St. Jude Medical Merlin home EX1100, User Manual

Page 1: ...Merlin home Transmitter Model EX1100 EX1100W User s Manual ...

Page 2: ...ark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical LLC and its related companies Pat http patents sjm com 2018 St Jude Medical LLC All Rights Reserved ...

Page 3: ...it 2 Can You Use the Transmitter While Traveling 3 Important Safeguards 3 Setting Up the Transmitter 3 Merlin home Session 4 Device Check 4 Shut Down 5 Transmitter Reset 5 Transmitter Messages 5 Software Updates and Your Transmitter 5 Caring for the Transmitter 5 Glossary 6 Technical Support 6 Indications 6 Contraindications 6 Symbols 6 Technical Information 9 Transmitter Accessories 10 Electromag...

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Page 5: ...r reads the information Your doctor can use this information to help check the status of your device Depending on the transmitter provided by your doctor either EX1100 or EX1100W your Merlin home transmitter works with the following Model EX1100 telephone landline cellular adapter wireless broadband kit Model EX1100W cellular adapter wireless broadband kit NOTES The Merlin home transmitter model E...

Page 6: ...ling You must use a push button telephone with a standard RJ 11 plug Your telephone wall jack must also accept a standard RJ 11 plug If you have an older plug or jack you can purchase an RJ 11 adapter that allows you to use the transmitter 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 c...

Page 7: ...thing 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 Do not reach for a transmitter that has fallen into water Unplug it immediately To reduce the risk of burns shock fire or injury to persons Supervision is necessary when the transmitter is used by on or near children Use the transmitter only ...

Page 8: ...e system complies with the requirements for medical electrical systems Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt consult your local representative or the technical service department Sometimes issues with your phone cellular adapter or internet service provider may prevent your transmitter from sending your information Contact Te...

Page 9: ...page 6 For more information on transmitter errors and messages and how to respond to them see the Merlin home Transmitter Quick Start Guide provided with your transmitter Note Occasionally the software in your Merlin home transmitter is automatically updated If any action is required on your part you will be notified Software Updates and Your Transmitter It is important to keep your transmitter po...

Page 10: ...sent Transmitter The part of the Merlin home Remote Monitoring System that reads the information in your device and sends it to the server Technical Support For Merlin home transmitter issues Monday through Friday 8AM to 8PM Eastern Standard Time 1 877 696 3754 1 877 MY MERLIN toll free within North America 1 818 493 4258 Monday through Friday 8AM to 5PM Central European Time 46 8 474 4756 Sweden ...

Page 11: ...rature Consult instructions for use Follow instructions for use on this website 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 Manufacturing facility Authorized Representative in the European Community Australian Sponsor ...

Page 12: ...orks with a cellular adapter Transmitter does not work with a landline telephone Date of Manufacture 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 Type BF applied part Serial number Part number For prescription use only Temperature limitations Humidity limitations TÜV Listed US and Canada...

Page 13: ...ction and disposal of electrical and electronic equipment Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem 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 against a solid...

Page 14: ...aximum Humidity 75 Minimum Atmospheric Pressure hPa 700 Maximum Atmospheric Pressure hPa 1060 Transmitter Accessories Telephone accessories included with the transmitter are model EX1100 only Telephone cable Phone connector Optional transmitter accessories are Model EX1151 Wireless USB Adapter series Model EX1170 Wireless Broadband1 Kit series2 1 St Jude Medical is the distributor of products incl...

Page 15: ... transmitter complies with the limits for medical devices contained in IEC EN 60601 1 2 However the Merlin home transmitter may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to mitigate this effect by reorienting or relocating the receiving device or shielding the location Table 5 Guidance and manufacturer s declaration electromagnetic emissions Test...

Page 16: ...ance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 8 kV contact 15 kV air 15 kV air None Electrical fast transient burst IEC 61000 4 4 2 kV for input output lines 2 kV for input output lines None Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 30 A m 30 A m None 3 Figures in parentheses are the immunity compliance levels for each test ...

Page 17: ...ur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 Vrms 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 ...

Page 18: ...ile communications equipment and the Merlin home transmitter Rated maximum output power of transmitter W Recommended separation distance according to frequency of transmitter m 5 150 kHz to 80 MHz 80 MHz to 800 MHz6 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 0 1 2 1 2 2 3 10 0 3 8 3 8 7 3 100 0 12 12 23 Inductive Telemetry Wand RF Transmission Carrier frequency below 100 kHz induc...

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