplete. and disposing of the used lancet DO NOT re-use the Lancet disinfecting. Wipe surface with towel (DISPATCH) until completely wet. Allow to remain wet for one minute at room 1. Inspect for blood, debris,temperature dust, or (68-77˚F). lint anywhere on the lancing device. Continued on next page 2. Clean or disinfect4. lancing To disinfect device. the lancing device allow 2 minutes contact at room temperature. Wipe dry or allow to air dry. Gross soil must 10 To remove the used Lancet from the Lancing Device, first twist off the Lancing Device Cover. While holding be removed prior to disinfection. the Sliding Barrel., leave the Lancet in the Lancet Carrier and firmly stick the Lancet Needle into the Lancet 3. To clean the lancing device and endcap, blood/body fluids must be thoroughly cleaned from surface and objects before Removing and disposing of the used lancet disinfecting. Wipe5. surface Wash hands with towel with soap(DISPATCH) and water. until completely wet. Allow to remain wet for one minute at room Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. temperature (68-77˚F). Press the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover. 4. To disinfect the lancing device allow 2 minutes contact at room temperature. Wipe dry or allow to air dry. Gross soil must 10 To remove the used Lancet from the Lancing Device, first twist off the Lancing Device Cover. While holding be removed priorNote: to disinfection. the Sliding Barrel.,11 Toleave dispose the Lancet the used in the Lancet Lancet safety, Carrier discard and firmlyit into stickthe appropriate the Lancet sharpsNeedle orinto biohazard the Lancet container. 5. Wash hands with• soap Keep and Dispatch water. out of reach of children. Needle Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. 19 • User should wash hands thoroughly with soap and water after handling the lancing device. Press the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover. • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Manufactured for: lancing device. Note: 11 To dispose the Apexused BiotechnologyLancet safety, discard Corporation it into the appropriate sharps or biohazard container. • Keep Dispatch out of reach of children. #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. TEL: 1-877-979-5454 Website: www.apexbio.com • User should wash hands thoroughly with soap and water after handling the lancing device. P/N 65070000002 Rev.11/10 • Only DISPATCH Hospital Cleaner Disinfectant Towel should be used to do cleaning and disinfection with the Manufactured for: lancing device. Apex Biotechnology Corporation #7, Li Hsin V Rd., Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. TEL: 1-877-979-5454 Website: www.apexbio.com P/N 65070000002 Rev.11/10 ® ® Telcare Blood Glucose Monitoring System

Testing Using an Alternate Test Site 6 Important Information on Alternate Site Testing

Your Telcare BGM® is capable of testing your blood glucose from your palm, usually referred to as an alternate site test, or AST.

Alternate site testing can be less painful than fingertip testing. However, because of the physiological differences between your fingertip and palm, AST results may be significantly different.

Alternate site testing should not be used to calibrate continuous glucose monitor nor should it be used in insulin dose calculations.

Alternate site testing should only be used during steady state blood glucose conditions when glucose is not changing rapidly.

You should consult with your doctor before using alternate site testing. 20 ® Telcare Blood Glucose Monitoring System ®

Testing on Your Palm

Prepare the lancing device with a new lancet and clear cap. Cock the lancing device so that it is ready to use. Select a site on your palm that does not have veins, moles, excessive hair, or bone. Vigorously rub the side of your palm with your other hand for at least 10 seconds. You should feel it get quite warm.

Press the opening of the clear cap against a fleshy area of the palm. Press the lancing device up and down in a slow pumping motion for several seconds to help the flow of blood.

Keep steady pressure on the area and press the release button. Do not be afraid to apply pressure to the area with the lancing device to assist the flow of blood. Continue to press the cap against the area for a few seconds to allow blood to come to the surface. You can see the blood drop through the clear cap. Do not smear the blood when removing the lancing device. If the blood drop is too small, the meter will show Error: Not Enough Blood. Insert a new strip and obtain a new blood drop.

Choosing Lancet guage Telcare users have found that a 26-gauge lancet or thicker (a number lower than 26) is needed in order to obtain an adequate blood drop for palm testing. Ultra-fine lancets that are adequate for finger testing will often fail to yield enough blood for palm testing.

If the results from alternate site testing differ from how you feel, use fingertip testing instead.

21 ® ® Telcare Blood Glucose Monitoring System

IMPORTANT SAFETY INFORMATION ON AST

A We recommend that Alternate Site Testing SHOULD NOT BE USED WHEN:

n You have hypoglycemic unawareness (not able to tell if you have low blood sugar).

n You are within 2 hours of eating a meal, exercising, or taking medication.

n You will be operating machinery or driving a car.

n You are sick.

n You think your blood glucose is low.

n Your Alternate Site Testing results do not match the way you feel.

n You are testing for hyperglycemia.

B Alternate Site Testing should not be used for patients who are dehydrated, hypotensive, in shock, critically ill, or in a hyperosmolar state.

C Alternate Site Testing measurements should never be used for insulin dose calculations.

D Please see your lancing device’s user manual for further instructions.

Note: If not using Telcare’s provided lancing device, please refer to your lancing device’s instruction for use.

22 ® Telcare Blood Glucose Monitoring System ®

IMPORTANT INFORMATION FOR LANCING DEVICE

A Use the Telcare Lancing Device included in your Telcare Blood Glucose Monitoring System to obtain a blood sample. The minimum blood sample volume is 0.8 microliters.

B Purchase an additional Telcare Lancing Device by calling Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International). (9AM - 9PM EST, M-F).

C If using another type of lancing device, please refer to its user manual.

23 ® ® Telcare Blood Glucose Monitoring System

Applying Blood to the Test Strip 7 Gently touch the test strip to the drop of blood. The test strip will absorb the blood. Keep the test strip in the blood drop until you see the blood sample end of the test strip fill.

Tagging Your Data 8 The screen will start to count down. After 6 seconds, your glucose level will appear on the display screen. You will then have time to select a Reading Tag (e.g., “Before Breakfast”) from the list displayed. Use the DOWN button to scroll to the correct tag. Press the ENTER button to select that tag.

Your test result will be automatically stored into the meter history. If a Reading Tag is not selected in the allotted time, it will automatically be tagged as “No Selection.”

Remove the Test Strip 9 In order to send results to the Telcare server, remove the test strip from the meter when you see the screen shown here.

24 ® Telcare Blood Glucose Monitoring System ®

Sending Your Results 10 As soon as you remove the test strip, your Telcare BGM® will send the results to Telserve, Telcare’s secure server. Telserve data can be viewed at MyTelcare.com.

Important steps to follow if If you see High or Low If you see High or Low displayed, your blood glucose level may be above 600 mg/dL or below 20 mg/dL. Wash your hands. Dry your hands completely. Test again using fingertip testing. DO NOT test on your palm or forearm. If you still receive the same message, call your caregiver immediately.

25 ® ® Telcare Blood Glucose Monitoring System

OPTIONAL: After successful data transmissions to Telserve, you may receive a multiple choice question to answer. This may be a question from your caregiver or relate to reordering supplies. Use the UP/DOWN buttons to select the appropriate answer. Press the ENTER button to transmit.

CLINICAL RESPONSE SCREEN: After data transmission, you will see a graph that compares your reading to your set target. To change your set target, go to MyTelcare.com or call Customer Support at (888) 666-4530 (US) or (1) (978) 610-4688 (International). You may also see helpful guidance from your caregiver regarding this reading to manage your diabetes.

26 ® Telcare Blood Glucose Monitoring System ®

If Your Data Transmission Is Not Successful

If the device cannot communicate with Telserve, the following message will appear:

No data connection, Data will be stored Your test results will be stored in your device. You can send the reading on your own by going into History from the main menu. See page 29. For the transmission to be successful, network connection is required. The meter will attempt to forward unsent readings automatically. Readings that have been transmitted to Telserve will be marked with a green check in the History List.

IF DATA TRANSFER FAILS, YOU MAY USE THIS PRODUCT LIKE ANY OTHER GLUCOSE METER. FOLLOW YOUR HEALTH CARE PROFESSIONAL’S INSTRUCTIONS ON TREATMENT.

27 ® ® Telcare Blood Glucose Monitoring System

Understanding Your Blood Glucose Test Results Blood glucose value will vary depending on food intake, medication, health, stress, and exercise. The ideal ranges for people without diabetes are as follows1: n 70 to 100 mg/dL before meals, and n 70 to 140 mg/dL after meals

What to do if you get a high or low reading AND you feel ill. If the Telcare BGM® displays results that are “High” or “Low,” or you get a result that is more than 250 mg/dL or below 50 mg/dL AND you feel ill:

n Treat your diabetes according to the instructions from your doctor. If the Telcare BGM displays results that are “High” or “Low,” or you get a result that is more than 250 mg/dL or below 50 mg/dL AND you DO NOT feel ill: n Test your Telcare BGM with a control solution: refer to page 8, ”Step-by- Step Guide to Control Testing.” n Wash your hands, dry thoroughly and test again using your fingertip. If you still get a high or low reading, contact your doctor immediately.

References 1. American Diabetes Association. Standards of Medical Care in Diabetes—2008. Diabetes Care. 2008;31:S12–S54.

28 ® Telcare Blood Glucose Monitoring System ®

View Your History on the Meter or Online View your history on your meter Your Telcare BGM® stores up to 300 test and control results. Each result is stored with date and time.

Power on the Telcare BGM by using 1 the PWR button. Use the UP/DOWN keys to access 2 History. Use the UP/DOWN keys to scroll through 3 the stored readings.

To exit the History menu, scroll to the bottom of your reading history and select “BACK.” ( Shortcut: VIEW YOUR METER’S HISTORY Press the UP button when your most recent reading is highlighted. Doing so will display the BACK option.)

Access Your readings at www.MyTelcare.com Access your readings at www.MyTelcare.com. Use the log in credentials that you can obtain by calling (888) 666-4530 (US) or (1) (978) 610-4688 (International). For additional questions or login support, turn your meter off and contact Telcare by phone or e-mail at [email protected].

29 ® ® Telcare Blood Glucose Monitoring System

Charging Your Telcare BGM®

Your Telcare BGM uses a rechargeable battery. It can be charged and discharged hundreds of times, but eventually the battery will lose its charge. If you notice significant reduction in the duration of your meter’s operating time, please contact Telcare technical support at (888) 666-4530 (US) or (1) (978) 610-4688 (International), or e-mail [email protected]. If left unused, a fully charged battery will lose its charge over time. Always charge indoors.

To Charge Your Device Plug the power cord into 1 an electrical outlet.

Plug the other end of the 2 cord into the BGM’s Charging Port.

MAINTENANCE OF YOUR TELCARE BGM AND LANCING DEVICE Charging Troubleshooting If your device does not turn on when you switch the power button on, your battery may not be fully charged. Charge the battery. If after 3 hours of charging the device does not turn on, contact Telcare technical support at (888) 666-4530 or (1) (978) 610-4688 (International).

30 ® Telcare Blood Glucose Monitoring System ®

Cleaning & Disinfecting What is the difference between cleaning and disinfecting? Cleaning and disinfecting are not the same thing. Cleaning simply removes blood and dirt. Disinfecting kills germs and provides an extra level of safety. In the following procedure, the first disinfectant towel is used for cleaning, and the second towel provides for disinfection. You should disinfect areas where there are both high concentrations of germs and a possibility that they will be spread to others. The Caltech DISPATCH Cleaner/ Disinfectant with Bleach Premoistened Towels™ have ingredients that clean and disinfect your meter, lancing device, and endcaps. While surfaces may look clean, many infectious germs may be lurking around. Some germs can live on surfaces for hours and even for days! The disinfection process shown in the pages that follow is effective in destroying dangerous Hepatitis B viruses. If the meter or lancing device is being operated by a second person who is providing testing assistance to the user, the meter should be disinfected prior to assistance from the second person. See your lancing device’s user manual for instructions on decontaminating your lancing device.

To acquire canisters of Caltech DISPATCH towels, please contact: Medex Supply - www.medexsupply.com - (888) 433-2300 Sears - www.sears.com - (800) 349-4358 Berktree - www.berktree.com - (866) 505-5333 Optics Planet - www.opticsplanet.com - (800) 504-5897 Amazon - www.amazon.com A full list of authorized dealers of Caltech DISPATCH towels is at www.MyTelcare.com. 31 ® ® Telcare Blood Glucose Monitoring System

Cleaning and Disinfecting Your Meter Clean and disinfect your meter at least 1 time per week using Caltech DISPATCH Cleaner/Disinfectant with Bleach Premoistened Towels™ using the following method: Dispense the DISPATCH towel from its 1 package or container.

Clean the outside of the meter to remove any 2 blood or dirt.

Discard used towel in a sealed container where it will not 3 be touched by others. Dispense a second DISPATCH towel from its package or 4 container.

Disinfect the meter with the second towel by wiping all 5 outside surfaces.

Discard used towel in a sealed container where it will 6 not be touched by others.

12 Wait at least one minute and make sure device is 9 3 7 completely air dried before next blood test. 6 32 ® Telcare Blood Glucose Monitoring System ®

The Telcare BGM® has been validated for 1,825 cleaning and disinfection cycles. Please obtain a new meter after cleaning and disinfecting the meter 1,825 times or once the lifetime of the meter (5 years) has been reached, whichever comes first.

Meter Cleaning Dos and Don’ts

n Do not allow cleaning solution to run in or around the strip port. Doing so may cause a malfunction.

n Do not let the meter come in contact with water.

n Do not use any glass or household cleaners on the meter.

n IMPORTANT: If the meter is being operated by a second person who is providing testing assistance to the user, the meter should ALWAYS be disinfected prior to assistance from the second person.

n Stop using the meter and contact customer service immediately if you notice any of the following signs of deterioration: • The meter does not turn on.

• The meter’s screen has been cracked or has become clouded.

• The meter is damaged or has stopped working.

For technical support, contact Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International).

33 ® ® Telcare Blood Glucose Monitoring System

Cleaning and Disinfecting Your Lancing Device Cleaning and disinfecting of your lancing device should be done with the Caltech DISPATCH Cleaner/Disinfectant with Bleach Pre-moistened Towels when it appears dirty or contaminated with blood. The lancing device should be cleaned and disinfected daily. The Telcare Lancing Device has been validated for 1,825 cleaning and disinfection cycles, which corresponds to daily cleaning over a five-year lifetime. Please obtain a new lancing device after five years of daily cleaning or if signs of deterioration are seen. Please follow this cleaning method:

Dispense the DISPATCH towel from its 1 package or container.

Clean the outside of the lancing device 2 and the inside and outside of the cap to remove any blood or dirt.

Discard used towel in a sealed 3 container where it will not be touched by others.

Dispense a second DISPATCH towel 4 from its package or container.

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Wipe all surfaces again, just as you 5 did in step 2, in order to disinfect them.

Discard the second towel in a sealed 6 container where it will not be touched by others.

Wait at least one minute. Then rinse 7 briefly with water and allow to dry before next use.

IMPORTANT LANCING SAFETY MEASURES If the lancing device is being operated by a second person who is providing testing assistance to the user, the lancing device and endcap should ALWAYS be disinfected prior to assistance from the second person.

Stop using the lancing device and contact customer service immediately for a replacement if you notice any of the following signs of deterioration: n Any buttons have fallen off or stopped working. n The device is cracked. n The device is discolored.

n The device does not yield an adequate blood drop.

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Storing Your Telcare BGM® and Test Strips

n Your meter is a delicate electronic device that should be handled with care. Severe shock, such as dropping the meter, could damage it.

n The meter and test strips only work in the temperature range of 50˚F (10˚C) to 104˚F (40˚C).

n Store the test strips between 39°F (4˚C) and 86°F (30˚C). Do not freeze. See the test strip instructions for more details.

n Don’t leave the meter in a place that is extremely hot or extremely cold (e.g., anywhere near a heat source or in an extremely hot or cold car).

n Do not expose the meter or test strips to high levels of humidity, such as in AND TEST STRIPS ® the bathroom or kitchen.

n Immediately close the bottle cap tightly after removing a test strip.

n Do not attempt to open the meter. Opening the meter will void the warranty and may cause it to operate improperly. If you have technical problems or questions, turn your meter off and contact Telcare at STORING YOUR BGM YOUR STORING (888) 666-4530 (US) or (1) (978) 610-4688 (International). Support is available Monday through Friday, 9AM - 9PM EST.

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Troubleshooting

Error Codes In the event your device experiences an error, you will see the following screen along with an error message.

1. Error Message: “Meter Failure” What it means: As with any computer device, sometimes the meter may need to be restarted. Action to take: Restart meter and contact Telcare support if the problem continues. Turn your meter off before calling Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International).

2. Error Message: “Used Strip Inserted” What it means: Your test strip may be used or damaged.

Action to take: Repeat the test with a new test strip. Remember, add the TROUBLESHOOTING sample only when you see the prompt on the display screen.

3. Error Message: “Not Enough Blood” or “Not Enough Control Solution” What it means: There is not enough blood or too much blood or control solution on the test strip to give a reliable reading. Action to take: Remove the test strip and repeat the test with a new test strip.

4. Error Message: “No data connection, Data will be stored” What it means: The meter cannot find a cellular connection. Action to take: See “Communication Errors” on page 39.

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5. Error Message: “Temp. Too Low” or ”Temp. Too High” What it means: The meter is too hot or too cold. Action to take: Move the meter into an area that is between 50˚F (10˚C) and 104˚F (40˚C).After receiving this error, allow the meter to be at room temperature for at least 30 minutes before testing blood or control solution.

6. Error Message: “Unable to Connect, Will Retry at Next Test” What it means: The meter unable to connect to Telserve. Action to take: See “Communication Errors” below. If this is not resolved and you have more than 1 bar of cellular signal strength, call customer service.

Other Messages Low Battery icon 1. Icon Message: Low Battery icon Displayed What it means: The meter is about to lose power. Action to take: Charge the battery (see page 30)

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2. Icon Message: Wireless Signal Indicator Bars Two bars or less of wireless signal strength may result in unreliable transmission and reception of data. The strength indicator is located at the top left of the meter’s screen.

3. Message: “High” or ”Low” Displayed What it means: If you see either High or Low displayed on your device, your blood sugar level may be out of range (either in excess of 600 mg/dL [High] or lower than 20 mg/dL [Low]). Action to take: See “Troubleshooting” on page 13, and wash your hands. Dry your hands completely. Test again using fingertip testing. DO NOT test on your palm or forearm. If you still receive the same message, call your caregiver immediately.

Communication Errors If you are having trouble uploading your results to Telserve, you may want to try the following: n If testing indoors, move closer to a window for better cellular reception. n Check to see if there is cellular coverage in your area. Two bars or less of wireless signal strength may result in unreliable transmission and reception of data. n Restart meter and send reading within History (see page 29).

If the above actions do not resolve your problem, contact Telcare technical support at (888) 666-4530 (US) or (1) (978) 610-4688 (International), or e-mail [email protected].

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Terms of Warranty

Telcare warrants the Telcare BGM® Blood Glucose Meter to be free of defects in workmanship and materials under normal use for a period of one (1) year from the date of purchase. The liability of Telcare is limited to repair or replacement. In no event shall Telcare be liable for any collateral or consequential damages or loss. Instruments subjected to misuse, abuse, neglect, exposure to water, unauthorized repair, or modification are excluded from this warranty. This guarantee specifically excludes expendables and consumables. Please direct any questions or claims to the authorized dealer from whom you purchased your system, or to: Telcare, LLC 150 Baker Avenue Extension

TERMS OF WARRANTY OF TERMS Suite 300 Concord, MA 01742, USA Phone: (888) 666-4530 (US) or (1) (978) 610-4688 (International) This warranty applies only to the original purchaser of the system.

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Specifications

Test Strips: Telcare Blood Glucose Test Strips

Minimum Sample: 0.8 microliters

Test Range: 20 – 600 mg/dL

Calibration: Plasma, calibrated against the YSI Glucose Analyser (YSI, Inc.) reference instrument, which is traceable to NIST SRM 917c reference standard.

Hematocrit Range: 30 – 55%

Display Type: Color LCD screen

Memory: 300 blood test results with date and time

Result Averaging: 7, 14, and 30 days averaging displayed on Telserve Data System (not on Telcare BGM®)

Dimensions: 100L x 60W x 15H (mm) SPECIFICATIONS

Weight: 115g

Battery: Rechargeable, Lithium Ion 1100 mA hour battery, permanently installed

Battery Life: 1 year

Automatic Sleep Mode: After 2.0 minutes of nonuse

Operating Temperature: 50°F~104°F (10˚C~40˚C)

Relative Humidity: Less than 85%

Storage Conditions: Meter at 39°F~122°F (4˚C~50˚C), Test Strips at 39°F~86°F (4˚C~30˚C). Control Solution at 39˚F~86˚F (4˚C~30˚C)

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About Telcare®

Telcare is committed to creating the very best medical device experience for patients and doctors. Connecting powerful hardware and innovative software via a “no wires” approach, Telcare’s offerings aim to provide convenient and effective disease management tools.

The Telcare Blood Glucose Monitoring System won the People’s Choice Award at CTIA Wireless 2009, Best in Show at MobiTechFest 2009, was an E-tech Finalist at CTIA Wireless 2010, and won the First Prize 2011 CTIA E-Tech Award for Enterprise Healthcare Solution and the First Prize 2011 CTIA E-Tech Award for Mobile Healthcare Solution.

I found the Telcare meter a refreshing change, and a significant step toward ABOUT TELCARE “ bringing consumer medical devices closer to the world of modern technology.“ — Walt Mossberg, Tech Columnist, Wall Street Journal

“Most importantly, the Telcare BGM sends my BG data automatically ... it is also well designed and instantly user friendly, like my iPad and Kindle.“ — David Mendosa, Medical Journalist, HealthCentral

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Contact Telcare®

Telcare, LLC 150 Baker Avenue Extension, Suite 300, Concord, MA 01742 USA Phone: (888) 666-4530 (US) or (1) (978) 610-4688 (International) Hours: M - F, 9AM - 9PM EST E-mail: [email protected] Website: www.MyTelcare.com

For any medical questions, contact your health care professional. CONTACT TELCARE CONTACT

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FCC Interference Statement

Federal Communication Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 18 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 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. n This device complies with Part 18 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. n FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. FCC Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.