Merlin@home Transmitter Model EX1100 Users Manual Oct 2011

ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. © 2011 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.

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...4 Setting up the transmitter using a telephone line... 4 Merlin@home® session...5 Implant check...5 Transmitter reset...6 Transmitter messages...6 Caring for the transmitter...7 Glossary...7 Technical Support...7 Symbols...8 Technical Information...11 Transmitter accessories... 12 Electromagnetic Compatibility...12 Inductive Telemetry Wand... 15 FCC Information...16 Warranty...18

Merlin@home® Transmitter Model EX1100 User’s Manual

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Table of Contents

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® transmitter conducts your Merlin@home session. During your Merlin@home session, the transmitter reads the information from your implant (implanted device) and sends it to a server where your clinic can view it. This information includes: • The type and serial number of your implant • The settings for your implant • What has happened since your last follow-up session • Your implant’s battery status Your transmitter can also conduct an implant check, which checks your implant’s status. Your implant continues to work normally while the transmitter reads the information. Your doctor can use this information to help check the status of your implant. Note • Only your clinic, and ”Technical Support” (page 7) if requested by your doctor, can view the confidential information you send during your Merlin@home session. • Normal use of the transmitter has little impact on your implant’s battery usage. Conduct your sessions according to the schedule provided by your clinic.

How does the Merlin@home® transmitter affect your telephone? Note The following information is applicable if you are using a telephone line to connect the transmitter. If you are using the cellular or wireless adapters to connect the transmitter, a telephone line is not needed. The Merlin@home® transmitter plugs into your telephone line (see ”Setting up the transmitter” on page 4) and uses the telephone network to send information to the server, where your clinic can view the information. As far as your telephone is concerned, this is like any other telephone call to a toll-free number within the United States and Canada. Before your Merlin@home session starts, you must hang up all phones. If someone calls during your session, you receive a Can't send information message. For more information, see the Merlin@home Transmitter Model EX1100 Quick Start Guide.

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When the transmitter is not reading or sending information, it is idle. Leaving the transmitter connected to your telephone does not affect your telephone’s normal operation. You can still make and receive calls. 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. If your Merlin@home session is interrupted, the transmitter attempts to send your information at a later time.

Can you use the transmitter while traveling? The Merlin@home™ transmitter works within your country, but it might not work outside your country. Check with your doctor before traveling with the 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.

Important Safeguards Always follow basic safety precautions when using electrical products, especially when children are present. These include: • Read all instructions before using. • Keep these instructions.

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Important Safeguards

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. • 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 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. Contact ”Technical Support” (page 7) for service or replacement instructions. • Keep the cord away from heated surfaces. • Do not operate the transmitter on heated surfaces. • Do not use outdoors or operate where aerosol (spray) products are being used. Do not operate in an oxygen-rich environment (for example, in an oxygen tent or oxygen chamber). • Do not use the transmitter near flammable substances.

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Setting up the transmitter For instructions on how to set up the transmitter, see the Merlin@home Transmitter Model EX1100 Set Up Guide. Note • Place the transmitter on a sturdy, flat, hard surface. The transmitter must be flat on the surface at all times. • The Merlin@home transmitter is not magnetic and has no moving parts. However, you should avoid devices which generate a strong electric or magnetic interference (EMI). EMI could interfere with the performance of the transmitter. Moving the source of EMI away from the transmitter or turning the source of EMI off will usually allow the transmitter to return to its normal mode of operation. Sources of EMI may include communication equipment, wireless communication devices, household appliances, and industrial equipment. • Do not press the Reset button on the back of the transmitter unless requested to do so by ”Technical Support” (page 7) • 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. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the 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 or wireless service provider prevent your transmitter from sending your information. Contact ”Technical Support” (page 7) or your clinic. Keep the original shipping box in case you need to return the transmitter for service.

Setting up the transmitter using a telephone line To use the Merlin@home® transmitter, your telephone service provider must support touch-tone dialing. 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.

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Setting up 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 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 phone connector into the filter. For more information on how to use the filter, contact your DSL service provider.

CAUTION The transmitter is designed for use with direct analog telephone lines. It may be damaged by any other type of phone line. See ”Technical Support” (page 7).

Merlin@home® session Conduct a Merlin@home® session according to the schedule set by your clinic. For instructions on how to set up and use the transmitter, see the Merlin@home Transmitter Model EX1100 Set Up Guide and Merlin@home Transmitter Model EX1100 Quick Start Guide.

Implant check Conduct an implant check only if your clinician instructs you to do so. To conduct an implant check: 1. Place the wand, green side towards you, over your implant. 2. Press the Start button. The “Stars” icon lights up. 3. Press the Start button for 3 to 4 seconds until you hear two beeps. 4. The “Read” icon lights up when the transmitter reads your implant. 5. The “Tower” icon lights up when the transmitter sends information about your implant. You can remove your wand. 6. The “Stars” icon lights up when your information has been sent successfully.

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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 7) or your clinic instructs you to do so. To reset your transmitter: 1. Unplug the power supply for the transmitter and plug it back in.

RESET

Progress lights

2. When you see the five progress lights flash from left to right on the front of the transmitter, press and hold the Start button.

Start button 3. While holding the Start button, reach around the back of the transmitter and quickly press and release the Reset button.

RESET

4. When you hear a long beep, release the Start button. 5. Set up the transmitter. For instructions, see the Merlin@home Transmitter Model EX1100 Set Up Guide.

Transmitter messages Errors may result from variations in telephone equipment, information transmission time, or the quality of the telephone connection. If the transmitter is plugged in and the green power light does not come on, contact ”Technical Support” (page 7). For more information on transmitter errors and messages and how to respond to them, see the Merlin@home® Transmitter Model EX1100 Quick Start Guide.

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Transmitter reset

Note Occasionally the software in your Merlin@home transmitter is automatically updated. If any action is required on your part, you will be notified.

Caring for the transmitter If necessary, you can clean the outside of the Merlin@home® transmitter with a cloth dampened with water. Do not clean the transmitter while a session is in progress. The transmitter is classified as IPX0 because it is not waterproof. Do not immerse the transmitter in any liquid. The transmitter does not contain any user-serviceable parts. Do not open the case. If there is a problem with the transmitter, contact ”Technical Support” (page 7) for a replacement.

Glossary Clinic - The place that views your information after the Merlin@home® transmitter sends your information to the server. Implant- Your implanted device, also known as an ICD (implantable cardioverter-defibrillator), CRT-D (cardiac resynchronization therapy defibrillator), pacemaker, or CRT-P (cardiac resynchronization therapy pacemaker). Information - The information stored in your implant. The information includes your implant’s type and serial number, settings, and battery status. Merlin@home session - A remote monitoring session in which your information is sent to the server, where the clinic can view your information. Server - The place where your information from the Merlin@home session is sent. Transmitter - The part of the Merlin@home Remote Monitoring System that reads the information in your implant and sends it to the server.

Technical Support For Merlin@home® 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) (Support in English and Swedish. For additional assistance, contact your clinic.)

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Symbols Definitions of globally recognized hardware, applied part, and packaging symbols required by regulatory authorities are described below. Symbol

Description Transmitter

Contents

1 Model EX1100 Merlin@home® system Merlin@home

Phone cord and splitter (phone connector)

Merlin@home inductive wand

Literature

Consult instructions for use

USB wireless adapter

USB wireless adapter’s clip and USB cable

Table 1. Symbols

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Symbols

Symbol

Description 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. Equipment is suitable for alternating current only; identifies relevant terminals. A terminal to which a telephone adapter is to be connected.

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.

Table 1. Symbols (continued)

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Symbol

Description Type BF applied part.

Serial number.

Part number.

For prescription use only.

Only For use within temperature limits.

For use within humidity limits.

TUV Listed, US and Canada. Conforms to UL 60601-1. Certified to CAN/CSA C22.2 No. 601.0-M90.

Affixed to this device in accordance with European Council Directive 90/385/EEC and 1999/5/EC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of these Directives. The label is affixed to this device in accordance with European Council Directives 2002/96/EC. These directives call for separate collection 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. Table 1. Symbols (continued) 10

Symbols

Technical Information The Merlin@home® transmitter is Class II medical equipment and complies with IEC60601-1:2005 and UL60601-1:2003 and CAN/CSA-C22.2 No. 601.1-M90. The Merlin@home transmitter is a Canadian ICES-003 Class B digital apparatus. Operation is subject to the following two conditions: 1) This device may not cause interference, and 2) This device must accept any interference that may cause undesired operation of the device. 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 (maximum)

33 VA

Power consumption (standby)

3 VA

Table 2. Electrical ratings

Parameter

Condition

Minimum Temperature

-4°F (-20°C)

Maximum Temperature

158°F (70°C)

Maximum Humidity

90%

Table 3. Storage conditions

Parameter

Condition

Minimum Temperature

50°F (10°C)

Maximum Temperature

104°F (40°C)

Maximum Humidity

75%

Table 4. Operating conditions

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Transmitter accessories Telephone accessories included with the transmitter are: • Telephone cable • Phone connector Optional transmitter accessories are: • Model EX1151 Wireless USB Adapter series • Model EX1170 Wireless Broadband Kit series1 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 compatibility (EMC) and should be used in accordance with the information provided in this manual. The Merlin@home transmitter complies with the requirements of the international EMC standard IEC 60601-1-2:2001 when used with the cables listed in ”Transmitter accessories” on page 12. The Merlin@home transmitter is intended for use in the electromagnetic environment specified in Tables 5 through 8. The user should ensure that it is used in such an environment. WARNING The Merlin@home transmitter complies with the limits for medical devices contained in IEC/EN 60601-1-2:2001. 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.

1. You can use an equivalent access point instead of the wireless access point provided in the Model EX1170 Wireless Broadband Kit series. For more information, see Technical Support.

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Electromagnetic Compatibility

Test

Compliance

Electromagnetic Environment – Guidance

RF Emission CISPR 11

Group 1

The Merlin@home® transmitter must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF Emission CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class B

The Merlin@home transmitter is suitable for use in all establishments, including domestic establishments 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

Table 5. Guidance and manufacturer’s declaration – electromagnetic emissions

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. Figures in parentheses are the immunity compliance levels for each test.

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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 2.5 GHz) 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 survey2, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Table 7. Guidance and manufacturer’s declaration – electromagnetic immunity (conducted RF and radiated RF) 1. At 80 MHz and 800 MHz, the higher frequency range applies. 2. 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 of the location in which the Merlin@home transmitter is used exceeds the applicable RF compliance level above, the Merlin@home transmitter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Merlin@home transmitter.

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Electromagnetic Compatibility

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. For transmitters rated at a maximum output power not listed in Table 8, the recommended separation distance (d) in meters 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.

Rated maximum output power of transmitter (W)

Recommended separation distance according to frequency of transmitter (m)1 150 kHz to 80 MHz

80 MHz to 800 MHz2

800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

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

Table 8. Recommended separation distances between portable and mobile communications equipment and the Merlin@home transmitter 1. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 2. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Inductive Telemetry Wand • RF Transmission – Carrier frequency below 100 kHz (magnetic field), 100% AM modulation. The effective radiated power is below the limits as specified in EN 302 195-2. • RF Reception – Below 100 kHZ (magnetic fields). Note Maintain a reasonable distance between other electronic equipment and the Merlin@home® transmitter.

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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 following format. If requested, this number must be provided to the telephone company. Identifier

Description

FCC Registration Number

US: SJMMM01BMERLIN

Ringer Equivalence Number (REN)

0.8B

USOC Jack Type

RJ11 (US)

Table 9. FCC identification information

A FCC compliant telephone cord and modular plug is provided with this equipment. This equipment is designed to be connected to the telephone network or premises wiring using a compatible modular jack that is Part 68 compliant. See installation instructions for details. The REN is used to determine the quantity of devices that may be connected to the telephone line. Excessive RENs on the telephone line may result in the devices not ringing in response to an incoming call. Typically, 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. If the Merlin™@home transmitter 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. The telephone company may make changes to it's facilities, equipment, operations or procedures that could affect the operation of the equipment. If this happens the telephone company will provide advance notice so you can make the necessary modifications to maintain uninterrupted service. If you have trouble with the Merlin@home transmitter, for repair or warranty information, contact Technical Service. 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. Connection to party line service is subject to state tariffs. (Contact the state public utility commission, public service commission or corporation commission for information.) CAUTION Per FCC Rules, changes or modifications of the Merlin@home transmitter not approved by St. Jude Medical could void your right to operate the Merlin@home transmitter.

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FCC Information