Boston Scientific LATITUDE 6288 User manual

LATITUDE™Communicator
PATIENT MANUAL

LATITUDE™ Communicator Patient Manual i
About This Manual
This manual applies to Models 6288 and 6290 LATITUDE
Communicators, as well as to multiple countries. Unless
specied as applying to a particular model or country,
instructions apply to all.
The model number for your Communicator is located on its
bottom label.
Model 6288 is not available in all locations. Model 6290 is
available everywhere.
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.
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.
LATITUDE is a trademark of
Boston Scientic Corporation or its aliates.
GlobTek is a trademark of GlobTek, Inc.
Excelsus is a trademark of Pulse Electronics.
MultiConnect is a trademark of Multi-Tech Systems, Inc.
SL Power Electronics is a trademark of SL Delaware Holdings, Inc.
The
Bluetooth ® word mark and logos are registered trademarks owned by
Bluetooth SIG, Inc. and any use of such marks by Boston Scientic Corporation is
under license. Other trademarks and trade names are those of their respective
owners.

LATITUDE™ Communicator Patient Manual
ii

LATITUDE™ Communicator Patient Manual iii
Table of Contents
ABOUT THE LATITUDE
PATIENT MANAGEMENT SYSTEM......................................... 1
The LATITUDE Communicator.................................................2
Components of Your Communicator...............................4
Optional Accessories ............................................5
The Clinician Website......................................................5
Summary of Safety and Clinical Performance.................5
Clinical Benets of the Communicator............................6
USING YOUR COMMUNICATOR................................................7
Important Notes.....................................................................7
Where to Place Your Communicator...................................... 8
Heart Button and Indicators...................................................9
Heart Button and Indicator Descriptions .......................11
Normal Operation of the Communicator ...................... 16
Using the Heart Button ................................................. 16
Status Button........................................................................ 19
Conrming Successful Operation..................................19
Conrming Connection to the Clinician Website...........20
Canceling an Interrogation...................................................20
Loss of Power ....................................................................... 21
Traveling With Your Communicator...................................... 21
Care and Maintenance .........................................................22
Cleaning the Communicator and Accessories ...............23
Returning, Replacing, or Disposing of the
Communicator or Accessories....................................23

LATITUDE™ Communicator Patient Manual
iv
SETTING UP YOUR COMMUNICATOR .....................................25
Setup Overview....................................................................25
Conrming/Setting Switch Settings.....................................26
Special Instructions if Using the Standard
Telephone Connection Method .................................32
Traveling.............................................................32
Setting Switches 1-3 for Dial-out or
Prex Number.................................................32
Setting Up Your Connection Method....................................34
Cellular Connection .......................................................35
Using Previous Cellular Connection
Accessories......................................................38
Replacement ......................................................39
Internet Connection ..................................................... 40
Replacement ......................................................42
Standard Telephone Connection ..................................43
Communicator Use of the Telephone .................45
Using the Telephone While the
Communicator is Making a Call...................... 46
DSL Internet Service ...........................................47
Replacement ......................................................47
Hotspot Connection (Mobile Device).............................47
USB Accessory Adapter Connection ............................. 48
Software Download and Installation ...................................49
TROUBLESHOOTING.............................................................. 51
Overview .............................................................................. 51
Indicator Light Errors............................................................52
Yellow Wave Errors.............................................................. 60

LATITUDE™ Communicator Patient Manual v
ADDITIONAL INFORMATION .................................................75
LATITUDE Support ................................................................75
Frequently Asked Questions................................................ 77
Specications ...................................................................... 80
Safety and Standards Compliance........................................85
European Union Importer ....................................................87
Essential Performance..........................................................87
Software Statement .............................................................87
Electromagnetic Emissions and Immunity.......................... 88
Explanation of Product and Label Symbols ........................ 90

LATITUDE™ Communicator Patient Manual
vi
List of Figures
Figure 1. Front of Communicator...........................................9
Figure 2. Status Button........................................................ 19
Figure 3. Location of Switches.............................................26
Figure 4. Dial-out Number Switch Settings (1-3).................33
Figure 5. Back of Communicator .........................................34
Figure 6. Connecting a USB Cellular Adapter......................35
Figure 7. Connecting a USB Ethernet Adapter.................... 40
Figure 8. Connecting a Telephone Cable.............................43
Figure 9. Connecting a USB Accessory Adapter ................. 48

1
LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
ABOUT THE LATITUDE
PATIENT MANAGEMENT SYSTEM
The LATITUDE Patient Management System (“LATITUDE
System”) is a remote monitoring system that uses the LATITUDE
Communicator to collect data from your implanted device. Your
Communicator then sends this data to the Clinician Website for
access by your health care provider.
The LATITUDE System is designed to help your health care
provider manage your ongoing care in a manner that is
convenient for both of you.
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 password-protected Clinician Website.
CAUTIONCAUTION: The LATITUDE System is not meant to assist with
health emergencies. If you are not feeling well or need
urgent health care, call your health care provider or your local
emergency service.

2LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
The LATITUDE Communicator
The LATITUDE Communicator is an in-home, wireless monitor
that automatically collects and sends your implanted device
data to the Clinician Website for access by your health care
provider.
The Communicator collects data from your implanted device in
three dierent ways:
• Routine Device ChecksRoutine Device Checks: The Communicator “checks in” on
your implanted device daily or weekly, depending on what
type of implanted device you have. The collected data will be
sent to the Clinician Website only as needed.
• Scheduled Follow-upsScheduled Follow-ups: At times set by your health care
provider (typically every few months), your Communicator
collects and then sends your implanted device data to the
Clinician Website.
• ManualManual: If this feature is enabled by your health care provider,
you may initiate the Communicator to read your implanted
device by pressing the Heart button on your Communicator.
Only use this feature when the Heart button is ashing or
when instructed to do so by your health care provider.
Routine device checks and scheduled follow-ups may happen
automatically without your knowledge, or you may need to
press the Heart button when it ashes to complete the process.

3
LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Refer to “Using the Heart Button” on page 16 for more
information.
Your health care provider may also send periodic updates to
your Communicator to change the schedule for reading data
from your implanted device.
In order for your Communicator to be able to send your
implanted device data to the Clinician Website, a connection
accessory must be set up on your Communicator. Refer to
“Setting Up Your Communicator” on page 25 for directions.
Contact your health care provider to learn which connection
accessory is right for you.
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.
The Communicator does not provide continuous monitoring.
The Communicator does not reprogram or change any
functions of your implanted device. Only your health care
provider can do this during an oce visit.
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
Scientic device.
Ask your health care provider if you have questions about any
risks with using the Communicator or your implanted device.
For valuable information about the risks and reliability of
your implanted device, refer to your implanted device patient
handbook.

4LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Components of Your Communicator
Every LATITUDE Communicator comes with a power supply, a
Quick Start Guide, and this Patient Manual.
The following table lists compatible accessories for your
Communicator. Availability of these accessories depends on
your location and the method you are using to connect to the
Clinician Website. For more information about the accessories or
how to obtain them, contact your health care provider.
Boston Scientic
Model Number
Accessory Name
(as referenced in this manual)
6250* Power supply (replacement)
Connection Accessories
6359 3G USB cellular adapter (current model)
6205/6213 4G USB cellular adapter (current models)
6293 USB Ethernet adapter
6250* Telephone cable (may be included)
6250* Telephone jack adapter
6421 DSL lter
6454 USB accessory adapter
6296 3G USB cellular adapter
(previous model)
6456 (MT200A2W
Multi-Tech Model Number)
Analog-to-wireless cellular converter
(previous model)
Optional (must be prescribed by your health care provider)
6487 Weight scale
6452 Blood pressure monitor
* Available only through Model 6250 accessory kit.
Only use the accessories listed in the table or provided by your
health care provider. Accessories acquired elsewhere may not
work with your Communicator.

5
LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Optional Accessories
(The optional accessories described in this section are not
available in all locations. Contact your health care provider for
more information.)
If prescribed by your health care provider, your Communicator
may include a weight scale and blood pressure monitor.
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
for more information.
A USB accessory adapter is included with the weight scale and
blood pressure monitor. The USB accessory adapter provides
a wireless connection between these products and your
Communicator. Refer to “USB Accessory Adapter Connection” on
page 48 for more information.
The Clinician Website
Between oce visits, the Clinician Website gives your health
care provider access to the implanted device data that was
collected and sent by your Communicator. The Clinician Website
features advanced analysis and trending tools designed to help
your health care provider improve your care.
Your implanted device information is typically available
on the Clinician Website within 15 minutes of when your
Communicator sent it. However, it may sometimes take longer
due to external factors.
Summary of Safety and Clinical Performance
For customers in the European Union: visit https://ec.europa.
eu/tools/eudamed to view a summary of this device’s safety
and clinical performance information.

6LATITUDE™ Communicator Patient Manual
About the
LATITUDE System
Clinical Benets of the Communicator
If used as indicated, when compared to in-person clinical
evaluations only, remote monitoring:
• Reduces the number of in-person clinical evaluations at the
clinic.
• Improves the consistency of follow-up by your health care
provider.
• Provides more information on certain heart conditions to your
health care provider.
For a more detailed description of clinical benets, please
consult https://ec.europa.eu/tools/eudamed, and discuss with
your health care provider which provisions may apply to you.

7
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
USING YOUR COMMUNICATOR
Before you can use your Communicator, you must rst set it up
to connect to the Clinician Website. Refer to “Setting Up Your
Communicator” on page 25 for directions on setting up your
connection accessory. Contact your health care provider to learn
which connection accessory is right for you.
NoteNote: If there is a delay between receiving your Communicator
and setting it up, a newer version of Communicator may be
necessary in order to connect to the Clinician Website.
Important Notes
Check your Communicator every day to see if any of the
indicators are lit solid or ashing. Refer to “Heart Button and
Indicators” on page 9 and the Troubleshooting section
starting on page 51 for more information on the meaning
of indicator lights.
Call your health care provider if the Call Doctor Icon
lights red (ashing or solid).
It is very important that the Communicator is alwaysalways plugged
into an electrical outlet that has power.
• Electrical safety: It is recommended that you 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.

8
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
Where to Place Your Communicator
Place your Communicator:
• Near an electrical outlet that is easily accessible.
• Within 3 m (10 ft) from your bedside or where you sleep. If
this is not possible, place your Communicator where you
spend a considerable amount of time each day.
• Where you can sit comfortably and see the front of the
Communicator.
• Where the Communicator and all its cables and accessories
will be kept dry and not exposed to humidity or potential
water contact.
• Refer to the following sections for more placement advice
depending on your connection method:
• “Cellular Connection” on page 35
• “Internet Connection” on page 40
• “Standard Telephone Connection” on page 43
• 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, it
should be at least 30 cm (12 in) away from televisions, digital
video disc (DVD) players, personal computers, modems,
routers, microwaves, and other electronic equipment.
• If you have an S-ICD implanted device supported on
LATITUDE, the wireless communication between the
Communicator and your S-ICD is sensitive to distance
and orientation. You may need to move closer to the
Communicator, or you may need to position your body
such that a clear signal exists between your S-ICD and the
Communicator. If you need assistance, contact LATITUDE
Support at the telephone number for your country listed on
page 75.

9
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
• Boston Scientic personnel may contact you or your health
care provider if it is determined that your implanted device
is using too much radio-frequency (RF) telemetry due to the
placement of your Communicator. Boston Scientic will give
advice on better Communicator placement to correct this
issue.
Heart Button and Indicators
The following gure shows the Heart button and all the
indicators on the front of your Communicator. Use this gure for
reference as you follow this manual’s instructions for using your
Communicator.
Figure 1.
1 2
3 4 5
6 7 8
(1) Patient icon; (2) Collecting Waves; (3) Heart button; (4) Sending Waves; (5) Doctor
icon; (6) Sensor Reading icon; (7) LATITUDE indicator; (8) Call Doctor icon
Front of Communicator

10
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
The Heart button and indicators are intended to inform you of
the status of your Communicator or actions you may need to
take. The lights, colors, and sequence of each indicator shown in
Figure 1 are explained in the following section.
NoteNote: When the words “interrogate” or “interrogation” are used
in this manual, it means that the Communicator is collecting
data from your implanted device.
If indicators light other than as explained in this section, refer to
the applicable error in the Troubleshooting section starting on
page 51 to nd out if you need to take any action.

11
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
Heart Button and Indicator Descriptions
Heart Button
• A ashing white Heart button
indicates:
• Setup is occurring (refer to “Setting
Up Your Communicator” on page
25), or
• You need to complete a scheduled
follow-up (interrogation).
Press the Heart button to complete.
• A solid white light for 2 minutes
means the interrogation is complete.
Note that the solid white light may
appear dim.
• An unlit Heart button may also
be used to manually initiate an
interrogation of your implanted
device. Only press an unlit Heart
button when instructed to do so by
your health care provider. Refer to
“Using the Heart Button” on page
16 before pressing this button.

12
Using Your
Communicator
LATITUDE™ Communicator Patient Manual
Patient Icon
Shows the Communicator is
interrogating your implanted device.
• Lights solid blue when the
Heart button is pressed and an
interrogation has started.
• Lights solid blue for 2 minutes after
a successful interrogation.
Collecting Waves
Shows the Communicator is
interrogating your implanted device.
• Each wave ashes green in
sequence and repeats, showing the
Communicator is interrogating your
implanted device.
• All three waves light green for 2
minutes to indicate the interrogation
was a success.