Boston Scientific LATITUDE 6280 Patient Manual
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Boston Scientific LATITUDE 6280 Patient Manual

Boston Scientific LATITUDE 6280 Patient Manual

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PATIENT MANUAL
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Summary of Contents for Boston Scientific LATITUDE 6280

  • Page 1 PATIENT MANUAL LATITUDE ™ Communicator...
  • Page 3 Communicator information in a convenient location for easy access in the future. LATITUDE is a trademark of Boston Scientific Corporation or its affiliates. GlobTek is a trademark of GlobTek, Inc. MultiConnect is a trademark of Multi-Tech Systems, Inc. SL Power Electronics is a trademark of SL Delaware Holdings, Inc.
  • Page 4 Communicator Patient Manual LATITUDE ™...

  • Page 5: Table Of Contents

    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 USING YOUR COMMUNICATOR ......6 Important Notes ............6 Where to Place Your Communicator ......
  • Page 6 SETTING UP YOUR COMMUNICATOR ....27 Setup Overview ............27 Confirming/Setting Switch Settings ......28 Special Instructions if Using the Standard Telephone Connection Method ..... 29 Traveling ..........29 Setting Switches 1-3 for Dial-out or Prefix Number ....29 Setting Up Your Connection Method ...... 31 Cellular Connection ..........
  • Page 7 ADDITIONAL INFORMATION ....... 83 Frequently Asked Questions........83 Specifications ............87 Safety and Standards Compliance ......91 Essential Performance ........... 96 Software Statement ..........96 Electromagnetic Emissions and Immunity ....97 Explanation of Product and Label Symbols .... 99 Communicator Patient Manual LATITUDE ™...
  • Page 8 List of Figures Figure 1. Front of Communicator ......9 Figure 2. Status Button .......... 21 Figure 3. Location of Switches....... 28 Figure 4. Dial-out Number Switch Settings (1-3) ... 30 Figure 5. Back of Communicator ......32 Figure 6. Connecting a USB Cellular Adapter ..33 Figure 7.

  • Page 9: About The Latitude Patient Management 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.

  • Page 10: The Latitude Communicator

    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 different ways: •...
  • Page 11 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. LATITUDE Communicator Patient Manual ™...

  • Page 12: Components Of Your Communicator

    Clinician Website. For more information about the accessories or how to obtain them, contact your health care provider or Patient Services at 1-866-484- 3268. Boston Scientific Accessory Name Model Number (as referenced in this manual) Power supply (replacement)

  • Page 13: Optional Accessories

    Only use the accessories listed in the table or provided by your health care provider. Accessories acquired elsewhere may not work with your Communicator. Optional Accessories If prescribed by your health care provider, your Communicator may include a weight scale and blood pressure monitor.

  • Page 14: Using Your Communicator

    USING YOUR COMMUNICATOR Before you can use your Communicator, you must first set it up to connect to the Clinician Website. Refer to “Setting Up Your Communicator” on page 27 for directions on setting up your connection accessory. Contact your health care provider to learn which connection accessory is right for you.

  • Page 15: Where To Place Your Communicator

    Where to Place Your Communicator Place your Communicator: • Near an electrical outlet that is easily accessible. • Within 10 feet (3 meters) 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.
  • Page 16 S-ICD and the Communicator. If you need assistance, contact Patient Services at 1-866- 484-3268. • Boston Scientific 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.

  • Page 17: Heart Button And Indicators

    Heart Button and Indicators The following figure shows the Heart button and all the indicators on the front of your Communicator. Use this figure for reference as you follow this manual’s instructions for using your Communicator. (1) Patient icon; (2) Collecting Waves; (3) Heart button; (4) Sending Waves;...
  • Page 18 Note: 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 56 to find out if you need to take any action.

  • Page 19: Heart Button And Indicator Descriptions

    Heart Button and Indicator Descriptions Heart Button • A flashing white Heart button indicates: • Setup is occurring (refer to “Setting Up Your Communicator” on page 27), or • You need to complete a scheduled follow-up (interrogation). Press the Heart button to complete.
  • Page 20 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.
  • Page 21 Sending Waves Shows the Communicator is connecting to the Clinician Website. • Each wave flashes green in sequence and repeats, showing a connection to the Clinician Website is in progress. • All three waves light green for 2 minutes to indicate the connection to the Clinician Website was a success and any collected device data was...
  • Page 22 Sensor Reading Icon Shows the Communicator has successfully communicated with a prescribed weight scale or blood pressure monitor. Note: This icon does not apply to your implanted device. • Flashes green 5 times and lights solid green for 5 minutes to indicate the Communicator successfully received a weight or blood pressure...
  • Page 23 LATITUDE Indicator Shows the Communicator is connected to electrical power and ready to use. It also shows if the Communicator startup process is being performed. • Lights green to indicate the Communicator is connected to electrical power and is ready to use.
  • Page 24 Call Doctor Icon Lights yellow or red (flashing or solid) to signal a problem that you should report to your health care provider. Refer to the applicable error in the Troubleshooting section starting on page 56 for more information. • Flashes yellow briefly after the Communicator is plugged into electrical power (does not require contacting your health...

  • Page 25: Normal Operation Of The Communicator

    Normal Operation of the Communicator When operating normally, only the LATITUDE indicator will light green as shown above. None of the other Communicator indicators will typically light when collecting or sending your implanted device data, except when the Heart button has been pressed. Note: In this manual, a gray heart shown inside the blue circle means that it is not lit;...

  • Page 26: Using The Heart Button

    Using the Heart Button Always press the Heart button when it is flashing or when told to do so by your health care provider. Stay next to the Communicator until lights are lit as shown here. Do not press the Heart button if it is unlit unless instructed to do so by your health care provider.
  • Page 27 2. The Patient icon lights blue. The Collecting Waves flash green in sequence and repeat while the Communicator interrogates your device. 3. All three Collecting Waves light green. The Heart button lights solid white, showing the interrogation was a success. 4.
  • Page 28 5. The Doctor icon lights blue showing the Communicator successfully sent your data to the Clinician Website. The indicators stay lit for 2 minutes to show the entire process was a success. No further action is required. CAUTION: Normal use of the LATITUDE System has been accounted for in the projected battery life of your implanted device.

  • Page 29: Status Button

    Status Button Confirming Successful Operation Periodically press the Status button on the back of the Communicator (“Figure 2. Status Button”) for 1 second to confirm that it has been successfully collecting data from your implanted device and sending it to your health care provider. Figure 2.

  • Page 30: Confirming Connection To The Clinician Website

    Note: If you pressed the Heart button before pressing the Status button, the Status button will not function until the resulting interrogation is completed or is canceled. For information on canceling an interrogation, see page 23. Confirming Connection to the Clinician Website If you have moved your Communicator, changed the connection method, or made other changes to...

  • Page 31: Canceling An Interrogation

    Canceling an Interrogation 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 flash yellow in sequence and repeat while the interrogation is being canceled.

  • Page 32: Care And Maintenance

    about connecting to the Clinician Website in the new country. There may be limitations depending on the country, model of Communicator, and connection method. In general, telephone connections are limited to specific countries. Cellular connections work in most but not all countries. Internet works everywhere, depending on signal availability.

  • Page 33: Cleaning The Communicator And Accessories

    • 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 or Patient Services at 1-866-484-3268.

  • Page 34: Returning, Replacing, Or Disposing Of The Communicator Or Accessories

    Returning, Replacing, or Disposing of the Communicator or Accessories If you need to replace your Communicator or any accessories because of damage or malfunction, or if you need a different model, contact your health care provider or Patient Services at 1-866-484-3268 to learn how to return and replace it.

  • Page 35: Setting Up Your Communicator

    SETTING UP YOUR COMMUNICATOR Setup Overview Setting up your Communicator to connect to the Clinician Website can be done in 2 main steps: 1. Confirm/set the switches on the bottom of your Communicator. Refer to “Confirming/Setting Switch Settings” on page 28. 2.

  • Page 36: Confirming/Setting Switch Settings

    Confirming/Setting Switch Settings The 8 white switches located on the bottom of your Communicator must be set correctly for connection to the Clinician Website. The switches are either “on” (in the up position) or “off” (in the down position). The switches may or may not already be correctly set when you receive your Communicator.

  • Page 37: Special Instructions If Using The Standard Telephone Connection Method

    Special Instructions if Using the Standard Telephone Connection Method For more information on setting up the standard telephone connection, see page 48. Traveling If you travel to another country and use a standard telephone to connect to the Clinician Website, you may need to change the country switch settings.

  • Page 38: Figure 4. Dial-Out Number Switch Settings (1-3)

    To set your Communicator for a dial-out or prefix number, slide switches 1-3 up or down so that they match the settings for the dial-out number shown in the following figure. Dial-out Dial-out Number Number None Figure 4. Dial-out Number Switch Settings (1-3) LATITUDE Communicator Patient Manual ™...

  • Page 39: Setting Up Your Connection Method

    Setting Up Your Connection Method This section explains how to set up a connection method on your Communicator. The connection method enables your Communicator to send your implanted device data to the Clinician Website for access by your health care provider. Your connection method will be one of the following: •...

  • Page 40: Figure 5. Back Of Communicator

    The following figure shows the Status button and all the connectors on the back of your Communicator. Use this figure for reference as you follow this manual’s instructions for setting up your Communicator with a connection method. (1) Status button; (2) USB ports, used for optional accessories and cellular or internet connections;...

  • Page 41: Cellular Connection

    Cellular Connection When using the cellular connection method, do not use another connection method, such as standard telephone, internet, or hotspot. The cellular connection only sends data; it does not send voice signals. It is completely separate and cannot be used with your cell phone. Your cellular connection may be affected by such things as terrain, weather, foliage, buildings and other construction, signal strength, customer equipment,...
  • Page 42 When using the cellular connection method: • Place your Communicator in a location where you will get a good cellular signal. • Place your USB cellular adapter away from electronic products or metal surfaces, and place it alongside the Communicator, not under or on top •...
  • Page 43 4. Insert the USB connector of the cable extension into one of the USB ports labeled on the back of your Communicator. • The LED light on the USB cellular adapter will blink and remain blinking. At times the light may be lit solid.
  • Page 44 You can verify the cellular connection by following the instructions in “Confirming Connection to the Clinician Website” on page 22. If you travel to another location with your Communicator, verify the connection from that location. Setup is complete, and no further action is needed at this time.

  • Page 45: Using Previous Cellular Connection Accessories

    Using Previous Cellular Connection Accessories If you have a Model 6295 USB cellular adapter from a previous Communicator, you may continue to use it for cellular connection to the Clinician Website. If you have a Multi-Tech Systems MultiConnect™ MT200A2W analog-to-wireless cellular converter from a previous Communicator, you may continue to use it for cellular connection to the Clinician Website.

  • Page 46: Internet Connection - Using A Usb Ethernet Adapter

    Internet Connection Using a USB Ethernet – Adapter When using the internet connection method, do not use another connection method, such as standard telephone, cellular, or hotspot. Complete the following steps to set up your Communicator with an internet connection to send your data to the Clinician Website.
  • Page 47 2. Plug the power supply into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to 1 minute. • All the Communicator indicators will light for approximately 1 second. • If the LATITUDE indicator is not lit, check that both ends of the power supply are plugged in firmly.
  • Page 48 • Your Communicator’s wave lights will flash green in sequence and repeat for several minutes as shown in “Using the Heart Button” on page 18. • If this process takes longer than several minutes, software download and installation may be occurring. If the Heart button flashes again, press it again.

  • Page 49: Replacement

    Replacement If you need a replacement internet connection accessory or a different connection method (standard telephone, cellular, or hotspot), contact your health care provider or Patient Services at 1-866-484-3268. For information on returning, replacing, or disposing of your internet connection accessory, see page 26. LATITUDE Communicator Patient Manual ™...

  • Page 50: Internet Connection - Using A Wireless Internet Adapter

    Internet Connection Using a Wireless Internet – Adapter When using the internet connection method, do not use another connection method, such as standard telephone, cellular, or hotspot. Complete the following steps to set up your Communicator with an internet connection to send your data to the Clinician Website.
  • Page 51 2. Plug the power supply into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to 1 minute. • All the Communicator indicators will light for approximately 1 second. • If the LATITUDE indicator is not lit, check that both ends of the power supply are plugged in firmly.

  • Page 52: Figure 9. Wireless Internet Adapter-Connecting The Wireless Internet Adapter

    Wireless internet adapter ** Internet modem/router Figure 9. Wireless Internet Adapter–Connecting the Wireless Internet Adapter • Position the Communicator within 100 feet (30 meters) of the wireless internet adapter. • Some household appliances and other sources of electromagnetic energy could interfere with wireless communication between the Communicator and the wireless internet adapter.

  • Page 53: Figure 10. Wireless Internet Adapter-Pairing

    6. Plug the USB power adapter into an electrical outlet. • The power light on the front of the wireless internet adapter will light solid green. For the following steps, make sure you use the Ethernet cable provided with the wireless internet adapter and not the telephone cable provided with the Communicator.
  • Page 54 • Your Communicator’s wave lights will flash green in sequence and repeat for several minutes as shown in “Using the Heart Button” on page 18. • If this process takes longer than several minutes, software download and installation may be occurring. If the Heart button flashes again, press it again.

  • Page 55: Replacement

    When using the wireless internet adapter connection method, keep your Communicator and wireless internet adapter plugged in to the electrical outlet. Keep the wireless internet adapter connected to your internet modem/router. Replacement If you need a replacement internet connection accessory or a different connection method (standard telephone, cellular, or hotspot), contact your health care provider or Patient Services at 1-866-484-3268.

  • Page 56: Standard Telephone Connection

    Standard Telephone Connection When using the standard telephone connection method, do not use another connection method, such as cellular, internet, or hotspot. Complete the following steps to set up your Communicator with a standard telephone connection to send your data to the Clinician Website. The numbers in Figure 11 refer to the corresponding steps.
  • Page 57 1. Insert the power supply (included) into the jack labeled 2. Plug the power supply into an electrical outlet that is easily accessible. • The LATITUDE indicator will flash yellow for up to 1 minute. • All the Communicator indicators will light for approximately 1 second.

  • Page 58: Communicator Use Of The Telephone

    • If you have previously completed initial setup, the Heart button will not flash at this point. Instead of pressing the Heart button, follow the instructions for pressing the Status button in “Confirming Connection to the Clinician Website” on page 22. 6.
  • Page 59 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...

  • Page 60: Using The Telephone While The Communicator Is Making A Call

    Using the Telephone While the Communicator is Making a Call If you pick up the phone while the Communicator is using the telephone line, there will be no dial tone. Hang up the receiver, wait 3 or more seconds, and then pick up the telephone receiver again.

  • Page 61: Replacement

    Replacement If you need a replacement telephone cable or a different connection accessory (cellular, internet, or hotspot), contact your health care provider or Patient Services at 1-866-484-3268. For information on returning, replacing, or disposing of your telephone cable, see page 26. Hotspot Connection (Mobile Device) The hotspot feature on your mobile device may be used for a wireless connection to the Clinician...

  • Page 62: Usb Accessory Adapter Connection

    USB Accessory Adapter Connection The USB accessory adapter is used to establish a wireless connection between the prescribed weight scale and blood pressure monitor and your Communicator. The USB accessory adapter may also be used to connect your Communicator to the Clinician Website using a hotspot connection, as described in “Hotspot Connection (Mobile Device)”...

  • Page 63: Software Download And Installation

    Software Download and Installation Updated software may occasionally be made available to your Communicator for download and installation. During initial Communicator setup: If a software update is waiting, pressing the Heart button will trigger the download and installation process, which could take an additional several minutes.

  • Page 64: Troubleshooting

    TROUBLESHOOTING This Troubleshooting section first shows various combinations of indicator lights that signal an error, and then shows Yellow Wave light errors. A description of the issues, actions to take, and verification steps, as applicable, are shown for each type of error. For clarity, only the pertinent error colors are shown in the images in this Troubleshooting section.

  • Page 65: Indicator Light Errors

    Indicator Light Errors ► Heart Button is Flashing ► LATITUDE Indicator is Green Issue: You need to complete a scheduled interrogation or perform a manual device check. Action: Press the Heart button to complete setup or the interrogation. Refer to “Using the Heart Button”...
  • Page 66 ► No Indicators are Lit Issue: • The Communicator is not connected to electrical power or it is not functioning. • The Communicator has just been plugged into electrical power or may be downloading and installing software. This process typically lasts 5 minutes but may take longer.
  • Page 67 Verify: • If indicator lights flash, and then you get a solid green LATITUDE indicator as shown below, the issue is resolved. • If all indicators are still unlit, including the LATITUDE indicator, contact your health care provider or Patient Services at 1-866-484-3268. LATITUDE Communicator Patient Manual ™...
  • Page 68 ► LATITUDE Indicator is Flashing Yellow ► No Other Indicators are Lit Issue: The Communicator has just been plugged into electrical power or may be downloading and installing software. This process typically lasts 5 minutes but may take longer. Action: Wait 5 minutes for a possible software update to complete.
  • Page 69 ► Call Doctor Icon is Red (Flashing or Solid) ► LATITUDE Indicator is Yellow Issue: • A potential problem with your implanted device was detected, but the Communicator cannot send any information collected from your implanted device to the Clinician Website.
  • Page 70 ► Call Doctor Icon is Yellow (Flashing or Solid) ► LATITUDE Indicator is Yellow Issue: • This indicates one of the following errors: • Your Communicator is currently unable to read your implanted device or send its data to the Clinician Website.
  • Page 71 Verify: • If successful, the LATITUDE indicator will light green as shown below. • If the Call Doctor icon and LATITUDE indicator remain yellow, contact your health care provider or Patient Services at 1-866-484-3268. LATITUDE Communicator Patient Manual ™...
  • Page 72 ► Call Doctor Icon is Solid Yellow ► LATITUDE Indicator is Not Lit Issue: This indicates your Communicator is having a problem connecting. Action: Unplug the power supply from both the wall outlet and the Communicator for 1 minute. After 1 minute, reconnect the power supply to both.

  • Page 73: Yellow Wave Errors

    Yellow Wave Errors Yellow Wave light errors stay lit for 60 minutes unless the error is resolved sooner. The LATITUDE indicator is lit yellow at the same time. After 60 minutes, all wave lights are turned off and the LATITUDE indicator is lit green, even if the problem was not resolved.
  • Page 74 ► One Yellow Collecting Wave Issue: 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”...
  • Page 75 Verify: • If the indicators are lit as shown below, the interrogation was a success. • If one Yellow Collecting Wave remains, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 76 ► Two Yellow Collecting Waves Issue: 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 7. •...
  • Page 77 Verify: • If the indicators are lit as shown below, the interrogation was a success. • If two Yellow Collecting Waves remain, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 78 ► Three Yellow Collecting Waves Issue: One 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. • You may be sitting too close to your modem/router.
  • Page 79 Verify: • If the indicators are lit as shown below, the interrogation was a success. • If three Yellow Collecting Waves remain, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 80 ► One Yellow Sending Wave Issue: An attempt to connect to the Clinician Website failed due to issues relating to the cellular, internet, or telephone connection. Action if • Make sure the USB cellular adapter using a is plugged into the Communicator. cellular •...
  • Page 81 Action if • Make sure the USB cable provided using an with the USB Ethernet adapter is internet connected at one end to the USB (USB Ethernet adapter and at the other adapter) end to the USB port on the back of connection: the Communicator.
  • Page 82 Action if • Make sure the wireless internet using an adapter is powered on by verifying internet that the power light on the front is lit (wireless solid green. adapter) connection: • Make sure the USB accessory adapter is connected to the back of the Communicator.
  • Page 83 Action if • Check that the telephone cable is using a plugged in tightly to a telephone standard wall jack and the Communicator. telephone • Pick up the telephone that is using connection: the same telephone wall jack as the Communicator, and check for dial tone.
  • Page 84 Verify (all • If the connection was a success, the connection indicators will be lit as shown below. types): • If one Yellow Sending Wave remains, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 85 ► Two Yellow Sending Waves Issue: An attempt to connect to the Clinician Website failed due to issues relating to the cellular, internet, or telephone connection. Action if • Move the Communicator to another using a location that may provide a stronger cellular cellular signal.
  • Page 86 Action if • If using the USB adapter, make using an sure the Ethernet cable provided internet with the USB Ethernet adapter is connection: connected to the Ethernet port for your internet service. • If using the wireless adapter, make sure the USB accessory adapter is connected to the back of the Communicator.
  • Page 87 Action if • Make sure your telephone is not using a being used at this time. standard • Pick up the telephone that is using telephone the same telephone wall jack as the connection: Communicator, and check for dial tone. If no dial tone, try a different telephone wall jack.
  • Page 88 Verify (all • If the connection was a success, the connection indicators will be lit as shown below. types): • If two Yellow Sending Waves remain, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 89 ► Three Yellow Sending Waves Issue: The Communicator was able to establish a connection to the Clinician Website, but no information reached Action for Check that the switches on the any type of bottom of the Communicator are set connection: correctly for your country and whether you need to dial a number to get an outside line.
  • Page 90 Verify (all • If the connection was a success, the connection indicators will be lit as shown below. types): • If three Yellow Sending Waves remain, contact your health care provider or Patient Services at 1-866-484-3268. • If other Yellow Wave errors remain, refer to the applicable error in this section.

  • Page 91: Additional Information

    ADDITIONAL INFORMATION Frequently Asked Questions These FAQs are designed to point you to the right section in this manual for the answers. What should I do if the Heart button is flashing? Press the Heart button to complete a scheduled interrogation.
  • Page 92 How do I set up my Communicator using a USB Ethernet adapter? Refer to “Internet Connection–Using a USB Ethernet Adapter” on page 38. How do I set up my Communicator using the wireless internet adapter? Refer to “Internet Connection–Using a Wireless Internet Adapter”...
  • Page 93 If you see ... It means ... Do this ... The Communicator Press the Heart needs help button. completing a scheduled device Stay next to the check. Communicator until Note: This does not all lights are as indicate a problem shown in the next with your implanted row.
  • Page 94 How do I dispose of my Communicator and Accessories? Refer to “Returning, Replacing, or Disposing of the Communicator or Accessories” on page 26. Where can I go for more help? Contact your health care provider or Patient Services at 1-866-484-3268. LATITUDE Communicator Patient Manual ™...

  • Page 95: Specifications

    Specifications Model: 6280 and 6290 (Unless specified, values apply to all 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 (included): AC adapter (power supply): GlobTek...
  • Page 96 Storage and Transport Up to 93% noncondensing Humidity*: Operating Pressure: 70 to 106 kPa Storage and Transport 50 to 106 kPa Pressure*: Protection Against Ingress of Solid Foreign IP21 (≥12.5 mm diameter) Objects: Protection Against IP21 (light rain proof) Ingress of Water: * Storage and transport specifications apply with or without Communicator protective packaging.
  • Page 97 USB Accessory Adapter: 2.4 GHz wireless USB dongle Boston Scientific Model 6454 (included with weight scale and blood pressure monitor; may also be available separately) Operational 2400.0 to 2480.0 MHz Frequency: Modulation Type: Adaptive Frequency Hopping Effective Radiated +19.4 dBm (87.1 mW)
  • Page 98 Network and Connectivity Specifications Required Characteristics of IT Network Ethernet: IEEE 802.3, 10 Mbps IEEE 802.3u, 100 Mbps Wi-Fi: None Hazardous situations The Communicator fails to report a resulting from network potential problem with the implanted failure: device to the Clinician Website Required Configuration of IT Network Ethernet: Static IP addressing...

  • Page 99: Safety And Standards Compliance

    Safety and Standards Compliance • Changes or modifications not expressly approved by Boston Scientific could void the user’s authority to operate this equipment. • Allow 10 minutes for the Communicator to return to the ambient temperature (68° F, 20° C, or as applicable) when starting from the storage temperature limits.
  • Page 100 other equipment, please contact your health care provider or Patient Services at 1-866-484-3268 to verify normal operation. • Do not use the Communicator in the presence of flammable gas mixtures, including anesthetics, oxygen, or nitrous oxide. • 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.
  • Page 101 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. • The REN is used to determine the number of devices that may legally connect to a telephone line.
  • Page 102 guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. • 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.
  • Page 103 • This equipment has been tested and found to comply with applicable safety portions of the following standards: • IEC 60601-1:2005/A1:2012 • ANSI/AAMI ES60601-1:2005(R)2012 • EN 60601-1:2006 + A1:2013 • IEC 60601-1-11-2015 • CAN/CSA-C22 No. 60601-1:2014 • This equipment has been tested and found to comply with the following electromagnetic compatibility (EMC) standard: IEC 60601-1-2:2014.

  • Page 104: Essential Performance

    Essential Performance In accordance with clause 4.3 of IEC/EN 60601-1, the Communicator has no performance that qualifies as essential performance. Software Statement 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...

  • Page 105: Electromagnetic Emissions And Immunity

    Electromagnetic Emissions and Immunity Table 1. Guidance and manufacturer’s declaration— electromagnetic compatibility The LATITUDE Communicator is suitable for use in a professional health care facility or home environment. Electromagnetic Test Compliance environment—guidance Protection of radio services CISPR 11 The LATITUDE and other equipment Group 1 Communicator uses RF...
  • Page 106 The LATITUDE Communicator is suitable for use in a professional health care facility or home environment. Electromagnetic Test Compliance environment—guidance Conducted disturbances 3 V/m from 0.15 MHz to The ISM bands between induced by RF fields 80 MHz 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz 6 V/m in ISM bands from 13.553 MHz to 13.567 MHz...

  • Page 107: Explanation Of Product And Label Symbols

    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/catalog number Non-ionizing electromagnetic radiation IEC 60601 Class II medical equipment, protection against electrical shock Manufacturer Date of manufacture...
  • Page 108 Symbol Meaning Power indicator (applies to USB cellular adapter) Wireless indicator (applies to Model 6295 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) Temperature range limits Humidity range limits Atmospheric pressure range limits...
  • Page 110 Boston Scientific Corporation 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 © 2018 Boston Scientific Corporation or its affiliates. All rights reserved. 359371-005 en USA 2018-11 *359371-005*...

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