Medtronic MMT-7900 User Manual

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.
IV3000
®
is a registered trademark of Smith & Nephew, Inc.
YSI 2300 STAT Plus™ is a trademark of YSI Incorporated.
The Guardian RT System is covered by the following Patent Nos: 5,390,671; 5,391,250; 5,568,806; 5,586,533; 5,586,553; 5,777,060; 5,779,665; 5,786,439; 5,851,197; 5,882,494; 5,954,643; 6,093,172; 6,248,067; 6,293,925; 6,368,141; 6,418,332; 6,424,847; 6,462,162; 6,520,326; 6,607,509; DES 433,755.
The Guardian RT System is covered by other/pending patents.
6024979-012 072505
0459/0976
Table of Contents i
Table of Contents
Chapter 1: Introduction ......................... 1
System Function....................................................... 2
System Components .................................................. 2
Glucose Sensor.................................................................... 2
Transmitter .......................................................................2
Monitor............................................................................. 3
Monitor Buttons ..................................................................3
Monitor Button Functions .......................................................4
Monitor User Guide Terms ......................................................4
Test Plug.......................................................................... 5
Sen-serter ........................................................................ 5
Availability............................................................. 5
Help..................................................................... 6
Record Keeping........................................................ 6
Warranty ............................................................... 6
User Safety .................................... ......................... 7
Indications for Use...............................................................7
Contraindications ................................................................7
Warnings...........................................................................8
Precautions........................................................................ 9
Adverse Reactions.............................................................. 11
Symptoms of Hypoglycemia .................................................. 11
Symptoms of Hyperglycemia ................................................. 12
Blood Glucose Meter........................................................... 12
ii Table of Contents
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.................................................................... 19
The Main Screens.................................................... 20
Programming the Monitor..................................................... 21
Setting the Language ......................................................... 22
Setting the Time Display Format ........................................... 23
Setting the Time and Date................................................... 24
Clearing the Glucose History ................................................ 26
Setting the Glucose Unit ..................................................... 29
Setting the Low Glucose Alert............................................... 30
Setting the High Glucose Alert.............................................. 33
Setting the Alert Type........................................................ 36
Entering the Transmitter ID ................................................. 37
Inserting the Sensor................................................ 39
Sensor Storage and Handling ................................................ 44
Sen-serter Maintenance...................................................... 44
Affixing the Transmitter............................................ 45
Searching for the Transmitter............................................... 46
Connecting the Sensor to the Transmitter ................................ 47
Sensor Initialization........................................................... 48
Sensor Calibration............................................................. 48
Calibration Pending........................................................... 50
No Sync ......................................................................... 50
Replacing the Glucose Sensor ..................................... 51
Removing the Sensor.......................................................... 51
Table of Contents iii
Chapter 3: Routine Operation.................. 53
Glucose History ...................................................... 53
Entering Meter BG for Calibration................................ 55
BG Due................................................................ 56
Enter BG......................................................................... 57
Calibration Pending............................................................ 57
No Sync .......................................................................... 58
Replacing the Glucose Sensor ................................................ 58
Events.......................................... ........................59
Units of Insulin Taken ......................................................... 60
Carbohydrate Amount ......................................................... 61
Duration of Exercise ........................................................... 61
Other Events.................................................................... 62
Glucose Alarm History...............................................63
Search .................................................................65
Signals .................................................................65
The Snooze Option...................................................66
Chapter 4: Troubleshooting and Alarms ........ 67
List of Alarms........................................................ 68
No ID ............................................................................. 68
High .............................................................................. 69
Low............................................................................... 70
Check Sensor.................................................................... 71
Low Batt......................................................................... 72
Off/No Power................................................................... 73
Service C60/61 ................................................................. 74
Re Init............................................................................ 74
No Sync .......................................................................... 75
Cal Err............................................................................ 76
Key Held......................................................................... 77
Enter BG......................................................................... 77
Set Time......................................................................... 78
Replace Sensor ................................................................. 79
System Alarms....................................................... 80
Test Plug Procedure ................................................ 81
iv Table of Contents
Chapter 5: Performance Characteristics .......83
Performance Results................................................ 84
Accuracy of Guardian RT Readings ............................... 85
Precision of Guardian RT Readings ............................... 89
Low and High Alerts................................................. 89
The Low Glucose Alert ....................................................... 90
The High Glucose Alert........................................................ 91
Guardian RT Sensor Performance and Calibration .............. 92
Affects of Calibration Frequency ................................. 94
Time-Elapsed Plots.................................................. 95
Chapter 6: System Maintenance ................99
Belt Clip .............................................................. 99
Installation ...................................................................... 99
Removal........................................................................ 100
Leather Case ....................................................... 100
Protection from Water ............................................100
Protection from Impact ...........................................101
Protection from High and Low Temperatures..................101
Cleaning the Monitor............................................... 102
Cleaning the Transmitter ......................................... 102
Cleaning the Sen-serter ........................................... 104
Interference from Electrical Equipment ........................ 105
Ordering Supplies................................................... 106
Product Specifications............................................. 107
FCC Notice for the Monitor ....................................... 110
FCC Notice for the Transmitter .................................. 110
Icon Table ........................................................... 111
Fixed Elements Table.............................................. 113
Appendix........................................ 115
Electromagnetic Compatibility Compliance Information .... 115
Glossary ........................................ 121
1
Introduction
Congratulations on buying one of the most exciting devices in the field of diabetes care! The Medtronic MiniMed Guardian® RT (Real Time) System (M MT-7900) continuously monitors glucose levels, provides real-
time 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. The Sensor is inserted in the abdomen in fluid under the skin (Interstitial Fluid) and is attached to the Transmitter. The Transmitter takes information from the Sensor and sends it to the Monitor. The Monitor is a device that can store this information for real-time review, or can download it to a personal computer using a Medtronic MiniMed Com-Station™ (MMT-7301) and the Guardian Solutions™ Software (MMT-7315). This information is used by you and your doctor to identify glucose patterns and to improve your diabetes management.
We know you are ready to start, but before you do, please read the following user guide to learn all about the Guardian RT. Chapter 1 gives a general overview of the system. Chapter 2 offers step-by-step instructions to get you started. Chapter 3 explains the routine operation of the Guardian RT. Chapter 4 walks you through the system alarms and troubleshooting approach. Chapter 5 goes over performance characteristics, and Chapter 6 covers system maintenance and other important information.
Figure 1.1
Monitor
Transmitter
Sensor
2
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. Data from the Sensor (which is placed under the skin into the interstitial fluid) triggers the low blood glucose alert if your Sensor glucose value is less than or equal to the preset limit. The high blood glucose alert is triggered if your Sensor glucose value is greater than or equal to the preset limit. Glucose values are calculated and displayed based on the blood glucose reference values entered periodically into the Monitor for calibration.
NOTE -
Before taking action based on glucose values or High and Low glucose alerts, check your blood
glucose using a home glucose meter available from your doctor or pharmacy.
System Components
Glucose Sensor
Figure 1.2
The Sensor (MMT-7002) is inserted through the skin into interstitial fluid. The Sensor gives off a signal that is related to the amount of glucose in the interstitial fluid at the insertion site. (See Figure 1.2.)
Transmitter
Figure 1.3
The Transmitter (MMT-7700) connects to the Sensor and is fixed to the skin with medical tape. The Transmitter receives and processes signals from the Sensor, and it sends the signals by radio frequency to the Monitor. (See Figure 1.3.)
Introduction 3
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).
The system is calibrated by entering into the Monitor blood glucose values from a home glucose meter. Six hours before a meter BG entry for the purpose of calibration is due, the word CAL will appear on the Monitor screen. This icon will remain on the display until you enter a meter value. If you do not enter a meter value within 12 hours of the last entry, an ENTER BG alarm is triggered. This alarm is also triggered if a calibration has not been done in the last 8 hours since the first calibration. For best performance, enter a meter value every 6 hours. A minimum of one meter value must be entered at least every 12 hours into the Guardian RT for the real-time glucose display and the low and high glucose alerts to work.
Monitor Buttons
The Monitor is controlled by 5 buttons. (See Figure 1.4.) Always press the Monitor buttons slowly and firmly.
Figure 1.4
Up Arrow
Down Arrow
Backlight Button
Select Button
Activate
Button
On/Off Button
Display
Screen
4
Monitor User Guide Terms
The following terms and icons are used to describe the Monitor in this User Guide:
Press means to push and release the button. Hold means to push and keep pressure on the button. Flashing words or numbers (but not icons) on the screen mean that you can change this information
in the Monitor.
Information that cannot be changed appears on the screen in characters that do not flash. Button names are always UPPERCASE and bold, e.g., ACT and SEL. ➠ Screen names are always UPPERCASE, e.g., HOME and HIGH.
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. Press either arrow once to pick the next highest or lowest value. Hold down either arrow to scroll through the list of values. Hold down either arrow for more than 5 seconds to speed up scrolling. When you reach the wanted value press ACT to set. If you do not press ACT within 10-20 seconds, the display will go back to the default screen.
Located on the Down arrow and used from the HOME screen, the Backlight button turns On or Off the screen light, letting you see the display at night or in dim lighting. The light will stay on for about 15 seconds after the last button press.
Introduction 5
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. (See Figure 1.6.)
Availability
The Guardian RT and supporting products are available from Medtronic MiniMed and authorized distributors.
6
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.
Record Keeping
A serial number is found on the back of the Monitor and on the top of the Transmitter. Please enter the serial numbers and purchase date in the table below.
Warranty
Please read the enclosed warranty card carefully as it lists the terms of coverage.
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.minimed.com
Serial Number Purchase Date
Monitor: Transmitter:
Introduction 7
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. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on Guardian RT values.
The Guardian RT provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software for analysis of historical glucose values.
Contraindications
Use of the Guardian RT is not recommended for persons whose impaired vision or hearing does not allow
full recognition of the Guardian RT signals and alarms/alerts.
The Sen-serter is not indicated for use with product other than the Glucose Sensor. Medtronic MiniMed
cannot guarantee this product’s safety and/or efficacy if other sets are used.
8
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.
Sensor/Sen-serter
The Sensor may create special needs regarding your medical conditions or medications. Please discuss these conditions and medications with your doctor before using the Sensor. Bleeding, swelling, irritation and/or infection at the insertion site are possible risks associated with inserting the Sensor and may result from improper insertion and maintenance of insertion site.
After insertion, wait 2-3 minutes before attaching the Transmitter to watch for bleeding at the insertion site. If bleeding occurs, apply steady pressure using a sterile gauze or clean cloth for up to 3 minutes.
If bleeding stops:
1. Attach the Sensor to the system connector.
If bleeding does not stop:
CAUTION: Do NOT attach the Sensor to the system connector.
1. Remove the Sensor and discard.
2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat
accordingly.
3. Insert a new Sensor in a different location.
Introduction 9
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.
The Sensor is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use any
Sensor if its sterile package has been previously opened or damaged. Always inspect packaging for
damage prior to use. Do not use a Sensor that exceeds the expiration date printed on the package.
Remove plastic needle cover before inserting Sensor.
If Sensor is not securely placed in Sen-serter prior to insertion, pain or minor injury may occur.
Never point loaded Sen-serter toward any body part where insertion is not desired.
Precautions
Monitor
You should be trained by your healthcare professional on how to program and operate the Monitor and
respond to alarm/alert conditions before using the system.
Do not expose the Monitor to water. The Monitor should be set aside or placed in a Shower-Pak™ (MMT-
117) before doing activities in which the Monitor would be expected to get wet.
Contact sports or other activities may damage the Monitor and should be avoided. Prior to exercising,
make sure the Sensor is firmly attached.
If the Monitor shows a NO POWER alarm on the display, there will be an immediate shut-off as soon as the
alarm is acknowledged, and data collection will automatically stop. Batteries must be replaced
immediately to avoid the need for Sensor replacement and potential loss of data stored in memory. Upon
battery replacement, a SEARCH must be performed. (Refer to Searching for the Transmitter section in
Chapter 2: Getting Started.)
10
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. Avoid sites that are constrained by clothing, scar tissue, accessories or subjected to rigorous movement during exercise.
Sensor
Always wash hands with soap and water before opening the Sensor package and handling Sensor. After opening the package, avoid touching any Sensor surfaces that will come in contact with the body. These surfaces include: the Sensor, needle, connector adhesive surfaces and tape.
Prior to inserting the Sensor, select insertion site, and use antiseptic to cleanse site. Allow area to dry. If you also wear an insulin pump, make sure that the Sensor insertion site is at least three (3) inches
(7.62 cm) away from the insulin infusion site. If you inject insulin, you should give injections at least three (3) inches (7.62 cm) away from the Sensor insertion site. When replacing Sensor, select new insertion site at least two (2) inches (5.08 cm) from previous site.
Do not insert Sensor through tape, and do not use sticky preps before insertion. After inserting the Sensor and attaching the Transmitter, cover the Sensor site with sterile/occlusive
dressing, such as IV3000® (MMT-174). Be aware that excessive perspiration can loosen dressing. Check dressing after any activity in which
excessive perspiration has resulted. Establish a rotation schedule for choosing each new Sensor site. Avoid sites that are constrained by
clothing, scar tissue, accessories or subjected to rigorous movement during exercise. Dispose of used Sensors and introducer needles in a sharps container after single use. Do not clean or
resterilize, and do not recap needle with Sensor needle cover.
Introduction 11
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. and Canadian customers please contact your
doctor and the Product Help Line at 800-MINIMED (800-646-4633) or 818-576-5555. All other international
customers please contact your local sales office.
Symptoms of Hypoglycemia
Hypoglycemia (low blood glucose) may occur in persons with diabetes who take insulin or certain oral
medications. There are symptoms linked to low blood glucose that should not be ignored no matter how
mild they are, even if the Guardian RT does not display a low glucose value or give a low glucose alert. If
you have any of the following symptoms, take a meter blood glucose reading, and check with your doctor
before you treat:
sweating confusion hunger
dizziness headache blurred vision
palpitations speech impairment
trembling drowsiness
12
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. If you have any of the following symptoms, take a meter blood glucose reading, and check with your doctor before you treat:
Blood Glucose Meter
Be sure to periodically maintain your home blood glucose meter periodically, and check its accuracy when using it for calibration of your Guardian RT system. Check with your BG meter’s user guide for information on meter coding, calibration, and testing against solutions and other laboratory instruments. Ask your doctor about verifying the relative accuracy of your meter, or to find a BG meter that is right for you.
fatigue blurred vision excessive thirst
hunger frequent urination
13
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.
NOTE -
If the ACT button has not yet been pressed, mistakes in programming often can be fixed by
simply waiting 10-20 seconds without pressing any buttons.
Quick-Reference Guide
PROGRAM MONITOR
Set Language Select Time Display Format Set Date and Time Clear Glucose History Set Gluco se Units Set Low Alert Set High Alert Set Alert Typ e Enter Transmitter ID
14 Chapter 2
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
Getting Started 15
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 Strip Lots, and Run Controls
16 Chapter 2
LIST OF ALARMS See Chapter 4, Troubleshooting and Alarms, for More Information.
No ID (C52): Missing Transmitter ID in Setup
Sensor Glucose HIGH: Sensor Glucose Above High Setting
Sensor Glucose LOW: Sensor Glucose Below Low Setting
Check Glucose Sensor (C54): Sensor Current Outside Range
Low BATT: Monitor Batteries are Running Low
Off/No Power: Monitor Batteries are Used Up
Service C60/C61: Transmitter Battery is Low or Used Up
Re Init C62: Setup Information Not Received by Monitor
No Sync (C76): Monitor Lost Communication with Transmitter
Cal Err (Calibration Error): Last BG Entry Differed from Expected Reading
Key Held (C77): Button Pressed for Too Long/Button Stuck
Enter BG (C78): Enter New BG Value for Calibration
Set Time (C79): Time Reset to Default
Replace Sensor (C80): No More Glucose Readings/End of Sensor Life
System Alarms (F##): System Diagnostic Problem
Test Plug Procedure
Getting Started 17
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.
If batteries are not changed within 10 minutes of taking out a used-up set, an alarm will be triggered, and the Sensor will have to be replaced. (See Chapter 4: Troubleshooting and Alarms.) Be sure to have a new set of batteries ready when replacing the old set.
In order to properly save and keep stored Monitor information, always turn the Monitor off before changing batteries.
4. Find the battery compartment on the back side of the Monitor.
5. With the screwdriver provided, loosen the screw while holding the Monitor’s battery compartment
lid. Do not try to fully remove the screw; it is meant to stay attached to the lid.
6. Take off the battery compartment lid.
7. If you are changing batteries, first pull on the ribbon to loosen. Next, take out the old batteries with
your fingers.
8. Place the battery strap around the new batteries. Refer to the diagram on the inside of the battery
compartment lid.
CAUTION: If the batteries are put in with the positive and negative
terminals switched, they will become very warm, and the Monitor will not work. Carefully, place the batteries in the Monitor correctly.
18 Chapter 2
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.
NOTE -
If Monitor display is blank, or not responding to button presses, 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.
CAUTION: Batteries must be recycled or disposed of properly. Do not
dispose of batteries by putting them in fire.
+
-
Getting Started 19
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. If a problem is found, it will trigger an
audible (or vibrating) alarm and an error message. See Chapter 4: Troubleshooting and Alarms.
Turning Off the Monitor
Information, including the Sensor values gathered before the Monitor was turned off, will be saved in the Monitor. No new information will be collected.
1. Press the On/Off button.
2. The Monitor will beep or vibrate, and CONFIRM will blink on the screen.
3. Press ACT to confirm. If you don’t, the Monitor will stay on and return to the HOME screen.
4. The screen will go blank when successfully turned off.
Home Screen
The HOME (Time of Day) screen for the Monitor shows the time in the upper left-hand corner. Once the Search procedure has been successfully done, the antenna icon ( ) will show that the Monitor is getting information from the Transmitter, i.e., telemetry has been achieved. The antenna icon will stay on the screen as long as there is telemetry. This screen, as shown to the right, is displayed if no buttons have been pressed or no alarms/alerts have been triggered. From any screen, if no buttons are pressed, the Monitor will “time out” and return to the HOME screen.
12:00 PM
20 Chapter 2
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 Operati on.
Figure 2.8
SETUP
12: 00
AM
SIGNALS
GLUCOSE
SENSOR
events
GLUCOSE
mg/dl
_ _ _
search
SEL
SEL
SEL
SEL
11:57
PM
CONFIRM
--:--
BG DUE
SNOOZE
11:57
PM
SEL
SET-UP
SUB-SCREENS
UP ARROW
SEL
SEL
ACT
UP ARROW/
SEL
SEL
UP ARROW
POWER
OFF
HOME SCREEN
GLUCOSE
ALARMS
meter bg
mg/dl
_ _ _
SEL
ACT
BLANK SCREEN/
OFF
3:00
PM
NOW
Getting Started 21
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. This process will be explained in the following pages. Figure 2.3 describes the subscreen flow.
SET-UP SUB-SCREENS
Figure 2.9
NOTE -
Always set time and date before using the Monitor for the first time.
clear
TRANS ID
SET TIME
ALERT
UNIT
SEL
SEL
SEL
SEL
DISPLAY
language
EXIT
SEL
SEL
SEL
ACT
SEL
MAIN MENU
SEL
LIMIT
GLUCOSE
LOW
GLUCOSE LIMIT
HIGH
12:00
AM
12:H r
GLUCOSE
GLUCOSE
SETUP
ACT
mg/dl
mg/dl
mg/dl
_ _ _
_ _ _
HIST:
22 Chapter 2
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.
4. Press ACT. The screen will display the word ENGLISH blinking.
5. Use Up or Down arrow button to scroll through the different languages. Each language will appear
blinking until selected when the ACT button is pressed. a. With each press of the Up arrow button, this is the language order as it appears on the screen:
English —> French —> Spanish —> Italian —> Swedish —> German —> Dutch
b. With each press of the Down arrow button, this is the language order as it appears on the screen:
English —> Dutch —> German —> Swedish —> Italian —> Spanish —> French
6. Press ACT to choose the desired language.
7. The display will change to the EXIT screen. The screen information will now be shown in the chosen
language.
NOTE -
If when on a language screen SEL is pressed instead of ACT, the display will go to the EXIT
screen, and the language change will not be made.
8. Press ACT to return to the HOME screen.
LANGUAGE
Getting Started 23
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.
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. Use the Up or Down arrow button to choose either “12” (AM/PM) or “24” (International) which is the time format to be used.
5. Press the ACT button to set the time format.
6. Press the SEL button and the Monitor will go to the UNIT sub-screen. Press SEL 4 times to go to EXIT.
Press ACT to go back to the HOME screen.
DISPLAY
12:HR
or
DISPLAY
24:Hr
DISPLAY
12:Hr
SET
SET
24 Chapter 2
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 Hour
1. Press the ACT button once, and the word HOURS will appear. The first two digits will be blinking,
and the word SET will appear.
2. Use the Up or Down arrow button to choose the correct hour. If using the 12-hour format, make sure
the screen shows the correct AM or PM text. For example: AM is displayed and you need PM; press the Up or Down arrow to scroll through the times until the correct time with PM appears.
3. If using the 24-hour time format, choose hours between “0” and “23.”
4. Press the ACT button once, and the word MINUTES will appear.
or
SET TIME
00:00
SET TIME
12:oo
AM
or
HOURS
00:00
HOURS
12:oo
AM
SET
SET
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