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Customer Care available 24 hours a day,
7 days a week at: 1-866-597-5520
www.continuousmonitor.com
User’s Guide
This product and its use are protected under U.S. Patent Numbers:
5,262,035; 5,264,104; 5,264,105; 5,593,852; 5,899,855; 5,918,603; 5,965,380; 6,071,391; 6,103,033;
6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,162,611; 6,175,752; 6,284,478; 6,299,757; 6,329,161;
6,338,790; 6,461,496; 6,484,046; 6,503,381; 6,514,718; 6,560,471; 6,565,509; 6,591,125; 6,592,745;
6,605
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Indications for Use The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the resul
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How to Use this Guide? This guide has many Sections arranged in a logical sequence that will be useful for the first time use and every use thereafter. Most Sections begin with a purpose for that Section, when to perform the steps in that Section, materials required to perform the steps in that Section and important cautions, warnings and helpful information. The first page of each Section will be very useful when you are getting familiar with the system. Once you are familiar with the syst
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Table of Contents n Section 1: Getting Acquainted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 – 12 Parts of the System. Daily Activities and Traveling. Preparing the System for the First Time. Warnings, Cautions and Important Notes. Hypoglycemia Unawareness. Modes of Operation (Continuous Monitoring Mode (CM) and Blood Glucose Mode (BG)). n Section 2: Install or Replace Transmitter and Receiver Batteries . . . . . . . . . .
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n Section 10: Respond to Alarms, Errors, and Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 – 108 Alarm Messages: What are they, What do they mean, and What you should do. Error Codes: What are they, What do they mean, and What you should do. Problems: How to troubleshoot the problems you may encounter. n Section 11: Add Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 – 114 Enter Events: In
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1 Getting Acquainted
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Section 1 – Key Terms n Alarms n Blood Glucose Mode n Continuous Monitoring Mode n FreeStyle Navigator Continuous Glucose Monitoring System n FreeStyle Test Strips n in vitro n Interstitial Fluid n Le FT/RIGh T Option Buttons n Receiver n Receiver Display Screen n Receiver Test Strip Port n Reports n Sensor n Sensor Delivery Unit n Sensor Inserter n Sensor Insertion Button n Sensor Locking Pin n Sensor Release Tabs n Sensor Support Mount n Transmitter n Transmitter
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Section 1 1 Getting Acquainted 1 1 Getting Acquainted Introduction Important: Read all of the instructions in this User’s Guide and the FreeStyle® Test Strip package insert before using your FreeStyle Navigator® Continuous Glucose Monitoring System. Adjustments to your treatment should be done under the guidance of your healthcare team. Your FreeStyle Navigator system continuously reads, displays, and records the glucose levels in the fluids found between the cells under your skin (interst
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2 Section 1 Getting Acquainted How are the parts packaged? Your FreeStyle Navigator system comes with two kits: • A System kit. • A Sensor kit. The System Kit 1 FreeStyle Navigator Receiver in a Receiver Skin • 2 AAA Alkaline Batteries (for the receiver) • 1 FreeStyle Navigator Transmitter • 1 Silver Oxide 357 HC Battery (for the transmitter) • 1 Belt Clip (for the receiver) • 1 FreeStyle Lancing Device • 1 Finger Cap (for the lancing device) • 1 User’s Guide • 1 Getting Started Guid
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Section 1 3 Getting Acquainted What are the key parts of my system? Your FreeStyle Navigator system includes the following major parts: Sensor Measures your glucose level. Sensor Tip Locking Pin Prevents accidental discharge; Part of sensor inserted into your skin. must be removed before insertion. Insertion Button Sensor Support Mount Pushes a tiny needle into the Stays on your skin after sensor is inserted. skin to place the sensor tip just Holds the sensor in place. Attaches the under
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4 Section 1 Getting Acquainted Key features of the System Alarms Stats 21 day 08:30A Highest CM: 298 mg/dL Lowest CM: 61 mg/dL Ave. CM: 160 mg/dL Std. Dev: 20 mg/dL Above Target: 19% Next Back Statistics Select Event 08:30A Insulin Meals Exercise State of Health Generic Main Select e vent Log Line Graph Your receiver comes with backlight capability to
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Section 1 5 Getting Acquainted Using your system For Daily Activities You will be wearing a sensor and a transmitter at all times while you are using the system. Keep the following in mind as you go about your normal routine. • Only wear the sensor and transmitter on a flat surface of either your abdomen or the back of your upper arm. • Sleeping – The sensor and transmitter should not interfere with your normal sleeping patterns. As you get ready to go to sleep, place the receiver within
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6 Section 1 Getting Acquainted How do I prepare my system for the first time? When you are setting up your receiver for the first time, perform all of the procedures listed below in the order that they are listed. Check each procedure off when you complete it. Install batteries in the transmitter first and then in the receiver (see Section 2). o Set the time and date (see Section 3). o Perform a control solution test (see Section 4). o Insert your sensor (see Section 5). o Attach your tr
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Section 1 7 Getting Acquainted Warnings, Cautions And Important Notes Important Notes About System Performance The following items describe situations that could lead to inaccurate or unreliable continuous glucose results. Cautions: • Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and cause the sensor to dislodge. If t
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8 Section 1 Getting Acquainted Important Things to Remember About System Calibration (con’t) Important: In clinical trials, we observed that the sensor signal sometimes temporarily decreases from the true value. This typically happens at night during sleep, and recovers rapidly when the user moves or is awakened. However, in order to avoid being affected by this phenomenon the system should not be calibrated when the wearer is asleep. • You may not be able to calibrate the system if your g
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Section 1 9 Getting Acquainted Before You Get Started (con’t) Cautions: • Low or high glucose measurements can indicate a potentially serious medical condition. • If you have hypoglycemia, or hypoglycemia unawareness, then test ONLY on your fingers. • The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia. The alarms should always be used in conjunction with other indications of glycemic state s
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10 Section 1 Getting Acquainted Before You Get Started (con’t) • If your results from the continuous monitoring mode do not reflect how you feel, test your glucose using the Blood Glucose mode. • If you observe a significant change in your continuous glucose readings that you think is erroneous, or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source, move away from the source of interference and check
