front cover.fm Page 1 Wednesday, November 24, 2004 10:20 AM Patient’s Manual Draft - 11/11/04 LATITUDE Communicator Restricted Device: Federal law (USA) restricts the device to sale, distribution, and use by or on the lawful order of a physician.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT Draft - 12/2/04 Table of Contents LATITUDE Patient Management . . . . . . . . . . . . . . . . . . . . . . 3 Patient Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Clinician Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The LATITUDE Communicator . . . . . . . . . . . . . . . . . . . . . . . 5 Items You Should Receive. . . . . . . . . . . . . . . . . . . . . . . .
56173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT Draft - 12/2/04 Options Menu Screen . . . . . . . . . . . . . . . . . . . . . . . Answering Health Related Questions . . . . . . . . . . . . . . Viewing Your Latest Readings. . . . . . . . . . . . . . . . . . . . Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . How to set the time zone . . . . . . . . . . . . . . . . . . . . . Using the Check Communicator Option. . . . . . . . . . . . . Install/Set Up . . . . . . . . . .
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 3 Thursday, December 2, 2004 3:27raft PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 4 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 Patient Website Patients can view information about their implanted device and condition from a personalized patient website by using an internetconnected personal computer. The patient website also provides access to a wide range of cardiac related health information.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 5 Thursday, December 2, 2004 3:27raft PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 6 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 Please keep this manual for future reference. You can store this manual, along with your other LATITUDE Patient Management documents, in the documentation box that was shipped with your Communicator.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 7 Thursday, December 2, 2004 3:27raft PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 8 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
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356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 10 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 Buttons and Indicator Lights Button/Light Color Meaning White light Answer health questions. Indicates that you need to answer a set of personal health questions. Refer to “Answering Health Related Questions” on page 22. Action Button Yellow light Respond to system alert. Indicates some type of system problem. Respond to the information displayed on the screen.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 11 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 12 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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. Find the Communicator Communicator Telephone Cord telephone cord that came with the Communicator and plug one end into the jack labeled on the back of the Communicator. 2.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 13 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 Connecting a telephone is optional 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 4. Insert the power supply plug into the 5 jack on the back of the Communicator. 5. Plug the power supply into an electrical outlet.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 14 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 6. Make sure the AC power light on the Communicator is illuminated. AC Power Light (green) 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.) 7. The installation of the Communicator is now complete. Instructions should appear on the screen.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 15 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 16 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 17 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 18 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 19 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 20 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 21 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 For displaying date/time, measurements, messages, and instructions Menu choices Thu 04/21/2005 03:40 PM Set Up Answer Questions Options 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 22 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 23 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 24 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 25 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 26 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 • 26 If you feel poorly or are in need of immediate care, contact your physician.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 27 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 28 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 29 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT BodyClean.fm Page 30 Thursday, December 2, 2004 3:27 PM Draft - 12/2/04 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.
356173-003 Rhythm Assistant, Patient mnl, UK/US GR FR SP IT D BodyClean.fm Page 31 Thursday, December 2, 2004 3:27 PM raft Draft - 12/2/04 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.
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back cover.
back cover.fm Page 2 Thursday, December 2, 2004 3:36 PM 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 Draft - 12/2/04 © 2005 Guidant Corporation All rights reserved.
