4-9-08 Draft User’s Manual Merlin™@home Transmitter Model EX1150
4-9-08 Draft CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. © 2008 St. Jude Medical Cardiac Rhythm Management Division. All Rights Reserved. Unless otherwise noted, ® or ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical, Inc. or its subsidiaries.
4-9-08 Draft Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 What does the Merlin™@home transmitter do? . . . . . . . . . . . . . . . . 1 How does the Merlin™@home transmitter affect your telephone? . . 1 Can you use the transmitter while traveling?. . . . . . . . . . . . . . . . . . . 2 Important Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Setting up the transmitter . . . . . . . .
-9-08 Draft ii
Introduction 4-9-08 Draft Your doctor has given you the Merlin™@home transmitter that is part of the St. Jude Medical® Merlin@home Remote Monitoring System. This manual describes this system and explains how to set up and use the transmitter. What does the Merlin™@home transmitter do? The Merlin™@home transmitter conducts your Merlin@home session. During your Merlin@home session, the transmitter reads the data from your defibrillator and sends it to a server where your clinic can view it.
4-9-08 Draft Can you use the transmitter while traveling? Check with your doctor before traveling with the Merlin™@home transmitter. If he or she agrees that it is all right, carefully repackage the transmitter in its carrying case. You may want to purchase an RJ-11 telephone plug adapter in case you need to plug the transmitter into an older telephone wall jack. Note You can use the transmitter in the United States only.
4-9-08 Draft WARNING • For emergencies, call 911. • Do not spill any liquid on the transmitter. If you spill any liquid, unplug the transmitter and wipe the liquid off right away. Do not plug the transmitter in until it is completely dry. To reduce the risk of shock: • Do not use the transmitter while bathing. • Do not place or store the transmitter where it can fall or be pulled into a tub or sink. • Do not place or drop the transmitter into water or other liquid.
4-9-08 Draft Note • If your telephone is wired into the wall, you cannot use the transmitter unless you install standard telephone wall jacks. To do this, contact the telephone company for help. • If DSL shares your telephone line, contact your DSL service provider for a filter to prevent any possible interference. Plug the filter into the telephone wall jack and plug the phone line splitter into the filter. For more information on how to use the filter, contact your DSL service provider.
4-9-08 Draft Note Do not press the Start button while the Merlin@home transmitter is reading or sending your data. Scheduled session and device check Scheduled sessions and device checks occur automatically. Your schedule is defined by your clinician. Most often the data transfer occurs sometime during the night while you sleep. After setting up your Merlin@home transmitter, you don’t need to do anything for a scheduled session or a device check to occur.
4-9-08 Draft The transmitter does not contain any user-serviceable parts. Do not open the case. If there is a problem with the transmitter, contact ”Technical Service” (page 6) for a replacement. Glossary Clinic — The place that views your data after the Merlin™@home transmitter sends your data to the server. Data — The information stored in your defibrillator. The information includes your defibrillator’s type and serial number, settings, and battery status.
Symbols 4-9-08 Draft Definitions of globally recognized hardware, applied part, and packaging symbols required by regulatory authorities are described below. Symbol Description Manufacturer EC REP Authorized Representative in the European Community Refer to the instruction manual. Direct current. Equipment is suitable for alternating current only; identifies relevant terminals. To identify the terminals to which a telephone adapter is to be connected. Non-ionizing electromagnetic radiation.
4-9-08 Draft Technical Information The Merlin™@home transmitter is Class II medical equipment and complies with IEC60601-1:2005 and UL60601-1:2003 and CAN/CSAC22.2 No. 60601.1-M90. Note • There are no user-serviceable parts in the Merlin@home transmitter. No calibration is required. Do not modify the Merlin@home transmitter. • When used under normal operating circumstances, this equipment generates no pollution. Input/Output Rating Transmitter input 100-240 VAC, 50-60 Hz Power consumption 0.
4-9-08 Draft Telephone accessories Telephone accessories included with the transmitter are: • Telephone cable • Phone line splitter An optional telephone accessory is the Model EX 1151 USB cellular adapter. Electromagnetic Compatibility The Merlin™@home transmitter requires special precautions with regard to electromagnetic compatibility (EMC) and should be used in accordance with the information provided in this manual.
4-9-08 Draft Test Electrostatic Discharge (ESD) IEC 61000-4-2 IEC 60601 Test Level (Actual Level)1 ±6 kV contact (±6 kV contact) Electromagnetic Environment – Guidance None ±8 kV air (±8 kV air) Electrical fast transient/burst IEC 61000-4-4 ±1 kV for input/output lines (±1 kV for input/output lines) None Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8 3 A/m (3 A/m) None Table 6. Guidance and manufacturer’s declaration – electromagnetic immunity 1.
4-9-08 Draft Test IEC 60601 Test Level1 Immunity Compliance Level Electromagnetic Environment – Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Merlin@home transmitter, including cables, than the recommended separation distance. Recommended separation distance: Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms d = 1.2 P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 Vrms d = 1.2 P (80 MHz to 800 MHz) d = 2.3 P (800 MHz to 2.
4-9-08 Draft Note The Merlin@home transmitter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Merlin@home transmitter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Merlin@home transmitter as recommended below in Table 8, according to the maximum output power of the communications equipment.
4-9-08 Draft Radio Frequency Information MICS band: 402-405 MHz. The effective radiated power is below the limits as specified in: • Europe: EN ETSI 301 839-2 • USA: FCC 47 CFR Part 95.601-95.673 Subpart E, 95.1201-95.1219 Subpart I 2.45 GHz. The effective radiated power is below the limits as specified in: • Europe: EN ETSI 300 328 • USA: FCC 47 CFR Part 15.249 Note Maintain a reasonable distance between other electronic equipment and the Merlin™@home transmitter.
4-9-08 Draft FCC Information This equipment complies with Part 68 of the FCC rules and the requirements adopted by the ACTA. On the exterior of this equipment is a label that contains, among other information, a product identifier in the format: Antenna: US: RIASJMRFANT Modem: US: 3A4M508BSM2-T-W If requested, this number must be provided to the telephone company.
4-9-08 Draft Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Warranty 4-9-08 Draft St. Jude Medical warrants that for a period of one year following delivery to the original purchaser, the Merlin™@home Transmitter will be free from defects in materials and workmanship. This warranty does not cover damage due to external causes, including but not limited to accident, electrical power problems, servicing not authorized by St. Jude Medical, usage not in accordance with product instructions, failure to perform required preventive maintenance, abuse, and misuse.
4-9-08 Draft
4-9-08 Draft Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 Veddestavägen 19 SE-175 84 Järfälla Sweden +46 8 474 4000 701 E.
