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

3
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