FCC ID: QXS-TX030301 Glucose Monitor Transmitter

TheraSense Continuous Glucose Monitoring System July 8, 2002 Table of Contents Preface . iii Safety and Precautions . iv Important Information About Your Continuous Glucose Monitor . iv Important Health Related Information . iv Help is Available . iv Learning the System . 1 Introduction . 1 The Complete System . 1 Receiver . 1 Transmitter . 2 Sensor Support Mount and Inserter . 2 FreeStyle Test Strip . 3 Lancing Device . 4 The Receiver/Transmitter Connection . 4 Using the System . 5 Operating the Receiver . 5 Selecting a Menu Option . 5 Replacing the Sensor . 6 Removing the Old Sensor . 6 Inserting a New Sensor . 7 Testing Your Blood Glucose . 10 When to Perform a Blood Glucose Test . 10 Using the Lancing Device . 13 Checking the System . 15 When to Perform a Control Solution Test . 15 Important Information about the Control Solution . 15 How to Perform a Control Solution Test . 15 Control Solution Results . 17 Troubleshooting . 19 Error Codes . 19 Error Messages . 19 Problems . 21 Table of Contents i ii TheraSense Continuous Glucose Monitor Users Guide Preface The TheraSense Continuous Glucose Monitor is intended for use... I still do not have an intended use statement. It should not be used for the diagnosis of diabetes?

The TheraSense Continuous Glucose Monitor helps people with diabetes monitor their sugar (glucose) level. The system provides glucose values on a continual basis allowing you to see patterns in your glucose levels. The Continuous Glucose Monitor System includes:

a sensor, which is inserted under your skin and takes glucose measurements for up to 72 hours a wireless transmitter that connects to the sensor and sends glucose results to a receiver a wireless receiver that captures and displays the glucose measurements sent by the transmitter Glucose levels are measured and displayed every 3 minutes from a tiny sensor inserted just below the surface of your skin. The top of the sensor sits above the skin and connects to a transmitter, which sends glucose readings to a receiver that you keep with you like a pager. The receiver displays the glucose values, and also functions as a FreeStyle blood glucose meter, allowing you to perform discrete blood glucose tests using a FreeStyle Test Strip. By getting more frequent glucose results over time, you can monitor your glucose levels more closely and gain more control of your diabetes. Understanding the continuous trend of glucose levels, rather than several isolated readings will help you and your healthcare professional to adjust your treatment plan and understand how your diet, insulin, exercise, and medication are affecting your diabetes. iii Safety and Precautions Important Information About Your Continuous Glucose Monitor Before using the Continuous Glucose Monitor to test your glucose, read this owners booklet and practice the testing procedures. Glucose monitoring should be done with the guidance of a healthcare professional. Do not leave a sensor inserted under your skin for more than 3 days (72 hours). Do not fly on an airplane while you are wearing a transmitter. Do not swim in salt water. Do not drop the receiver or allow it to get wet. The receiver should be used only with the FreeStyle Test Strips and Control Solution. Using other brands of test strips or control solution with the receiver can give you inaccurate results. Important Health Related Information Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician immediately. Test results below 60 mg/dL (3.3 mmol/L) mean low blood glucose (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L) mean high blood glucose (hyperglycemia). If you get results below 60 mg/dL or above 240 mg/dL, and you do not have symptoms of hypoglycemia or hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall below 60 mg/dL or above 240 mg/dL, follow the treatment advice of your healthcare professional. If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in the Continuous Glucose Monitor Owners Booklet, call your healthcare professional. Help is Available Help is available from your clinical trial site coordinator 24 hours a day, 7 days a week. Your site coordinator will provide you with contact information. You may also visit our website at www.therasense.com. If the receiver displays an error message or if you have any questions about your TheraSense Continuous Glucose Monitor, call:

during business hours (8:00 am to 5:00 pm PST): ____________________________ nights and weekends: _________________________________________________ iv TheraSense Continuous Glucose Monitor Users Guide Learning the System Introduction The Continuous Glucose Monitor System... (Neil, still waiting for mktg literature that talks about the product features) (readings are taken from interstitial fluid, sensor is inserted under the skin and worn for 72 hours, Would be good to have an illustration (line drawing) showing the relationship between receiver and transmitter while the transmitter is being worn with the sensor. The Complete System The Continuous Glucose Monitor System includes:

a sensor, which is inserted under your skin and takes glucose measurements for up to 3 days (72 hours) a wireless transmitter that connects to the sensor and sends glucose results to a receiver a wireless receiver that captures and displays the glucose measurements sent by the transmitter Receiver The receiver is like a pager. You may wear it on your belt or carry it in your pocket or purse. It receives glucose readings sent from the transmitter. You can see the readings, which are updated about every 3 minutes, on the display screen. The receiver also acts as a FreeStyle blood glucose meter, allowing you to perform regular blood glucose tests using a FreeStyle test strip. Refer to Testing Your Blood Glucose on page 10 for information on performing a FreeStyle test with the receiver. Display screen Displays the glucose result and other messages. Test Strip Port Where you insert the test strip. Scroll buttons Allow you to move the cursor up or down to scroll through a list. The top button scrolls up. The bottom button scrolls down. Selection buttons Allow you to select options displayed on the screen. The options change depending on the screen that is displayed. NOTE: To conserve on battery power, the receiver screen goes blank after 10 seconds. To turn on the display, simply press the right selection button. Learning the System 1 Transmitter The transmitter is a small electronic device that gets glucose readings from the sensor, inserted under your skin, and sends them to the receiver. Always keep the receiver within 10 feet of the transmitter. Contact points Connect to the sensor support mount. Sensor Support Mount and Inserter The sensor is a small device that is attached to the support mount. The tiny tip of the sensor is placed just below the surface of your skin by the sensor inserter. The top of the sensor connects to the transmitter. The sensor takes the glucose readings from under the skin. Plunger Fires a needle into the skin, placing the tip of the sensor just below the surface of the skin. Sensor inserter Used to insert the sensor in the skin. Release tabs Releases the sensor inserter from the support mount after the sensor is inserted in the skin. Safety tabs Unlock the sensor inserter to prepare it for firing. Press the safety tabs when you are ready to insert the sensor into the skin. Sensor support mount Sticks to the skin and holds the sensor in place. The transmitter slides onto a track on top of the support mount. Sensor (not visible) Located in the support mount. Measures your glucose levels. The tip of the sensor is inserted just below the surface of your skin. 2 TheraSense Continuous Glucose Monitor Users Guide FreeStyle Test Strip Use the FreeStyle Test Strip to run a FreeStyle blood glucose test. The receiver will prompt you to perform a blood glucose test each time you insert a new sensor and then periodically after that. Apply blood to only one side of the test strip for each test. Insert this end into the receiver. Apply blood to only ONE side of the test strip. IMPORTANT: Do not apply blood to both sides. Gently touch one edge of the test strip to the blood sample. The blood sample will be pulled up into the test strip. Important Test Strip Information For detailed information on FreeStyle Test Strips, refer to the FreeStyle Test Strips package insert. Store the test strip package in a cool, dry place below 86F (30C). Do not refrigerate or freeze. Keep away from direct sunlight and heat. Store test strips in their original vial only. Never transfer test strips to another vial or container. Do not store individual test strips in your carrying case. See your clinical trial site coordinator to get additional test strips. To ensure accurate results, use the test strips at room temperature. After removing a test strip from the vial, immediately replace the vial cap and close tightly. With clean, dry hands, you may gently touch the test strip anywhere when removing it from the vial or inserting it into the receiver. Do not use test strips beyond the expiration date printed on the package or you may get inaccurate results. Do not use test strips that are bent, cut, torn, or altered in any way. WARNING: Keep the test strip vial away from children. The cap is a choking hazard. The cap contains a pouch filled with a drying agent that may be harmful if inhaled or swallowed and may cause skin and eye irritation. Learning the System 3 Lancing Device Use the lancing device to get a blood sample when you perform a FreeStyle blood glucose test. cocking handle depth settings dial depth indicator window release button clear cap The Receiver/Transmitter Connection The receiver and the transmitter must be kept within 10 feet of one another for glucose readings to be successfully transmitted. If the receiver is moved more that 10 feet from the transmitter, the connection will be broken and the receiver will not be able to receive glucose readings. When the connection is broken, the following screen appears and the receiver beeps once every minute. To silence the alarm, move the receiver within 10 feet of the transmitter. NOTE: If you hear the receiver beep, check the display screen for a message. Refer to the Troubleshooting section for information on the receiver messages. Glucose&Alarm Reconnect Acknowledge Main 4 TheraSense Continuous Glucose Monitor Users Guide Using the System Operating the Receiver In addition to continually displaying glucose readings, the receiver displays messages to help you use the system and to inform you of problems. Some messages prompt you to make a selection or perform a task. Use the buttons on the front of the receiver to acknowledge the information displayed and make selections. Use the scroll buttons on the right to scroll through a list or increase or decrease a number when entering the test strip code, for example. Use the selection buttons on the bottom to select the option. Selecting a Menu Option 1 To select an option from the main menu, use the scroll button on the right to move the cursor up or down the list. Main Glucose Reconnect New Sensor Receiver status Transmitter status Select Press the scroll button to move the cursor down the list. 2 Press a selection button on the bottom to select the option displayed on the screen just above the button. In this example, press the right button to select New Sensor. Main Glucose Reconnect New Sensor Receiver status Transmitter status Select Press the right selection button to select the New Sensor option. Using the System 5 Replacing the Sensor Once inserted, a sensor can be left if place for 3 days (72 hours). After 72 hours the receiver prompts you to remove the old sensor. After you remove the old sensor and insert a new one, the receiver will prompt you to perform a FreeStyle blood glucose test. Removing the Old Sensor The receiver will prompt you to remove the used sensor. Remove Sensor Cancel 1 Select Cancel, then choose New Sensor from the main menu. 2 Spray a small amount of adhesive remover around the edges of the support mount. (Or, moisten a cotton ball with the adhesive remover, then dab the cotton ball around the edges of the support mount.) Allow the adhesive remover to soak under the support mount. 3 With the transmitter still attached to the support mount, grasp the edge of the support mount and slowly peel it off of your skin in one continuous motion. 4 Slide the transmitter off the support mount and discard the support mount. It cannot be reused. Do not discard the transmitter. 5 Gently wash the contact points on the transmitter with soapy water. Rinse thoroughly. Shake the transmitter to remove excess water, then blot the contact points on a soft cloth or lint-free paper towel or tissue. Set it aside. If necessary, use the adhesive remover, baby oil, or a wet, soapy wash cloth to remove any adhesive residue left on your skin. 6 6 TheraSense Continuous Glucose Monitor Users Guide 7 The receiver can detect that the sensor has been removed and will automatically prompt you for the code number of the new sensor. The code number can be found on the foil package. Use the scroll arrows to display the correct code, then select Set. Sensor Code 101 Cancel Set Use scroll arrows to select sensor code. Select Set. 8 When the code number has been set, the receiver prompts you to insert the new sensor. Refer to Inserting a New Sensor in the following section for information. Insert Sensor Cancel Inserting a New Sensor Before inserting a new sensor, be sure you have the following materials:

sensor inserter (in its unopened, foil package) transmitter receiver soap and water 1 Select an insertion site. You can insert the sensor at one of the following sites:

on the middle of your abdomen at least 2 inches away from your navel and above the belt line on the backside of your upper arm NOTE: Avoid areas where the edges of clothing may catch or rub against the sensor. Avoid inserting the sensor in the same place as it was previously inserted. 2 Wash your hands thoroughly with soap and water. 3 Clean the insertion site with soap and water. Be sure to thoroughly rinse and dry the area. 4 Carefully disable the safety mechanism by squeezing the safety tabs on the sides of the plunger. You may find it easier to press one safety tab at a time. CAUTION! Once the safety tabs are pressed, the sensor inserter will fire if the plunger is depressed. Be careful not to press the plunger until you have correctly placed the sensor inserter on the skin and are ready to insert the sensor. Using the System 7

*GRAPHIC squeezing safety tabs/pulling pin*

5 Remove the adhesive backing at the bottom of the support mount. 6 Place the sensor inserter, adhesive-side down, on the skin at the insertion site. Hold it firmly in place to ensure it sticks to the skin. If inserting the sensor on your arm, position the sensor support mount so that it runs lengthwise down your arm. 8 TheraSense Continuous Glucose Monitor Users Guide 7 Press the plunger on the top of the sensor inserter. A needle will quickly penetrate your skin to place the sensor, then withdraw leaving the sensor in place. NOTE: Once the plunger is pressed, the sensor inserter cannot be reused. 8 While holding the sensor inserter at the site, firmly squeeze the release tabs at the base of the inserter, then lift the sensor inserter straight up and out of the support mount. Make sure the support mount remains on your skin. NOTE: A small drop of blood appearing at the sensor site is normal. 9 Discard the sensor inserter. 10 Firmly slide the transmitter onto the support mount and push it until it clicks into place. It is important to get a tight connection. Using the System 9 IMPORTANT: Make sure you keep the receiver within 10 feet of the transmitter. The receiver must be kept close to the transmitter so that glucose readings taken by the sensor can be sent to the receiver. If you move more than 10 feet from the receiver, the receiver will begin to beep once each minute. 11 When the sensor has been correctly inserted and the transmitter is in place, the receiver beeps once, displays the Sensor Settling screen, beeps twice, then displays the main menu. Sensor Settling Cancel 12 In approximately 1 hour after you insert the sensor, the receiver will prompt you to perform a blood glucose test. Proceed to Testing Your Blood Glucose in the following section when you see this prompt. Testing Your Blood Glucose Before performing a blood test, be sure you have the following materials:

receiver Free Style Test Strips FreeStyle Lancing Device sterile lancets soap and water When to Perform a Blood Glucose Test The receiver will prompt to perform a blood glucose test after you insert a new sensor. You will also need to perform a test at various other times throughout the day. when the receiver prompts you to perform a blood glucose test at 1, 4, and 24 hours after a new sensor insertion before each meal 1 and 2 hours after each meal before you go to bed at midnight Glucose&Alarm Peform Blood Glucose Test Acknowledge Main 10 TheraSense Continuous Glucose Monitor Users Guide 1 Insert a test strip into the receiver. Push the test strip until it stops. NOTE: If you do not start the test within 2 minutes of inserting the test strip, the receiver will automatically turn off. To restart the receiver, take out the unused test strip and reinsert it into the receiver. Glucose&Alarm Peform Blood Glucose Test Acknowledge Main 2 When the receiver detects the test strip, the strip code number appears on the display. Compare the code number on the display to the code number shown on the test strip vial. Make sure the code numbers match. If the code numbers match, select Set and proceed to step 4. If the code numbers do not match, proceed to step 3 to change the code number on the receiver. IMPORTANT: To ensure accurate results, make sure the code number shown on the receiver screen matches the code number on the test strip vial. Strip Code 22 Cancel Set Make sure test strip code numbers match. 3 If the code number on the receiver screen does not match the code number on the test strip vial, use the scroll buttons to the right of the display screen to change the code number on the receiver. Select Set when the code numbers match. 4 The receiver prompts you to apply a sample and displays a test strip and blood drop. Wash the testing site with soap and water. Be sure there is no cream or lotion where you will lance. Lance your forearm or finger to get a blood sample. Refer to Using the Lancing Device on page 13. Apply Sample Main Cancel Using the System 11 5 Apply blood to the test strip. Bring the test strip to the blood sample at a slight angle. Gently touch one edge of the test strip to the blood sample on your arm. The blood will be pulled into the test strip. A single beep means that enough sample was applied. CAUTION!

Do not press the test strip down hard against your arm. Do not scrape the blood. Do not apply blood to the flat side of the test strip. Do not apply blood to both edges of the test strip. NOTE: If after 5 seconds, your meter has not beeped, the blood sample may be too small. You can continue to fill the test strip for up to 60 seconds as long as you continue to apply blood to the same edge with which you started. Sample goes here or here Not on both edges A clock appears as the receiver measures the glucose result. The time it takes depends on your blood glucose level. The higher your glucose value, the longer it takes. Normal blood glucose levels will take an average of 15 seconds. 6 The test is complete when you hear 2 beeps. The receiver prompts you to indicate if the result is a control solution result. Select No. Select No indicating this is not a result from a control solution test. Glucose 189 mg/dL Control Solution?

Yes No 7 Remove and discard the test strip. Glucose 189 mg/dL Home 12 TheraSense Continuous Glucose Monitor Users Guide Using the Lancing Device 1 Snap off the clear cap. 2 Insert a new lancet into the white lancet holder cup. 3 Hold the lancet firmly in place with one hand while you use your other hand to twist off the round disk on the top of the lancet. 4 Replace the clear cap on the lancing device. It will snap into place. Be careful not to touch the exposed needle on the lancet. Using the System 13 5 Select a depth setting. The lancing device has five depth settings1 is for a shallow puncture and 5 is for the deepest puncture. Turn the settings dial to the desired setting as shown in the depth indicator window. If this is your first time lancing, start at level 3. 6 Pull the dark blue cocking handle out until it clicks. If the handle is already out, you may have cocked the device in step 2 when you inserted the lancet. 7 Rub the test site until you feel it getting warm. This will bring blood to the surface of the skin. 8 Lance your skin by pressing the clear cap down against your skin and pressing the release button. DO NOT LIFT UP. 9 Continue to hold the lancing device on your arm and gradually increase pressure for several seconds. Look through the clear cap on your arm. The blood sample should be about the size of a pinhead or about this big 10 Lift the lancing device straight up. Be careful not to smear the blood sample. 11 Gently touch one edge of the test strip to the blood sample. Refer to step 5 on page 12 for information on applying blood to the test strip. 14 TheraSense Continuous Glucose Monitor Users Guide 12 To remove the lancet from the lancing device:

Remove the clear cap of the lancing device. Hold the lancet over a puncture-proof container. Pinch the white clip that holds the lancet. The lancet will fall out. Checking the System When to Perform a Control Solution Test When you open a new vial of test strips When your healthcare professional advises you to do so If you suspect that your meter or test strips are not working properly If you think your test result is not accurate, or if your test results are not consistent with how you feel If you drop your receiver or expose it to liquids Important Information about the Control Solution Use only FreeStyle brand control solution. Use of other brands may produce inaccurate results. Replace the cap on the control solution vial immediately. Results from a control solution test do not reflect your glucose levels. Discard the control solution 3 months after you open the vial. Write the discard date on the vial when you first open. The discard date is 3 months from the day you open the vial. Do not use the control solution past the expiration date or you may get inaccurate results. Do not add water or any liquid to the control solution How to Perform a Control Solution Test 1 Insert a test strip into the receiver. Push the test strip until it stops. 2 The receiver automatically turns on and displays the test strip code number. Compare the code on the display to the code number shown on the test strip vial. Make sure the code numbers match. Using the System 15 If the code numbers match, select Set and proceed to step 4. If the code numbers do not match, proceed to step 3 to change the code number on the receiver. IMPORTANT: To ensure accurate results, make sure the code number shown on the receiver screen matches the code number on the test strip vial. Strip Code 22 Cancel Set Make sure test strip code numbers match. 3 If the code number on the receiver screen does not match the code number on the test strip vial, use the scroll buttons to the right of the display screen to change the code number on the receiver. Select Set when the code numbers match. The receiver prompts you to apply a sample and displays a test strip and blood drop. Apply Sample Main Cancel 4 Apply the control solution as follows:

turn the vial to the side and gently squeeze it to bring a drop to the vial tip touch one edge of the test strip to the control solution a beep means that enough sample was applied 5 The test result is complete when you hear 2 beeps. The receiver prompts you to indicate if the result is a control solution result. Select Yes. Glucose 106 mg/dL Control Solution?

No Yes Select Yes indicating this is a result from a control solution test. 16 TheraSense Continuous Glucose Monitor Users Guide 6 The receiver displays the result marked as a control solution. Compare the control solution result to the range printed on the test strip vial. Glucose 106 mg/dL Marked as control Home 7 Record the result in your log book. 8 Remove and discard the test strip. Control Solution Results Compare the control solution result to the range printed on the test strip vial. The control result should fall within the range printed on the test strip vial. IMPORTANT: If the control solution result continues to fall outside the range printed on the test strip vial, the receiver may not be working properly. If the control solution result falls outside this range, repeat the control test with a new test strip. Do not use the system to test your blood. Call your clinical trial site coordinator. Out-of-range control results may be caused by:

expired control solution expired or damaged test strip error in performing the test code number on receiver does not match code number on test strip vial receiver malfunction Using the System 17 18 TheraSense Continuous Glucose Monitor Users Guide Troubleshooting What It Means What To Do 1. Not enough blood was applied to test 1. If you have symptoms such as 2. Problem with test strip. 3. Problem with meter. 4. Very low blood glucose (less than 20 strip. mg/dL) weakness or sweating, follow your doctors advice. 2. If meter beeps, call your clinical trial coordinator for help. 3. If meter does not beep, run a control solution test. If control solution test works, repeat blood test using new test strip. If control solution test does not work, call your clinical trial coordinator. 1. Incorrect procedure (for example, a used test strip was inserted). 2. Problem with test strip. 3. Problem with meter. 4. Very high blood glucose (greater than 500 mg/dL) 1. Incorrect procedure (for example, blood was applied to test strip before test strip was inserted). 2. Problem with test strip. 3. Problem with meter. Receiver Malfunction. Faulty or damaged test strip. 1. If you have symptoms such as thirst or blurry vision, follow your doctors advice. 2. If in doubt about your symptoms, test again with a new test strip. 1. Be sure you see Apply Sample on display before you apply sample. 2. Test with control solution. If out of range or error persists, call your clinical trial coordinator. Call your clinical trial coordinator for a replacement. Try another test strip or clean the test strip port. Error Codes Error Code Er1 Er2 Er3 Er4 Er5 Error Messages Error Code Failed Sensor Cal expire soon What It Means What To Do The receiver has detected a damaged or irregular sensor. Be sure the sensor was inserted cor-

rectly, the support mount is securely in place, and the transmitter is firmly inserted. Troubleshooting 19 Error Code Cannot Find PC for Data Upload File System Error High glucose History log full Impending high Impending low Log cleared Log data corrupted Low glucose New Sensor Time Out No glucose data No Sensor Detected Perform blood glucose test See Help #25 Reconnect to Tx See Help #23 Replace the sensor See Help #24 Sensor expire soon Stabilize Conditions See Help #26 System Time Error Reestablish link Rx battery low What It Means What To Do The receiver cannot establish commu-

nications with a PC. not for clinicals The receiver has not detected a new sensor. Insert a new sensor and attach the trans-

mitter to the support mount. If you have already done so, make sure the trans-

mitter is pushed firmly into the support mount. The transmitter was not correctly installed into the support mount. The receiver will prompt you to per-

form a blood test in approximately 1, 4, and 24 hours after a new sensor is inserted. The receiver cannot detect the transmitter. Once inserted a sensor is good for 72 hours, after that you need to replace it with a new sensor. The transmitter temperature is above XF or below XF or changing rapidly. Perform a blood test using a test strip. Refer to Testing Your Blood Glucose on page 10. Be sure the receiver and transmitter are within 10 feet of one another. Remove the sensor and insert a new one. Refer to Replacing the Sensor on page 6. The receiver battery power is low. Replace the batteries. 20 TheraSense Continuous Glucose Monitor Users Guide What It Means What To Do The transmitter battery is very low. for clinicals?

The receiver has linked to an unidenti-

fied transmitter. Change the battery. Turn off any transmitters not in use. Reestablish the link. Error Code Tx battery low Tx Link Failure Upload Failure Problems Problems What To Do The support mount is not sticking to your skin. 1. Make sure your skin is clean and thoroughly dry before placing the support mount on the skin. 2. Place an over-bandage over the transmitter after connecting the transmitter to the support mount. Troubleshooting 21

email: tom@tncokenias.org EMC &Radio Approvals Thomas N. Cokenias Test & Consulting Services for Commercial, Military, International Compliance P.O. Box 1086 El Granada, CA 94018 20 March 2003 Applicant: Therasense Inc. FCC ID: QXS-TX030301 The draft manual for the referenced product will be modified to include the following statement:

FCC regulations state that changes or modifications not expressly approved by Therasense could void the user's authority to operate the equipment. The applicant has been informed of this requirement . Sincerely, THOMAS N. COKENIAS EMC Consultant/Agent for Therasense Inc. tel: 650-726-1263 fax: 650-726-1252 tom@tncokenias.org