Boston Scientific CRM648204 Communicator User Manual CommunicatorManualTOC clean
Boston Scientific Corporation Communicator CommunicatorManualTOC clean
User Manual
Patient’s Manual
Restricted Device:
Federal law (USA)
restricts the device to
sale, distribution, and
use by or on the
lawful order of a
physician.
Draft - 11/11/04
LATITUDE
Communicator
LATITUDE
Communicator
front cover.fm Page 1 Wednesday, November 24, 2004 10:20 AM
Table of Contents 1
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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
2Table of Contents
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Options Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 21
Answering Health Related Questions . . . . . . . . . . . . . . 22
Viewing Your Latest Readings. . . . . . . . . . . . . . . . . . . . 23
Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . 23
How to set the time zone . . . . . . . . . . . . . . . . . . . . . 23
Using the Check Communicator Option. . . . . . . . . . . . . 24
Install/Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
View Test Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Interrogating Your Implanted Device . . . . . . . . . . . . . . . 25
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
LATITUDE Patient Management 3
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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.
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4LATITUDE 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 internet-
connected 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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The LATITUDE Communicator 5
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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
LATITUDE Weight
Scale and Blood Pressure Monitor Patient’s Manual
that is included
with these devices.
Read the instructions in this manual thoroughly before using
the Communicator.
!
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6The LATITUDE Communicator
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Please keep this manual for future reference.
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)
You can store this manual, along with your
other LATITUDE Patient Management
documents, in the documentation box that
was shipped with your Communicator.
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When to Use Your Communicator 7
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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.
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8Important Safety Notes
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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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Identifying Parts 9
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Identifying Parts
Non-adjustable Antenna
Action Button
Interrogation
Button (blue)
Power On
Indicator
LCD Screen
Menu Selection
Buttons (4)
Volume Control
Speaker
To Telephone
Wall Jack
To Telephone
Power
Input
Volume
Down
Volume
Up
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10 Identifying Parts
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Buttons and Indicator Lights
Button/Light Color Meaning
Action
Button
White light Answer health questions. Indicates that you
need to answer a set of personal health
questions. Refer to “Answering Health Related
Questions” on page 22.
Yellow light Respond to system alert. Indicates some type of
system problem. Respond to the information
displayed on the screen.
Red light Respond to urgent alert. Indicates the
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
Buttons (4)
Gray Used to submit appropriate responses to
messages appearing on the display.
Power On Green light Indicates the Communicator has power
connected.
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Voice Messages 11
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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.
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12 How to Connect Your Communicator
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How to Connect Your Communicator
Complete the steps below to connect and install the Communicator.
These instructions also appear in the
LATITUDE Patient
Management Communicator Setup Guide
.
1
1. Find the Communicator
telephone cord that came
with the Communicator and
plug one end into the jack
labeled on the back of
the Communicator.
2. Plug the other end of the cord
into the telephone jack on the
wall of your room.
Communicator Telephone Cord
2
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How to Connect Your Communicator 13
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3. If you also wish to use a
telephone with this wall jack,
you may plug your telephone into
the jack labeled on the
back of the Communicator. 3
Connecting a
telephone is optional
4
5
4. Insert the power supply plug into
the jack on the back of
the Communicator.
5. Plug the power supply into an
electrical outlet.
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14 How to Connect Your Communicator
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7. The installation of the Communicator is now complete.
Instructions should appear on the screen.
Important: Your Communicator should remain connected to the
power outlet and telephone line.
8. Complete the instructions shown on the Communicator screen as
described in “Using the Communicator for the First Time” on
page 18.
6. Make sure the AC power light on
the Communicator is illuminated.
The green light indicates that the
Communicator is connected to
AC power. (If the green light is
not illuminated, check that both
ends of the AC adapter cord are
plugged in firmly.)
AC Power Light
(green)
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How to Use the Communicator 15
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How to Use the Communicator
The Communicator provides step-by-step instructions that are
displayed on the screen and announced over the speaker. The
information in this section describes use of the buttons and lights in
addition to instructions for performing menu items and options that
are displayed on the screen.
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.
• Cellular phones will not affect your Communicator.
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16 How to Use the Communicator
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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 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 screen and view the alert message.The light
will stop flashing but will remain lit. Respond to the alert message
and press a menu button next to the appropriate text, 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 or error
codes that appear in alert messages before selecting OK or
Continue, as doing so causes the Communicator to display a
different screen and the alert message will no longer appear.
Changing the Volume of Voice Messages
You can change the volume of the voice messages by using the
volume control (page 9) on the right-side of the Communicator. You
can increase or decrease the volume of the voice messages or turn
the volume off if you don’t want to hear the messages.
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How to Use the Communicator 17
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When you press and hold the up or down volume control, you will
hear the current message or an audible tone at the next volume level
and each following level until the highest/lowest volume is reached.
To increase the volume: push the volume up control
To decrease the volume: push the volume down control
To turn messages off: press and hold the volume down control
until you can no longer hear a tone or
voice
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18 How to Use the Communicator
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What to Do if the Electrical Power is Interrupted
The Communicator has internal memory that stores all important
setup information in case the electric power is interrupted or the AC
power adapter is unplugged. This information is stored for up to
seven days.
A message appears when power is restored to the Communicator
asking if you want to check the installation. If the Communicator has
been moved, select Yes and follow the check installation instructions.
You can select No if the Communicator wasn’t moved and the power
was out for only a short time.
What to do if the Screen is Black
The Communicator screen will dim and go black after the
Communicator has not been used for 10 minutes. If the screen is
black, press the Action button to turn the screen on. Check for a
message or instruction on the top of the screen.
One of the alert lights may also flash when the Communicator is not
being used and the screen is black. Refer to “Responding to Action
Button Alert Lights” on page 16 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 is installed to make
sure the Communicator is connected correctly and that it can
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How to Use the Communicator 19
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communicate with your implanted device, make a telephone call to
the LATITUDE secure database, and receive signals from the
optional weight scale and blood pressure devices.
The setup process may also need to be performed if the
Communicator was powered off (or 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 on following screen.
B. Press the button next to the Begin text and follow the remaining
instructions on the screen.
The Communicator will continue to display and read all the
remaining setup instructions, including placing a telephone call to
the secure database and interrogating your implanted device.
You will be led through
some activities to make
sure the Communicator is
installed properly.
Please press the button
next to the word Begin.
Begin
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20 How to Use the Communicator
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Menu Screens
When using the Communicator, there are two primary menu screens
from which most all operations begin:
• Main menu screen
• Options menu screen
Main Menu Screen
The main menu screen and the types of information that is displayed
on the top and bottom portions of the screen is shown below. The
main screen serves as the starting point for most operations that you
may perform.
The Set Up choice is displayed only when this function needs to be
performed or after power has been interrupted. The Answer
Questions Options choice appears only for patients who are
prescribed this feature. See “Answering Health Related Questions”
on page 22.
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Options Menu Screen
The options menu screen is shown below. Refer to the page
numbers listed for instructions on using each option. Selecting the
Cancel option returns you to the main menu screen.
Thu 04/21/2005
03:40 PM
Set Up
Answer Questions
Options
For displaying
date/time,
measurements,
messages, and
instructions
Menu choices
View Latest Readings
Set Time Zone
Check Communicator
Cancel
page 23
Return to
Main Menu
page 23
page 24
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22 How to Use the Communicator
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Answering Health Related Questions
The Communicator may prompt some patients to answer a set of
personal health questions. Patients who are prescribed this service
typically answer these questions on a regular frequency, such as
once a week.
The Communicator sends responses to these questions, along with
information read from you implanted device to the LATITUDE Patient
Management database over the telephone line.
The Action button will illuminate with a white light when these
questions need to be answered. If this white light is on or is flashing,
press the Action button and the Communicator will display the first
question. The white light remains on until you answer the first
question.
For each question, press the menu button that corresponds to the
answer that best describes how you feel. The Communicator will
repeat your answer asking if it is the correct choice. You can select
No if you need to change your answer. Answer all questions. Here is
an example question with possible answers:
Have you felt faint or dizzy over the past few days?
•no
• once
•twice
• several times
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Viewing Your Latest Readings
The latest readings screen displays the time and date when your
implanted device was last interrogated and when you last answered
the health related questions. The screen also displays the time, date,
and measured values of the latest weight and blood pressure
readings, if you use these devices.
Selecting the Cancel option at the bottom of the screen returns you
to the options menu.
Setting the Time Zone
The Communicator originally receives the date and time when it
makes a telephone call to the LATITUDE Patient Management
secure database as part of the setup process. After that, the
Communicator verifies its date and time setting whenever it makes a
call to the database. You only need to set the time zone. The time on
the Communicator automatically adjusts for daylight savings time
(DST).
The Communicator stores the date, time, and time zone up to seven
days if power is interrupted. Therefore, you should only need to reset
the time zone if the Communicator is without power for an extended
period, for example when moving to a new location or taking the
Communicator on an extended vacation.
How to set the time zone
1. From the Options menu screen (page 21), select Set Time Zone.
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24 How to Use the Communicator
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2. The next screen will show the current time zone setting followed
by a question asking if you would like to change this setting. To
change the current setting, select Yes and follow the remaining
instructions.
Using the Check Communicator Option
The Check Communicator screen provides two choices:
• Install/Set Up
• View Test Log
(This feature is not meant for general use by the patient.)
Install/Set Up
This option starts the same installation and setup instructions that
are automatically displayed when you first install and setup the
Communicator and optional weight scale and blood pressure
monitor. This option provides a means to manually go through the
setup process in situations where you may have moved the
Communicator or scale and you want to run the setup process again
to verify that these devices can still communicate with each other
and that they are functioning properly.
View Test Log
The Communicator periodically runs tests to check all internal
operations and places results in the test log file. This option is
designed as a troubleshooting tool to help identify the source of a
problem, should one occur with the Communicator. When talking to
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Guidant Patient Services, you may be asked to view the test log
screen and report any messages or codes that appear on the
screen.
Interrogating Your Implanted Device
The Communicator automatically interrogates your implanted device
on a regular schedule that is set by your physician. This may happen
without your awareness and requires no action on your part.
The blue Interrogate button is designed to enable a patient to
manually interrogate their implanted device, as prescribed by their
physician. This feature is normally disabled unless your physician
desires the option that you can manually interrogate your device.
When you press the Interrogate button, the Communicator checks to
make sure that the interrogation is permitted. If the interrogation is
not permitted either because the limit has been reached or because
the feature has been disabled, a message is displayed asking
whether you want the Communicator to initiate a call to the
LATITUDE database to check for a change in the status of this
feature. If you respond yes, the Communicator automatically
attempts the call. A response of the status of patient initiated
interrogations will be displayed on the Communicator screen.
CAUTIONS:
• Use the manual interrogate device (blue) button as instructed
by your physician. Excessive use can lead to a decrease in
the battery life of your implanted device.
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• If you feel poorly or are in need of immediate care, contact
your physician.
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Traveling with the Communicator
You can use your Communicator away from home if you will be gone
for an extended period (within the U.S.). However, you should consult
your physician before planning to do so. Settings to some of the
scheduled events programmed into the communicator may need to
be temporarily changed to use your Communicator away from home.
Communicator Use of the Telephone System
The Communicator periodically makes toll-free telephone calls to
send data to the LATITUDE Patient Management secure database.
These calls usually occur once a week at night and last for
10 to 30
minutes.
If you have other telephone equipment (including, fax machine,
answering system, or computer modem) connected to the same
phone line and the line is in use, the Communicator will wait and
attempt to place a call later.
The Communicator keeps trying to place the call for
up to a week
.
However, if you have heavy phone line usage that delays or prevents
the Communicator from placing or completing phone calls, it may be
appropriate to install an additional telephone line.
When the Communicator is using the telephone line, it will detect if
another device attempts to use the line. The Communicator will end
its call and release the line, allowing the other device to use the
telephone line. Your Communicator and a telephone can share the
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same telephone wall jack; however, they can’t be used at the same
time. Your telephone has priority over use of the telephone line.
The Communicator can only make outgoing calls, it can not receive
any calls. The Communicator functions with either pulse or tone
dialing service.
Care and Maintenance
In order to insure optimum performance of your Communicator and
protect it from damage, follow these directions:
CAUTIONS:
• Do not drop or mishandle the Communicator in a manner that
would cause damage.
• Avoid getting liquid on the unit other than cleaning it as
recommended. Do not use abrasive cloth or solvents to clean the
unit.
• Do not submerge the Communicator in liquid.
• Do not attempt to open the Communicator.
• Use this unit as described in this instruction manual. Use only
authorized parts and accessories.
If your Communicator becomes damaged, or it malfunctions, contact
Guidant Patient Services at 1-866-GUIDANT (1-866-484-3268).
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Cleaning the Communicator
When necessary, clean the Communicator housing and screen with
a soft, clean, lint-free cloth moistened in water or mild detergent. If
necessary, you may use isopropyl alcohol or window cleaner.
CAUTION: Do not use other cleaning fluids. They may damage the
Communicator screen. Never spray any cleaning fluid directly on
the Communicator screen. Do not allow moisture to accumulate
on or around the buttons or speaker holes.
Returning the Communicator
Do not dispose of the Communicator. Contact Guidant Patient
Services to make arrangements for returning the Communicator.
Guidant will replace your Communicator if it becomes defective and
provide a postage-paid return label for returning your Communicator.
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30 Specifications
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT
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Specifications
Model: 6482
LCD Display: Monochrome, 240 x 320 pixel
Power Source: 5 VDC 2.6 A, AC adapter, GlobTek model
GTM21089-1305-W2 (included)
Dimensions: Length: 8.00 in (20.3 cm)
Width: 7.50 in (19.1 cm)
Height: 7.25 in (18.4 cm)
Weight: 2.15 lb. (0.97 kg)
Operating Temperature: 50° F to 104° F (10° C to 40° C)
Storage Temperature: - 40° F to 158° F (-40° C to 70° C)
Operating and Storage
Humidity: 25% to 95% noncondensing
Atmospheric Pressure: 7.3 psi to 15.4 psi
Protection from Electric
Shock (IEC 601-1): Class II, Type BF
Protection Against
Ingress of Water: IXP0 Ordinary equipment
Mode of Operation: Short time
Safety and Compatibility
Standards
UL60601-1/EN60601-1-2. Medical electrical
equipment; FCC CFR Title 47, Part 15. Radio
frequency devices; FCC CFR Title 47, Part
68. Connection of terminal equipment to the
telephone network.
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Safety, EMC and FCC Compliance Standards 31
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D
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Safety, EMC and FCC Compliance Standards
This equipment has been tested and found to comply with applicable
safety portions of UL 60601-1:2003.
This equipment has been tested and found to comply with the
following EMC standards: EN 60601-1-2:2001
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
Changes or modifications not expressly approved by Guidant could
void the user's authority to operate this equipment.
This equipment complies with Part 68 of the FCC rules and the
requirements adopted by the ACTA. On the bottom of this equipment
is a label that contains, among other information, a product identifier
in the format US: ESCM500B6482. If requested, this number must
be provided to the telephone company.
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32 Explanation of Product and Label Symbols
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT
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Explanation of Product and Label Symbols
Symbol Meaning
Input from telephone jack
Output to telephone (optional)
AC/DC adapter power input
Non-ionizing electromagnetic radiation
See instruction manual
Class II medical equipment, protection against electrical
shock
Mark for nationally recognized testing for safety
standards
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Explanation of Shipping Box Symbols 33
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Explanation of Shipping Box Symbols
Symbol Meaning
This side up
Fragile, handle with care
Keep dry
Do not use hooks
Temperature limitations
Humidity limitations
Atmospheric pressure limitations
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34 Explanation of Shipping Box Symbols
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT
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back cover.fm Page 1 Thursday, December 2, 2004 3:36 PM
Draft - 12/2/04
Guidant Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798 USA
Tel: 651.582.4000 Fax: 651.582.4166
Medical Professionals: 1.800.CARDIAC (227.3422) Toll Free
Patients and Families: 1.866.GUIDANT (484.3268) Toll Free
www.guidant.com
© 2005 Guidant Corporation
All rights reserved. 357227-001 A US 01/05
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