Medtronic 29901B 26901 User Manual MAPS ID 502334 012

Medtronic, Inc. 26901 MAPS ID 502334 012

Contents

User Manual

CARELINK ENCORE™ 29901Programmer for Medtronic and Vitatron DevicesReference Manual
CARELINK ENCORE™ 29901Reference ManualA guide for setting up and using the CareLink Encore 29901 Programmer.
The following list includes trademarks or registered trademarks of Medtronic in the UnitedStates and possibly in other countries. All other trademarks are the property of their respectiveowners.CareLink, CareLink Encore, Marker Channel, Medtronic, Paceart, SessionSync, Vitatron
Contents1 Introduction to the programmer ....................................... 81.1 CE mark of conformity ................................................ 81.2 Explanation of packaging and product symbols ........................... 81.3 About this guide .................................................... 121.4 Description ........................................................ 121.5 Intended use ....................................................... 131.6 Contraindications ................................................... 131.7 Warnings .......................................................... 131.8 Precautions ........................................................ 161.9 Declaration of Conformity ............................................ 181.10 Regulatory compliance .............................................. 191.11 Programmer functions ............................................... 191.12 Security features of the programmer ................................... 211.13 Software requirements ............................................... 221.14 Compatible components ............................................. 221.15 Obtain technical manuals ............................................ 232 Set up the programmer .............................................. 242.1 System components ................................................. 242.2 Programmer button panel ............................................ 272.3 Basic setup ........................................................ 282.4 Charge the battery .................................................. 352.5 Use external printers ................................................ 373 Configure the programmer ........................................... 423.1 Display screen features .............................................. 423.2 About the Between Patient Sessions tool palette ........................ 453.3 Change the language setting ......................................... 463.4 Use the on-screen keyboard .......................................... 473.5 View and update programmer location and hardware information .......... 473.6 Adjust programmer time and date ..................................... 483.7 Select audible tones ................................................. 49Medtronic CARELINK ENCORE™ 29901Reference Manual 5
3.8 Check the software version ........................................... 503.9 Select other software ................................................ 513.10 Remove other software applications ................................... 513.11 Improve the detection of pacing artifacts ................................ 523.12 Start the Demonstrations option ....................................... 523.13 Configure network using the Network Configuration window ............... 534 Update programmer software using the Software DistributionNetwork ........................................................... 564.1 The Software Distribution Network ..................................... 564.2 Connect to the SDN using a wired network connection ................... 564.3 Connect to the SDN using a wireless network connection ................. 615 Conduct a patient session ........................................... 645.1 Prepare for a patient session ......................................... 645.2 Initiate a patient session ............................................. 705.3 Electronic Strip Chart (eStrip) recorder ................................. 745.4 Emergency VVI button ............................................... 785.5 End a patient session ................................................ 795.6 Store components .................................................. 796 Manage session data and reports ..................................... 806.1 Session data ....................................................... 806.2 Reports ............................................................ 806.3 Save to a PDF file ................................................... 806.4 Save to USB ....................................................... 816.5 View reports that are saved to media ................................... 826.6 View reports on the programmer using PDF Viewer ...................... 836.7 Viewing and printing PDF files on a computer ........................... 836.8 Manage patient data privacy .......................................... 846.9 Set the interval for report deletion ..................................... 877 SessionSync (Optional) .............................................. 897.1 About SessionSync ................................................. 897.2 Enable and disable SessionSync ...................................... 897.3 SessionSync Status icon ............................................. 907.4 Use Automatic SessionSync .......................................... 91Medtronic CARELINK ENCORE™ 299016 Reference Manual
7.5 Use Manual SessionSync for supported devices ........................ 927.6 SessionSync error message descriptions ............................... 927.7 View SessionSync Status screen ...................................... 937.8 Update SessionSync status .......................................... 938 Service the programmer ............................................. 958.1 Clean the system components ........................................ 958.2 Sterilize the programming head, ECG cable, and lead wires ............... 958.3 Programmer specifications ........................................... 978.4 Special notice ..................................................... 1008.5 Medtronic limited warranty .......................................... 100A End-user license agreement ......................................... 101A.1 End-user license agreement (EULA) terms ............................ 101Index ................................................................... 106Medtronic CARELINK ENCORE™ 29901Reference Manual 7
1 Introduction to the programmer1.1 CE mark of conformityCE Mark ModelsApplies to all Medtronic hardware and software (including 29901 and desk-top software SW028).Applies to all Vitatron software (including desktop software VSH02).Applies to Bluetooth only.1.2 Explanation of packaging and product symbolsRefer to the package label and product to see which symbols apply to this product.CautionConsult instructions for useSystem meets the applicable Canadian and U.S. electrical safety stand-ards.System meets the applicable Canadian and U.S. electrical safety stand-ards.Conformité Européenne (European Conformity). This symbol means thatthe device fully complies with applicable European Union Acts.This product conforms to IP21. There are no openings that allow the user toinsert a finger or similar sized objects. The product is resistant to drippingwater or vertically falling drops.Medtronic CARELINK ENCORE™ 299018 Reference Manual
ACMA (Australian Communications and Media Authority) and the NewZealand Ministry of Economic Development Radio Spectrum Manage-ment standards for radio communications products symbol for Australiaand New Zealand.MIC (Ministry of Internal Affairs and Communications) symbol for JapanICASA (Independent Communications Authority of South Africa) mark forSouth Africa.Use only with specified power supply.Class II ME EquipmentType BF applied partTemperature limitationHumidity limitationRF transmitterNotice of proper disposal.Do not dispose of this product in the unsorted municipal waste stream.Dispose of this product according to local regulations. Seehttp://recycling.Medtronic.com for instructions on proper disposal of thisproduct.Caution: Strong magnetNetwork connection portMedtronic CARELINK ENCORE™ 29901Reference Manual 9
USB portDC inputExpressCardBatteryVGA monitorManufacturerDate of manufactureAuthorized representative in the European communityReorder numberSerial numberLot numberHumidity limitationPackage contentsProgrammer, software installedMedtronic CARELINK ENCORE™ 2990110 Reference Manual
Power cordProduct documentationAccessoriesProgrammerStylus / tetherProgramming headPower supplyPower cordBatteryChina RoHSThis product contains lead (Pb). Do not dispose of this product in theunsorted municipal waste stream. Dispose of this product according tolocal regulations. See http://recycling.Medtronic.com for instructions onproper disposal of this product.Turn the pageStore programming headMedtronic CARELINK ENCORE™ 29901Reference Manual 11
Do not wrap cord behind headDo not wrap cord around head1.3 About this guideThis guide describes the features and functions of the CareLink Encore 29901 Programmer(referred to as the “programmer”).Note: Screen images in this guide are for reference only. The content and presentation mayvary depending on user selections, desktop, and device being interrogated.1.4 DescriptionThe CareLink Encore 29901 Programmer is a portable, line-powered (AC) orbattery-powered microprocessor-based system with software to interrogate and programMedtronic and Vitatron implantable devices. Other features include:●Automated software updates using a wireless or local area network (LAN) connection.This connection allows the programmer to program new devices and to provide newfeatures as they become available.●A large, bright screen that is adjustable for viewing when sitting or standing.Medtronic CARELINK ENCORE™ 2990112 Reference Manual
1.5 Intended useThe programmer is intended to be used to interrogate and program Medtronic and Vitatronimplantable devices.1.6 ContraindicationsThere are no known contraindications to the use of the 29901 Programmer; the 29901Programmer does not provide therapy.1.7 WarningsThese warnings apply in general to using the programmer for programming implantabledevice parameter settings. For more information related to specific implantable devicemodels, see the reference guides for the implantable device and the programmer software.Battery charging – Use the programmer for charging batteries by installing the battery andconnecting the power supply. Unapproved charging equipment may damage the battery orcause excessive heating, battery case rupture, or ignition of the battery cells. Use of adamaged battery may damage equipment or cause user or patient injury.Battery disposal – Do not dispose of batteries in fire, in order to avoid the risk of explosion.Battery exposure – Exposing the battery to cold temperatures may result in a loss ofperformance and shortened battery service life. Use of a damaged battery may cause injury,damage equipment, or impact user or patient safety.Battery handling – Do not puncture batteries. Do not disassemble batteries as this cangenerate a gas that may irritate the throat and lungs. If the battery is opened, lithium in thebattery may react with moisture and generate heat or fire, which could result in injury.Battery overheating – Do not store the programmer battery in direct sunlight, inside a car,or in an enclosed space in extremely hot weather. Overheating the battery may result in aloss of performance and shortened battery service life. The battery contains built-in thermalprotection circuitry that prevents the battery from charging when hot. Excessive heating ofthe battery may cause battery case rupture or ignition of the battery cells.Battery replacement – If you receive a message on the programmer to replace the battery,you need to replace the battery with a new battery. Use of a failed battery will reduceprogrammer operating time and may cause user or patient injury. For more information, seeSection 2.4.Connection of external devices – Additional equipment connected to medical electricalequipment must comply with the respective IEC or ISO standards (for example, IEC 60950for data processing equipment). All configurations must comply with the requirements forMedtronic CARELINK ENCORE™ 29901Reference Manual 13
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC60601-1, respectively). Anyone connecting additional equipment to medical electricalequipment configures a medical system and is therefore responsible that the systemcomplies with the requirements for medical electrical systems. Local laws take priority overthe above mentioned requirements. If in doubt, consult your local Medtronic representativeor the technical service department.Damage due to impact – Do not use the programmer if it has sustained impact damage.Internal components may be damaged or exposed. Use of damaged equipment may impactuser or patient safety.Defective equipment – If technical and safety inspection reveals a defect that could harmthe patient, clinicians, or third parties, the programmer should not be used until it has beenproperly repaired. The operator must immediately notify Medtronic or Vitatron of thesedefects.Diagnostic ECG – Do not use the programmer ECG display for recording or diagnosis. Usea separate ECG device if recording or diagnostic ECG capabilities are required.Electric shock risk – Do not simultaneously touch the patient and any metal parts of theprogrammer, such as the USB port or the power connector, as voltage may be present.Application of voltage to the patient may impact user or patient safety.Equipment compatibility – The programmer must be used only for interrogating andprogramming compatible Medtronic or Vitatron implantable devices. If the programmer isused on other implanted devices, direct stimulation through energy coupling may occur. Theprogrammer is not compatible with programmable devices of other manufacturers.Flammable anesthetic mixture – The programmer is not suited for use in the presence ofa flammable anesthetic mixture.High sound pressure levels – The programmer speaker may emit alert tones at high soundpressure levels. Consider speaker position when setting up the programmer, and dismissalerts as soon as possible, in order to avoid hearing damage. Exposure to high soundpressure levels may damage hearing and impact patient health.Importance of reference documentation – Implantable device programming should bedone only after careful study of the reference guide for the implantable device and aftercareful determination of appropriate parameter values based on the patient’s condition andpacing system used. The implantable device reference guide contains a completedescription of implantable device operation and important information, such as indicationsfor use, contraindications, warnings, and precautions. The instructions contained in thisreference guide and the reference guide supplied with the programmer software are limitedto the mechanics of setting up the programmer and selecting the correct options for thedesired programming function. Improper use of the programmer could result in erroneous orinadvertent programming and improper operation of telemetry and measurement functions.Medtronic CARELINK ENCORE™ 2990114 Reference Manual
Internal electrodes – Do not connect the programmer to wires or electrodes internal to thebody. The programmer is designed to be medically safe only when attached to surfaceelectrodes.Internal RTC battery replacement – The real-time clock (RTC) battery, located inside theprogrammer on a circuit board, is not replaceable by the user. The battery needsreplacement if the time-of-day clock cannot keep time. Return the programmer to Medtronicfor replacement. Use of damaged equipment may impact user or patient safety.Light-emitting diode (LED) radiation – This device contains Class 1M LEDs. To avoid eyeinjury, do not view LEDs directly with optical instruments or magnifiers.Magnetic Resonance (MR) Unsafe – The programmer is MR Unsafe. Do not bring theprogrammer into Zone 4 (magnet room), as defined by the American College of Radiology.Measurement function – The programmer is also designed to detect and measure pulserate, AV interval and pulse width, and implantable device artifacts. The device takes thesedigital measurements with the assistance of optional skin electrodes. Medtronic and Vitatronmake no claims or warranties as to the effectiveness of the programmer as a diagnostic toolto the physician.Modification of equipment – Do not modify this equipment. Modifications may reducesystem effectiveness and impact user or patient safety.Programmer ventilation – Ensure that the fan is running and programmer ventilationopenings are not blocked, in order to prevent overheating. Overheating may causeequipment damage or user or patient safety.Supply mains with protective earth – To avoid the risk of electric shock, connect thepower supply only to a hospital-grade supply mains receptacle which has a protective earth.If the integrity of the supply mains protective earth is in doubt, operate the device using thecharged internal battery only.Use of approved components – Use the specified, Medtronic-supplied power cord, powersupply, battery, and components only. The battery is a custom component designed to beused solely in the programmer; replace with and use only the battery supplied by Medtronic.Use of unapproved components may reduce device effectiveness or impact user or patientsafety.Use of unapproved ports and connections – Do not connect unapproved or unsupportedequipment or components, such as a docking station, to the programmer. Use ofunapproved components may damage equipment or impact user or patient safety.Use of unapproved power supply – Use only the Medtronic-supplied power supply model26907 (APS100EM-190530) with the programmer. Use of an unapproved power supply maydamage equipment or impact user or patient safety.Medtronic CARELINK ENCORE™ 29901Reference Manual 15
Use of wireless devices – The programmer incorporates radio-frequency (RF)communications components which may affect other devices and equipment in the medicalenvironment. The use of wireless devices in the medical environment must be evaluated andauthorized by the responsible organization. RF interference may affect device performance.1.8 PrecautionsCare in handling ECG cable wire – Do not pull on the insulated cable wire to disconnectthe cable. Tension on the insulated cable wire may result in damage to the cable.Electrocautery/external defibrillation – Do not position the programming head over animplanted device during electrocautery or external defibrillation procedures.Do not immerse – Take care to prevent liquid from entering the programmer andprogramming head. Do not immerse the programmer or any accessories in any liquid orclean them with aromatic or chlorinated hydrocarbons.Autoclaving – Do not autoclave the programming head or ECG cable and lead wires.Electromagnetic interference (EMI) – The programming head has been tested forcompliance with industrial and medical EMI regulations. Any use outside the patientenvironment may result in the programming head malfunctioning.Radio-frequency (RF) interference – Portable and mobile RF communicationsequipment can interfere with the operation of the programmer. Although this system hasbeen approved, there is no guarantee that it will not receive interference or that any particulartransmission from this system will be free from interference.Damaged equipment – If the case of the programmer is cracked or if any of the connectorsare damaged, contact your Medtronic or Vitatron representative. If there is insulationdamage to the power cord or accessory cables or if any of the wall or equipment plugs aredamaged, replace the part and dispose of it according to local regulations or return the partto Medtronic.Electrode quality – Use of high-quality silver/silver chloride (Ag/AgCl) electrodes canminimize the occurrence of small DC voltages that can block the ECG signal. Use electrodesthat are fresh and from the same box. Prepare the patient’s skin according to the directionsprovided with the electrodes.Avoid damage from programming head – Keep the programming head away from anydevice or material that will be damaged by the magnetic field, including magnetic media,watches, and other electronic devices.Finger injury – Do not place fingers in the hinge area when opening or closing the stand. Donot place fingers near the storage doors when opening or closing the storage doors. Apainful pinch may result.Medtronic CARELINK ENCORE™ 2990116 Reference Manual
Programmer and power cord positioning – Position the programmer and power cord sothat the power cord can be easily accessed and disconnected. If it is necessary to removethe programmer from the AC mains, the power cord is the power disconnect at the mainsoutlet.Connection or disconnection of programming head – Do not connect or disconnect theprogramming head while the programmer power is on. Disconnecting the programminghead causes an error that requires the programmer to be shut down and restarted.Product and packaging labels and information – If labels or information appear to bemissing from the product or packaging, contact your local Medtronic representative at theaddress and telephone number located on the back cover of this document.1.8.1 Environmental precautionsTo ensure safe and effective operation, use the device with care to avoid damage to theprogrammer from environmental factors that may impair its function. Care is exercised indesign and manufacturing to minimize damage to devices under normal use. However,electronic devices are susceptible to many environmental stresses including, but not limitedto, the following examples.●The unit is designed to be used indoors in a clinic or hospital.●The unit should not be dropped or mishandled in such a manner as to cause physicaldamage to the unit. This may impair device function. Even if the unit works immediatelyafter being dropped, operational damage may have occurred that may not be observeduntil some future time.●Fluid should not be spilled on the unit. Even though care is exercised in design andmanufacture of the unit to minimize leakage, fluid incursion may occur, which couldimpair functioning of the unit.●The programmer may be affected by electrostatic discharge (ESD). In an environmentlikely to cause ESD, such as a carpeted floor, discharge any charge collected on yourbody before touching the device.●The programmer should be placed on a table or other hard surface and positioned toavoid contact with the physician or patient; it is not intended to be used while supportedby or in contact with the physician or patient.●The programmer should maintain a distance of at least 20 cm away from patients andclinicians when the programmer is using Wi-FI or Bluetooth radios.●Printers and other connected office equipment should be placed at least 1.5 m from thepatient environment.Medtronic CARELINK ENCORE™ 29901Reference Manual 17
●Electrically-operated medical devices, such as the programmer require special care (interms of electromagnetic compatibility) when being installed. Refer to theaccompanying insert: Electromagnetic Compatibility Declaration.●Do not open the device. The programmer is constructed to minimize risk fromenvironmental factors. Opening the unit may make the unit susceptible to environmentalfactors and may expose the patient or user to hazardous voltage or current.●Rapid temperature changes may affect proper operation. Always allow the temperatureto stabilize in the environment in which the device is used before using the device.●Prolonged storage or operation of the device in high humidity may affect properoperation.If there is any concern that damage has occurred, the unit should be returned to Medtronicor Vitatron for inspection and any needed repair.Besides these listed examples, various other environmental factors may impair properperformance of the unit in the hospital setting. Always use good health managementpractices to prevent environmental damage to the unit.1.9 Declaration of ConformityMedtronic declares that this product is in conformity with the essential requirements ofDirective 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive90/385/EEC on Active Implantable Medical Devices (AIMD).For additional information, contact Medtronic or Vitatron at the telephone numbers andaddresses provided on the back cover.Medtronic CARELINK ENCORE™ 2990118 Reference Manual
1.10 Regulatory compliance1.10.1 US Federal Communications Commission (FCC)See label on bottom of programmer for specific ID number for your programmer.1.10.1.1 The following provision applies to the low frequencycommunications system in the device:This device complies with Part 15 of the FCC Rules. Operation is subject to the following twoconditions: (1) this device may not cause harmful interference, and (2) this device mustaccept any interference received, including interference that may cause undesiredoperation. The user is cautioned that changes or modifications not expressly approved bythe party responsible for compliance could void the user’s authority to operate theequipment.1.10.2 Industry CanadaSee label on bottom of programmer for specific ID number for your programmer.Operation is subject to the following two conditions: (1) this device may not causeinterference, and (2) this device must accept any interference, including interference thatmay cause undesired operation of the device.This device may not interfere with stations operating in the 400.150-406.000 MHz band inthe meteorological aids, meteorological-satellite, and earth exploration-satellite servicesand must accept any interference received, including interference that may cause undesiredoperation.1.11 Programmer functionsThe following list summarizes some of the programmer functions. Specific functions dependon the implantable device model being programmed or monitored and the software installed.1.11.1 Programming functions:●Permanent and temporary adjustment of parameter values.●Selection of nominal parameter values established by Medtronic, Vitatron or by the user.●Emergency button for VVI pacing.Medtronic CARELINK ENCORE™ 29901Reference Manual 19
1.11.2 Telemetry functions:●Automatic detection of the device model, and automatic application start-up, if theprogramming head is in proper position when the programmer is turned on.●Automatic confirmation of a programmed change.●Reporting of currently programmed parameter values in effect, battery status of theimplanted device, saved implantable system information, and patient status information.●Display and save as a PDF file an atrial and/or ventricular intracardiac electrogram(EGM) taken from the electrodes of the implantable device lead system or MarkerChannel telemetry.1.11.3 ECG functions:●Live Rhythm Monitor window on programming and telemetry data screens provides acontinuous view of the patient’s ECG.●Full-window Live Rhythm display including a freeze option and an amplitude adjustmentfeature; Live Rhythm display includes Marker Channel telemetry, EGM waveforms, orboth when available.●Continuous multi-channel storage.●Stimulation threshold test functions.●Direct measurement of pulse rate, AV interval, and pulse width from the desktop.Warning: Do not use the programmer ECG display for recording or diagnosis. Use aseparate ECG device if recording or diagnostic ECG capabilities are required.1.11.4 Software update function:●Automated software updates using a wireless or local area network (LAN) connection.This connection allows the programmer to program new devices and to provide newfeatures as they become available.●Updates available from Medtronic personnel.●Clinical software applications that have Uninstall Software capability may be removedusing the programmer desktop.Medtronic CARELINK ENCORE™ 2990120 Reference Manual
1.12 Security features of the programmerGood security practices are needed to protect patient data and the integrity of anynetwork-connected product. The programmer incorporates features that facilitatemanagement of security. These features work in conjunction with the security practices ofhospitals and clinics to provide safe and secure operation of the programmer and protect theattached network.1.12.1 How the programmer promotes securityAll installed software has been approved by Medtronic. It is not possible to install generalpurpose software on the programmer. Controlling installed software minimizes the potentialfor vulnerabilities. Internal software that runs the programmer is locked from change. Everytime the programmer is started, a clean version of the installed software is used.Patient data is encrypted. The length of time that patient data can be stored on theprogrammer is limited. The programmer limits patient data stored on the programmer bydeleting it after at most 14 days. When patient data is removed from the programmer, it iscompletely erased so that it is no longer recoverable.The programmer limits how it communicates on a network. When communicating on anetwork, the programmer uses industry-accepted protocols for authenticating servers andencrypting transmitted data. Only required network connections are open. Networkcommunications are originated by the programmer. Unauthorized software is not permittedto originate communications with the programmer.Unsupported hardware, including unsupported USB devices, is ignored by the programmerand is not accessed.Medtronic continues to work with its partners to analyze emerging threats and evaluatepotential impact on the programmer.1.12.2 What hospitals and clinics can do to promote the security ofprogrammersMaintain good physical controls over the programmer. Having a secure physicalenvironment prevents access to the internals of the programmer.Only connect the programmer to managed, secure networks.Update the software on the programmer when Medtronic updates are available.Medtronic CARELINK ENCORE™ 29901Reference Manual 21
1.12.3 What to do if you suspect the programmer has been compromisedIf you believe that the programmer has been compromised by a security threat, turn off theprogrammer, disconnect it from the network, then restart the system. Discontinue use of theprogrammer if it does not behave as expected. Contact your Medtronic or Vitatronrepresentative for further assistance.1.13 Software requirementsThe programmer requires software from Medtronic and Vitatron to operate. Once installed,the software remains on the programmer.Medtronic and Vitatron periodically update the software to add functions to the programmer.The programmer will not operate properly without the appropriate software installed. If theprogrammer does not operate properly, check the version of software that is loaded on theprogrammer, and update it if necessary.1.14 Compatible componentsThe following compatible components are available for the programmer:●Battery 26902●EC 2090 ECG Cables, Electrode Lead Wires, and Plug●EC ECL 2090 ECG Cables, Electrode Lead Wires, and Plug●Power Cord 26906●Power Supply 26907 (APS100EM-190530)●Programming Head 26901●Stylus and Tether 26905Contact your local Medtronic representative to order them.The following components are available as repair parts during authorized service only:●Articulating Stand 26909●Storage Doors 26908Medtronic CARELINK ENCORE™ 2990122 Reference Manual
1.15 Obtain technical manualsMedtronic technical manuals, including the manual you are reading, are available in anumber of different formats from the Medtronic eManuals website listed on the back cover ofthis manual. The website offers real-time access to the latest version of manuals 24 hoursper day, seven days per week. Manuals can be viewed online, downloaded for viewing orprinting, or ordered from the website.All manuals are available online in English. Most manuals are also available in additionallanguages in online, CD-ROM, or paper format. New manuals are added to this site regularly.If you do not find the manual you want, contact your Medtronic or Vitatron representative.Your order for CD-ROM or printed versions of manuals ships from our facility within 24 hoursand should reach you within 3 business days. If you need a copy before the shipment arrives,download the manual and print it, or contact your Medtronic or Vitatron representative.1.15.1 Access the eManuals website1. Point your browser to the address listed on the back cover of this manual.2. Select location and language, and click [Continue].3. Select one or more manual languages, and click [Continue].To see lists of CRDM manuals, click the desired category on the left of the screen. You canalso search for manuals using a product name or model number.Medtronic CARELINK ENCORE™ 29901Reference Manual 23
2 Set up the programmer2.1 System componentsFigure 1. Programmer components - front view1 Programming head2 Button panel3 Stylus and Tether4 Product documentation5 Ethernet cable (not supplied)6 Display screen7 Battery8 Power cord9 Power supply10 Electrode leads (not supplied)11 ECG cable with plug (not supplied)Warning: Use only the specified, Medtronic-supplied power cord, power supply, andcomponents. Use of unapproved components may reduce device effectiveness or impactpatient health.Programming head – Provides the communication link between the programmer and thepatient’s implantable device. The programming head contains a strong permanent magnet,radio-frequency (RF) transmitter and receiver, and light array. It must be held over theimplantable device during a program or interrogate operation.Medtronic CARELINK ENCORE™ 2990124 Reference Manual
Display screen – Display can be positioned horizontally, vertically, or at an angle.Programming options are selected on the screen with the stylus.Stylus – Used to select options on the display screen. Predetermined options are selectedby applying the stylus to the screen.Ethernet cable – Used to connect the programmer to the clinic’s network. The Ethernetcable must be Category 5 or better. (Not supplied by Medtronic.)Power cord – Connects the power supply to an AC power outlet.Power supply – Connects the programmer to the power cord.Electrode leads/ECG cable – Connects the programmer to skin electrodes on the patientfor ECG and measurement functions requiring surface detection of cardiac and implantabledevice signals. Four color-coded lead wires connect the cable to standard, disposable skinelectrodes applied to the patient. (The electrode leads/ECG cables are optional.)Figure 2. Right view1 ExpressCard slot2 Battery coverExpressCard slot – Intended for future use.Battery cover – Covers the battery compartment. Push the cover forward and slide it out toinsert or remove the battery.Medtronic CARELINK ENCORE™ 29901Reference Manual 25
Figure 3. Left view1 USB ports2 VGA output port3 Integrated Ethernet4 Power inputUSB port(s) – Allows installation of software, software updates, and future deviceapplication installations. The USB port can also be used to connect to a USB printer or a USBflash drive.VGA output port – Allows porting the screen image of the programmer to an external VGAmonitor or for conversion of the output signal to NTSC/PAL format for presentation on atelevision monitor.Integrated Ethernet – Allows the programmer to connect to the Software DistributionNetwork and the Paceart data management system using an Ethernet connection.Power input – Used to connect the programmer to an AC power outlet using the powersupply and power cord.Medtronic CARELINK ENCORE™ 2990126 Reference Manual
Figure 4. Back view (doors open)1 Programming head connector2 ECG cable connector2.2 Programmer button panelFigure 5. Programmer button panelThe programmer button panel contains these buttons and indicators:Medtronic CARELINK ENCORE™ 29901Reference Manual 27
Table 1. Buttons and indicators on the programmer button panelButton or indi-cator Name FunctionElectronic Strip Chart(eStrip) buttonUsed to insert a highlight into the recorded Elec-tronic Strip Chart (eStrip) waveform data.Emergency VVI button Provides immediate access for emergency VVIpacing during a session.RFID button Not used.Bluetooth button Used to enable or disable Bluetooth power. Forinformation about programmer Bluetooth capa-bility, see Section 2.5.4.2.Wi-Fi button Used to enable or disable Wi-Fi power.Battery Status indicator Provides information about the status of the bat-tery.Battery Charge indicator Provides information about the charge of the bat-tery.Power button Turns on and turns off the programmer.2.3 Basic setupBefore setting up the programmer, select a sturdy location for it without blocking the air ventson the back. The programmer uses an AC power supply and has a backup battery. To use thepower supply, the location of the programmer must be near a hospital-grade supply mainsreceptacle which has a protective earth.This section describes how to:●Attach and store the stylus●Connect the programming head●Install the battery●Connect the power supplyMedtronic CARELINK ENCORE™ 2990128 Reference Manual
●Turn on the programmer●Position the programmer●Connect the ECG cable●Troubleshoot potential interference2.3.1 Attach and store the stylusFigure 6 shows how to attach and store the stylus.Figure 6. Attach and store the stylus1 Attach one end of the tether to the stylus and the other end to the programmer.2 Store the stylus in the handle of the programmer by inserting it into the hollow end of the handle,tip first.Medtronic CARELINK ENCORE™ 29901Reference Manual 29
2.3.2 Connect the programming head1. Open the door on the left rear of the programmer.2. Line up the black arrows on the programming head cable and the programming headconnector.3. Plug the cable into the programming head connector with the yellow marker.4. Close the door, making sure the cable passes through the notch on the bottom of thedoor.Warning: Do not connect or disconnect the programming head while the programmer poweris on. Disconnecting the programming head causes an error that requires the programmerto be shut down and restarted.Medtronic CARELINK ENCORE™ 2990130 Reference Manual
2.3.3 Install the battery1. Open the battery door on the lower right side of the programmer by pressing forward onthe battery door recess and flipping the door to the left.2. Slide the battery in until you hear it click into position. The battery is kept in position bya hook located on the bottom of the opening.3. Close the battery door.Caution: If the programmer is operating on battery power during a patient session, eitherend the patient session or connect the programmer to AC power before removing the battery.If the battery is removed during a patient session and the programmer is not connected to ACpower, the patient session will end, the programmer will turn off, and any unsaved patientdata will be lost.Notes:●The battery can be installed or replaced while the programmer is turned on if theprogrammer is operating on AC power.●The battery is supplied partially charged. After installing a new or replacement battery,connect the power supply and charge the battery for 2 hours before operating theprogrammer on battery power.Medtronic CARELINK ENCORE™ 29901Reference Manual 31
2.3.4 Connect the power supply1. Open the power input cover on the lower left side of the programmer.2. Plug the power supply into the programmer.3. Plug the power cord into the power supply.4. Position the programmer and power cord so that the power cord can be easily accessedand disconnected.5. Plug the power cord into the AC power outlet (AC mains).Note: If it is necessary to remove the programmer from the AC power outlet (AC mains), thepower cord is the power disconnect at the mains outlet.Warnings:●To avoid the risk of electric shock, connect the power supply only to a hospital-gradesupply mains receptacle that has a protective earth. If the integrity of the supply mainsprotective earth is in doubt, operate the device using the charged internal battery only.●Use only the specified, Medtronic-supplied power cord, power supply, and components.Use of unapproved components may reduce device effectiveness or impact patienthealth.Medtronic CARELINK ENCORE™ 2990132 Reference Manual
2.3.5 Turn on the programmer1. Locate the Power button on the front right corner of the programmer button panel.2. Press and release the Power button.2.3.6 Position the programmerThe programmer can be positioned horizontally or at an angle.1. To position the programmer at an angle, pull out the stand on the rear of theprogrammer.2. Place it at a comfortable viewing angle.Medtronic CARELINK ENCORE™ 29901Reference Manual 33
Caution: Do not place fingers in the hinge area when opening or closing the stand. A painfulpinch may result.2.3.7 Connect the ECG cable1. Open the right rear door.2. Line up the ECG cable with the arrow next to the ECG connector.3. Plug the cable into the connector.4. Close the door, making sure that the cable passes through the notch on the lower leftside.Notes:●Improper insertion of the ECG cable plug may damage the connector pins.●The ECG cable and electrode leads are not supplied with the programmer.Medtronic CARELINK ENCORE™ 2990134 Reference Manual
2.3.8 Troubleshoot potential interferenceTo address possible harmful interference between the programmer and other devices, youare encouraged to take one or more of the following measures to address the situation:●Reorient or relocate the devices.●Increase the separation between the devices.●Connect the equipment to an outlet on a different circuit.●Consult Medtronic or Vitatron for help.2.4 Charge the battery2.4.1 About battery chargeWhen the programmer is connected to AC power, the battery automatically charges until itreaches a full charge. Charging occurs when the unit is turned on, turned off or hibernating.Typically an empty battery can be fully charged in two hours. A new, fully charged batteryoperates for 1.75 hours (typical).Warning: Use the programmer for charging batteries, by installing the battery andconnecting the power supply. Unapproved charging equipment may damage the battery orcause excessive heating, battery case rupture, or ignition of the battery cells. Use of adamaged battery may damage equipment or cause user or patient injury.2.4.2 Battery status indicatorsThere are two battery indicators on the programmer button panel that indicate the batterystatus and the charging status, when active, as shown in Figure 7. The indication variesdepending on the operating condition (power state) of the programmer.Figure 7. Battery indicators1 Battery Status indicator2 Battery Charge indicatorMedtronic CARELINK ENCORE™ 29901Reference Manual 35
Table 2. Indicator color and indicationIndicator IndicationBattery Status indicator is solid amber The programmer is running on battery power,battery power is 20% or less than the full charge,and the programmer should plugged into ACpower to be recharged.Battery Status indicator is flashing amber The programmer is running on battery power,battery power is critically low, and the program-mer needs to be plugged in to AC power imme-diately to prevent shutdown.Battery Charge indicator is solid green The programmer is running on AC power and thebattery has more than 90% of the full charge.Battery Charge indicator is flashing green The programmer is running on AC power and thebattery has less than 90% of the full charge.If the programmer is running on battery power and the battery power is getting low, theBattery Power icon displays the power as yellow and a message displays a caution:“Programmer battery is low. Connect the programmer to outlet power or continue at risk oflosing power. Estimating 20% or less programmer battery power remaining.”.If the programmer is running on battery power and battery power is critically low, the BatteryPower icon changed to a caution symbol and displays a warning: ”Critically low programmerbattery. Programmer will shut down. Plug in the programmer immediately to prevent shutdown.”. The programmer beeps once every 30 seconds and the Battery Power icon bouncesevery 30 seconds for 9 seconds until it is replaced by another icon or you select the warning.Warning: If you receive a message on the programmer to replace the battery, you need toreplace the battery with a new battery. Use of a failed battery will reduce programmeroperating time and may cause user or patient injury.2.4.3 Battery pack indicatorsIn addition to the battery status indicators, the battery pack itself provides information aboutthe remaining charge and the charge capacity. By pressing the button on the front side of thebattery pack for less than 2 seconds, the indicator lights are lit displaying the remainingcharge:●The first 4 lights each represent 20% of the total charge.●The fifth light represents a minimum of 15% of the total chargeFor example, if all 5 lights are lit, the remaining charge is more than 95% of the original/newcharge capacity. If only 2 lights are lit, the remaining charge is more than 40% but less than60% of the original/new charge capacity.Medtronic CARELINK ENCORE™ 2990136 Reference Manual
By holding the button for more than 5 seconds until the lights start to flash, the indicator lightsdisplay the indication of how the charge capacity has degraded with respect to the originaldesign capacity after an amount of time or number of charge cycles.Figure 8. 80-100% of the original/new charge capacityFigure 9. 60-79% of the original/new charge capacityFigure 10. Less than 40% of the original/new charge capacityCheck the battery charge capacity periodically with the built-in indicator. Replace the batterypack when the battery charge capacity is less than 60% of the original/new charge capacity,and/or when the battery charge time increases significantly.2.5 Use external printersConnecting a compatible printer to the programmer allows you to print full, page-size reportsof session data when available. For more information, see the reference guide for theimplanted device. This section describes how to connect a printer to your programmer.Medtronic CARELINK ENCORE™ 29901Reference Manual 37
All printers listed by this software are certified to IEC 60950-1, UL 60950-1 or equivalent.Only printers listed by this software may be connected to the programmer.2.5.1 Printer compatibilityThe programmer is compatible with many printers. A list of compatible printers can beaccessed from the Print Queue screen.Note: When programming a Vitatron device, refer to the applicable Vitatron reference guidefor information about printing.2.5.2 View a list of supported printers1. If you are conducting a patient session, press the Reports icon, and then selectPrint Queue.If you are not conducting a patient session, press the Print Queue icon.2. On the Print Queue screen, select the Printer field to open the list of supported printers.2.5.3 Materials you needTo connect the programmer to a printer, you need either a Bluetooth printer or a USB printercable. One end of the USB cable must be a USB Type A connector. The other end of thecable must fit the USB port on your printer.Note: For information about programmer Bluetooth capability, see Section 2.5.4.2.2.5.4 Connect the printerNote: The connection method you use depends on your printer.Medtronic CARELINK ENCORE™ 2990138 Reference Manual
2.5.4.1 Connect to a printer with a USB cable1. To connect to a printer with a USB cable, locate a USB port. There are two USB portslocated on the left front side of the programmer.2. Open the input cover on the upper left side of the programmer.3. Connect the printer cable to a USB port on the programmer.4. Connect the other end of the cable to the printer. Connect the printer power cord to anoutlet and turn on the printer. Make sure that the printer has paper.5. Turn on the programmer and select the Print Queue icon.6. If not previously done, select the correct printer driver from the options listed when youselect the Printer field on the Print Queue window. You are now ready to use yourprogrammer with the connected printer.Medtronic CARELINK ENCORE™ 29901Reference Manual 39
2.5.4.2 Connect to a printer with Bluetooth (Bluetooth enabledprogrammers only)1. To connect to a printer with Bluetooth, turn on the programmer and turn the Bluetoothradio on for the programmer by pressing the Bluetooth button on the programmerbutton panel.Note: Your programmer may or may not have Bluetooth capability. If the Bluetoothbutton does not illuminate when pressed, your programmer is not enabled for Bluetoothprinting.2. Connect the printer power cord to an outlet and turn on the printer. Turn Bluetooth on forthe printer.Note: For more information on turning on Bluetooth for the printer, refer to the printermanual.3. Launch the Bluetooth configuration application by pressing the Bluetooth icon on theprogrammer taskbar.4. Press [Search] to search for available Bluetooth printers. If the Bluetooth radio isdisabled on the programmer, a message is displayed that you need to enable theBluetooth radio on the programmer by pressing the Bluetooth button on theprogrammer button panel.5. The Pair Bluetooth Printer window is displayed listing the available Bluetoothprinters. Select the printer you would like to pair with the programmer.Note: Only one printer can be paired with the programmer. To pair a new printer with theprogrammer, you must unpair the currently paired printer.6. Press [Pair]. Depending on your printer configuration, you will use one of the followingmethods to pair to the printer:●Enter the printer PIN on the programmer●Enter the Passkey (PIN) on the printer●Confirmation code sent to the printerMedtronic CARELINK ENCORE™ 2990140 Reference Manual
The programmer will automatically identify which method is needed to pair with aspecific printer.a. To pair using a PIN, enter the PIN code found on the printer or in the printer manual.The PIN can be between 1 and 16 characters. When you tap the PIN text field theon-screen keyboard is displayed. Enter the PIN with the on-screen keyboard in thePair Bluetooth Printer window. After the PIN has been entered, press [OK].b. To pair using a passkey, enter the PIN from the Pair Bluetooth Printer window onyour printer. The dialog automatically closes if the passkey is entered correctly.Note: The passkey is referred to as a “PIN”, but it is different from the PIN suppliedby the printer and entered on the programmer.c. To pair using a confirmation code, the programmer generates a code and sends itto the printer. The Pair Bluetooth Printer window displays the confirmation code.Confirm that the correct code was sent to the printer and press [Yes].7. The Pair Bluetooth Printer window shows a pairing activity indicator. When pairinghas completed successfully, the Configure Bluetooth window confirms that theprinter you selected is currently paired.8. Select the Print Queue icon.Note: Be sure to select the correct printer driver from the options listed when you selectthe Printer field on the Print Queue window. Make sure that the printer has paper. Youare now ready to use your programmer with the paired printer.Medtronic CARELINK ENCORE™ 29901Reference Manual 41
3 Configure the programmer3.1 Display screen featuresThe programmer display screen is a touch-sensitive interface that displays text andgraphics. It is also a control panel that displays buttons and menu options that you can select.3.1.1 Features and conventions of the display screenThis section provides an overview of the features of the display screen. For more information,see the reference guide for the implanted device. The main elements of a typical displayscreen before you select a model, when you turn the programmer on, and when you end apatient session, are shown in Figure 11.Figure 11. Main elements of the display screen1 Task bar2 Status bar3 Live Rhythm Monitor window4 Waveform adjustment bars5 Task area6 Command bar7 Buttons8 Tool paletteMedtronic CARELINK ENCORE™ 2990142 Reference Manual
Vitatron display screens may be different. For more information, see the reference guide forthe implanted device. If you see a Medtronic/Vitatron switch button, press it to display theVitatron Select Model screen.3.1.1.1 Task barThe task bar can contain these icons/indicators:Table 3. Task bar icons/indicatorsIcon Name FunctionTelemetry strength Turns green to indicate successful communicationbetween the programming head and the device. Moregreen bars on the array indicates better communication. Aminimum of two green bars should be lit. An amber lightmeans the device is out of range.SessionSync Provides information about the connection and data trans-fer status between the Programmer and the data manage-ment system. SessionSync is an optional feature.External USB drive Turns green to indicate a USB flash drive or other externalstorage media are available for saving PDF reports andpatient data. When inserting a USB flash drive, you mayexperience a slight delay before the device is available foruse.AC Power Appears in the taskbar to indicate that the programmer isconnected to AC power.Battery Power Provides information about the status of the battery powerwhen the programmer is not connected to AC power.Bluetooth configuration Opens the Configure Bluetooth window for connecting aBluetooth-enabled printer to the programmer. For informa-tion about programmer Bluetooth capability, see Sec-tion 2.5.4.2.Network Configuration Opens the Network Configuration window for configuringnetwork preferences.PDF Viewer Used to view PDFs from a USB flash drive. PDFs can beviewed while in a device application or on the programmerdesktop.Medtronic CARELINK ENCORE™ 29901Reference Manual 43
Table 3. Task bar icons/indicators (continued)Icon Name FunctionElectronic Strip Chart(eStrip) selectorUsed to go to the Electronic Strip Chart (eStrip) recorderscreen.Device ApplicationselectorUsed to go to the Select Model screen on the programmerdesktop. During a patient session, the indicator box turnsblue to indicate that the programmer is on a device appli-cation screen.3.1.1.2 Status barBefore selecting a model, the status bar has no information. For specific information aboutthe status bar, refer to the reference guide for the implanted device. After model selection,the status bar may include:●The present pacing mode.●Test condition status.●The device model.3.1.1.3 Live Rhythm Monitor windowThis window is a partial view of the full-screen display of the ECG, and contains a Waveformadjustment bar that allows you to change the size of the waveform. You can expand thiswindow to full size by selecting the small square button in the upper-right corner of thewindow or by pressing [Adjust…].After model selection, Marker Channel and telemetered EGM waveform traces may beavailable.3.1.1.4 Task areaThe portion of the screen between the Live Rhythm Monitor window near the top of thescreen and the command bar at the bottom of the screen changes according to the task orfunction you select.3.1.1.5 Command barThe bar at the bottom of the screen shows the command buttons for automatically launchingthe proper software application and displaying the Vitatron Select Model screen. Forinformation on what command buttons are available after selecting a model, see thereference guide for the implanted device.Medtronic CARELINK ENCORE™ 2990144 Reference Manual
3.1.1.6 ButtonsButtons allow you to operate the programmer. You can “press” a button by touching it with thetip of the stylus or your finger.Buttons may directly execute a command, such as [Freeze], or they may open a window thatprompts another action. Buttons that open a window usually have a label ending with anellipsis, such as [Strips…] or [Adjust…].A procedure may instruct you to “press and hold” a button. Press the button and maintainpressure until it is time to “release” the button.When a button is inactive, it appears a lighter color and does not execute a command whenyou press it.3.1.1.7 Tool paletteThe collection of buttons and icons along the edge of the screen is referred to as the “toolpalette”. These buttons and icons are the controls you use to choose the task or functionscreen you want to display. Each of the icons acts like a button. Touch the icon to select it. Formore information, see Section 3.2. For information about the session tool palette, see thereference guide for the implanted device.3.2 About the Between Patient Sessions tool paletteThe Between Patient Sessions tool palette is on the Select Model screen. The Select Modelscreen appears before you select a model, when you turn the programmer on, and when youend a patient session.The tools that are available between patient sessions are described in Table 4.Note: When programming a Vitatron device, refer to the applicable reference guide forinformation about the tool palette.Table 4. Between Patient Sessions tool paletteTool Selecting the tool (button or icon)…Freezes a segment of the live rhythm display.Note: A frozen strip can be viewed, printed, or saved to PDF betweenpatient sessions. Markers and EGM traces are not present betweenpatient sessions.The [Strips…] button is not available between patient sessions. Savedrhythm strips can only be accessed during a patient session.Opens a window of options for adjusting the live rhythm display.Note: Additional adjustment options are present during a patient session.Medtronic CARELINK ENCORE™ 29901Reference Manual 45
Table 4. Between Patient Sessions tool palette (continued)Tool Selecting the tool (button or icon)…Displays the screen for selecting a model and starting a patient session.Displays a queue of print requests from previous sessions as well as frozenwaveform reports requested between sessions. Refer to the referenceguide for the implanted device to determine if these features are available.Displays the programmer setup options.PreferencesTime and DateArtifact DetectionSoftwareDemonstrationsProgrammer ProfileSessionSync StatusSessionSync Network Configuration…Other SoftwareToolsLicensingNote: When some functions are active on the display, pressing a tool button or icon has noeffect. Closing the active window restores operation of the tool palette.3.3 Change the language settingThe software is translated into several languages. Use the following procedure to determinewhich languages are available. For Vitatron devices, see the applicable reference guide.3.3.1 Choose a language1. Press the Programmer icon, and then select Preferences.2. From the Preferences screen, select the Language field to display the options.Note: The programmer screen goes blank for about 2 minutes after selecting a language.The programmer then resumes operation in the selected language.Medtronic CARELINK ENCORE™ 2990146 Reference Manual
3.4 Use the on-screen keyboardThe on-screen keyboard is used for entering text into an editable field. When you tap in aneditable field, the on-screen keyboard displays. When you tap outside the editable field, theon-screen keyboard stops displaying. For fields that have frequently re-used names, termsor medical terminology, a selectable library displays when the field is selected. The libraryprovides you with the ability to add or reuse words when entering text.3.5 View and update programmer location andhardware informationInformation about the location of the programmer and its hardware is on the ProgrammerProfile screens.The Programmer Profile location screen has the following information:●Clinic’s name, address, telephone number, contact person, and customer accountnumber●Service representative’s name, telephone number, fax number, and e-mail addressThe Programmer Profile hardware screen has the model and serial numbers for theprogrammer. You can also enter the model and serial numbers for the programming head.Information on the screen may be updated by selecting the appropriate field and then usingthe keyboard.3.5.1 Verify Programmer Profile informationEach programmer has a profile screen that contains identifying information about theinstalled hardware, the programmer location, and contact information for the Medtronicservice representative.Typically, the profile is completed when the programmer is first installed, and then updatedonly when necessary.1. Press the Programmer icon, and then select Programmer Profile. LocationInformation appears by default.2. Complete the location information or verify that the information shown is correct.3. To view hardware information, select Hardware Information.Medtronic CARELINK ENCORE™ 29901Reference Manual 47
Figure 12. Programmer Profile screen 3.6 Adjust programmer time and dateIf the time or date displayed and printed by the programmer is incorrect, use the followingprocedure to enter the correct settings. For Vitatron devices, see the applicable referenceguide.3.6.1 Set the time and date1. Press the Programmer icon then Time and Date.2. From the Programmer Time and Date screen, press the up or down button to increaseor decrease the value for the unit of time you want to change. Press and release thebutton for single unit changes or press and hold the button to effect greater changes.3. When all fields show the correct time and date, press [Apply]. Select another toolpalette icon to close the Programmer Time and Date windowMedtronic CARELINK ENCORE™ 2990148 Reference Manual
Figure 13. Programmer Time and Date screenNote: Time must be entered based on a 24-hour clock, with 00:00 being midnight, and12:00 being noon.3.7 Select audible tonesCertain events in the operation of the programmer result in an audible signal. The followingtones alert you to the success or failure of an action.●A two-tone beep (low-to-high) indicates confirmation of an Interrogate or a Programcommand.●A double low-tone beep indicates that an Interrogate, Program, or Emergencycommand was not confirmed. It can also indicate that the selected command cannot beexecuted.Note: For some devices, the tones may not be turned off. For more information, see thereference guide for the implanted device. For Vitatron devices, see the applicable referenceguide.3.7.1 Turn tones on or off1. Press the Programmer icon, and then select Preferences.2. From the Preferences screen, select [Audio ON] or [Audio OFF] as desired.Medtronic CARELINK ENCORE™ 29901Reference Manual 49
Figure 14. Audio Preferences screen 3.8 Check the software versionThis section describes how to determine the version of software that is loaded on theprogrammer.If you need to know what version of software is currently loaded on the programmer for anyof the device models, use the following procedure.For Vitatron devices, see the applicable reference guide.3.8.1 To check the software version number1. Select Programmer, and then select Software.2. For each device model with software loaded on the programmer, the screen displaysthe software version number next to the model number.Medtronic CARELINK ENCORE™ 2990150 Reference Manual
Figure 15. Software on This Programmer screen Note: If the model that you require is not displayed, the software to support that model is notcurrently loaded on the programmer. Contact your Medtronic or Vitatron representative.3.9 Select other softwareIn addition to the standard application software, there are some programmers that haveother applications installed. These applications may include supplemental software orsoftware used in clinical studies for research. If you have other software installed, you mayaccess the software, using the following procedure.1. Press the Programmer icon, and then select Other Software.2. When the programmer displays the list of available software, select the application andpress [Start].3.10 Remove other software applicationsProgrammers with other software installed, such as supplemental software or those used inclinical studies for research, may allow the applications to be removed from the programmerdesktop. If you have software installed that permits removal, you may remove it using thefollowing procedure.Medtronic CARELINK ENCORE™ 29901Reference Manual 51
1. Press the Programmer icon, and then select Software.2. Press [Uninstall Software…].3. When the programmer displays the list of removable software, select the application tobe removed, and then press [Uninstall].4. Select the check box next to the acknowledgment statement, and then press[Continue].5. The software is removed, and the programmer reboots.6. Verify that the software has been removed.3.11 Improve the detection of pacing artifactsThe Artifact Detection function allows you to improve the detection of pacing artifacts wheninterference causes either false artifacts or no artifacts to appear on the patient’s ECG.Pacing artifacts are displayed on the patient’s ECG when the artifact detection option (ShowArtifacts) has been enabled.To determine if this feature is applicable, see the reference guide for the implanted device.3.11.1 Enable artifact detection1. Press the Programmer icon, and then select Artifact Detection.2. Make sure the current settings include ARTIFACT DISPLAY IS ON.3. Make sure the current settings include MV FILTER IS ON.3.12 Start the Demonstrations optionThe demonstrations option allows you to run a demonstration program on the programmer.For Vitatron devices, see the applicable reference guide.Note: Device applications and reference manuals may still refer to using the “demonstrationdisk” or “demonstration diskette” to run a demonstration program. The need for ademonstration diskette to access demonstration mode is no longer required. All referencesto a demonstration diskette can be ignored. All demonstration mode features are accessiblewith or without a demonstration diskette.Medtronic CARELINK ENCORE™ 2990152 Reference Manual
3.12.1 Access demonstrations1. Press the Programmer icon, and then select Demonstrations.2. From the Demonstration Model Selection screen, select the desired View option to listthe available demonstration programs.3. Select the desired demonstration program and press [Start] followed by [Continue].3.13 Configure network using the Network Configurationwindow3.13.1 About the Network Configuration windowFigure 16. Network Configuration windowThe Network Configuration window is used to set up connections to the Software DistributionNetwork (SDN) and SessionSync using wireless and Ethernet conections. The first time theNetwork Configuration window is accessed the Clinic Name field is empty. For SessionSync,the SessionSync Gateway Address field also needs to be filled in. Until the Clinic Name andSessionSync Gateway Address fields are filled in, the [OK] is disabled. After you click [OK],the values are saved and the dialog closes. The next time the dialog is opened, the fields willbe populated with the previously saved values and the [OK] will be enabled. If you manuallyclear one or more fields, the [OK] is disabled and the “Some fields empty…“ message isdisplayed in the entry error text box.Medtronic CARELINK ENCORE™ 29901Reference Manual 53
3.13.2 Configure network connection1. Press the Network Configuration icon on the task bar. The programmer displays theNetwork Configuration window.2. Select the radio button for SDN or SessionSync.Note: If you selected SessionSync, you also need to enter the SessionSync GatewayAddress. The field is visible only after selecting SessionSync.3. Enter the Clinic Name.4. Enter the Network Name (SSID). To select the Network Name from the AvailableNetworks, see Section 3.13.3.5. Select Network Authentication from the drop-down list.6. Enter Network Key.7. Re-enter the Network Key in the Confirm Network Key field.8. Press [OK].3.13.3 View available networksNote: Wi-Fi must be enabled to view available networks. Press the Wi-Fi button to enableWi-Fi. If there is an Ethernet connection when the Network Configuration window islaunched, a Wi-Fi connection cannot be established.1. Press [View Available Networks]. The View Available Networks dialog displays with nonetwork selected and the [OK] button disabled. When you select a network, the [OK]button is enabled.Note: If there are no available networks, the View Available Networks dialog will nothave any networks listed. If there are more than 3 available networks, the first three arevisible and a vertical scroll bar is displayed.2. After you select the network and press the [OK] button, the Network Name (SSID) fielddisplays the network you selected in the Network Configuration dialog.3.13.4 Test the network connectionAfter connecting to the network, you can test the connection to make sure the programmeris connected properly. From the Network Configuration window, press [Test NetworkConnection]. The Test Output: field displays the results of the test and is scrollable using theup and down arrows on the right.Medtronic CARELINK ENCORE™ 2990154 Reference Manual
Use the Test Network Connection feature if your programmer is having difficulty connectingto your clinic’s network. Contact Medtronic Technical Support if you need assistance ininterpreting results.3.13.5 Save network connection test results to media1. Connect a USB flash drive to the programmer.2. Press [Save To Media].Note: This button is available only if the Test Network Connection tests have been run.The programmer displays the Save to Media dialog.3. Press [Save].A text file (NtwkTestOutput.log) containing the test results is saved to the USB flash drive.Download the file to a compatible computer for viewing and/or transfer to Medtronicpersonnel.Medtronic CARELINK ENCORE™ 29901Reference Manual 55
4 Update programmer software using theSoftware Distribution Network4.1 The Software Distribution NetworkProgrammer software can be updated by Medtronic customers or Medtronic personnel byaccessing the Medtronic Software Distribution Network (SDN) and downloading thesoftware. The SDN uses a world-wide network to connect to servers in the United States.These servers are able to download software to many programmers simultaneously throughsecure connections.The SDN is available 24 hours per day, 7 days per week and always contains the most currentsoftware. For this reason, it is recommended that you download the software from the SDNrather than from the flash drive. You can connect to the SDN using a wired or wirelessnetwork connection.Notes:●It is recommended that the SDN be checked on a regular basis. Checking regularlyreduces the size of the download and the time it takes to receive the software.●If the download was interrupted, the download will resume the next time the programmerattempts to access the SDN.●Normal programmer functions are unavailable during software installation.4.2 Connect to the SDN using a wired network connectionYou can connect to the SDN using the Integrated Ethernet connection and your clinic’snetwork. By connecting through your network, software download time can be reduced.Before you begin, make sure that the Ethernet cable is correctly connected to the IntegratedEthernet connection.Medtronic CARELINK ENCORE™ 2990156 Reference Manual
4.2.1 Connect the Ethernet cable1. Open the input cover on the lower left side of the programmer.2. Connect the Ethernet cable to the Integrated Ethernet connection.3. Connect the opposite end of the Ethernet cable to a network jack.Medtronic CARELINK ENCORE™ 29901Reference Manual 57
4.2.2 How to connect to the SDN using a wired network connection1. Press the Programmer icon, and then select Software.The programmer displays the Software on This Programmer screen and lists thesoftware already installed on the programmer. For each model, the screen displays thesoftware version.Note: The SDN cannot be accessed from Vitatron screens. Change to the MedtronicSelect Model screen.2. Press [Install from Medtronic…].3. Follow the prompts that are displayed to start the download.orPress [Cancel]. The download process is canceled and the programmer redisplays theSoftware on This Programmer screen.Medtronic CARELINK ENCORE™ 2990158 Reference Manual
4. The programmer displays the Scheduled Software Update screen.Choose to either start the download at a particular time by selecting a time from theScheduled Update Time pull-down menu, or begin the download as soon as possibleby pressing [Start].5. The Scheduled Software Update window displays a countdown window showing howmuch time remains until the download begins. Press [Start Now] to override thecountdown or press [Cancel] to interrupt the countdown and the download request andreturn to the Software on This Programmer screen.Medtronic CARELINK ENCORE™ 29901Reference Manual 59
6. The programmer displays a list of software that will download and install.Note: Individual software cannot be selected or rejected.You may press [Stop] at anytime and resume the download at a future time.7. When the download is complete, the programmer disconnects from the SDN,automatically reboots, and displays a screen listing the software that was downloaded.8. To obtain technical manuals for the new software, see Section 1.15.9. Press the Select Model icon. The programmer is then available for patient use.Note: The first time the newly downloaded software is accessed, some additionalinstallation steps may be completed but these steps are automatic and no user interventionis requiredMedtronic CARELINK ENCORE™ 2990160 Reference Manual
4.3 Connect to the SDN using a wireless networkconnectionNote: Before you begin, make sure that the wireless connection is correctly configured. Formore information, see Section 3.13.4.3.1 How to connect to the SDN using a wireless network connection1. Press the Programmer icon, and then select Software.The programmer displays the Software on This Programmer screen and lists thesoftware already installed on the programmer. For each model, the screen displays thesoftware version.Note: The SDN cannot be accessed from Vitatron screens. Change to the MedtronicSelect Model screen.2. Press [Install from Medtronic…].3. Follow the prompts that are displayed to start the download.orPress [Cancel] if you do not agree to the terms. The download process is canceled andthe programmer redisplays the Software on This Programmer screen.Medtronic CARELINK ENCORE™ 29901Reference Manual 61
4. The programmer displays the Scheduled Software Update screen. Press [Configure].5. On the Scheduled Software Update screen, either choose to start the download at aparticular time by selecting a time from the pull-down menu, or begin the download assoon as possible by pressing [Start]. The programmer shuts down and displays awindow telling you to please wait.6. The Scheduled Software Update window displays a countdown window showing howmuch time remains until the download begins. Press [Start Now] to override thecountdown or press [Cancel] to interrupt the countdown and the download request andreturn to the Software on This Programmer screen.Medtronic CARELINK ENCORE™ 2990162 Reference Manual
7. The programmer displays a list of software that will download and install.Note: Individual software cannot be selected or rejected.You may press [Stop] at anytime and resume the download at a future time.8. When the download is complete, the programmer disconnects from the SDN,automatically reboots, and displays a screen listing the software that was downloaded.9. To obtain technical manuals for the new software, see Section 1.15.10. Press the Select Model icon. The programmer is then available for patient use.Note: The first time the newly downloaded software is accessed, some additionalinstallation steps may be completed but these steps are automatic and no user interventionis required.Medtronic CARELINK ENCORE™ 29901Reference Manual 63
5 Conduct a patient session5.1 Prepare for a patient sessionFamiliarize yourself with the information in this section before beginning a patient session.5.1.1 Connect the programmer to skin electrodesAt the start of each patient session, ECG cable leads must be connected to the patient todetect cardiac and pulse artifact signals.Note: The quality of disposable skin electrodes used with the programmer is important to theperformance of the programmer signal sensing functions. Chemical reactions occur at theelectrode/paste interface and produce small DC voltages that can block the ECG signal.Using high quality silver/silver chloride (Ag/AgCl) electrodes can minimize this problem.Electrodes should be fresh and from the same box. The patient’s skin should be preparedaccording to the directions provided with the electrodes.Protocols covering attachment of leads to disposable skin electrodes may vary. Leads maybe attached to the electrodes either before or after the electrodes are applied to the patient.The order of the following procedure is arbitrary.Warning: Do not connect the programmer to wires or electrodes internal to the body. Theprogrammer is designed to be medically safe only when attached to surface electrodes.5.1.2 Attach electrodesAttach four standard, disposable electrodes to the patient in the positions shown.Note: Electrodes are intended for one-time use and should not be reused.Medtronic CARELINK ENCORE™ 2990164 Reference Manual
5.1.3 Connect the ECG cable1. As shown, attach a color-coded lead wire to each of the four electrodes. Match a colorto each electrode as in Table 5.Note: The chest lead is not used. The middle cable port of the ECG cable is sealed offwith the chest ECG plug.2. Connect each lead wire to the ECG cable as in Table 6. Match each lead connector tothe proper cable port.Table 5. Electrode lead wire color codingAHA CodingaIEC CodingbBody AreaBlack Yellow to left armRed Green to left legGreen Black to right legWhite Red to right armaAmerican Hospital AssociationbInternational Electrotechnical CommissionTable 6. ECG cable color codingAHA Coding IEC CodingBlack to LA Yellow to LRed to LL Green to FGreen to RL Black to NWhite to RA Red to RMedtronic CARELINK ENCORE™ 29901Reference Manual 65
Note: Occasionally, mutual interference occurs between the programmer skin electrodesignals and signals from an external ECG recorder or monitor attached directly to the patient.This interference may cause erratic operation of the programmer functions that depend onsurface signal detection. If interference occurs, temporarily disconnect the leads from theattached ECG recorder or monitor. This interference does not affect the programmingfunctions of the programmer.5.1.4 Use the stylusThe stylus is used to select programming functions provided by the software. Proper use ofthe stylus is described in Figure 17 and in Section 5.1.5.You can also use your finger to make selections on the screen. However, for accuracy astylus is recommended. Because the screen is responsive to touch, avoid resting your handon the screen or touching multiple screen locations while using the programmer. Avoidpointing and touching the screen while others are using the programmer. You should alsoavoid touching the screen with sharp objects.Figure 17. Hold the stylusMedtronic CARELINK ENCORE™ 2990166 Reference Manual
5.1.5 Select an option on the screenFigure 18. Position the stylus1. Move the tip of the stylus to a position directly over the desired option. If the desiredoption is a displayed key or button, position the stylus tip within the rectangular outline.If the desired option is a name or number, such as a parameter or parameter value,position the stylus directly over the letters or numbers forming the option.2. Touch the stylus to the screen to select an option.5.1.6 Position the programming headAt some point during most applications of the programmer, the programming head must bepositioned over the implantable device. Positioning the programming head is required forany interaction between the programmer and the implantable device.5.1.7 When to position the programming headCaution: Do not position the programming head over an implanted device duringelectrocautery or external defibrillation procedures.Medtronic CARELINK ENCORE™ 29901Reference Manual 67
During a patient session, properly position the programming head over the implanted devicebefore any of the following actions:●Selection of any command that initiates a programming transmission. The programminghead must be held in position until completion of the transmission, which usually isindicated by a confirmation message.●Selection of any command that initiates data transmission from the implantable device.The programming head should be held steady until data reception is complete, whichusually is indicated by a confirmation message.●Selection of a measurement function that requires the implantable device to beoperating asynchronously as a result of the programming head magnet.For any temporarily programmed state or function or for reception of continuous data suchas Marker Channel telemetry or EGM waveforms, the programming head must be held inplace over the implantable device for the duration of the function or until termination isdesired. Lifting the programming head cancels a temporary program and terminatescontinuous telemetry. The implantable device reverts to permanently programmed values.5.1.8 Determine the correct positionFor an implantable device, the programming head should be held directly against thepatient’s skin. The face of the programming head must be parallel to and typically within 5 cmof the implantable device. Optimum position of the programming head may not be directlycentered over the implantable device. The distal end of the programming head should beplaced over the device with the device under the antenna. For best telemetry performance,do not use the programming head close to the programmer or other sources of electricalnoise.Medtronic CARELINK ENCORE™ 2990168 Reference Manual
Figure 19. Position the programming head1 Light array2 Green3 Amber/green4 AntennaCorrect placement of the programming head is indicated in two places: the position headarray in the top left corner of the screen and the array of seven lights on the programminghead (see Figure 19).Programming and Interrogation are not recommended when fewer than three green lightsare lit.Note: The number of lights used on the light array may vary for some devices. For moreinformation, see the Carelink Encore Programmer Software Application Supplement.5.1.9 Program and interrogate the implanted device1. Select the appropriate software parameters according to the reference guide for theimplanted device.2. Position the programming head near the implanted device.Programming and Interrogation can begin when the LED lights on the position head arrayindicate satisfactory positioning and telemetry strength.Medtronic CARELINK ENCORE™ 29901Reference Manual 69
Notes:●If the programmer is operated in an environment in which the ambient temperature is35 °C, the programming head may reach a temperature of 42 °C.●The programming head array shows the signal strength of the communication link.Medtronic recommends moving the programming head to maximize the number ofgreen lights. All lights may not illuminate for all models. For more information, see thereference guide for the implanted device.●Misalignment of the programming head could result in failure of a programmingtransmission and/or failure to receive data from the implantable device. Medtronicrecommends that you interrogate the device after programming to confirm that anysetting changes were successful.5.1.10 The programming head magnetThe programming head contains a strong magnet. For more information about the effects ofa magnet, see the reference guide for the implanted device.The programming head may attract metal instruments or may be attracted to metal surfaces.The magnet is susceptible to partial demagnetization when it is subjected to opposingmagnetic fields, such as those present when forcing the programming head against anothermagnet. The programming head should be stored as shown in Figure 22 when not in use.Caution: Keep the programming head away from any device or material that will bedamaged by the magnetic field, including magnetic media, watches, and other electronicdevices.5.2 Initiate a patient sessionA patient session involves the application of the various programmer functions to suchprocedures as programming implantable device parameters, analyzing or assessingimplantable device operation, troubleshooting, and routine follow-up. The instructions forusing each programmer function are covered in the reference guide for the implanted device.Note: Before proceeding, ensure that all preparations covered in Section 2.3 andSection 5.1 have been completed.5.2.1 Programmer checklist1. Is the programmer set up according to the procedures in Section 2.3?2. Are the ECG cable, stylus, and programming head connected to the programmer?Medtronic CARELINK ENCORE™ 2990170 Reference Manual
3. Is the battery installed and charged?4. If you are charging the battery or are using AC power instead of the battery, does thepower supply cord connect the programmer to a hospital-grade outlet?5. Has the appropriate software been installed? Refer to Section 3.8 for a description ofhow to verify the software version.6. Are the programmer ECG cable leads connected to electrodes on the patient asdescribed in Section 5.1.1?Specific information related to each implantable device model or family of models is includedin the reference guide for the device.Before beginning a patient session, see the reference guide for the implanted device.5.2.2 Model identificationBecause the programmer collects and stores data on a session-by-session basis, it isimportant to start and end each session correctly.The programmer supports both a Medtronic and Vitatron desktop. Whichever desktop is inuse when the programmer is powered down, that same desktop appears when theprogrammer is powered on. To switch from the Vitatron desktop to the Medtronic desktopand vice versa, press the Vitatron/Medtronic switch button that appears on the bottom of thescreen.There are two ways to begin a patient session:●Before turning on the programmer, position the programming head over the patient’sdevice. When you turn on the programmer, the programmer attempts to interrogate thedevice. Depending on the device, either the software application is launchedautomatically or a message appears with further instructions.●After turning on the programmer, position the programming head over the patient’sdevice. During the first 5 minutes, the Medtronic desktop displays the Find Patientscreen. Afterward, it displays the Select Model screen. The Vitatron desktop displaysthe Select Model screen immediately. A patient session can begin at either the FindPatient screen or the Select Model screen. Follow the instructions on the screen that isdisplayed.5.2.2.1 Find Patient screenWhen the programmer is first turned on, the Medtronic desktop displays the Find Patientscreen. If it does not detect a device within about 5 minutes, the programmer removes theFind Patient screen to reveal the Select Model screen.Medtronic CARELINK ENCORE™ 29901Reference Manual 71
When the Find Patient screen is displayed, you may begin a patient session.Place the programming head over the patient’s device and hold it steady. For most devices,the programmer identifies the device model and automatically starts up the proper softwareapplication. If a device cannot be automatically identified, the programmer displays amessage at the top of the Find Patient screen. Perform one of the following steps, dependingon the message instructions:●Press [Cancel] and manually select the software application from the Select Modelscreen.●Press [Cancel] and then press the Vitatron/Medtronic switch button to go to the Vitatrondesktop.●If the message indicates that the needed software application has not been installed,contact your Medtronic or Vitatron representative.Medtronic CARELINK ENCORE™ 2990172 Reference Manual
5.2.2.2 Select Model screenA patient session may also begin from the Select Model screen. The Select Model screenappears after one of the following actions:●Shortly after the programmer has been turned on●After you end a patient sessionIf the Select Model screen is not displayed, use the stylus to press the Select Model icon. Ifthe Select Model icon is not displayed, a patient session is in progress. You must end thatsession before starting a new session.If you are between patient sessions, you can access other screens by using the icons andbuttons described in Section 3.2.If the Select Model screen does not look like this example and you see a different button inthe command bar, press the Vitatron/Medtronic switch button to display this screen.If the device is a Vitatron device and it is not listed on the Select Model screen, seethe Vitatron Software Programming Guide.Position the programming head over the patient’s device and hold it steady. Press [FindPatient] shown on the Medtronic desktop or manually select the device from the displayedlist of devices and press [Start].Medtronic CARELINK ENCORE™ 29901Reference Manual 73
When a device is manually selected from the list of devices, the programmer starts up theapplication that corresponds to your selection, not the device that is under the programminghead. The Find Patient screen is displayed briefly as the programmer starts up the propersoftware application. If the software application has not been installed, the programmerdisplays a message indicating that the software must be installed before proceeding.The programmer may automatically interrogate the patient’s implanted device to retrievemost of the data that might be needed during the session. To take advantage of thisautomatic interrogation, position the programming head over the implanted device andcontinue to hold it in place until the interrogation is complete.For more information about determining the model, see the reference guide for the implanteddevice.5.3 Electronic Strip Chart (eStrip) recorderThe Electronic Strip Chart (eStrip) recorder retains continuous rhythm information collectedduring a session. Patient ECG and EGM are recorded without interrupting the deviceapplication. Live rhythm is viewable in both the device application and the eStrip recorder.The last 30 minutes of strip information is available. By highlighting areas of interest, stripreports can be generated using the highlighted information. Highlighted strips can be viewedusing the eStrip recorder and the scale, length and other strip information can be changed.The grid on the screen is the same size and ratio as printed strip chart paper.Medtronic CARELINK ENCORE™ 2990174 Reference Manual
5.3.1 eStrip recorder screen featuresFigure 20. eStrip recorder screen1 Real-time waveform viewer–shows real-time waveforms.2 Holter view selector–shows overview of waveforms.3 List view selector–shows available strips.4 Expanded view–shows expanded view of a segment of a waveform.5.3.2 eStrip recorder screen icons/selectorsThe eStrip recorder screen contains these icons/selectors:Table 7. Icons/selectors on the eStrip recorder screenIcon Name FunctionCaliper Initiates interval caliper tool.Markup tool Provides ability to draw notes on a waveform.Medtronic CARELINK ENCORE™ 29901Reference Manual 75
Table 7. Icons/selectors on the eStrip recorder screen (continued)Icon Name FunctionUndo Erase the most recent caliper or markup.Redo Replaces the most recently erased caliper ormarkup.Print Opens the print screen.Add highlight Add highlight to previously unhighlighted wave-form.Remove highlight Removes existing highlight from a waveform.Strip preferences Opens preferences screen.Chart speed adjust Presents chart speed choices. Selecting a newchart speed changes data presentation in expan-ded view based on new chart speed.Previous highlight Navigates to previous highlight.Next highlight Navigates to next highlight.Lead/vector selector Changes the lead/vector in the expanded view.Selecting None removes the lead/vector from theexpanded view.Gain adjust Changes trace gain.5.3.3 Highlight an area of interest during a session1. Press the Electronic Strip Chart (eStrip) button on the button panel to highlight an areaof interest.2. Open the eStrip recorder from the Task bar to view the highlight.Medtronic CARELINK ENCORE™ 2990176 Reference Manual
5.3.4 Change the length of a strip1. Select a strip.2. Press and hold the border of the strip.3. Drag the border of the strip to make it longer or shorter.5.3.5 Measure intervals using calipers1. Select a strip.2. Press the Caliper icon.3. Press the arrow icon on the bottom right corner of the strip to walk the calipers.4. To save caliper measurement to strip, press the tack icon.5.3.6 Change the name of a strip1. Press the List View button to display available strips.2. Press the name of the strip in the expanded view on the bottom half of the screen.3. Change the name of the selected strip by either typing a new name when the keyboarddisplays or selecting a name from the library by clicking the down arrows next to thename field.4. Press [OK].5.3.7 Create test strip report from the eStrip recorder1. Run a test in the device application.2. Open the eStrip recorder from the Task bar.3. Press the List View button to display available strips.4. Select the strip or strips you want to use to create a report.5. Press the Print icon.6. From the Reports – Strip Chart window, press [Print Now] to print the report or [Save toPDF File] to save the report to PDF. You can select the number of copies to print or pressSelect Strips to change which strips will be included in the report.Note: To save a report to PDF, you must have a USB flash drive connected to theprogrammer where the PDF will be saved to.Medtronic CARELINK ENCORE™ 29901Reference Manual 77
5.4 Emergency VVI buttonThe red emergency VVI button on the programmer button panel provides immediate accessfor emergency VVI pacing during a patient session. Pressing the red emergency VVI buttondisplays the emergency screen options and delivers VVI pacing.Figure 21. Programmer button panel1 Red emergency VVI buttonSpecific parameter values for emergency VVI pacing are determined by each deviceapplication. The red emergency VVI button may be available after a system error.Note: For all ICD applications, the [Emergency] button is also implemented in the softwareand is available from the display screen. For more information on the [Emergency] buttonavailable from the display screen, see the reference guide for the implanted device.5.4.1 Deliver emergency bradycardia pacingTo initiate emergency pacing, correctly position the programming head over the implanteddevice and press the red emergency VVI button. A message confirms programming, andemergency VVI operation begins.5.4.2 Deliver emergency tachyarrhythmia therapyTo deliver therapy, press the red emergency VVI button to display the emergency screen onthe programmer and press the on-screen [Deliver] button.For complete instructions regarding the use of the [Deliver] button for specific applications,see the appropriate device Reference Guide, System Reference Guide, or ClinicianManual.Medtronic CARELINK ENCORE™ 2990178 Reference Manual
5.5 End a patient sessionWhen you want to end a patient session, you may save data to a supported storage deviceor end the session without saving.Refer to the reference guide for the implanted device for specific information on savingdevice data.5.6 Store componentsFigure 22 shows the proper way to store components.Figure 22. Store components1 Store the stylus in the handle of the programmer.2 Store the programming head in the left rear door.3 Store the ECG cable in the right rear door.Medtronic CARELINK ENCORE™ 29901Reference Manual 79
6 Manage session data and reports6.1 Session dataPatient session data may be saved to a USB flash drive.6.2 ReportsDepending on the implanted device model, various types of reports can be created. Refer tothe reference guide for the implanted device for specific information on report types andcontents. During an active session, reports may be printed, or saved as PDF files on a USBflash drive. Reports held for later printing may be printed while at the desktop or whenreturning to a session. Reports might not be available for later printing from the desktop,depending on the device application and on the current print queue deletion schedule. Formore information, see Section 6.9.6.3 Save to a PDF filePrintable reports, frozen strips, and other data may be saved to a PDF file. A PDF file is anelectronic version of a printed document; therefore, the feature is accessible under theprinting commands.To save to a PDF file, perform the following steps:1. Open or create the report or file.2. Press [Print…] or [Print Options…] to display the Print – Options dialog box.Note: If the Print – Options dialog box does not display, open Preferences, and thenselect the Printing: Pop up these options when any print button is selected checkbox.3. From the list of supported printers, select the Save to PDF File option. The report issaved to an attached USB flash drive. For more information on saving to USB, seeSection 6.4.Medtronic CARELINK ENCORE™ 2990180 Reference Manual
6.4 Save to USBMany device applications support the use of USB flash drives for saving and loading sessiondata.Note: Device applications and reference manuals may still use the terms “disk” or “diskette”in the context of saving and retrieving device data. When a USB flash drive is connected tothe programmer and available for use as described below, the terms disk or diskette shouldbe interpreted as applying to the USB flash drive, rather than the diskette.6.4.1 Supported USB storage devicesIn order to ensure the integrity and security of patient health information, it is recommendedthat you use USB flash drives that are dedicated to storing programmer data only.6.4.2 OperationA USB flash drive should be connected or disconnected while at the desktop or in a session.Connect a writable USB flash drive to the programmer using any available USB port. A slightdelay may occur while the USB flash drive is authorized. The USB indicator on the task barturns green to indicate that the USB flash drive is available for use.Note: The USB ports on the programmer are USB 2.0.Figure 23. USB indicator status1 No USB connected2 USB connectedUSB flash drives should not be connected or disconnected while the following actions are inprogress:●Programming a device●Performing a Save to Media●Performing a Read from Media●Saving a report as a PDF fileMedtronic CARELINK ENCORE™ 29901Reference Manual 81
Notes:●While a Save to Media action is in progress, the progress indicator and the message“Saving…” display. The progress indicator displays the completion percentage. Beforeremoving the USB flash drive, wait a few seconds after the progress indicator shows100%.●After a report is saved as a PDF file, the message “PDF report(s) saved to media” isdisplayed for about 5 seconds. Wait a few seconds after the message goes away beforeremoving the USB flash drive.●If an active session is ended while reports are currently printing or pending, the reportsare canceled and may not be available from the desktop print queue.Any action to read or write data (such as Save to Media, Read from Media, save reports toa PDF file) will use the USB flash drive after it is connected. Refer to the reference guide forthe implanted device for specific information on saving device data. For more information onsaving reports to PDF file, see Section 6.3.Connect only one writable USB flash drive at a time. Connecting two or more USB flashdrives results in an error during data-saving operations. This condition is indicated by theUSB disabled icon.6.5 View reports that are saved to mediaSaved report PDFs may be viewed on the programmer or on a computer.All reports from one patient’s session are contained in one PDF file. File names areautomatically assigned according to a naming convention that ensures uniqueness on thestorage media:●Patient’s name (if previously provided in Patient Information)●Device serial number●“Session Report”●Clinic visit date in MM_DD_YY format●Version number (the first PDF saved to this storage media gets “1”)For example: John Q Patient_aaannnnnna_Session Report_06_25_10_1.PDFMedtronic CARELINK ENCORE™ 2990182 Reference Manual
6.6 View reports on the programmer using PDF ViewerThe PDF Viewer allows you to view and print PDF reports previously saved on a USB flashdrive.1. Connect a USB flash drive with saved PDF reports.2. Select the PDF Viewer in the taskbar. The list of the available PDF files on the USB flashdrive is displayed in the left panel.3. Click the file name to open a preview of the PDF. To open the PDF, press [Opendocument] or double-click the PDF file namePDF files on the USB flash drive other than previously-saved PDF reports are also viewablewith the PDF Viewer.●You can use the toolbar at the top of the PDF to go to a specific page, increase ordecrease the size of the document, or search within the PDF.●To hide the list of PDFs to provide a larger viewing area for the PDF, press [Hide] in thelower left corner of the PDF viewer. To restore the list, press [Show].●To print a PDF, with a report open in the PDF Viewer, press the Print icon.6.7 Viewing and printing PDF files on a computerInsert the USB flash drive containing the reports into a computer equipped to display filesthat are in PDF format.Due to computer and software variations, some PDF files may not be displayed properlywhen viewed on a computer monitor.The use of Adobe Reader 9 or later is recommended. Adjusting the following settings mayreduce or eliminate display imperfections:●Replace document colors with white page background and black text (in Adobe Reader9, select: Edit > Preferences > Accessibility > Replace Document Colors > CustomColor)●Deselect the option to enhance thin lines (in Adobe Reader 9, select: Edit > Preferences> Page Display)Imperfections that may be seen on screen:●On graphs that contain rectangles drawn with thin lines, e.g., bar graphs, the thin linesmay not be displayed at various zoom levels.●On Pacing and Tachy Trigger Episode reports, unfilled circles may be displayed as filledcircles.Medtronic CARELINK ENCORE™ 29901Reference Manual 83
PDF reports print properly at a resolution of 300 dpi or greater.6.8 Manage patient data privacyYou can immediately remove from the programmer all Protected Health Information (PHI).This feature deletes all of the following files:●Contents of the Print Queue (unless files are currently being printed or copied)●Temporary files residing on the programmer●Memory dumps (applies to Vitatron devices only)You cannot delete any PHI data if a session is in progress or while files are being printed orcopied to media. If deletion is interrupted manually, some PHI remains on the programmer.Note: The user of the programmer is responsible for the use of this feature, as well as formanagement of patient data that has already been removed from the programmer (forexample on paper or a USB flash drive).6.8.1 Delete Protected Health Information1. Press the Programmer icon, and then select Tools. The programmer displays theTools screen as shown in Figure 24.Figure 24. Tools screen with Patient Data Privacy index item selected Medtronic CARELINK ENCORE™ 2990184 Reference Manual
2. Press [Delete Protected Health Information]. The programmer displays the dialog boxas shown in Figure 25.Figure 25. Delete Protected Health Information confirmation dialog box 3. Press [Delete] to continue.One of the following events may occur:The programmer displays an “In progress…” dialog box as shown in Figure 26. Deletionmay last several minutes, depending on the amount of data to delete.Figure 26. In progress dialog boxIf there are SessionSync files on the programmer that have not been transferred yet, theprogrammer displays a message indicating that there are SessionSync files waiting tobe transferred, as shown in Figure 27. Press [Delete] to delete the SessionSync files or[Cancel] to wait until the SessionSync files have transferred.Figure 27. SessionSync files waiting dialog boxMedtronic CARELINK ENCORE™ 29901Reference Manual 85
If there are reports currently printing, the programmer displays a message directing youto wait until printing is complete, as shown in Figure 28. Press [Close].Figure 28. Printing in progress dialog box 4. If pressing [Delete] in Step 3 resulted in protected health information deletion, theprogrammer displays a message stating that deletion was successful, as shown inFigure 29. Press [Close].Figure 29. Deletion successful dialog boxOr,If the programmer is unable to complete deletion of files, it displays a message statingthat there was an error and that some data may remain on the programmer, as shown inFigure 30. Press [Close]. Contact Medtronic Technical Support if the message recurs.Figure 30. Error deleting files dialog box Medtronic CARELINK ENCORE™ 2990186 Reference Manual
6.9 Set the interval for report deletionFor patient data security, the programmer permanently deletes reports automatically fromthe Medtronic desktop print queue at the time when the programmer is powered up. You cancontrol how long reports are retained in the print queue before automatic deletion.6.9.1 Select a report deletion interval1. Press the Programmer icon, and then select Preferences.2. From the Preferences screen, select Delete Reports. The programmer displays theDelete Reports screen as shown in Figure 31.Figure 31. Delete Reports screen 3. Select a radio button to specify which reports the programmer deletes:●All Reports●Reports older than 1 Day●Reports older than 2 Days●Reports older than 7 Days (Default)●Reports older than 14 DaysThe age of a report is determined by the date and time it was created. When the programmeris powered on, reports that meet the deletion criteria are permanently deleted.Medtronic CARELINK ENCORE™ 29901Reference Manual 87
6.9.2 Delete a report immediatelyTo delete a report immediately, directly access it from the print queue and press [Delete].Medtronic CARELINK ENCORE™ 2990188 Reference Manual
7 SessionSync (Optional)7.1 About SessionSyncSessionSync is an optionally installed feature that provides network connectivity betweenthe programmer and the Medtronic Paceart data management system. Using your clinic’snetwork, the programmer can send downloaded device data through SessionSync to thedata management system.The SessionSync status icon and the SessionSync status screen provide information on theconnection status of the programmer to the data management system.You must configure the programmer network settings to allow for this data transfer.7.2 Enable and disable SessionSync1. Select Programmer > Preferences.2. Select SessionSync from the Index menu.3. Select [Enabled] to enable SessionSync or Select [Disabled] to disable SessionSync.Note: The SessionSync icon in the task bar will be grayed out when the feature is disabled.SessionSync functions are not available within a patient session unless you have enabledthis feature prior to starting a patient session.Figure 32. Preferences screen with Session Sync selectedMedtronic CARELINK ENCORE™ 29901Reference Manual 89
7.3 SessionSync Status iconThe SessionSync status icon provides information on the network connection between theprogrammer and the data management system.Figure 33. The task bar with the SessionSync Status icon1 The SessionSync Status iconIf SessionSync is not installed on the programmer, the icon is not visible in the task bar.Figure 34. Parts of the SessionSync Status icon1 The data management system status2 The connection status between the programmer and the data management system3 The programmer statusThe sections of the SessionSync Status icon change colors to indicate data ready fortransfer, a valid connection between the programmer and the data management system,and successful data transfer to the data management system.Note: When the whole icon is grayed out, SessionSync has been disabled under theprogrammer preferences.Table 8. SessionSync Status icon statesPart of SessionSync Status Icon Color What the color indicatesProgrammer Gray No session data files are in the TransferQueue.Note: The transfer queue is the list ofsession data files that have been savedto the programmer hard disk but are wait-ing for transfer.Blue Session data files exist in the TransferQueueMedtronic CARELINK ENCORE™ 2990190 Reference Manual
Table 8. SessionSync Status icon states (continued)Part of SessionSync Status Icon Color What the color indicatesConnection Not visible No valid connection exists between theprogrammer and the data managementsystemGreen Valid connection exists between the pro-grammer and the data management sys-temRed circlewith a linethrough itDevice application in use does not sup-port SessionSyncData Management System Gray No session data has been transferred tothe data management systemBlue All session data has been successfullytransferred to the data management sys-tem7.4 Use Automatic SessionSyncAutomatic SessionSync allows you to perform a SessionSync automatically at the end of apatient session. This feature is available for all SessionSync enabled devices.7.4.1 Save the patient session with Manual SessionSync1. Press the Session icon.2. Select SessionSync….3. The SessionSync - Saving Session Data On Programmer window is opened and forsome devices an interrogation is automatically started. The SessionSync - SavingSession Data On Programmer window shows the progress of the save. TheProgrammer side of the SessionSync Status icon turns blue after the data has beensaved on the Programmer hard disk. If the subsequent transfer is successful, the datamanagement system side of the SessionSync Status icon turns blue.7.4.2 End a patient session with Automatic SessionSync enabled1. Press [End Session…]. If an interrogation is required before the SessionSync datatransfer, the Interrogation Required window is displayed.2. Verify that the Automatic SessionSync box is checked, and then press [End Now].Medtronic CARELINK ENCORE™ 29901Reference Manual 91
3. The SessionSync - Saving Session Data On Programmer window is opened. For somedevices, an interrogation is automatically started. The SessionSync - Saving SessionData On Programmer window shows the progress of the save. The programmer side ofthe SessionSync Status icon turns blue after the data has been saved on theprogrammer hard disk. If the subsequent transfer is successful, the data managementsystem side of the SessionSync Status icon turns blue.7.5 Use Manual SessionSync for supported devicesManual SessionSync allows you to send interrogated data to the Paceart data managementsystem without ending the patient session on the Programmer.Manual SessionSync is not available for all SessionSync supported devices. If manualSessionSync is available for a device, the SessionSync… option appears in the Sessionmenu.7.6 SessionSync error message descriptionsYou may receive error or information messages at different times in the SessionSyncprocess. For a list of error messages, see Table 9. If you have any issues with theprogrammer contact Medtronic Technical Support at the telephone number on the backcover of this manual.Table 9. SessionSync error messagesError Message What it meansData Transfer Failed A device communication error has occurred during the interrog-ation and you have cancelled out of the interrogation window. Thesession data has not been saved on the programmer hard disk.Do one of the following:Press [Retry] to retry the operation.Press [Cancel] to close the window.Ending a Session without Auto-matic SessionSyncYou have cleared the Automatic SessionSync check box on theEnd Session window before pressing the [End Now] button.Interrogation Required You must conduct an interrogation before starting a SessionSyncdata transfer for this device.Press [OK] to close the window.Medtronic CARELINK ENCORE™ 2990192 Reference Manual
Table 9. SessionSync error messages (continued)Error Message What it meansInterrogate - Unsuccessful The programmer cannot interrogate the device. You must reposi-tion the programming head.Do one of the following:Press [Retry] or [Continue] after repositioning the programminghead.Press [Cancel] to close the window.Unable to Save Session Data The session data cannot be saved on the programmer hard disk.Do one of the following:Press [Save to Media] or [Save Session] to save the session datato media.Press [End Now] to end the session without saving the devicedata.Press [Cancel] to close the window without saving the devicedata.7.7 View SessionSync Status screenThe SessionSync Status screen displays information on the data files being transferred tothe data management system using SessionSync. Each message includes the date, time,and event information for the associated SessionSync event.7.8 Update SessionSync statusMedtronic CARELINK ENCORE™ 29901Reference Manual 93
1. Press the Programmer icon, and then select SessionSync Status.2. Press [Update Status].Note: SessionSync status does not dynamically update when the window is open. Toupdate, press [Update Status].Medtronic CARELINK ENCORE™ 2990194 Reference Manual
8 Service the programmer8.1 Clean the system componentsThe exterior surfaces of the programmer and its accessories may be cleaned with a spongeor soft cloth moistened with water, mild detergent, hydrogen peroxide, or alcohol.Thoroughly clean the surfaces of the programmer wires; the bottom surface of theprogramming head; and the wire connecting the programming head to the programmer.Caution: Take care to prevent liquid from entering the programmer and programming head.Do not immerse the programmer or any accessories in any liquid or clean them with aromaticor chlorinated hydrocarbons.The lead wires may be cleaned by wiping each lead wire with a sponge or soft clothmoistened with the cleaning material, then wiped with a sponge or soft cloth moistened withclean water, and then wiped dry.The exterior surfaces of the lead wires can be cleaned up to 15 times with each of thefollowing materials without functional degradation:●Green soap, green soap tincture, or alcohol-free hand soap●2% gluteraldehyde solution (such as Cidex)●Sodium hypochlorite (bleach solution 10% in water)8.2 Sterilize the programming head, ECG cable, andlead wiresExcept for the programming head or ECG cable and lead wires, the programmer and itsaccessories cannot be sterilized.Caution: Do not autoclave the programming head or ECG cable and lead wires.Visually inspect the cable and connections of the programming head after sterilizing. Do notuse the programming head if it appears damaged. Damage includes, but is not limited to,deterioration of the cable insulation (brittleness, cracking, thinning, or bare spots). Do notuse the programming head if the conductive wires are exposed.Medtronic CARELINK ENCORE™ 29901Reference Manual 95
8.2.1 Ethylene oxideNote: The programming head or ECG cable and lead wires must be completely dry beforebeing ethylene-oxide sterilized.1. Wrap the programming head or ECG cable and lead wires in packaging permeable toethylene oxide.2. Medtronic recommends normal gas concentration of 725 mg/L ethylene oxide followedby a minimum of 12 hours of aeration. The worst case cycle will consist of no more than3 hours exposure to EO.3. Do not exceed 55 °C, 50% RH.4. Do not resterilize the programming head more than 20 EO cycles. Do not resterilize theECG cable and lead wires more than 10 EO cycles.Biological indicators should be used to ensure that proper sterilization standards have beenmet. A previously validated sterilization cycle should be used.Due to the variability in sterilization systems, precise sterilization instructions cannot beprovided. Contact the manufacturer of your sterilization system for more informationregarding procedures.8.2.2 Gas plasma (programming head only STERRAD 100S gas plasmasystem)1. Place the programming head in packing material appropriate for gas plasmasterilization.2. Sterilize by procedures validated for effectiveness using suitable biological controls.a. Do not exceed 55 °C.b. Do not use an H2O2 concentration below 1 mg/L (nominal 1.8 mg/L).c. Do not expose the programming head to a sterilizer cycle longer than 72 min(nominal 55 min).d. Do not resterilize the programming head more than 20 cycles.Medtronic CARELINK ENCORE™ 2990196 Reference Manual
8.3 Programmer specificationsTable 10. Programmer specificationsStandards (The programmer complies with the following:)Radio frequency wireless specifications and applicable standardsEMC EN / IEC 60601-1-2EN 301 489EN 302 195EN 55022 Class B/CISPR 22EN 55024 Class B/CISPR 24Radio FCC CFR 47 P.15RSS-210Patient safety UL/CUL 60601-1, Class I, Type BF ordinary EN 60601-1, ClassI, Type BF, continuous operationAC power requirementVoltage 100 to 125 VAC nominal or 200 to 240 VAC nominalFrequency 50/60 Hz nominalPower 100 WBatteryType Li-ion, rechargeableCapacity 3900 mAhCharge duration Standby: 15 daysOperating: 1.75 hours (typical)Voltage 11.1 VPower cordAC/DC adapter in 100-240 VAC 1.5 A @ 50/60 HzAC/DC adapter out 19 VDC 5.3 AElectrical safety requirements per IEC 60601-1:1988, Clause 19Enclosure leakage current ≤ 0.1 mAEarth leakage current ≤ 0.5 mAPatient leakage current A.C. ≤ 0.1 mAPatient auxiliary current D.C. ≤ 0.01 mAPatient auxiliary current A.C. ≤ 0.1 mAElectrical safety requirements per IEC 60601-1:2005, Clause 8.7Touch leakage current ≤0.1 mAEarth leakage current ≤0.1 mAPatient leakage current A.C. ≤0.1 mAPatient auxiliary current D.C. ≤ 0.01 mAPatient auxiliary current A.C. ≤0.1 mAMedtronic CARELINK ENCORE™ 29901Reference Manual 97
Table 10. Programmer specifications (continued)IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) - AMD 7643: July 1993;AMD 10931: August 2000Ingress IP21 (with the programmer turned off, and with both of the backdoors, the battery door, all connector ports, the ExpressCardslot, and the input covers closed)Physical dimension and weightHeightWidthDepthWeight35.5 cm35.5 cm10.2 cm4.94 kgTemperature limitsOperatingStorage5 °C to 35 °C- 20 °C to 60 °CHumidity limitsOperatingStorage80%95% at 35 °CAltitudeMaximum 3000 mConnectivity and controlsOnboard LANData Interface RJ-45 Ethernet connectorData Modulation IEEE 802.3 10 Mbps full-duplex and half-duplex on 10Base-TIEEE 802.3u 100 Mbps full-duplex and half-duplex on100Base-TxWireless LANFrequency range 2.4 GHz, 5 GHzModulation 802.11 a/b/g/nOutput power 17 dBm (typical)Bluetooth 2.1Frequency range 2.4 GHzOutput power +4 dBm (maximum)Medtronic CARELINK ENCORE™ 2990198 Reference Manual
8.3.1 Functional test, maintenance, and safety checks8.3.1.1 Functional test at installationBefore putting the programmer into service for the first time, the device and its accessoriesshould be visually inspected and tested for operability by a designated Medtronic person.Visual inspection requires examining the programmer case for cracks, verifying that allconnectors are properly fastened, checking for insulation damage to the power cord andother accessory cables, and inspecting for wall plug and equipment plug damage.Verify operation by turning on the programmer and checking monitor functionality.8.3.1.2 MaintenanceMedtronic recommends that you should test the programmer for operability and also visuallyinspect the programmer and its accessories (e.g., power cord, cables) before each use asoutlined in the previous section.Caution: If the case of the programmer is cracked or if any of the connectors are damaged,contact your Medtronic or Vitatron representative. If there is insulation damage to the powercord or accessory cables or if any of the wall or equipment plugs are damaged, replace thepart and dispose of it according to local regulations or return the part to Medtronic.8.3.1.3 Safety checksSafety checks require a functional test and electrical safety tests once every two years or asdirected by local requirements. It is not necessary that technical and safety inspections areperformed by Medtronic or Vitatron personnel; however, technical and safety inspections ofthe programmer and its accessories must be performed by persons, who, based on theirtraining, knowledge, and practical experience, are capable of adequately performing suchinspections and who do not require instructions with regard to the technical and safetyinspection.Warning: If technical and safety inspection reveals a defect which could harm the patient,clinicians, or third parties, the device should not be used until it has been properly repaired.The operator must immediately notify Medtronic or Vitatron of these defects.Medtronic CARELINK ENCORE™ 29901Reference Manual 99
8.3.2 Disposal of the programmerReturn the programmer to Medtronic or Vitatron for proper disposal.8.4 Special noticeThe CareLink Encore 29901 Programmer (the “programmer”) is designed to program theadjustable parameters of the Medtronic or Vitatron programmable implantable devicesincluded in the applications of the software used with the programmer. Refer to theappropriate reference guides for a list of the implantable device models applicable to thesoftware. The programming and telemetry functions of the programmer are not compatiblewith any other implantable device models.The programmer also functions as a digital measuring device intended for measurement ofthe pulse rate, AV interval, and pulse width of implantable device artifacts as detected by skinelectrodes. Medtronic and Vitatron make no claims or warranties as to the effectiveness ofthe programmer as a diagnostic tool to the physician.For information regarding difficulties, which may be encountered using the programmer,consult other portions of this reference guide.8.5 Medtronic limited warrantyFor complete warranty information, see the accompanying card enclosed in the package.Medtronic CARELINK ENCORE™ 29901100 Reference Manual
A End-user license agreementA.1 End-user license agreement (EULA) termsYou have acquired a device (“DEVICE”) that includes software licensed by Medtronic froman affiliate of Microsoft Corporation (“MS”). Those installed software products of MS origin,as well as associated media, printed materials, and “online” or electronic documentation(“SOFTWARE”) are protected by international intellectual property laws and treaties.Manufacturer, MS and its suppliers (including Microsoft Corporation) own the title, copyright,and other intellectual property rights in the SOFTWARE. The SOFTWARE is licensed, notsold. All rights reserved.This EULA is valid and grants the end-user rights ONLY if the SOFTWARE is genuine and agenuine Certificate of Authenticity for the SOFTWARE is included. For more information onidentifying whether your software is genuine, please seehttp://www.microsoft.com/piracy/howtotell.IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT (“EULA”), DO NOTUSE THE DEVICE OR COPY THE SOFTWARE. INSTEAD, PROMPTLY CONTACTMEDTRONIC FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR AREFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ONTHE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (ORRATIFICATION OF ANY PREVIOUS CONSENT).GRANT OF SOFTWARE LICENSE – This EULA grants you the following license:You may use the SOFTWARE only on the DEVICE.Restricted Functionality – You are licensed to use the SOFTWARE to provide only thelimited functionality (specific tasks or processes) for which the DEVICE has been designedand marketed by Medtronic. This license specifically prohibits any other use of the softwareprograms or functions, or inclusion of additional software programs or functions that do notdirectly support the limited functionality on the DEVICE. Notwithstanding the foregoing, youmay install or enable on a DEVICE, systems utilities, resource management or similarsoftware solely for the purpose of administration, performance enhancement and/orpreventive maintenance of the DEVICE.If you use the DEVICE to access or utilize the services or functionality of Microsoft WindowsServer products (such as Microsoft Windows Server 2003), or use the DEVICE to permitworkstation or computing devices to access or utilize the services or functionality ofMicrosoft Windows Server products, you may be required to obtain a Client Access Licensefor the DEVICE and/or each such workstation or computing device. Please refer to the enduser license agreement for your Microsoft Windows Server product for additionalinformation.Medtronic CARELINK ENCORE™ 29901Reference Manual 101
NOT FAULT TOLERANT – THE SOFTWARE IS NOT FAULT TOLERANT. MEDTRONICHAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE,AND MS HAS RELIED UPON MEDTRONIC TO CONDUCT SUFFICIENT TESTING TODETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE.NO WARRANTIES FOR THE SOFTWARE – THE SOFTWARE is provided “AS IS” and withall faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE,ACCURACY, AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO,THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OFTHE SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANYWARRANTIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE WARRANTIESDO NOT ORIGINATE FROM, AND ARE NOT BINDING ON, MS.No Liability for Certain Damages – EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVENO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTALDAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCEOF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OFITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT INEXCESS OF U.S. TWO HUNDRED FIFTY DOLLARS (U.S.$250.00).Restricted Uses – The SOFTWARE is not designed or intended for use or resale inhazardous environments requiring fail-safe performance, such as in the operation of nuclearfacilities, aircraft navigation or communication systems, air traffic control, or other devices orsystems in which a malfunction of the SOFTWARE would result in foreseeable risk of injuryor death to the operator of the device or system, or to others.Limitations on Reverse Engineering, Decompilation, and Disassembly – You may notreverse engineer, decompile, or disassemble the SOFTWARE, except and only to the extentthat such activity is expressly permitted by applicable law notwithstanding this limitation.SOFTWARE as a Component of the DEVICE - Transfer – This license may not be shared,transferred to or used concurrently on different computers. The SOFTWARE is licensed withthe DEVICE as a single integrated product and may only be used with the DEVICE. If theSOFTWARE is not accompanied by a DEVICE, you may not use the SOFTWARE. You maypermanently transfer all of your rights under this EULA only as part of a permanent sale ortransfer of the DEVICE, provided you retain no copies of the SOFTWARE. If the SOFTWAREis an upgrade, any transfer must also include all prior versions of the SOFTWARE. Thistransfer must also include the Certificate of Authenticity label. The transfer may not be anindirect transfer, such as a consignment. Prior to the transfer, the end user receiving theSOFTWARE must agree to all the EULA terms.Consent to Use of Data – You agree that MS, Microsoft Corporation and their affiliates maycollect and use technical information gathered in any manner as part of product supportservices related to the SOFTWARE. MS, Microsoft Corporation and their affiliates may usethis information solely to improve their products or to provide customized services orMedtronic CARELINK ENCORE™ 29901102 Reference Manual
technologies to you. MS, Microsoft Corporation and their affiliates may disclose thisinformation to others, but not in a form that personally identifies you.Internet Gaming/Update Features – If the SOFTWARE provides, and you choose toutilize, the Internet gaming or update features within the SOFTWARE, it is necessary to usecertain computer system, hardware, and software information to implement the features. Byusing these features, you explicitly authorize MS, Microsoft Corporation and/or theirdesignated agent to use this information solely to improve their products or to providecustomized services or technologies to you. MS or Microsoft Corporation may disclose thisinformation to others, but not in a form that personally identifies you.Internet-Based Services Components – The SOFTWARE may contain components thatenable and facilitate the use of certain Internet-based services. You acknowledge and agreethat MS, Microsoft Corporation or their affiliates may automatically check the version of theSOFTWARE and/or its components that you are utilizing and may provide upgrades orsupplements to the SOFTWARE that may be automatically downloaded to your DEVICE.Microsoft Corporation or their affiliates do not use these features to collect any informationthat will be used to identify you or contact you. For more information about these features,please see the privacy statement at http://go.microsoft.com/fwlink/?LinkId=25243.Links to Third Party Sites – You may link to third party sites through the use of theSOFTWARE. The third party sites are not under the control of MS or Microsoft Corporation,and MS or Microsoft are not responsible for the contents of any third party sites, any linkscontained in third party sites, or any changes or updates to third party sites. MS or MicrosoftCorporation is not responsible for webcasting or any other form of transmission receivedfrom any third party sites. MS or Microsoft Corporation are providing these links to third partysites to you only as a convenience, and the inclusion of any link does not imply anendorsement by MS or Microsoft Corporation of the third party site.Notice Regarding Security – To help protect against breaches of security and malicioussoftware, periodically back up your data and system information, use security features suchas firewalls, and install and use security updates.No Rental/Commercial Hosting – You may not rent, lease, lend or provide commercialhosting services with the SOFTWARE to others.Separation of Components – The SOFTWARE is licensed as a single product. Itscomponent parts may not be separated for use on more than one computer.Additional Software/Services – This EULA applies to updates, supplements, add-oncomponents, product support services, or Internet-based services components(“Supplemental Components”), of the SOFTWARE that you may obtain from Medtronic, MS,Microsoft Corporation or their subsidiaries after the date you obtain your initial copy of theSOFTWARE, unless you accept updated terms or another agreement governs. If otherterms are not provided along with such Supplemental Components and the SupplementalComponents are provided to you by MS, Microsoft Corporation or their subsidiaries then youMedtronic CARELINK ENCORE™ 29901Reference Manual 103
will be licensed by such entity under the same terms and conditions of this EULA, except that(i) MS, Microsoft Corporation or their subsidiaries providing the Supplemental Componentswill be the licensor with respect to such Supplemental Components in lieu of Medtronic forthe purposes of the EULA, and (ii) TO THE MAXIMUM EXTENT PERMITTED BYAPPLICABLE LAW, THE SUPPLEMENTAL COMPONENTS AND ANY (IF ANY) SUPPORTSERVICES RELATED TO THE SUPPLEMENTAL COMPONENTS ARE PROVIDED AS ISAND WITH ALL FAULTS. ALL OTHER DISCLAIMERS, LIMITATION OF DAMAGES, ANDSPECIAL PROVISIONS PROVIDED BELOW AND/OR OTHERWISE WITH THESOFTWARE SHALL APPLY TO SUCH SUPPLEMENTAL COMPONENTS. MS, MicrosoftCorporation or their subsidiaries reserve the right to discontinue any Internet-based servicesprovided to you or made available to you through the use of the SOFTWARE.Recovery Media – If SOFTWARE is provided by Medtronic on separate media and labeled“Recovery Media” you may use the Recovery Media solely to restore or reinstall theSOFTWARE originally installed on the DEVICE.Backup Copy – You may make one (1) backup copy of the SOFTWARE. You may use thisbackup copy solely for your archival purposes and to reinstall the SOFTWARE on theDEVICE. Except as expressly provided in this EULA or by local law, you may not otherwisemake copies of the SOFTWARE, including the printed materials accompanying theSOFTWARE. You may not loan, rent, lend or otherwise transfer the backup copy to anotheruser.End User Proof of License – If you acquired the SOFTWARE on a DEVICE, or on acompact disc or other media, a genuine Microsoft “Proof of License”/Certificate ofAuthenticity label with a genuine copy of the SOFTWARE identifies a licensed copy of theSOFTWARE. To be valid, the label must be affixed to the DEVICE, or appear on Medtronic’ssoftware packaging. If you receive the label separately other than from Medtronic, it is invalid.You should keep the label on the DEVICE or packaging to prove that you are licensed to usethe SOFTWARE.Product Support – Product support for the SOFTWARE is not provided by MS, MicrosoftCorporation, or their affiliates or subsidiaries. For product support, please refer to Medtronicsupport number provided in the documentation for the DEVICE. Should you have anyquestions concerning this EULA, or if you desire to contact Medtronic for any other reason,please refer to the address provided in the documentation for the DEVICE.Termination – Without prejudice to any other rights, Medtronic may terminate this EULA ifyou fail to comply with the terms and conditions of this EULA. In such event, you must destroyall copies of the SOFTWARE and all of its component parts.EXPORT RESTRICTIONS – You acknowledge that SOFTWARE is subject to U.S. andEuropean Union export jurisdiction. You agree to comply with all applicable international andnational laws that apply to the SOFTWARE, including the U.S. Export AdministrationMedtronic CARELINK ENCORE™ 29901104 Reference Manual
Regulations, as well as end-user, end-use and destination restrictions issued by U.S. andother governments. For additional information see http://www.microsoft.com/exporting/.Medtronic CARELINK ENCORE™ 29901Reference Manual 105
IndexAAC power input ........................ 25Adjust button .......................... 45[Adjust…] button ....................... 45Adobe settings ........................ 83AHA codingelectrodes ........................ 65annotationsMarker Channel ..................... 44parameter programming ................ 44artifact detection ....................... 52Auto Identify .......................... 73see also Find PatientBbattery ........................... 25, 31charge .......................... 35status ........................... 35Bluetooth .......................... 40, 43buttonsAdjust ........................... 45[Adjust…] ......................... 45Auto Identify ....................... 73Bluetooth ......................... 28[Deliver] .......................... 78description ........................ 45Electronic Strip Chart (eStrip) ............. 28[Emergency] ....................... 78Emergency VVI ..................... 28Find Patient ..................... 44, 73[Freeze] .......................... 45inactive .......................... 46Power ......................... 28, 33RFID ........................... 28Strips ........................... 45[Strips…] ......................... 45Vitatron/Medtronic switch ............... 73VVI ............................. 78Wi-Fi ........................... 28see also Find Patientsee also iconsCcommand bar, programmer ................. 44componentsstoring ........................... 79connectorECG cable ........................ 27programming head ................... 27Contraindications ....................... 13Ddate and timesetting ........................... 48Declaration of Conformity .................. 18[Deliver] button ........................ 78demonstrations option .................... 52dimensions, programmer .................. 98display screenfeatures of screen .................... 42EECG ............................... 20cable ........................... 25cable connections .................... 34functions on the programmer ............. 20electrodesAHA coding ....................... 65attaching ....................... 64, 65IEC coding ........................ 65[Emergency] button ...................... 78Emergency VVI button .................... 28environmental precautionsdisposal of programmer .............. 9, 11while using programmer ................ 17Ethernet cable ......................... 25connecting ........................ 57Ffeaturesprogrammer ....................... 12Federal Communications Commission (FCC) ...... 19Find Patient button ...................... 73Find Patient screen ...................... 71[Freeze] button ........................ 45Hhardware informationprogrammer ....................... 47humidity limitsprogrammer ....................... 98Medtronic CARELINK ENCORE™ 29901106 Reference Manual
IiconsAC power indicator ................... 43battery indicator ..................... 28battery power indicator ................. 43Bluetooth configuration ................ 43device application indicator/selector ......... 44Electronic Strip Chart (eStrip) indicator/selector .. 44inactive .......................... 46network configuration .................. 43PDF Viewer ....................... 43Print Queue ....................... 46programmer ....................... 46Select Model ....................... 46SessionSync ....................... 43SessionSync status ................... 90telemetry strength .................... 43USB indicator ...................... 43IEC codingelectrodes ........................ 65Industry Canada ........................ 19interference .......................... 16troubleshooting ..................... 35LLive Rhythm Monitor ..................... 44switching views ..................... 44locationprogrammer ....................... 47Mmanualsobtaining from website ................. 23model (device)selection screen ..................... 73model numbers ........................ 47modes, pacingdisplay of active mode ................. 44NNetwork configuration .................... 43Ooperating humidityprogrammer ....................... 98operating preferences .................... 49operating temperatureprogrammer ....................... 98other softwareoption ........................... 51Ppatient sessionconducting ........................ 70PDFviewing .......................... 83PDF, saving to ......................... 80PDF Viewer .......................... 83power supply .......................... 25precautionsenvironmental ...................... 17programmer ....................... 16programmer modification ............... 16printercompatibility ....................... 38connecting ........................ 38specifications ...................... 97print queue settings ...................... 87profileprogrammer ....................... 47programmercomponents ....................... 20device status ....................... 44dimensions ........................ 98display screen ...................... 42functions ......................... 19hardware information .................. 47location .......................... 47preferences ....................... 49profile ........................... 47setting time and date .................. 48specifications ...................... 97task area ......................... 44tool palette ........................ 45view or update serial numbers ............ 47waveform traces ..................... 44weight ........................... 98see also buttonssee also iconssee also Live Rhythm Monitorprogramming headdetermining the correct position ........... 68magnet .......................... 70positioning ...................... 67, 69sterilizing ......................... 95when to position ..................... 67Rregulatory compliance .................... 19Medtronic CARELINK ENCORE™ 29901Reference Manual 107
reportsdeleting .......................... 87saving to PDF ...................... 80saving to USB ...................... 81viewing .......................... 82RFID button .......................... 28RTTE Directivedevice conformance .................. 18SscreenFind Patient ....................... 71Select Model ....................... 73selecting the device model ................. 73serial numbers ......................... 47SessionSync ........................ 43, 89automatic ......................... 91color indicators ..................... 90components of status icon ............... 90enabling and disabling ................. 89error messages ..................... 92manual .......................... 92status icon ........................ 90viewing status of ..................... 93skin electrodes ...................... 64, 65see also electrodessoftware requirements .................... 22specificationsprinter ........................... 97programmer ....................... 97standards, compliance .................... 97status bar, programmer ................... 44storage humidityprogrammer ....................... 98storage temperatureprogrammer ....................... 98Strips button .......................... 45[Strips…] button ........................ 45stylusstoring ........................... 29using ........................... 66system preferences ...................... 49Ttask bar, programmer ..................... 43telemetryfunctions ......................... 20temperature limitsprogrammer ....................... 98time and datesetting ........................... 48traces, waveform ....................... 44UUSBsaving to ......................... 81storage devices ..................... 81VVitatron/Medtronic switch button .............. 73VVI button ........................... 78Wwarningsprogrammer ....................... 13warranty informationprogrammer ...................... 100waveform traces ........................ 44websiteaccessing technical manuals ............. 23weight, programmer ..................... 98Wi-Fi .............................. 28wireless ............................. 61Medtronic CARELINK ENCORE™ 29901108 Reference Manual
Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAwww.medtronic.com+1 763 514 4000Authorized Representative in the EuropeanCommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe Netherlands+31 45 566 8000Europe/Middle East/AfricaMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerland+41 21 802 7000AustraliaMedtronic Australasia Pty Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaCanadaMedtronic of Canada Ltd99 Hereford StreetBrampton, Ontario L6Y 0R3Canada+1 905 460 3800Technical manualswww.medtronic.com/manualsVitatron Holding B.V.Endepolsdomein 56229 GW MaastrichtThe Netherlands+31 43 356 6551© 2016 MedtronicM963797A001 B2016-04-08*M963797A001*

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