Therasense Confidential TheraSense Continuous Glucose Monitoring System Therasense Confidential July 8, 2002
Therasense Confidential Therasense Confidential
Table of Contents Therasense Confidential Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii Safety and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Important Information About Your Continuous Glucose Monitor . . . . . . . . . . . . . . . . . . . . . . Important Health Related Information . . . . . . . . . . . . . . . . . . . . . .
Therasense Confidential Therasense Confidential ii TheraSense Continuous Glucose Monitor User’s Guide
Preface Therasense Confidential 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.
Safety and Precautions Important Information About Your Continuous Glucose Monitor Confidential • Therasense Before using the Continuous Glucose Monitor to test your glucose, read this owner’s 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.
Learning the System Therasense Confidential 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.
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. Therasense Confidential 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.
FreeStyle Test Strip Use the FreeStyle Test Strip to run a FreeStyle blood glucose test. The receiver will prompt youTherasense to “perform aConfidential 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. Apply blood to only ONE side of the test strip. Insert this end into the receiver. IMPORTANT: Do not apply blood to both sides. Gently touch one edge of the test strip to the blood sample.
Lancing Device Use the lancing device to get a blood sample when you perform a FreeStyle blood glucose test. Therasense Confidential 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.
Using the System Therasense Confidential 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.
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 Therasense Confidential 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.
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. Therasense Confidential Sensor Code Use scroll arrows to select sensor code. 101 Set Cancel Select Set. 8 When the code number has been set, the receiver prompts you to insert the new sensor.
*GRAPHIC squeezing safety tabs/pulling pin* Therasense Confidential 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.
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. Therasense Confidential 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.
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. Confidential 11 Therasense 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.
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. Therasense Confidential Glucose&Alarm Peform Blood Glucose Test Acknowledge 2 Main When the receiver detects the test strip, the strip code number appears on the display.
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 Therasense Confidential 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.
Using the Lancing Device 1 Snap off the clear cap. Therasense Confidential 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.
5 Select a depth setting. The lancing device has five depth settings—1 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 Therasense your first timeConfidential 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.
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. Therasense Confidential • Pinch the white clip that holds the lancet. The lancet will fall out.
• • 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 Therasense code number onConfidential the test strip vial. Strip Code 22 Set Cancel 3 Make sure test strip code numbers match.
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. Therasense Confidential 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.
Therasense Confidential Therasense Confidential 18 TheraSense Continuous Glucose Monitor User’s Guide
Troubleshooting Therasense Confidential Error Codes Error Code What It Means What To Do Er1 1. Not enough blood was applied to test strip. 2. Problem with test strip. 3. Problem with meter. 4. Very low blood glucose (less than 20 mg/dL) 1. If you have symptoms such as weakness or sweating, follow your doctor’s advice. 2. If meter beeps, call your clinical trial coordinator for help. 3. If meter does not beep, run a control solution test.
Error Code What It Means What To Do Cannot Find PC The receiver cannot establish commuforTherasense Data UploadConfidential nications with a PC. not for clinicals File System Error High glucose History log full Impending high Impending low Log cleared Log data corrupted Low glucose New Sensor Time Out The receiver has not detected a new sensor. Insert a new sensor and attach the transmitter to the support mount.
Error Code What It Means What To Do Tx battery low The transmitter battery is very low. Change the battery. Tx Link Failure The receiver has linked to an unidentified transmitter. Turn off any transmitters not in use. Reestablish the link. Therasense Confidential for clinicals? Upload Failure Problems Problems The support mount is not sticking to your skin. What To Do 1. Make sure your skin is clean and thoroughly dry before placing the support mount on the skin. 2.
