MySentry TM User Guide 1
© 2008, Medtronic MiniMed. All rights reserved. U.S., International, and foreign patent applications are pending. Paradigm® is a registered trademark of Medtronic MiniMed. MySentry™ is a trademark of Medtronic MiniMed.
MySentry Monitor Contents Chapter 1: Introduction ............................................................................. 1 Assistance .............................................................................................................2 How to use this guide ...............................................................................................2 User safety ............................................................................................................4 Indications ......
MySentry Monitor Chapter 3: Getting started ......................................................................... 15 Setting up communication ........................................................................................ 15 Linking the Monitor to the pump ........................................................................... 15 Linking the Monitor to the Outpost ........................................................................ 16 Checking the communication status .................
MySentry Monitor Chapter 5: Maintenance ............................................................................31 Cleaning the Monitor .............................................................................................. 31 Chapter 6: Specifications ...........................................................................33 MySentry Monitor specifications ................................................................................. 33 Monitor size ......................................
MySentry Monitor Chapter 8: End user software license agreement ..............................................
MySentry Monitor 1 Introduction Thank for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in diabetes management. We believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the MySentry™ system will provide many benefits for you. Your MySentry system is designed to provide a simple and reliable way to remotely monitor a sensorenabled insulin pump that is worn by a person in your care.
MySentry Monitor 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 MySentry system, and who are able to answer any system-related questions. When calling the HelpLine or your local Medtronic Diabetes office, please have the MySentry device and its serial number available.
MySentry Monitor Convention Menu paths Description Displayed in bold text; for example: Main Menu > Go to Utilities menu > Link to Pump The previous instruction directs you to do the following: 1 From the monitor, go to Main menu, then select Go to Utilities menu. 2 In the Utilities menu, choose Link to Pump. NOTE Provides additional information. CAUTION Warns of a potential hazard which, if not avoided, could result in death or serious injury.
MySentry Monitor User safety This section describes all user safety information that you need to know regarding the use of your MySentry system. Indications The MySentry system is indicated for the remote monitoring, within your home, of a single Medtronic MiniMed Paradigm 523/723 sensor-enabled insulin pump. The real-time glucose values provided by the Monitor, as received from the Paradigm 523/723 insulin pump, are not intended to be used directly for making therapy adjustments.
MySentry Monitor Required distance MySentry only displays real-time glucose values and alarms/alerts that are transmitted by a Paradigm 523/723 insulin pump. The required distance between the pump and the Outpost is six feet (1.8 meters) or less. The distance between the Outpost and the Monitor can be up to 100 feet (30.5 meters).
MySentry Monitor Precautions Review the following precautions before operating your device. Monitor • The Monitor does not control or affect the Paradigm 523/723 insulin pump in any way. It only displays operational and glycemic data received from the pump. • The Monitor displays only the most essential alarms received from the Paradigm 523/723 insulin pump. • The Monitor also displays certain alarms only one time.
MySentry Monitor 2 These devices generate, use, and can radiate radio frequency energy and, if installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the devices do cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures: • • • Reorient or relocate the MySentry components.
MySentry Monitor 8 Introduction
MySentry Monitor 2 Basics The MySentry system MySentry is an integrated system consisting of a monitor, a radio-frequency-operated repeater, and a power supply. The Monitor provides remote viewing of Paradigm 523/723insulin infusion pump status, glucose data, trends and alarms. The Outpost repeater relays the insulin pump data to the Monitor. The power supply connects the Monitor to a standard electrical wall socket.
MySentry Monitor CAUTION: Never use sharp objects to press the buttons on your MySentry device as this can damage the buttons or compromise the seal of the device. Some examples of sharp objects that may damage the keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys. The Outpost The Outpost (MMT-9102) receives data produced by the Paradigm 523/723 sensor-enabled insulin pump and transmits this data to the Monitor.
MySentry Monitor Monitor screens This section describes the general types of Monitor screens. It does not include all screens. Glucose screens Access the Glucose screens by pressing use chapter for more information. . See the Monitoring glucose levels section in the Everyday Alarm screens The Alarm screens are displayed when the Monitor receives an alarm or glucose alert from the pump, or when the Monitor has a communication problem.
MySentry Monitor Quick status view MySentry allows you to quickly view pump and sensor status. The following information icons are displayed along the top of each glucose-related screen, as well as the confidential screen. 1 2 3 4 5 6 7 1. User: Displays the initials and image of the monitored pump user. 2. Battery: Indicates how much power remains in the monitored pump battery. 3. Reservoir: Indicates how many insulin units remain in the monitored pump reservoir. 4.
MySentry Monitor MySentry buttons The Monitor screen display important information such as alarm messages, insulin pump status, and glucose trends. The buttons on the Monitor face are used to navigate through the MySentry system options and screens. The Monitor buttons work by creating an electrical connection between your finger and an embedded sensor. Unlike regular buttons, they require a certain amount of surface contact between your finger and the button in order to work properly.
MySentry Monitor Button Uses • Switches the nightlight on and off • Silences alarms and disables the audio so that alarms display only on screen, such as when the pump that is being monitored has gone out of range.
MySentry Monitor 3 Getting started Setting up communication Before you can use the MySentry system, you must set up communication from the pump to the Monitor, and the Monitor to the Outpost (if used). The following linking procedures only need to be performed once, unless the Monitor or Outpost is unplugged or an alarm has cleared the pump settings. If so, then you must re-link the Monitor to the pump.
MySentry Monitor 4 Follow the onscreen instructions on your Monitor to set up the pump. A rotating circle indicates that the linking step is in process, while the Monitor locates the pump. It takes up to approximately two minutes to complete the linking process. If the linking process fails, reposition the Monitor and pump and repeat steps 1 through 4. If the Monitor is still unable to link to the pump, call the 24 Hour Helpline (1-800-646-4633).
MySentry Monitor Checking the communication status To verify that the Monitor is successfully communicating with the pump and the Outpost, go to the Network Status screen. Main Menu > View Network Status Communication status is shown for the link between the Monitor and the pump, and the link between the Monitor and the Outpost. Solid bars indicate successful communication. Empty, flashing bars indicate a communication problem. The more bars, the stronger the connection signal strength.
MySentry Monitor Home configuration Once MySentry is linked to the pump, use the following examples as guidelines for positioning the system within your home.
MySentry Monitor Adjusting Monitor settings Follow the procedures in this section to adjust your monitor settings. You can change these settings at any time. NOTE: In the procedures below, use the and buttons to scroll through each list of options. Adjusting user information The Enter User Info screen enables you to adjust the initials of the person wearing the pump, and the pump user image. It also displays the pump serial number, which is obtained when the pump is linked to a Monitor.
MySentry Monitor Adjusting the nightlight brightness There is a nightlight on the back of the Monitor to help you find it in the dark. You can adjust the nightlight to your desired level of brightness. 1 From the Main Menu, go to the Adjust Nightlight screen. Main Menu > Go to Utilities Menu > Adjust Nightlight Brightness 2 Follow the instructions on screen to adjust the brightness to your desired level. NOTE: To switch off the nightlight, press .
MySentry Monitor Adjusting the alarm volume This setting allows you to adjust the alarm volume. 1 From the Main Menu, go to the Adjust Alarm Volume screen. Main Menu > Go to Utilities Menu > Adjust Alarm Volume 2 Follow the instructions on screen to adjust the volume to your desired level. NOTE: If the Alarm Silence option is on, then the alarm is silent. See the Alarm settings section in the Everyday use chapter for information about the Alarm Silence feature.
MySentry Monitor 22 Getting started
MySentry Monitor 4 Everyday use This chapter contains information about MySentry features that you are likely to use on a daily basis. This includes responding to alarms, checking current glucose levels, and viewing the glucose graphs. Monitoring glucose levels MySentry gives you the ability to quickly view the pump user’s most recent glucose reading at any time, or view a more detailed graph that shows glucose readings over a number of hours.
MySentry Monitor To view the current glucose snapshot, press . NOTE: If the glucose level is less than 40 mg/dL (2.2 mmol/L) or greater than 400 mg/dL (19.4 mmol/L), then the Monitor indicates that the glucose level is out of range. time of the glucose snapshot current unit of measure The snapshot shows all of the (mmol/L or mg/dL) pump’s current settings and current glucose measurements.
MySentry Monitor 6-hour view glucose scale target glucose range glucose readings time and glucose reading at cursor location Everyday use 25
MySentry Monitor 3-hour view 12-hour view 26 Everyday use
MySentry Monitor 24-hour view Viewing the Privacy screen The Privacy screen allows you to see an overview of the system data without displaying any specific glucose details. To activate this screen, press from the glucose graphs screen.
MySentry Monitor Alarms MySentry displays three types of alarms: • Monitor alarms display when there are communication issues encountered by the Monitor. They indicate whether the communication issue is with the pump or the Outpost, and include the time that communication was lost. If this type of alarm occurs, do the following: • Move the pump closer to the Outpost. • Move the Outpost closer to the Monitor. You can check the communication status by going to the View Network Status screen.
MySentry Monitor • Alarm Silence feature — To switch the Alarm Silence feature on or off, make sure there are no alarms currently displayed on the monitor, then press . indicates alarms are silent Responding to an alarm The Monitor displays alarms sent from the pump. However, clearing an alarm on the Monitor does not clear it on the pump. When an alarm is received, one of the following happens, depending on the alarm mode: • • Standard mode — the alarm tone sounds and the alarm text is displayed.
MySentry Monitor Daily alarm reset To account for planned periods of time when the pump is out of the range of the Monitor or Outpost, perform the following daily procedure. Morning 1 Before the pump goes out of range, silence your Monitor. 2 If the pump has already gone out of range and the Monitor alarms, clear the alarm. 3 Silence the Monitor to avoid future lost connection alarms while the pump is out of range. Evening 1 Press to clear the alarm. 2 Press to un-silence the Monitor.
MySentry Monitor 5 Maintenance This section provides information on how to clean your Monitor. Make sure you have the following items before you begin cleaning your Monitor: • • • Clean cloths Clean water Mixture of clean water and mild liquid soap Cleaning the Monitor The following procedure describes how to clean your Monitor. Never place the Monitor directly in water. Never try to clean the inside of the Monitor. Use only a damp cloth and mild liquid soap to clean the Monitor.
MySentry Monitor 32 Maintenance
MySentry Monitor 6 Specifications MySentry Monitor specifications Monitor size • • • Height: approximately 5.7 inches (14.4 cm) Width: approximately 7.0 inches (18.0 cm) Depth: (thickness) approximately 3.7 inches (9.4 cm) Monitor weight Approximately 1.5 lbs (680.4 grams) Alarm types • • Audible tone — The alarm tone increases from a beep to a siren when no action is taken for that alarm. Visual — The alarm name displays and the key flashes.
MySentry Monitor Alarm/alert history Maximum number of recent alarms or alerts recorded: 12 Display Type: LCD (Liquid Crystal Display) Default settings Feature Alarm Silence Options Default Setting Possible values – On – Off Limits, Range of Values Off – On – Off Alarm Type – Sound and visual – Visual only Sound and visual Possible values Beep values – Volume settings from 1 to 6 Visual only – Flashing indicator Alarm table Every pump alarm that stops insulin delivery is sent to MySentry to
MySentry Monitor • • Humidity: 5% to 85% relative humidity. Transportation: +41° F (+5°C) to +104° F (+40°C). Storage conditions • • • Temperature: +23° F (-5°C) and +113° F (+45°C). Humidity: Up to 95% relative humidity. Transportation: 5% to 85% relative humidity. MySentry Outpost specifications Outpost size • • • Height: approximately 4.0 inches (10.2 cm) Width: approximately 2.6 inches (6.60 cm) Depth: (thickness) approximately 2.0 inches (5.0 cm) Outpost weight Approximately 0.3 lbs (131.
MySentry Monitor Storage conditions • • • Temperature: +23° F (-5°C) and +113° F (+45°C). Humidity: Up to 95% relative humidity. Transportation: 5% to 85% relative humidity. MySentry power supply specifications Power supply • • • Standard AC power supply: 5VDC Part Number MMT-9103 Protection against electric shock: Class II Recycling Recycle all parts and packaging materials per your local regulations.
MySentry Monitor Icon table Attention: See Instructions for Use Date of manufacture (year - month) Catalogue number REF Device serial number S/N Quantity per package (1) (1X) Radio communication Polarity of d.c. power connector Guidance and manufacturers declaration Guidance and Manufacturers Declaration – Electromagnetic Emissions The MySentry system is intended for use in the electromagnetic environment specified below.
MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Emissions The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment.
MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment.
MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or the user of the MySentry system should assure that it is used in such an environment. Immunity Test Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 60601 Test Level Compliance Level <5% UT (>95% dip in UT) for 0.
MySentry Monitor Guidance and Manufacturers Declaration – Electromagnetic Immunity The MySentry system is intended for use in the electromagnetic environment specified below. The customer or user of the MySentry system should assure that it is used in such an electromagnetic environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Level 10Vrms 150kHz to 80MHz 3V/m 80MHz to 2.
MySentry Monitor Recommended separation distances between portable and mobile RF communications equipment and the MySentry System The MySentry system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
MySentry Monitor Warranty Medtronic Diabetes warrants the Medtronic MySentry Monitor and MySentry Outpost against defects in materials and workmanship for a period of three months from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new or recertified Monitor or Outpost, at Medtronic Diabetes’ discretion) any defective Monitor or Outpost, subject to the conditions and exclusions stated herein.
MySentry Monitor 44 Specifications
MySentry Monitor Frequently asked questions 7 This chapter answers and provides further information for the most frequently asked questions about the MySentry system. How do I turn the monitor on/off? Turn the Monitor on/off by plugging it into, and out of, the power supply. There is no power switch. How many pumps does MySentry monitor? MySentry is designed to monitor a single pump. How often does the pump send a transmission? The pump sends a transmission every minute.
MySentry Monitor How do I resolve RF interference issues? When you experience an RF communication issue, the MySentry Monitor identifies which device is having the problem by issuing an alarm. Communication problems can usually be resolved by: • • • ensuring that there is less than six feet (1.8 meters) between the pump and Monitor, or the pump and Outpost; turning off or moving away from other RF transmitting devices; reorienting or relocating the transmitter or receiving device, or both.
MySentry Monitor What if I cannot resolve RF interference issues? Re-link MySentry with the pump by performing the procedures in the Getting started chapter. What is the RF power used by our devices? Conducted RF:150KHz to 80MHz; Radiated radio frequency: 80 MHz to 2.
MySentry Monitor My Outpost is flashing very quickly. Does this indicate a problem? Yes. This indicates that the Outpost needs to be reset. To reset the Outpost, unplug it from the power outlet and then plug it back in. If unplugged, how long does it take for the pump and monitor to reconnect? It might take up to seven minutes. How long will it take for the pump and monitor to link during setup? It typically takes between five and 30 seconds for the pump to link to the Monitor.
MySentry Monitor End user software license agreement 8 NOTICE TO USER: This is a legal agreement between you (an individual or entity, referred to hereinafter as “you”) and Medtronic MiniMed, Inc. (“MiniMed”) for any software embedded in the MySentry Monitor (“the Product”), including any related documentation, updates and upgrades (collectively referred to hereinafter as the “Software”). The Software is provided by MiniMed and its suppliers for use only as embedded in the Product.
MySentry Monitor registered mark and other proprietary notices on any copies of the Software. MiniMed and its suppliers reserve all rights not granted. 4 Open Source.
MySentry Monitor 7 Limitation of Liability.
MySentry Monitor the United Nations Convention on Contracts for the International Sale of Goods, the application of which is expressly excluded. This Agreement is the entire agreement between the parties related to the Software and supersedes any purchase order, communication, advertisement, or representation concerning the Software. This Agreement shall be binding upon, and inure to the benefit of, the parties hereto and their respective successors, assigns and legal representatives.
MySentry Monitor Warranty Medtronic Diabetes warrants the Medtronic MySentry Monitor and MySentry Outpost against defects in materials and workmanship for a period of six months from the date of purchase. During the warranty period, Medtronic Diabetes will replace (with a new Monitor or Outpost) any defective Monitor or Outpost, subject to the conditions and exclusions stated herein. In the event that the Monitor or Outpost is replaced, the warranty period will not be extended.
MySentry Monitor 54 End user software license agreement
MySentry Monitor Index C Numerics 24 Hour HelpLine 2 523/723 insulin pump 9 A ACT button 14 Alarm screens 11 alarm volume, alarm silence, silence alarm, mute alarm 21 alarms glucose alarms 28 history of 29 monitor alarms 28 pump alarms 28 responding to 29 settings 28 stopping 29 assistance 2 B backlight 20 battery installing 13–?? brightness 20 buttons 13 ACT 14 DOWN 13 communication status 17 confidential screen 27 contraindications 4 I immunity 39 indications 4 insulin pump 9 D display light 20 DO
MySentry Monitor P precautions 6 pump alarms 28 R receiver 10 RF communications 42 S screens Alarm 11 Glucose 11 status 12 Utilities 11 sensor 9 T transmitter 10 U UP button 14 Utilities screens 11 V VIEW button 13 56 W warnings 4
