Dexcom G4 PLATINUM Sensor Instructions

WARNINGS
• Review all indications, contraindications, warnings, precautions and detailed procedures in your user’s guide before using
your Dexcom G4 PLATINUM Sensor.
• In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values
compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision.
• In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on
CGM alerts to detect low glucose.
STERILE DEVICE
PRECAUTION: Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might
cause infection.
STORAGE AND HANDLING
• Keep the sensor in its sterile packaging until you are ready to use it.
• Do not insert sensors past the expiration date. The expiration date format is YYYY-MM-DD. Insert sensors on or before the
end of the calendar day printed on the sensor package label.
• Store at temperatures between 36° F - 77° F. Storing outside this temperature may result in reduced sensor response
to glucose and may cause inaccurate CGM readings. You may store your sensors in the refrigerator if it is within this
temperature range. Sensors should not be stored in a freezer.
• Store at humidity levels between 15% - 85% relative humidity.
• Consult your local waste management authorities for instructions to dispose of devices containing electronic waste
(transmitter and receiver) and blood contacting parts (sensor and applicator).
PRESCRIPTION DEVICE
CAUTION: U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM Systems to sale by or on order of a physician.
SYSTEM COMPONENTS
The Dexcom G4 PLATINUM Sensor includes an applicator, a sensor pod, and a sensor wire. The applicator inserts the wire
under your skin, and the wire measures glucose levels in your tissue fluid.
• Applicator – A disposable piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a
needle inside the applicator that you remove after you insert the sensor.
• Sensor Pod – The small plastic base of the sensor attached to your skin that holds the transmitter in place.
• Sensor Wire – The sensor wire is thin and flexible, and inserts just under your skin. It is attached to the sensor pod, and
is made of silver and platinum metal with polymer membranes. You discard the sensor at the end of the session.
CGM PERFORMANCE IN PEDIATRIC AND ADULT STUDIES
The CGM device performance in two independent clinical studies (one study in a pediatric population and one study in an
adult population) is summarized (Tables 1-3).
Table 1. Overall Accuracy
CGM to YSI CGM to SMBG
Number of MARD Number of MARD
Studies Matched Pairs (%) % 20/20 Matched Pairs (%) % 20/20
Pediatric Study (2 to 17 years old) 2922 17% 68% 16318 15% 76%
Adult Study (18 or more years old) 9152 13% 82% 7508 14% 81%

Table 2. Hypoglycemic Alert Rate

Pediatric Study (2 to 17 years old) Adult Study (18 or more years old)
Hypoglycemic Alert True Alert True Alert
Hypoglycemia Detection Rate Hypoglycemia Detection Rate
Levels mg/dL (mmol/L) Rate Rate
55 (3.1) 0% 0% 50% 71%
60 (3.3) 11% 25% 64% 75%
70 (3.9) 47% 50% 79% 83%
80 (4.4) 55% 55% 87% 86%
90 (5.0) 69% 62% 90% 89%
100 (5.6) 75% 62% 93% 90%

Table 3. Hyperglycemic Alert Rate

Pediatric Study (2 to 17 years old) Adult Study (18 or more years old)
Hyperglycemic Alert Level True Alert Hyperglycemia Detection True Alert Hyperglycemia Detection
mg/dL (mmol/L) Rate Rate Rate Rate
120 (6.7) 91% 98% 95% 98%
140 (7.8) 87% 99% 94% 97%
180 (10.0) 75% 99% 92% 97%
200 (11.1) 71% 98% 92% 97%
220 (12.2) 67% 97% 91% 95%
240 (13.3) 62% 96% 91% 94%
300 (16.7) 43% 93% 82% 86%
BEFORE YOU BEGIN
1. Wash your hands thoroughly and dry them.
2. Find a flat, “pinchable” area on your skin free from where rubbing can occur. See your user’s guide or owner’s booklet for
the correct insertion sites. Clean your skin with an alcohol wipe. Make sure the area is clean and completely dry before
you insert the sensor.
3. Enter your transmitter ID Number (Serial Number) into the receiver if it is not already set. See your product instructions for
how to do this.
4. Wipe the bottom of the transmitter with a damp cloth or an alcohol wipe and dry before you start a new sensor session.
5. Carefully remove the sensor from its packaging. Look closely at the sensor to make sure it is not damaged.
INSTRUCTIONS
These instructions describe how to insert the sensor. Please refer to the pictures for help.
Step 1. After you have cleaned your skin, remove the adhesive backing from the sensor pod
one half at a time, using the white tabs on the backing. Hold the sensor by the applicator
barrel and try not to touch the sticky adhesive patch.

Remove the adhesive backing

Step 2. Place the sensor horizontally, NOT vertically, on your skin. Move your fingers around the
adhesive patch to secure the tape to your skin.

Adhere the sensor on the skin

Step 3. Hold the applicator, and pull the safety lock straight out
away from the applicator, in the direction of the arrows in
the picture. Save the safety lock to help you remove the
transmitter at the end of your sensor session. The safety lock
can be used for transmitter removal but is not required.
Remove the safety lock

Step 4. Place the fingers of one hand at the edge of the white
adhesive (at the opposite side of the sensor from the “2 CLICKS”

transmitter latch). You may pinch up on your skin using this

hand. Do not pinch up in the middle section of the plastic
base. While still pinching, use your other hand to place two
fingers above the collar on the applicator barrel so they Push down the plunger – Insert the needle and sensor
are resting above the collar. Place your thumb on the white
plunger. Push the plunger down completely, making sure it is
flush against the applicator barrel. You should hear 2 clicks. You might feel pressure as you pull back the collar, but
continue to pull it back completely, as shown in the picture. This inserts the needle and sensor under your skin.
Step 5. Keep pinching up on your skin with one hand. With the other hand, place two fingers
under the collar. Keep your thumb lightly on top of the white plunger, and pull the collar “ 2 CLICKS”
back towards your thumb until you hear 2 clicks or cannot pull back anymore. This
leaves the sensor under your skin and removes the needle from your body.

Pull back the collar -

retract the needle

Step 6. Squeeze the center of the ribbed release tabs on the sides of the sensor pod to remove
the applicator barrel. Only the sensor pod will be left on your body.
• Make sure the transmitter latch is down (against your body) before squeezing the tabs
to remove the applicator barrel.
• Squeeze the center of the ribbed part of the release tabs.
• While squeezing the tabs, rock the applicator barrel forward and out away from your Release the applicator barrel
body.

To start your continuous glucose monitoring sensor session, you must snap your transmitter in the sensor pod. Refer
to your User’s Guide for detailed instructions on inserting your transmitter and beginning your sensor session.
If you need more information regarding use of the Dexcom G4 PLATINUM Sensor, contact the Dexcom Technical ®

Support team at 1.877.339.2664 or 1.858.200.0200 24 hours a day, 7 days a week.

Between The Lines

®

Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
1.858.200.0200
1.877.339.2664
www.dexcom.com
Between The Lines, Dexcom, Dexcom G4 and Dexcom G4 PLATINUM are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other
product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners.
© 2013 Dexcom, Inc. All rights reserved. LBL-011816 Rev 01 MT22022