Boston Scientific LATITUDE User manual

Restricted Device:
Federal law (USA) restricts this device
to sale, distribution, and use by, or on
the lawful order of a physician trained
or experienced in device implant and
follow-up procedures.
LATITUDE®Patient Management
Communicator Patient Manual
Look inside the back cover
for a Communicator
setup video DVD.

A Message to Patients
Boston Scientific Corporation acquired Guidant
Corporation in April 2006. During our transition
period, you may see both the Boston Scientific
and Guidant names on product and patient
materials. As we work through the transition,
we will continue to offer doctors and their
patients technologically advanced and high
quality medical devices and therapies.

1
Table of Contents
Table of Contents
LATITUDE Patient Management . . . . . . . . . . . . . . . . . . . . . .3
Patient Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Clinician Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
The LATITUDE Communicator . . . . . . . . . . . . . . . . . . . . . . .5
Items You Should Receive. . . . . . . . . . . . . . . . . . . . . . . .6
When to Use Your Communicator . . . . . . . . . . . . . . . . . . . . .7
When Not to Use Your Communicator. . . . . . . . . . . . . . . . . .7
Important Safety Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Identifying Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Buttons and Indicator Lights . . . . . . . . . . . . . . . . . . . . .10
Touch Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . .11
Non-adjustable Antenna . . . . . . . . . . . . . . . . . . . . . . . .11
Where to Place Your Communicator . . . . . . . . . . . . . . . . . .11
How to Connect Your Communicator . . . . . . . . . . . . . . . . .12
How to Use Your Communicator . . . . . . . . . . . . . . . . . . . . .14
Responding to Action Button Alert Lights. . . . . . . . . . . .15
What to Do if the Electrical Power is Interrupted . . . . . .16
What to Do if the Touch Screen is Black . . . . . . . . . . . .16
Using the Communicator for the First Time . . . . . . . . . .17

2Table of Contents
Menu Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Options Menu Screens . . . . . . . . . . . . . . . . . . . . . . . . .20
Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Answering Health-related Questions . . . . . . . . . . . . . . . . . .24
Interrogating Your Implanted Device . . . . . . . . . . . . . . . . . .26
Traveling with Your Communicator . . . . . . . . . . . . . . . . . . .28
Communicator Use of the Telephone System . . . . . . . . . . .28
What to Do If You Need to Use the Phone While the
Communicator is Making a Call. . . . . . . . . . . . . . . . . . .29
DSL Internet Service . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Cleaning the Communicator . . . . . . . . . . . . . . . . . . . . .31
Returning the Communicator. . . . . . . . . . . . . . . . . . . . .32
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Safety, EMC and FCC Compliance Standards . . . . . . . . . .34
Electromagnetic Emissions and Immunity. . . . . . . . . . . . . .36
Explanation of Product and Label Symbols. . . . . . . . . . . . .42
Explanation of Shipping Box Symbols. . . . . . . . . . . . . . . . .43

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LATITUDE Patient Management
LATITUDE Patient Management is a remote monitoring
system that provides implanted device data to both clinicians
and cardiac device patients. This remote monitoring system is
designed to improve patient care while providing convenience
to you. LATITUDE Patient Management provides clinicians
access to your implanted device data via the Internet.
A key component of the system is the LATITUDE Communicator,
an easy-to-use in-home monitoring device for patients. The
Communicator uses wireless communication technology to
automatically gather data from your implanted device at times
scheduled by your physician. This data is sent to the LATITUDE
database through a standard telephone line. The LATITUDE
Patient Management system uses advanced security methods
to protect your personal medical information.
The LATITUDE Patient Management system is not intended to
assist with medical emergencies. If you are not feeling well, call
your physician or 911.
Patient Website
Patients can view information about their implanted device from
a personalized patient website by using an Internet-connected
personal computer. The patient website also provides access to
a wide range of cardiac related health information. Patients must
LATITUDE Patient Management

4
have approval by their clinic to gain access to the password-
protected patient website. If your clinic approves, you should
receive a user name and password a few days after receiving
your Communicator. Contact your clinic or physician to get
approval to access the patient website.
Use of the website is not required and has no effect on the
operation of your Communicator. After being received by the
Communicator, information from your implanted device may
take a reasonable amount of time to appear on the patient
website. The patient website is located at:
www.latitude.bostonscientific.com
CAUTION: Information provided on the patient website is
not intended to replace professional medical care. If you
are feeling poorly or are in need of immediate care, call
your physician or 911.
Clinician Website
The clinician website provides doctors and clinicians a
convenient and secure way to obtain and analyze the data
and health-related information that they scheduled the
Communicator to collect from your implanted device. After
being received by the Communicator, information from your
implanted device may take a reasonable amount of time to
appear on the clinician website.
LATITUDE Patient Management

5
The website provides advanced analysis and trending tools
designed at improving patient care. Only your physician and
medical personnel authorized by your physician have access
rights to your medical data by logging on to the password-
protected clinician website.
The LATITUDE Communicator
The LATITUDE Communicator is an in-home monitoring
system that communicates with your implanted device. The
Communicator provides an easy-to-use system that you can
use from the comfort of your home, saving you a trip to your
physician’s office. While use of the Communicator does not
eliminate the need for in-office visits that may be scheduled
by your physician, it can minimize the number of them.
The Communicator automatically reads implanted device
information at times scheduled by your physician. The
Communicator does not reprogram or change any functions
of your implanted device. Only your clinician can do this
during an office visit.
The Communicator can also collect information from an optional
LATITUDE weight scale or blood pressure monitor (if your
physician prescribed the LATITUDE Heart Failure Management
System). These specially designed products provide additional
information to monitor your health. Refer to the LATITUDE
Weight Scale and Blood Pressure Monitor Patient Manual that
is included with these products.
The LATITUDE Communicator

6
Read the instructions in this manual thoroughly before
using the Communicator.
Please keep this
manual for future
reference.
Keep all of your
LATITUDE information,
including this manual
(with setup DVD) and
the setup guide, in a
convenient location
for easy access in
the future.
Items You Should Receive
The following items are included with the Communicator:
• Communicator unit with attached antenna
• Communicator telephone cord
• Power supply (Globtek Model GTM21089-1305-W2)
•Communicator Setup Guide
•Communicator Patient Manual
• Communicator Setup Video DVD (inside the back cover of
this manual)
!
The LATITUDE Communicator
Setup Guide
Patient Manual
Setup DVD
(inside Patient
Manual)

7
When to Use Your Communicator
The Communicator performs many functions automatically on a
regular schedule that is set by your physician. Other functions
require you to respond to messages, follow instructions and
answer questions displayed on the touch screen.
Use the Communicator only as instructed by your physician or
clinician. The Communicator’s Action button (see “Identifying
Parts” on page 9) will light or flash whenever there are
messages or instructions you need to follow. Check the Action
button every day. If it is lit or flashing, press it and then follow
the instructions on the Communicator screen.
When Not to Use Your Communicator
The Communicator is designed to work only with the implanted
device of the patient for whom it was prescribed. It will not work
with other patients’ implanted devices and should be used only
as authorized by the prescribing physician. The Communicator
is contraindicated for use with any pulse generator other than a
Guidant or Boston Scientific device.
Ask your physician 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.
When to Use Your Communicator

8
Important Safety Notes
• The Communicator interrogates your implanted device, as
scheduled by your physician, and sends this information
to the LATITUDE Patient Management secure database,
which provides access to your information by your
authorized physician(s). Therefore, it is very important
that the Communicator remain plugged into the power
outlet and telephone line.
• Electrical safety advisory notice: It is recommended that
the customer install a surge arrestor in the electrical outlet
to which the Communicator is connected. This is to avoid
damage to the Communicator caused by local lightning
strikes and other electrical surges.
• The Communicator is designed to operate on standard,
analog telephone lines like those found in most homes.
The Communicator may work on other telephone systems,
such as Digital Subscriber Line (DSL) and Voice Over
IP (VoIP) Internet systems, if those systems provide
an analog interface for connecting the Communicator.
The Communicator should not be connected to a digital
phone interface, such as those commonly used in some
businesses, hotels, and managed care facilities where
telephones are typically provided by the facility.
• Your Communicator is designed to be used in the
continental United States, Alaska, Hawaii, and Puerto Rico.
Important Safety Notes

9
Identifying Parts
Identifying Parts
Non-adjustable antenna
Action button
LCD touch screen
Power On
indicator
Interrogate button (blue)
To telephone
wall jack
To telephone
Power
input

10
Buttons and Indicator Lights
Button/Light Color Meaning
Action Button White light Interrogate your device or answer
health questions. Refer to
“Interrogating Your Implanted Device”
on page 26 and “Answering Health-
related Questions” on page 24.
Yellow light Respond to Communicator alert.
Indicates some type of Communicator
problem. Respond to the information
displayed on the touch screen.
Red light Your immediate response is required.
Indicates that the Communicator
identified a potential change in your
implanted device that your physician
asked to be alerted to. Write down any
telephone numbers and/or codes that
appear in alert messages. Call the
LATITUDE Patient Services number on
the screen and report any codes. Then
press the menu button next to the OK
text.
Interrogation
Button
Blue Used to initiate an interrogation
of your implanted device. Refer to
“Interrogating Your Implanted Device”
on page 26 before using this button.
Power On Green light Indicates the Communicator is
connected to power.
Identifying Parts

11
Touch Screen Display
The Communicator has a touch screen display that is sensitive
to the touch of a finger. Gently touching the screen surface with
your finger operates the touch screen. Respond to onscreen
instructions or questions by touching the desired button with
your fingertip. Do not use tools or sharp objects as they can
damage the touch screen. If you need to use the Communicator
and the touch screen is dim (black), simply touch any part of the
screen or press the Action button to turn on the screen.
Non-adjustable Antenna
The antenna on the Communicator is used to communicate with
your implanted device using radio frequency signals.
CAUTION: The antenna does not pivot or extend. Do not
attempt to bend or adjust the antenna. Do not pick the
Communicator up by the antenna or handle it in a manner
that could damage the antenna.
Where to Place Your Communicator
Place your Communicator:
• close to where you sleep—for optimum performance, the
Communicator should be no more than 8 feet from where
you sleep;
• where you can comfortably see the touch screen;
Identifying Parts

12
• near an electrical outlet;
• and near a telephone wall jack.
The Communicator may typically be placed on a nightstand in
your bedroom.
CAUTION: If you do not plug a telephone into the back of
the Communicator, make sure there are no objects behind
the Communicator that could come in contact with the open
telephone jack as it is a live jack.
How to Connect Your Communicator
Complete the following steps to connect and install the
Communicator. These instructions also appear in the LATITUDE
Patient Management Communicator Setup Guide.
1. Find the Communicator
telephone cord that came
with the Communicator and
plug one end into the jack
labeled on the back of
your Communicator.
2. Plug the other end of the
cord into the telephone jack
on the wall of your room.
Where to Place Your Communicator
Communicator
Telephone Cord
2
1

13
How to Connect Your Communicator
3. If you also want to use a
telephone with this wall
jack, you may plug your
telephone into the jack
labeled on the back
of your Communicator.
CAUTION: Once you
connect the Communicator
to a telephone wall jack,
the second telephone jack
becomes a live jack. Do
not touch the inside of this
telephone jack.
4. Insert the power supply
plug into the jack labeled
on the back of your
Communicator.
5. Plug the power supply into
an electrical outlet.
4
5
3
Connecting a
telephone is
optional

14
6. Make sure the power light on
the Communicator is on.
The green light indicates the
Communicator is connected
to power. (If the green light is
not on, check that both ends
of the adapter cord are
plugged in firmly.)
7. The installation of the Communicator is now complete.
Instructions should appear on the touch screen.
Important: Your Communicator should remain connected to
the power outlet and telephone line.
8. Complete the instructions shown on the Communicator touch
screen as described in “Using the Communicator for the First
Time” on page 17.
How to Use Your Communicator
The Communicator provides step-by-step instructions that are
displayed on the touch screen. The information in this section
describes use of the buttons, lights, and touch screen in addition
to instructions for performing menu items and options that are
displayed on the touch screen.
How to Use Your Communicator
6
Power Light
(green)

15
CAUTIONS:
• The Communicator may not communicate with your
implanted device if you are too close to some household
appliances. You should be at least 36 inches (3 ft.) away
from televisions, VCRs, and personal computers when
you are using the Communicator.
• The Communicator uses a wireless (radio frequency)
communication system to communicate with your
implanted device and optional weight scale and blood
pressure monitor. This communication can be disrupted
by electromagnetic interference. Avoid placing your
Communicator next to or in the immediate vicinity of
other wireless products and sources of electromagnetic
energy. Call LATITUDE Patient Services at 1-866-484-
3268 if you need help finding a suitable location for your
Communicator or have questions about possible sources
of interference.
Responding to Action Button Alert Lights
Action button alert lights serve to notify you that some sort of
action needs to be taken. The colors and meanings of each light
are described in the table on page 10.
If the Communicator touch screen is dim when one of the
colored lights turns on, the light will flash to attract your attention.
Press the Action button to brighten the touch screen and view
the alert message. The light will stop flashing, but will remain lit.
How to Use Your Communicator

16
Respond to the alert message and touch the appropriate button
on the touch screen, such as OK or Continue. The light will then
turn off. Please respond to alert messages as soon as possible.
Important: You should write down any telephone numbers
and/or codes that appear in alert messages before
touching the OK or Continue button, as doing so causes the
Communicator to display a different screen and the alert
message will no longer appear.
What to Do if the Electrical Power is Interrupted
The Communicator has internal memory that stores your
interrogation and setup information in case the electric power
is interrupted or the power supply is unplugged.
A message appears when power is restored to the
Communicator asking if you want to check the setup. If the
Communicator has been moved, touch the Yes button and
follow the check setup instructions. You can touch the No
button if the Communicator wasn’t moved.
What to Do if the Touch Screen is Black
The Communicator touch screen will dim (go black) after
the Communicator has not been used for 10 minutes. To turn
the touch screen on, press the Action button or touch the
screen. Then check for a message or instruction on the top
of the screen.
How to Use Your Communicator

17
The Action button light may also flash when the Communicator
is not being used and the touch screen is black. Refer to
“Responding to Action Button Alert Lights” on page 15 for
additional information.
Using the Communicator for the First Time
The Communicator is programmed to display a series of
instructions to step you through a personalized setup process.
This process needs to be performed after the Communicator
or optional weight scale and blood pressure devices are
installed. This is done to make sure the Communicator is
connected correctly and that it can communicate with your
implanted device, make a telephone call to the LATITUDE
database, and receive signals from the weight scale and
blood pressure devices.
The setup process may also need to be performed if the
Communicator was moved, to make sure everything is
functioning properly.
A. When you first connect and install the Communicator, you
should see a message similar to the one shown in Figure 1.
How to Use Your Communicator

18
B. Touch the Press here to begin button and follow the remaining
instructions on the touch screen. The Communicator will
continue to display all the remaining setup instructions,
including placing a telephone call to the LATITUDE database
and interrogating your implanted device.
Menu Screens
When using the Communicator, there are two primary menu
screens from which most operations begin:
• Main Menu screen
• Options Menu screen
Menu Screens
You will be led through some
activities to make sure the
Communicator is installed properly.
Press here to begin.
Figure 1. Starting the setup process.