Guardian® RT Continuous Glucose Monitoring System REF MMT-7900 User Guide
© 2005, Medtronic MiniMed. All rights reserved. Guardian®, MiniMed® and Sen-serter® are registered trademarks of Medtronic MiniMed. Com-Station™, Shower-Pak™, Solutions™ Software are trademarks of Medtronic MiniMed. BD Logic™ is a trademark of Becton, Dickinson and Company Detachol® is a registered trademark of Ferndale Laboratories, Inc. Polyskin® is a registered trademark of the Kendall Healthcare Products Company. CaviCide® is a registered trademark of the Metrex Research Corporation.
Table of Contents Chapter 1: Introduction ......................... 1 System Function....................................................... 2 System Components .................................................. 2 Glucose Sensor.................................................................... 2 Transmitter ....................................................................... 2 Monitor............................................................................. 3 Monitor Buttons ......................
Chapter 2: Getting Started .....................13 Quick-Reference Guide ............................................. 13 Start-Up Process ..................................................... 17 Installing the Batteries ....................................................... 17 Turning On the Monitor........................................................ 19 Turning Off the Monitor ....................................................... 19 Home Screen .....................................................
Chapter 3: Routine Operation .................. 53 Glucose History...................................................... 53 Entering Meter BG for Calibration ................................ 55 BG Due................................................................ 56 Enter BG ......................................................................... Calibration Pending ............................................................ No Sync ......................................................................
Chapter 5: Performance Characteristics .......83 Performance Results ................................................ Accuracy of Guardian RT Readings ............................... Precision of Guardian RT Readings ............................... Low and High Alerts................................................. 84 85 89 89 The Low Glucose Alert ....................................................... 90 The High Glucose Alert ........................................................
Introduction Congratulations on buying one of the most exciting devices in the field of diabetes care! The Medtronic MiniMed Guardian® RT (Real Time) System (MMT-7900) continuously monitors glucose levels, provides realtime glucose values, and gives high and low glucose alerts. The Guardian RT uses three separate components—Sensor, Transmitter, and Monitor—to measure and display glucose levels in persons with diabetes.
System Function The Guardian RT measures glucose levels in interstitial fluid: the fluid found between the body’s cells. It is from this fluid that cells get oxygen and nutrients, including glucose. Glucose levels in interstitial fluid typically match glucose levels in the blood. The system gives real-time interstitial fluid glucose values on demand (updated every five minutes). The system also features low glucose and high glucose alerts that are triggered once limits you have preset are reached.
Monitor The Transmitter sends Sensor data in the form of radio signals to the Monitor (MMT-7901) about every 5 minutes. The Monitor stores this information and uses it to provide real-time glucose values and to trigger low or high glucose alerts. This information can also be downloaded for analysis to a personal computer by means of a Medtronic MiniMed Com-Station™ (MMT-7301) and the Guardian Solutions™ Software (MMT-7315).
Monitor Button Functions This button turns the Monitor On or Off. SEL The SEL (Select) button scrolls through the menu screens. It is used with the ACT button to clear alarms/alerts. ACT The ACT (Activate) button lets you make changes to programming, save information to memory or clear alarms/alerts. You will hear a beep when you press ACT to confirm the selection. Up and Down Arrows The Up and Down arrows are used to change values or settings.
Test Plug Figure 1.5 The Test Plug (MMT-7400) is a device used to troubleshoot the Guardian RT system. (See Figure 1.5.) If there is a problem with the Guardian, it can give information that will tell if the Sensor, Transmitter, or Monitor are working correctly. See Chapter 4: Troubleshooting and Alarms for more details. Sen-serter Figure 1.6 The Sen-serter® (MMT-7500) is a spring-loaded reusable device that inserts the Sensor (MMT-7002) at an angle under the skin and into the interstitial fluid.
Help Medtronic MiniMed provides a 24-Hour Product Help Line in the United States and Canada. The help line is staffed with personnel trained in the set-up and use of the Guardian RT system, and they are able to answer your questions. When calling, please have the Guardian RT system and this User Guide with you. Department Telephone Number 24-Hour Product Help Line U.S. and Canada 800-MINIMED (800-646-4633) or 818-576-5555 International Contact your local sales office Medtronic MiniMed Website www.
User Safety Indications for Use The Guardian RT is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (ages 18 and older) with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required.
Warnings Monitor The Monitor and Transmitter need to be kept within 6 feet (approximately 2.0 meters) of each other to ensure that communication is not interrupted. Transmitter The Transmitter should be removed if irritation or reaction to the Transmitter tape develops. The Transmitter should be disconnected from the Sensor while traveling on an aircraft, or if it interferes with another transmitting device.
The Sensor should be removed if redness, pain, tenderness, or swelling develop at the insertion site, or if you experience unexplained fevers. Check site often for these conditions and to make sure Sensor is still in place, especially before going to bed and upon waking. Confirm symptoms of low blood glucose and high blood glucose, as well as displayed glucose values and alerts, with a home blood glucose meter available from your doctor or pharmacy.
Although the Monitor is tested and complies with the applicable standards, the use of the Monitor in close proximity to strong electromagnetic sources, such as MRI equipment, television transmitters, highvoltage power lines, or high-power radio transmitters is not recommended. Keep the Monitor in its leather case to protect against electrostatic discharges that are common in cold and dry climates. Transmitter Establish a rotation schedule for choosing each new Transmitter site.
Adverse Reactions Operation of the Medtronic MiniMed Guardian RT requires the insertion of a Glucose Sensor into the skin. Bleeding, swelling, bruising, or infection at the Sensor insertion site are possible risks of Sensor use. The Sensor should be removed if redness, pain, tenderness, or swelling develop at the insertion site. The Transmitter should be removed if irritation or a reaction to the Transmitter tape develops. In the event of any adverse reaction associated with this system, U.S.
Symptoms of Hyperglycemia Hyperglycemia (high blood glucose) may develop if you do not have enough insulin. There are symptoms linked to high blood glucose that should not be ignored no matter how mild they are, even if the Guardian RT does not display a high glucose value or give a high glucose alert.
Chapter 2 Getting Started Now that you are ready to use the Medtronic MiniMed Guardian RT, there is a Start-Up process that you must follow to ensure a rewarding glucose sensing experience. Read the Quick-Reference section below, as it outlines the steps needed to successfully operate the Guardian RT. Use this section as a general reference guide. But please read the rest of this chapter carefully for the detailed steps needed to Program the Monitor and Set up the Sensor.
SENSOR START Clean Site Insert Sensor Affix Transmitter to Skin Perform Search Connect Sensor to Transmitter Verify Initialization Place Tape Over Sensor and Connector Enter BG for Calibration at End of Initialization 14 Chapter 2
ROUTINE OPERATION Review Glucose Sensor Values Check Sensor Signals Periodically Check BG Due Status Enter BG Values for Calibration Enter Events: Insulin, Meals, Exercise, Others Set High Alarm Snooze as Needed Modify Alarm Limits for Overnight and Daytime Address Alarms and Follow Up Actions Enter BG Values for Calibration in Response to High and Low Alarms Check Sensor Site Periodically Replace Tape and Secure Transmitter As Needed Replace Sensor at 72 Hours Code BG Meter When Changing Test
LIST OF ALARMS See Chapter 4, Troubleshooting and Alarms, for More Information.
Start-Up Process Installing the Batteries The Monitor uses two (2) AAA alkaline batteries. When changing out used-up batteries, make sure to use new batteries. The Monitor will alert you when a battery change is needed. Batteries should be installed right after unpacking the Guardian RT. NOTE - Use only disposable AAA alkaline batteries in the Monitor. Do not use rechargeable batteries or other battery types. These batteries can damage the Monitor or affect Monitor operation.
9. Put in the new batteries, following the diagram on the bottom of the compartment. (See Figure 2.1) Figure 2.7 - + 10. Place the battery compartment lid back into place, aligning it correctly against compartment seal. 11. With the screwdriver, tighten the screw to close the battery compartment and hold the lid in place. Do not overtighten lid. NOTE - After changing the batteries, all programmed settings should be checked, and changed if needed.
Turning On the Monitor NOTE - The Monitor will turn on and automatically run a self-test when batteries are put in correctly. NOTE - If the Monitor does not turn On, and before that you got a LOW BATT alarm, change out the batteries. 1. Press the On/Off ( ) button. 2. The Monitor will beep and vibrate, display the software version used, and display the HOME screen. NOTE - Every time the Monitor is turned on, a test is run.
The Main Screens There are eight main screens in the Guardian RT Monitor: HOME (TIME AND ALARM), GLUCOSE HISTORY, METER BLOOD GLUCOSE (BG), EVENTS, GLUCOSE ALARMS HISTORY, SEARCH, SIGNALS and SETUP. You can enter any of these screens from the one before by pressing SEL and then ACT. Figure 2.2 describes the screen flow. These screens will be explained in detail in Chapter 3: Routine Operation. Figure 2.
Programming the Monitor There are ten Setup subscreens in the Guardian RT Monitor: LOW, HIGH, ALERT, SET TIME, DISPLAY, UNIT, TRANS ID, CLEAR, LANGUAGE, and EXIT. To get to these subscreens: From the HOME Screen (See Figure 2.2) press the SEL button 7 times to reach the SETUP Screen, and press the ACT button to enter. Then press SEL to scroll through the subscreens and ACT to enter any given one. The subscreens have to be programmed before starting on the Guardian RT.
Setting the Language The Guardian RT offers the choice of displaying Monitor information in seven different languages: English, French, Spanish, Italian, Swedish, German and Dutch. From the HOME screen: 1. Press SEL 7 times to get to the SETUP screen. 2. Press ACT once. 3. Press SEL 8 times to get to the LANGUAGE screen. LANGUAGE 4. Press ACT. The screen will display the word ENGLISH blinking. 5. Use Up or Down arrow button to scroll through the different languages.
Setting the Time Display Format The Monitor gives you a choice of using either 12 or 24-hour time format. From the HOME screen: 1. Press the SEL button 7 times until the SETUP screen appears. 2. Press the ACT button once to get to the SETUP sub-screens. 3. Press the SEL button 4 times until the DISPLAY sub-screen appears. 12:HR DISPLAY 4. Press the ACT button once and the upper left-hand corner of the screen will be blinking. The word SET will appear under the blinking number.
Setting the Time and Date NOTE - All steps to set up the Time and Date must be done, or the time and date will not be saved. NOTE - If the SEL button is pressed while in a Time/Date subscreen, the display will automatically change to the Time Display option. From the HOME screen: 1. Press the SEL button 7 times until the SETUP screen appears. 2. Press the ACT button once to get to the SETUP sub-screens. 3. Press the SEL button 3 times until the SET TIME sub-screen appears.
Setting the Current Minutes 1. The word MINUTES will now appear with the last two digits of the time blinking. 00:00 12:oo AM SET or SET MINUTES MINUTES 2. Use the Up or Down arrow button to choose the current minute from “00” to “59.” 3. Press the ACT button once, and the word YEAR will appear. Setting the Current Year 1. The YEAR will now appear with the number “00” blinking in the upper right-hand corner of the screen. The starting year is 2000. 12:00 AM SET 00 2.
Setting the Current Day 1. The word DAY will now appear with the number “01” blinking in the upper right-hand corner of the screen. 2. Use the Up or Down arrow button to choose the digits for the 12:00 SET AM 01 current day of the month, from 1 to 31. 3. Press the ACT button once to save date and time values chosen. 4. The current time and date will appear briefly, and the DAY Monitor will go to the DISPLAY sub-screen. Press SEL 5 times to go to EXIT. Press ACT once to return to the HOME screen.
3. Press the SEL button 7 times until the CLEAR sub-screen appears. GLUCOSE HIST: CLEAR 4. Press the ACT button once. The Monitor will beep, and the word NO will appear on the screen blinking. NO GLUCOSE HIST: CLEAR 5. Use the Up or Down arrow button to choose between YES and NO. Select YES to clear the Monitor memory. 6. With YES displayed on the screen, press the ACT button once. The Monitor will display YES with CONFIRM blinking.
7. Press the ACT button again. The Monitor will beep or vibrate and the word CLEARING will appear for a few seconds. CLEARING 8. The Monitor will then go to the LANGUAGE screen. The memory will now be cleared. Press SEL to go to the EXIT screen, followed by ACT to go back to the HOME screen. 9. If NO is selected, the Monitor memory will NOT be cleared, and the Monitor will go to the LANGUAGE screen. Press SEL to go to the EXIT screen, followed by ACT to go back to the HOME screen.
Setting the Glucose Unit The Monitor gives you a choice of entering meter BG values and setting the low blood glucose and high blood glucose limits in either mg/dl or mmol/l. From the HOME screen: 1. Press the SEL button 7 times until the SETUP screen appears. 2. Press the ACT button once to go to the SETUP sub-screens. 3. Press the SEL button 5 times until the UNIT sub-screen appears. GLUCOSE mg/dl UNIT 4. Press the ACT button once, and use the Up or Down arrow button to choose either mg/dl or mmol/l.
Setting the Low Glucose Alert The Monitor is designed to alert the user when the system finds glucose values at or above the set high glucose limit, or at or below the set low glucose limit. These alerts may be turned off if not needed or wanted. If an alert is triggered, you should confirm the glucose value with a home glucose meter before taking any action. Also, you should use a home blood glucose meter to confirm the symptoms of high and low blood glucose.
5. Press the Up or Down arrow button to choose either ON or OFF or rEP (Repeat Function - See Next Page). If you do not want to use this feature, choose OFF and the low glucose alert feature will be turned off. 6. Press the ACT button. 7. If ON is entered, the current value will begin blinking. 60 SET GLUCOSE LIMIT LOW mg/dl 8. Use the Up or Down arrow button to choose the value you want to set a low glucose alert. Press the ACT button to save the chosen value. The value 65 mg/dl (3.
11. To customize the time delay for a specific time period between recurrences of the LOW glucose alert, repeat steps 1-4. Next, use the Up or Down arrow button to select rEP (blinking), and press the ACT button. rEP SET GLUCOSE LIMIT LOW 12. The previously set time interval (or 20 minutes default) will be blinking. Use the Up or Down arrow button to select the desired interval, in 10-minute increments, from 20 minutes to 60 minutes (1 hour). Press the ACT button.
Setting the High Glucose Alert The high glucose alert range is 105-400 mg/dl (5.8-22.2 mmol/l). Enter a glucose value within this range to set a high glucose alert. Typically, the number entered is below the value that causes you to have symptoms of high blood glucose. Confirm the alert limit with your doctor. For this feature to work, you must select ON, a value, and CONFIRM to save the value in memory. Always treat high blood glucose per the advice of your doctor. From the HOME Screen: 1.
6. If ON is activated, the default value will be blinking. SET GLUCOSE 200 LIMIT HIGH mg/dl 7. Use the Up or Down arrow button to choose the value you want to set a high glucose alert. 8. Press the ACT button to save the chosen value. The following screen will appear with CONFIRM blinking. The value 240 mg/dl (13.3 mmol/l) has been entered in this example.
11. To customize the time delay for a specific time period between recurrences of the HIGH glucose alert, repeat steps 1-4. Next, use the Up or Down arrow button to select rEP (blinking), and press the ACT button. rEP SET GLUCOSE LIMIT HIGH 12. The previously set time interval (or 1 hour default) will be blinking. Use the Up or Down arrow to select the desired interval, in 30-minute increments, from 60 minutes to 180 minutes (3 hours). Press the ACT button. The CONFIRM screen will be displayed.
Setting the Alert Type The Set Alert feature gives the choice of BEEP, VIBRATE, or BOTH whenever an alert is triggered. The default setting for the Monitor is the audible BEEP. Choose the Alert type as follow: From the HOME screen: 1. Press the SEL button 7 times until the SETUP screen appears. 2. Press the ACT button once to get to the SETUP sub-screens. 3. Press the SEL button 2 times until the ALERT sub-screen appears. ALERT 4.
6. If you choose the BEEP or BOTH alert, a number 2 (default) will appear blinking above the words BEEP VOL. You can choose between three different beep volumes: 1 = Low, 2 = Medium, and 3 = High. Use the Up or Down arrow button to choose 1, 2, or 3. (While scrolling, corresponding beep tones will sound.) 2 BEEP VOL 7. Press the ACT button to save your choice. The Set Time and Date screen will appear. Press SEL 6 times to go to EXIT. Press ACT to go back to the HOME screen.
5. Press the ACT button again to go to the second digit. 6. The second digit will now be blinking. Use the Up or Down arrow button to choose the second digit in your Transmitter ID number. 7. Press the ACT button once again to go to the third digit. 8. Keep using the Up or Down arrow to choose numbers for each of the digits left. Then press the ACT button to go to the next digit. The example below uses 7596. SET 0007596 NOTE - If the ID number is less than 7 digits, make sure leading zeros are entered.
Inserting the Sensor Before handling the Sensor, wash hands thoroughly. Choose a site with enough subcutaneous fat for Sensor insertion. The abdominal area and upper buttocks are the best and most common-used sites for insertion of the Glucose Sensor. See Figure 2.4 for all body areas where the Glucose Sensor can be inserted. Figure 2.10 As a rule, AVOID the following areas: ➠ Frequently used injection or pump sites. (Never insert Sensor closer than 3 inches (7.
1. Carefully open sterile Sensor pouch, and take out Sensor from package by holding base or tape. Do not hold Sensor by introducer needle handle. Place the Sensor in the Sen-serter until it fits snugly. 2. Hold Sen-serter as shown: 3. Secure white tape of Sensor, and take off clear tape using counterclockwise motion.
4. Place fingers on back of white tape, and push carrier down until it clicks in place. 5. As a safety measure, when the Sen-serter is in the loaded position you can set the lock at the top of the device until you are ready to insert. a. To Lock: Rotate the white knobs 90o away from the arrows on the side of the Sen-serter. b. To Unlock: Rotate the white knobs 90o so that they align with the arrows on the side of the Sen-serter.
6. Take off needle guard from introducer needle. NOTE - While the use of gloves at this point is required for clinicians, it is optional for patients. 7. Rest Sen-serter legs against skin at 45-degree angle, placing two fingers of opposite hand on Sen- serter legs to keep this angle. NOTE - Sensor may not penetrate skin if insertion angle is less than 45 degrees. 8.
9. While holding Sensor in place, gently slide Sen-serter away from Sensor. Do not twist, bend or lift Sen-serter while taking it off Sensor. 10. Holding Sensor base, take off white paper from adhesive pad. Press adhesive against skin. 11. ➠ ➠ ➠ Hold Sensor with two fingers on base, and gently take out introducer needle at 45-degree angle.
Sensor Storage and Handling ➠ ➠ ➠ ➠ ➠ Store Sensors in refrigerator at +36° to +50°F (+2° to 10°C). Do not freeze. Before opening, allow individual Sensor package to reach room temperature and 5% to 95% relative humidity to avoid condensation. Sensors taken out of refrigeration must be kept at or below room temperature, +50° to +75°F (+10° to 24°C), and used within 1 week to ensure Sensor sensitivity.
Affixing the Transmitter 1. Find a comfortable, protected area on the abdomen (away from the belt-line) that is within Cable reach of the Sensor. Clean the area with isopropyl alcohol and allow to dry. 2. Use the disposable Transmitter adhesive pad (MMT-7006) to affix the Transmitter to your body. 3. Take off the paper backing from the Transmitter side of the adhesive pad (side labeled “1”). 4. Stick the adhesive pad to the smooth, flat, unlabeled side of the Transmitter. 5.
Searching for the Transmitter The Search procedure starts communication so that the Monitor can receive and recognize the data signals from the Transmitter. NOTE - Before starting a SEARCH, make sure the Transmitter ID has been entered into the Monitor. Caution: Do not press any button on the Monitor while doing a Search. This interferes with the Search action. From the HOME screen: 1. Press the SEL button 5 times until the SEARCH screen appears. SEARCH 2.
Connecting the Sensor to the Transmitter NOTE - To extend Transmitter battery life, do not leave Sensor or Test Plug connected to the Transmitter when system is not in use. 1. With the Monitor in SEARCH mode, hold the base of the Sensor between the thumb and forefinger so that it doesn’t move. Hold the Transmitter connector in the other hand. Place the Sensor connector so that the two connectors are closely aligned. Push together to connect the Transmitter to the Sensor.
Sensor Initialization After the Transmitter Search is done, the SUCCESS screen will be briefly displayed. The INIT screen will then appear. The system automatically initializes the Sensor before starting to record glucose data. Initialization takes about 120 minutes (2 hours). The Monitor, however, will count down from 140 minutes (2 hours and 20 minutes) toward 0 hours and 0 minutes, or until finished (whichever comes first), in one-minute intervals.
3. Press the ACT button, and the glucose value (dashes) will blink. Use the Up or Down arrow buttons to scroll through the values until the right one is displayed in increments of 1 mg/dl or 0.1 mmol/l. Holding down either button will scroll faster through the list of values. The METER BG feature lets you enter values from 20 to 600 mg/dl (1.1 to 33.1 mmol/l). However, only values between 40-400 mg/dl (2.2-22.2 mmol/l) are used for calibration.
Calibration Pending If a BG value has been recently entered, but the Up arrow is pressed from the HOME screen within 15 minutes of the entry, not giving the Sensor enough time to calibrate, the screen below will be displayed. The example 90 mg/dl (5.0 mmol/l) is the recently entered Meter BG value. 90 GLUCOSE mg/dl PENDING No Sync If the Sensor is not in INIT, (Initialize mode) and still working, and the Guardian RT is not synchronized, then the screen below will be displayed.
Replacing the Glucose Sensor If the word REPLACE is displayed on the screen along with a time that is not the current time (i.e., the time displayed is a future time), the Sensor must be changed before the next calibration is due. The time displayed is the end of Sensor life. If REPLACE and the current time are displayed on the screen, then the Sensor is not working and the system is no longer sending Sensor glucose values. Change out the Sensor immediately to continue using the Guardian RT system.
52 Chapter 2
Chapter 3 Routine Operation This chapter explains how to use the Main Screens of the Guardian RT. From the HOME screen, press the SEL button to go to each of these operating screens. Press ACT to enter these screens. NOTE - Pressing the SEL button from the SETUP screen will take you back to the HOME screen. Glucose History The glucose history will display the last 8 hours of glucose values.
2. Scroll through the history by using the Up arrow button to go from oldest to newest glucose value in 5-minute increments. Press the Down arrow button to go from newest to oldest glucose value in 5-minute increments. In the example below, the glucose value was 112 mg/dl (6.22 mmol/l), 5 hours and 25 minutes ago. 11:57 PM GLUCOSE HIST: 112 mg/dl -5h 25M 3.
Entering Meter BG for Calibration In order for the electronic signals from the Sensor to be converted into glucose values, Meter BG (Blood Glucose) readings must be entered into the Guardian RT for the purpose of calibration. See Chapter 2: Getting Started, Sensor Calibration. From the HOME screen: 1. Press the SEL button 2 times and the METER BG screen will appear. In the example below, the last entered meter blood glucose value was 95 mg/dl (5.3 mmol/l). This value will thus appear on the display.
BG Due One useful feature of the Guardian RT is the BG DUE screen. This screen lets you know when to enter the next needed blood glucose (BG) value into the Guardian RT to go on with calibration. From the HOME screen: 1. Press the Up arrow button once. If an initial Sensor calibration has already been performed, the screen will display when the next BG entry is due. Pressing SEL or ACT once, or the Up arrow 2 times, will return you to the HOME screen.
Enter BG If no calibration has been done, and no calibration is pending, the screen below will be displayed if the Up arrow is pressed from the HOME screen. 12:45 PM ENTEr bg Calibration Pending If a BG value has been recently entered, but the Up arrow is pressed within 15 minutes of the entry, not giving the Sensor enough time to calibrate, the screen below will be displayed. The example 90 mg/dl (5.0 mmol/l) is the recently entered Meter BG value.
No Sync If the Sensor is not in INIT (Initialize mode), and still working, and the Guardian RT is not synchronized, then the screen below will be displayed. This means that the Monitor is not getting Sensor data from the Transmitter at this point in time. 12:00 AM No SYNC Replacing the Glucose Sensor If the word REPLACE is displayed on the screen along with a time that is not the current time (i.e., the time displayed is a future time), the Sensor must be changed before the next calibration is due.
Events The EVENT screens are used to record information that might affect glucose values. Events are stored but they cannot be reviewed on the Monitor display (except previously entered values). Event markers and related values can be downloaded, along with the glucose Sensor history, to the Guardian Solutions Software using the Com-Station cradle. Event information is helpful in evaluating glucose trends and patterns displayed in the software reports.
Units of Insulin Taken From the HOME screen: 1. Press the SEL button 3 times, and the EVENTS screen will appear. 2. Press the ACT button once, and the screen will display SET and INSULIN will be blinking. (Dashes will be displayed if no insulin amount was entered before.) NOTE - If you are an insulin pump user, the dose refers to your bolus, not basal insulin.
Carbohydrate Amount After an Insulin dose has been entered and the ACT button pressed, the screen will display SET, and CARB AMT will be blinking. (Dashes will be displayed if no carb amount was entered before.) If you do not want to enter a carbohydrate amount, press SEL until the HOME screen appears. Otherwise, follow these steps. 1. Press the ACT button. 2. Press the Up or Down arrow button to enter the amount of carbohydrate eaten. (Example: One baked (6 ounce) potato is 30 grams of carbohydrate.
4. Press the ACT button. Use the Up or Down arrow buttons to enter how long you have exercised. You can enter Exercise in 10-minute increments up to 4 hours. 0:30 H SET EXERCISE 5. Press the ACT button to save the exercise length and go back to the HOME screen. Other Events Any other important events, such as illness, menstrual cycle, etc., can be entered using the OTHER screen. From the HOME screen: 1. Press the SEL button 3 times, and the EVENTS screen will appear. 2. Press the ACT button once.
Glucose Alarm History The glucose alarm history will display the last 20 high and low glucose alarms received. From the HOME Screen: 1. Press the SEL button 4 times until the GLUCOSE ALARMS screen appears. GLUCOSE ALARMS 2. Press the ACT button to view the saved alarms. 3. If there are no alarms in the history, the following screen will appear: - -: - - NONE 4. If there are alarms in the history, the newest one will be displayed first.
6. If the glucose value was outside the “operational range” of 40-400 mg/dl (2.2 -22.2 mmol/l), then the Guardian RT will display either of these two screens: 13:04 GLUCOSE 13:04 GLUCOSE LO 03AUG02 HI 03AUG02 7. Use the Up or Down arrow button to go through the rest of the Glucose Alarm History. Pressing the DOWN arrow will display the previous (next-most recent) alarm. Pressing the UP arrow will display the oldest alarm. Press SEL to return to the HOME screen.
Search The Search procedure start synchronized communication between the Monitor and the Transmitter. The Search procedure is explained in detail in Chapter 2: Getting Started, Searching for the Transmitter. Please refer to that section for more information. SEARCH Signals The SIGNALS screen is useful to make sure the ISIG (Input Signal, i.e., Sensor signal) readings are in the correct range.
NOTE - While unlikely, moisture may enter the Guardian RT Transmitter connector during normal use. This may lead to erratic ISIG values above 200 nA. Stop Sensor use if problems with moisture are suspected. Remove the Transmitter from the skin surface and allow to air dry for 3-4 hours. (More or less drying time may be needed, depending on the air temperature and humidity.) Once dry, perform the Test Plug Procedure. If the ISIG values are in the range of 24-29 nA, then the Transmitter is working correctly.
Chapter 4 Troubleshooting and Alarms This chapter lists the Monitor alarms and how to troubleshoot and respond to them to keep the system working smoothly. If an alarm is triggered, the Monitor will beep, vibrate, or do both, depending on the Alert setting. All alarms are cleared by pressing the SEL button, followed by the ACT button. If an alarm is not cleared within 10 minutes, a continuous tone will sound. Alarms with the letter “F” on the display are system errors.
List of Alarms No ID 12:00 AM C52 NO ID Error Message: C52/NO ID (Missing Transmitter ID) Cause: A Transmitter ID has not been entered in the Monitor. Action: Press the SEL button and then the ACT button to clear the alarm. Enter the Transmitter ID (serial number) into the Monitor’s TRANS ID setup screen. See Chapter 2: Getting Started.
High 250 12:00 AM GLUCOSE mg/dl HIGH NOTE - If the alert pattern is set on beep, a series of ascending tones will be heard. This tone is unique to the HIGH alert. If the alert type is set on vibrate, vibrations do not vary for different alarms. NOTE - In the screen above, 250 mg/dl is being used as an example. Error Message: HIGH (High Glucose Alarm) Cause: Glucose value is higher than or equal to the high glucose limit. Action: 5.
Low 60 12:00 AM GLUCOSE mg/dl LOW NOTE - If the alert pattern is set on beep, a series of descending tones will be heard. This tone is unique to the LOW alert. If the alert type is set on vibrate, there is no differentiation between the vibrations for the different alarms. NOTE - In the screen above, 60 mg/dl is being used as an example. Error Message: LOW (Low Glucose Alarm) Cause: Glucose value is lower than or equal to the low glucose limit set. Action: 1.
Check Sensor C54 check 12:00 AM GLUCOSE SENSOR Error Message: C54/CHECK Cause: The Monitor picked up a Sensor current that is outside the operating range or is unstable. Action: 1. Press the SEL button and then the ACT button to clear the alarm. The alarm will turn off, and the HOME screen will reappear. The alarm will repeat periodically until the condition is corrected. 2. Make sure the insertion site appears normal and the Sensor is still connected. DO NOT REMOVE CONNECTOR. 3.
Low Batt 12:00 AM +- LOW BATT Error Message: LOW BATT (Low Batteries) Cause: The voltage of the AAA batteries in the Monitor is low. Action: Press the SEL button and then the ACT button to take care of the alarm. When this alarm is first triggered, the batteries have about eight hours of normal operating life left. The time of the first alarm is recorded into the Monitor memory. The Battery icon will be displayed on the HOME screen. 1. Turn Off the Monitor. 2. Change the batteries.
Off/No Power OFF NO POWER 12:00 AM + - Error Message: OFF/NO POWER (Replace Batteries) Cause: There is less than one (1) hour of battery life left. The Monitor will turn off. Action: 1. Press the SEL button and then the ACT button to CLEAR the alarm. 2. CHANGE THE BATTERIES RIGHT AWAY TO AVOID LOSS OF DATA STORED IN MEMORY! Follow steps in Chapter 2: Getting Started. 3. Perform the manual Search procedure: a. From the HOME Screen, press the SEL button 5 times until the SEARCH screen appears. b.
Service C60/61 12:00 AM C60 SERvice Error Message: C60/SERVICE (Transmitter Battery Low/End of Battery Life) Cause: The Transmitter battery is low when C60 appears. The C60 service alarm will repeat each day around 12:00 noon. Service C61 means that the Transmitter battery is used up. Action: Press the SEL button and then the ACT button to clear the alarm. The battery cannot be changed in the Transmitter. The battery life is about one year. Change out the Transmitter as soon as possible.
No Sync C76 NO sync 12:00 AM Error Message: C76/NO SYNC (Loss of Communication) Cause: The Monitor and Transmitter are out of synchronization. As a result, the Monitor is unable to get data from Transmitter. The search for the Transmitter has failed, or communication has been lost. Action: 1. Press the SEL button and then the ACT button to clear alarm. If Transmitter Search is not done, the alarm will repeat every 20 minutes. 2.
7. If alarm continues, U.S. and Canadian customers please contact the Product Help Line at 800-MINIMED (800-646-4633) or 818-576-5555. All other international customers please contact your local sales office. Cal Err 12:00 AM CAL ERR Error Message: CAL ERR (Calibration Error) Cause: Calibration cannot be done successfully due to Monitor and Transmitter not communicating, Meter BG outside expected range from Sensor reading, or Monitor was turned off for more than 2 hours. Action: 1.
Key Held 12:00 AM C77 Key HELD Error Message: C77/KEY HELD Cause: A Monitor key has been pressed and held for more than 3 minutes. Action: Press the SEL button and then the ACT button to clear the alarm. Enter BG 12:00 AM C78 ENTER BG Error Message: C78/ENTER BG (Enter Calibration Value) Cause: Calibration is needed. No new glucose values will be recorded until calibration is done. Calibration value must be between 40-400 mg/dl (2.22-22.2 mmol/l).
Set Time 12:00 AM C79 SET TIME Error Message: C79/SET TIME (Reset Date and Time in Monitor) Cause: The internal clock has cleared. Most likely the batteries were taken out and not placed back for more than 10 minutes, and the clock does not have the right time. Action: Press the SEL button and then the ACT button to take care of the alarm. Reprogram your Monitor, and change Sensor, if prompted, following the instructions in Chapter 2: Getting Started.
Replace Sensor 12:00 AM GLUCOSE SENSOR C80 REPLACE Error Message: C80/REPLACE (Change Sensor/End of Sensor Life) Cause: The maximum expected life of the Sensor has been reached. In other words, either the Monitor has seen a problem with the Sensor, triggering two calibration alarms, one after the other, or 72 hours have passed since the Sensor was first put in and initialized. This alarm will repeat every 20 minutes until the Sensor is changed and initialized. Action: 1.
System Alarms These alarms are triggered when a diagnostic test finds an error in the Monitor. If an alarm code has an “F” followed by two numbers (example shown below), do the following procedure: F## Service 12:00 AM 1. Write down the alarm code. 2. Download data into a personal computer right away (using the Com-Station and Guardian Solutions Software) to help with troubleshooting the device. 3. To report the alarm, U.S.
Test Plug Procedure If you come across an operating problem, the Test Plug gives information that can let you know if a Sensor, Monitor or Transmitter is working correctly. The Test Plug sends a constant electronic signal to the Monitor. This data can be read on the Monitor Signals screen. The normal signal range is about 24-29 nA (nanoamperes). 1. Disconnect the Sensor from the Transmitter’s Sensor connector. 2. Press the SEL button until the SEARCH screen appears, and start the search for the Transmitter.
6. When the Monitor displays between 2:13 and 2:10 h, go to the SIGNALS screen (From the HOME screen, press SEL 6 times and then press ACT) to view the ISIG. GLUCOSE SENSOR Signals NOTE - Do not go to the signals screen until the Monitor has counted down to between 2:13 and 2:10 h. 7. If the ISIG value is between 24 and 29 nA, and the Initialization screen shows 2:00 h or less, the Transmitter and Monitor are working properly. Change the Sensor. Initialize and calibrate the new Sensor.
Chapter 5 Performance Characteristics NOTE - Users should have the information in this chapter reviewed by their healthcare provider. The Medtronic MiniMed Guardian RT uses a glucose Sensor to continuously monitor your glucose levels. The Guardian RT Sensor is “calibrated” using your home blood glucose meter. Once calibrated, the Guardian RT reports glucose values every 5 minutes.
Performance Results The performance of the Guardian RT was evaluated in a clinical study. Guardian RT results were compared to plasma glucose values from a reference method, the YSI 2300 STAT PlusTM glucose analyzer (referred to as YSI). Sixteen subjects with Type I diabetes participated in a single-site in-clinic study. Subjects ranged in age from 18 to 65 years old. Each subject wore 2 Guardian RT systems simultaneously. One Guardian system was calibrated an average of 3.
Accuracy of Guardian RT Readings In this study, YSI measurements (taken every half hour) were paired with the corresponding Guardian RT reading (taken every 5 minutes). Pairing was done by selecting the Guardian RT value closest in time to the YSI test result. Agreement was analyzed by comparing paired glucose measurements. Agreement between the matched pair was estimated by evaluating the difference between the Guardian RT reading and the YSI measurement.
The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RT readings and the comparative YSI measurements. The Clarke Error Grid divides a correlation plot into 5 zones. See Table 5.3. Results in zones A and B are considered clinically acceptable, while results in zones C, D, and E are potentially dangerous and, therefore, clinically significant errors. The Clarke Error Grid zones are labeled on the correlation plot. Table 5.
Figure 5.1 is a correlation plot of Guardian RT readings versus readings from the reference method, the YSI 2300 Glucose Analyzer. It is overlaid with the Clarke Error Grid. The total number of paired data points is 3941. Figure 5.
The percent of Guardian RT readings in the above graph are presented in Table 5.4 below according to the percentage of points falling within each zone (A-E). Results are further broken down (stratified) according to the range of glucose concentrations. Table 5.4: Stratified Clarke Error Grid Analysis Glucose Range (mg/dl) Number A+B and (%) of Data Points Evaluated A B C D E 40-80 356 (9) 1 (0.1) 80 (22.5) N/A* 3 (0.8) 769 (20) N/A 121-240 2362 (60) 4 (0.2) N/A 6 (0.
Precision of Guardian RT Readings This study was also designed to look at the reproducibility of two Sensors worn simultaneously at different locations on the body. Precision was estimated by comparing the glucose readings from the two Guardian RT systems. In this study 11,475 paired Sensor Guardian RT values were obtained. On average, they were different by 17.2%. Figure 5.2 is an example of how data was paired in this study. In the graph there are two tracings of Guardian RT values.
The Low Glucose Alert The Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dl (3.9 mmol/l), or below, using the YSI 2300 STAT Plus glucose analyzer. As a reference, with the Low Glucose Alert set at 70 mg/dl (3.8 mmol/l), 49% (100/205) of low glucose events were detected by the Guardian RT. Better detection of low blood glucose can be obtained by setting the Low Glucose Alert level higher. For example, setting the Low Glucose Alert at 90 mg/dl (5.
The High Glucose Alert The High Glucose Alert was evaluated for its ability to detect glucose levels at 250 mg/dl (13.8 mmol/l), or above, using the YSI analyzer. As a reference, with the High Glucose Alert set at 250 mg/dl 13.8 mmol/l), 53% (195/365) of high glucose events were detected by the Guardian RT. Better detection of high blood glucose can be obtained by setting the High Glucose Alert level lower. For example, setting the High Glucose Alert at 190 mg/dl (10.6 mmol/l), instead of 250 mg/dl (13.
Guardian RT Sensor Performance and Calibration Stability As a Function of Time The Guardian RT Sensor may be worn for up to 3 days (72 hours) and must be calibrated at least twice a day. Two sets of data, approximately equal in number, were collected during the clinical trial. One data set was generated when the frequency of calibrations averaged 3.5 per day (Data Set A), and the other averaged 5 times a day (Data Set B). During the study, a total of 38 Sensors were evaluated in 16 individuals.
An analysis of the mean percentage of Absolute Relative Error (ARE %) and standard deviations, across 12-hour increments of wear periods, appears in Table 5.8 below. Both data sets are pooled together in this data. Table 5.8: Performance As a Function of Sensor-Insertion Time Hours From Insertion Mean ARE (%) Std. Dev. 0-12 hrs 24.84 20.04 12-24 hrs 19.66 16.17 24-36 hrs 16.43 15.62 36-48 hrs 18.23 19.27 48-60 hrs 16.59 14.25 >60 hrs 22.95 23.
Table 5.10 Percentage of Guardian RT values within 20% of YSI laboratory readings Percentage of Guardian RT values within 30% of YSI laboratory readings Glucose Range (mg/dl) During first 60 hours of Sensor wear After 60 hours of Sensor wear During first 60 hours of Sensor wear After 60 hours of Sensor wear 81-120 57-66% 48% 72-84% 66% Performance of the Guardian RT was evaluated according to the length of time since calibration.
Time-Elapsed Plots Figure 5.3 is a representative example of continuous Sensor tracing vs. reference blood glucose reading, where Sensor showed excellent performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the Sensor glucose value. Figure 5.
Figure 5.4 is a representative example of continuous Sensor tracing vs. reference blood glucose reading, where Sensor showed average (typical) performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the Sensor glucose value. Figure 5.
Figure 5.5 is a representative example of continuous Sensor tracing vs. reference blood glucose reading, where Sensor showed poor performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the Sensor glucose value. Figure 5.
98 Chapter 5
Chapter 6 System Maintenance Belt Clip The Belt Clip is used to attach the Monitor to a belt or to clothing. Installation The Belt Clip is attached to the back of the Monitor by sliding the triangular-shaped ridge on the back of the clip into a groove on the back of the Monitor. Push the clip until it stops and clicks into place. (See Figure 6.1.) Figure 6.
Removal Using your finger, lift up on the oval shaped end of the Belt Clip. Gently slide the clip out of its groove. (See Figure 6.2.) Figure 6.2 Oval-Shaped End Leather Case The Leather Case helps protect the Monitor against moisture, dirt, debris and electrostatic discharge. Protection from Water Although the Transmitter and Sensor are water resistant, repeated direct contact with water or other liquids should be avoided. ➠ The Monitor should never be placed under water.
Protection from Impact The Monitor has been designed to be rugged and resistant to wear during everyday use. However, users should avoid rough sports or other activities that could damage the Monitor, the Transmitter, or the Sensor. ➠ ➠ ➠ The Monitor should be protected from mechanical damage, such as a fall or impact. If the Monitor is dropped, check for damage before using. The Monitor should be placed inside the leather case when it is worn.
Cleaning the Monitor 1. Use only a damp cloth and mild detergent mixed with water to clean the outside of your Monitor. 2. Wipe excess soap from the Monitor with a clean, damp cloth. 3. Dry with a separate clean cloth. 4. Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your Monitor. 5. Keep the reservoir and battery compartments dry and away from moisture. 6. Do not use any lubricants with your Monitor. 7.
For multiple-patient use 1. Wash your hands thoroughly. 2. Dampen a clean cloth with a mild liquid soap solution. CAUTION: Do not place the Transmitter into the liquid soap solution. 3. Wipe the outside of the Transmitter, cable, and connector. Make sure the inside of the connector does not get wet. 4. Hold by the Transmitter end and rinse the Transmitter under warm tap water. Be careful not to get the inside of the connector wet. 5. Apply 3-4 drops of a quaternary ammonium compound disinfectant (e.g.
Cleaning the Sen-serter For single-patient use 1. Dampen a clean cloth with mild liquid soap and warm water and wipe the sen-serter. 2. Rinse with warm tap water. 3. Using an antibacterial hand-sanitizer (readily available at your local drugstore), wipe down the sen-serter. 4. Place the sen-serter on a clean dry cloth and allow to air dry. 5. Store sen-serter in the released position to maintain optimum product performance and life. For multiple-patient use 1.
Interference from Electrical Equipment The Monitor is designed to meet all IEC standards for electromagnetic interference. The Monitor should withstand common electrostatic and electromagnetic interference. However, using the Monitor in close distance to strong electromagnetic sources, such as MRIs, X-rays, CT scans, television sets, cell phones, cordless phones, hand-held and mobile two-way radios, radio transmitters, high-voltage power lines, and store anti-theft security devices, is not recommended.
Ordering Supplies Medtronic MiniMed stocks a wide range of Guardian RT supplies, including Glucose Sensors, Transmitters, leather cases, belt clips, dressings, and other accessories. (See Tables 6.1 and 6.2.) U.S. and Canadian customers, place orders by calling 800-MINIMED (800-646-4633) or 818-576-5555. All other international customers please contact your local sales office. Orders can be placed online at www.minimed.com. Table 6.
Product Specifications The following tables list Monitor, Test Plug and Transmitter performance specifications. (See Tables 6.3, 6.4 and 6.5.) Table 6.3: Monitor Component Performance Specification Glucose Measurement Range 40-400 mg/dl (2.2-22.2 mmol/l) Typical Operating Range 6 feet (2 meters) Display Liquid crystal display (LCD) Display Window Length: 1.40 inches (3.56 centimeters) Height: 0.70 inches (1.78 centimeters) Dimensions Length: 3.56 inches (9.04 centimeters) Height: 2.
Table 6.3: Monitor Component 108 Chapter 6 Performance Specification Battery Life Exceeds one month under anticipated normal use Case Material High impact ABS/polycarbonate composite Safety Checks Diagnostic signals verify proper Sensor and measurement system operation Operating Conditions Temperature: 0 to +50 degrees Celsius (+32 to +122 degrees Fahrenheit).
Table 6.4: Test Plug Component Performance Specifications Operating Conditions Temperature: 0 to +50 degrees Celsius (+32 to +122 degrees Fahrenheit) Relative Humidity: 15% to 95% with no condensation Storage Conditions Temperature: -20 to +55 degrees Celsius (-4 to +131 degrees Fahrenheit) Relative Humidity: 10% to 100% with condensation Approved Cleaners A mild household liquid detergent diluted with water, a quaternary ammonia solution, or isopropyl alcohol on a wipe.
Table 6.5: Transmitter Storage Conditions Temperature: -20 to +55 degrees Celsius (-4 to +131 degrees Fahrenheit) Relative Humidity: 10% to 100% with condensation Approved Cleaners A mild household liquid detergent diluted with water, a quaternary ammonia solution, or isopropyl alcohol on a wipe. (DO NOT place liquids into either connector.) Approved Disinfectants Tap water, 10% bleach solution, 3% hydrogen peroxide solution, 70% isopropyl alcohol.
2. This device must accept any interference received, including interference that may cause undesired operation.
Icon Table Table 6.6: Icons Attention: See Instructions for Use Date of Manufacture (year - month) CAUTION: U.S. law restricts the Guardian RT and system components to sale by or on the order of a physician.
Table 6.6: Icons Radio Communication Manufacturer CE Mark By Notified Body As a Medical Device 0459 CE Mark With a Radio Transmitter Under The R&TTE1999/5/EC Directives 0459/0976 IPX1 IPX8 Monitor: Protected Against the Effects of Vertically Falling Water Drops. Transmitter and Sensor: Protected Against the Effects of Continuous Immersion in Water.
Fixed Elements Table Table 6.7: Fixed Elements 114 Chapter 6 CAL Displayed as a reminder or warning to the user to enter a BG value for glucose sensor calibration. GLUCOSE Displayed on screens related to glucose readings. Not used on Alarm History Screen but on the Alarm History Selection screen. GLUCOSE HIST Displayed on screens used for viewing or clearing glucose history values. Not used on the NOW screen. GLUCOSE LIMIT Displayed on screens showing hypoglycemia or hyperglycemia alarm limits.
Appendix Electromagnetic Compatibility Compliance Information In accordance with IEC 60601-1-2, the following information on electromagnetic compatibility compliance has been provided. Also refer to the section “Interference from Electrical Equipment” in Chapter 6: System Maintenance. Table A1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Guardian RT is intended for use in the electromagnetic environment specified below.
Table A2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Guardian RT is intended for use in the electromagnetic environment specified below. The user of the Guardian RT should assure that it is used in such an environment. 116 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 + 6 kV + 8 kV air > + 8 kV > + 30 kV air Typical commercial, hospital, or home environment.
Table A2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Guardian RT is intended for use in the electromagnetic environment specified below. The user of the Guardian RT should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Table A3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Guardian RT The Guardian RT is intended for use in an electromagnetic environment in which RF disturbances are controlled.
120
Glossary Alarm - An audible tone or physical vibration that lets the user know of an important event. Calibration - The process of adjusting how the Guardian RT turns electronic signals from the Sensor into glucose values. The Sensor is calibrated by entering fingerstick meter values into the Guardian RT memory. Com-Station - A device that lets a personal computer (PC) communicate with the Guardian RT to download data.
122
