Merlin@home Transmitter [RF] [symbol Update] [RED Comp .

Device CheckTo conduct an unscheduled device check:Do one of the following: If only the green light is lit, go to Step 1. If the "Stars" icon is lit, go to Step 2.1.Press the Start button. The "Stars" icon lights up.2.Press the Start button for 3 to 4 seconds until you hear two beeps.3.Move close to your transmitter.4.The "Read" icon flashes when the transmitter searches for your device. It will stop flashingbut remains lit while the transmitter reads the device and the progress lights will move left toright.5.The "Tower" icon lights up when the transmitter has read your device.6.The "Stars" icon lights up when your device check is complete. The "Stars" icon will turn offafter a short time.Shut DownTo power down the Merlin@home transmitter, unplug the power supply from the wall electricaloutlet. If using a telephone, you may leave the phone cord from the transmitter plugged into thewall or disconnect it. It should not affect your telephone.Transmitter ResetReset your transmitter only if Technical Support (page 6) instructs you to do so.Transmitter MessagesErrors may result from variations in telephone equipment, information transmission time, or thequality of the telephone connection. For information on transmitter errors and messages and howto respond to them, see the Merlin@home Transmitter Quick Start Guide provided with yourtransmitter.Caring for the TransmitterIf necessary, you can clean the outside of the Merlin@home transmitter with a cloth dampenedwith water. Do not clean the transmitter while a session is in progress. The transmitter is classifiedas IPX0 because it is not waterproof. Do not immerse the transmitter in any liquid.Preventative maintenance, including periodic safety checks, is not required for this device. If thereis a problem with the transmitter, contact Technical Support (page 6) for a replacement.WARNINGThe transmitter does not contain any user-serviceable parts. This productcomplies with medical product regulatory standards. In order to maintain thatcompliance, do not open the case.GlossaryClinic — The place that views your information after the Merlin@home transmitter sends your5

information to the server.Device— Your implanted device, also known as an ICD (implantable cardioverter-defibrillator),CRT-D (cardiac resynchronization therapy defibrillator), pacemaker, or CRT-P (cardiacresynchronization therapy pacemaker).Information — The information stored in your device. The information includes your device typeand serial number, settings, and battery status.Merlin@home session — A remote monitoring session in which your information is sent to theserver, 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 theinformation in your device and sends it to the server.Technical SupportFor 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 4258Monday through Friday (8AM to 5PM Central European Time) 46 8 474 4756 (Sweden) (Support in English and Swedish. For additional assistance,contact your clinic.)IndicationsThe Merlin@home transmitter is indicated for use by patients with supported St. Jude Medicalimplanted devices.ContraindicationsThe Merlin@home transmitter is contraindicated for use with any implanted medical deviceother than supported St. Jude Medical implanted devices.SymbolsTable 1. The following symbols may be found on the product or product label:SymbolDescriptionTransmitterContentsModel EX1150, EX1150W Merlin@home transmitters6

SymbolDescriptionPhone cord and splitter (phone connector)Product literatureConsult instructions for useFollow instructions for use on this websiteUSB wireless adapterUSB wireless adapter's clip and USB cableWireless access pointWireless access point's ethernet cableWireless access point's power supplyManufacturerAuthorized Representative in the European Community7

SymbolDescriptionFollow the instructions for useDirect currentTo identify the terminals to which a telephone adapter is to be connectedTransmitter works with a landline telephoneInterference may occur in the vicinity of this equipmentClass II equipment. Meets safety requirements specified for Class IIequipment according to IEC 60601-1.To identify a combined input/output connector or modeSerial numberPart numberTransmitter works with a wireless broadband kitTransmitter works with a cellular adapterTransmitter does not work with a landline telephone8

SymbolDescriptionFor prescription use onlyTemperature limitationsHumidity limitationTÜV Listed, US and Canada.Conforms to UL60601-1.Certified to CAN/CSA C22.2 No.601.1-M90European conformity, affixed according to the relevant provisions of AIMDdirective 90/385/EEC and RE directive 2014/53/EU Annex III. Hereby,St. Jude Medical declares that this device complies with the essentialrequirements and other relevant provisions of these directives.The full text of the European Union RE directive 2014/53/EU declaration ofconformity is available at the following internet address:www.sjmglobal.com/euconformity.This product operates in the 2.4-2.4835 GHz band with an RF output powerof less than 9.2 mW EIRP.This product operates in the 402-405 MHz band with an effective radiatedpower of less than 25 µW ERP.Australian Communications and Media Authority (ACMA) and New ZealandRadio Spectrum Management (RSM) Regulatory Compliance Mark (RCM)This equipment is certified for type certification pursuant of Article 38-24 ofthe Japan Radio LawKorea Certification mark for electrical devices9

SymbolDescriptionAffixed to this device in accordance with European Council Directives2002/96/EC.These directives call for separate collection and disposal of electrical andelectronic equipment. Sorting such waste and removing it from other forms ofwaste lessens the contribution of potentially toxic substances into municipaldisposal 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 isprotected against a solid object 12.5 mm. "1" indicates the enclosure isprotected against vertically falling drops of water.Technical InformationThe Merlin@home transmitter is Class II medical equipment and complies with IEC606011:2005 and UL60601-1:2003 and CAN/CSA-C22.2 No. 601.1-M90. The Merlin@hometransmitter is a Canadian ICES-003 Class B digital apparatus. Operation is subject to the followingtwo conditions: 1) This device may not cause interference, and 2) this device must accept anyinterference that may cause undesired operation of the device.Note There are no user-serviceable parts in the Merlin@home transmitter. Nocalibration is required. Do not modify the Merlin@home transmitter. When used under normal operating circumstances, this equipmentgenerates no pollution.Table 2. Electrical ratingsInput/OutputRatingTransmitter input100-240 VAC, 50-60 HzPower consumption (maximum)350 - 150 mAPower consumption (standby)4 VATable 3. Storage conditionsParameterConditionMinimum Temperature-4 F (-20 C)Maximum Temperature158 F (70 C)Maximum Humidity90%Minimum Atmospheric Pressure (hPa)500Maximum Atmospheric Pressure (hPa)106010

Table 4. Operating conditionsParameterConditionMinimum Temperature50 F (10 C)Maximum Temperature104 F (40 C)Maximum Humidity75%Minimum Atmospheric Pressure (hPa)700Maximum Atmospheric Pressure (hPa)1060Transmitter AccessoriesTelephone accessories included with the transmitter are (model EX1150 only): Telephone cable Phone connectorOptional transmitter accessories are: Model EX1151 Wireless USB Adapter series Model EX1170 Wireless Broadband 1 Kit series 2NoteAs with all wireless communications, there is a very small chance that transmittedinformation might be intercepted. For added security, your transmissions to the secureserver are encrypted.Electromagnetic CompatibilityThe Merlin@home transmitter requires special precautions with regard to electromagneticcompatibility (EMC) and should be used in accordance with the information provided in thismanual.The Merlin@home transmitter complies with the requirements of the international EMC standardIEC 60601-1-2 when used with the cables listed in Transmitter Accessories (page 11).The Merlin@home transmitter is intended for use in the electromagnetic environment specified inTables 5 through 8. The user should ensure that it is used in such an environment.WARNINGThe Merlin@home transmitter complies with the limits for medical devicescontained in IEC/EN 60601-1-2.However, the Merlin@home transmitter may cause radio interference or maydisrupt the operation of nearby equipment. It may be necessary to mitigate thiseffect by reorienting or relocating the receiving device or shielding the location.St. Jude Medical is the distributor of products included in the Model EX1170 Wireless Broadband Kit series. The products are CEmarked by their respective manufacturers.You can use an equivalent access point instead of the wireless access point provided in the Model EX1170 Wireless BroadbandKit series. For more information, see Technical Support.1211

Table 5. Guidance and manufacturer's declaration - electromagnetic emissionsTestComplianceElectromagnetic Environment - GuidanceRF EmissionCISPR 11Group 1The Merlin@home transmitter must emitelectromagnetic energy in order to perform itsintended function. Nearby electronic equipment maybe affected.RF EmissionCISPR 11Class BHarmonic emissionsIEC 61000-3-2Class AVoltagefluctuations/flickeremissions IEC61000-3-3CompliesThe Merlin@home transmitter is suitable for use in allestablishments, including domestic establishmentsand those directly connected to the public low-voltagepower supply network that supplies buildings used fordomestic purposes.Table 6. Guidance and manufacturer's declaration - electromagnetic immunityTestIEC 60601 Test Level (ActualLevel) 3Electromagnetic Environment GuidanceElectrostaticDischarge (ESD)IEC 61000-4-2 8 kV contact( 8 kV contact)None 15kV air( 15 kV air)Electrical fasttransient/burstIEC 61000-4-4 2 kV for input/output lines( 2 kV for input/output lines)NonePower Frequency(50/60 Hz)Magnetic FieldIEC 61000-4-830 A/m(30 A/m)NoneTable 7. Guidance and manufacturer's declaration - electromagnetic immunity (conducted RFand radiated RF)TestIEC 60601Test Level 4ImmunityComplianceLevelElectromagnetic Environment - GuidanceConductedRFIEC 610004-63 Vrms150 kHz to80 MHz3 VrmsPortable and mobile RF communications equipmentshould be used no closer to any part of theMerlin@home transmitter, including cables, than therecommended separation distance.34Figures in parentheses are the immunity compliance levels for each test.At 80 MHz and 800 MHz, the higher frequency range applies.12

Radiated RF 3 V/mIEC 61000- 80 MHz to4-32.5 GHz3 VrmsRecommended separation distance:(80 MHz to 800 MHz)(800 MHz to 2.5 GHz)where P is the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer and d is the recommended separationdistance in meters (m).Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey*,should be less than the compliance level in eachfrequency range. Interference may occur in thevicinity of equipment marked with the followingsymbol:*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 broadcastcannot be predicted theoretically with accuracy. To assess the electromagnetic environment dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength of the location in which the Merlin@home transmitter is used exceeds the applicableRF compliance level above, the Merlin@home transmitter should be observed to verify normaloperation. If abnormal performance is observed, additional measures may be necessary, such asre-orienting or relocating the Merlin@home transmitter.NoteThe Merlin@home transmitter is intended for use in an electromagnetic environment inwhich radiated RF disturbances are controlled. The user of the Merlin@hometransmitter can help prevent electromagnetic interference by maintaining a minimumdistance between portable and mobile RF communications equipment (transmitters)and the Merlin@home transmitter as recommended below in Table 8, according to themaximum output power of the communications equipment. For transmitters rated at amaximum 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 thetransmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.13

Table 8. Recommended separation distances between portable and mobile communicationequipment and the Merlin@home transmitter and St. Jude Medical RF deviceRated maximumoutput power oftransmitter (W)Recommended separation distance according tofrequency of transmitter (m) 5150 kHz to 80 MHz80 MHz to 800 MHz 6800 MHz to 2.5 3.83.87.3100.0121223Radio Frequency InformationMICS band: 402-405 MHz. The effective radiated power is below the limits as specified in: Europe: EN ETSI 301 839 USA: FCC 47 CFR Part 95.601-95.673 Subpart E, 95.1201-95.12192.45 GHz. The effective radiated power is below the limits as specified in: Europe: EN ETSI 300 328 USA: FCC 47 CFR Part 15.249The following is applicable to Canada only:This device may not interfere with stations operating in the 400.150-406.000 MHz band in themeteorological aids, meteorological-satellite, and earth exploration-satellite services and mustaccept any interference received, including interference that may cause undesired operation.NoteMaintain a reasonable distance between other electronic equipment and theMerlin@home transmitter.WARNINGThis transmitter is authorized by rule under the Medical Implant CommunicationsService (part 95 of the FCC Rules) and must not cause harmful interference tostations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids(that is, transmitters and receivers used to communicate weather data), theMeteorological Satellite, or the Earth Exploration Satellite Services and mustaccept interference that may be caused by such aids, including interference thatmay cause undesired operation. This transmitter shall be used only in accordancewith the FCC Rules governing the Medical Implant Communications Service.Analog and digital voice communications are prohibited. Although this transmitterhas been approved by the Federal Communications Commission, there is noThese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fromstructures, objects, and people.6At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.514

guarantee that it will not receive interference or that any particular transmissionfrom this transmitter will be free from interference.15

Manufacturer:St. Jude MedicalCardiac RhythmManagement Division15900 Valley View CourtSylmar, CA 91342 USA 1 818 362 6822European Authorized Representative:St. Jude MedicalCoordination Center BVBAThe Corporate VillageDa Vincilaan 11 Box F11935 ZaventemBelgium 32 2 774 68 11Manufacturing Site:St. Jude Medical Puerto Rico LLCLot A Interior - #2 Rd Km. 67.5Santana Industrial ParkArecibo, PR 00612USAManufacturing Site:St. Jude Medical Operations (M) Sdn. Bhd.Plot 102, Lebuhraya Kampung Jawa,Bayan Lepas Industrial Zone11900 PenangMalaysiasjm.comApril 2017ARTEN100159784 AAustralian Sponsor:St. Jude Medical Australia Pty. Limited17 Orion RoadLane Cove NSW 2066Australia

The Merlin@home transmitter model EX1150 and the Merlin@home transmitter model EX1150W can be used with the cellular adapter provided with your transmitter. For more information, see the Set Up Guide, Quick Start Guide, and the Icons and Connections Guide provided with your transmitter. Can