BLINDED MODE USERS GUIDE SUPPLEMENT

BLINDED MODE USERS GUIDE SUPPLEMENT

BLINDED MODE user s guide SUPPLEMENT WARNING: The SEVEN PLUS when set to Blinded Mode using the Data Manager Software will not provide real-time continuous glucose readings, trend graphs, low or high glucose alerts or the Low ALARM (55 mg/dl). Review all contraindications, warnings, precautions and detailed instructions in the complete SEVEN PLUS System User s Guide prior to using the System. NOTE: Three dashed lines (---) will appear in the upper right corner ( Status Box ) while in blinded mode. You will always need to refer to your blood glucose meter for any treatment-related decisions. SEVEN PLUS Transmitter SEVEN PLUS Receiver SEVEN Sensor and Applicator BEFORE YOU START 1. Wash your hands thoroughly. 2. Find a flat area on your abdomen (belly) with no scarring or rough patches of skin, and clean that area with an isopropyl alcohol swab. Allow the area to dry completely. Make sure your Receiver is fully charged and that your Transmitter is talking with your Receiver. Check this first: Look for the Antenna Symbol,, in the lower right corner of the Receiver Screen. This symbol means they are talking. 2 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 3

STARTING A SENSOR SESSION Step 1: Inserting a New Sensor These instructions describe how to insert the Sensor into your abdomen, or belly. Please refer to the pictures and complete User s Guide for further help. The Sensor must only be placed on your belly. a. After you have cleaned your skin, then remove the adhesive backing from the Sensor Pod. Hold the Sensor by the plastic Applicator and try not to touch the sticky adhesive patch. b. Place the Sensor on the area. You can place the Sensor flat facing to the left or right of your belly button. Make sure the Sensor is placed in the same direction shown in the picture to the right. You should not place the Sensor pointing in the up or down direction. c. After placing the Applicator, press firmly on and around the outside of the adhesive patch to make sure it is flat. d. Hold on to the Applicator. Then pull the Safety Lock/Transmitter Key straight out away from the Applicator, in the direction the arrows show below. The Safety Lock also serves as the Transmitter Key. Keep this piece to help you remove the Transmitter at the end of your Continuous Glucose Monitoring (CGM) session. Hold down the Pod with one hand. With your other hand, place two fingers above the collar on the barrel of the Applicator. Place your thumb on the plunger. Push the plunger down completely. This action inserts the needle and Sensor Probe under your skin. When you are pushing down on the plunger, do not pull back on the collar. 2 CLICKS CLICK h. The used Applicator can be thrown in the trash. e. To remove the needle, keep holding the Sensor Pod with one hand. With your other hand, place two fingers under the collar. Then pull the collar back towards your thumb. Stop when you hear 2 clicks or cannot pull back any more. This step pulls the needle back into the Applicator and keeps the Sensor Probe under your skin. f. Squeeze the ribbed release tabs on the sides of the Sensor Pod to remove the Applicator. When you squeeze the front release tabs, the back tabs will widen, allowing you to pull off the Applicator. After this step, only the Sensor Pod will be left on your body. Make sure the Transmitter Latch is down (against your body) to remove the Applicator. To start your CGM session, you must snap your Transmitter in the Sensor Pod and tell the Receiver of a new Sensor insertion. 4 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 5

Step 2: Attach Transmitter a. Clean and dry the bottom of the Transmitter with a damp cloth or alcohol wipe before every use. b. Place the Transmitter into the Sensor Pod with the flat side facing down. c. Pull the Transmitter Latch over the Transmitter to snap it into place. The Transmitter should lie flat in the Sensor Pod. You should hear 2 clicks. d. Press the OK button to confirm the start of a new Sensor, and you will see this screen to the right: e. Your Receiver will return to the 3-Hour Trend Graph. The 2-hour Start-Up period has begun. The Status Box will display a partially shaded gray box that will count down during the 2-hour Start-Up period, and the Trend Screen will stay blank. f. The blank (not gray) Trend Screen confirms you are in Blinded Mode and in the Start-up Period. e. Press any button on the Receiver to check for the Antenna Symbol at the lower right corner of the Receiver. If the Antenna Symbol does not appear refer to your complete User s Guide. d. Remove the Transmitter Latch by holding the end of the latch and quickly twisting off the latch away from the body. Step 4: Start-Up Calibration Two hours after you start the Sensor, your Receiver will tell you that you need to calibrate your Sensor. The Receiver will show you the screen to the right. The Receiver will also vibrate and beep to notify you, but this depends on your Other Alert Settings. Press the C Button to clear the prompt. A Blood Drop Symbol will appear in the Status Box. Take 2 fingerstick readings. Step 3: Starting a New Session a. Press any button to turn on the Receiver. b. Press the OK button to reach the Menu Screens. c. Use the Up p and Down q Arrows to scroll until you highlight Start Sensor. 6 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 7

OPENCHOICE CALIBRATION a. Press the OK button to reach the Menu screens. b. Use the Up p and Down q Arrows to scroll until you highlight Enter BG. c. Press the OK button to select this option. You will see a number in mg/dl units. NOTE: The default setting is 120 mg/dl. d. To enter the fingerstick reading taken from your meter, press the Up p and Down q Arrows until you arrive at the correct reading. Enter a reading between 40-400 mg/dl taken within the past 5 minutes. Press the OK button to enter the reading. i) Press the OK button again to confirm the reading is correct. ii) If the fingerstick reading displayed is incorrect, press the C button and enter in the correct reading for calibration. iii) If you do not press any button, the Receiver will time out and no fingerstick reading information will be entered. e. The Glucose Readings Processing screen will appear, followed by the Results Added screen. f. For Start-Up Calibration, repeat these steps for the second fingerstick reading. g. Your continuous glucose readings will be updated every 5 minutes, but you will not see them displayed in the Status Box. NOTE: OpenChoice calibration BG readings must be entered into the Receiver within 5 minutes of being taken. If greater than 5 minutes has passed, take new fingerstick readings. AUTO UPLOAD CALIBRATION a. Make sure the OneTouch Ultra Meter display is off (blank screen) before connecting. To turn the display off, press the M button once. b. Use the Connection Cable to first plug the cable into the connection port at the bottom of the OneTouch Ultra Meter. c. Then connect the wide end of the cable into the Receiver. Make sure the raised Push button on the cable is facing down. After a few seconds PC will appear on the OneTouch screen. d. Three Receiver screens will appear in this order: Connection Screen g Processing Screen g Results Screen e. Once you see the Results Screen, then press the Push button on the Connection Cable to disconnect the cable from the OneTouch Ultra Meter and the Receiver (the order that you disconnect the cable does not matter). 8 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 9

CGM BLINDED MODE Once calibrated, the SEVEN PLUS will record readings but will not display glucose readings, trend graphs, glucose Alerts or ALARM. Glucose readings can be viewed later on the Data Manager 2 Software. CALIBRATION UPDATE You must update the Seven System calibration every 12 hours. The Receiver will remind you to do this by displaying the following screen if you haven t recently calibrated. When the Single Blood Drop Prompt appears, clear the prompt, take a fingerstick using your meter, and enter the meter reading into the Receiver. After you enter a BG reading for calibration the Receiver may prompt you again by displaying the Single Blood Drop Prompt Screen (with vibrate/beep, depending on your settings). This means the last BG reading could not be used for calibration. You will need to enter one more fingerstick to recalibrate. CALIBRATION ALERT SCREENS During calibration you may see the following screens: 1. New Meter Screen (Auto Upload Only): Indicates you have connected a new One Touch Ultra meter to the Receiver. This meter has a different serial number from the meter that was last connected to the Receiver. Press the OK button. 2. Connection Failure (Auto Upload Only): Indicates the OneTouch meter and the Receiver are not connected properly. If you see this screen the meter readings will not be transferred successfully. Clear the alert by pressing any button, and disconnect the Connection Cable from the Receiver. Make sure the meter is off, then reconnect the Cable to the Receiver (the cable must be plugged into the meter first, as in Auto Upload Calibration). 3. Double Blood Drop Prompt: Appears about 2 hours after you insert a new Sensor and tells you that you need to take 2 fingerstick readings on your meter. Clear the prompt by pressing any button on the Receiver, and enter 2 more fingersticks as prompted. 4. Shaded-Out Blood Drop Prompt: This tells you that only 1 fingerstick reading has been successfully entered. You need to take and enter at least 1 more fingerstick for calibration. Clear the prompt by pressing any button, and enter 1 more fingerstick as prompted. GLUCOSE RECORD GAPS (see MISSING GLUCOSE READINGS in the User s Guide) If the System does not display --- in the Status Box it is not recording glucose readings. This may be for the following reasons: 1. Awaiting Fingerstick Reading/Blood Drop in Status Box: Indicates that you need at least 1 more fingerstick to calibrate. This symbol will appear when it is time for the Start-Up Calibration or If you receive this screen during Auto Upload calibration, your will have to re-take any fingersticks needed for calibration and then connect the 2 devices again for Calibration Update. Re-Calibration. 10 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 11

2. Unknown Sensor Glucose Readings/??? In Status Box: Sometimes the SEVEN PLUS may tell you it cannot provide a glucose reading. Check the placement of your Sensor to make sure it is sticking well to your skin, and nothing is rubbing on the Sensor. The system will display --- when it is recording glucose readings again. 3. Out of Range/Antenna in Status Box: When you see the Out of Range Symbol in the Status Box instead of a glucose reading, this means the Receiver has missed the last glucose reading sent by the Transmitter. Move the Receiver closer to make sure the Receiver and Transmitter are within 5 feet of each other. If you have moved the Receiver closer and waited 5-10 minutes, the Out of Range Symbol in the Status box should go away. The Antenna Symbol should reappear in the lower right corner. If you are still having trouble, contact DexCom Technical Support at 1-888-SEVENGO (738-3646). 4. Sensor Error 0/ Err0 in Status Box: This screen means your Sensor cannot calibrate. Enter at least 1 more calibration fingerstick reading in the next 10-15 minutes. If Err0 remains in the Status Box after you enter 2 more fingersticks into the Receiver, you may need to replace the Sensor. 5. Sensor Error 1/ Err1 in Status Box: This screen tells you that the Sensor is not calibrating correctly. If you see this screen, wait approximately one hour. Then you may enter at least 1 more calibration fingerstick reading. If Err1 remains in the Status Box after you enter 2 more fingersticks in the Receiver, you may need to replace the Sensor. ADDITIONAL ALERTS AND FEATURES Alerts Even though High and Low Glucose Alerts and the Low Glucose ALARM (55mg/dL) are disabled in blinded mode, Other Alerts will remain active (e.g. battery, calibration update, out of range). Event Markers You will still be able to enter event information (insulin, carbs, exercise, health, etc.) while in Blinded Mode. Please refer to your complete SEVEN PLUS User s Guide for information on how to use and set these additional Alerts and use these features. SENSOR EXPIRATION NOTIFICATION The Receiver displays screens that notify you how long you have until the end of your CGM Session. You will be notified at 6 hours, 2 hours, 30 minutes, and at the end of your session. Once the session completely counts down, press the C button to clear the prompt, and remove the Sensor. Glucose readings will stop recording and the Status Box will be completely gray. 12 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 13

MANUALLY ENDING A SESSION To intentionally end a Seven Sensor session early: 1. Select the Stop Sensor Menu. ERROR CODE The Error Code indicates the Receiver is not working properly. Note the Error Code displayed, and contact DexCom Technical Support at 1-888-SEVENGO (738-3646). 2. Press the OK button to indicate that you want to stop the Sensor. 3. Press the OK button again to Stop the Sensor, or press the C button if you do not want to stop. 4. Your Receiver will no longer record glucose readings and you can remove your Sensor. A gray box will appear in the Status Box. EARLY SENSOR SHUTOFF You may see the Failed Sensor Screen during your continuous glucose monitoring session. If the screen to the right appears, the Transmitter has notified the Receiver that the Sensor is no longer working. A gray box will appear in the Status Box. Remove the Sensor and insert a new one. The Failed Sensor Screen can appear during the Start-Up period or at any time after calibration. REMOVING THE SENSOR/ TRANSMITTER Remove the Sensor Pod by gently peeling up the adhesive patch from the skin and pulling out the Sensor Probe. Make sure the Transmitter is still inside the Sensor Pod. Once the Sensor is off your body, you will need to remove the Transmitter from the Sensor Pod. Follow either of the two methods below to remove the Transmitter. Method 1 requires you to use the Safety Lock/Transmitter Key once removed from the Applicator. Method 2 allows you to remove the Transmitter with your fingers. After you remove the Transmitter, store it in a cool, dry place until your next glucose monitoring session. Method 1: 1. Place the Sensor Pod on a flat surface. Hold the rounded edge of the Transmitter Key. Make sure the jagged edge of the Transmitter Key is facing down away from the removal arrow as shown to the right: 14 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 15

2. Insert the jagged edges so that they hug the Transmitter wings in the Sensor Pod. Press the Transmitter Key down until you cannot press down anymore, and the Transmitter wings will pop out of the Sensor Pod. Transmitter Key (from Applicator) Sensor Pad with Transmitter snapped in Method 2: Use your pointer finger on each hand and spread out the tabs on the back end of the Sensor Pod (the end closest to the Transmitter wings), and the Transmitter wings will pop out of the Sensor Pod. UPLOADING RECEIVER READINGS AFTER YOUR SESSION ENDS Use the Data Manager Software to upload Receiver readings to your personal computer. The Data Manager Software displays the glucose readings and calibration blood glucose readings to help analyze trends and patterns in glucose levels. The Data Manager Software can also be used to blind and unblind the Receiver. 16 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode SEVEN PLUS Users Guide Supplement 17

BLINDED MODE user s guide SUPPLEMENT

DexCom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Technical Support 1-888-SEVENGO (738-3646) www.dexcom.com LBL 010116 Rev 02 MT 20485 Rev 01 20 SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode