Medtronic MiniMed 9101 My Sentry Monitor User Manual MP6025332 011 1

Medtronic MiniMed, Inc. My Sentry Monitor MP6025332 011 1

Users Manual

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MySentry TM
User Guide
© 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.
6025332-011 061108
REF MMT-9100
MySentry Monitor
Contents
Chapter 1: Introduction ............................................................................. 1
Assistance .............................................................................................................2
How to use this guide ...............................................................................................2
User safety ............................................................................................................4
Indications .......................................................................................................4
Contraindications ...............................................................................................4
Warnings .........................................................................................................4
Power supply ..............................................................................................4
Required distance .........................................................................................5
Additional safety instructions ...........................................................................5
Precautions ......................................................................................................6
Monitor .....................................................................................................6
Notice .................................................................................................................6
RF communication .............................................................................................6
Chapter 2: Basics ..................................................................................... 9
The MySentry system ................................................................................................9
The Monitor .....................................................................................................9
The Outpost ................................................................................................... 10
The power supply ............................................................................................ 10
Monitor screens .................................................................................................... 11
Glucose screens ............................................................................................... 11
Alarm screens ................................................................................................. 11
Utilities screens .............................................................................................. 11
Quick status view ............................................................................................. 12
MySentry buttons .................................................................................................. 13
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 ....................................................................... 17
Home configuration ................................................................................................ 18
Monitor with Outpost ................................................................................... 18
Monitor without Outpost ............................................................................... 18
Adjusting Monitor settings ........................................................................................ 19
Adjusting user information .................................................................................. 19
Adjusting the nightlight brightness ........................................................................ 20
Adjusting the display light .................................................................................. 20
Adjusting the alarm volume ................................................................................. 21
Chapter 4: Everyday use ........................................................................... 23
Monitoring glucose levels ......................................................................................... 23
Viewing a glucose snapshot ...................................................................................... 23
Viewing the glucose graph ........................................................................................ 24
6-hour view ............................................................................................... 25
3-hour view ............................................................................................... 26
12-hour view ............................................................................................. 26
24-hour view ............................................................................................. 27
Viewing the Privacy screen ....................................................................................... 27
Alarms ............................................................................................................... 28
Alarm settings ................................................................................................. 28
Responding to an alarm ...................................................................................... 29
Alarm history .................................................................................................. 29
Daily alarm reset ............................................................................................. 30
Morning ......................................................................................................... 30
Evening ......................................................................................................... 30
ii
MySentry Monitor
Chapter 5: Maintenance ............................................................................31
Cleaning the Monitor .............................................................................................. 31
Chapter 6: Specifications ...........................................................................33
MySentry Monitor specifications ................................................................................. 33
Monitor size ................................................................................................... 33
Monitor weight ................................................................................................ 33
Alarm types ................................................................................................... 33
Alarm messages and codes .................................................................................. 33
Alarm/alert history .......................................................................................... 34
Display ......................................................................................................... 34
Default settings ............................................................................................... 34
Alarm table .................................................................................................... 34
Power .......................................................................................................... 34
Operating Conditions ........................................................................................ 34
Storage conditions ........................................................................................... 35
MySentry Outpost specifications ................................................................................ 35
Outpost size ................................................................................................... 35
Outpost weight ............................................................................................... 35
Power .......................................................................................................... 35
Operating conditions ......................................................................................... 35
Storage conditions ........................................................................................... 36
MySentry power supply specifications .......................................................................... 36
Power supply .................................................................................................. 36
Recycling ............................................................................................................ 36
Icon table ........................................................................................................... 37
Guidance and manufacturers declaration ..................................................................... 37
Warranty ............................................................................................................ 43
Chapter 7: Frequently asked questions ..........................................................45
iii
MySentry Monitor
Chapter 8: End user software license agreement .............................................. 49
iv
MySentry Monitor
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. This device is ideally suited for nighttime
use, when you worry most about glucose variations.
This user guide is designed to help you understand the operation of your MySentry system. Please read
this guide in its entirety before you begin using the system.
Introduction
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.
The phone number for the 24 Hour HelpLine, as well as your MySentry serial number, is also listed on
the back of the MySentry Monitor.
Department
Telephone number
24 Hour HelpLine (within the United States)
800.646.4633
24 Hour HelpLine (outside the United States)
818.576.5555
Web site
www.medtronicdiabetes.com
How to use this guide
The terms and symbols used in this guide are in the following table.
Convention
Description
Press
Push and release the button.
Select
Press or
to select an item, then press
to perform the action (such as
choosing a menu item or displaying a particular screen.)
Monitor buttons
Indicated by images; for example, press
Introduction
to return to the Utilities menu.
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. It may also describe potential serious adverse reactions and
safety hazards.
WARNING
Notifies you of a potential hazard which, if not avoided, could result in
death or serious injury. It may also describe potential serious adverse
reactions and safety hazards.
Go to the...screen.
When a step instructs you to go to a screen, the path to that screen is
included in the step.
For example:
Go to the LINK TO PUMP screen.
Main menu > Go to Utilities menu > Link to Pump
MySentry Monitor
Referred to within procedures as Monitor.
MySentry Outpost
Referred to within procedures as Outpost.
NOTE: This user guide shows sample screens only. Your monitor screens may look slightly different.
Introduction
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. Rather, they provide an
indication that may require a confirmation fingerstick measurement. All therapy adjustments should
be based on measurements obtained using a home glucose monitor and not based on the value
displayed by the Monitor or Paradigm 523/723 insulin pump.
Contraindications
None known.
Warnings
MySentry is intended to act as a personal sentry for your loved ones, but it is not a substitute for
personal visual monitoring. Although MySentry has been designed and tested to meet or exceed the
latest industry standards as required by EN, FDA and Underwriters Laboratories, MySentry can be
susceptible to RF or electrical interference. Transmission of all data or alarms cannot be guaranteed
with MySentry. This product does not provide any medical advice and should not be relied upon for
such purpose.
Power supply
• MySentry notifies you if its power source (household current) fails. If this occurs, check pump data
directly from the insulin pump.
• Using an unqualified power supply may affect the operation of MySentry. Use only the Medtronic
MiniMed power supply, part number MMT-9103.
Introduction
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). If a pump is not within the required distance from the MySentry Monitor or MySentry Outpost,
then real-time glucose values and any associated alarms or alerts from the Paradigm 523/723 insulin
pump might not be received and displayed on the MySentry Monitor. Refer to your Paradigm 523/723
insulin pump for real-time glucose values and alarms or alerts.
Additional safety instructions
• Please refer to the Paradigm 523/723 user guide for pump warnings.
• Read, follow, and keep all instructions identified within this guide.
• Heed all warnings identified on the product, and within this guide.
• Protect the power cord from being walked on or pinched, particularly at plugs, convenience
receptacles, and the point where it exits from the device.
• To reduce the risk of fire or electric shock, MySentry should not be exposed to water or moisture of any
kind, including, but not limited to, dripping or splashing. Do place the Monitor or Outpost near objects
filled with water, such as vases, sinks or bathtubs.
• Do not block any ventilation openings.
• Install MySentry in accordance with the manufacturer’s instructions.
• Refer all servicing to qualified service personnel. Servicing is required when MySentry operates
abnormally or has been damaged in any way, to include: dropping, crushing, exposure to rain, water or
other liquids, or power supply cord or plug damage. If the MySentry is damaged in any way, refer to the
Paradigm 523/723 pump for all operational and glycemic information.
Introduction
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.
Notice
CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic
Diabetes could interfere with your ability to operate the equipment and void your warranty.
RF communication
These devices comply with the United States Federal Communications Commission and international
standards for electromagnetic compatibility.
These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept
any interference received, including interference that may cause undesirable operation. It does not
interfere with any RF signals transmitted from outside sources.
These standards are designed to provide reasonable protection against excessive radio frequency
interference, and prevent undesirable operation of the devices from unwanted electromagnetic
interference. Operation is subject to the following two conditions:
These devices have been tested and found to comply with the regulations governing such devices in
your area. For the specific regulation and test results for your area, please contact your local
representative.
Introduction
MySentry Monitor
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.
•
Decrease the distance between the MySentry Monitor and Paradigm Revel insulin pump to six feet
or less.
•
Increase the separation between MySentry devices and the device that is receiving/emitting
interference.
Decrease the distance between the MySentry Monitor and MySentry Outpost to 100 feet or less.
Decrease the distance between the MySentry Outpost and Paradigm Revel insulin pump to six feet
or less.
If other devices that employ radio frequencies are in use, such as cell phones, cordless phones and
wireless networks, they may prevent communication between the MySentry system and the Paradigm
Revel insulin pump. This interference does not cause any incorrect data to be sent and does not cause
any harm to your devices. Moving away from, or turning off, these other devices may enable
communication. If you continue to experience RF interference, please contact your local Medtronic
MiniMed representative, or call the 24 Hour HelpLine (see the Assistance section in this chapter).
RF power
The MySentry and Outpost system operate at a frequency of 2.4 GHz and a power of 100 milliwatts. It must be
used at distances greater than 7.9 inches (20 cm) from the human body, except for hands and wrists.
WARNING:The MySentry Monitor and Outpost have been approved for use
where the Monitor and Outpost are used at distances greater than 20 cm
from the human body (with the exception of hands and feet). Operation at
distances of less than 20 cm is strictly prohibited.
Introduction
MySentry Monitor
Introduction
MySentry Monitor
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.
The Monitor
The Monitor (MMT-9100) receives data directly
from the Paradigm 523/723 sensor-enabled
pump (if within range), or remotely through the
Outpost. The Monitor powers on when you plug
the power supply into both the Monitor and a
wall socket. It does not use batteries, and has
no On or Off button. After the Monitor is
properly linked to an insulin pump, it does not
display data from other MySentry systems or
insulin pumps, even if they are in the vicinity.
The Monitor can, with minimum user
interaction, receive data transmitted by the
insulin pump, including glucose sensor values,
historical graphs, pump status, alarms,
remaining insulin in the reservoir, and the
amount of time remaining until a glucose sensor
calibration is required.
Basics
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. It plugs
into a regular wall socket and communicates with the pump and Monitor
while maintaining data integrity. The required distance between the
Outpost and the pump 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).
The power supply
The 5V DC power supply (MMT-9103) plugs into
the back of the Monitor and a regular wall socket
and provides electrical power to the Monitor.
10
Basics
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. See the Alarms section in the Everyday use
chapter for more information.
Utilities screens
The Utilities menu screens allow you to set up communication with the pump and Outpost, enter user
information, and adjust preferences such as alarm volume. See the Setting up communication and
Adjusting Monitor settings sections in the Getting started chapter, for more information.
Basics
11
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. 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. Time: Displays the time currently shown on the monitored pump.
5. Communication status: Shows the signal strength between the pump and Monitor.
More bars means stronger signal.
6. Next sensor recalibration: Indicates how many hours remain before the monitored
pump must be recalibrated.
7. Next sensor change: Indicates how much time remains before the sensor must be
replaced on the monitored pump user.
12
Basics
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. The illustration
to the right shows the correct and incorrect way to
activate the Monitor buttons.
Incorrect
Correct
The buttons are also lighted when they are active for
a given screen; they are not lighted when they are not
active for a given screen. The following table shows
you the functions and properties of each button.
Button
Uses
VIEW
•
•
•
Accesses the Main Menu
Cycles through the Glucose screens
Updates the display with another view of data
BACK
•
•
•
Cancels the current operation
Cycles backwards through the sensor graph
Displays the previous screen in a sequence
Basics
13
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.
•
•
Selects the previous menu option
Increases the glucose graph display range
•
•
Selects the highlighted option
Moves forward in time on the graph screen
•
•
Selects the next menu option
Decreases the glucose graph display range
NIGHTLIGHT
SILENCE
UP
NEXT
DOWN
14
Basics
MySentry Monitor
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.
NOTE: It is recommended that you place the pump, Monitor, and Outpost in one location during
the setup process, and you not move any component until they are linked. After the components
are successfully linked, you can move them to their permanent locations. The Monitor and
Outpost work best if they stay in one location in your home.
Linking the Monitor to the pump
Do not move the pump or Monitor during this process.
Remove the pump from the user and place it within six feet (183 cm) of the Monitor.
Use the power supply provided with the MySentry system to plug the Monitor into a standard electrical
wall outlet.
If the Monitor is not linked to a pump, the Link to Pump screen displays.
If the Link to Pump screen does not display, follow these steps:
a. Press
until the main menu displays.
b. Go to the Link to Pump screen.
Main Menu > Go to Utilities Menu > Link to Pump
Getting started
15
MySentry Monitor
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).
Linking the Monitor to the Outpost
Do not move the Monitor or Outpost during this process.
Place the Outpost within six feet of the Monitor. Do not plug in the Outpost until directed to do so.
From the Main Menu, go to the Link to Outpost screen.
Main menu > Go to Utilities menu > Link to Outpost
Follow the onscreen instructions.
It takes approximately two minutes to complete the linking process, and during this time the Outpost
flashes slowly. Once the linking process is complete, the Outpost stays lit. If the linking process fails,
reposition the components and repeat steps 1 through 4.
If the Monitor is unable to link to the Outpost, call the 24 Hour Helpline. The phone number for the 24
Hour HelpLine and the Outpost serial number are listed on the back of the Outpost.
16
Getting started
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.
If communication is lost, a Monitor alarm displays that
indicates whether the issue is with the pump or the
Outpost. Communication issues are typically resolved
by moving the devices closer to one another.
Getting started
17
MySentry Monitor
Home configuration
Once MySentry is linked to the pump, use the following examples as guidelines for positioning the
system within your home.
Monitor with Outpost
Monitor without Outpost
18
Getting started
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.
To adjust this information, perform the following procedure.
From the Main Menu, go to the Enter User Info screen.
Main Menu > Go to Utilities Menu > Edit User Info
Scroll to locate each user initial, pressing
to confirm your
selection. After you select the second initial, the user image
displays.
Scroll to choose your desired image, then press
confirmation screen displays.
.A
Getting started
19
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.
From the Main Menu, go to the Adjust Nightlight screen.
Main Menu > Go to Utilities Menu > Adjust Nightlight Brightness
Follow the instructions on screen to adjust the brightness to your desired level.
NOTE: To switch off the nightlight, press
Adjusting the display light
The display light is used during waking hours. You can adjust the display light to your desired level of
brightness.
From the Main Menu, go to the Adjust Screen Brightness screen.
Main Menu > Go to Utilities Menu > Adjust Screen Brightness
Follow the onscreen instructions to adjust the brightness to your desired level.
20
Getting started
MySentry Monitor
Adjusting the alarm volume
This setting allows you to adjust the alarm volume.
From the Main Menu, go to the Adjust Alarm Volume screen.
Main Menu > Go to Utilities Menu > Adjust Alarm Volume
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.
Getting started
21
MySentry Monitor
22
Getting started
MySentry Monitor
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. If the
glucose readings exceed the values defined in the pump, or if there is a problem with the sensor or
transmitter, a glucose alarm displays. See the Responding to an alarm section in the Everyday use
chapter for more information about alarms.
Viewing a glucose snapshot
The Glucose Snapshot screen displays the current glucose reading recorded in the pump, and the time
at which the reading was made.
Everyday use
23
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. The glucose trend
reading
indicates whether glucose levels
are stable, rising, rising rapidly,
dropping, or dropping rapidly, and correspond to the rapid change arrows on the pump.
Viewing the glucose graph
The glucose graph displays glucose data in a range of 3 hours, 6 hours, 12 hours, or 24 hours. To view
the glucose graph, press
from the Glucose Snapshot screen. Press
and
to navigate forward
and backward in time across the graph. Press
and
to increase or decrease the amount of time
represented on the graph.
24
Everyday use
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.
Everyday use
27
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.
Main Menu > View Network Status
•
•
Pump alarms display when your pump generates an alarm or alert. The Monitor displays most alarms
and alerts generated by the pump, such as Weak Battery or Empty Reservoir. An explanation of each
pump alarm or alert can be found in the pump user guide.
Glucose alarms display when a glucose reading causes a sensor alert on the pump (for example, Rise
Rate), or when there is an issue with the sensor or the transmitter (for example, Change Sensor). An
explanation of each glucose alarm can be found in the pump user guide.
Alarm settings
You can adjust the alarms as follows:
•
Setting the volume — Go to the Adjust Alarm Volume screen.
Main Menu > Go to Utilities Menu > Adjust Alarm Volume
For more information, see the Adjusting the alarm volume section in the Getting started chapter.
28
Everyday use
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. The alarm text remains
on the screen. Press
once to silence the alarm, and twice to clear it.
Silent Alarm mode — the alarm text is displayed. Press
to clear the alarm.
If the pump is out of range of either the Monitor or Outpost, the Monitor does not display alarms sent
from the pump. See the Alarms section in the Everyday use chapter for examples and descriptions of
the each type of alarm screen.
Alarm history
You can view up to the 12 most recent alarms the Monitor has
received. From the Monitor, go to the Alarm History screen.
Main menu > View Alarm History
Press
and
to scroll through the available alarms.
Everyday use
29
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
Before the pump goes out of range, silence your Monitor.
If the pump has already gone out of range and the Monitor alarms, clear the alarm.
Silence the Monitor to avoid future lost connection alarms while the pump is out of range.
Evening
Press
to clear the alarm.
Press
to un-silence the Monitor.
30
Everyday use
MySentry Monitor
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.
Never use organic solvents such as lighter fluid, nail polish remover, or
paint thinner to clean the Monitor.
• Never use lubricants of any kind to clean the Monitor.
CAUTION: •
•
•
•
To clean the Monitor:
Make sure the Monitor is unplugged from the power supply.
Dampen a clean cloth with mild liquid soap and warm water, and wipe the outside of the Monitor.
Dry the Monitor by wiping it with the dry part of the cloth.
Maintenance
31
MySentry Monitor
32
Maintenance
MySentry Monitor
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.
Alarm messages and codes
•
•
Alarm information appears on the monitor screen.
Types of alarm information:
• alarm source (Monitor, pump, glucose sensor)
• alarm name
• alarm message (what to do when you receive the alarm)
Specifications
33
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 notify you of the condition.
However, it is possible that the cause of the alarm may prevent further communication until the
condition is fixed.
Power
Medtronic MiniMed AC power supply, part number MMT-9103.
Operating Conditions
•
Temperature: +41° F (+5°C) to +104° F (+40°C).
34
Specifications
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 (131.0 grams)
Power
•
•
•
Standard AC power, 5VDC 3A
Part Number MMT-9102
Protection against electric shock: Class II
Operating conditions
•
•
•
Temperature: +41° F (+5°C) to +104° F (+40°C).
Humidity: 5% to 85% relative humidity.
Transportation: +41° F (+5°C) to +104° F (+40°C).
Specifications
35
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.
36
Specifications
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. The customer or the
user of the MySentry system should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment
– Guidance
RF emissions
Test: CISPR 11
Group 2
MySentry system must emit electromagnetic energy
in order to perform its intended function. Nearby
electronic equipment may be affected.
Specifications
37
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.
Emissions Test
Compliance
Electromagnetic Environment
– Guidance
RF emissions
Class B
CISPR 11
Harmonic emissions
Class B
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
38
Specifications
TBD
The MySentry system is suitable for use in all
establishments, including domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
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
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment – Guidance
Electrostatic discharge (ESD)
±6 kV contact
±30 kV air
IEC 61000-4-2
±8 kV air
(<5% relative
humidity)
Electrical fast transient/burst
±2 kV for power supply lines
±2 kV for power
supply lines
TBD
IEC 61000-4-4
±1 kV for input/output lines
±1 kV for input/
output lines
TBD
Surge
±1 kV line(s) to line(s)
±1 kV line(s) to
line(s)
TBD
±2 kV line(s) to earth
±2 kV line(s) to
earth
TBD
IEC 61000-4-5
TBD
Specifications
39
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 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
TBD
40% UT
(60% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 5 cycles
TBD
70% UT
(30% dip in UT)
for 25 cycle
70% UT
(30% dip in UT)
for 25 cycle
TBD
<5% UT
(>95% dip in UT)
for 5 seconds
<5% UT
(>95% dip in UT)
for 5 seconds
TBD
3 A/m
3 A/m
TBD
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
40
Electromagnetic
Environment – Guidance
Specifications
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 2.5GHz
Compliance Level
10Vrms
150kHz to
80MHz
Electromagnetic Environment Guidance
TBD
3V/m
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption, and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically
with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the MySentry System
is used exceeds the applicable RF compliance level above, the MySentry System should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MySentry System.
Specifications
41
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. The customer or the MySentry users can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the MySentry
system as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter (W)
Separation distance according to the frequency of transmitter (m)
80MHz to 800MHz
800MHz to 2,5GHz
d = 0.35 P
d = 0.70 P
0.01
0.035
0.07
0.1
0.11
0.11
0.35
0.7
10
1.1
2.2
100
3.5
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
42
Specifications
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. In the event that the Monitor or Outpost is
repaired or replaced, the warranty period will not be extended.
This warranty is valid only if the MySentry Monitor or MySentry Outpost is used in accordance with the
manufacturer’s instructions. This warranty will not apply:
•
•
If damage results from changes or modifications made to the Monitor or Outpost by the user or third
persons after the date of manufacture.
If damage results from service or repairs performed by any person or entity other than the
manufacturer.
If damage results from a Force Majeure or other event beyond the control of the manufacturer.
•
If damage results from negligence or improper use, including but not limited to: improper storage,
submersion in water or physical abuse, such as dropping or otherwise.
This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the
product covered by this warranty to or by a user other than the original user shall cause this warranty
to immediately terminate. This warranty does not apply to any accessories.
The remedies provided for in this warranty are the exclusive remedies available for any breach
hereof. Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental,
consequential, or special damage of any nature or kind caused by or arising out of a defect in the
product.
All other warranties, expressed or implied, are excluded, including the warranties of merchantability
and fitness for a particular purpose.
Specifications
43
MySentry Monitor
44
Specifications
MySentry Monitor
Frequently asked questions
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.
What is the RF frequency that the MySentry transmitter uses?
The MySentry operates at ultra high frequency, similar to a mobile phone.
What situations will cause RF interference?
Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may cause
significant interruption of transmitter-receiver communication. It is likely that other devices
operating in similar frequency ranges will have a similar effect. This interference, however, does not
cause any incorrect data to be sent and will not cause any harm to your transmitter.
The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected
transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR
alert if communication is interrupted for an extended period of time.)
Frequently asked questions
45
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.
Communication problems may also occur due to cellular telephone interference. Testing conducted
with several different cellular telephones indicates that, while a glucose value is being transmitted,
using a cell phone within 12 inches (31 cm) of receiving devices, transmitters, or RF glucose meters
can interfere with the reception of transmitted values. In the event of such interference, normal
communication can be re-established by:
•
•
turning the cell phone off;
keeping the cell phone at least 12 inches (31 cm) away from the receiving device, transmitter or glucose
meter when a glucose measurement is being transmitted.
What is the recommended distance to keep the pump/transmitter away from other RF devices?
There is no need to separate the pump from other RF devices unless you are receiving interference. If
you are receiving interference, reposition the devices until the interference stops.
How often do I need to re-link the pump to MySentry?
Unless you are experiencing RF interference that you cannot resolve, or there has been a system
failure that has cleared the settings on the pump, you only need to link the pump to MySentry once.
After initial linking, even if the power supply is unplugged, MySentry will automatically resynchronize
upon power-up.
If you do need to re-link, it may take up to seven minutes.
46
Frequently asked questions
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 2.5GHz
•
•
•
Paradigm 523/723 insulin pump:
MySentry Monitor:
Outpost:
If I lose RF communication, what do I need to do to recover communication?
If you lose RF communication, do the following:
•
•
•
Reorient or relocate the MySentry devices.
Decrease the distance between the MySentry Monitor and MySentry Outpost to 100 feet or less.
Decrease the distance between the MySentry Outpost and Paradigm 523/723 insulin pump to six feet
or less.
What if MySentry experiences a power failure?
If a power failure occurs, the Monitor alarms for 15 seconds before turning itself off.
Why are the buttons on the MySentry Monitor sometimes lighted and sometimes not lighted?
To help you with navigate the system, only the active buttons are illuminated.
What do the bars on the Outpost indicate?
The bars are for cosmetic purposes only. The Outpost stays illuminated when there is a connection
between it and the pump.
Frequently asked questions
47
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.
48
Frequently asked questions
MySentry Monitor
End user software license agreement
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. BEFORE USING THE PRODUCT OR THE SOFTWARE,
YOU NEED TO REVIEW AND AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT. If you do not
agree with the terms and conditions of this Agreement, return the Product, along with the packaging
and related materials, to MiniMed or the place of purchase for a full refund.
Grant of License. MiniMed grants you a limited, non-exclusive license to use the Software as
embedded in the Product.
Other Rights and Limitations. You agree not to reproduce, modify, separate the components of,
adapt or translate or otherwise create derivative works from, the Software and further agree not to
attempt to reverse engineer, decompile, disassemble or otherwise attempt to discover the source
code of the Software. You may not rent, lease, distribute or lend the Software to third parties. You
may, however, transfer all of your rights to use the Software to another person or legal entity to whom
you provide the Product, provided that the recipient also agrees to the terms of this Agreement.
Ownership. Title, ownership rights, and intellectual property rights in and to the Software shall
remain with MiniMed or its suppliers. The Software is protected by United States Copyright Law and
international copyright treaties, as well as other intellectual property laws and treaties. There is no
transfer to you of any title to or ownership of the Software and this License shall not be construed as a
sale of any rights in the Software. You agree not to remove or alter any copyright, trademark,
End user software license agreement
49
MySentry Monitor
registered mark and other proprietary notices on any copies of the Software. MiniMed and its suppliers
reserve all rights not granted.
Open Source. Notwithstanding anything else stated in this Agreement, to the extent, if any, all or any
portion of the Software is provided under public license by third parties, such as that which is provided
under any version of the GNU General Public License or GNU General Public License, both of which can
be obtained through the GNU web site at http://www.gnu.org/copyleft/gpl.html (collectively, “Open
Source”), such is licensed to you subject to the terms and conditions of the separate software license
agreement for such Open Source. Use of the Open Source by you shall be governed entirely by the
terms and conditions of such license. The source code for any Open Source can be obtained, for a
nominal fee to cover the cost of shipping and media, by contacting MiniMed (see contact information
below). The Software is also based in part on the work of the Qwt project (http://qwt.sf.net).
Upgrades. If you acquire an upgrade, updated version, modified version, or additions to or for the
Software from MiniMed, the upgrade, updated version, modified version, or addition, shall be included
in the term Software and governed under this Agreement.
Limited Warranty and Remedy. MiniMed warrants to you that the Software will perform substantially
in accordance with the related explanatory written materials for a period of the ninety (90) days
following the date of your original Product purchase. MiniMed does not warrant that the operation of
the Software will be uninterrupted or error free or that the functions of the Software will meet your
needs or requirements. MiniMed’s sole and exclusive liability and your exclusive remedy for breach of
warranty shall be limited to either, at MiniMed’s option, the replacement of the Product or the
Software therein, or to refund your money upon returning the Product. Any replacement will be
warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer. If
the above remedy fails for any reason, MiniMed’s entire liability for a breach of warranty shall be
limited to a refund of the price paid for the Product. This Limited Warranty is void if failure of the
Software resulted from accident, abuse, or misapplication. You are solely responsible for decisions
made and actions taken based on Software. THE STATED LIMITED WARRANTIES AND REMEDY ARE
EXCLUSIVE AND IN LIEU OF ALL OTHERS. MINIMED DISCLAIMS ALL OTHER WARRANTIES, EITHER EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION, ALL WARRANTIES OF NON-INFRINGEMENT,
MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE. SOME STATES OR JURISDICTIONS,
HOWEVER, DO NOT ALLOW EXCLUSIONS OR LIMITATIONS OF IMPLIED WARRANTIES, AND IN SUCH
STATES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
50
End user software license agreement
MySentry Monitor
Limitation of Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL
MINIMED OR ITS SUPPLIERS BE LIABLE FOR ANY DAMAGES, WHATSOEVER, WHETHER DIRECT, INDIRECT,
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER ARISING UNDER CONTRACT, TORT
(INCLUDING NEGLIGENCE), STRICT LIABILITY, BREACH OF WARRANTY, MISREPRESENTATION, OR
OTHERWISE, INCLUDING WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS
INTERRUPTION, LOSS OF BUSINESS INFORMATION, OR OTHER PECUNIARY LOSS, ARISING OUT OF THE
USE OF OR INABILITY TO USE THE SOFTWARE, OR ARISING OUT OF THIS AGREEMENT, EVEN IF MINIMED
OR ITS REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME STATES DO
NOT ALLOW THE EXCLUSION OR LIMITATION OF DAMAGES IN CERTAIN TRANSACTIONS, AND IN SUCH
STATES, THE ABOVE LIMITATIONS AND EXCLUSIONS MAY NOT APPLY.
U.S. Government Acquisition of the Software. This Section applies to all acquisitions of the Software
by or for the U.S. Government (“Government”), or by any prime contractor or subcontractor (at any
tier) under any contract, grant, cooperative agreement, “other transaction” (“OT”), or other activity
with the Government. By accepting delivery of the Software, the Government, any prime contractor,
and any subcontractor agree that the Software qualifies as “commercial” computer software within
the meaning of FAR Part 12, paragraph (b) of FAR Subpart 27.405, or DFARS Subpart 227.7202, as
applicable, and that no other regulation, or FAR or DFARS data rights clause, applies to the delivery of
this Software to the Government. Accordingly, the terms and conditions of this Agreement govern the
Government’s (and the prime contractor and subcontractor’s) use and disclosure of the Software, and
supersede any conflicting terms and conditions of the contract, grant, cooperative agreement, OT, or
other activity pursuant to which the Software is delivered to the Government. If this Software fails to
meet the Government’s needs, if this Agreement is inconsistent in any respect with Federal law, or if
the above cited FAR and DFARS provisions do not govern, the Government agrees to return the
Software, unused, to MiniMed.
Export Restriction. You agree that the Product and the Software will not be shipped, transferred or
exported into any country or used in any manner prohibited by the United States Export Administration
Act or any other export laws, restrictions or regulations.
10 Governing Law and General Provisions. This Agreement shall be governed and construed under the
laws in the State of California without regard to its conflicts of law rules. Any suit brought with
respect to this Agreement may only be brought in Los Angeles, California and must be filed no later
than one year after the date the Software is first acquired. This Agreement will not be governed by
End user software license agreement
51
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. If any provision
herein is found void or unenforceable, it will not affect the validity of the balance of the Agreement,
which shall remain valid and enforceable according to its terms. This Agreement may only be modified
in writing signed by an authorized representative of MiniMed. Without prejudice to any other rights
MiniMed has, your warranty rights under Section 6 above, shall automatically terminate upon failure by
you to comply with its terms, and MiniMed shall also have the right to terminate your license to use the
Software and demand return of the Product for a refund based on the then present value of the
Product.
11 Arbitration; Waiver of Right to Jury Trial and Participation in Class Actions. To the maximum
extent permissible under applicable law:
a. WAIVER OF JURY TRIAL. EACH OF US WAIVES OUR RESPECTIVE RIGHTS TO A TRIAL BY JURY OF
ANY CONTROVERSY OR CLAIM (“CLAIM”) BETWEEN US ARISING OUT OF OR RELATING TO THE
SOFTWARE OR THIS AGREEMENT (INCLUDING WITHOUT LIMITATION ANY COMMUNICATION OVER
THE INTERNET INITIATED BY OR UNDER THE CONTROL OF THE SOFTWARE) OR ANY RELATED
AGREEMENTS, INCLUDING WITHOUT LIMITATION ANY CLAIM BASED ON OR ARISING FROM AN
ALLEGED TORT. ANY CLAIM SHALL INSTEAD BE DETERMINED BY BINDING ARBITRATION – EACH
PARTY THUS WAIVES ITS RIGHT TO A JURY TRIAL.
b. ARBITRATION. Arbitration shall be conducted in accordance with the Federal Arbitration Act
(Title 9, U.S. Code), notwithstanding any choice of law provision in this Agreement, and under the
rules of the American Arbitration Association (“AAA”). Either you or we may, by summary
proceedings (e.g., a motion to stay further proceedings) bring an action in any court having
jurisdiction for the sole purpose of compelling compliance with this arbitration provision. MiniMed
may also initial any action in any court having jurisdiction for the additional purpose of obtaining
temporary or preliminary injunctive relief that MiniMed reasonably believes necessary to protect
its copyrights, and other proprietary and intellectual property rights, in the Software. The
Proceeding shall be commenced at the request of the claiming party. A Claim shall be decided by
one arbitrator who shall be a lawyer licensed to practice law in the state in which the arbitration
52
End user software license agreement
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.
This warranty is valid only if the MySentry Monitor or MySentry Outpost is used in accordance with the
manufacturer’s instructions. This warranty will not apply:
•
•
•
•
•
If damage results from changes or modifications made to the Monitor or Outpost by the user or third persons
after the date of manufacture.
If damage results from service or repairs performed by any person or entity other than the manufacturer.
If damage results from a Force Majeure or other event beyond the control of the manufacturer.
If damage results from negligence or improper use, including but not limited to: improper storage, submersion
in water or physical abuse, such as dropping or otherwise.
If changes or modifications not expressly approved by the party responsible for compliance are made. Such
changes could void the user’s authority to operate the equipment.
This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product
covered by this warranty to or by a user other than the original user shall cause this warranty to immediately
terminate. This warranty does not apply to any accessories.
The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither
Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental, consequential, or special
damage of any nature or kind caused by or arising out of a defect in the product.
All other warranties, expressed or implied, are excluded, including the warranties of merchantability and
fitness for a particular purpose.
Specifications
53
MySentry Monitor
54
End user software license agreement
MySentry Monitor
Index
Numerics
24 Hour HelpLine 2
523/723 insulin pump 9
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
backlight 20
battery
installing 13–??
brightness 20
buttons 13
ACT 14
DOWN 13
communication status 17
confidential screen 27
contraindications 4
immunity 39
indications 4
insulin pump 9
display light 20
DOWN button 13, 14
electromagnetic 37, 39, 42
emissions 37
environment 42
glucose
alarms 28
graphs 24
monitoring 23
sensor 9
viewing snapshot of 23
Glucose screens 11
glucose snapshot screen 23
graphs, glucose 24
Guidance and manufacturer’s
declaration 37
help line 2
history of alarms 29
linking
outpost 16
pump 15
monitor 9
buttons
ACT 14
DOWN 13
monitor alarms 28
monitor screens 11
MySentry Monitor 9
MySentry Outpost 10
network loss 28
network status 17
NEXT button 14
nightlight 20
outpost 10
55
MySentry Monitor
precautions 6
pump alarms 28
receiver 10
RF communications 42
screens
Alarm 11
Glucose 11
status 12
Utilities 11
sensor 9
transmitter 10
UP button 14
Utilities screens 11
VIEW button 13
56
warnings 4

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Linearized                      : No
Author                          : heidr1
Create Date                     : 2008:08:08 09:04:16Z
Modify Date                     : 2009:09:17 17:58:03-07:00
XMP Toolkit                     : Adobe XMP Core 4.2.1-c041 52.342996, 2008/05/07-20:48:00
Producer                        : Acrobat Distiller 7.0.5 (Windows)
Creator Tool                    : FrameMaker 7.2
Metadata Date                   : 2009:09:17 17:58:03-07:00
Format                          : application/pdf
Title                           : MP6025332-011_1.book
Creator                         : heidr1
Document ID                     : uuid:fae788c6-2666-448a-b060-dfecb73b0766
Instance ID                     : uuid:977ca67d-49ef-4996-9891-ee6fcf6880e1
Page Mode                       : UseOutlines
Page Count                      : 62
EXIF Metadata provided by EXIF.tools
FCC ID Filing: OH29101

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