Boston Scientific LATITUDE Patient Manual

Boston Scientific LATITUDE Patient Manual

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PATIENT MANUAL
MANUAL DEL PACIENTE
®
Communicator
LATITUDE
®
Comunicador
LATITUDE

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Summary of Contents for Boston Scientific LATITUDE

  • Page 1 PATIENT MANUAL MANUAL DEL PACIENTE ® Communicator LATITUDE ® Comunicador LATITUDE...
  • Page 3 English ............ 1 Español........... 75...
  • Page 5 ENGLISH Communicator ® LATITUDE...
  • Page 6 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 identifi ed where appropriate. The model number for your Communicator is located on its bottom label.
  • Page 7: Table Of Contents

    Confi rming Switch Settings Connecting Your Communicator Software Download and Installation Connecting to a Landline Telephone Jack Connecting to the LATITUDE NXT USB Cellular Adapter Where to Place Your USB Cellular Adapter Normal Operation of the Communicator Indicator Sequence When Using the Heart Button...
  • Page 8 LATITUDE Cellular Data Plan Cellular Converter Activating the LATITUDE Cellular Data Plan Troubleshooting and Support Discontinuing Your LATITUDE Cellular Data Plan 42 Interrogating Your Implanted Device Interrupted Electrical Power Checking that the Communicator Can Connect to the LATITUDE System Traveling with Your Communicator...
  • Page 9: Latitude Patient Management System

    Only authorized health care providers have access to your information through the secure clinician website. 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.
  • Page 10: Items You Should Receive

    Items You Should Receive The following items are included with the Communicator: • Communicator unit • Alternating current (AC) adapter (GlobTek Model GTM41061-1512-7.0) ® • Communicator installation guide • Communicator patient manual (this book) • Communicator telephone cord Communicator Patient Manual ® LATITUDE...
  • Page 11: Optional Health Monitoring Equipment

    If prescribed by your health care provider, your Communicator can also collect information from an optional LATITUDE heart failure management system. This system includes a LATITUDE weight scale and LATITUDE blood pressure monitor. These specially designed products provide additional information to monitor your health. Refer to the handbook that is included with the weight scale and blood pressure monitor products.
  • Page 12: When To Use Your Communicator

    Ask your health care provider if you have questions about any risks with using the Communicator or your implanted device. There is also valuable information about risks and reliability in the patient handbook for your implanted device. Communicator Patient Manual ® LATITUDE...
  • Page 13: Where To Place Your Communicator

    Place your Communicator: • Near a telephone wall jack (not required if you are subscribed to the LATITUDE Cellular Data Plan). • Near an electrical outlet that is easily accessible. • Where you can sit comfortably and see the front of the Communicator.
  • Page 14 • Boston Scientifi c personnel may contact the clinic or patient to advise on the best Communicator placement if an implanted device uses too much radio-frequency (RF) telemetry. Communicator Patient Manual ® LATITUDE...
  • Page 15: Buttons, Connectors, And Indicators

    Heart button LATITUDE indicator Status button USB ports* Power To telephone To telephone input (optional) wall jack * to connect the USB sensor adapter and/or the LATITUDE NXT USB Cellular Adapter Figure 1. Buttons and connectors Communicator Patient Manual ® LATITUDE...
  • Page 16 Yellow = error sending data. 5. Doctor Icon: Data successfully sent when lit. 6. Sensor Reading Icon: Sensor reading received when lit. 7. LATITUDE Indicator: Green = Communicator is active and ready to use. Yellow = Flashes yellow during start-up process or to indicate an error.
  • Page 17: Installing Your Communicator

    Refer to “Setting Switches for PBX or Dial-out Numbers” on page 52 for those switch settings. United States and Puerto Rico *6290* Dial-out Country Canada Mexico Figure 3. Switch settings Communicator Patient Manual ® LATITUDE...
  • Page 18: Connecting Your Communicator

    “Connecting to a Landline Telephone Jack” on page 11 to connect your Communicator to the LATITUDE system. • If using the LATITUDE NXT USB Cellular Adapter, follow the steps in “Connecting to the LATITUDE NXT USB Cellular Adapter” on page 13.
  • Page 19: Connecting To A Landline Telephone Jack

    3. 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. Communicator Patient Manual ® LATITUDE...
  • Page 20 Communicator then lights all the indicators for approximately one second to indicate all indicators are working. If the LATITUDE indicator is not lit, check that both ends of the AC adapter are plugged in fi rmly. Check if the light on the AC adapter is on.
  • Page 21: Connecting To The Latitude Nxt Usb Cellular Adapter

    Connecting to the LATITUDE NXT USB Cellular Adapter If you have signed up for the LATITUDE Cellular Data Plan, no telephone cords need to be attached. Instead, a cellular adapter provided upon subscription to the Data Plan must be connected to the Communicator.
  • Page 22 fl ash at various times and at various sequences. This indicator is of no concern during normal operation. • The LATITUDE indicator fl ashes for up to one minute while the Communicator starts up. The Communicator then lights all the indicators for approximately one second to indicate all indicators are working.
  • Page 23 Heart button to fl ash with a white light. Press the fl ashing Heart button to check if the Communicator can interrogate your implanted device and send your data to the LATITUDE system. Continue with step 6 unless installation takes longer than 5 minutes or the Heart button fl...
  • Page 24: Normal Operation Of The Communicator

    Heart button as described in “Interrogating Your Implanted Device” on page 43 or when using the Status button as described in “Checking that the Communicator Can Connect to the LATITUDE System” on page 45. Note: When color is used in this manual to explain operation of the Communicator, an indicator shown as gray means that it is not lit.
  • Page 25: Indicator Sequence When Using The Heart Button

    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.
  • Page 26 LATITUDE system. The Doctor icon lights blue showing the Communicator successfully sent your data to the LATITUDE system. All the indicators shown stay lit for 2 minutes to show the entire process was a success.
  • Page 27: Indicator Descriptions

    • 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 fl ash a different color to indicate some type of action may need to be taken.
  • Page 28 • Lights a solid white for 2 minutes to indicate the interrogation is complete. • May also be used to manually initiate an interrogation of your implanted device. Refer to “Interrogating Your Implanted Device” on page 43 before using this button. Communicator Patient Manual ® LATITUDE...
  • Page 29 Show the Communicator is connecting to the LATITUDE system. • Light 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.
  • Page 30 • Flashes green fi ve times and remains lit 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.
  • Page 31 • Flashes yellow briefl y after the Communicator is plugged into AC power. • The light turns off after the Communicator completes the startup process. • If the startup process does not complete, it remains lit solid yellow. Communicator Patient Manual ® LATITUDE...
  • Page 32: Status Button

    Communicator indicators will light to display: • The status of the last interrogation. • The status of the last connection to the LATITUDE system. The indicators will light for 2 minutes. If the Call Doctor icon was blinking, it will stop blinking and stay lit.
  • Page 33: Confi Rming Successful Operation

    Collecting and Sending Waves are lit green, confi rming 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.
  • Page 34: Troubleshooting Errors

    One or more of the indicators on the front of the Communicator may light or fl ash to indicate some type of Communicator, communication, or LATITUDE system error. A general description of the types of errors are shown in Figure 7. A description of each error is provided in this section, along with suggested actions to resolve each error.
  • Page 35 No Indicators are Lit Description: The Communicator is not connected to electric power or it is not functioning. • If the LATITUDE indicator is not Action: lit, check that both ends of the AC adapter are plugged in fi rmly.
  • Page 36 Communicator cannot send any information collected from your implanted device to the LATITUDE system. The Call Doctor icon and LATITUDE indicator will stay lit until the problem is resolved. Action: Your immediate response is required.
  • Page 37 • Monitoring of your implanted device was suspended through the LATITUDE system. The Call Doctor icon and LATITUDE indicator will stay lit until the problem is resolved. Action: Call your health care provider. Communicator Patient Manual ®...
  • Page 38 Call Doctor Icon Lit LATITUDE Indicator Not Lit Description: The Call Doctor icon is lit yellow, and the LATITUDE indicator is not lit. This indicates your Communicator may not be working properly. Action: You may need a replacement Communicator. Contact your health care provider.
  • Page 39: Wave Indicator Colors

    Wave sections. Wave indicators light 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. Note: In addition to the Wave indicators lighting yellow to indicate an error, the LATITUDE indicator lights yellow at the same time.
  • Page 40 (1 m) of the Communicator. To verify that troubleshooting was a success: • Press the Heart button to start another interrogation. If the interrogation was a success, all three Collecting Waves will light green for 2 minutes. Communicator Patient Manual ® LATITUDE...
  • Page 41 Communicator. To verify that troubleshooting was a success: • Press the Heart button to start another interrogation. If the interrogation was a success, all three Collecting Waves will light green for 2 minutes. Communicator Patient Manual ® LATITUDE...
  • Page 42 • Do not press the Heart button while the interrogation is in progress unless you intend to stop the interrogation. • If you see three yellow waves after pressing the Heart button, contact your health care provider. Communicator Patient Manual ® LATITUDE...
  • Page 43 One Yellow Sending Wave Description: 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.
  • Page 44 If using the LATITUDE Cellular Data Plan: • If you have not activated the LATITUDE Cellular Data Plan, see page 40. • Make sure the USB cellular adapter is plugged into the Communicator. • Move the Communicator to another location that may have better cellular reception.
  • Page 45 Two Yellow Sending Waves Description: An attempt to connect to the LATITUDE system failed due to connection issues relating to the landline telephone or cellular network. If using a landline telephone connection, another device (telephone, answering machine, or computer) may be using or attempting to use the telephone line.
  • Page 46 Refer to “Confi rming Switch Settings” on page 9. If using the LATITUDE Cellular Data Plan: • If you have not activated the LATITUDE Cellular Data Plan, see page 40.
  • Page 47 Sending Waves light green and show progress. • If you see three yellow waves after trying the above action, your Communicator may not be set up correctly in the LATITUDE system. Contact your health care provider. Communicator Patient Manual ® LATITUDE...
  • Page 48: Latitude Cellular Data Plan

    LATITUDE Cellular Data Plan 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.
  • Page 49: Activating The Latitude Cellular Data Plan

    Activating the LATITUDE Cellular Data Plan Contact LATITUDE Patient Services at 1-866-484- 3268 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...
  • Page 50: Discontinuing Your Latitude Cellular Data Plan

    Discontinuing Your LATITUDE Cellular Data Plan Contact LATITUDE Patient Services to discontinue use of the LATITUDE Cellular Data Plan. Your subscription will automatically be discontinued if you miss two or more payments. 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.
  • Page 51: Interrogating Your Implanted Device

    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. Communicator Patient Manual ® LATITUDE...
  • Page 52: Interrupted Electrical Power

    Communicator automatically calls the LATITUDE system. This is done to check for a change in the number of manual interrogations allowed or to check if this feature has been re-enabled.
  • Page 53: Checking That The Communicator Can Connect To The Latitude System

    Status button long enough. Pressing the Status button for less than 3 seconds displays the status of the last interrogation and the status of the last attempt to connect to the LATITUDE system. 3. Watch the front of the Communicator. The Sending...
  • Page 54: Traveling With Your Communicator

    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 45. Communicator Patient Manual ® LATITUDE...
  • Page 55: Communicator Use Of The Telephone System

    Communicator Use of the Telephone System The Communicator makes telephone calls when there is a need to send data to the LATITUDE system. These calls usually last for approximately 5 minutes. The Communicator can only make outgoing calls. It cannot receive calls. The Communicator is designed...
  • Page 56: Using The Telephone While The Communicator Is Making A Call

    DSL fi lter to use the Communicator. If you use a dual-port DSL fi lter, connect the Communicator to the port labeled PHONE or where you would typically connect a telephone. For assistance, contact your DSL service provider or LATITUDE Patient Services at 1-866-484-3268. Communicator Patient Manual ®...
  • Page 57: Care And Maintenance

    • 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. Communicator Patient Manual ® LATITUDE...
  • Page 58: Cleaning The Communicator And Accessories

    Never spray any cleaning fl uid directly on the Communicator front lens. Do not allow moisture to accumulate on or around the lens or Heart button. • Avoid using any cleaning fl uid near the electrical plugs on the back of the Communicator. Communicator Patient Manual ® LATITUDE...
  • Page 59: Returning, Replacing, Or Disposing Of The Communicator Or Usb Cellular Adapter

    • Puerto Rico, Canada, or Mexico: Do not dispose of the Communicator or adapter. Contact your health care provider to learn how to return it. Your Communicator may contain encrypted health data. Dispose of it only as described above. Communicator Patient Manual ® LATITUDE...
  • Page 60: Setting Switches For Pbx Or Dial-Out Numbers

    Switch settings for different dial-out numbers are shown in Figure 8. Refer to “Confi rming Switch Settings” on page 9 for information on switches 4-8. Dial-out Dial-out Number Number None Figure 8. Dial-out number switch settings Communicator Patient Manual ® LATITUDE...
  • Page 61: Connecting The Usb Sensor Adapter

    Connecting the USB Sensor Adapter 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 9. Figure 9. USB sensor adapter connection 1.
  • Page 62: Specifi Cations

    Analog Dialing Mode: Tone Operating 41° F to 104° F (5° C to 40° C) Temperature: Storage and Transport -13° F to 158° F Temperature: (-25° C to 70° C) Operating Humidity: 15% to 93% noncondensing Communicator Patient Manual ® LATITUDE...
  • Page 63 Type: (Amplitude-Shift keying) Effective Radiated Power: <-1.25 dBm (0.75 mW) Communicator Implanted Device Radio (Model 6290): Receive Bandwidth: <300 kHz MICS/MedRadio: 402-405 MHz Modulation Transmit Type: (Frequency-Shift keying) Effective Radiated Power: <-16 dBm (25 μW) Communicator Patient Manual ® LATITUDE...
  • Page 64 USB Sensor Adapter: 2.4 GHz wireless USB dongle Delta Mobile Systems Model DM210 ® Boston Scientifi c Model 6454 (included with LATITUDE weight scale and blood pressure monitor) Operational Frequency: 2400.0 to 2480.0 MHz Modulation Type: Adaptive Frequency Hopping Effective Radiated...
  • Page 65 LATITUDE NXT USB Cellular Adapter (Model 6295): TX 824-849 MHz GSM-850: RX 869-894 MHz Effective Radiated Power: 22.93 dBm 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...
  • Page 66: Safety And Standards Compliance

    • The use of accessories and cables other than those specifi ed may result in increased emissions or decreased immunity of the LATITUDE Communicator. • Keep your Communicator and all accessories out of the reach of small children and pets.
  • Page 67 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 identifi er. The digits represented by ## are the REN. Communicator Patient Manual ® LATITUDE...
  • Page 68 Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. Communicator Patient Manual ® LATITUDE...
  • Page 69 Contact the state public utility commission, public service commission or corporation commission for information. • This equipment has been tested and found to comply with applicable safety portions of the AAMI ES 60601-1:2005, CAN/CSA-C22.2 NO. 60601-1:08 and IEC 60601-1:2005 standards. Communicator Patient Manual ® LATITUDE...
  • Page 70 16 of IEC 60601-1:2005. If in doubt, consult the technical service department or your local representative. Communicator Patient Manual ® LATITUDE...
  • Page 71: Essential Performance

    • 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. • Communicate measurements and alert conditions from optional health monitoring equipment to the LATITUDE system.
  • Page 72 Communicator Patient Manual ® LATITUDE...
  • Page 73: Electromagnetic Emissions And Immunity

    The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment. b. The LATITUDE Communicator is also compliant with IEC 60601-1- 2:2007.
  • Page 74 Surge ±1 kV ±1 kV Mains power quality (IEC differential differential should be that of a 61000-4-5) mode mode typical commercial or hospital environment. ±2 kV ±2 kV common common mode mode Communicator Patient Manual ® LATITUDE...
  • Page 75 The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment. b. U is the AC main’s voltage prior to application of the test level.
  • Page 76 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...
  • Page 77 The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment. At 80 MHz and 1 GHz, the higher frequency range applies.
  • Page 78 To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the LATITUDE Communicator is used exceeds the applicable RF compliance level above, the LATITUDE Communicator should be observed to verify normal operation.
  • Page 79 Communicator Patient Manual ® LATITUDE...
  • Page 80: Software

    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. Communicator Patient Manual ® LATITUDE...
  • Page 81 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 water. Light rain proof. Communicator Patient Manual ® LATITUDE...
  • Page 82 Indicates this product has passed a comprehensive testing procedure and the production plant is regularly monitored as certifi ed by a Nationally Recognized Testing Laboratory Temperature range limits Humidity range limits Atmospheric pressure range limits Communicator Patient Manual ® LATITUDE...
  • Page 84 Boston Scientific 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 © 2013 Boston Scientific Corporation or its affiliates. All rights reserved. 359081-001 ENES US 2013-07 *359081-001*...

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