359165-001_US ClinicianManual.book Page 1 Thursday, July 18, 2013 8:23 AM CLINICIAN USER MANUAL LATITUDE Consult™ System CAUTION: Federal (USA) law restricts this device to distribution and use by or on the lawful order of a physician.
359165-001_US ClinicianManual.
59165-001_US ClinicianManual.book Page 1 Thursday, July 18, 2013 8:23 AM Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How the System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
359165-001_US ClinicianManual.
359165-001_US ClinicianManual.book Page 3 Thursday, July 18, 2013 8:23 AM INTRODUCTION The LATITUDE Consult™ system provides clinicians a convenient and secure way to review data from a Boston Scientific implanted device. Intended Use The LATITUDE Consult system is intended to read data from a compatible Boston Scientific implanted device and transfer it to a central server. The LATITUDE Consult system can provide implanted device data that may be used as part of the clinical evaluation of the patient.
359165-001_US ClinicianManual.book Page 4 Thursday, July 18, 2013 8:23 AM Contraindications The LATITUDE Consult Communicator is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE Consult system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being read.
359165-001_US ClinicianManual.book Page 5 Thursday, July 18, 2013 8:23 AM • Telephone system. Variations in infrastructure compatibility among telephone service providers as well as variations in the quality of the telephone line from the health care facility to the telephone company equipment and switching stations can affect sending the LATITUDE Consult Communicator implanted device data. • Health Care environment.
359165-001_US ClinicianManual.book Page 6 Thursday, July 18, 2013 8:23 AM LATITUDE Consult™ Communicator A key component of the LATITUDE Consult system is the LATITUDE Consult Communicator. The Communicator is able to read data from an implanted Boston Scientific device, and then send that data to the LATITUDE Consult server through a standard analog line. The Communicator supports pulse and tone analog dialing modes.
359165-001_US ClinicianManual.book Page 7 Thursday, July 18, 2013 8:23 AM Table 1. Communicator components ▼Callout Description A Start Action button (round, blue) • Can be pressed to – start reading data from a patient's implanted device, send implanted device data to the server, or illuminate the LCD touch screen when it is dim (black). B Touch Screen • Gently touching the screen surface with a finger operates the touch screen.
359165-001_US ClinicianManual.book Page 8 Thursday, July 18, 2013 8:23 AM SETUP The following items are included with the Communicator: • Communicator unit with attached telemetry wand • Communicator telephone cord • Power supply • Clinician User Manual A 110 VAC outlet is needed to complete the setup. connecting a telephone is optional Figure 2. Connecting the Communicator Powering up the Communicator 1. Insert the power supply cord into the jack labeled as shown below. 15 V 2.
359165-001_US ClinicianManual.book Page 9 Thursday, July 18, 2013 8:23 AM Initial Configuration This needs to be performed only once, unless the Communicator is connected to an analog line with a different PBX2 prefix or dialing method. 1. From the Home screen, press the gear icon Settings screen. to display the 2. Press the phone icon 3. Press the Pulse (rotary dial) or Tone dialing icon to correspond to the dialing service of the analog line that will be used for sending implanted device data. 4.
359165-001_US ClinicianManual.book Page 10 Thursday, July 18, 2013 8:23 AM READING DATA FROM THE PATIENT’S IMPLANTED DEVICE NOTE: Should it be necessary to stop reading the patient’s implanted device for any reason, simply move the wand away from the device. Then cancel the operation on the Communicator screen. 1. Ensure that the Communicator is powered On. See “Powering up the Communicator” on page 8 for details. 2.
359165-001_US ClinicianManual.book Page 11 Thursday, July 18, 2013 8:23 AM SENDING (TRANSMITTING) THE PATIENT’S IMPLANTED DEVICE DATA 1. Ensure that the Communicator is powered On. See Figure 2 on page 8. 2. Plug one end of the Communicator telephone cord into the jack labeled on the back of the Communicator. 3. Plug the other end of the Communicator telephone cord into the analog wall jack such as those used by many fax machines. 4.
359165-001_US ClinicianManual.book Page 12 Thursday, July 18, 2013 8:23 AM REVIEWING TRANSMITTED DEVICE DATA Upon successful transmission of the implanted device data, to ensure review by Boston Scientific, call LATITUDE Consult Technical Services at 1-800-CARDIAC (227-3422) and request a LATITUDE Consult review of the implanted device data. Upon request, optional reports3 can be made available.
359165-001_US ClinicianManual.book Page 13 Thursday, July 18, 2013 8:23 AM CARE AND MAINTENANCE To ensure optimum performance of the Communicator and protect it from damage, follow these directions: Prior to each use, perform a visual inspection and verify the following: • Mechanical and functional integrity of the Communicator, cables, and power supply. • Legibility and adherence of the Communicator labels. • Appearance of Home screen after power is supplied to the Communicator.
359165-001_US ClinicianManual.book Page 14 Thursday, July 18, 2013 8:23 AM Returning, Replacing, or Disposing of the Communicator Do not dispose of the Communicator in the trash. If return or replacement is necessary, contact Boston Scientific at 1-800-CARDIAC (227-3422) for return and replacement instructions. The Communicator may contain encrypted personal health information.
359165-001_US ClinicianManual.book Page 15 Thursday, July 18, 2013 8:23 AM APPENDIX A: COMMUNICATOR TECHNICAL SPECIFICATIONS Specifications Table 1. LATITUDE Consult™ Communicator Specification Specification Value Model: 6299 LCD Display: Monochrome, 240 x 320 pixel, with touch screen control Dimensions: Length: 20.6 cm (8.1 in.) Width: 18.0 cm (7 in.) Height: 10.4 cm (4 in.) Weight: 0.78 kg (1.7 lb.) Power Source: 100-240 VAC, 47-63Hz Power Supply 15.0 VDC, 1.2 A, 18.
359165-001_US ClinicianManual.book Page 16 Thursday, July 18, 2013 8:23 AM Table 1. LATITUDE Consult™ Communicator Specification (continued) Specification Value Radio Frequency Transmitters: Bluetooth® Radio Operational Frequency: 2402.0 to 2480.0 MHz Modulation Type: Adaptive Frequency Hopping Effective Radiated Power: 13.82 dBm (24 mW) Implanted Device (PG) Radio Receive Bandwidth: 10kHz to 110 kHz Receive Frequencies: 2.8 kHz / 56.9 kHz / 102.4 kHz Transmit Frequency: 57.0 kHz +/- 11.
359165-001_US ClinicianManual.book Page 17 Thursday, July 18, 2013 8:23 AM APPENDIX B: COMMUNICATOR STANDARDS INFORMATION This appendix provides LATITUDE Consult™ Communicator (Model 6299) instructions for use information that is required by applicable standards and regulations. Safety and Standards Compliance • Changes or modifications not expressly approved by Boston Scientific could void the user’s authority to operate this equipment.
359165-001_US ClinicianManual.book Page 18 Thursday, July 18, 2013 8:23 AM equipment. If this happens the telephone company will provide advance notice in order to make necessary modifications to maintain uninterrupted service. • If the Communicator causes harm to the telephone network, the telephone company will notify you in advance that temporary discontinuance of service may be required. But if advance notice isn't practical, the telephone company will notify the customer as soon as possible.
359165-001_US ClinicianManual.book Page 19 Thursday, July 18, 2013 8:23 AM • This equipment has been tested and found to comply with the following EMC standards: IEC 60601-1-2:2007. • The LATITUDE Consult Communicator does not provide any performance which is essential to maintain freedom from unacceptable risk as defined by IEC 60601-1:2005.
359165-001_US ClinicianManual.book Page 20 Thursday, July 18, 2013 8:23 AM Table 2. Guidance and manufacturer’s declaration—electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Model 6299 LATITUDE Consult™ Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6299 LATITUDE Consult Communicator should assure that it is used in such an environment.
359165-001_US ClinicianManual.book Page 21 Thursday, July 18, 2013 8:23 AM Table 3. Guidance and manufacturer’s declaration—electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Model 6299 LATITUDE Consult™ Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6299 LATITUDE Consult Communicator should assure that it is used in such an environment.
359165-001_US ClinicianManual.book Page 22 Thursday, July 18, 2013 8:23 AM Table 3. Guidance and manufacturer’s declaration—electromagnetic immunity (continued) Guidance and manufacturer’s declaration – electromagnetic immunity The Model 6299 LATITUDE Consult™ Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6299 LATITUDE Consult Communicator should assure that it is used in such an environment.
359165-001_US ClinicianManual.book Page 23 Thursday, July 18, 2013 8:23 AM Table 3. Guidance and manufacturer’s declaration—electromagnetic immunity (continued) Guidance and manufacturer’s declaration – electromagnetic immunity The Model 6299 LATITUDE Consult™ Communicator is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 6299 LATITUDE Consult Communicator should assure that it is used in such an environment.
359165-001_US ClinicianManual.book Page 24 Thursday, July 18, 2013 8:23 AM Table 4. Recommended separation distances between portable and mobile RF communications equipment and the LATITUDE Consult™ Communicator Recommended separation distances between portable and mobile RF communications equipment and the LATITUDE Consult Communicator The LATITUDE Consult Communicator is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled.
359165-001_US ClinicianManual.book Page 25 Thursday, July 18, 2013 8:23 AM APPENDIX C: SYMBOLS ON PACKAGING, DEVICE, AND ACCESSORIES This appendix provides explanations of the symbols used on the LATITUDE Consult™ Communicator, its packaging, and its accessories. Table 1.
359165-001_US ClinicianManual.book Page 26 Thursday, July 18, 2013 8:23 AM Table 1.
359165-001_US ClinicianManual.book Page 27 Thursday, July 18, 2013 8:23 AM Table 1.
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359165-001_US ClinicianManual.book Page 30 Thursday, July 18, 2013 8:23 AM Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA 1.800.CARDIAC (227.3422) +1.651.582.4000 www.bostonscientific.com © 2013 Boston Scientific Corporation or its affiliates. All Rights Reserved.
