PATIENT MANUAL MANUAL DEL PACIENTE LATITUDE® Communicator Comunicador LATITUDE®
English............................................................... 1 Español.........................................................
English English LATITUDE® Communicator LATITUDE® Communicator Patient Manual 1
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 registered trademark of Boston Scientific Corporation or its affiliates. Delta Mobile Systems is a registered trademark of Delta Mobile Systems.
LATITUDE Patient Management System The LATITUDE Communicator Items You Should Receive Optional Health Monitoring Equipment Clinician Website 7 7 9 9 10 When to Use Your Communicator 11 When Not to Use Your Communicator 11 Where to Place Your Communicator 12 Important Notes 12 Buttons, Connectors, and Indicators 14 Installing Your Communicator 16 16 Confirming Switch Settings Connect Your Communicator to the LATITUDE System 17 Using a Landline Telephone Jack Connection 18 Using the LA
English Troubleshooting Errors Troubleshooting Icon and LATITUDE Indicator Errors Troubleshooting Yellow Wave Indicator Errors 38 LATITUDE Cellular Data Plan Cellular Converter Activating the LATITUDE Cellular Data Plan Troubleshooting and Support Discontinuing Your LATITUDE Cellular Data Plan 55 55 56 56 Interrogating Your Implanted Device 57 Interrupted Electrical Power 59 Checking that the Communicator Can Connect to the LATITUDE System 59 Traveling with Your Communicator 60 Comm
78 Software 85 Explanation of Product and Label Symbols 86 88 Frequently Asked Questions Does the Communicator call 911 in an emergency? 88 88 Where should I place my Communicator? How do I set up my Communicator using a landline telephone? 88 How do I set up my Communicator using the LATITUDE Cellular Data Plan and a USB Cellular Adapter? 88 How do I set up my Communicator using a USB Ethernet Adapter? 88 How do I know the Communicator is working? 89 What do these lights mean? 89 89 How do I
English 6 LATITUDE® Communicator Patient Manual
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. The LATITUDE system uses advanced security methods to protect your personal medical information.
English The Communicator receives periodic schedule updates made by your health care provider when it connects to the LATITUDE system. 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 60.
English Items You Should Receive The following items are included with the Communicator: • Communicator unit • Alternating current (AC) adapter • Communicator Quick Start Guide • Communicator Patient Manual (this book) • Communicator telephone cord The following items are optional connection accessories, available separately: • LATITUDE NXT USB Cellular Adapter • USB Ethernet Adapter Optional Health Monitoring Equipment If prescribed by your health care provider, your Communicator can also collect informa
English 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.
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 solid or flashing. Use the Communicator only as instructed by your health care provider.
English Where to Place Your Communicator Place your Communicator: • Near an electrical outlet that is easily accessible. • Where you can sit comfortably and see the front of the Communicator. • Depending on the communication method used: • Standard telephone line: Near a telephone wall jack. • Cellular data network: In a location where you get a good signal. • Ethernet (Internet): Near an Internet connection. • Close to where you sleep or near your bedside.
• 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.
English Buttons, Connectors, and Indicators 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 31 for a description of each indicator. Heart button LATITUDE indicator Status button USB ports* Power input To telephone (optional) To telephone wall jack * USB ports are used to connect the USB sensor adapter and/or the LATITUDE NXT USB Cellular Adapter or USB Ethernet Adapter. Figure 1.
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 any color. 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 blue. 6.
English Installing Your Communicator Confirming Switch Settings • 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.
Follow one of the three connection methods listed below to connect to the LATITUDE system: • Standard landline telephone: Follow the steps in “Using a Landline Telephone Jack Connection” on page 18. • Cellular data network: Follow the steps in “Using the LATITUDE Cellular Data Plan” on page 21. • Ethernet (Internet): Follow the steps in “Using a USB Ethernet Adapter Connection” on page 25.
English Using a Landline Telephone Jack Connection Complete the steps below to set up the Communicator for a landline telephone connection. 5. Connecting a telephone is optional. Figure 4. Using a Landline Telephone Jack Connection 1. Insert the AC adapter (included) into the jack . labeled 2. Plug the AC adapter into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to one minute. • All the Communicator indicators will light for approximately one second.
4. 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 63. 5. 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. 6.
English 7. Your Communicator has successfully connected to the LATITUDE system if the wave lights are lit a solid green as shown below. Setup is complete, and no further action is needed at this time. Leave your Communicator plugged in. • If this process takes longer than several minutes, software download and installation may be occurring. Refer to “Software Download and Installation” on page 27. • If the wave lights are not lit a solid green, refer to “Troubleshooting Errors” on page 38.
If you have signed up for the LATITUDE Cellular Data Plan, no telephone or Ethernet cables need to be attached. Instead, a USB Cellular Adapter provided upon subscription to the Data Plan must be connected to the Communicator. Refer to “LATITUDE Cellular Data Plan” on page 55 for more information. Where to Place Your USB Cellular Adapter Important: Maintain a distance of at least 6 inches (15 cm) between the USB Cellular Adapter and your implanted device.
English How to Set Up Your USB Cellular Adapter Complete the steps below to set up the Communicator for a cellular data network connection. Figure 5. Using the LATITUDE Cellular Data Plan 1. Insert the AC adapter (included) into the jack . labeled 2. Plug the AC adapter into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to one minute. • All the Communicator indicators will light for approximately one second.
• Confirm that the USB Cellular Adapter is properly connected by verifying that the power indicator on the top of the Cellular Adapter is lit. It will remain lit except during a LATITUDE system reboot. Note: The wireless indicator on the top of the USB Cellular Adapter will flash at various times and at various sequences. This indicator is of no concern during normal operation. 4. When the Heart button flashes, press it.
English 5. Your Communicator has successfully connected to the LATITUDE system if the wave lights are lit a solid green as shown below. Setup is complete, and no further action is needed at this time. Leave your Communicator plugged in. • If this process takes longer than several minutes, software download and installation may be occurring. Refer to “Software Download and Installation” on page 27. • If the wave lights are not lit a solid green, refer to “Troubleshooting Errors” on page 38.
6 Adapter light Figure 6. Using a USB Ethernet Adapter Connection 1. Insert the AC adapter (included) into the jack . labeled 2. Plug the AC adapter into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to one minute. • All the Communicator indicators will light for approximately one second. • 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 lit.
English Important: For the following steps, make sure you use the Ethernet cable provided with the USB Ethernet Adapter and not the telephone cord provided with the Communicator. 3. Insert the narrow end of the USB cable (included with the USB Ethernet Adapter) into one of the . USB ports on the Communicator labeled 4. Insert the square end of the USB cable into the end of the USB Ethernet Adapter nearest the adapter light. 5.
Setup is complete, and no further action is needed at this time. Leave your Communicator plugged in. • If this process takes longer than several minutes, software download and installation may be occurring. Refer to “Software Download and Installation” on page 27. • If the wave lights are not lit a solid green, refer to “Troubleshooting Errors” on page 38. Important: Your Communicator should remain connected to the electrical outlet and your Internet service.
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.
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 flash green in sequence and repeat while the Communicator interrogates your device.
English All three Collecting Waves will light green. The Heart button lights solid white, showing the interrogation was a success. The Sending Waves flash 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 as shown for 2 minutes to show the entire process was a success.
English Indicator Descriptions The indicators will light to indicate the Communicator’s progress when: • 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 38.
English Collecting Waves Show the Communicator is collecting data from your implanted device. • Flash 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 • A flashing white light means you need to complete a previously scheduled interrogation. Press Heart button to complete. • A solid white light for 2 minutes means the interrogation is complete.
English Sending Waves Show the Communicator is connecting to the LATITUDE system. • Flash 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.
English Sensor Reading Icon Shows the Communicator has successfully communicated with a prescribed weight scale or blood pressure monitor. • Flashes green five times and lights solid green 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 yellow or red (flashing or solid) to signal a problem that you should report to your health care provider. Refer to the error in “Troubleshooting Errors” on page 38. 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.
English Status Button The Status button is located on the back of the Communicator as shown in Figure 7. Figure 7. 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 show: • The status of the last interrogation. • The status of the last connection to the LATITUDE system. The indicators will light for 2 minutes.
English Confirming Successful Operation 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.
English Troubleshooting Errors Troubleshooting Icon and LATITUDE Indicator 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 8. A description of each error is provided in this section, along with suggested actions to resolve each error.
English Heart Button is Flashing LATITUDE Indicator is Green Description: You need to complete a previously scheduled interrogation. Action: • Press the Heart button to complete the interrogation. • If the Heart button is lit a solid white, the interrogation has been a success. No further action is required.
English No Indicators are Lit Description: No indicators are lit. 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 lit. • If the Communicator is plugged into electric power and the light on the AC adapter is lit, contact your health care provider.
English LATITUDE Indicator is Flashing Yellow No Other Indicators are Lit Description: The LATITUDE indicator is flashing yellow. The Communicator is starting up or may be downloading and installing software. This process typically lasts only one minute but may take up to 10 minutes. Action: • No action is required unless the LATITUDE indicator flashes for longer than 10 minutes. In that case, contact LATITUDE Patient Services at 1-866-484-3268.
English Call Doctor Icon is Red LATITUDE Indicator is Yellow Description: The Call Doctor icon is red (flashing or solid), 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 light solid as shown until the problem is resolved. Action: 42 Your immediate response is required.
Description: English Call Doctor Icon is Yellow LATITUDE Indicator is Yellow The Call Doctor icon is yellow (flashing or solid), 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 light solid yellow until the problem is resolved. Action: Call your health care provider.
English Call Doctor Icon is Yellow LATITUDE Indicator Not Lit Description: The Call Doctor icon is lit a solid yellow, and the LATITUDE indicator is not lit. This indicates your Communicator may not be working properly. Action: 44 You may need a replacement Communicator. Contact your health care provider.
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 yellow 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. If the error fails to resolve after trying the action steps in the following section, call your health care provider.
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 12. • Face the Communicator. Sit directly in front of the Communicator. Make sure you are within 10 ft (3 m) of the Communicator.
English Two Yellow Collecting Waves 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 12. • 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.
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.
Description: English One Yellow Sending Wave 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: • No Ethernet connection was detected when attempting to connect using the USB Ethernet Adapter.
English • 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. If using the LATITUDE Cellular Data Plan: • If you have not activated the LATITUDE Cellular Data Plan, see page 55. • Make sure the USB Cellular Adapter is plugged into the Communicator. • Move the Communicator to another location that may have better cellular reception.
• Make sure the USB cable provided with the USB Ethernet Adapter is connected at one end to the USB Ethernet Adapter and at the other end to the Communicator. • Make sure the Ethernet cable provided with the USB Ethernet Adapter is firmly connected at one end to the USB Ethernet Adapter and at the other end to the Ethernet port for your Internet service. • If the green light on the front of the USB Ethernet Adapter is not on, make sure the Internet modem or router is powered on.
English Two Yellow Sending Waves Description: An attempt to connect to the LATITUDE system failed due to connection issues relating to the landline telephone, cellular network, or Ethernet. 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 using the LATITUDE Cellular Data Plan: • If you have not activated the LATITUDE Cellular Data Plan, see page 55. • 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. If using the USB Ethernet Adapter: • Make sure the Ethernet cable provided with the USB Ethernet Adapter is connected to the Ethernet port for your Internet service.
English Three Yellow Sending Waves 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 16.
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 USB Cellular Adapter that enables cellular communication between your Communicator and the LATITUDE system.
English Activating the LATITUDE Cellular Data Plan 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.
Contact LATITUDE Patient Services at 1-866-4843268 to discontinue use of the LATITUDE Cellular Data Plan. 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 65.
English 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.
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. Checking that the Communicator Can Connect to the LATITUDE System Complete the following steps to check that the Communicator can connect to the LATITUDE system.
English 3. Watch the front of the Communicator. The Sending Waves should flash green in sequence and repeat, showing a connection to the LATITUDE system is in progress. 4. Wait several minutes for the connection to complete. 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.
English 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 may be 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 59.
English 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.
This section applies only if you are using a landline telephone jack connection to the LATITUDE system. 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.
English 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 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.
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.
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 10. Figure 10. 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.
English Specifications Models: 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.
Up to 93% noncondensing Operating Pressure: 70 to 106 kPa Storage and Transport Pressure*: 50 to 106 kPa Protection Against Ingress of Solid Foreign Objects: IP21 (≥12.5 mm diameter) Protection Against Ingress of Water: English Storage and Transport Humidity*: 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.
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.
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 71 English LATITUDE NXT USB Cellular Adapter (Model 6295): TX 824-849 MHz GSM-850: RX 869-894 MHz Effective Radiated Power: 22.
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.
• 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. • 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.
English • 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.
• 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. • The telephone company may make changes in its facilities, equipment, operations, or procedures that could affect the operation of the equipment.
English • 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.
English Essential Performance 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: • 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.
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.
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 Surge (IEC 61000-4-5) ±1 kV differential mode ±1 kV differential mode ±2 kV common mode ±2 kV common mode Immunity test Electromagnetic environment—guidance The relative humidity should be at lea
English Immunity test Voltage dips, short interruptions, and voltage variations on power supply input lines (IEC 61000-4-11) Power frequency (50/60 Hz) magnetic field (IEC 61000-4-8) IEC 60601 test level Compliance level <5% UTb (>95% dip in UT) for 0.5 cycle <5% UT (>95% dip in UT) for 0.
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.
English Immunity test 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.
d. e. f. g. h. i. 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.
Table 4. Recommended separation distances between portable and mobile RF communications equipment and the LATITUDE Communicatora b c d e Separation distance according to frequency of transmitter (meters) 80 MHz to 1000 MHz d = 0.5 √P 0.029 380 MHz to 390 MHz d = 0.29 √P 0.11 0.036 430 MHz to 470 MHz d = 0.36 √P 0.066 0.021 0.54 0.17 0.20 0.063 5.1 GHz to 5.8 GHz d = 0.63 √P 0.050 0.092 2.0 0.63 1 GHz to 2.7 GHz d = 1.7 √P 0.17 0.16 5.4 1.7 150 kHz to 80 MHz d = 1.7 √P 0.01 0.54 0.
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.
English Explanation of Product and Label Symbols Symbol 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 solid foreign objects and water 86 LATITUDE® Communica
3.0 Meaning English Symbol Ready for LATITUDE NXT 3.
English Frequently Asked Questions These FAQs are designed to point you to the right section in this manual for the answers. Does the Communicator call 911 in an emergency? No. 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. See “LATITUDE Patient Management System” on page 7. Where should I place my Communicator? See “Where to Place Your Communicator” on page 12.
See “Normal Operation of the Communicator” on page 28. What do these lights mean? See “Indicator Descriptions” on page 31 or “Troubleshooting Errors” on page 38. How do I manually send my data? See “Indicator Sequence When Using the Heart Button” on page 29. When do I use my Communicator? See “When to Use Your Communicator” on page 11 or “Interrogating Your Implanted Device” on page 57. What do I need to do with my Communicator if I travel? See “Traveling with Your Communicator” on page 60.
English 90 LATITUDE® Communicator Patient Manual
