Sanofi-aventis BG STAR User manual

Application number: 184338 Page 1 of 48
Date of revision: August 18, 2011
s-a Version 2.1 dated August 26, 2011
Blood Glucose Monitoring System
OWNER’S GUIDE

Application number: 184338 Page 2 of 48
Date of revision: August 18, 2011
s-a Version 2.1 dated August 26, 2011
Key Features of the BGStarTM
No Coding Required – The BGStar doesn’t require you to enter a code. Insert a test strip and
you are ready to start the test.
Pre/Post Meal Tagging – After you test, tag your reading with the mealtime. You can organize
your data, and see how your test results change before and after meals.
Positive Feedback – The BGStar will also display a smiley face icon if your result is within the
target range.
Toll free sanofi-aventis 24 hour support Tel.: [phone] or visit us at www.bgstar.ca
In case of emergency, contact your health professional or emergency medical response.
Manufactured by AgaMatrix Inc., 7C Raymond Avenue, Salem NH 03079 USA
For sanofi-aventis Canada Inc., 2150 St. Elzear Blvd. West, Laval (Quebec) Canada H7L 4A8
www.bgstar.ca
©2011 sanofi-aventis
Meter Firmware ©2011AgaMatrix, Inc.
U.S. and International Patents Pending. All rights reserved. All trademarks and/or copyrights are
properties of their respective owners.

Application number: 184338 Page 3 of 48
Date of revision: August 18, 2011
s-a Version 2.1 dated August 26, 2011
Contents
Chapter Page
1 Getting Started
2 Important Health-related Information
3 Important Information about Your BGStar System
4 About the BGStar System
5 Meter Basics
6 Preparing For a Test With Your BGStar Meter
7 Performing a Control Solution Test
8 How To Test Your Blood Glucose Level
9 Testing on Your Palm or Forearm
10
10.1
10.2
10.3
10.4
10.5
Data Management Features
Viewing Individual Results
Viewing 14 Day Statistics
Viewing 14, 30 and 90 Day Averages
Viewing Pre/Post Mealtime Averages & Glucose Variability Tracking
Viewing 1 Month, 2 Week, and 3 Day Trend Graphs
11 Setting the Mealtime Tag
12 Setting Meter Volume
13 Setting the Time
14 Setting the Date
15 Setting Hypoglycemic Warning Alarms
16 Setting Hyperglycemic Warning Alarms
17 Setting the Glucose Target Range
18 Setting Alarms
19 Errors and Troubleshooting
20 Display Messages
21 Batteries
22 Caring for Your Meter and Lancing Device
23 Meter Specifications
24 Symbols

Application number: 184338 Page 4 of 48
Date of revision: August 18, 2011
s-a Version 2.1 dated August 26, 2011
CHAPTER 1 Getting Started
Unpack your BGStarTM System Kit. Dispose of the packing material properly.
IMPORTANT: To ensure accurate use of meter, verify the time, date and units of measure.
For step-by-step instructions on changing the time and date settings, please refer to chapters 13
and 14.
CHAPTER 2 Important Health-related Information
Please Read the Following:
[1] Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar
state, with or without ketosis. Critically ill patients should not be tested with blood glucose
meters.
[2] Severe dehydration and excessive water loss may yield inaccurate results. If you believe you
are suffering from severe dehydration, consult your health professional immediately.
[3] Patients undergoing oxygen therapy may receive inaccurate results.
[4] Results below 3.9 mmol/L may mean low blood glucose levels (hypoglycemia).
[5] Results over 13.3 mmol/L may mean high blood glucose levels (hyperglycemia). Checking
ketones may be advisable.
[6] If you get results below 3.9 mmol/L or above 13.3 mmol/L and do not have symptoms of
hypoglycemia or hyperglycemia, repeat the test. If you have symptoms, or continue to get results
below 3.9 mmol/L or above 13.3 mmol/L, contact your health professional immediately.
[7] If you are experiencing symptoms that are not consistent with your blood glucose test and you
have followed all instructions described in the BGStar Owner’s Guide, follow the treatment plan
recommended by your health professional team or contact your health professional immediately.
[8] Do not use test strips that are expired or appear to be damaged as they may return inaccurate
results.
[9] Health professionals should follow their institution’s infection control protocols.
[10] Always follow your health professional’s recommendations.
CHAPTER 3 Important Information about Your BGStar System
The BGStar System should be used:

Application number: 184338 Page 5 of 48
Date of revision: August 18, 2011
s-a Version 2.1 dated August 26, 2011
[1] For quantitative measuring of blood glucose levels from fresh capillary whole blood samples
taken from the fingertip, palms (at the base of the thumb), or forearms.
[2] For in vitro diagnostic (i.e. outside of the body) use only.
[3] With BGStar Test Strips and BGStar Control Solution only. Do not use other brands of test
strips and control solution with this meter. This may produce inaccurate results.
[4] For use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by
health professionals, as an aid to monitor the effectiveness of diabetes control.
Do not use the BGStar System for:
[1] The diagnosis of diabetes.
[2] Testing the glucose levels of neonates (children under 4 weeks).
[3] Testing glucose levels of arterial or venous blood.
[4] Testing glucose from sites other than the fingertip, palm (at the base of the thumb), or
forearm.
Possible test sites:
The BGStar System requires only 0.5 μL of blood to perform a glucose test. For best results, test
using blood from the tip of any finger. The palm (at the base of the thumb) and forearm are
alternate, but less accurate test sites. Only select soft and fleshy areas to lance. Avoid lancing any
bony areas, obvious veins and moles.
Physiological differences in circulation between the fingertip, palm (at the base of the thumb),
and forearm may result in differences in blood glucose measurements between these sites.
Differences in glucose concentrations may be observed after eating, taking insulin, medication, or
exercise. Changes in blood glucose may be detected at the fingertips before the palm (at the base
of the thumb) and forearm.
It is recommended that you use a fingertip sample if:
[1] you are testing for hypoglycemia or if you suffer from hypoglycemia unawareness;