Boston Scientific CRM629913 6299 User Manual 359165 001 US ClinicianManual
Boston Scientific Corporation 6299 359165 001 US ClinicianManual
User Manual
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| Date Submitted | 2013-09-19 00:00:00 |
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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.book Page 2 Thursday, July 18, 2013 8:23 AM 359165-001_US ClinicianManual.book Page 1 Thursday, July 18, 2013 8:23 AM Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How the System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LATITUDE Consult™ Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Powering up the Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Initial Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Reading Data from the Patient’s Implanted Device . . . . . . . . . . . . . . . . . . . 10 Sending (Transmitting) the Patient’s Implanted Device Data . . . . . . . . . . . 11 Reviewing Transmitted Device Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning the Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Returning, Replacing, or Disposing of the Communicator . . . . . . . . . . . . . Software Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 13 14 14 APPENDIX A: Communicator Technical Specifications . . . . . . . . . . . . . . . 15 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 APPENDIX B: Communicator Standards Information . . . . . . . . . . . . . . . . . 17 Safety and Standards Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . 19 APPENDIX C: Symbols on Packaging, Device, and Accessories . . . . . . . 25 Clinician User Manual - 1 359165-001_US ClinicianManual.book Page 2 Thursday, July 18, 2013 8:23 AM 2 - Clinician User Manual 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. This literature is intended for use by health care providers of the LATITUDE Consult Communicator System. How the System Works The LATITUDE Consult Communicator is used to read data from a patient's implanted device via a telemetry wand placed over the patient's device. Once the data is read, the clinician uses the Communicator to send the data to the secure LATITUDE Consult server. The clinician then contacts Boston Scientific to request a review of the data and optionally obtain reports. LATITUDE Consult is a trademark of Boston Scientific or its affiliates. Clinician User Manual - 3 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. Warnings The Communicator is MR (Magnetic Resonance) Unsafe. The Communicator is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices1. Under no circumstances should the Communicator be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas. Precautions In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call LATITUDE Consult Technical Services at 1-800-CARDIAC (227-3422) after sending the data. Adverse Effects None known. System Limitations This system is intended for use by health care providers in a health care facility. As appropriate, clinical care needs to be provided to the patient, separate from the use of the Communicator. The LATITUDE Consult system can only read data from an implanted device and cannot reprogram, command lead tests, or change any functions of the implanted device. Therefore, LATITUDE Consult Communicator interrogations are not intended to be used in place of inoffice follow ups that involve programming of the implanted device (e.g., changing device settings) or commanding lead tests (e.g., pacing threshold test). The implanted device can only be programmed with a Programmer/ Recorder/Monitor (PRM). There are many internal and external factors that can hinder, delay, or prevent reading and sending implanted device information. These factors include: 1. American College of Radiology (ACR), AJR June 2007;188:1-27 4 - Clinician User Manual 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. • • • Delays in contacting clinicians may occur for a variety of reasons including fax and computer equipment that may be down or offline, and the unavailability of health care staff. • To read or send implanted device data, the Communicator must be plugged into an electrical outlet. The Communicator also needs an analog line to send (transmit) data to the remote, secure server. Equipment. Reading or sending implanted data can be prevented due to: • The implanted device cannot establish and complete a telemetry (reading implanted device data) session • The Communicator is damaged or malfunctions Data processing. Sending implanted device data can be delayed or prevented due to: • Temporary, scheduled, and unscheduled downtime of computer servers • Variations in server loads and processing times • Other data processing issues NOTES: • The system does not provide continuous real-time monitoring. • The LATITUDE Consult Communicator is non-sterile equipment. DO NOT STERILIZE. The wand must be contained in a sterile barrier to be used in the sterile field. • The Communicator is designed for use only in the United States. Use of the Communicator in other countries is restricted. Clinician User Manual - 5 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. The Communicator is a portable device which can be used provided there is an accessible AC power outlet available. When the Communicator has completed collecting data from the implantable system, it can be unplugged without losing data, and used in another location with an accessible analog line and AC power outlet. The Communicator is designed to operate on standard analog lines, such as those used by many fax machines. The Communicator may work on other telephone systems, such as Digital Subscriber Line (DSL) and Voice Over IP (VoIP), if those systems provide an analog interface for connecting the Communicator. If you have Digital Subscriber Line (DSL) Internet service provided through your telephone lines, you may need to install a DSL filter between the wall phone jack and the LATITUDE Communicator. Due to the size and portability of the Communicator, it is recommended that it be placed in an area that is secure. Figure 1 and Table 1 identify the main parts of the Communicator. Figure 1. Communicator (front and rear views) 6 - Clinician User Manual 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. Respond to on-screen instructions or questions by touching the screen with a fingertip. Do not use tools or sharp objects as they can damage the touch screen. If the Communicator touch screen is dim* (black), simply touch any part of the screen to illuminate the screen. * After a period of non-use, the Communicator enters a power-saving mode and the LCD screen dims. C Indicator Light (oval) Press to illuminate the LCD touch screen when it is dim (black). The Indicator Light is lit or flashes when there are messages or instructions to follow: • White Light Blinking - Notification that clinician action is required: • Implanted device is out of range: While reading implanted device data, the indicator will blink if communication with the implanted device has been lost. If this occurs, move the wand closer to the implanted device, the flashing should stop, and reading should resume. • Reading of implanted device data is complete and ready to send. • No dial tone or other issue with analog line when attempting to connect to the server. • Waiting for confirmation to erase implanted device data. • Solid White - Implanted device data has been successfully sent. Call Boston Scientific at 1-800-227-3422 to request a LATITUDE Consult review of the implanted device data. • Yellow Light - Notification that an error has occurred that requires clinician attention: • Blinking Yellow Reading of implanted device data was unsuccessful. - or Sending of implanted device data was unsuccessful. • Solid Yellow - Communicator error, call Boston Scientific at 1-800-227-3422. D Power Light (round, green) – Indicates the Communicator is connected to power. E Wand Cradle – Place the telemetry wand in the cradle when not in use. F Telemetry Wand The telemetry wand is used to read the data from the patient's implanted device. The telemetry wand should remain in the cradle when not in use. G Power Input jack – Connection for the Communicator’s power supply. H Connection to telephone or fax machine The Communicator and a telephone/fax can share the same telephone wall jack. To do this, connect the telephone or fax machine to this jack on the back of the Communicator. I Connection to telephone wall jack Connect one end of the telephone cord to this jack and the other end to a telephone wall jack that supports an analog line. Clinician User Manual - 7 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. Plug the power supply into an electrical outlet that is easily accessible. 3. Make sure the green power light on the Communicator is On (see Figure 1 on page -6). • If the power light is not On, check that both ends of the power supply are plugged in firmly (steps 1 and 2). 8 - Clinician User Manual 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. Press OK to confirm and continue. 5. If the analog line has a PBX prefix (the number to dial to get an outside to display the two phone line choices. line), press the or icons on the screen to display the desired prefix number. Press OK to confirm the selection. NOTE: If there is no PBX prefix, just press OK when the default selection for No PBX displays. 6. Press the Home icon to return to the Home screen. The settings are saved in the Communicator. The analog line is now configured and ready for use. 2. PBX - private branch exchange; a private telephone network used within an enterprise. Clinician User Manual - 9 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. Have the patient sit or lie down in a comfortable position where the wand can reach and the Communicator screen can be viewed. 3. Place the telemetry wand over the patient’s implanted device and keep it in place until the reading is complete. 4. Press the patient icon on the Home screen to begin reading data from the patient’s implanted device. NOTE: If the wand moves away from the implanted device during the reading process, the Communicator displays a message to reposition the wand. Once communication is restored, reading of the implanted device data automatically continues. 5. When the Communicator finishes reading the implanted device data, Continue the Continue button will be displayed. Place the wand back in the cradle and see the next section for Sending data. NOTES: • If the reading of the implanted device data is unsuccessful and a retry is not successful, call Boston Scientific at 1-800-CARDIAC (227-3422). • A patient's implanted device data remains on the Communicator until it is sent or erased. It must be either sent or erased before another patient’s implanted device data can be read. • To erase the implanted device data from the Communicator, press the Erase Data icon from the Home screen. Once it is erased, this data will not be recoverable from the Communicator. 10 - Clinician User Manual 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. If the data has been read from the patient's implanted device and the Communicator has remained powered On, press the Continue button to begin sending. Then, continue with step 6. 5. If the Communicator was unplugged after reading the implanted device data and then powered back On, press the send icon the Home screen to begin sending the data. on NOTE: Do not disconnect the power or phone cord until the data has been sent. If either cord becomes disconnected, simply reconnect it and retry sending the data. Implanted device data will not be lost. 6. When the implanted device data has been sent, press the Done icon NOTES: • If the sending of the implanted device data is unsuccessful and a retry is not successful, call Boston Scientific at 1-800-CARDIAC (227-3422). • As soon as the patient’s implanted device data has been successfully sent, that data is erased from the Communicator. • The Communicator and a telephone or fax machine can share the same wall jack. To continue to use the telephone or fax machine, plug its telephone cord into the jack with the telephone icon located on the back of the Communicator. The Communicator is designed to relinquish the line when a connected fax/telephone is used. If the Communicator does not relinquish the line (e.g. restore dial tone), unplug the Communicator from electrical power. The Communicator can be plugged back in after the line has been used. • Occasionally, a software upgrade might be available for the Communicator unit, in which case the touch screen will display that a software upgrade is in progress. Do not unplug the power cord or the phone cord until the update has completed. Clinician User Manual - 11 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. The following is a list of the available optional reports: • Transmission Report • Quick Notes Report • Combined Follow-up Report • Presenting EGM Report • Arrhythmia Logbook Report • Event Detail / Episodes Report • Device Settings Report The implanted device data in each report is current as of the time the device was read, which can include up to 12 months of device/lead trend data and the most recent 72 hours of stored episodes. The LATITUDE Consult system collects data that are protected health information. Designated Boston Scientific personnel have access to this data. In certain circumstances, Boston Scientific may contact clinician(s) regarding data received and/or Communicator status. 3. Adobe Acrobat Reader® program or compatible PDF viewer is required to view reports that are created in Portable Document Format (PDF). 12 - Clinician User Manual 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. (The normal power-up process verifies that the Communicator has passed its internal checks and is ready for use.) CAUTIONS: • Do not drop or mishandle the Communicator in a manner that would cause damage. • Avoid getting liquid on the unit other than cleaning it as recommended. Do not use abrasive cloth or solvents to clean the unit. • Do not submerge the Communicator in liquid. • Do not attempt to open the Communicator. The Communicator contains no user-accessible fuses or batteries. • Use this unit as described in this clinician manual. Use only authorized parts and accessories. Do not attempt to modify or alter this unit or accessories. If the Communicator becomes damaged or malfunctions, contact Boston Scientific at 1-800-CARDIAC (227-3422). • The Communicator is not waterproof or explosion-proof and cannot be sterilized. Do not use it in the presence of flammable gas mixtures including anesthetic mixture with air, oxygen, or nitrous oxide. Cleaning the Communicator When necessary, clean the Communicator housing and touch screen with a soft, clean, lint-free cloth moistened in water, isopropyl alcohol, or mild detergent. Note that the finish on some types of furniture could be affected as a result of continuous contact with rubber material such as the type used on the base of the Communicator. CAUTIONS: • Do not use other cleaning fluids. They may damage the Communicator touch screen. Never spray any cleaning fluid directly on the Communicator touch screen. Do not allow moisture to accumulate on or around the buttons. • Avoid using any cleaning fluid near the electrical or phone jacks on the back of the Communicator. Clinician User Manual - 13 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. Software Maintenance If a software upgrade is available, it will be automatically installed on the Communicator immediately after sending implanted device data. • If there is implanted device data on the unit from a previously un-sent transmission, the data will be sent automatically before the upgrade is installed. • If this data is not to be sent, it must be erased before checking for upgrades by pressing the Erase data icon and following the prompts. from the Home screen To manually check for software upgrades, perform the following: 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. 4. From the Home screen, press the gear icon Settings screen. 5. Press the upgrade icon prompts. 6. When the upgrade is complete, press the Done icon to display the to connect to the server and follow the NOTE: Do not disconnect the power or phone cord until the upgrade is complete. If either cord becomes disconnected, simply reconnect it and retry the manual upgrade check. 14 - Clinician User Manual 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, 18.0 W, AC adapter, Globtek model GTM41061-1818-3.0 (included) Supply Mains Isolation: AC adapter plug Protection against electrical shock: Class II Minimum Operational Loop Current: 20 mA Expected Service Life: 15 years Duty Cycle: Continuous Safety Classification of Ports: RJ11 ports: TNV-3 circuit Operating Temperature: 50° F to 95° F (10° C to 35° C) Wand Temperature: 34° F [1° C] (typical) to 48° F [9° C] (maximum) above operating temperature Storage and Transport Temperature: -22° F to 158° F (-30° C to 70° C) Operating Humidity: 25% to 75% Storage and Transport Humidity: 25% to 95% Storage and Transport Pressure: 50 to 106 kPa Altitude Rating: ≤ 2,000 m Protection Against Ingress of Water: IPX0 Ordinary equipment Clinician User Manual - 15 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 +/- 11.4 kHz Modulation Transmit Type: OOK (On-Off keying) Effective Radiated Power: ≤ 5.32 μW (@ 300 m) Phone Line: Analog line with Pulse or Tone dialing Software 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, the complete Corresponding Source code may be obtained from us for a period of three years after our shipment of this product. The software is based in part of the work of the FreeType Team. 16 - Clinician User Manual 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. • The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the Communicator. Using accessories and cables supplied with the Communicator in other medical equipment and systems may result in increased emissions or decreased immunity of the other medical equipment or systems. • Do not insert anything other than a telephone connector into the telephone jacks on the back of the Communicator. There can be voltage on the electrical contacts in the connector, and there is potential to receive a shock. CAUTION: Once the Communicator is connected to the telephone wall jack, the second telephone jack on the back of the Communicator becomes a live jack. Avoid contact inside this telephone jack if it is not being used. • Accessory equipment connected to the Communicator must be certified according to the respective standards. Anyone connecting such accessories to the Communicator may be configuring a medical system and is responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems. • A plug and jack used to connect this equipment to the premises wiring and telephone network must comply with the applicable FCC Part 68 rules and requirements adopted by the ACTA. A compliant telephone cord and modular plug is provided with this product. It is designed to be connected to a compatible modular jack that is also compliant. See installation instructions for details. • Other wireless communication equipment could interfere with the Communicator even if the other equipment complies with CISPR (Special International Committee on Radio Interference) emission requirements. • The telephone company may make changes in its facilities, equipment, operations or procedures that could affect the operation of the Clinician User Manual - 17 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. Also, you will be advised of your right to file a complaint with the FCC if you believe it is necessary. • If trouble is experienced with the Communicator, for repair or warranty information, please contact Boston Scientific at 1-800-227-3422. If the equipment is causing harm to the telephone network, the telephone company may request that you disconnect the equipment until the problem is resolved. • If the facility has specially wired alarm equipment connected to the telephone line, ensure the installation of the Communicator does not disable the alarm equipment. If there are questions about what will disable alarm equipment, consult the telephone company or a qualified installer. • Do not use the Communicator adjacent to or stacked with other equipment. If it is necessary to use the Communicator adjacent to or stacked with other equipment, please contact Boston Scientific at 1800-227-3422 to verify normal operation. • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • This equipment complies with Part 68 of the FCC rules and the requirements adopted by the ACTA. On the [insert location of the label] of this equipment is a label that contains, among other information, a product identifier in the format US:AAAEQ##TXXXX. If requested, this number must be provided to the telephone company. The Ringer Equivalence Number (REN) for this product is part of the product identifier. The digits represented by ## are the REN. The REN is used to determine the number of devices that may be connected to a telephone line. Excessive RENs on a telephone line may result in the devices not ringing in response to an incoming call. In most but not all areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. The REN for this product is 0.0. • 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. 18 - Clinician User Manual 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. • The LATITUDE Consult Communicator has the ability to: • Communicate with a Boston Scientific implanted device • Communicate implanted device data to the LATITUDE Consult System • Receive configuration updates from the LATITUDE Consult System Electromagnetic Emissions and Immunity Table 1. Guidance and manufacturer’s declaration—electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions 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. Emissions test Compliance Electromagnetic environment—guidance RF emissions CISPR 11 Group 1 The Model 6299 LATITUDE Consult Communicator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A Harmonic emissions IEC 61000-3-2 Class A The Model 6299 LATITUDE Consult Communicator is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies Clinician User Manual - 19 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment— guidance Electrostatic ±6 kV contact discharge (ESD) ±8 kV air IEC 61000-4-2 ±8 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines IEC 61000-4-4 ±1 kV for input/ output lines ±1 kV for input/ output lines Surge ±1 kV differential mode ±1 kV differential Mains power quality should be that of a typical mode commercial or hospital ±2 kV common environment. mode IEC 61000-4-5 ±2 kV common mode Voltage dips, short interruptions, and voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle Mains power quality should be that of a typical commercial or hospital environment. 70% UT (30% dip in UT) for 25 cycles <5% UT Mains power quality should (>95% dip in UT) be that of a typical commercial or hospital for 0.5 cycle environment. If the user of the LATITUDE Consult 40% UT Communicator requires (60% dip in UT) continued operation during for 5 cycles power mains interruptions, it is recommended that the LATITUDE Consult 70% UT (30% dip in UT) Communicator be powered from an uninterruptible for 25 cycles power supply or a battery. <5% UT (>95% dip in UT) for 5 sec <5% UT (>95% dip in UT) for 5 sec 3 A/m 30 A/m 40% UT (60% dip in UT) for 5 cycles IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field ±15 kV air IEC 61000-4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. 20 - Clinician User Manual 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. Immunity test IEC Compliance 60601 level test level Electromagnetic environment—guidance Portable and mobile RF communications equipment should be used no closer to any part of the LATITUDE Consult Communicator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distances: Conducted RF IEC 610004-6 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 610004-3 3 V/m 80 MHz to 2.5 GHz 3 Vrms d =1.7 √P 10 Vrms in ISM and amateur radio bandsc between 150 kHz and 80 MHz 10 V/m (80 MHz to 1000 MHz) d = 0.5 √P (80 MHz to 1000 MHz) 17 V/m (380 MHz to 390 MHz) d = 0.29 √P (380 MHz to 390 MHz) 14 V/m (430 MHz to 470 MHz) d = 0.36 √P (430 MHz to 470 MHz) 24 V/m (800 MHz to 960 MHz) d = 0.21 √P (800 MHz to 960 MHz) 3 V/m (1 GHz to 2.7 GHz) d = 1.7 √P (1 GHz to 2.7 GHz) 24 V/m (1.7 GHz to 1.99 GHz) d = 0.21 √P (1.7 GHz to 1.99 GHz) 24 V/m (2.4 GHz to 2.57 GHz) d = 0.21 √P (2.4 GHz to 2.57 GHz) 8 V/m (5.1 GHz to 5.8 GHz) d = 0.63 √P (5.1 GHz to 5.8 GHz) Clinician User Manual - 21 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. Immunity test IEC Compliance 60601 level test level Electromagnetic environment—guidance where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTE 3 The recommended separation distance is calculated using the formula d = [5/E1] √P. 22 - Clinician User Manual 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. Immunity test IEC Compliance 60601 level test level Electromagnetic environment—guidance a.Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 6299 LATITUDE Consult Communicator is used exceeds the applicable RF compliance level above, the Model 6299 LATITUDE Consult Communicator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Model 6498 LATITUDE Communicator. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. c. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 150 kHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz. Clinician User Manual - 23 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. The customer or the user of the LATITUDE Consult Communicator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LATITUDE Consult Communicator as recommended below, according to the maximum output power of the communications equipment. Rated Separation distance according to frequency of transmitter (meters) maximum output 150 kHz 80 MHz to 380 MHz 430 MHz 800 - 960 1 GHz to 5.1 GHz power of to 2.7 GHz to 5.8 1000 MHz to 390 to 470 MHz trans80 MHz MHz GHz MHz 1.7 - 1.99 mitter (W) d = 1.7 √P d = 0.5 √P GHz d = 1.7 √P d = 0.29 √P d = 0.36 √P d = 0.63 √P 2.4 - 2.57 GHz d = 0.21 √P 0.01 0.17 0.050 0.029 0.36 0.021 0.17 0.063 0.1 0.54 0.16 0.092 0.11 0.066 0.54 0.20 1.7 0.50 0.29 0.36 0.21 1.7 0.63 10 5.4 1.6 0.92 1.1 0.66 5.4 2.0 100 17 5.0 2.9 3.6 2.1 17 6.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTE 3 The recommended separation distance is calculated using the formula d =[5/E1] √P. 24 - Clinician User Manual 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. Symbols on Packaging, Device, and Accessories Symbol Meaning Do not use if package is damaged Date of manufacture Follow instructions for use Manufacturer MR Unsafe Non-ionizing radiation TUV (Technischer Überwachungs-Verein) mark Type B applied part (telemetry wand) WEEE symbol (waste of electrical and electronic equipment) Do not throw in the trash. Analog line connection jack on Communicator Telephone/fax connection jack on Communicator Clinician User Manual - 25 359165-001_US ClinicianManual.book Page 26 Thursday, July 18, 2013 8:23 AM Table 1. Symbols on Packaging, Device, and Accessories (continued) Symbol Meaning Power input jack on Communicator 15 V Direct Current symbol on Communicator Symbols on power supply: Refer to Instructions 30 Standard of the electronics industry of the People’s Republic of China Indoor use only EISA Energy Star tier 2 Intertek S mark (Europe) Intertek ETL mark (North America) China Quality Certification (CQC) and Japan Product Safety Electric Appliance and Materials mark (PSE) Do not dispose of in trash Keep dry 26 - Clinician User Manual 359165-001_US ClinicianManual.book Page 27 Thursday, July 18, 2013 8:23 AM Table 1. Symbols on Packaging, Device, and Accessories (continued) Symbol Meaning Class II electrical device CE mark of conformity Voluntary Control Council for Interference by Information Technology Equipment (Japan) DC power jack Symbols on shipping carton: Temperature symbol on outer shipping carton Humidity symbol on outer shipping carton Pressure symbol on outer shipping carton Clinician User Manual - 27 359165-001_US ClinicianManual.book Page 28 Thursday, July 18, 2013 8:23 AM 28 - Clinician User Manual 359165-001_US ClinicianManual.book Page 29 Thursday, July 18, 2013 8:23 AM 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. 359165-001 EN US 2013-06 *359165-001*
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