Boston Scientific LATITUDE 6280 User manual

LATITUDE™Communicator
PATIENT MANUAL

i
LATITUDE™ Communicator Patient Manual
About This Manual
This manual applies to Models 6280 and 6290
LATITUDE Communicators. Unless specied as
applying to a particular model, instructions apply to
both.
The model number for your Communicator is located
on its bottom label.
When color is used in this manual to explain operation
of the Communicator, an indicator shown as gray
means that it is not lit. An indicator shown as any
other color, including white, means that it is lit.
Follow the instructions in this manual when
using the Communicator. Keep all of your
Communicator information in a convenient
location for easy access in the future.
LATITUDE is a trademark of
Boston Scientic Corporation or its afliates.
GlobTek is a trademark of GlobTek, Inc.
MultiConnect is a trademark of Multi-Tech Systems, Inc.
SL Power Electronics is a trademark of SL Delaware Holdings, Inc.

ii LATITUDE™ Communicator Patient Manual

iii
LATITUDE™ Communicator Patient Manual
Table of Contents
ABOUT THE LATITUDE
PATIENT MANAGEMENT SYSTEM..................... 1
The LATITUDE Communicator................................. 2
Components of Your Communicator .................. 4
Optional Accessories ................................ 5
The Clinician Website............................................... 5
USING YOUR COMMUNICATOR............................ 6
Important Notes........................................................ 6
Where to Place Your Communicator ........................ 7
Heart Button and Indicators...................................... 9
Heart Button and Indicator Descriptions........... 11
Normal Operation of the Communicator........... 17
Using the Heart Button..................................... 18
Status Button.......................................................... 21
Conrming Successful Operation..................... 21
Conrming Connection to the
Clinician Website........................................... 22
Canceling an Interrogation ..................................... 23
Loss of Power......................................................... 23
Traveling With Your Communicator ........................ 23
Care and Maintenance ........................................... 24
Cleaning the Communicator and Accessories.. 25
Returning, Replacing, or Disposing of the
Communicator or Accessories ...................... 26

iv LATITUDE™ Communicator Patient Manual
SETTING UP YOUR COMMUNICATOR................ 27
Setup Overview ...................................................... 27
Conrming/Setting Switch Settings ........................ 28
Special Instructions if Using the Standard
Telephone Connection Method ..................... 29
Traveling ................................................. 29
Setting Switches 1-3 for
Dial-out or Prex Number .................... 29
Setting Up Your Connection Method ...................... 31
Cellular Connection .......................................... 33
Using Previous Cellular Connection
Accessories.......................................... 37
Replacement........................................... 37
Internet Connection–
Using a USB Ethernet Adapter...................... 38
Replacement........................................... 41
Internet Connection–
Using a Wireless Internet Adapter................. 42
Replacement........................................... 47
Standard Telephone Connection ..................... 48
Communicator Use of the Telephone...... 50
Using the Telephone While the
Communicator is Making a Call ........... 52
DSL Internet Service ............................... 52
Replacement........................................... 53
Hotspot Connection (Mobile Device)................ 53
USB Accessory Adapter Connection ................ 54
Software Download and Installation ....................... 55
TROUBLESHOOTING........................................... 56
Indicator Light Errors .............................................. 57
Yellow Wave Errors ................................................ 65

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LATITUDE™ Communicator Patient Manual
ADDITIONAL INFORMATION ............................... 83
Frequently Asked Questions................................... 83
Specications ......................................................... 87
Safety and Standards Compliance......................... 91
Essential Performance ........................................... 96
Software Statement................................................ 96
Electromagnetic Emissions and Immunity.............. 97
Explanation of Product and Label Symbols............ 99

vi LATITUDE™ Communicator Patient Manual
List of Figures
Figure 1. Front of Communicator............................. 9
Figure 2. Status Button.......................................... 21
Figure 3. Location of Switches............................... 28
Figure 4. Dial-out Number Switch Settings (1-3) ... 30
Figure 5. Back of Communicator ........................... 32
Figure 6. Connecting a USB Cellular Adapter ....... 33
Figure 7. Connecting a USB Ethernet Adapter...... 38
Figure 8. Wireless Internet Adapter–
Connecting USB Accessory Adapter and
Power Supply ...................................................... 42
Figure 9. Wireless Internet Adapter–
Connecting the Wireless Internet Adapter........... 44
Figure 10. Wireless Internet Adapter–Pairing........ 45
Figure 11. Connecting a Telephone Cable............. 48
Figure 12. Connecting a USB Accessory Adapter . 54

1
LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
ABOUT THE LATITUDE
PATIENT MANAGEMENT SYSTEM
The LATITUDE Patient Management System
(“LATITUDE System”) is a remote monitoring system
that uses the LATITUDE Communicator to collect data
from your implanted device. Your Communicator then
sends this data to the Clinician Website for access by
your health care provider.
The LATITUDE System is designed to help your
health care provider manage your ongoing care in a
manner that is convenient for both of you.
The LATITUDE System uses advanced security
methods to protect your personal medical information.
Only authorized health care providers have access
to your information through the password-protected
Clinician Website.
CAUTION: The LATITUDE System is not meant
to assist with health emergencies. If you are not
feeling well or need urgent health care, call your
health care provider or dial 911.

2LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
The LATITUDE Communicator
The LATITUDE Communicator is an in-home, wireless
monitor that automatically collects and sends your
implanted device data to the Clinician Website for
access by your health care provider.
The Communicator collects data from your implanted
device in three different ways:
• Routine Device Checks: The Communicator
“checks in” on your implanted device daily or
weekly, depending on what type of implanted device
you have. The collected data will be sent to the
Clinician Website only as needed.
• Scheduled Follow-ups: At times set by your
health care provider (typically every few months),
your Communicator collects and then sends your
implanted device data to the Clinician Website.
• Manual: If this feature is enabled by your health
care provider, you may initiate the Communicator to
read your implanted device by pressing the Heart
button on your Communicator. Only use this feature
when the Heart button is ashing or when instructed
to do so by your health care provider.

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LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Routine device checks and scheduled follow-ups may
happen automatically without your knowledge, or you
may need to press the Heart button when it ashes
to complete the process. Refer to “Using the Heart
Button” on page 18 for more information.
Your health care provider may also send periodic
updates to your Communicator to change the
schedule for reading data from your implanted device.
In order for your Communicator to be able to
send your implanted device data to the Clinician
Website, a connection accessory must be set up
on your Communicator. Refer to “Setting Up Your
Communicator” on page 27 for directions. Contact
your health care provider to learn which connection
accessory is right for you.
This equipment needs to be installed and put into
service in accordance with the information in the
provided documentation. Call your health care
provider or Patient Services at 1-866-484-3268
if you need assistance setting up or using your
Communicator.
The Communicator does not provide continuous
monitoring.
The Communicator does not reprogram or change
any functions of your implanted device. Only your
health care provider can do this during an ofce
visit.
The Communicator is designed to work only with your
implanted device. It will not work with another patient’s
implanted device. The Communicator should be
used only as authorized by the prescribing physician.
The Communicator is not for use with any implanted
device other than a Boston Scientic device.

4LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Ask your health care provider if you have questions
about any risks with using the Communicator or your
implanted device. For valuable information about the
risks and reliability of your implanted device, refer to
your implanted device patient handbook.
Components of Your Communicator
Every LATITUDE Communicator comes with a power
supply, a telephone cable, a Quick Start Guide, and
this Patient Manual.
The following table lists compatible accessories for
your Communicator. Availability of these accessories
depends on the method you are using to connect to
the Clinician Website. For more information about
the accessories or how to obtain them, contact your
health care provider or Patient Services at 1-866-484-
3268.
Boston Scientic
Model Number
Accessory Name
(as referenced in this manual)
N/A Power supply (replacement)
Connection Accessories
6359 USB cellular adapter (current model)
6293 USB Ethernet adapter
6390 Wireless internet adapter
N/A Telephone cable (replacement)
6454 USB accessory adapter
6295 USB cellular adapter
(previous model)
6456 (MT200A2W
Multi-Tech Model Number)
Analog-to-wireless cellular converter
(previous model)
Optional (must be prescribed by your health care provider)
6487 Weight scale
6452 Blood pressure monitor

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LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Only use the accessories listed in the table or
provided by your health care provider. Accessories
acquired elsewhere may not work with your
Communicator.
Optional Accessories
If prescribed by your health care provider, your
Communicator may include a weight scale and blood
pressure monitor.
These specially designed products provide additional
information to monitor your health. Refer to the
handbook that is included with the weight scale and
blood pressure monitor for more information.
A USB accessory adapter is included with the
weight scale and blood pressure monitor. The USB
accessory adapter provides a wireless connection
between these products and your Communicator.
Refer to “USB Accessory Adapter Connection” on
page 54 for more information.
The Clinician Website
Between ofce visits, the Clinician Website gives
your health care provider access to the implanted
device data that was collected and sent by your
Communicator. The Clinician Website features
advanced analysis and trending tools designed to
help your health care provider improve your care.
Your implanted device information is typically
available on the Clinician Website within 15 minutes
of when your Communicator sent it. However, it may
sometimes take longer due to external factors.

6LATITUDE™ Communicator Patient Manual
Using Your
Communicator
USING YOUR COMMUNICATOR
Before you can use your Communicator, you must
rst set it up to connect to the Clinician Website. Refer
to “Setting Up Your Communicator” on page 27 for
directions on setting up your connection accessory.
Contact your health care provider to learn which
connection accessory is right for you.
Important Notes
Check your Communicator every day to see if any
of the indicators are lit solid or ashing. Refer to
“Heart Button and Indicators” on page 9 and the
Troubleshooting section starting on page 56 for
more information on the meaning of indicator lights.
Call your health care provider if the Call
Doctor Icon lights red (ashing or solid).
It is very important that the Communicator is always
plugged into an electrical outlet that has power.
• Electrical safety: It is recommended that you install
a surge protector between the electrical wall outlet
and the Communicator. This is to avoid damage
to the Communicator caused by local lightning
strikes and other electrical surges. Electrical cable
wall plugs and other accessories must be in good
condition before use.

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LATITUDE™ Communicator Patient Manual
Using Your
Communicator
Where to Place Your Communicator
Place your Communicator:
• Near an electrical outlet that is easily
accessible.
• Within 10 feet (3 meters) from your bedside
or where you sleep. If this is not possible,
place your Communicator where you spend a
considerable amount of time each day.
• Where you can sit comfortably and see the front
of the Communicator.
• Where the Communicator and all its cables and
accessories will be kept dry and not exposed to
humidity or potential water contact.
• Refer to the following sections for more
placement advice depending on your connection
method:
• “Cellular Connection” on page 33
• “Internet Connection–Using a USB Ethernet
Adapter” on page 38
• “Internet Connection–Using a Wireless
Internet Adapter” on page 42
• “Standard Telephone Connection” on page
48
• Some household appliances and other sources of
electromagnetic energy could interfere with wireless
communication between the Communicator and
your implanted device. When you are using the
Communicator, it should be at least 3 feet (1 meter)
away from televisions, digital video disc (DVD)
players, personal computers, modems, routers, and
other electronic equipment.

8LATITUDE™ Communicator Patient Manual
Using Your
Communicator
• If you have an S-ICD implanted device supported
on LATITUDE, the wireless communication between
the Communicator and your S-ICD is sensitive to
distance and orientation. You may need to move
closer to the Communicator, or you may need to
position your body such that a clear signal exists
between your S-ICD and the Communicator. If you
need assistance, contact Patient Services at 1-866-
484-3268.
• Boston Scientic personnel may contact you or your
health care provider if it is determined that your
implanted device is using too much radio-frequency
(RF) telemetry due to the placement of your
Communicator. Boston Scientic will give advice
on better Communicator placement to correct this
issue.

9
LATITUDE™ Communicator Patient Manual
Using Your
Communicator
Heart Button and Indicators
The following gure shows the Heart button and all
the indicators on the front of your Communicator. Use
this gure for reference as you follow this manual’s
instructions for using your Communicator.
Figure 1.
1 2
3 4 5
6 7 8
(1) Patient icon; (2) Collecting Waves; (3) Heart button; (4) Sending
Waves; (5) Doctor icon; (6) Sensor Reading icon; (7) LATITUDE
indicator; (8) Call Doctor icon
Front of Communicator
The Heart button and indicators are intended to inform
you of the status of your Communicator or actions you
may need to take. The lights, colors, and sequence of
each indicator shown in Figure 1 are explained in the
following section.

10 LATITUDE™ Communicator Patient Manual
Using Your
Communicator
Note: When the words “interrogate” or “interrogation”
are used in this manual, it means that the
Communicator is collecting data from your implanted
device.
If indicators light other than as explained in
this section, refer to the applicable error in the
Troubleshooting section starting on page 56 to nd
out if you need to take any action.

11
LATITUDE™ Communicator Patient Manual
Using Your
Communicator
Heart Button and Indicator Descriptions
Heart Button
• A ashing white Heart button
indicates:
• Setup is occurring (refer
to “Setting Up Your
Communicator” on page
27), or
• You need to complete
a scheduled follow-up
(interrogation).
Press the Heart button to
complete.
• A solid white light for 2 minutes
means the interrogation is
complete. Note that the solid
white light may appear dim.
• An unlit Heart button may also
be used to manually initiate an
interrogation of your implanted
device. Only press an unlit
Heart button when instructed
to do so by your health care
provider. Refer to “Using the
Heart Button” on page 18
before pressing this button.

12 LATITUDE™ Communicator Patient Manual
Using Your
Communicator
Patient Icon
Shows the Communicator is
interrogating your implanted
device.
• Lights solid blue when the
Heart button is pressed and an
interrogation has started.
• Lights solid blue for 2
minutes after a successful
interrogation.
Collecting Waves
Shows the Communicator is
interrogating your implanted
device.
• Each wave ashes green
in sequence and repeats,
showing the Communicator is
interrogating your implanted
device.
• All three waves light green
for 2 minutes to indicate the
interrogation was a success.