Guidant Corporation LATITUDE Patient Manual
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Patient’s Manual
Draft - 11/11/04
LATITUDE
LATITUDE
Communicator
Communicator
Restricted Device:
Federal law (USA)
restricts the device to
sale, distribution, and
use by or on the
lawful order of a
physician.
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Table of Contents
LATITUDE Patient Management . . . . . . . . . . . . . . . . . . . . . . 3
Patient Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
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
Non-adjustable Antenna . . . . . . . . . . . . . . . . . . . . . . . . 11
Voice Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Where to Place for Your Communicator . . . . . . . . . . . . . . . 11
How to Connect Your Communicator . . . . . . . . . . . . . . . . . 12
How to Use the Communicator . . . . . . . . . . . . . . . . . . . . . . 15
Responding to Action Button Alert Lights . . . . . . . . . . . 16
Changing the Volume of Voice Messages . . . . . . . . . . . 16
What to Do if the Electrical Power is Interrupted . . . . . . 18
What to do if the Screen is Black. . . . . . . . . . . . . . . . . . 18
Using the Communicator for the First Time . . . . . . . . . . 18
Menu Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . 20
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Answering Health Related Questions . . . . . . . . . . . . . . 22
Viewing Your Latest Readings. . . . . . . . . . . . . . . . . . . . 23
Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Using the Check Communicator Option. . . . . . . . . . . . . 24
Interrogating Your Implanted Device . . . . . . . . . . . . . . . 25
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Options Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 21
How to set the time zone . . . . . . . . . . . . . . . . . . . . . 23
Install/Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
View Test Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Traveling with the Communicator . . . . . . . . . . . . . . . . . . . . 27
Communicator Use of the Telephone System . . . . . . . . . . . 27
Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Cleaning the Communicator . . . . . . . . . . . . . . . . . . . . . 29
Returning the Communicator . . . . . . . . . . . . . . . . . . . . . 29
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Safety, EMC and FCC Compliance Standards. . . . . . . . . . 32
Explanation of Product and Label Symbols . . . . . . . . . . . . . 34
Explanation of Shipping Box Symbols. . . . . . . . . . . . . . . . . 35
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LATITUDE Patient Management
LATITUDE Patient Management is a remote monitoring system that
provides implant device data to both clinicians and cardiac device
patients that formerly required an office visit. LATITUDE Patient
Management provides clinicians anytime, anywhere access to the
status of your implanted device data.
A key component of the system is the LATITUDE Communicator, an
easy-to-use in-home monitoring device for patients. The
Communicator uses advanced medical monitoring technology to
automatically gather and send implanted device data to the
LATITUDE secure database through a standard telephone line.
The LATITUDE Patient Management system employs multiple levels
of security and encryption methods to protect patients' personal
medical information.
LATITUDE Patient Management
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Patient Website
Patients can view information about their implanted device and
condition from a personalized patient website by using an internetconnected personal computer. The patient website also provides
access to a wide range of cardiac related health information. Patients
must register and have approval by their clinic to gain access to the
password-protected patient website. The patient website is located
at: www.latitude.guidant.com.
CAUTION: Personal information provided on the patient website is
not intended to replace professional medical care. If you are not
feeling well, call your physician.
Clinician Website
The clinician website uses the power of the internet to provide
doctors and clinicians with a convenient and secure way to obtain
and analyze a patient’s implanted device and health-related
information. The website provides advanced analysis and trending
tools aimed 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.
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LATITUDE Patient Management
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The LATITUDE Communicator
The LATITUDE Communicator is an in-home monitoring system that
communicates with your implanted Guidant 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 routine follow-up visits.
The Communicator automatically reads implanted device information
at times specified by the patient's physician. The Communicator
does not reprogram or change any functions of the patient's
implanted device. Only the patient's 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 prescribed by
your physician). These specially designed devices may be
prescribed by your physician to provide additional information in
monitoring the health of the patient. Refer to the
Scale and Blood Pressure Monitor Patient’s Manual
LATITUDE Weight
that is included
with these devices.
Read the instructions in this manual thoroughly before using
!
the Communicator.
The LATITUDE Communicator
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Please keep this manual for future reference.
You can store this manual, along with your
other LATITUDE Patient Management
documents, in the documentation box that
was shipped with your Communicator.
Items You Should Receive
The following items are included with the Communicator:
• Communicator unit with attached antenna
• Communicator telephone cord
• AC power adapter
• Documentation box
Communicator Setup Guide
•
• Communicator Patient’s Manual
• Communicator Setup Video (DVD and VHS formats)
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The LATITUDE Communicator
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When to Use Your Communicator
The Communicator performs many functions automatically on a
regular schedule. Other functions require you to respond to
messages, follow instructions, and answer questions displayed on
the screen and announced over the speaker.
Use the Communicator as instructed by your physician or clinician.
The Communicator’s Action button will light or flash whenever there
are messages or instructions you need to follow. Check daily to see if
the Action button is lit or flashing.
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.
Ask your physician if you have questions about any risks. Refer to
your handbook for your implanted device for more information.
When to Use Your Communicator
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Important Safety Notes
• The Communicator monitors your implanted device 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.
• Your Communicator is designed to be used in the continental
Unites States, Alaska, and Hawaii.
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Important Safety Notes
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Identifying Parts
Non-adjustable Antenna
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Action Button
Interrogation
Button (blue)
Menu Selection
Buttons (4)
Volume
Down
Volume Control
LCD Screen
Power On
Indicator
Volume
Up
Speaker
To Telephone
Wall Jack
Power
Input
To Telephone
Identifying Parts
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Buttons and Indicator Lights
Button/Light Color Meaning
White light Answer health questions. Indicates that you
need to answer a set of personal health
questions. Refer to “Answering Health Related
Action
Button
Yellow light Respond to system alert. Indicates some type of
Red light Respond to urgent alert. Indicates the
Questions” on page 22.
system problem. Respond to the information
displayed on the screen.
Communicator read a fault error from your
implanted device. Call the Guidant Patient
Services number on the screen as soon as
possible and report the error code on the
screen. Then press the menu button next to the
OK text.
Interrogation
Button
Blue Used by patient to initiate an interrogation of
their implanted device. Refer to “Interrogating
Your Implanted Device” on page 25 before using
this button.
Menu
Selection
Gray Used to submit appropriate responses to
messages appearing on the display.
Buttons (4)
Power On Green light Indicates the Communicator has power
connected.
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Identifying Parts
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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.
Voice Messages
The Communicator uses voice messages to reinforce screen
messages and assist patients with visual impairments. Each voice
message corresponds to the text message or instruction on the
screen. The volume of these messages can be controlled as
described in “Changing the Volume of Voice Messages” on page 16.
Where to Place for Your Communicator
Where to place your Communicator:
• within 8 ft. of where you sleep
• where you can sit and see the screen comfortably
• near an AC electrical outlet
• near a telephone wall jack
The Communicator may typically be placed on a night stand or
dresser top in the patient’s bedroom.
Voice Messages
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