Dexcom 9402 Glucose Monitoring System User Manual

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Date Submitted	2006-08-29 00:00:00
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DexCom™ STS™-7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Transmitter model number 9400-02
www.DexCom.com
STS
TM
-7 Sensor & STS
TM
T2 Transmitter
Technical Support at
1-877-(DEXCOM4) 339-2664.
STSTM -7 Sensor & STSTM Applicator
STSTM R2 Receiver
Starting Continuous Glucose Monitoring
STEP 1 INSERTING A NEW STS™ -7 Sensor
warning
Treatment decisions should not be
based solely on results from the
DexCom STS-7 System. You must
confirm with a blood glucose meter
before making therapeutic adjustments.
Safety Lock
Push Plunger
Pull Collar
Press Tabs
Choose a site on your abdomen (belly) to put 1. Remove the adhesive backing from the STS
Sensor Pod and place the STS-7 Sensor on
the STS-7 Sensor that is a flat area and where
the selected site. Pull the safety lock out
you don’t have any scarring or rough patches
from the STS Applicator (pull near the arof skin and clean the site with an alcohol
row).
swab.
2. Place 2 fingers under the collar, with your
thumb on the plunger, and push the plunger
down completely.
*MAKE SURE YOUR STS R2
RECEIVER IS CHARGED BEFORE
YOU BEGIN.
STS-7 Transmitter Installed
Remove STS Transmitter Latch
STS Transmitter Latch
1. Place the STS T2 Transmitter into the
4. Press any buttons on the STS R2 Receiver
STS Sensor Pod with the flat side facing
to check for the Antenna Icon (Y) at the
down.
bottom right hand corner of the screen. If
2. Pull the STS Transmitter Latch up onto
the Antenna
the STS T2 Transmitter to snap it into
Icon appears in
place.
the upper right
3. Remove the STS Transmitter Latch by
hand corner of
holding the end of the latch and quickly
the screen, refer
twisting off the latch away from your
to your User’s
body.
Guide
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.
1. 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
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):
2. Use the Up p and Down q Arrows to
enter the STS License Code found in
your shipment and press the OK button to
confirm the STS License Code.
Press the OK button.
The antenna (Y)
should appear here
Step 4 how to start YOUR CONTINUOUS GLUCOSE MONITORING SESSION
Step 5 Calibrating your sts™-7 system
1. 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 Insertion Screen (If you have already entered
a STS License Code).
1. Dual Blood Drop Prompt: After 2 hours
the STS R2 Receiver will vibrate and display the Dual Blood Drop Prompt to alert
you to calibrate the STS-7 Sensor. Press
the C Button to clear the prompt.
2. Press the OK button to confirm Sensor
Insertion and you will see the following
Confirmation Screen:.
1. Dual Blood Drop Prompt
3. Your Start-Up Period begins once you
press the OK button.
Confidential
STS Sensor Pod Remains Adhered
Step 3 Entering a STS license code
Step 2 Installing Your STS™ T2 Transmitter
Install STS-7 Transmitter in
STS Sensor Pod
Remove STS Applicator
Collar Completely Back
Draft Under FDA Review
2. Meter Connection Screen: After you take 2
fingersticks using your blood glucose meter, upload the values to your STS R2 Receiver. Upload the meter values to the STS
R2 Receiver by plugging the connection
cable into the meter first (the meter must
be off) and then into the STS R2 Receiver.
The Meter Connection Screen (“PC”) will
appear on your blood glucose meter.
2. Meter Connection Screen
Receiver Calibration Alert Screens
Step 5 Calibrating your sts™-7 system (continued)
During Calibration you may see the following screens:
3. Receiver Connection Screen: The Receiver 4. 1-Hour Trend Screen: Once the upload is
Connection Screen will appear on the STS
complete the 1-Hour Trend Screen will
R2 Receiver while the BG values are being
appear. Disconnect the cable from the
transferred from the meter to the STS R2
meter and STS R2 Receiver. A glucose
Receiver.
value should appear in about 15 minutes
and glucose values will be updated every 5
minutes.
1. New Meter Screen
2. Connection Failure Screen
1. New Meter Screen: Indicates that you
have connected a new meter to the STS R2
Receiver. Press OK. You must re-take the
fingersticks and connect the meter to the
STS R2 Receiver.
3. Receiver Connection Screen
2. Connection Failure Screen: Indicates the
meter and STS R2 Receiver are not connected properly. If you see this screen
the meter values will not be transferred
successfully. Clear the alert by pressing
4. 1-Hour Trend Screen
3. Shaded-Out Blood Drop Prompt
any 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 first).
3. Shaded-Out Blood Drop Prompt: Notifies
you that 1 more fingerstick is needed for
calibration. Take another fingerstick and
upload it to your STS R2 Receiver.
Continuous Monitoring
Viewing your continuous Glucose Information
STS™ R2 Receiver Alert Screens
You can view glucose trends and patterns
using the 1-hour, 3-hour, and 9-hour Glucose
Trends Screens. (See screens below).
The device may vibrate and/or beep and display one of the following screens during use:
Always take a fingerstick before you make any
treatment decisions.
Press
Glucose Value
Press
3-Hour
Glucose Trend Screen
1-Hour
Glucose Trend Screen
2. Low Glucose Alert: The STS R2 Receiver
will vibrate/beep if your current STS-7 Sensor glucose value is below the Low Alert
setting. Press any button on the STS R2
Receiver to acknowledge the alert; if you
1. Calibration Update Screen: If the Calibration
do not the STS R2 Receiver will continue
Update Screen appears you should clear the
to alert you for the next 10 minutes. The
prompt, take a fingerstick using your meter,
Factory Low Alert setting is 80 mg/dL. You
and upload the meter value to the STS R2
should work with your diabetes management
Receiver.
team to determine the best alert setting for
you. (Take a fingerstick before you make
any treatment decisions.)
1. Calibration Update Screen
9-Hour
Glucose Trend Screen
2. Low Glucose Alert
STS™ R2 Receiver Glucose Data Gaps
3. High Glucose Alert: The STS R2 Receiver
4. Low Glucose Alarm: In addition to your
will beep/vibrate if your current STS-7 Senpersonal glucose alert settings, your STS R2
sor glucose value is above the High Alert
Receiver will beep/vibrate if your glucose
setting. Press any button on the STS R2
falls below 55 mg/dL. Press any button to
Receiver to acknowledge the alert; if you
acknowledge the alert if you do not the STS
do not the STS R2 Receiver will continue to
R2 Receiver will continue to alert you every
alert you for the next 10 minutes. The Fac5 minutes.
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 fingerstick before you make
any treatment decisions.)
2. Your STS-7 Sensor is sending the STS
If the STS-7 System is not displaying
R2 Receiver “noisy” glucose readings
glucose values it could be for the following
that the STS R2 Receiver will not display.
reasons:
1. 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
Once the “noise” stops, your STS R2 ReR2 Receiver and STS T2 Transmitter are
ceiver will display glucose values again.
within 5 ft. of each other.
3. If you upload a fingerstick to update
calibration you may see the Calibration
Update Screen due to the fingerstick not
closely matching your STS-7 System
glucose readings. Take a fingerstick and
upload it to the STS R2 Receiver to update
calibration.
4. Low Glucose Alarm
3. High Glucose Alert
Ending Your Continuous Glucose Monitoring Session
STS™ Receiver
Early Shut-Off SCREENS
You may see the STS Sensor Removal
Screen during your continuous glucose monitoring session. If the screen below appears
your the STS-7 Sensor has notified the STS
R2 Receiver that STS-7 Sensor is no longer
good. Remove the STS-7 Sensor and insert a
new one.
Error code
STS™-7 Sensor Expiration Notification
The error code indicates the STS R2 Receiver is not functioning properly. Note the
Error code, use your meter to check your
blood glucose readings, and contact Dexcom Technical Support at 1-877-DEXCOM4
(339-2664) immediately. Your Continuous
Glucose Monitoring Session is finished and
you should remove the STS-7 Sensor.
The STS R2 Receiver will display screens
that notify you how long you have until the
end of your Continuous Glucose Monitoring Session. You will be notified at 6 hours,
2 hours, 30 minutes before your session
ends, and when your session is finished.
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).
6 hour STS Sensor Expiration Notification
30 minute STS Sensor Expiration Notification
2 hour STS Sensor Expiration Notification
0 hour STS Sensor Expiration Notification
STS Sensor Removal
Confidential
Draft Under FDA Review
© DexCom 2006 All rights reserved
FCC Requirements
The DexCom STS™ Transmitter covered by this User’s Guide has been certified
under FCC ID:
PH29402
The 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.
The 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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