MEDTRONIC CARELINK 2090

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MEDTRONIC CARELINK 2090ProgrammerReference ManualCaution: Federal law (USA) restricts this device to sale by or on theorder of a physician.

MEDTRONIC CARELINK 2090Reference ManualA guide for setting up and using the Medtronic CareLink 2090 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, Jewel, Marker Channel, Medtronic, Medtronic CareLink, Paceart, RemoteView,Reveal, SessionSync, Vitatron

MedtronicMEDTRONIC CARELINK 2090Contents1Introduction to the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81.1Explanation of packaging and product symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 81.2About this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111.3Description and intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111.4Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121.5Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121.6Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131.7Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151.8Regulatory compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151.9Programmer functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161.10Security features of the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181.11Software requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191.12Obtain technical manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1922.12.22.32.42.52.62.72.8Set up the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Basic setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Connect peripheral devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Use external printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Install printer paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Printer buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Tear off a printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Low paper supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21212632333638383933.13.23.33.43.53.63.7Configure the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Display screen features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .About the Between Patient Sessions tool palette . . . . . . . . . . . . . . . . . . . . . . . .View and update programmer location and hardware information . . . . . . . . . .Adjust programmer time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Select audible tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Check the software version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Select other software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4040434445464748Reference Manual5

Medtronic3.83.93.104MEDTRONIC CARELINK 2090Remove other software applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Improve the detection of pacing artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Start the Demonstrations option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 494.14.24.3Update programmer software using the Software DistributionNetwork . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The Software Distribution Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Connect to the SDN using a network connection . . . . . . . . . . . . . . . . . . . . . . . .Connect to the SDN using a dial-up connection . . . . . . . . . . . . . . . . . . . . . . . . .5151515555.15.25.35.45.5Conduct a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prepare for a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Initiate a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Emergency VVI button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .End a patient session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Store components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63637175777766.16.26.36.46.56.66.76.86.9Manage session data and reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Session data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Save to a PDF file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Save to diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Save to USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .View reports that are saved to media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Set the interval for report deletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Manage patient data privacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Vitatron Manual-Guided Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7878787879798081838677.17.27.37.4RemoteView Programmer Consultation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .About RemoteView . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .RemoteView status icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Use RemoteView . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Data privacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .878787889088.18.2SessionSync (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91About SessionSync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Configure SessionSync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 916Reference Manual

9.6MEDTRONIC CARELINK 2090Enable and disable SessionSync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SessionSync Status icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Use Automatic SessionSync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Use Manual SessionSync for supported devices . . . . . . . . . . . . . . . . . . . . . . . .SessionSync error message descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .View SessionSync Status screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Update SessionSync status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Test the SessionSync network connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Service the programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Clean the system components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Sterilize the programming head, ECG cable, and lead wires . . . . . . . . . . . . . .Replace a PC card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Programmer specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Special notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Medtronic limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9293949596979797100100100101102105105Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Reference Manual7

MEDTRONIC CARELINK 2090Medtronic1 Introduction to the programmer1.1 Explanation of packaging and product symbolsRefer to the package label and product to see which symbols apply to this product.Conformité Européenne (European Conformity). This symbol means thatthe device fully complies with European Union Acts.The use of this device might be subject to individual country licensingregimes in Europe.CautionConsult instructions for useSystem meets the applicable Canadian and U.S. IEC safety standards.Type BF applied partType CF applied partSerial numberTemperature limitationFor U.S. audiences only.Off8Reference Manual

MEDTRONIC CARELINK 2090MedtronicOnWireless communication enabledDo 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.RF transmitterCaution: Strong magnetThe product fully complies with the Australian Communications and MediaAuthority (ACMA) and the New Zealand Ministry of Economic Development Radio Spectrum Management standards for radio communicationsproducts.VGA monitorBatteryDisketteNetwork connection portUSB portPCMCIA card slotMicrophone portReference Manual9

MEDTRONIC CARELINK 2090MedtronicHeadphones portAuthorized representative in the European communityAlternating currentDate of manufactureManufacturerReorder numberLot numberHumidity limitationPackage contentsProgrammer, software installedProduct documentationAccessoriesMagnetic Resonance (MR) UnsafeSoftware series number10Reference Manual

MEDTRONIC CARELINK 2090MedtronicUL recognized componentChina RoHSCaution: Federal Law (USA) restricts this device to sale by or on the orderof a physicianThe product complies with both Canadian and U.S. requirements for meeting UL safety standards1.2 About this guideThis guide describes the features and functions of the Medtronic CareLink 2090Programmer (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.1.3 Description and intended useThe Medtronic CareLink 2090 Programmer is a portable, line-powered (AC)microprocessor-based system with software to interrogate and program Medtronic andVitatron implantable devices. Other features include: Automated software updates using a dial-up or local area network (LAN) connection,depending on the hardware configuration. This connection allows the programmer toprogram new devices and to provide new features as they become available. A large, bright screen that is adjustable for viewing when sitting or standing. Keyboard to make entering information easier. Fast printing speed of 50 mm/s on recorder paper. ECG recording and diagnostic data reporting. Refer to the technical manuals suppliedwith the software and hardware accessories for specific details.The Medtronic CareLink 2090 Programmer should be used by healthcare personnel only ina clinical or hospital environment.Reference Manual11

MedtronicMEDTRONIC CARELINK 20901.4 ContraindicationsThere are no known contraindications to the use of the 2090 Programmer when not in adevice application. For contraindications specifically related to the implantable devices thatcan be interrogated or programmed by the programmer, see the instructions for use for theimplanted device.1.5 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.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.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.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.12Reference Manual

MedtronicMEDTRONIC CARELINK 2090Internal 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.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.Telecom voltage limitation – When using a modem or combo card, make sure that thetelecom voltage does not exceed 125 V. Excessive voltage may damage the programmer.1.6 PrecautionsVGA monitor use – To protect against interference or surge/leak currents, the use of asecondary VGA monitor must meet an applicable safety standard such as UL 60950-1 orIEC 60950-1. The user is responsible for the safety of the resulting medical electrical system.ECG cable integrity – Upon opening the package, if the ECG cable appears damaged, donot use it. Contact your local Medtronic or Vitatron representative.Care 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.Reference Manual13

MedtronicMEDTRONIC CARELINK 2090Damaged 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.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.1.6.1 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. 14The 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.Printers and other connected office equipment should be placed at least 1.5 m (5 ft) fromthe patient environment.Reference Manual

Medtronic MEDTRONIC CARELINK 2090Electrically-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.1.7 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.1.8 Regulatory compliance1.8.1 Industry CanadaID:3408D-MICSOperation 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.Reference Manual15

MedtronicMEDTRONIC CARELINK 20901.8.2 Australia/New ZealandThe device fully complies with Australian Communications and Media Authority (ACMA) andthe New Zealand Ministry of Economic Development Radio Spectrum Managementstandards. The C-tick symbol indicates that the product complies with the applicableEMC/Radio standard for radio communications products.1.8.3 US Federal Communications Commission (FCC)FCC ID:LF5MICS (for programmer)FCC ID:LF59767 (for programming head)1.8.4 The following provision applies to the low frequency communicationssystem 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.1.8.5 The following provision applies to the UHF communications system inthe device:This transmitter is authorized by rule under the Medical Device Radio CommunicationsService (47 C.F.R. Part 95) and must not cause harmful interference to stations operating inthe 400.150 - 406.000 MHz band in the Meteorological Aids (i.e., transmitters and receiversused to communicate weather data), the Meteorological Satellite, or the Earth ExplorationSatellite Services and must accept interference that may be caused by such aids, includinginterference that may cause undesired operation. This transmitter shall be used only inaccordance with the FCC Rules governing the Medical Device Radio CommunicationsService. Analog and digital voice communications are prohibited. Although this transmitterhas been approved by the Federal Communications Commission, there is no guarantee thatit will not receive interference or that any particular transmission from this transmitter will befree from interference.1.9 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.16Reference Manual

MedtronicMEDTRONIC CARELINK 20901.9.1 Programming functions: Permanent and temporary adjustment of parameter values. Selection of nominal parameter values established by Medtronic, Vitatron or by the user. Emergency buttons for VVI pacing.1.9.2 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 and battery status of theimplanted device.Reporting of real-time measurements of implantable device operating parameters suchas battery voltage, output energy, etc.Display and printout of Marker Channel telemetry to simplify EGM analysis.Display and printout of an atrial and/or ventricular intracardiac electrogram (EGM) takenfrom the electrodes of the implantable device lead system.1.9.3 ECG and other diagnostic functions: ECG window on programming and telemetry data screens provides a continuous viewof the patient’s ECG.Full-window ECG display including a freeze option and an amplitude adjustment feature;ECG display includes Marker Channel telemetry, EGM waveforms, or both whenavailable.Continuous multi-channel recording (ECG and Marker Channel telemetry or ECG andEGM, for example). Stimulation threshold test functions. Direct measurement of pulse rate, AV interval, and pulse width. Temporary implantable device inhibition. Printout of programmed and measured information for permanent record.Reference Manual17

MedtronicMEDTRONIC CARELINK 20901.9.4 Software update function: Automated software updates using a network connection, depending on the hardwareconfiguration. This connection allows the programmer to program new devices and toprovide new features as they become available.Updates available from Medtronic personnel.Clinical software applications that have Uninstall Software capability may be removedusing the programmer desktop.1.10 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.1.10.1 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.The length of time that patient data can be stored on the programmer is limited. When patientdata is removed from the programmer, it is completely erased so that it is no longerrecoverable.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 and they are onlyopen when being used. Network communications are originated by the programmer.Unauthorized software is not permitted to 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.18Reference Manual

MedtronicMEDTRONIC CARELINK 20901.10.2 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.1.10.3 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.1.11 Software requirementsThe programmer requires software from Medtronic and Vitatron to operate. Once installed,the software remains on the programmer hard drive.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.1.12 Obtain technical manualsMedtronic technical manuals, including the manual you are reading, are available from theMedtronic Manual Library website listed on the back cover of this manual. The MedtronicManual Library website offer

body. The programmer is designed to be medically safe only when attached to surface electrodes. Magnetic Resonance (MR) Unsafe – The programmer is MR Unsafe. Do not bring the programmer into Zone 4 (magnet room), as defined by the American College of Radiology. Measurement function – The programmer is also designed to detect and measure pulse

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