Boston Scientific LATITUDE 6288 Patient Manual
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Boston Scientific LATITUDE 6288 Patient Manual

Communicator
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PATIENT MANUAL
LATITUDE
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Communicator

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  • Page 1 PATIENT MANUAL LATITUDE ™ Communicator...
  • Page 3 SL Power Electronics is a trademark of SL Delaware Holdings, Inc. The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Boston Scientific Corporation is under license. Other trademarks and trade names are those of their respective owners.
  • Page 4 LATITUDE™ Communicator Patient Manual...

  • 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 Summary of Safety and Clinical Performance ....5 Clinical Benefits of the Communicator ......6 USING YOUR COMMUNICATOR ..........7 Important Notes ..............7 Where to Place Your Communicator ........
  • Page 6 SETTING UP YOUR COMMUNICATOR ........25 Setup Overview ..............25 Confirming/Setting Switch Settings ........26 Special Instructions if Using the Standard Telephone Connection Method .........32 Traveling .............32 Setting Switches 1-3 for Dial-out or Prefix Number ..........32 Setting Up Your Connection Method ........34 Cellular Connection ............35 Using Previous Cellular Connection Accessories............38 Replacement ............39...
  • Page 7 ADDITIONAL INFORMATION ..........75 LATITUDE Support ..............75 Frequently Asked Questions ..........77 Specifications ..............80 Safety and Standards Compliance ........85 European Union Importer ............87 Essential Performance ............87 Software Statement .............87 Electromagnetic Emissions and Immunity ......88 Explanation of Product and Label Symbols ......90 LATITUDE™...
  • Page 8 List of Figures Figure 1. Front of Communicator ...........9 Figure 2. Status Button ............19 Figure 3. Location of Switches ..........26 Figure 4. Dial-out Number Switch Settings (1-3) ....33 Figure 5. Back of Communicator .........34 Figure 6. Connecting a USB Cellular Adapter ......35 Figure 7.

  • 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 Refer to “Using the Heart Button” on page 16 for more information. Your health care provider may also send periodic updates to your Communicator to change the schedule for reading data from your implanted device. In order for your Communicator to be able to send your implanted device data to the Clinician Website, a connection accessory must be set up on your Communicator.

  • Page 12: Components Of Your Communicator

    Clinician Website. For more information about the accessories or how to obtain them, contact your health care provider. Boston Scientific Accessory Name Model Number (as referenced in this manual)

  • Page 13: Optional Accessories

    Optional Accessories (The optional accessories described in this section are not available in all locations. Contact your health care provider for more information.) If prescribed by your health care provider, your Communicator may include a weight scale and blood pressure monitor. These specially designed products provide additional information to monitor your health.

  • Page 14: Clinical Benefits Of The Communicator

    Clinical Benefits of the Communicator If used as indicated, when compared to in-person clinical evaluations only, remote monitoring: • Reduces the number of in-person clinical evaluations at the clinic. • Improves the consistency of follow-up by your health care provider. •...

  • Page 15: 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 25 for directions on setting up your connection accessory. Contact your health care provider to learn which connection accessory is right for you.

  • Page 16: Where To Place Your Communicator

    Where to Place Your Communicator Place your Communicator: • Near an electrical outlet that is easily accessible. • Within 3 m (10 ft) from your bedside or where you sleep. If this is not possible, place your Communicator where you spend a considerable amount of time each day.

  • Page 17: Heart Button And Indicators

    • 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. Boston Scientific will give advice on better Communicator placement to correct this issue.
  • Page 18 The Heart button and indicators are intended to inform you of the status of your Communicator or actions you may need to take. The lights, colors, and sequence of each indicator shown in Figure 1 are explained in the following section. Note Note: When the words “interrogate”...

  • 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 25), 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 sent.
  • Page 22 Sensor Reading Icon Shows the Communicator has successfully communicated with a prescribed weight scale or blood pressure monitor. Note 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 measurement.
  • Page 23 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 51 for more information. • Flashes yellow briefly after the Communicator is plugged into electrical power (does not require contacting your health care...

  • Page 24: 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.
  • Page 25 The Communicator begins interrogating your implanted device after the Heart button is pressed. 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.
  • Page 26 4. The Sending Waves flash green in sequence and repeat while the Communicator sends your data to the Clinician Website. 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.

  • Page 27: 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 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 28: Confirming Connection To The Clinician Website

    Confirming Connection to the Clinician Website If you have moved your Communicator, changed the connection method, or made other changes to the Communicator, you should confirm that your Communicator still successfully connects to the Clinician Website. To do so, press and hold the Status button for more than 3 seconds 3 seconds.

  • Page 29: Loss Of Power

    Loss of Power The Communicator has internal memory that stores your implanted device data and other information in case the electrical power is interrupted or the power supply is unplugged. The LATITUDE indicator will transition back to green from being unlit once power is restored to the Communicator. If the LATITUDE indicator does not transition back to green within 15 seconds after power is restored, unplug the power supply from both the wall outlet and the Communicator for 1 1...

  • Page 30: Care And Maintenance

    Europe only : When traveling to a country outside of the European Economic Area, the data transmitted from the Communicator will be subject to laws of that country. The laws of that country may provide less privacy protection for your data than the laws of your home country.

  • Page 31: Cleaning The Communicator And Accessories

    Cleaning the Communicator and Accessories When necessary, clean the Communicator and its accessories with a soft, clean, lint-free cloth moistened in water or mild detergent. CAUTIONS CAUTIONS: • Do not use other cleaning fluids. They may damage the front of the Communicator. Never spray any cleaning fluid directly on the front of the Communicator.
  • Page 32 LATITUDE™ Communicator Patient Manual...

  • Page 33: 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: Confirm/set the switches on the bottom of your Communicator. Refer to “Confirming/Setting Switch Settings” on page 26. 2.

  • Page 34: 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 35 Table 1. Switch Settings Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Country Country Cellular or Internet Cellular or Internet Standard Telephone* Standard Telephone* Australia Australia Austria Austria Belgium Belgium Czech Czech Republic Republic Denmark Denmark Finland Finland France...
  • Page 36 Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Country Country Cellular or Internet Cellular or Internet Standard Telephone* Standard Telephone* Germany Germany Greece Greece Hong Kong Hong Kong Hungary Hungary Iceland Iceland Not available Not available Ireland Ireland (Republic)
  • Page 37 Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Country Country Cellular or Internet Cellular or Internet Standard Telephone* Standard Telephone* Kuwait Kuwait Not available Not available Lebanon Lebanon Not available Not available Malaysia Malaysia Not available Not available Netherlands Netherlands...
  • Page 38 Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Country Country Cellular or Internet Cellular or Internet Standard Telephone* Standard Telephone* Portugal Portugal Qatar Qatar Not available Not available Saudi Arabia Saudi Arabia Not available Not available Singapore Singapore Not available...
  • Page 39 Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Country Country Cellular or Internet Cellular or Internet Standard Telephone* Standard Telephone* Spain Spain Sweden Sweden Switzerland Switzerland Thailand Thailand Not available Not available United Arab United Arab Not available Not available Emirates...

  • Page 40: 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 43. 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 41: Figure 4. Dial-Out Number Switch Settings (1-3)

    Dial-out Dial-out Number Number None Figure 4. Dial-out Number Switch Settings (1-3) LATITUDE™ Communicator Patient Manual...

  • Page 42: 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 43: 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.
  • Page 44 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 it. •...
  • Page 45 • The LED light on the USB cellular adapter will blink and remain blinking. At times the light may be lit solid. Different light colors are normal. The light will be off when collecting data from your implanted device and during a LATITUDE System reboot.

  • Page 46: Using Previous Cellular Connection Accessories

    You can verify the cellular connection by following the instructions in “Confirming Connection to the Clinician Website” on page 20. 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 47: Replacement

    Replacement If you need a replacement USB cellular adapter or a different connection accessory (standard telephone, internet, or hotspot), contact your health care provider. For information on returning, replacing, or disposing of your USB cellular adapter, see page 23. If you wish to discontinue using your USB cellular adapter, contact your health care provider.

  • Page 48: Internet Connection

    Internet Connection 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 49 • 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. Check if the light on the power supply is lit.

  • Page 50: Replacement

    • If this process takes longer than several minutes, software download and installation may be occurring. If the Heart button flashes again, press it again. Refer to “Software Download and Installation” on page 49. • If you have previously completed initial setup, the Heart button will not flash at this point.

  • Page 51: 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.
  • Page 52 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 53: 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 20. 6.

  • Page 54: Using The Telephone While The Communicator Is Making A Call

    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 are typically provided by the facility.

  • Page 55: Dsl Internet Service

    DSL Internet Service 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.

  • Page 56: Usb Accessory Adapter Connection

    USB Accessory Adapter Connection (This adapter is not available in all locations. Contact your health care provider for more information.) 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...

  • Page 57: 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 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 58 LATITUDE™ Communicator Patient Manual...

  • Page 59: Troubleshooting

    TROUBLESHOOTING Overview 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 60: Indicator Light Errors

    Indicator Light Errors ◊ Heart Button is Flashing ◊ LATITUDE Indicator is Green You need to complete a scheduled Issue: 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 61 ◊ 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 62 • If indicator lights flash, and then you get a Verify: 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. LATITUDE™ Communicator Patient Manual...
  • Page 63 ◊ 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. Wait 5 minutes 5 minutes for a possible software update Action: to complete.
  • Page 64 ◊ 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 65 ◊ 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 66 • If successful, the LATITUDE indicator will Verify: light green as shown below. • If the Call Doctor icon and LATITUDE indicator remain yellow, contact your health care provider. LATITUDE™ Communicator Patient Manual...
  • Page 67 ◊ 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 1 minute. After 1 minute, reconnect the power supply to both.

  • Page 68: 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 69 ◊ 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 70 • If the indicators are lit as shown below, the Verify: interrogation was a success. • If one Yellow Collecting Wave remains, contact your health care provider. • If other Yellow Wave errors remain, refer to the applicable error in this section. LATITUDE™...
  • Page 71 ◊ 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 8. •...
  • Page 72 • If the indicators are lit as shown below, the Verify: interrogation was a success. • If two Yellow Collecting Waves remain, contact your health care provider. • If other Yellow Wave errors remain, refer to the applicable error in this section. LATITUDE™...
  • Page 73 ◊ 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 74 • If the indicators are lit as shown below, the Verify: interrogation was a success. • If three Yellow Collecting Waves remain, contact your health care provider. • If other Yellow Wave errors remain, refer to the applicable error in this section. LATITUDE™...
  • Page 75 ◊ 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. • Make sure the USB cellular adapter is Action if using a cellular plugged into the Communicator. connection: •...
  • Page 76 • Make sure the USB cable provided with Action if using an internet the USB Ethernet adapter is connected at connection: one end to the USB Ethernet adapter and at the other end to the USB port on the back of the Communicator. •...
  • Page 77 • Check that the telephone cable is plugged Action if using a standard in tightly to a telephone wall jack and the telephone Communicator. connection: • Pick up the telephone that is using the same telephone wall jack as the Communicator, and check for dial tone.
  • Page 78 ◊ 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 using • Move the Communicator to another a cellular location that may provide a stronger connection: cellular signal.
  • Page 79 • Make sure your telephone is not Action if using a standard being used at this time. telephone • Pick up the telephone that is using connection: the same telephone wall jack as the Communicator, and check for dial tone. If no dial tone, try a different telephone wall jack.
  • Page 80 • If the connection was a success, the Verify (all connection indicators will be lit as shown below. types): • If two Yellow Sending Waves remain, contact your health care provider. • If other Yellow Wave errors remain, refer to the applicable error in this section.
  • Page 81 ◊ Three Yellow Sending Waves Issue: The Communicator was able to establish a connection to the Clinician Website, but no information reached it. Check that the switches on the bottom Action for any type of of the Communicator are set correctly for connection: your country and whether you need to dial a number to get an outside line.
  • Page 82 LATITUDE™ Communicator Patient Manual...

  • Page 83: Additional Information

    ADDITIONAL INFORMATION LATITUDE Support Your implanted device and the LATITUDE Communicator are manufactured by Boston Scientific. In certain instances, your health care provider may instruct you to contact Boston Scientific for help with your Communicator. When instructed to contact Boston Scientific, call the applicable telephone number from the following list.
  • Page 84 Boston Scientific and to the relevant local regulatory authority for medical devices in your country. For customers in Australia, report any serious incident that occurs in relation to your device to Boston Scientific and to the Therapeutic Goods Administration (https://www.tga.gov.au). LATITUDE Communicator Patient Manual ™...

  • Page 85: Frequently Asked Questions

    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. A flashing Heart button does not indicate there is a problem with your implanted device.
  • Page 86 How do I know the Communicator is working? Refer to “Heart Button and Indicator Descriptions” on page 11 and “Normal Operation of the Communicator” on page What do these lights mean? See the following chart, and refer to “Heart Button and Indicators”...
  • Page 87 When do I use my Communicator? Refer to “The LATITUDE Communicator” on page 2 and “Using the Heart Button” on page 16. What do I need to do with my Communicator if I travel? Refer to “Traveling With Your Communicator” on page 21. How do I dispose of my Communicator and Accessories? Refer to “Returning, Replacing, or Disposing of the Communicator or Accessories”...

  • Page 88: Specifications

    Specifications Model: 6288 and 6290 (Unless specified, values apply to all models.) Dimensions: Length: 20.3 cm (8.00 in) Width: 11.4 cm (4.50 in) Height: 6.9 cm (2.71 in) Weight: 0.38 kg (0.83 lbs) Power Source (included): 5.0 VDC, 3.0 A, continuous service Class II AC adapter (power supply): Model 6288: GlobTek...
  • Page 89 Storage and Transport -25°C to 70°C Temperature*: (-13°F to 158°F) Operating Humidity: 15% to 93% noncondensing 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 IP21 (≥12.5 mm diameter) of Solid Foreign Objects: Protection Against Ingress...
  • Page 90 Monopole Antenna Gain: 2.6 dBi at 2442 MHz DSL Filter (if supplied): Digital Subscriber Line (DSL) in-line filter Excelsus™ Technologies, Inc. - Model Z-200SM Boston Scientific - Model 6421 DC Loop Current: 20-100 mA DC LATITUDE Communicator Patient Manual ™...
  • Page 91 LATITUDE NXT USB Cellular Adapter (Model 6296): EGSM-900: TX 880–915 MHz RX 925–960 MHz Effective Radiated Power: 28.7 dBm Antenna Type: Monopole Antenna Gain: 1.7 dBi at 897.4 MHz DCS-1800: TX 1710–1785 MHz RX 1805–1880 MHz Effective Radiated Power: 26.7 dBm Antenna Type: Monopole Antenna Gain: 2.2 dBi at 1747.4 MHz W-CDMA 900:...
  • Page 92 Required Configuration of IT Network Ethernet: Static IP addressing Wi-Fi: None Ethernet MAC address: On dongle label Internet protocol: IPv4 Dynamic Host Configuration Protocol Automatic DHCP mode supported (DHCP) mode: Wi-Fi MAC address: None LATITUDE Communicator Patient Manual ™...

  • Page 93: 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 (20°C or as applicable) when starting from the storage temperature limits.
  • Page 94 responsible that the system complies with the requirements of clause 16 of EN 60601-1:2006+ A1:2013 or IEC 60601-1:2005/A1:2012. If in doubt, consult the technical service department or your local representative. • This equipment has been tested and found to comply with applicable safety portions of the following standards: •...

  • Page 95: European Union Importer

    European Union Importer EU Importer: Boston Scientific International B.V., Vestastraat 6, 6468 EX Kerkrade, The Netherlands. 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).

  • Page 96: Electromagnetic Emissions And Immunity

    Electromagnetic Emissions and Immunity Table 2. 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 and CISPR 11 The LATITUDE Communicator other equipment Group 1 uses RF energy only for its...
  • Page 97 The LATITUDE Communicator is suitable for use in a professional health care facility or home environment. Electromagnetic Test Compliance environment—guidance Conducted disturbances induced 3 V/m from 0.15 MHz to 80 MHz The ISM bands between 0.15 MHz by RF fields and 80 MHz are 6.765 MHz to 6 V/m in ISM bands from 0.15 6.795 MHz 13.553 MHz to 13.567...

  • Page 98: 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 USB Connection Direct Current Reference Number Solid foreign objects and water protection Follow instructions for use Class II equipment (IEC 60601) Non-Ionizing electromagnetic radiation Discard with electronic waste ACMA compliance mark...
  • Page 99 Symbol Meaning Representative sample of label that indicates this REGISTERED No: product complies with applicable United Arab Emirates nnnnnnn telecommunications standards DEALER No: xxxxxxx Indicates this product complies with applicable South African telecommunications standards Representative sample of label that indicates this product Complies with IMDA Standards complies with applicable Singaporean telecommunications...
  • Page 100 Symbol Meaning Australian sponsor address Corrugated recycles Consult instructions for use (applies to USB accessory adapter) Indicates this product complies with applicable Japanese telecommunications standards (applies to USB accessory adapter) LATITUDE Communicator Patient Manual ™...
  • Page 102 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 *92435999-001* 92435999-001 en OUS 2020-07 © 2020 Boston Scientific Corporation or its affiliates. All rights reserved.

This manual is also suitable for:

Latitude 6290

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