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Related Manuals for St. Jude Medical Merlin@home EX1150
Summary of Contents for St. Jude Medical Merlin@home EX1150
- Page 1 Merlin@home™ Transmitter Model EX1150 User’s Manual...
- Page 2 ST. JUDE MEDICAL and the nine-squares symbol are registered trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2013 St. Jude Medical, Inc. All Rights Reserved. Unless otherwise noted, ™ indicates that the name is a trademark of,...
- Page 3 Table of Contents Introduction ..........1 What Does the Merlin@home™...
- Page 5 Introduction ™ 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™...
- Page 6 Note At any time during your Merlin@home session, you can interrupt your session to use the telephone. If you do not hear a dial tone when you pick up your telephone handset, hang up and pick up your telephone handset again.
- Page 7 • Use the transmitter only for its intended use as described in this manual. Do not use attachments not recommended by St. Jude Medical. • Never operate the transmitter if it is not working properly, if it has been dropped or damaged, or if it has been dropped into water.
- Page 8 • Do not press the Reset button on the back of the transmitter unless requested to do so by ”Technical Support” (page 8) • Use only St. Jude Medical supplied accessories in the USB port. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g.
- Page 9 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.
- Page 10 Unscheduled Session An unscheduled session sends your data manually. Conduct an unscheduled session or implant check only if your clinician instructs you to do so. For instructions on how to send your data manually, see the Merlin@home Transmitter Model EX1150 Set Up Guide. Implant Check To conduct an unscheduled implant check: Do one of the following:...
- Page 11 Transmitter Reset When you get a new implant, you might need to reset your transmitter so that it can send information about your new implant to your clinic. Reset your transmitter only if ”Technical Support” (page 8) or your clinic instructs you to do so. To reset your transmitter: 1.
- Page 12 Transmitter Messages Errors may result from variations in telephone equipment, information transmission time, or the quality of the telephone connection. For information on transmitter errors and messages and how to respond to them, see the Merlin@home™ Transmitter Model EX1150 Set Up Guide. Caring for the Transmitter If necessary, you can clean the outside of the Merlin@home™...
- Page 13 • +46 8 474 4756 (Sweden) (Support in English and Swedish. For additional assistance, contact your clinic.) Indications The Merlin@home™ transmitter is indicated for use by patients with supported St. Jude Medical implanted devices. Contraindications The Merlin@home™ transmitter is contraindicated for use with any implanted medical device other than supported St.
- Page 14 Symbol Description Consult instructions for use USB wireless adapter USB wireless adapter’s clip and USB cable Wireless access point Wireless access point’s ethernet cable Wireless access point’s power supply Manufacturer Authorized Representative in the European Community EC REP Follow the instructions for use. Direct current.
- Page 15 Symbol Description Interference may occur in the vicinity of this equipment. Class II equipment. Meets safety requirements specified for Class II equipment according to IEC 60601-1. To identify a combined input/output connector or mode. Serial number. Part number. For prescription use only. Only For use within temperature limits.
- Page 16 Return the device to St. Jude Medical at the end of its operating life. Ingress Protection Rating. “2” indicates the Merlin@home enclosure is protected a solid object >...
- Page 17 • Model EX1170 Wireless Broadband Kit series • Model LAP3695 USB Hub series 1. St. Jude Medical is the distributor of products included in the Model EX1170 Wireless Broadband Kit series.The products are CE marked by their respective manufacturers. 2. You can use an equivalent access point instead of the wireless access point provided in the Model EX1170 Wireless Broadband Kit series.
- Page 18 Note As with all cellular wireless communications, there is a very small chance that transmitted information might be intercepted. For added security, your transmissions to the secure server are encrypted. Electromagnetic Compatibility The Merlin@home™ transmitter requires special precautions with regard to electromagnetic compatibil- ity (EMC) and should be used in accordance with the information provided in this manual.
- Page 19 Electromagnetic Test IEC 60601 Test Level (Actual Level) Environment – Guidance Electrostatic Discharge (ESD) ±6 kV contact None IEC 61000-4-2 (±6 kV contact) ±8 kV air (±8 kV air) Electrical fast transient/burst ±1 kV for input/output lines None IEC 61000-4-4 (±1 kV for input/output lines) Power Frequency (50/60 Hz) 3 A/m...
- Page 20 Immunity IEC 60601 Electromagnetic Environment – Test Compliance Test Level Guidance Level 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: 3 Vrms ...
- Page 21 100.0 Table 8. Recommended separation distances between portable and mobile communications equipment and the Merlin@home transmitter and St. Jude Medical RF device 1. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
- Page 22 The following is applicable to Canada only: This device may not interfere with stations operating in the 400.150-406.000 MHz band in the meteo- rological aids, meteorological-satellite, and earth exploration-satellite services and must accept any interference received, including interference that may cause undesired operation. Note Maintain a reasonable distance between other electronic equipment and the Merlin@home™...
- Page 24 Cardiac Rhythm Management Division Manufacturer: European Authorized Representative: St. Jude Medical St. Jude Medical Cardiac Rhythm Management Division Coordination Center BVBA 15900 Valley View Court The Corporate Village Sylmar, CA 91342 USA Da Vinci laan, 11, Box F-1 +1 818 362 6822 1935 Zaventem...
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