Dexcom 9402 Glucose Monitoring System User Manual

Dexcom, Inc. Glucose Monitoring System Users Manual

Users Manual

STSTM -7 Sensor & STSTM ApplicatorSTSTM -7 Sensor & STSTM T2 TransmitterSTSTM R2 Receiverwww.DexCom.com*MAKE SURE YOUR STS R2 RECEIVER IS CHARGED BEFORE YOU BEGIN.Choose a site on your abdomen (belly) to put the STS-7 Sensor that is a at area and where you don’t have any scarring or rough patches of skin and clean the site with an alcohol swab. 1. Remove the adhesive backing from the STS Sensor Pod and place the STS-7 Sensor on the selected site. Pull the safety lock out from the STS Applicator (pull near the ar-row). 2. Place 2 ngers under the collar, with your thumb on the plunger, and push the plunger down completely.3. Pull the collar back completely until you hear a click.4. Press the tabs on the sides of the STS-7 Sensor and pull off the STS Applicator.5. The STS Sensor Pod remains adhered to the skin after the STS Applicator is removed.Install STS-7 Transmitter in  STS Sensor PodSTS-7 Transmitter InstalledSTS Transmitter LatchRemove STS Transmitter Latch23Place the STS T2 Transmitter into the STS Sensor Pod with the at side facing down. Pull the STS Transmitter Latch up onto the STS T2 Transmitter to snap it into place.  Remove the STS Transmitter Latch by holding the end of the latch and quickly twisting off the latch away from your body.1.2.3.Press any buttons on the STS R2 Receiver to check for the Antenna Icon (Y) at the bottom right hand corner of the screen. If 4.1. Dual Blood Drop Prompt: After 2 hours the STS R2 Receiver will vibrate and dis-play the Dual Blood Drop Prompt to alert you to calibrate the STS-7 Sensor. Press the C Button to clear the prompt.the Antenna Icon appears in the upper right hand corner of the screen, refer to your User’s GuidePress the Down q Arrow 3 times until you come to the 9-hour Glucose Trend Screen. Then hold the Down q Arrow for at least 7 seconds until you see the STS License Code Screen (If you have already inserted a STS-7 Sensor, press the Down q Arrow 1 more time to get to the STS License Code Screen):1.Press the OK button.The antenna (Y) should appear hereUse the Up p and Down q Arrows to enter the STS License Code found in your shipment and press the OK button to conrm the STS License Code.2.2. Meter Connection Screen: After you take 2 ngersticks using your blood glucose me-ter, upload the values to your STS R2 Re-ceiver. Upload the meter values to the STS R2 Receiver by plugging the connection cable into the meter rst (the meter must be off) and then into the STS R2 Receiver. The Meter Connection Screen (“PC”) will appear on your blood glucose meter.1. Dual Blood Drop Prompt2. Meter Connection ScreenM C1. Press the Down q Arrow 3 times until you come to the 9-hour Glucose Trend Screen. Then hold the Down q Arrow for at least 7 seconds until you see the STS Sensor In-sertion Screen (If you have already entered a STS License Code). 2. Press the OK button to conrm Sensor Insertion and you will see the following Conrmation Screen:.3. Your Start-Up Period begins once you press the OK button. CondentialTransmitter model number 9400-02Draft Under FDA ReviewSafety Lock Push Plunger Pull Collar Collar Completely Back Remove STS Applicator23 Press Tabs STS Sensor Pod Remains Adhered
The error code indicates the STS R2 Re-ceiver is not functioning properly. Note the Error code, use your meter to check your blood glucose readings, and contact Dex-com Technical Support at 1-877-DEXCOM4 (339-2664) immediately. Your Continuous Glucose Monitoring Session is nished and you should remove the STS-7 Sensor.© DexCom 2006 All rights reserved     ™The STS R2 Receiver will display screens that notify you how long you have until the end of your Continuous Glucose Monitor-ing Session. You will be notied at 6 hours, 2 hours, 30 minutes before your session ends, and when your session is nished.                                30 minute STS Sensor Expiration Notication0 hour STS Sensor Expiration Notication2 hour STS Sensor Expiration Notication6 hour STS Sensor Expiration Notication3. Receiver Connection Screen3. Receiver Connection Screen: The Receiver Connection Screen will appear on the STS R2 Receiver while the BG values are being transferred from the meter to the STS R2 Receiver.4. 1-Hour Trend Screen4. 1-Hour Trend Screen: Once the upload is complete the 1-Hour Trend Screen will appear. Disconnect the cable from the meter and STS R2 Receiver. A glucose value should appear in about 15 minutes and glucose values will be updated every 5 minutes. 3. Shaded-Out Blood Drop PromptNew Meter Screen: Indicates that you have connected a new meter to the STS R2 Receiver. Press OK. You must re-take the ngersticks and connect the meter to the STS R2 Receiver.Connection Failure Screen: Indicates the meter and STS R2 Receiver are not con-nected properly. If you see this screen the meter values will not be transferred successfully. Clear the alert by pressing 1.2.1. New Meter Screen 2. Connection Failure Screenany button and disconnect the cable from the STS Receiver. Make sure the meter is off and reconnect the cable to the STS R2 Receiver (the cable must be plugged into the meter rst).Shaded-Out Blood Drop Prompt: Noties you that 1 more ngerstick is needed for calibration. Take another ngerstick and upload it to your STS R2 Receiver.3.Press C button to clear the alert and the STS R2 Receiver will notify the STS-7 Sensor that the Continuous Glucose Monitoring Session is complete (00:00:00).You may see the STS Sensor Removal Screen during your continuous glucose moni-toring session. If the screen below appears your the STS-7 Sensor has notied the STS R2 Receiver that STS-7 Sensor is no longer good. Remove the STS-7 Sensor and insert a new one.™STS Sensor RemovalIf the STS-7 System is not displaying glucose values it could be for the following reasons:™Your STS™ T2 Transmitter and STS R2 Receiver are not communicating. The Antenna Icon will appear in the upper right hand corner of the screen (there is no Antenna Icon (Y) in the bottom right hand corner of the screen). Make sure your STS R2 Receiver and STS T2 Transmitter are within 5 ft. of each other.1.If you upload a ngerstick to update calibration you may see the Calibration Update Screen due to the ngerstick not closely matching your STS-7 System glucose readings. Take a ngerstick and upload it to the STS R2 Receiver to update calibration.3.Your STS-7 Sensor is sending the STS R2 Receiver “noisy” glucose readings that the STS R2 Receiver will not display.      2.Once the “noise” stops, your STS R2 Re-ceiver will display glucose values again. ™The device may vibrate and/or beep and dis-play one of the following screens during use: Always take a ngerstick before you make any treatment decisions.Calibration Update Screen: If the Calibration Update Screen appears you should clear the prompt, take a ngerstick using your meter, and upload the meter value to the STS R2 Receiver.1.1. Calibration Update ScreenLow Glucose Alert: The STS R2 Receiver will vibrate/beep if your current STS-7 Sen-sor glucose value is below the Low Alert setting. Press any button on the STS R2 Receiver to acknowledge the alert; if you do not the STS R2 Receiver will continue to alert you for the next 10 minutes. The Factory Low Alert setting is 80 mg/dL. You should work with your diabetes management team to determine the best alert setting for you. (Take a ngerstick before you make any treatment decisions.)2.2. Low Glucose AlertHigh Glucose Alert: The STS R2 Receiver will beep/vibrate if your current STS-7 Sen-sor glucose value is above the High Alert setting.    Press any button on the STS R2 Receiver to acknowledge the alert; if you do not the STS R2 Receiver will continue to alert you for the next 10 minutes. The Fac-tory High Alert setting is 200 mg/dL. You should work with your diabetes management team to determine the best alert setting for you. (Take a ngerstick before you make any treatment decisions.)3.3. High Glucose AlertLow Glucose Alarm: In addition to your personal glucose alert settings, your STS R2 Receiver will beep/vibrate if your glucose falls below 55 mg/dL. Press any button to acknowledge the alert if you do not the STS R2 Receiver will continue to alert you every 5 minutes.4.4. Low Glucose AlarmYou can view glucose trends and patterns using the 1-hour, 3-hour, and 9-hour Glucose Trends Screens. (See screens below).Glucose ValueGlucose Trend ScreenGlucose Trend ScreenPresspqGlucose Trend ScreenPresspqCondential Draft Under FDA Review
 FCC RequiRementse DexCom STS™ Transmitter covered by this User’s Guide has been certified under FCC ID: PH29402e STS T2 Transmitter is authorized by rule under the Medical Implant Communications Service (part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e. transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such aids, including interference that may cause undesired operation. e STS T2 Transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service. Analog and digital voice communications are prohibited. Although the STS T2 Transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from the STS T2 Transmitter will be free from interference.

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