User Guide
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User Guide
CONTINUOUS GLUCOSE MONITORING SYSTEM
Guardian® REAL-Time Continuous Glucose Monitoring System User Guide
©2006, Medtronic MiniMed, Inc. All rights reserved. This product is covered by U.S. Patent No. 6,809,653. Other U.S. and/or foreign patents may be pending. Guardian®, Medtronic CareLink® and Sen-serter® are registered trademarks of Medtronic MiniMed, Inc. CareLink Personal™, ComLink™, and Medtronic MiniLink™ are trademarks of Medtronic MiniMed, Inc. Energizer® is a registered trademark of Eveready Battery Company. Glucagon Emergency Kit® is a registered trademark of Eli Lilly and Company. Cavicide ® is a registered trademark of Metrex Research Corporation, an indirect subsidiary of Sybron Dental Specialties, Inc. LifeScan®, OneTouch®, OneTouch® Ultra® and OneTouch® UltraLinkTM are trademarks of LifeScan, Inc.
6025254-015 070408
REF CSS72, CSS7100, CSS7100K, CSS7707
Contacts: ಘ Africa: Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help) Belgie/Belgique: N.V. Medtronic Belgium S.A. Tel: 02-456-0900 Brasil: Medtronic Comercial Ltda. Tel: +(11) 3707-3707 Canada: Medtronic of Canada Ltd. Tel: 1-800-284-4416 (toll free/sansfrais) Ceska Republika: Medtronic Czechia s.r.o. Tel: +420 296 579 580 China: Medtronic (Shanghai) Ltd. Tel: +86 40 0820 1981 or 80 0820 1981 Danmark: Medtronic Danmark A/S Tel: +45 32 48 18 00 Deutschland: Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633 East Asia: Medtronic International Ltd. Tel: +852 2891 4300
Eire: Accu-Science LTD. Tel: +353 45 433000 España: Medtronic Ibérica S.A. Tel: + 34 91 625 05 42 Fax: +34 91 625 03 90 24 hour: +34 901 120 335 Europe: Medtronic Europe S.A. Europe, Middle East and Africa Headquarters Tel: +41 (0) 21-802-7000 France: Medtronic France S.A.S. Tel: +33 (0) 1 55 38 17 00 Hellas: Medtronic Hellas S.A. Tel: +30 210677-9099 Italia: Medtronic Italia S.p.A. Tel. +390 2 24137 261 Servizio assistenza tecnica: No verde 24h: 800 712 712 Tel. 06-328141 Fax 06-3215812 Japan: Medtronic Japan Co. Ltd. Tel: +81-3-6430-2019 Latin America: Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244 Latvija: Ravemma Ltd. Tel: +371 7273780 Magyarország: Medtronic Hungária Kft. Tel: +36 1 889 0600
Malaysia: Medtronic International Ltd. Tel: (+65) 6436-5094 or (+65) 6436-5097 Middle East and North Africa: Regional Office Tel: +961-1-370 670 Nederland, Luxembourg: Medtronic B.V. Tel: +31 (0) 45-566-8290 New Zealand: Medica Pacifica Tel: +0800 106 100 24-hr After-Hours: +0800 633 487 Norge: Medtronic Norge A/S Tel: +47 67 10 32 00 Fax: +47 67 10 32 10 POCCƐƧ: Medtronic B. V. Tel: +7 095 5807377/1161 Polska: Medtronic Poland Sp. z.o.o. Tel: +48 22 4656 900 Portugal: Medtronic Portugal Lda Tel: +351 21 7245100 Fax: +351 21 7245199 Puerto Rico: Medtronic Puerto Rico Tel: 787-753-5270 Republic of Korea: Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600
Schweiz: Medtronic (Schweiz) AG Tel: + 41 (0)31 868 0160 24-Stunden-Hotline 0800 633 333 Fax Allgemein: +41 (0)31 8680199 Serbia & Montenegro: Novolab Serbia & Montenegro Epsilon Research Ltd. Tel: +381 63 219 827 Singapore: Medtronic International Ltd. Tel: (+65) 6436-5094 or (+65) 6436-5097 Slovenija: Zaloker & Zaloker d.o.o. Tel: +34 91 625 0400 Slovenská Republika: Medtronic Slovakia o.z. Tel: +421 2 68 20 69 12 Suomi: Medtronic Finland OY Tel: +358-9-755 25 00 Sverige: Medtronic AB Tel: +46 8 568 585 00 Fax: +46 8 568 585 01 Taiwan: Medtronic-Mediland Ltd. Tel: +886.2.2517.0308 Thailand: Medtronic (Thailand) Ltd. Tel: (+65) 6436-5094 or (+65) 6436-5097 Turkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330
USA: Medtronic Diabetes Global Headquarters Tel: 800-826-2099 24-hour Help Line: 818-576-5555 To order supplies 800-843-6687 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Yisrael: Agentek Tel: +972 3649 3111 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline 0820 820 190
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Contents Chapter 1: Introduction ... 1 Assistance ... 2 Emergency kit ... 2 Your system ... 3 Accessories ... 4 Conventions used in this guide ... 5 User safety ... 6 Indications: CSS7100 ... 6 Indications: CSS7100K (pediatric version) ... 6 Contraindications ... 7 Safety Warnings ... 7 Sensor ... 7 Transmitter ... 7 Meter ... 7 Precautions ... 7 Avoid extreme temperatures ... 7 Sensor ... 8 Meter ... 8 Adverse reactions ... 8 Damage due to radiation ... 8 Compliance information ... 9 RF interference from other devices ... 10
Chapter 2: The basics ... 11 The monitor ... 11 Installing the battery ... 12 The monitor buttons ... 15
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An important message about alarms and alerts ... 16 The monitor screen ... 17 The HOME screen ... 17 Icons ... 17 Sensor icon ... 17 Battery icon ... 18 Time of day icon ... 18 Alert icon ... 18 Alarm icon ... 18 Scroll bar ... 18 Screen backlight ... 18 Alarm/alert types ... 19 Operating modes ... 19 Normal mode ... 19 Special mode (Alerts) ... 19 Attention mode (Alarms) ... 20 Menus ... 20 MAIN MENU ... 20 SENSOR MENU ... 20 CAPTURE EVENT ... 20 UTILITIES MENU ... 21 The STATUS screen ... 22
Chapter 3: Entering your settings ... 23 Basic steps ... 23 Setting the time and date ... 24 Selecting the language ... 26 Setting your Alarm/Alert Type ... 26 Entering your glucose monitoring settings ... 27 Turning on the sensor ... 27 Selecting the BG units ... 28 Turning on the Glucose Alerts ... 28 Setting the Glucose Limits ... 28 Setting the Glucose Limits start time ... 30 Setting the High Snooze ... 31 Setting the Low Snooze ... 32
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Setting the Predictive glucose alert ... 32 Setting the Rate Alerts ... 34 Setting the AUC Limits ... 35 Setting the Alarm Snooze ... 35 Setting the Cal Reminder ... 36 Entering the transmitter identification number ... 36 Setting up the Missed Data option ... 37 Setting the sensor glucose graph timeout ... 37 Reviewing your settings ... 38 Using the Sensor Demo ... 38
Chapter 4: Setting up your transmitter, sensor and meter ... 39 Basic steps ... 39 Setting up the transmitter ... 40 MiniLink charger ... 40 Installing a new charger battery ... 40 Charging the transmitter ... 41 Inserting the sensor ... 42 Before you begin ... 43 Make sure that the transmitter is fully charged ... 43 Make sure that the sensor is ready to be inserted ... 43 Where to insert the sensor ... 43 Do NOT insert the sensor in ... 43 How to prepare the insertion site ... 44 Connecting the transmitter to the sensor ... 46 Starting the sensor ... 47 Entering the first meter blood glucose ... 47 Meter option ... 48 Meter rules ... 49 Add, delete, review meter IDs ... 50
Chapter 5: Using your system ... 51 Calibrating your system ... 51 Guidelines for calibrating the system ... 52 Capturing Events ... 54 Entering non-calibration meter BG measurements ... 55
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Entering insulin injection information ... 55 Entering information about carbohydrates ... 56 Entering exercise information ... 57 Entering Other markers ... 58 Reading the sensor glucose graphs ... 58 Opening and viewing the graphs ... 59 The graphs ... 60 Examples of real-time sensor glucose graphs ... 61 3-hour graph ... 61 6-hour graph ... 62 12-hour graph ... 63 24-hour graph ... 64 How to check for rapid changes in sensor glucose ... 65 The rapid change arrows ... 65 Checking the status of the system ... 67 Checking the monitor battery status ... 67 Checking the sensor status ... 68 Checking the transmitter status ... 69 How to make glucose alerts silent ... 70 Viewing the sensor update history ... 71 Viewing your current settings ... 72 Disconnecting the transmitter and removing the sensor ... 72 Disconnecting the sensor from the transmitter ... 72 Removing the sensor ... 73 Using your system in water ... 73
Chapter 6: Utilities ... 75 The data management feature ... 75 Sensor glucose information ... 76 Meter blood glucose information ... 77 The Alarm Clock ... 78 Reviewing your current Alarm Clock reminders ... 79 Deleting Alarm Clock reminders ... 79 The Block feature ... 80 The Lock Keypad feature ... 80 Running the Selftest ... 81
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User settings ... 82 Saving your settings ... 82 Restoring your settings ... 83 Clearing your settings ... 83 Viewing your User Settings history ... 84
Chapter 7: Therapy software ... 85 CareLink Personal™ ... 85 Reports ... 85 Logbook ... 86
Chapter 8: Troubleshooting and alarms/alerts ... 87 About alarms and alerts ... 87 What to do when you get an alarm/alert ... 88 Sensor alerts ... 89 WEAK SIGNAL ... 89 LOST SENSOR ... 89 LOW TRANSMTR ... 89 CHARGE TRANSMTR ... 90 CHANGE SENSOR ... 90 SENSOR END ... 90 CAL ERROR ... 90 METER BG NOW ... 91 METER BG BY ... 91 LOW SG ... 91 HIGH SG ... 91 LOW PREDICTED ... 91 HIGH PREDICTED ... 91 FALL RATE ... 92 RISE RATE ... 92 SENSOR ERROR ... 92 LOW BATTERY ... 92 Viewing your sensor alert history ... 93 System alarms ... 94 A (Alarm) (nn) ... 94 BATT OUT LIMIT ... 94
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BUTTON ERROR ... 94 CHECK SETTINGS ... 94 E (Error) (nn) ... 94 FAILED BATT TEST ... 95 OFF NO POWER ... 95 RESET ... 95 WEAK BATTERY ... 95 Viewing your system alarm history ... 95 Troubleshooting the MiniLink transmitter and charger ... 97 Checking battery status of the charger and transmitter ... 97 Troubleshooting the transmitter ... 99 Connecting the tester ... 99 Disconnecting the tester ... 100 Troubleshooting the monitor ... 100 My monitor will not display my BG measurement from my meter ... 100 Reconnect old sensor ... 101 Find lost sensor ... 101 What happens if I leave the monitor battery out for more than ten minutes? ... 101 Why doesn't my monitor battery last very long? ... 102 What is a CHECK SETTINGS alarm? ... 102 My screen looks distorted ... 102 I dropped my monitor ... 102 I submerged my monitor in water ... 103 I cannot get to the User Settings screen ... 103
Chapter 9: System maintenance ... 105 Replacing the battery ... 105 Storing the system ... 105 Storing the monitor ... 105 Storing the MiniLink transmitter ... 105 Storing the Sen-serter ... 105 Cleaning the system ... 106 Cleaning the monitor ... 106 Cleaning the Sen-serter ... 107 Cleaning the transmitter ... 107 Cleaning the transmitter ... 108
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Chapter 10: System specifications ... 109 Alarm/alert types ... 110 Alarm/alert messages and codes ... 110 Alarm/alert history ... 110 Backlight ... 110 Screen and menu timeout ... 110 Sensor glucose graph timeout ... 111 High and low Glucose Limits (CSS7100) ... 111 High and low Glucose Limits (CSS7100K) ... 111 Daily totals ... 112 Default screen ... 112 Default settings ... 112 ENTER BG meter values ... 119 Meter ID entries ... 119 Power supply ... 119 System safety checks ... 119 Monitor size ... 119 Monitor weight ... 120 TIME/DATE SET screen ... 120 STATUS screen ... 120 Guidance and manufacturer's declaration ... 121 MiniLink specifications ... 127 Symbol table ... 128
Appendix A: Sensor accuracy ... 131 Performance results in adults ... 132 Accuracy of Guardian RT readings ... 133 Precision of Guardian RT readings ... 137 Low and High Alerts in adults ... 138 The Low Glucose Alert ... 138 The High Glucose Alert ... 139 Guardian RT Sensor Performance and Calibration Stability As a Function of Time ... 141 Effects of calibration frequency ... 144 Time-Elapsed Plots ... 145 Performance results in children and adolescents ... 148 Accuracy of Guardian RT readings ... 148
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Low and High alerts in children and adolescents ... 152 The Low Glucose Alert ... 152 The High Glucose Alert ... 153
Glossary ... 155 Index ... 161
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Introduction
Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your diabetes management partner. Your new Guardian® REAL-Time Continuous Glucose Monitoring (CGM) System is a big step forward in diabetes management for people with diabetes mellitus because it: • • • •
provides continuous or periodic monitoring of glucose levels in the fluid under your skin; provides real-time glucose values so that you can track glucose concentration patterns and possibly identify episodes of low and high blood glucose; stores glucose data so that it can be analyzed to track patterns and/or downloaded to PC software for analysis of historical glucose values; and alerts you in real time if a glucose level falls below or rises above pre-set values.
Pre-set values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Guardian REAL-Time CGM System values. Therefore, we strongly recommend that you work closely with your healthcare professional when you start your Guardian REAL-Time CGM System, and for ongoing support.
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In this chapter: • • • • • • •
Assistance Emergency kit Your system Accessories Conventions used in this guide User Safety Compliance information
Assistance Medtronic Diabetes provides a 24 Hour HelpLine for assistance. The HelpLine is staffed with representatives who are trained in the setup and operation of the Guardian REAL-Time CGM System and are able to answer related questions. When calling the HelpLine, please have your Guardian monitor available. The monitor serial number and the 24 Hour HelpLine phone number are on the back of your monitor.
Department
Telephone number
24 Hour HelpLine (calls within the United States)
800.646.4633
24 Hour HelpLine (calls outside the United States)
+1.818.576.5555
Web site
www.medtronicdiabetes.com
Emergency kit You should keep a diabetes emergency kit with you at all times - and be sure a family member, friend or co-worker knows where it is. Your emergency kit may include these items: Fast-acting glucose tablets and Glucagon Emergency Kit® Urine ketone monitoring supplies and blood glucose monitoring supplies Insulin syringe and insulin (with dosage instructions from your healthcare professional) Guardian REAL-Time CGM System Wallet Card and extra AAA alkaline batteries for your monitor (Energizer® brand is recommended) Transparent dressing
• • • • •
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Your system This section describes the parts of your Guardian REAL-Time CGM System.
•
Monitor - Your monitor (CSS7100/CSS7100K) shows real-time glucose measurements, tells you about changes in glucose levels, provides historical information, and displays system information such as low battery alerts.
ಘ
•
•
Transmitter - The Medtronic MiniLink™ transmitter (MMT-7703) is a small rechargeable device that connects to the glucose sensor that is inserted into the body. When connected to the sensor, the MiniLink transmitter automatically initializes the sensor, collects glucose data, and wirelessly sends the data to your monitor. It comes with a blue tester (MMT-7706) and a charger (MMT-7705).
Transmitter
Tester
Charger
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Sensor - The sensor (MMT-7002/MMT-7003) is a membrane-covered electrode inserted through the skin into the fatty layer underneath with a device called the Sen-serter®. The sensor tells the transmitter how much glucose is in the interstitial fluid at the insertion site. The transmitter sends this data to the
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monitor and the monitor screen shows you the reading. CareLink USB Upload Device - The Medtronic Diabetes CareLink USB (MMT-7305) is a radio frequency (RF) device that plugs into your computer's USB port and uploads Guardian REAL-Time CGM System data to your diabetes management software.
•
Accessories Medtronic offers the following accessories to help you better use and more easily wear your monitor. Meter - Your Guardian REAL-Time can be used with an optional blood glucose meter powered by MWT1 technology (where or if available) that you can program to automatically transmit blood glucose test results to your Guardian monitor. MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit information from the meter to the monitor. (You can also use a non-RF meter with your monitor, and manually enter your BG measurements.) Holster - To wear the monitor on your belt. Monitor clip - To wear the monitor underneath your clothing. Leather case - Fine leather lined with nylon. Styling complements business and formal wear. Velcro flap provides easy programming access. Wear it vertically with the built-in belt clip.
•
• • •
To order supplies, call 800-646-4633, +1-828-362-5958 (outside U.S.), refer to the contacts list at the beginning of this user guide, or visit our web site at www.medtronicdiabetes.com.
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Introduction
Conventions used in this guide The conventions used in this guide are defined in the following table. Conventions
Meaning
Press
Push and release the button.
Hold
Press and keep pressure on the button.
Press ESC, ACT
Press the ESC button, then press the ACT button. When two buttons are separated by a comma (,) it means to press the first button, then press the next button.
Select
Choose an item or a value from a menu or screen. Use the
and
buttons
to make your selections.
Button names
Always bold and uppercase; for example, UP, DOWN, ACT.
Screen and menu names
Always uppercase; for example, MAIN MENU, STATUS screen.
Menu items
Always bold; for example, 12-Hour Setup, On, Off
CAUTION
A potential hazard that, if not avoided, may cause damage to your Guardian REAL-Time CGM System.
WARNING
A potential hazard that, if not avoided, may cause death or serious injury. It may also describe potential serious adverse reactions and safety hazards. The items on a menu you need to select to go to another menu or a screen. Each menu item is separated by the (>) symbol. For example: MAIN MENU > Utilities > Alarm
Menu item selections
The actual steps used to complete menu item selection shown above are: ಘ 1 Open the MAIN MENU. ಘ 2 Select Utilities, press ACT. ಘ 3 Select Alarm, press ACT. To make the steps for getting to a specific menu or screen easier to understand, the menu item selections do not include the steps for pressing the ACT button.
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User safety This section includes important safety information such as indications, contraindications, safety warnings, potential adverse reactions, and how to protect the system from radiation exposure damage.
Indications: CSS7100 The Guardian REAL-Time CGM System (CSS7100) is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, pre-set values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Guardian REAL-Time CGM System values. The Guardian REAL-Time CGM System 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. The Guardian REAL-Time monitor can be programmed to automatically receive fingerstick blood glucose calibration values transmitted from the LifeScan OneTouch® UltraLinkTM Meter or the BD Paradigm Link® glucose meters (calibration values from these meters can also be manually entered). Calibrations from all from other glucose meters must be manually entered into the monitor. The MiniLink transmitter is indicated for use as a component of select Medtronic Diabetes continuous glucose sensing systems and Medtronic Diabetes sensor-enabled pump systems.
Indications: CSS7100K (pediatric version) The Guardian REAL-Time system (CSS7100K) is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in children and adolescents (ages 7 through 17) with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, pre-set values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Guardian REAL-Time CGM System values. The Guardian REAL-Time CGM System (CSS7100K) 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. The Guardian REAL-Time monitor can be programmed to automatically receive
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Introduction
fingerstick blood glucose calibration values transmitted from the LifeScan OneTouch® UltraLinkTM Meter or the BD Paradigm Link® glucose meters (calibration values from these meters can also be manually entered). Calibrations from all other glucose meters must be manually entered into the monitor. The MiniLink transmitter is indicated for use as a component of select Medtronic Diabetes continuous glucose sensing systems and Medtronic Diabetes sensor-enabled pump systems.
Contraindications Glucose monitoring therapy is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day and to maintain contact with their healthcare professional. Successful monitor therapy requires sufficient vision or hearing to allow recognition of the monitor signals and alarms.
Safety Warnings Sensor The sensor can create special needs about your medical conditions or medications. Please discuss these conditions and medications with your healthcare professional before using the sensor.
Transmitter Product contains small parts and may pose a choking hazard for young children. The transmitter should be disconnected from the sensor while traveling on an aircraft or if it interferes with another transmitting device.
Meter Do not use an RF-capable meter to send blood glucose measurements to your monitor while traveling on an aircraft or if it interferes with another transmitting device.
Precautions Although the monitor has multiple safety alarms, it cannot tell you about all potential problems. You must test your blood glucose levels at least two times per day. If your blood glucose is out of range, then check your blood glucose using your blood glucose meter.
Avoid extreme temperatures • •
Avoid exposing the system to temperatures above 108°F (42°C) or below 34°F (1°C). Do not steam, sterilize, or autoclave your monitor, transmitter, or sensor.
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