Boston Scientific LATITUDE User manual

LATITUDE®Communicator
Comunicador LATITUDE®
PATIENT MANUAL
MANUAL DEL PACIENTE

English.................................................... 1
Español................................................... 75

English
LATITUDE®Communicator
ENGLISH

English
LATITUDE is a trademark of
Boston Scientific Corporation or its affiliates.
Delta Mobile Systems is a trademark of Delta Mobile Systems.
GlobTek is a trademark of GlobTek, Inc.
MultiConnect is a trademark of Multi-Tech Systems, Inc.
This manual contains instructions for the use of Models 6280 and 6290
LATITUDE Communicators. These instructions are identical for both
models. Technical differences, however, do exist between the models
and are identified where appropriate. The model number for your
Communicator is located on its bottom label.

LATITUDE® Communicator Patient Manual
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Table of Contents
LATITUDE Patient Management System 1
The LATITUDE Communicator 1
Items You Should Receive 2
Optional Health Monitoring Equipment 3
Clinician Website 3
When to Use Your Communicator 4
When Not to Use Your Communicator 4
Where to Place Your Communicator 5
Important Notes 5
Buttons, Connectors, and Indicators 7
Installing Your Communicator 9
Confirming Switch Settings 9
Connecting Your Communicator 10
Software Download and Installation 10
Connecting to a Landline Telephone Jack 11
Connecting to the LATITUDE NXT USB Cellular
Adapter 13
Where to Place Your USB Cellular Adapter 13
Normal Operation of the Communicator 16
Indicator Sequence When Using the Heart Button 17
Indicator Descriptions 19
Status Button 24
Confirming Successful Operation 25
Troubleshooting Errors 26
Wave Indicator Colors 31

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LATITUDE Cellular Data Plan 40
Cellular Converter 40
Activating the LATITUDE Cellular Data Plan 41
Troubleshooting and Support 41
Discontinuing Your LATITUDE Cellular Data Plan 42
Interrogating Your Implanted Device 43
Interrupted Electrical Power 44
Checking that the Communicator Can Connect to the
LATITUDE System 45
Traveling with Your Communicator 46
Communicator Use of the Telephone System 47
Using the Telephone While the Communicator is
Making a Call 48
DSL Internet Service 48
Care and Maintenance 49
Cleaning the Communicator and Accessories 50
Returning, Replacing, or Disposing of the
Communicator or USB Cellular Adapter 51
Setting Switches for PBX or Dial-out Numbers 52
Connecting the USB Sensor Adapter 53
Specifications 54
Safety and Standards Compliance 58
Essential Performance 63
Electromagnetic Emissions and Immunity 65
Software 72

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LATITUDE Patient Management System
The LATITUDE Patient Management System (referred
to as “LATITUDE system” throughout this manual) is
a remote monitoring system that gives your health
care provider access to your implanted device data
between scheduled office 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 meant to assist with
health 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 implanted 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 40). The Communicator receives periodic
schedule updates made by your health care provider
when it connects to the LATITUDE system.

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The Communicator does not reprogram or change any
functions of your implanted device. Only your health
care provider can do this during an office visit.
Model 6280 only: Your Communicator is designed to be
used only in the United States, Canada, Puerto Rico,
and Mexico. For more information, see “Traveling with
Your Communicator” on page 46.
The telephone (landline) 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
Internet Protocol (VoIP), if those systems provide an
analog interface for connecting the Communicator.
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.
Items You Should Receive
The following items are included with the
Communicator:
• Communicator unit
• Alternating current (AC) adapter
(GlobTek®Model GTM41061-1512-7.0)
• Communicator installation guide
• Communicator patient manual (this book)
• Communicator telephone cord

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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 weight 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.
A universal serial bus (USB) sensor adapter is included
with the weight scale and blood pressure monitor. The
USB sensor adapter provides a wireless connection
between these products and the Communicator. See
“Connecting the USB Sensor Adapter” on page 53.
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 schedule set by your health care
provider. Other functions need you to respond when
the indicators on the front of the Communicator light or
flash. Check the Communicator daily to see if any of
the indicators are lit or flashing.
Use the Communicator only as instructed by your
health care provider. The Communicator’s Heart button
(Figure 1 on page 7) will flash if it needs you to
manually complete an interrogation of your implanted
device as scheduled by your health care provider. If
the Heart button is flashing, press it and then watch the
indicators on the Communicator. Call your health care
provider if the Call Doctor icon (Figure 2 on page 8)
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 implanted device
other than a Boston Scientific 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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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.
• Where the Communicator and all its cables and
accessories will be kept dry and not exposed to
humidity or potential water contact.
Important Notes
• It is very important that the Communicator
remains 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.

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• 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, videocassette recorders (VCRs),
digital video disc (DVD) players, personal computers,
and other electronic equipment.
• 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. Electrical
cable wall plugs and other accessories must be in
good condition before use.
• Boston Scientific personnel may contact the clinic
or patient to advise on the best Communicator
placement if an implanted device uses too much
radio-frequency (RF) telemetry.

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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*
* to connect the USB sensor adapter and/or the
LATITUDE NXT USB Cellular Adapter
Heart button
LATITUDE
indicator

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1. Patient Icon: Stay close to the Communicator when lit.
2. Collecting Waves:
Green = successfully collecting data.
Yellow = error collecting data.
3. Heart Button: Press when flashing or press to send data.
4. Sending Waves:
Green = successfully sending data.
Yellow = error sending data.
5. Doctor Icon: Data successfully sent when lit.
6. Sensor Reading Icon: Sensor reading received when lit.
7. LATITUDE Indicator:
Green = Communicator is active and ready to use.
Yellow = Flashes yellow during start-up process or to
indicate an error.
8. Call Doctor Icon: Call your doctor when lit.
Figure 2. Indicators
For more information about indicators, see “Indicator
Descriptions” on page 19.
Heart
Button
Sending
Waves
Collecting
Waves
Patient
Icon
Doctor
Icon
LATITUDE
Indicator
Sensor
Reading Icon
Call
Doctor Icon

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Installing Your Communicator
Confirming Switch Settings
• Confirm that the white switches numbered 4-8 on
the bottom of the Communicator match the country
switch settings as shown in Figure 3.
• If the white switches on the bottom of your
Communicator do not match the switch settings
shown below, slide them up or down to set them as
shown.
• Landline telephone connection only: Switches
numbered 1-3 may differ from those shown if a dial-
out number or prefix is needed to place an outside
telephone call. Refer to “Setting Switches for PBX
or Dial-out Numbers” on page 52 for those switch
settings.
Figure 3.
*6290*
TM
United States
and Puerto Rico
Canada
Dial-out Country
Mexico
Switch settings

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Connecting Your Communicator
• If using a landline telephone jack, follow the steps
in “Connecting to a Landline Telephone Jack” on
page 11 to connect your Communicator to the
LATITUDE system.
• If using the LATITUDE NXT USB Cellular Adapter,
follow the steps in “Connecting to the LATITUDE NXT
USB Cellular Adapter” on page 13.
These instructions also appear in the Communicator
installation guide.
Note: Stay close to the Communicator during
the entire installation process to ensure the best
connection between your implanted device and the
Communicator.
Software Download and Installation
Updated software may occasionally be pushed to your
Communicator for download and installation.
If a software download is ready when installing the
Communicator for the first time, pressing the Heart
button will trigger the download and installation
process. Wait for this process to complete, which
could take anywhere from a few minutes to more than
an hour. When the Heart button flashes again, press
it and wait 5 minutes to determine if the installation
succeeded (all indicators are lit a steady color) or failed.
Refer to “Indicator Sequence When Using the Heart
Button” on page 17 for more information.
If your Communicator is already set up, software
download and installation may happen without your
knowledge.

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Connecting to a Landline Telephone Jack
Complete the steps below to set up the Communicator
for a landline telephone connection.
Figure 4. Connecting to a landline telephone jack
3. Connecting a telephone is optional.
1. Plug one end of the Communicator telephone cord
(included) into the jack labeled .
2. 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 filter between the telephone wall
jack and the Communicator. Refer to “DSL Internet
Service” on page 48.
3. Optional: To use a telephone with this wall jack, you
may plug your telephone into the jack labeled .
Note: Your Communicator and a telephone can
share the same telephone wall jack. However, they
cannot be used at the same time.

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4. Insert the AC adapter (included) into the jack
labeled .
5. Plug the AC adapter into an electrical outlet that is
easily accessible.
6. When electrical power is supplied, the
Communicator begins a startup process. The
LATITUDE indicator flashes for up to one
minute while the Communicator starts up. The
Communicator then lights all the indicators for
approximately one second to indicate all indicators
are working.
If the LATITUDE indicator is not lit, check that both
ends of the AC adapter are plugged in firmly. Check
if the light on the AC adapter is on.
Important: Your Communicator should remain
connected to the electrical outlet and telephone wall
jack.
7. When installing the Communicator for the first
time, wait for the Heart button to flash with a white
light. Press the flashing Heart button to check if
the Communicator can interrogate your implanted
device and send your data to the LATITUDE
system.
Continue with step 8 unless installation takes longer
than 5 minutes or the Heart button flashes again. In
that case, continue with “Software Download and
Installation” on page 10.
8. Determine whether the installation succeeded
(all indicators are lit a steady color) or failed by
referring to “Indicator Sequence When Using the
Heart Button” on page 17.