Boston Scientific LATITUDE User manual

PATIENT MANUAL
PATIENT MANUAL
PATIENT MANUAL
PATIENT MANUAL
Caution: Federal (USA) law
restricts this device to distribution
and use by or on the lawful order of
a physician.
LATITUDE®Communicator
LATITUDE®Communicator
LATITUDE®Communicator
LATITUDE®Communicator

LATITUDE is a registered trademark of Boston Scientic Corporation
or its afliates.
Delta Mobile Systems is a trademark of Delta Mobile Systems
GlobTek is a registered trademark of GlobTek, Inc.

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LATITUDE® Communicator Patient Manual
Table of Contents
LATITUDE Patient Management 3
The LATITUDE Communicator 3
Items You Should Receive 4
Optional Health Monitoring Equipment 5
Clinician Website 5
When to Use Your Communicator 6
When Not to Use Your Communicator 6
Where to Place Your Communicator 7
Important Notes 7
Identifying Buttons, Connectors and Indicators 9
How to Connect Your Communicator 10
Connections When Using a Telephone 11
Connections for the LATITUDE Cellular Data
Plan 14
Normal Operation of the Communicator 16
Indicator Sequence When Using the Heart Button 17
Indicator Descriptions 19
Status Button 24
Conrming Normal Operation 25
Troubleshooting Errors 27
Wave Indicator Colors 32
LATITUDE Cellular Data Plan 41
Activating the LATITUDE Cellular Data Plan 41
Troubleshooting and Support 42
Discontinuing Your LATITUDE Cellular Data
Plan 42
Interrogating Your Implanted Device 43

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What to Do if the Electrical Power is Interrupted 44
Checking that the Communicator Can Connect to
LATITUDE 45
Traveling with Your Communicator 46
Communicator Use of the Telephone System 46
What to Do If You Need to Use the Telephone
While the Communicator is Making a Call 48
DSL Internet Service 48
Care and Maintenance 49
Cleaning the Communicator 49
Returning or Replacing the Communicator 50
Communicator Disposal 50
Setting Switches for Your Country 51
Setting Switches for PBX or Dial-out Numbers 52
Connecting the USB Adapter 53
Specications 53
Safety and Standards Compliance 56
Software 58

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LATITUDE® Communicator Patient Manual
LATITUDE Patient Management
LATITUDE Patient Management is a remote monitoring
system that gives your health care provider access to
your implanted device data between scheduled ofce
visits. The LATITUDE system is designed to improve
patient care while providing convenience to 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 secure clinician website.
The LATITUDE system is not intended to assist with
medical emergencies. If you are not feeling well, call
your health care provider or dial 911.
The LATITUDE Communicator
The LATITUDE Communicator is an in-home
monitoring system that uses a wireless communication
system to communicate with your implanted device.
The Communicator does not provide continuous
monitoring. It automatically reads implanted device
information at times scheduled by your health care
provider.
At scheduled intervals, the Communicator sends
your device data to the LATITUDE system through a
standard telephone line or over a cellular data network
using the LATITUDE Cellular Data Plan (see page
41). The Communicator receives periodic schedule
updates made by your health care provider when it
connects to the LATITUDE system.

4LATITUDE® Communicator Patient Manual
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.
Your Communicator is designed to be used only in the
United States, Canada, and Puerto Rico.
The telephone (land line) feature of the Communicator
is designed to operate on standard telephone lines
like those found in most homes. The Communicator
supports tone dialing over an analog line. The
Communicator may work on other telephone systems,
such as Digital Subscriber Line (DSL) and Voice over
IP (VoIP), if those systems provide an analog interface
for connecting the Communicator.
Read the instructions in this manual
thoroughly before using the Communicator.
Keep all of your LATITUDE information in a
convenient location for easy access in the
future.
Items You Should Receive
The following items are included with the
Communicator:
• Communicator unit
• AC adapter (GlobTek® Model GTM41060-1505)
• Communicator installation guide
• Communicator patient manual (this book)
• Accessories:
• Communicator telephone cord

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LATITUDE® Communicator Patient Manual
Optional Health Monitoring Equipment
If prescribed by your health care provider, your
Communicator can also collect information from
an optional LATITUDE Heart Failure Management
System. This system includes a LATITUDE Scale and
LATITUDE 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 products.
An accessory for the Communicator is a USB adapter
that is included with the scale and blood pressure
monitor.
Clinician Website
The clinician website provides authorized health care
providers a convenient and secure way to obtain and
analyze information from a patient’s implanted device.
The LATITUDE system normally displays your device
information on the clinician website within 15 minutes.
However, it may take longer for your information to
appear due to many external factors.
The website provides advanced analysis and trending
tools designed at improving patient care. Only your
physician and medical personnel authorized by
your physician can access your medical data on the
password-protected clinician website.

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When to Use Your Communicator
The Communicator performs many functions
automatically on a regular schedule that is set by
your health care provider. Other functions require you
to respond when the indicators on the front of the
Communicator light or ash. Check the Communicator
daily to see if any of the indicators are lit or ashing.
Use the Communicator only as instructed by your
health care provider. The Communicator’s Heart button
(Figure 1 on page 9) may ash if it needs you to
manually complete a scheduled interrogation of your
implanted device. If the Heart button is ashing, press
it and then watch the indicators on the Communicator.
Call your health care provider if the Call Doctor icon
(Figure 2 on page 10) is lit.
When Not to Use Your Communicator
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 pulse generator
other than a Boston Scientic device.
Ask your health care provider if you have questions
about any risks with using the Communicator or your
implanted device. There is also valuable information
about risks and reliability in the patient handbook for
your implanted device.

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LATITUDE® Communicator Patient Manual
Where to Place Your Communicator
Place your Communicator:
• Near a telephone wall jack (not required if you are
subscribed to the LATITUDE Cellular Data Plan).
• Near an electrical outlet that is easily accessible.
• Where you can sit comfortably and see the front
of the Communicator.
• Close to where you sleep or near your bedside.
If this is not possible, place your Communicator
where you spend a considerable amount of time
each day.
Important Notes
• It is very important that the Communicator remain
plugged into the electrical outlet.
• Your Communicator should remain connected to
a telephone line unless you are subscribed to the
LATITUDE Cellular Data Plan.
• This equipment needs to be installed and put into
service in accordance with the information in the
provided documentation. Call your health care
provider if you need assistance setting up or using
your Communicator.
• 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, you should be at least 3 ft (1 m)
away from televisions, VCRs, DVD players, personal
computers, and other electronic equipment.

8LATITUDE® Communicator Patient Manual
• Electrical safety: It is recommended that the customer
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.
• Boston Scientic personnel may contact the clinic
or patient if an implanted device uses too much RF
telemetry to perform remote interrogations.

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LATITUDE® Communicator Patient Manual
Identifying Buttons, Connectors and
Indicators
Figure 1 and Figure 2 show the buttons, indicators and
connectors on the front and back of the Communicator.
Refer to “Indicator Descriptions” on page 19 for a
description of each indicator.
Figure 1. Buttons and connectors
To telephone
wall jack
To telephone
(optional)
Power
input
Status
Button
USB ports
(wireless
connection to
sensors)
Heart Button
LATITUDE
Indicator

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How to Connect Your Communicator
Complete the following steps to connect and install
the Communicator. There are two different procedures
depending on whether you use a standard telephone
line or the LATITUDE Cellular Data Plan:
• Connections When Using a Telephone (page 11)
• Connections for the LATITUDE Cellular Data Plan
(page 14)
These instructions also appear in the Communicator
installation guide.
NOTE: If you have DSL Internet service, you may
need to use a DSL lter between the wall phone
jack and the Communicator. Refer to “DSL Internet
Service” on page 48.
Figure 2. Indicators
Heart
Button
Sending
Waves
Collecting
Waves
Patient
Icon
Doctor
Icon
LATITUDE
Indicator
Sensor
Reading
Icon
Call Doctor
Icon

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LATITUDE® Communicator Patient Manual
Connections When Using a Telephone
Complete the following steps to setup the
Communicator.
1. Set switches 4 through 8 on the bottom of the
Communicator to match your country as shown
in Figure 3. If you are in a location that requires
you to enter a dial-out number or prex to place
an external telephone call, set switches 1, 2, and
3. Refer to “Setting Switches for PBX or Dial-out
Numbers” on page 52.
Figure 3. Switch settings
United States,
Puerto Rico
Canada

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Your Communicator and a telephone can share the
same telephone wall jack. However, they can not be
used at the same time.
2. Plug one end of the Communicator telephone cord
(included) into the jack labeled .
3. Plug the other end of the cord into the telephone
jack on the wall.
NOTE: If you have DSL Internet service, you may
need to use a DSL lter between the telephone wall
jack and the Communicator. Refer to “DSL Internet
Service” on page 48.
Figure 4. Connecting to a telephone wall jack
Connecting a telephone is optional

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LATITUDE® Communicator Patient Manual
4. If you also want to use a telephone with this wall
jack, you may plug your telephone into the jack
labeled .
5. Insert the AC adapter into the jack
labeled .
6. Plug the AC adapter into an electrical outlet that is
easily accessible.
7. Make sure the LATITUDE Indicator on the front
of the Communicator is lit. The LATITUDE
Indicator ashes for up to one minute while the
Communicator starts up.
If the LATITUDE Indicator is not lit, check that both
ends of the AC adapter are plugged in rmly. Check
if the light on the AC adapter is on.
Important: Your Communicator should remain
connected to the electrical outlet and telephone wall
jack.
8. When electrical power is supplied, the
Communicator begins a startup process. The
Communicator lights all the indicators for
approximately one second to indicate all indicators
are working.
9. During the initial startup process, the Heart button
will ash with a white light. Press the ashing Heart
button, then wait until the Sending Waves light.
This is done to check if the Communicator can
interrogate your implanted device and send
your data to the LATITUDE system. Refer to the

14 LATITUDE® Communicator Patient Manual
“Indicator Sequence When Using the Heart Button”
on page 17 section for more information.
Connections for the LATITUDE Cellular Data
Plan
If you have signed up for the LATITUDE Cellular Data
Plan, no telephone cords need to be attached. Refer to
“LATITUDE Cellular Data Plan” on page 41 for more
information.
1. Set switches 4 through 8 on the bottom of the
Communicator to match your country as shown in
Figure 3 on page 11.
Figure 5. Connections when using the LATITUDE®
Cellular Data Plan

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LATITUDE® Communicator Patient Manual
2. Insert the AC adapter into the jack
labeled .
3. Plug the AC adapter into an electrical outlet that is
easily accessible.
4. Make sure the LATITUDE Indicator on the front
of the Communicator is lit. The LATITUDE
Indicator ashes for up to one minute while the
Communicator starts up.
If the LATITUDE Indicator is not lit, check that both
ends of the AC adapter are plugged in rmly. Check
if the light on the AC adapter is on.
Important: Your Communicator should remain
connected to the electrical outlet.
5. When electrical power is supplied, the
Communicator begins a startup process. The
Communicator lights all the indicators for
approximately one second to indicate all indicators
are working.
6. During the initial startup process, the Heart button
will ash with a white light. Press the ashing Heart
button, then wait until the Sending Waves light.
This is done to check if the Communicator can
interrogate your implanted device and send your
data to the LATITUDE system. Refer to “Indicator
Sequence When Using the Heart Button” on
page 17 for more information.

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Normal Operation of the Communicator
During normal operation, only the LATITUDE indicator
will be lit (green). The Communicator automatically
interrogates your implanted device on a regular
schedule that is set by your health care provider.
Daily device checks are also performed automatically.
None of the Communicator indicators will light during
a scheduled interrogation or daily device check. They
will light when you use the Heart button as described in
“Indicator Sequence When Using the Heart Button” on
page 17.

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LATITUDE® Communicator Patient Manual
Indicator Sequence When Using the
Heart Button
This section describes how the indicators will light after
you press the Heart button. The Communicator
interrogates your implanted device and then sends your
data to the LATITUDE system. More detailed
information describing the colors and purpose of all the
indicators is provided later in the manual.
The Communicator begins interrogating your implanted
device after the Heart button is pressed.
The Patient icon lights blue. The Collecting Waves light
green in sequence and repeat while the Communicator
interrogates your device.

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All three Collecting Waves will light green. The Heart
button lights white indicating the interrogation was
successful.
The Sending Waves light green in sequence and
repeat while the Communicator places a call and starts
sending your data to the LATITUDE system.
The Doctor icon lights blue indicating the
Communicator successfully sent your data to the
LATITUDE system. All the indicators shown stay lit
for two minutes to indicate the entire process was
successful.