Dexcom Seven User manual

user’s guide

G-2-Co

User’s Guide

IMPORTANT CONTACTS AND NUMBERS:

DexCom Technical Support: 1-877-DEXCOM4 (339-2664)

DexCom Website: www.DexCom.com

Your Transmitter Serial Number:

Your Transmitter Expiration Date:

Your Receiver ID:

Your Healthcare Professional:

Nearest Hospital:

Other Notes:

and Take Control — Live Uninterrupted™ are trademarks of DexCom, Inc. All other trademarks and

copyrights are the property of their respective owners.

C

M

Y

CM

MY

CY

CMY

K

LBL-010025_Artwork_for_MT20094_6-24User's_Guide,_Seven_Manual_BG_Rev04 page 4.pdf 1 6/24/10 10:15 AM

Seven

™

System User’s Guide | 1

MC

Seven

™

Sensor and Applicator

Seven

™

Receiver

Blood Glucose Meter

Seven

™

Transmitter

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

2 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

KIT CONTENTS

*

:

Seven Transmitter•

Seven Receiver•

DexCom™ DM2 Accessory Software•

Receiver Carry Case/Belt Clip•

Receiver Charging Cable•

User’s Guide•

Package Insert•

Quick Start Guide•

Transmitter Card•

CD-ROM with electronic versions of user manuals•

* Sensors and optional Connection Cable for OneTouch® Ultra® Meter are sold

separately

Seven

™

System User’s Guide | 3

SEVEN SYSTEM CHECKLIST/SUMMARY

e following checklists summarize the basic information you should remember for

your continuous glucose monitoring sessions. You may ﬁnd it helpful to check oﬀ each

box during your ﬁrst Seven System glucose monitoring session. Refer to the Quick Start

Guide and this User’s Guide for more detailed information.

EQUIPMENT

Required Equipment for Every Session:

Seven Sensor (single use, up to 7 days)

Seven Receiver (reusable)

Seven Transmitter (reusable until battery expires)

Blood Glucose Meter and test strips (any FDA cleared meter can be used for

manual calibration)

Receiver Charging Cable

Optional Equipment:

Connection Cable (for Auto Upload of Lifescan® OneTouch® Ultra® meter to

Receiver)

DM2 Accessory Software (and included USB cable)

Receiver Carrying Case

REMEMBER

You can get your Sensor/Transmitter wet.

Do not get your Receiver wet.

Set your Receiver to the correct time. Your Receiver and meter times must

match for calibration.

If you are using Auto Upload for calibration, do not change the time on your

Meter. “Registering” the Receiver and meter will synchronize the meter to the

Receiver’s time.

If you see an Error Code, write down the number and call Technical Support at

1-877-DEXCOM4 (339-2664).

4 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

CONTINUOUS GLUCOSE MONITORING SESSION

Place the Receiver and Transmitter next to each other for at least 5 minutes to

make sure they are communicating (Y symbol in the lower right corner).

If you decide to use Auto Upload with a Lifescan OneTouch Ultra meter,

“Register” the meter to your Receiver before starting.

Insert Sensor (using Applicator).

Attach Transmitter.

Tell the Receiver you inserted a Sensor.

Keep the Receiver within 5 feet of your Sensor/Transmitter.

Wait 2 Hours.

At the Double Blood Drop Prompt, upload 2 ﬁngersticks (Auto Upload or

Manual Entry).

Upload another ﬁngerstick every 12 hours or when prompted by the Receiver.

View Trend Screens by Pressing the Up and Down Arrows.

Look at the Status Box (upper right corner) for glucose readings or to

troubleshoot.

Recharge your Receiver approximately every 5 days.

Watch for the Low Battery Alert.

•

It takes 3 hours to completely charge when the battery is drained.•

When you hear an Alert, press any button to stop the notiﬁcation (vibrating/

beeping).

You can change the Alert settings from these factory settings:

•

80mg/dL Low »

200mg/dL High »

When you hear a Low Glucose ALARM, press any button to stop the notiﬁcation

(vibrating/beeping).

e Receiver will automatically notify you again in 30 minutes if your glucose

•

readings are still at or below 55mg/dL.

You cannot change the ALARM setting of 55mg/dL.

•

Remove your Sensor when your session ends.

Seven

™

System User’s Guide | 5

Remove the Transmitter from the Sensor Pod and save the Transmitter for the

next use.

Charge the Receiver at least once a month (even when not in use) to prevent the

back-up battery from draining.

Read this entire guide before using your Seven Continuous Glucose Monitoring System.

If you do not understand something or have any questions, please ask your Diabetes

Management Team or another health care provider. Contraindications, warnings,

precautions, and other important safety information can be found in the “Important

Safety Information” section, and in boxes throughout your Seven System User’s

Guide. e Troubleshooting section (Section 8) contains important information on

troubleshooting your Seven System.

6 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

BEFORE YOU START

Wash your hands thoroughly.•

Fully charge your Seven Receiver to avoid running out of battery charge during use.•

Check that the date and time are correct on your Receiver.•

Place the Seven Transmitter next to the Receiver for at least 5 minutes to make sure •

the two devices are communicating (“talking”) with each other. ere will be an

Antenna Symbol in the bottom right hand corner of the Trend Screens.

Check the expiration date on the Sensor before you start a new continuous glucose

•

monitoring session to make sure you are not using an expired Sensor. “05/09”

indicates that the Sensor must be inserted before the last day in May in the year

2009.

Quality check (“QC”) your BG Meter per the manufacturer’s instructions to make

•

sure it is providing you the best readings for calibration.

Clean the bottom of your Transmitter with a damp cloth or alcohol wipe and dry

•

before each use.

If you are using Auto Upload from a Lifescan® OneTouch® Ultra® meter, you must

•

connect (or “register”) your meter to your Receiver before starting a new continuous

glucose monitoring session.

Make sure your meter and Receiver date and time are the same.

•

Seven

™

System User’s Guide | 7

TABLE OF CONTENTS

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM 1

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS 2

SEVEN SYSTEM CHECKLIST/SUMMARY 3

BEFORE YOU START 6

INTRODUCTION 11

INDICATIONS FOR USE 12

IMPORTANT SAFETY INFORMATION 13

Section 1

OVERVIEW OF THE SEVEN SYSTEM 15

1.1 GLOSSARY 16

1.2 SEVEN SENSOR OVERVIEW 19

1.3 SEVEN TRANSMITTER OVERVIEW 20

1.4 SEVEN RECEIVER OVERVIEW 21

1.4.1 Seven Receiver Screen Symbols 23

1.4.2 Viewing e Seven Receiver Screens 26

1.4.3 e Seven Receiver Display 29

Section 2

STARTING YOUR SEVEN

CONTINUOUS GLUCOSE MONITORING SESSION 30

2.1 SEVEN TRANSMITTER AND SEVEN RECEIVER COMMUNICATION 31

2.2 USING A NEW SEVEN SENSOR 33

2.2.1 Removing e Sensor From Its Packaging 34

2.2.2 Choosing A Insertion Site 35

2.2.3 Placing e Sensor 36

2.2.4 Sensor Insertion 37

8 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

2.3 SEVEN TRANSMITTER ATTACHMENT 39

2.4 STARTING A NEW SEVEN CONTINUOUS GLUCOSE MONITORING SESSION 41

2.5 SEVEN SENSOR STARTUP PERIOD 43

2.5.1 Problems During e Start-Up Period 44

Section 3

SEVEN SYSTEM CALIBRATION 45

3.1 THE SEVEN SYSTEM CALIBRATION PROMPT

THE END OF THE START UP PERIOD 47

3.2 AUTO UPLOAD CALIBRATION 49

3.2.1 OneTouch Ultra Meter - Seven Receiver Registration 49

3.2.2 Auto Upload Using the Connection Cable 51

3.3 MANUAL ENTRY CALIBRATION 53

3.3.1 Entering BG Readings To Your Receiver

For Calibration Using Manual Entry 53

3.4 CALIBRATION TROUBLESHOOTING 55

Section 4

VIEWING YOUR CONTINUOUS GLUCOSE INFORMATION 60

4.1 GLUCOSE TREND SCREENS 62

4.1.1 Glucose Trend Screen Information 63

4.2 HIGH AND LOW GLUCOSE ALERTS 64

4.3 LOW GLUCOSE ALARM ≤55 MG/DL 66

4.4 THE SEVEN SYSTEM AND WATER 67

4.5 SENSOR RECALIBRATION/12HOUR UPDATE 68

4.6 MISSING SEVEN SYSTEM GLUCOSE INFORMATION GLUCOSE DATA GAPS 69

4.6.1 Missing Glucose Readings – No “Y” 70

4.6.2 Missing Glucose Readings – “???” 71

4.6.3 Missing Glucose Readings – “

”

After Calibration Update/Recalibration 72

4.7 SEVEN SYSTEM EARLY SHUTOFF SCREENS 74

4.7.1 Early Shut-Oﬀ – Sensor Failure 74

Seven

™

System User’s Guide | 9

Section 5

ENDING YOUR SEVEN SYSTEM

CONTINUOUS GLUCOSE MONITORING SESSION 76

5.1 CONTINUOUS GLUCOSE MONITORING PERIOD END 77

5.1.1 Automatic Sensor Expiration Notiﬁcation 77

5.1.2 Manual Sensor Shut-Oﬀ 79

5.2 TRANSMITTER REMOVAL 81

Section 6

SEVEN RECEIVER BATTERY 83

6.1 LOW BATTERY ALERT 84

6.2 CHARGING THE SEVEN RECEIVER BATTERY 85

Section 7

SEVEN RECEIVER SETTINGS 86

7.1 GLUCOSE ALERT SETTINGS 87

7.1.1 High And Low Glucose Alert Levels (mg/dL Units) 87

7.2 SETTING THE TIME 89

7.2.1 Receiver Time Screen 89

7.2.2 Setting the Time (AM/PM Mode) 90

7.2.3 Time Loss Alert 91

7.3 ENTERING A NEW TRANSMITTER SERIAL NUMBER SN# 92

7.4 THE ABOUT SCREEN 94

Section 8

TROUBLESHOOTING 95

8.1 PROBLEMS UPLOADING BG READINGS

TO YOUR RECEIVER WITH THE CONNECTION CABLE 96

8.2 TIME DIFFERENCE BETWEEN BG METER AND RECEIVER 97

8.3 ERROR CODE 98

8.4 SYSTEM RECOVERY 99

10 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

Section 9

SEVEN SYSTEM MAINTENANCE AND STORAGE 100

9.1 MAINTENANCE 101

9.2 STORAGE 102

9.3 CLEANING 103

Section 10

TECHNICAL INFORMATION 104

10.1 DEVICE PERFORMANCE CHARACTERISTICS 105

10.2 PRODUCT SPECIFICATIONS 128

10.3 FCC REQUIREMENTS 136

Seven

™

System User’s Guide | 11

INTRODUCTION

e Seven Continuous Glucose Monitoring System provides you with real-time

continuous glucose measurements every 5 minutes for up to 7 days. ese readings will

help you detect trends and patterns in your glucose levels. e Seven System also features

adjustable High and Low Glucose Alerts and a Low Glucose ALARM to notify you

when you are outside of your target glucose levels. e Seven System consists of three

components: the Sensor, the Transmitter, and the Receiver. e Seven System is currently

compatible with all FDA cleared blood glucose meters for calibration using manual entry.

e Seven System is also directly compatible with the LifeScan® OneTouch® Ultra® Blood

Glucose meter for calibration using a connection cable (Auto Upload).

e Sensor is a disposable unit that you insert into your abdomen (belly) to continuously

monitor your glucose levels for up to 7 days. e Transmitter is a reusable device that

snaps into the Sensor Pod and wirelessly sends glucose information measured by your

Sensor to the Receiver. e Receiver is a hand-held device that receives and displays

glucose information every 5 minutes sent by the Sensor/Transmitter. e Receiver

displays your current glucose reading and also shows your glucose trend information

from the past 1-hour, 3-hours, and 9-hours. ese trends allow you to see where your

glucose levels have been and which direction your glucose levels are headed. e Receiver

also vibrates and beeps to let you know when your glucose levels are high or low.

is User’s Guide describes how to use your Seven System from start to ﬁnish of a

continuous glucose monitoring session. Important safety information, warnings,

precautions, cautions, and contraindications of the Seven System are described in the

next few pages and throughout this guide. Be sure to read this entire User’s Guide before

beginning your continuous glucose monitoring session.

12 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

INDICATION FOR USE

e SEVEN Continuous Glucose Monitoring System is a glucose-monitoring device

indicated for detecting trends and tracking patterns in adults (age 18 and older) with

diabetes. e SEVEN System is intended for use by patients at home and in health care

facilities. e device is for prescription use only.

e SEVEN Continuous Glucose Monitoring System is indicated for use as an adjunctive

device to complement, not replace, information obtained from standard home glucose

monitoring devices.

e SEVEN Continuous Glucose Monitoring System aids in the detection of episodes

of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy

adjustments, which may minimize these excursions. Interpretation of the SEVEN System

results should be based on the trends and patterns seen with several sequential readings

over time.

Seven

™

System User’s Guide | 13

IMPORTANT SAFETY INFORMATION

Read this entire guide before using your Seven Continuous Glucose Monitoring System.

If you do not understand something or have any questions, please ask your Diabetes

Management Team or another health care provider. Contraindications, warnings,

precautions, cautions, and other important safety information can be found in this section

and in boxes throughout your SEVEN System User’s Guide. The Troubleshooting section

(Section 8) contains important information on troubleshooting your SEVEN System.

The Technical Information Section (Section 10) provides information on the performance

characteristics of the device

CONTRAINDICATIONS

•

WARNINGS AND PRECAUTIONS

WARNINGS

•

e SEVEN System must be removed prior to Magnetic Resonance Imaging (MRI).

Use of acetaminophen-containing medications while the SEVEN Sensor is inserted

may aﬀect the performance of the device.

•

is device is not designed to replace a blood glucose meter. e SEVEN System must

be used with a blood glucose meter.

Treatment decisions should not be based solely on results from the SEVEN System.

You must conﬁrm with a blood glucose meter before making therapeutic adjustments.

Symptoms related to low or high blood glucose levels should not be ignored. If you

have symptoms of low or high glucose, use your blood glucose meter to check the

SEVEN System results.

You should update the SEVEN System’s calibration every 12 hours at a minimum to

ensure device performance. e performance of the SEVEN System when calibrated

less frequently than the recommendation to calibrate a minimum of every 12 hours

has not been studied.

14 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

PRECAUTIONS

•

CAUTION

U.S. federal law restricts the sale of the Seven System to sale by or on order of a physician.

WARN INGS

Sensors fracture on rare occasions. If a sensor breaks and no portion of it is visible

above the skin, do not attempt to remove it. Seek professional medical help if you

have symptoms of infection or inﬂammation—redness, swelling or pain—at the

insertion site. If you experience a broken sensor, please report this to our Technical

Support department.

e SEVEN System is not approved for use in children or adolescents, pregnant

women or persons on dialysis.

e safety and eﬀectiveness of the SEVEN System has not been evaluated for sensor

probe insertion sites other than the skin of the abdomen.

•

Always wash hands with soap and water before opening the SEVEN Sensor package.

After opening the package, avoid touching the adhesive area.

Before inserting the Sensor, always clean the skin at the Sensor insertion location

with a topical antimicrobial solution such as isopropyl alcohol. Do not apply the

SEVEN Sensor until the cleaned area is dry.

Establish a rotation schedule for choosing each new SEVEN Sensor location. Avoid

Sensor locations that are constrained by clothing, accessories, or subjected to rigorous

movement during exercise.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of a Sensor.

e Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if

its sterile package has been previously damaged or opened.

For OpenChoice Calibration you must enter the exact ﬁngerstick reading that your

blood glucose meter displays. Enter all ﬁngerstick readings for calibration within 5

minutes. Entering incorrect ﬁngerstick readings that occurred more than 5 minutes

ago will aﬀect device performance.

C

M

Y

CM

MY

CY

CMY

K

LBL-010025_Artwork_for_MT20094_User's_Guide,_Seven_Manual_BG_Rev04 page 14.pdf 1 6/24/10 9:57 AM

Seven

™

System User’s Guide | 15

SECTION 1

OVERVIEW OF THE SEVEN SYSTEM

16 | SEVEN

™

CONTINUOUS GLUCOSE MONITORING SYSTEM

e following list of terms will help you while reading though this guide.

1.1 GLOSSARY

Auto Upload

BG meter

BG reading

Calibration

Glucose Data

Gaps

Glucose Trends

Manual Entry

To transfer BG readings from the OneTouch Ultra Meter to

your Receiver directly with the connection cable.

Blood Glucose Meter. All FDA cleared meters are compatible

with the Seven System.

Blood Glucose reading. A ﬁngerstick blood glucose reading

taken on your FDA cleared meter.

Required for the Seven System to display continuous glucose

data and trend information. Performed by uploading

blood glucose readings to the Seven Receiver. (Do not use

alternative site testing for calibration.)

When the Receiver does not display glucose readings sent

from the Sensor to the Receiver. A symbol will appear instead

of a glucose reading to notify you of the Sensor issue

Allow you to see the pattern of your glucose levels; you can

see where your glucose levels have been and where your

glucose levels are headed. e Seven System has three glucose

trend screens: the 1-Hour, 3-Hour, and 9-Hour Screens. Each

trend screen shows glucose trends over the amount of time

indicated.

To manually enter BG readings from a FDA cleared meter to

your Receiver. You should always use the same glucose meter

to calibrate your Seven System that you routinely use to

measure your blood glucose. Do not switch your BG meter in

the middle of a Sensor session.

Page is loading ...

Dexcom Seven User manual

Dexcom Seven User manual

Related papers

Other documents