Boston Scientific CRM629013 6290 User Manual 359081 001 US EN indb

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PATIENT MANUAL
MANUAL DEL PACIENTE
LATITUDE® Communicator
Comunicador LATITUDE®
English .................................................... 1
Español................................................... 75
English
ENGLISH
LATITUDE® Communicator
English
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 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.
Table of Contents
When to Use Your Communicator
When Not to Use Your Communicator
Where to Place Your Communicator
Important Notes
Buttons, Connectors, and Indicators
Installing Your Communicator
Confirming Switch Settings
Connecting Your Communicator
Software Download and Installation
Connecting to a Landline Telephone Jack
Connecting to the LATITUDE NXT USB Cellular
Adapter
Where to Place Your USB Cellular Adapter
10
10
11
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
Wave Indicator Colors
26
31
LATITUDE® Communicator Patient Manual
13
13
English
LATITUDE Patient Management System
The LATITUDE Communicator
Items You Should Receive
Optional Health Monitoring Equipment
Clinician Website
English
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
Cleaning the Communicator and Accessories
Returning, Replacing, or Disposing of the
Communicator or USB Cellular Adapter
Setting Switches for PBX or Dial-out Numbers
49
50
Connecting the USB Sensor Adapter
53
Specifications
54
Safety and Standards Compliance
Essential Performance
58
63
Electromagnetic Emissions and Immunity
65
Software
72
ii
LATITUDE® Communicator Patient Manual
51
52
LATITUDE Patient Management System
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.
LATITUDE® Communicator Patient Manual
English
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.
English
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
LATITUDE® Communicator Patient Manual
Optional Health Monitoring Equipment
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.
LATITUDE® Communicator Patient Manual
English
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.
English
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.
LATITUDE® Communicator Patient Manual
Where to 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.
LATITUDE® Communicator Patient Manual
English
Place your Communicator:
English
• 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.
LATITUDE® Communicator Patient Manual
Buttons, Connectors, and Indicators
Heart button
LATITUDE
indicator
Status
button
USB ports*
Power
input
To telephone
(optional)
To telephone
wall jack
* to connect the USB sensor adapter and/or the
LATITUDE NXT USB Cellular Adapter
Figure 1. Buttons and connectors
LATITUDE® Communicator Patient Manual
English
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.
English
Patient
Icon
Collecting
Waves
Sensor
Reading Icon
Heart
Button
LATITUDE
Indicator
Sending
Waves
Doctor
Icon
Call
Doctor Icon
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.
LATITUDE® Communicator Patient Manual
Installing Your Communicator
• 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 dialout 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.
United States
and Puerto Rico
TM
*6290*
Dial-out
Canada
Country
Mexico
Figure 3. Switch settings
LATITUDE® Communicator Patient Manual
English
Confirming Switch Settings
English
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.
10
LATITUDE® Communicator Patient Manual
Connecting to a Landline Telephone Jack
3. Connecting a telephone is optional.
Figure 4. Connecting to a landline telephone jack
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.
LATITUDE® Communicator Patient Manual
11
English
Complete the steps below to set up the Communicator
for a landline telephone connection.
English
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.
12
LATITUDE® Communicator Patient Manual
If you have signed up for the LATITUDE Cellular Data
Plan, no telephone cords need to be attached. Instead,
a cellular adapter provided upon subscription to the
Data Plan must be connected to the Communicator.
Refer to “LATITUDE Cellular Data Plan” on page 40
for more information.
Where to Place Your USB Cellular Adapter
Place your USB cellular adapter:
• Away from other electronic products or metal
surfaces.
• Alongside the Communicator and not under or on
top of it.
Figure 5. Connecting to the LATITUDE NXT USB
Cellular Adapter
LATITUDE® Communicator Patient Manual
13
English
Connecting to the LATITUDE NXT USB Cellular
Adapter
English
1. Insert the AC adapter (included) into the jack
labeled
2. Plug the AC adapter into an electrical outlet that is
easily accessible.
3. Insert the USB connector into one of the USB ports
. Refer to “Figure 5. Connecting to the
labeled
LATITUDE NXT USB Cellular Adapter” on page
13.
Important: Maintain a distance of at least 6 inches
(15 cm) between the USB cellular adapter and your
implanted device.
4. When electrical power is supplied, the
Communicator begins a startup process.
• The power indicator on the top of the USB
cellular adapter lights and remains lit except
during a LATITUDE system reboot.
Note: The wireless indicator will flash at various
times and at various sequences. This indicator is
of no concern during normal operation.
• 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.
14
LATITUDE® Communicator Patient Manual
5. 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 6 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.
6. 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.
LATITUDE® Communicator Patient Manual
15
English
Important: Your Communicator should remain
connected to the electrical outlet and the USB
cellular adapter.
English
Normal Operation of the Communicator
Your Communicator performs device checks every day,
and when operating normally, only the LATITUDE
indicator will be lit (green). Also, the Communicator
automatically interrogates your implanted device on a
regular schedule set by your health care provider. None
of the Communicator indicators will light during a
scheduled interrogation or daily device check. They will
light when you use the Heart button as described in
“Interrogating Your Implanted Device” on page 43 or
when using the Status button as described in “Checking
that the Communicator Can Connect to the LATITUDE
System” on page 45.
Note: When color is used in this manual to explain
operation of the Communicator, an indicator shown
as gray means that it is not lit. An indicator shown
as any other color, including white, means that it is
lit.
(A gray heart shown inside the blue circle means
that it is not lit. A white heart shown inside the blue
circle means that it is lit.)
16
LATITUDE® Communicator Patient Manual
This section describes how the indicators will light
after you press the Heart button. The Communicator
interrogates your implanted device and then sends your
data to the LATITUDE system. More details about the
colors and purpose of the indicators appear later in this
manual.
The Communicator begins interrogating your implanted
device after the Heart button is pressed.
The Patient icon lights blue. The Collecting Waves light
green in sequence and repeat while the Communicator
interrogates your device.
LATITUDE® Communicator Patient Manual
17
English
Indicator Sequence When Using the
Heart Button
English
All three Collecting Waves will light green. The Heart
button lights white showing the interrogation was a
success.
The Sending Waves light green in sequence and
repeat while the Communicator places a call and starts
sending your data to the LATITUDE system.
The Doctor icon lights blue showing the Communicator
successfully sent your data to the LATITUDE system.
All the indicators shown stay lit for 2 minutes to show
the entire process was a success.
18
LATITUDE® Communicator Patient Manual
Indicator Descriptions
• Manually interrogating your implanted device
• Manually connecting and sending your implanted
device information to the LATITUDE system
• Collecting a measurement from a prescribed
weight scale or blood pressure monitor
One or more indicators may light or flash a different
color to indicate some type of action may need to be
taken. Refer to “Troubleshooting Errors” on page 26.
Patient Icon
Shows the Communicator is
interrogating (collecting data from)
your implanted device.
• Lights blue when the Heart
button is pressed and an
interrogation has started.
• Stays lit for 2 minutes after a
successful interrogation.
LATITUDE® Communicator Patient Manual
19
English
The indicators will light to indicate the Communicator’s
progress when:
English
Collecting Waves
Show the Communicator is
collecting data from your implanted
device.
• Light green in sequence
and repeat, showing the
Communicator is interrogating
your implanted device.
• Light green for 2 minutes to
indicate the interrogation was a
success.
Heart Button
• Flashes with a white light if you
need to complete a previously
scheduled interrogation.
• Lights a solid white for 2 minutes
to indicate the interrogation is
complete.
• May also be used to manually
initiate an interrogation of your
implanted device. Refer to
“Interrogating Your Implanted
Device” on page 43 before
using this button.
20
LATITUDE® Communicator Patient Manual
English
Sending Waves
Show the Communicator is
connecting to the LATITUDE
system.
• Light green in sequence and
repeat, showing a connection
to the LATITUDE system is in
progress.
• Light green for 2 minutes to
indicate the connection to
the LATITUDE system was
a success and any collected
device data was sent.
Doctor Icon
Lights blue for 2 minutes to indicate
the Communicator has successfully
connected to the LATITUDE
system. The Communicator sends
any data it has collected from your
implanted device, weight scale, or
blood pressure monitor.
LATITUDE® Communicator Patient Manual
21
English
Sensor Reading Icon
Shows the Communicator has
successfully communicated with a
prescribed weight scale or blood
pressure monitor.
• Flashes green five times and
remains lit for 5 minutes to
indicate the Communicator
successfully received a weight
or blood pressure measurement.
LATITUDE Indicator
Shows the Communicator is
connected to electrical power. It
also shows if the Communicator
startup process is being performed
or if the Communicator is ready to
use.
• Lights green to indicate the
Communicator is connected to
electrical power and is ready to
use.
• Flashes yellow during the startup
process.
• May flash yellow for a long
time. This means that new
software is being installed on the
Communicator.
22
LATITUDE® Communicator Patient Manual
Lights yellow or red to signal a
problem that you should report to
your health care provider. Refer
to the error in “Troubleshooting
Errors” on page 26.
A red light ranks higher than a
yellow light. If an error for each
color occurs at the same time, only
the red light is displayed.
• Flashes yellow briefly after the
Communicator is plugged into AC
power.
• The light turns off after the
Communicator completes the
startup process.
• If the startup process does not
complete, it remains lit solid
yellow.
LATITUDE® Communicator Patient Manual
23
English
Call Doctor Icon
English
Status Button
The Status button is located on the back of the
Communicator as shown in Figure 6.
Figure 6. Status button
The Status button performs one the following actions
depending on how long the button is pressed:
• Press for less than 3 seconds: The
Communicator indicators will light to display:
• The status of the last interrogation.
• The status of the last connection to the
LATITUDE system.
The indicators will light for 2 minutes. If the Call
Doctor icon was blinking, it will stop blinking and
stay lit.
• Press and hold for more than 3 seconds: The
Sending Waves light green in sequence and
repeat while the Communicator connects to the
LATITUDE system.
Note: If you pressed the Heart button, the
Status button will not function until the resulting
interrogation is completed or is cancelled.
24
LATITUDE® Communicator Patient Manual
Confirming Successful Operation
English
You can use the Status button to check if the
Communicator has been operating normally. The
above image shows that all the Collecting and
Sending Waves are lit green, confirming that the last
interrogation and the last connection to the LATITUDE
system were a success. When all the waves are green,
no action is needed.
LATITUDE® Communicator Patient Manual
25
English
Troubleshooting Errors
One or more of the indicators on the front of the
Communicator may light or flash to indicate some type
of Communicator, communication, or LATITUDE
system error. A general description of the types of
errors are shown in Figure 7. A description of each error
is provided in this section, along with suggested actions
to resolve each error.
Yellow Collecting Waves
Indicate errors collecting
information from your
implanted device
Yellow Sending Waves
Indicate errors sending
information to the LATITUDE
system
LATITUDE Indicator
Yellow light indicates an error
Call Doctor Icon
Call your doctor when lit
Figure 7. Types of errors
26
LATITUDE® Communicator Patient Manual
No Indicators are Lit
English
Description: The Communicator is not connected to
electric power or it is not functioning.
Action:
• 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.
• If the Communicator is plugged into
electric power and the light on the AC
adapter is on, contact your health care
provider.
LATITUDE® Communicator Patient Manual
27
English
Call Doctor Icon is Red
LATITUDE Indicator is Yellow
Description: The Call Doctor icon is red, and the
LATITUDE indicator is yellow.
A potential problem with your
implanted device was detected,
but the Communicator cannot send
any information collected from your
implanted device to the LATITUDE
system.
The Call Doctor icon and LATITUDE
indicator will stay lit until the problem is
resolved.
Action:
28
Your immediate response is required.
Call your health care provider.
LATITUDE® Communicator Patient Manual
English
Call Doctor Icon is Yellow
LATITUDE Indicator is Yellow
Description: The Call Doctor icon is yellow, and the
LATITUDE indicator is yellow.
Indicates one of the following errors:
• Your Communicator is currently
unable to monitor your implanted
device.
• Monitoring of your implanted
device was suspended through the
LATITUDE system.
The Call Doctor icon and LATITUDE
indicator will stay lit until the problem is
resolved.
Action:
Call your health care provider.
LATITUDE® Communicator Patient Manual
29
English
Call Doctor Icon Lit
LATITUDE Indicator Not Lit
Description: The Call Doctor icon is lit yellow, and
the LATITUDE indicator is not lit. This
indicates your Communicator may not
be working properly.
Action:
30
You may need a replacement
Communicator. Contact your health care
provider.
LATITUDE® Communicator Patient Manual
Wave Indicator Colors
Note: In addition to the Wave indicators lighting
yellow to indicate an error, the LATITUDE indicator
lights yellow at the same time.
LATITUDE® Communicator Patient Manual
31
English
One or more of the Wave indicators will light yellow to
indicate some type of error as described in the following
Wave sections. Wave indicators light for 60 minutes
unless the error is resolved sooner. After 60 minutes, all
Wave lights are turned off and the LATITUDE indicator
is lit green, even if the problem was not resolved.
English
One Yellow Collecting Wave
Description: The Communicator was unable to
start an interrogation of your implanted
device, or your implanted device was
out of range at the time of the attempted
interrogation.
Action:
• Ensure the Communicator is optimally
placed as described in “Where to
Place Your Communicator” on page
5.
• Face the Communicator. Sit directly
in front of the Communicator. Make
sure you are within 10 ft (3 m) of the
Communicator.
• Move any wireless electronic products
(such as cordless or cellular phones
or baby monitors) that are within 3 ft
(1 m) of the Communicator.
To verify that troubleshooting was a
success:
• Press the Heart button to start another
interrogation. If the interrogation was
a success, all three Collecting Waves
will light green for 2 minutes.
32
LATITUDE® Communicator Patient Manual
Two Yellow Collecting Waves
English
Description: The Communicator started but was not
able to complete the interrogation within
the time allowed.
Action:
• Ensure the Communicator is optimally
placed as described in “Where to Place
Your Communicator” on page 5.
• Face the Communicator. Sit directly
in front of the Communicator. Make
sure you are within 10 ft (3 m) of the
Communicator.
• Remain still until the interrogation is
complete. Do not move away from the
Communicator.
• Move any wireless electronic products
(such as cordless or cellular phones or
baby monitors) that are within 3 ft (1 m)
of the Communicator.
To verify that troubleshooting was a
success:
• Press the Heart button to start another
interrogation. If the interrogation was a
success, all three Collecting Waves will
light green for 2 minutes.
LATITUDE® Communicator Patient Manual
33
English
Three Yellow Collecting Waves
Description: Any of the following reasons could cause
this error:
• You may have exceeded your weekly
interrogation limit, or you may not be
allowed to use the Heart button.
• The Communicator was unable to
establish wireless communication
with your implanted device due to
interference from another person’s
implanted device.
Action:
• If you are planning to interrogate
your device, wait 10 minutes. Then
try pressing the Heart button again to
initiate the interrogation.
• Do not press the Heart button while the
interrogation is in progress unless you
intend to stop the interrogation.
• If you see three yellow waves after
pressing the Heart button, contact your
health care provider.
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LATITUDE® Communicator Patient Manual
One Yellow Sending Wave
English
Description: The Communicator was not able to
make a connection to the LATITUDE
system for one of the following reasons:
• No dial tone was detected when
attempting to use the telephone line.
• No cellular providers were detected
when attempting to connect using the
LATITUDE Cellular Data Plan.
Action:
If using a landline telephone connection:
• Check that the telephone cord
provided with the Communicator is
plugged in tightly to a telephone wall
jack and the Communicator.
• Pick up the telephone and check for
dial tone. If no dial tone, try a different
telephone wall jack.
• If you have DSL Internet service,
ensure you are using a DSL filter
between the Communicator and the
telephone wall jack.
• Check that the analog telephone
service supports the tone dialing
mode.
LATITUDE® Communicator Patient Manual
35
English
If using the LATITUDE Cellular Data
Plan:
• If you have not activated the
LATITUDE Cellular Data Plan, see
page 40.
• Make sure the USB cellular adapter is
plugged into the Communicator.
• Move the Communicator to another
location that may have better cellular
reception.
• If other locations do not work after
trying another connection, try plugging
the Communicator into an active
telephone wall jack.
To verify that troubleshooting was a
success:
• Press and hold the Status button
until the Sending Waves light green
in sequence and repeat. If the
connection is successful, all three
Sending Waves will light green for 2
minutes.
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LATITUDE® Communicator Patient Manual
Two Yellow Sending Waves
English
Description: An attempt to connect to the LATITUDE
system failed due to connection issues
relating to the landline telephone or
cellular network.
If using a landline telephone connection,
another device (telephone, answering
machine, or computer) may be using or
attempting to use the telephone line.
Action:
If using a landline telephone connection:
• Make sure your telephone is not being
used at this time.
• Pick up the telephone and check for
dial tone. If no dial tone, try a different
telephone wall jack.
• Remove any splitters between the
Communicator and the telephone wall
jack.
• If you have DSL Internet service,
ensure you are using a DSL filter
between the Communicator and the
telephone wall jack.
LATITUDE® Communicator Patient Manual
37
English
• Check that the switches on the
bottom of the Communicator are set
correctly for your country and whether
you need to dial a number to get an
outside line. Refer to “Confirming
Switch Settings” on page 9.
If using the LATITUDE Cellular Data
Plan:
• If you have not activated the
LATITUDE Cellular Data Plan, see
page 40.
• Move the Communicator to another
location that may provide a stronger
cellular signal.
• If other locations do not work after
trying another connection, try plugging
the Communicator into an active
telephone wall jack.
To verify that troubleshooting was a
success:
• Press and hold the Status button
until the Sending Waves light green
in sequence and repeat. If the
connection is successful, all three
Sending Waves will light green for 2
minutes.
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LATITUDE® Communicator Patient Manual
Three Yellow Sending Waves
English
Description: The Communicator was able to
establish a connection, but no
information reached the LATITUDE
system.
Action:
• Check that the switches on the
bottom of the Communicator are set
correctly for your country and whether
you need to dial a number to get an
outside line. Refer to “Confirming
Switch Settings” on page 9.
• Press and hold the Status button until
the Sending Waves light green and
show progress.
• If you see three yellow waves
after trying the above action, your
Communicator may not be set up
correctly in the LATITUDE system.
Contact your health care provider.
LATITUDE® Communicator Patient Manual
39
English
LATITUDE Cellular Data Plan
The LATITUDE Cellular Data Plan uses a cellular data
network rather than a standard landline telephone
connection to send your implanted device data to
the LATITUDE system. The LATITUDE Cellular Data
Plan is an optional subscription service that must be
activated before your Communicator can use this
service. Upon subscription, you will receive a cellular
adapter that enables cellular communication between
your Communicator and the LATITUDE system.
You need either a standard analog landline telephone
connection or the LATITUDE Cellular Data Plan to use
the LATITUDE system.
The LATITUDE Cellular Data Plan uses a data-only
network. It does not send voice signals and it cannot be
used with your cellular phone service.
Note: Your Communicator is designed to use
a landline telephone connection if it is plugged
into an active telephone jack. If connected, your
Communicator will send your device data over
the landline telephone connection even if you are
subscribed to the LATITUDE Cellular Data Plan.
Cellular Converter
You may already have a Multi-Tech Systems
MultiConnect™ MT200A2W analog-to-wireless
cellular converter from a previous Communicator.
Your LATITUDE Communicator may use the MultiTech Systems MultiConnect™ MT200A2W analog-towireless cellular converter to access a cellular network.
The MultiConnect Converter has been tested and found
to be compatible with the LATITUDE Communicator.
Use of the converter is optional.
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LATITUDE® Communicator Patient Manual
Activating the LATITUDE Cellular Data Plan
Once the LATITUDE Cellular Data Plan is activated,
you can verify the connection by following the
instructions in “Checking that the Communicator Can
Connect to the LATITUDE System” on page 45. If
you travel to another location with your Communicator,
check the connection from that location.
Troubleshooting and Support
Subscription to the LATITUDE Cellular Data Plan
does not guarantee coverage. Actual coverage may
be affected by such things as terrain, weather, foliage,
buildings and other construction, signal strength,
customer equipment, and other factors.
The Sending Waves may light yellow if your
Communicator cannot connect through an activated
LATITUDE Cellular Data Plan. If this happens, refer to
the Sending Waves sections of this manual, page 35
through page 39. If the Communicator is still unable
to connect, contact LATITUDE Patient Services for
assistance.
If your Communicator is not able to connect to the
LATITUDE system using the LATITUDE Cellular Data
Plan, try plugging the Communicator into an active
telephone jack.
LATITUDE® Communicator Patient Manual
41
English
Contact LATITUDE Patient Services at 1-866-4843268 to subscribe to the LATITUDE Cellular Data Plan.
There is a cost for this service unless your clinic has
made other arrangements. An activated plan works
only with your LATITUDE NXT USB Cellular Adapter. If
a replacement adapter is ever needed, or if you need
to update your subscription, contact LATITUDE Patient
Services.
English
Discontinuing Your LATITUDE Cellular Data
Plan
Contact LATITUDE Patient Services to discontinue use
of the LATITUDE Cellular Data Plan. Your subscription
will automatically be discontinued if you miss two or
more payments. You will need to discontinue your
subscription if you stop using the LATITUDE system
or if you want to return to using a landline telephone
connection. Make sure your health care provider is
aware of any changes in service.
For information on returning, replacing, or disposing of
your USB cellular adapter, see page 51.
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LATITUDE® Communicator Patient Manual
Interrogating Your Implanted Device
A scheduled interrogation will not be completed if you
are out of range (10 ft/3 m) from the Communicator
when it attempts to communicate with your implanted
device. If the Communicator is unable to automatically
interrogate your device after repeated attempts, the
Heart button will flash to allow you to complete the
interrogation manually. The Heart button also flashes
the first time you use the Communicator.
The Heart button is designed to enable you to
manually interrogate your implanted device. Manual
interrogation is a feature that must be enabled by
your health care provider. When you press the Heart
button, the Communicator checks to make sure that
the interrogation is permitted. You should only use the
Heart button if it is flashing or when instructed to do so
by your health care provider.
If you press the Heart button by mistake (not intending
to perform an interrogation), press and hold the Heart
button again for at least 5 seconds to cancel the
interrogation. The Collecting Waves may light yellow
and show progress while the interrogation is being
cancelled.
LATITUDE® Communicator Patient Manual
43
English
The Communicator automatically interrogates your
implanted device on a regular schedule set by your
health care provider. This may happen without your
awareness and should not require any action on
your part. Daily device checks are also performed
automatically. None of the Communicator indicators will
light during a scheduled interrogation or daily device
check.
English
When using the Heart button, you should stay close
to the Communicator during the entire interrogation
process to ensure optimum communication between
your implanted device and the Communicator.
If a manual interrogation is not permitted, either
because the limit has been reached or because the
feature is disabled, the Communicator automatically
calls the LATITUDE system. This is done to check for a
change in the number of manual interrogations allowed
or to check if this feature has been re-enabled.
CAUTIONS:
• Normal use of the LATITUDE system has been
accounted for in the projected battery life of your
implanted device. Using the Heart button more
often than when the Heart button flashes or more
often than instructed by your health care provider
may lead to a decrease in the battery life of your
implanted device.
• If you feel unwell or are in need of urgent health
care, call your health care provider or dial 911.
Interrupted Electrical Power
The Communicator has internal memory that stores
your interrogation and other information in case the
electrical power is interrupted or the AC adapter is
unplugged. The LATITUDE indicator will transition back
to green once power is restored to the Communicator.
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LATITUDE® Communicator Patient Manual
Complete the following steps to check that the
Communicator can connect to the LATITUDE
system. You should do this if you have moved the
Communicator or if there has been a change in your
telephone service or LATITUDE Cellular Data Plan
subscription.
1. Check that the Communicator is plugged in and the
LATITUDE indicator is green.
2. Press and hold the Status button on the back of
the Communicator for more than 3 seconds. The
Sending Waves light green in sequence and repeat
while the Communicator attempts to connect to the
LATITUDE system.
If both Collecting and Sending Waves light, you did
not press the Status button long enough. Pressing
the Status button for less than 3 seconds displays
the status of the last interrogation and the status
of the last attempt to connect to the LATITUDE
system.
3. Watch the front of the Communicator. The Sending
Waves should light in sequence and repeat,
showing a connection to the LATITUDE system is in
progress.
4. Wait approximately 5 minutes for the connection to
complete.
LATITUDE® Communicator Patient Manual
45
English
Checking that the Communicator Can
Connect to the LATITUDE System
English
5. If the connection was successful, all three of the
Sending Waves will light green for 2 minutes.
If the connection was unsuccessful, one or more
of the Sending Waves will light yellow. Refer to the
appropriate condition in the “Wave Indicator Colors”
section beginning on page 31 for actions to take.
Traveling with Your Communicator
You can use your Communicator away from home
if you will be gone for an extended period. Consult
your health care provider before planning to travel
for an extended period, whether or not you take your
Communicator. Your health care provider may need
to temporarily change your interrogation schedule
or, if you are traveling outside the country, give you
information about connecting to the LATITUDE system.
Note (Model 6280 only): Your Communicator is
designed to be used only in the United States,
Canada, Puerto Rico, and Mexico. Use of the
Communicator in other countries is restricted
due to radio-frequency (RF) laws. Please contact
LATITUDE Patient Services at 1-866-484-3268 for
specific information.
If you take your Communicator with you, check that
the Communicator can connect to the LATITUDE
system. Refer to “Checking that the Communicator Can
Connect to the LATITUDE System” on page 45.
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LATITUDE® Communicator Patient Manual
The Communicator makes telephone calls when there
is a need to send data to the LATITUDE system. These
calls usually last for approximately 5 minutes.
The Communicator can only make outgoing calls. It
cannot receive calls. The Communicator is designed
to operate on standard landline telephone connections
like those found in most homes and supports tone
dialing over an analog line. The Communicator may
work on other telephone systems, such as DSL and
VoIP, 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 (nursing homes,
skilled care facilities, rehabilitation centers) where
telephones are typically provided by the facility.
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. 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.
Your Communicator and a telephone can share the
same telephone wall jack; however, they cannot
be used at the same time. The Communicator will
relinquish control of the telephone line shortly after you
pick up the phone, provided that the telephone line
meets the specifications stated on page 54.
LATITUDE® Communicator Patient Manual
47
English
Communicator Use of the Telephone
System
English
Using the Telephone While the Communicator
is Making a Call
If you pick up the phone while the Communicator is
using the telephone line, hang up the receiver, wait 3 or
more seconds, and then pick up the telephone receiver
again. The Communicator will disconnect and dial tone
will be restored.
If the Communicator does not disconnect and restore
dial tone, hang up the receiver. Then unplug the
Communicator from electrical power. You can then use
your phone. Plug the Communicator back in after you
have finished using the phone.
The Communicator will attempt to reconnect later.
DSL Internet Service
If you have digital subscriber line (DSL) Internet service
provided through your telephone line, you may need to
install a DSL filter between the wall phone jack and the
LATITUDE Communicator.
Most DSL filters are small rectangular devices with
standard telephone jack connectors at each end. These
filters are typically provided by DSL service providers
to connect telephones, an answering machine, or a fax
machine to your telephone line.
If you use DSL filters for such devices, you will need to
install a DSL filter to use the Communicator. If you use
a dual-port DSL filter, connect the Communicator to
the port labeled PHONE or where you would typically
connect a telephone. For assistance, contact your
DSL service provider or LATITUDE Patient Services at
1-866-484-3268.
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LATITUDE® Communicator Patient Manual
Care and Maintenance
Your Communicator does not require electrical safety
testing after installation or during periodic maintenance.
To ensure optimum performance of your Communicator
and accessories and protect them from damage, follow
these directions:
CAUTIONS:
• Do not drop or mishandle the Communicator or
its accessories 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 or its
accessories in liquid.
• Do not attempt to open the Communicator or any
of its accessories.
• Use this unit as described in this instruction
manual. Use only authorized parts and
accessories. Do not attempt to modify or alter this
unit or accessories.
If your Communicator or accessories become damaged
or malfunction, contact your health care provider.
LATITUDE® Communicator Patient Manual
49
English
Your Communicator does not require any regular
service or maintenance.
English
Cleaning the Communicator and Accessories
When necessary, clean the Communicator and its
accessories with a soft, clean, lint-free cloth moistened
in water or mild detergent. Note that the finish on
some types of furniture could be affected as a result
of continuous contact with rubber material such as the
type used on the base of the Communicator.
CAUTIONS:
• Do not use other cleaning fluids. They may
damage the front lens of the Communicator.
Never spray any cleaning fluid directly on the
Communicator front lens. Do not allow moisture
to accumulate on or around the lens or Heart
button.
• Avoid using any cleaning fluid near the electrical
plugs on the back of the Communicator.
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LATITUDE® Communicator Patient Manual
If you need to replace either your Communicator or
USB cellular adapter because it is damaged or no
longer works, or if you need a different model, contact
your health care provider to learn how to return and
replace it.
If you no longer need to use either your Communicator
or USB cellular adapter:
• United States: Do not throw the Communicator
or adapter in the trash. Dispose of it at a local
recycling site that accepts electronics. Contact
your local authorities to learn how to dispose of it.
• Puerto Rico, Canada, or Mexico: Do not
dispose of the Communicator or adapter. Contact
your health care provider to learn how to return it.
Your Communicator may contain encrypted health data.
Dispose of it only as described above.
LATITUDE® Communicator Patient Manual
51
English
Returning, Replacing, or Disposing of the
Communicator or USB Cellular Adapter
English
Setting Switches for PBX or Dial-out Numbers
(This section applies only to landline telephone
connections.) You can use your Communicator with
a private branch exchange (PBX) in a managed care
facility, hotel, or other location that requires you to enter
a dial-out number or prefix to place an outside call. The
first three white switches (1, 2, and 3) on the bottom of
the Communicator must be set to match your dial-out
number. If using the USB cellular adapter, switches 1-3
do not matter.
Switch settings for different dial-out numbers are shown
in Figure 8. Refer to “Confirming Switch Settings” on
page 9 for information on switches 4-8.
Dial-out
Number
Dial-out
Number
None
*99
Figure 8. Dial-out number switch settings
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LATITUDE® Communicator Patient Manual
Connecting the USB Sensor Adapter
Figure 9. USB sensor adapter connection
1. Remove the cap from the USB sensor adapter.
2. Plug the USB sensor adapter into either of
on the back of the
the USB ports labeled
Communicator.
Leave the USB sensor adapter plugged into the
Communicator so the Communicator can receive
measurements whenever you use your weight scale or
blood pressure monitor.
LATITUDE® Communicator Patient Manual
53
English
The USB sensor adapter is included with a LATITUDE
weight scale and blood pressure monitor. The USB
sensor adapter provides a wireless connection between
these products and the Communicator. Refer to
Figure 9.
English
Specifications
Model:
6280 and 6290
(Unless specified, values apply
to both models.)
Dimensions:
Length: 8.00 in (20.3 cm)
Width: 4.50 in (11.4 cm)
Height: 2.71 in (6.9 cm)
Weight:
0.83 lbs ( 0.38 kg)
Power Source:
5.0 VDC, 3.0 A, continuous
service Class II AC adapter,
GlobTek® Model GTM410611512-7.0, part 350118-001
(included)
Power Supply:
Input: 100-240 VAC, 0.6 A, 50-60 Hz
Maximum Output: 15 W
Supply Mains
Isolation:
AC adapter plug
Minimum Operational
Loop Current:
20 mA
Protection Against
Electric Shock:
Class II
Expected Service Life:
Meets the useful life of the
implanted device, from 4.2 to
12.6 years
Analog Dialing Mode:
Tone
Operating
Temperature:
41° F to 104° F (5° C to 40° C)
Storage and Transport
Temperature:
-13° F to 158° F
(-25° C to 70° C)
Operating Humidity:
15% to 93% noncondensing
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LATITUDE® Communicator Patient Manual
15% to 93% noncondensing
Operating Pressure:
70 to 106 kPa
English
Storage and Transport
Humidity:
Storage and Transport/
50 to 106 kPa
Pressure:
Protection Against
Ingress of Water:
IP21 (light rain proof)
Communicator Implanted Device Radio (Model 6280):
Receive Bandwidth:
+190/-160 kHz
Frequency Band:
916.5 MHz
Modulation Transmit
Type:
ASK
(Amplitude-Shift keying)
Effective Radiated
Power:
<-1.25 dBm (0.75 mW)
Communicator Implanted Device Radio (Model 6290):
Receive Bandwidth:
MICS/MedRadio:
Modulation Transmit
Type:
Effective Radiated
Power:
<300 kHz
402-405 MHz
FSK
(Frequency-Shift keying)
<-16 dBm (25 μW)
LATITUDE® Communicator Patient Manual
55
English
USB Sensor Adapter:
2.4 GHz wireless USB dongle
Delta Mobile Systems® Model DM210
Boston Scientific Model 6454
(included with LATITUDE weight scale and
blood pressure monitor)
Operational Frequency: 2400.0 to 2480.0 MHz
Modulation Type:
Adaptive Frequency Hopping
Effective Radiated
14 dBm (25 mW)
Power:
Operating Temperature: 32° F to 158° F
(0° C to 70° C)
Storage Temperature:
-4° F to 185° F
(-20° C to 85° C)
Relative Humidity:
10% to 85% noncondensing
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LATITUDE® Communicator Patient Manual
PCS-1900:
TX 1850-1910 MHz
RX 1930-1990 MHz
Effective Radiated Power:
26.42 dBm
W-CDMA 850:
TX 824-849 MHz
RX 869-894 MHz
Effective Radiated Power:
15.83 dBm
W-CDMA 1900:
TX 1850-1910 MHz
RX 1930-1990 MHz
Effective Radiated Power:
18.76 dBm
LATITUDE® Communicator Patient Manual
57
English
LATITUDE NXT USB Cellular Adapter (Model 6295):
TX 824-849 MHz
GSM-850:
RX 869-894 MHz
Effective Radiated Power:
22.93 dBm
English
Safety and Standards Compliance
• Changes or modifications not expressly approved
by Boston Scientific could void the user’s
authority to operate this equipment.
• Before each use, visually inspect your
Communicator to make sure the housing has
no cracks and the AC adapter and any other
connecting items are intact.
• The use of accessories and cables other than
those specified may result in increased emissions
or decreased immunity of the LATITUDE
Communicator.
• Keep your Communicator and all accessories
out of the reach of small children and pets.
Small parts may cause choking or serious injury
if swallowed and attached cords may pose a
strangulation hazard. Consult a health care
professional immediately if this occurs.
• Do not insert any object other than a phone
connector into the phone jacks on the back of
the Communicator. There can be voltage on the
electrical contacts in the jacks. There is potential
to receive a shock.
• Do not use the Communicator adjacent to or
stacked with other equipment. If it is necessary
to use the Communicator adjacent to or stacked
with other equipment, please contact LATITUDE
Patient Services at 1-866-484-3268 to verify
normal operation.
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LATITUDE® Communicator Patient Manual
• To help prevent electromagnetic interference,
it may be necessary to keep other wireless
communications equipment such as cellular
telephones and their base stations, mobile
phones, and wireless home network devices at
least 1.6 ft (0.5 m) away from the Communicator.
• Other wireless communication equipment could
interfere with the Communicator even if the
other equipment complies with CISPR (Special
International Committee on Radio Interference)
emission requirements.
• 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.
• This equipment complies with Part 68 of the
FCC rules and the requirements adopted
by the Administrative Council for Terminal
Attachments (ACTA). On the bottom of this
equipment is a label that contains, among other
information, a product identifier in the format
US: AAAEQ##TXXX. If requested, this number
must be provided to the telephone company.
The Ringer Equivalence Number (REN) for this
product is part of the product identifier. The digits
represented by ## are the REN.
LATITUDE® Communicator Patient Manual
59
English
• The user is cautioned to maintain an 8 in. (20 cm)
spacing from the product to ensure compliance
with Federal Communications Commission/
Industry Canada (FCC/IC) requirements.
English
• The REN is used to determine the number of
devices that may legally connect to a telephone
line. In most, but not all areas, the sum of RENs
should not exceed five (5.0). You should contact
your telephone company to determine the
maximum REN for your calling area.
• This equipment uses the following Universal
Service Order Codes (USOC) jacks: RJ11C.
• An FCC compliant telephone cord and modular
plug are provided with this equipment, which is
designed to connect to the telephone network
or premises wiring using a Part 68 compliant
compatible jack. See installation instructions for
details.
• Model 6290 only: This transmitter is
authorized by rule under the Medical Device
Radiocommunication Service (in part 95 of
the FCC Rules) and must not cause harmful
interference to stations operating in the 400.150–
406.000 MHz band in the Meteorological
Aids (i.e., transmitters and receivers used to
communicate weather data), the Meteorological
Satellite, or the Earth Exploration Satellite
Services and must accept interference that may
be caused by such stations, including interference
that may cause undesired operation. This
transmitter shall be used only in accordance with
the FCC Rules governing the Medical Device
Radiocommunication Service. Analog and digital
voice communications are prohibited. Although
this transmitter has been approved by the
Federal Communications Commission, there is
no guarantee that it will not receive interference
or that any particular transmission from this
transmitter will be free from interference.
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LATITUDE® Communicator Patient Manual
• The telephone company may make changes in
its facilities, equipment, operations, or procedures
that could affect the operation of the equipment.
If this happens, the telephone company will
provide advance notice in order for you to make
necessary modifications to maintain uninterrupted
service.
• If the Communicator causes harm to the
telephone network, the telephone company
will notify you in advance that temporary
discontinuance of service may be required. But
if advance notice isn’t practical, the telephone
company will notify the customer as soon as
possible. Also, you will be advised of your right
to file a complaint with the FCC if you believe it is
necessary.
• Connection to party line service is subject to state
tariffs. Contact the state public utility commission,
public service commission or corporation
commission for information.
• This equipment has been tested and found to
comply with applicable safety portions of the
AAMI ES 60601-1:2005, CAN/CSA-C22.2 NO.
60601-1:08 and IEC 60601-1:2005 standards.
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61
English
• If your home has specially wired alarm equipment
connected to the telephone line, ensure the
installation of the Communicator does not disable
your alarm equipment. If you have questions
about what will disable alarm equipment, consult
your telephone company or a qualified installer.
English
• This equipment has been tested and found
to comply with the following electromagnetic
compatibility (EMC) standard: IEC 60601-12:2007.
• Accessory equipment connected to the analog
and digital interfaces (signal inputs and signal
outputs) must be certified according to the
respective IEC standards. Anyone who connects
additional equipment to the signal input parts
or signal output parts may configure a medical
system, and is therefore responsible that the
system complies with the requirements of clause
16 of IEC 60601-1:2005. If in doubt, consult
the technical service department or your local
representative.
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LATITUDE® Communicator Patient Manual
Essential Performance
• Communicate with your implanted device.
• Identify alert conditions in your implanted device.
• Receive measurements from optional health
monitoring equipment.
• Communicate implanted device data and alert
conditions to the LATITUDE system.
• Communicate measurements and alert conditions
from optional health monitoring equipment to the
LATITUDE system.
• Receive configuration updates from the
LATITUDE system.
LATITUDE® Communicator Patient Manual
63
English
The performance of the Communicator that is
determined to be essential by Boston Scientific for
electromagnetic compatibility (EMC) testing, as per IEC
60601-1-2, is the ability to:
English
64
LATITUDE® Communicator Patient Manual
English
Electromagnetic Emissions and
Immunity
Table 1. Guidance and manufacturer’s declaration—
electromagnetic emissions—for all equipment and systemsa b
Emissions test
Compliance
Electromagnetic environment—guidance
RF emissions
(CISPR 11)
Group 1
The LATITUDE Communicator
uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
(CISPR 11)
Class B
Harmonic
emissions (IEC
61000-3-2)
Class A
Voltage
fluctuations/flicker
emissions
(IEC 61000-3-3)
Complies
The LATITUDE Communicator
is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.
a. The LATITUDE Communicator is intended for use in the
electromagnetic environment specified above. The customer or the
user of the LATITUDE Communicator should assure that it is used
in such an environment.
b. The LATITUDE Communicator is also compliant with IEC 60601-12:2007.
LATITUDE® Communicator Patient Manual
65
English
Table 2. Guidance and manufacturer’s declaration—
electromagnetic immunity—for all equipment and systemsa b
IEC 60601 test
level
Compliance level
Electrostatic
discharge
(ESD) (IEC
61000-4-2)
±6 kV contact
±8 kV contact
±8 kV air
±15 kV air
Electrical fast
transient/
burst (IEC
61000-4-4)
±2 kV for
power supply
lines
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±1 kV for
input/output
lines
±1 kV
differential
mode
±1 kV
differential
mode
±2 kV
common
mode
±2 kV
common
mode
Immunity test
Surge
(IEC
61000-4-5)
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LATITUDE® Communicator Patient Manual
Electromagnetic
environment—guidance
The relative humidity
should be at least 15
percent.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Immunity test
Power
frequency
(50/60 Hz)
magnetic field
(IEC
61000-4-8)
Compliance level
<5% UTb
(>95% dip
in UT) for 0.5
cycle
<5% UT
(>95% dip
in UT) for 0.5
cycle
40% UT
(60% dip
in UT) for 5
cycles
40% UT
(60% dip
in UT) for 5
cycles
70% UT
(30% dip in
UT) for 25
cycles
70% UT
(30% dip in
UT) for 25
cycles
<5% UT
(>95% dip in
UT) for 5 sec
<5% UT
(>95% dip in
UT) for 5 sec
3 A/m
30 A/m
Electromagnetic
environment—guidance
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of
the LATITUDE
Communicator
requires continued
operation during
power mains
interruptions, it
is recommended
that the LATITUDE
Communicator be
powered from an
uninterruptible power
supply or a battery.
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
a. The LATITUDE Communicator is intended for use in the
electromagnetic environment specified above. The customer or the
user of the LATITUDE Communicator should assure that it is used
in such an environment.
b. UT is the AC main’s voltage prior to application of the test level.
LATITUDE® Communicator Patient Manual
67
English
Voltage
dips, short
interruptions,
and voltage
variations on
power supply
input lines
(IEC
61000-4-11)
IEC 60601 test
level
English
Table 3. Guidance and manufacturer’s declaration—
electromagnetic immunity—for equipment and systems that are not
life supportinga b c d
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment—
guidance
Portable and mobile RF
communications equipment
should be used no
closer to any part of the
LATITUDE Communicator,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distances:
Conducted
RF (IEC
61000-4-6)
3 Vrms
150 kHz
to 80 MHz
3 Vrms
d = 1.7 √P
10 Vrms in
ISM and
amateur
radio bands
between
150 kHz and
80 MHze
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
(150 kHz to 80 MHz)
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey,f should be less than
the compliance level in each
frequency range.g
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LATITUDE® Communicator Patient Manual
IEC 60601
test level
Radiated
RF (IEC
61000-4-3)
3 V/m
80 MHz to
2.5 GHz
Compliance
level
10 V/m
80 MHz to
1000 MHzh
3 V/m
1 GHz to
2.7 GHzi
8 V/m
5.1 GHz to
5.8 GHz
Electromagnetic environment—
guidance
d = 0.5 √P (80 MHz to 1000 MHz)
d = 0.29 √P (380 MHz to 390 MHz)
d = 0.36 √P (430 MHz to 470 MHz)
d = 0.21 √P (800 MHz to 960 MHz)
d = 1.7 √P (1 GHz to 2.7 GHz)
d = 0.21 √P (1.7 GHz to 1.99 GHz)
d = 0.21 √P (2.4 GHz to 2.57 GHz)
d = 0.63 √P (5.1 GHz to 5.8 GHz)
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey,e should be less than
the compliance level in each
frequency range.f
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Non-iodizing
electromagnetic
radiation
a.
b.
c.
d.
e.
The LATITUDE Communicator is intended for use in the electromagnetic
environment specified above. The customer or the user of the LATITUDE
Communicator should assure that it is used in such an environment.
At 80 MHz and 1 GHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
The separation distances are calculated using the following equation
adopted from the 4th edition draft of IEC 60601-1-2: d = (5/E) √P where P is
the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer, d is the separation distance in meters (m), and E is
the compliance level.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80
MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between
150 kHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz
to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz,
LATITUDE® Communicator Patient Manual
69
English
Immunity test
English
f.
g.
h.
i.
18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz,
28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field
strength in the location in which the LATITUDE Communicator is used exceeds
the applicable RF compliance level above, the LATITUDE Communicator
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the LATITUDE Communicator.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
The compliance level used in the following sub-bands is higher than in the
table: 380 – 390 MHz at 17 V/m, 430 – 470 MHz at 14 V/m, and 800 – 960
MHz at 24 V/m.
The compliance level used in the following sub-bands is higher than in the
table: 1700 – 1990 MHz at 24 V/m, and 2400 – 2570 MHz at 24 V/m.
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LATITUDE® Communicator Patient Manual
71
17
100
5.0
1.6
0.50
1.7
5.4
10
0.16
0.54
0.1
0.050
80 MHz to
1000 MHz
d = 0.5 √P
0.17
150 kHz
to
80 MHz
d = 1.7 √P
0.01
Rated
maximum
output
power of
transmitter
(Watts)
2.9
0.92
0.29
0.092
0.029
380 MHz
to
390 MHz
d = 0.29
√P
3.6
1.1
0.36
0.11
0.036
430 MHz
to
470 MHz
d = 0.36
√P
2.1
0.66
0.21
0.066
0.021
800-960
MHz
1.7-1.99
GHz
2.4-2.57
GHz
d = 0.21
√P
Separation distance according to
frequency of transmitter (meters)
17
5.4
1.7
0.54
0.17
1 GHz to
2.7 GHz
d = 1.7 √P
6.3
2.0
0.63
0.20
0.063
5.1 GHz
to
5.8 GHz
d = 0.63
√P
d.
c.
b.
environment in which radiated RF
disturbances are controlled. The
customer or the user of the LATITUDE
Communicator can help prevent
electromagnetic interference by
maintaining a minimum distance
between portable and mobile
RF communications equipment
(transmitters) and the LATITUDE
Communicator as recommended in
Table 4, according to the maximum
output power of the communications
equipment.
For transmitters rated at a maximum
output power not listed above, the
recommended separation distance d in
meters (m) can be estimated using the
equation applicable to the frequency
of the transmitter, where P is the
maximum output power rating of the
transmitter in Watts (W) according to
the transmitter manufacturer.
At 80 MHz, 800 MHz, and 1 GHz, the
separation distance for the highest
frequency range applies.
These guidelines may not apply in all
situations. Electromagnetic propagation
is affected by absorption and reflection
from structures, objects, and people.
Table 4. Recommended separation distances between portable and mobile RF a. The LATITUDE Communicator is
intended for use in an electromagnetic
communications equipment and the LATITUDE Communicatora b c d
English
LATITUDE® Communicator Patient Manual
English
Software
The software included in this product contains
copyrighted software that is licensed under the GNU
General Public License (GPL). Under the terms of the
GPL as published by the Free Software Foundation,
you may obtain the complete corresponding source
code from us for a period of three years after our
shipment of this product.
72
LATITUDE® Communicator Patient Manual
Symbol
English
Explanation of Product and Label
Symbols
Meaning
Input from telephone jack
Output to telephone (optional)
AC/DC adapter power input
Direct current (DC)
Universal serial bus (USB) connector
Part number
Serial number
Reference number
Non-ionizing electromagnetic radiation
IEC 60601 Class II medical equipment, protection
against electrical shock
Manufacturer
Date of manufacture
Follow instructions for use
Protection against ingress of water. Light rain proof.
LATITUDE® Communicator Patient Manual
73
English
Symbol
Meaning
CE mark of conformity
(applies to USB sensor adapter)
Indicates the product complies with applicable
Australia radiocommunications standards
(applies to USB sensor adapter)
Authorized representative in the European
Community (applies to distribution box)
Australian sponsor address
(applies to distribution box)
Power indicator (applies to USB cellular adapter)
Wireless indicator (applies to USB cellular adapter)
Waste, Electrical, and Electronic Equipment (WEEE)
symbol. Indicates separate collection for electrical
and electronic equipment (i.e., do not throw this
device in the trash)
Indicates this product has passed a comprehensive
testing procedure and the production plant is
regularly monitored as certified by a Nationally
Recognized Testing Laboratory
Temperature range limits
Humidity range limits
Atmospheric pressure range limits
74
LATITUDE® Communicator Patient Manual
Boston Scientific
4100 Hamline Avenue North
St. Paul, MN 55112-5798 USA
Telephone: 651.582.4000
Medical Professionals: 1.800.CARDIAC (227.3422)
Patients and Families: 1.866.484.3268
www.bostonscientific.com
© 2013 Boston Scientific Corporation or its affiliates.
All rights reserved.
359081-001 ENES US 2013-07
*359081-001*

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