LATITUDE® Patient Management Communicator Patient Manual Look inside the back cover for a Communicator setup video DVD. Restricted Device: Federal law (USA) restricts this device to sale, distribution, and use by, or on the lawful order of a physician trained or experienced in device implant and follow-up procedures.
A Message to Patients Boston Scientific Corporation acquired Guidant Corporation in April 2006. During our transition period, you may see both the Boston Scientific and Guidant names on product and patient materials. As we work through the transition, we will continue to offer doctors and their patients technologically advanced and high quality medical devices and therapies.
Table of Contents LATITUDE Patient Management . . . . . . . . . . . . . . . . . . . . . .3 Patient Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Clinician Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 The LATITUDE Communicator . . . . . . . . . . . . . . . . . . . . . . .5 Items You Should Receive . . . . . . . . . . . . . . . . . . . . . . . .6 When to Use Your Communicator . . . . . . . . . . . . . . . . . . . . .7 When Not to Use Your Communicator. . .
Menu Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Options Menu Screens . . . . . . . . . . . . . . . . . . . . . . . . .20 Setting the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Answering Health-related Questions . . . . . . . . . . . . . . . . . .24 Interrogating Your Implanted Device . . . . . . . . . . . . . . . . . .26 Traveling with Your Communicator . . . . . . . .
LATITUDE Patient Management LATITUDE Patient Management is a remote monitoring system that provides implanted device data to both clinicians and cardiac device patients. This remote monitoring system is designed to improve patient care while providing convenience to you. LATITUDE Patient Management provides clinicians access to your implanted device data via the Internet. A key component of the system is the LATITUDE Communicator, an easy-to-use in-home monitoring device for patients.
have approval by their clinic to gain access to the passwordprotected patient website. If your clinic approves, you should receive a user name and password a few days after receiving your Communicator. Contact your clinic or physician to get approval to access the patient website. Use of the website is not required and has no effect on the operation of your Communicator.
The website provides advanced analysis and trending tools designed at improving patient care. Only your physician and medical personnel authorized by your physician have access rights to your medical data by logging on to the passwordprotected clinician website. The LATITUDE Communicator The LATITUDE Communicator is an in-home monitoring system that communicates with your implanted device.
! Read the instructions in this manual thoroughly before using the Communicator. Please keep this manual for future reference. Keep all of your LATITUDE information, including this manual (with setup DVD) and the setup guide, in a convenient location for easy access in the future.
When to Use Your Communicator The Communicator performs many functions automatically on a regular schedule that is set by your physician. Other functions require you to respond to messages, follow instructions and answer questions displayed on the touch screen. Use the Communicator only as instructed by your physician or clinician. The Communicator’s Action button (see “Identifying Parts” on page 9) will light or flash whenever there are messages or instructions you need to follow.
Important Safety Notes • The Communicator interrogates your implanted device, as scheduled by your physician, 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.
Identifying Parts Non-adjustable antenna Interrogate button (blue) Action button Power On indicator LCD touch screen Power input To telephone To telephone wall jack Identifying Parts 9
Buttons and Indicator Lights Button/Light Color Action Button White light Interrogate your device or answer health questions. Refer to “Interrogating Your Implanted Device” on page 26 and “Answering Healthrelated Questions” on page 24. Yellow light Respond to Communicator alert. Indicates some type of Communicator problem. Respond to the information displayed on the touch screen. Red light Your immediate response is required.
Touch Screen Display The Communicator has a touch screen display that is sensitive to the touch of a finger. Gently touching the screen surface with your finger operates the touch screen. Respond to onscreen instructions or questions by touching the desired button with your fingertip. Do not use tools or sharp objects as they can damage the touch screen. If you need to use the Communicator and the touch screen is dim (black), simply touch any part of the screen or press the Action button to turn on the screen.
• near an electrical outlet; • and near a telephone wall jack. The Communicator may typically be placed on a nightstand in your bedroom. CAUTION: If you do not plug a telephone into the back of the Communicator, make sure there are no objects behind the Communicator that could come in contact with the open telephone jack as it is a live jack. How to Connect Your Communicator Complete the following steps to connect and install the Communicator.
3. If you also want to use a telephone with this wall jack, you may plug your telephone into the jack labeled on the back of your Communicator. Connecting a telephone is optional CAUTION: Once you connect the Communicator to a telephone wall jack, the second telephone jack becomes a live jack. Do not touch the inside of this telephone jack. 3 4. Insert the power supply plug into the jack labeled on the back of your Communicator. 5 4 5. Plug the power supply into an electrical outlet.
6. Make sure the power light on the Communicator is on. Power Light (green) The green light indicates the Communicator is connected to power. (If the green light is not on, check that both ends of the adapter cord are plugged in firmly.) 6 7. The installation of the Communicator is now complete. Instructions should appear on the touch screen. Important: Your Communicator should remain connected to the power outlet and telephone line. 8.
CAUTIONS: • The Communicator may not communicate with your implanted device if you are too close to some household appliances. You should be at least 36 inches (3 ft.) away from televisions, VCRs, and personal computers when you are using the Communicator. • The Communicator uses a wireless (radio frequency) communication system to communicate with your implanted device and optional weight scale and blood pressure monitor. This communication can be disrupted by electromagnetic interference.
Respond to the alert message and touch the appropriate button on the touch screen, such as OK or Continue. The light will then turn off. Please respond to alert messages as soon as possible. Important: You should write down any telephone numbers and/or codes that appear in alert messages before touching the OK or Continue button, as doing so causes the Communicator to display a different screen and the alert message will no longer appear.
The Action button light may also flash when the Communicator is not being used and the touch screen is black. Refer to “Responding to Action Button Alert Lights” on page 15 for additional information. Using the Communicator for the First Time The Communicator is programmed to display a series of instructions to step you through a personalized setup process. This process needs to be performed after the Communicator or optional weight scale and blood pressure devices are installed.
You will be led through some activities to make sure the Communicator is installed properly. Press here to begin. Figure 1. Starting the setup process. B. Touch the Press here to begin button and follow the remaining instructions on the touch screen. The Communicator will continue to display all the remaining setup instructions, including placing a telephone call to the LATITUDE database and interrogating your implanted device.
Main Menu Screen The Main Menu screen and the types of information and menu choices that are displayed on the top and bottom portions of the screen are shown in Figure 2. The Main Menu screen serves as the starting point for most operations that you may perform. A Set Up button is displayed only when this function needs to be performed. A Health Questions button appears only on the scheduled date for patients who are prescribed this feature. See “Answering Health-related Questions” on page 24.
Options Menu Screens The Options Menu screens are shown in Figure 3. (The Options Menu screens are displayed by touching the Options button from the Main Menu screen as shown in Figure 2.) Touch the More options button to advance through the multiple Options Menu screens. Refer to the following sections for instructions on using each option. Touching the Exit options button returns you to the Main Menu screen.
View schedule Connect to LATITUDE More options Exit options View readings Communicator status More options Exit options Adjust contrast Repeat options Exit options Figure 3. Options Menu screens.
use these products. The View Readings screen will be displayed only if you use the scale and blood pressure monitor. You can display this screen by touching the View readings button from the Options Menu screen as shown in Figure 3. Touching the OK button at the bottom of the screen returns you to the Main Menu screen. Communicator Status The Communicator Status screen displays the current status of the Communicator. Normally, the status will be “OK.
Press the + or – button to adjust the contrast. 5 – OK + Cancel Figure 4. Adjust Contrast screen. 2. Touch the + or – buttons to increase or decrease the contrast to your preference. The contrast can have a value from 1 to 10, with 1 having the least contrast. 3. When you have finished adjusting the contrast, touch the OK button to save your new contrast setting and return to the Main Menu screen. Touch the Cancel button to return to the Main Menu screen without making any changes to the contrast.
You should only need to reset the time zone if the Communicator is moved to a new location or taken on an extended vacation. If this occurs, the Communicator will prompt you for the time zone. 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 basis, such as once a week.
Have you felt faint or dizzy over the past few days? Press here to answer. Faint or dizzy over past few days? 1 – No 2 – Once 3 – Twice 4 – Several times 1 2 3 4 Faint or dizzy over past few days? You answered Once. Is this correct? Yes No Figure 5. Answering health-related questions.
Once you have answered all questions, the Communicator will display a message indicating that you are finished. Touch the OK button to return to the Main Menu 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 should not require any action on your part.
process to ensure optimum communication between your implanted device and the Communicator. When you press the Interrogate button, the Communicator checks to make sure that the interrogation is permitted, because some physicians will choose to turn this feature off. If the interrogation is permitted, messages appear on the Communicator that instruct you how to begin and complete the interrogation.
Traveling with Your Communicator You can use your Communicator away from home if you will be gone for an extended period. However, whenever you travel for an extended period of time, with or without your Communicator, 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.
should not be connected to a digital phone interface, such as those commonly used in some businesses, hotels, and managed care facilities 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.
DSL Internet Service If you have Digital Subscriber Line (DSL) Internet service provided through your telephone lines, 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 most DSL service providers to connect telephones, an answering machine, or a fax machine to your telephone line.
• Do not submerge the Communicator in liquid. • Do not attempt to open the Communicator. • Use this unit as described in this instruction manual. Use only authorized parts and accessories. If your Communicator becomes damaged, or it malfunctions, contact LATITUDE Patient Services at 1-866-484-3268. Cleaning the Communicator When necessary, clean the Communicator housing and touch screen with a soft, clean, lint-free cloth moistened in water or mild detergent.
Returning the Communicator Do not dispose of the Communicator. If return or replacement is necessary, contact LATITUDE Patient Services at 1-866-484-3268 to make arrangements for returning the Communicator. LATITUDE Patient Services will replace your Communicator if it becomes defective and provide a postagepaid return label, packaging and instructions for returning your Communicator.
Specifications Model: 6476 LCD Display: Monochrome, 240 x 320 pixel, with touch screen control Power Source: 5.0 VDC, 2.0 A, AC adapter, GlobTek model GTM21089-1305-W2 (included) Power Supply Input: 100-240 VAC, 0.5 A, 50-60 Hz Dimensions: Length: 7.75 in (19.7 cm) Width: 5.75 in (14.6 cm) Height: 7.00 in (17.8 cm) Weight: 1.
Safety, EMC and FCC Compliance Standards • This equipment has been tested and found to comply with applicable safety portions of the UL 60601-1:2003 standard. • This equipment has been tested and found to comply with the following EMC standards: EN 60601-1-2:2001. • This device complies with Title 47, Part 15 of the FCC Rules.
• 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. • 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.
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 Model 6476 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.
Table 2.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment— guidance Voltage dips, short interruptions, and voltage variations on power supply input lines (IEC 61000-4-11) <5% UTb (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.
Table 3. Guidance and manufacturer’s declaration—electromagnetic immunity—for equipment and systems that are not life-supportinga b c 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 Model 6476 LATITUDE Communicator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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,d should be less than the compliance level in each frequency range.e Interference may occur in the vicinity of equipment marked with the following symbol: a The Model 6476 LATITUDE Communicator is intended for use in the electromagnetic environment specified above.
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 Model 6476 LATITUDE Communicator is used exceeds the applicable RF compliance level above, the Model 6476 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 Model 6476 LATITUDE Communicator.
Explanation of Product and Label Symbols Symbol Meaning Input from telephone jack Output to telephone (optional) AC/DC adapter power input Non-ionizing electromagnetic radiation See instruction manual Waste, Electrical, and Electronic Equipment (WEEE) symbol. Indicates separate collection for electrical and electronic equipment (i.e.
Explanation of Shipping Box Symbols Symbol Meaning This side up Fragile, handle with care Keep dry Do not use hooks Temperature limitations Humidity limitations Atmospheric pressure limitations Explanation of Shipping Box Symbols 43
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