Medtronic 24965 24965 User Manual MAPS ID 502120 002

Medtronic, Inc. 24965 MAPS ID 502120 002

User Manual

24965Patient ConnectorDRAFTTechnical ManualCaution: Federal law (USA) restricts this device to sale by or on theorder of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United Statesand possibly in other countries. All other trademarks are the property of their respective owners.CareLink, Medtronic
Contents1 Introduction to the 24965 Patient Connector .............. 41.1 Explanation of packaging and product symbols ........... 41.2 Description ................................ 51.3 Intended use ............................... 61.4 Contraindications ............................ 61.5 Warnings ................................. 61.6 Precautions ................................ 71.7 Regulatory compliance ......................... 81.8 Patient Connector functions ...................... 81.9 Security .................................. 81.10 Compatible components ........................ 92 Setup and configuration ........................... 92.1 System components ........................... 92.2 Setup ....................................113 Conducting a patient session ....................... 143.1 Position the patient connector .....................143.2 Communicating with an implanted device ..............144 Maintaining the patient connector .................... 144.1 Cleaning and disinfecting the 24965 Patient Connector ......144.2 Software updates ............................154.3 Specifications ...............................153M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
1 Introduction to the 24965 Patient Connector1.1 Explanation of packaging and product symbolsRefer to the package label and product to see which symbols apply to this product.CautionConsult instructions for useIngress protectionUse only with specified power supplyType BF applied partHumidity limitationNon-ionizing electromagnetic radiationDo not dispose of this product in the unsorted municipalwaste stream. Dispose of this product according to local reg-ulations. See http://recycling.Medtronic.com for instructionson proper disposal of this product.Direct currentManufacturerDate of manufactureRe-order numberSerial numberPackage contentsProduct documentation4M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
AccessoriesChina RoHSBluetooth connectionFollow instructions for use (blue)Low batteryKeep dryACMA (Australian Communications and Media Authority andthe New Zealand Ministry of Economic Development RadioSpectrum Management standards) symbol for Australia andNew ZealandFor US audiences onlyETL Listed MarkTechnical Conformity (Ministry of Internal Affairs and Com-munications) mark for JapanTransit temperatureStorage temperatureSecurity keyPatient ConnectorTelemetry1.2 DescriptionThe 24965 Patient Connector (patient connector), when paired with Medtronic appson your mobile device, is used to interrogate and program implanted Medtronicdevices. Interrogated information can be viewed or sent to the CareLink Network.5M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
1.3 Intended useThe patient connector is a portable electronic device using low frequency inductivetelemetry to communicate with Medtronic implanted heart devices. The patientconnector uses Bluetooth technology to transmit implanted heart device data to aMedtronic Mobile app for further processing.1.4 ContraindicationsThere are no known contraindications for the use of this device.1.5 WarningsThese warnings apply in general to using the patient connector settings. For moreinformation related to specific implantable device models, see the reference guidesfor the implantable device and the software.Battery exposure – Exposing the patient connector to cold temperatures mayresult in a loss of performance and shortened patient connector service life.Damage due to impact – Do not use the patient connector if it has sustainedimpact damage. Internal components may be damaged or exposed. Use ofdamaged equipment may impact user or patient safety.Diagnostic ultrasound – Diagnostic ultrasound is an imaging technique that isused to visualize muscles and internal organs, their size, structures, and motion aswell as any pathological lesions. It also is used for fetal monitoring and to detect andmeasure blood flow. Diagnostic ultrasound, such as echocardiogram, poses no riskof electromagnetic interference.Diathermy treatment (including therapeutic ultrasound) – Diathermy is atreatment that involves the therapeutic heating of body tissues. Diathermytreatments include high frequency, short wave, microwave, and therapeuticultrasound. Except for therapeutic ultrasound, do not use diathermy treatments oncardiac device patients. Diathermy treatments may result in serious injury ordamage to an implanted device and lead system. Therapeutic ultrasound (includingphysiotherapy, high intensity therapeutic ultrasound, and high intensity focusedultrasound), is the use of ultrasound at higher energies than diagnostic ultrasoundto bring heat or agitation into the body. Therapeutic ultrasound is acceptable iftreatment is performed with a minimum separation distance of 15 cm (6 in) betweenthe applicator and the implanted device and lead system, as long as the ultrasonicbeam is pointing away from the device and lead system.Magnetic Resonance (MR) Unsafe – The patient connector is MR Unsafe. Do notbring the patient connector into Zone 4 (magnet room), as defined by the AmericanCollege of Radiology.Modification of equipment – Do not modify this equipment. Modifications mayreduce system effectiveness and impact user or patient safety. Modifying the devicewithout the approval of Medtronic could void the user’s authority to operate theequipment.Radiation therapy – Exposing the device to therapeutic levels of ionizing radiation(such as that produced by cobalt machines or linear accelerators used for cancertreatment) may trigger inappropriate episode detection or corrupt the data stored inmemory. It is advisable to check device function after radiation therapy. Cumulativeradiation levels above 5 Gy may permanently damage the device.Unauthorized use – The patient connector can be used with any compatiblemobile device onto which the app is installed. Inappropriate programming couldresult if untrained persons obtain the patient connector and a REVEAL LINQ patientallows them to use it with the patient’s device.6M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
Use of unapproved power supply – Use only the Medtronic-supplied powersupply with the patient connector. Use of an unapproved power supply may damageequipment or impact user or patient safety.1.6 PrecautionsAttaching the tether kit – Do not overtighten the screw when attaching the tetherkit.Autoclaving – Do not autoclave the patient connector.Damaged equipment – If the case of the patient connector is cracked or if any ofthe connectors are damaged, contact your Medtronic representative. If there isdamage to the power supply cord, replace the part and dispose of it according tolocal regulations or return the part to Medtronic.Do not immerse – Take care to prevent liquid from entering the patient connector.Do not immerse the patient connector or any accessories in any liquid or clean themwith aromatic or chlorinated hydrocarbons.Electrocautery/external defibrillation – Do not position the patient connectorover an implanted device during electrocautery or external defibrillationprocedures.Maintenance and service – Do not modify or do any maintenance or service onthe patient connector while you are using it. Doing any of these tasks on the patientconnector while it is in use can lower its effectiveness. Contact Medtronic at thenumber on the back cover of this manual if your patient connector is not workingproperly.Product and packaging labels and information – If labels or information appearto be missing from the product or packaging, contact your local Medtronicrepresentative at the address and telephone number located on the back cover ofthis document.Radio-frequency (RF) interference – Portable and mobile RF communicationsequipment can interfere with the operation of the patient connector. Although thissystem has been approved, there is no guarantee that it will not receive interferenceor that any particular transmission from this system will be free from interference. Toavoid interference, do not use the patient connector and mobile device within 2 m (6feet) of a television, computer monitor or screen, or other wireless communicationsequipment such as wireless home network devices, mobile phones, cordlesstelephones and their base stations, or “walkie-talkies”. Using your patient connectornear these devices could interfere with communication between your implantedheart device and the patient connector.Security – Maintain adequate physical security of the patient connector to preventunauthorized use that could lead to harm to patients. Bluetooth communication inthe patient connector is encrypted for security. Inductive telemetry (A/B) usesshort-range communication to protect patient information. If the patient connectorshould fail, there is no risk of patient harm.Use of wireless devices – The patient connector incorporates radio-frequency(RF) communications components which may affect other devices and equipmentin the medical environment. The use of wireless devices in the medical environmentmust be evaluated and authorized by the responsible organization. RF interferencemay affect device performance.1.6.1 Environmental precautionsTo ensure safe and effective operation, use the device with care to avoid damage tothe patient connector from environmental factors that may impair its function. Careis exercised in design and manufacturing to minimize damage to devices under7M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
normal use. However, electronic devices are susceptible to many environmentalstresses including, but not limited to, 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 causephysical damage to the unit. This may impair device function. Even if the unitworks immediately after being dropped, operational damage may haveoccurred that may not be observed until some future time.• Fluid should not be spilled on the unit. Even though care is exercised in designand manufacture of the unit to minimize leakage, fluid incursion may occur,which could impair functioning of the unit.• The patient connector may be affected by electrostatic discharge (ESD). In anenvironment likely to cause ESD, such as a carpeted floor, discharge anycharge collected on your body before touching the device.• Do not open the device. The patient connector is constructed to minimize riskfrom environmental factors. Opening the unit may make the unit susceptible toenvironmental factors and may expose the patient or user to hazardous voltageor current.• Rapid temperature changes may affect proper operation. Always allow thetemperature to stabilize in the environment in which the device is used beforeusing 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 toMedtronic for inspection and any needed repair.Besides these listed examples, various other environmental factors may impairproper performance of the unit in the hospital setting. Always use good healthmanagement practices to prevent environmental damage to the unit.1.7 Regulatory compliance1.7.1 US Federal Communications Commission (FCC)FCC ID: LF524965 (for patient connector). Contains FCC ID: T7V1316.This device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and(2) this device must accept any interference received, including interference thatmay cause undesired operation.1.8 Patient Connector functionsThe patient connector communicates with an implanted device. The patientconnector also communicates with the Medtronic app running on a mobile device.1.9 Security1.9.1 What hospitals and clinics can do to promote the security of patientconnectorsMaintain good physical controls over the patient connector. Having a securephysical environment prevents access to the internals of the patient connector.Only connect the patient connector to managed, secure networks.Update the software on the patient connector when Medtronic updates areavailable.To increase security, store the patient connector and paired mobile device togetherin a secure location when not in use.8M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
1.9.2 What to do if you suspect the patient connector has beencompromisedDiscontinue use of the patient connector if it does not behave as expected. Contactyour Medtronic representative for further assistance.1.10 Compatible componentsThe following compatible components are available for the patient connector:• Power supply• Tether kit• Medtronic Model 6177 sterile sleeveContact your local Medtronic representative to order them.Warning: Use the Medtronic-supplied components only. Use of unapprovedcomponents may reduce device effectiveness or impact user or patient safety.2 Setup and configuration2.1 System componentsFigure 1. Patient Connector components1 Power supply2 Patient Connector9M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
Patient Connector – Provides the communication link between the app and thepatient’s implanted device. The patient connector contains a radio-frequency (RF)transmitter and receiver. It must be held over the implanted device during acommunication session.Mobile device (not supplied) – When running the Medtronic app and paired withthe patient connector, provides the user interface to communicate and program theimplanted device, depending on the app installed.Power supply – Connects to an AC power outlet to charge the patient connectorbattery.Tether kit – Semi-permanently connects the patient connector to the power cord.Contains an Allen wrench, screw, and cable retainer.Warning: Do not modify this equipment. Modifications may reduce systemeffectiveness and impact user or patient safety. Modifying the device without theapproval of Medtronic could void the user’s authority to operate the equipment.10M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
2.1.1 Indicator lightsFigure 2.1 Telemetry Status2 Bluetooth Connection Status3 Battery StatusTable 1. Table with title and rules above and below headerIcon Indicator Color DescriptionTelemetry Status Green When lit, indicatesthat the patientconnector is com-municating with theimplanted device.Bluetooth Connec-tion StatusBlue When flashing,indicates thepatient connectoris paired to the appand ready to use.When steadily lit,indicates thepatient connectoris in use.Battery Status Amber When lit, indicatesthe patient connec-tor battery is lowand should becharged.2.2 SetupThis section describes how to:• Charge the patient connector battery• Download the app• Pair the patient connector with the app• Turn on the patient connector• Attach the tether kit (optional)• Troubleshoot potential interference11M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
2.2.1 Charging the patient connector battery1. Open the power supply connector cover located on the bottom edge of thepatient connector.2. Connect power supply to the patient connector.3. Plug the power cord into the AC power outlet (AC mains).Warning: Use only the Medtronic-supplied power supply with the patientconnector. Use of an unapproved power supply may damage equipment or impactuser or patient safety.2.2.2 Downloading the app1. Make sure the mobile device is connected to the Internet.2. Open the app store and search for the app.3. Touch the app icon to download the app onto the mobile device.12M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
4. Install the app.5. Touch the app icon to open it.6. Follow the instructions in the app to complete the installation.2.2.3 Pairing the patient connector with the appThe patient connector uses a Bluetooth connection to communicate with the mobiledevice. You will need to pair each patient connector to the mobile device. You canhave up to 20 patient connectors paired to one app.1. Enable Bluetooth on the mobile device, if it is not enabled.2. Open the app.3. Touch CONTINUE in the app.4. Locate the 8-digit security key code on the back of the patient connector.5. Enter the security key code and touch CONTINUE.6. Turn on the patient connector by pressing the button. The Bluetooth light on thepatient connector will flash when it is communicating with the mobile device.7. Accept the Bluetooth pairing request on the mobile device.8. Complete the configuration steps in the app.2.2.4 Turning on the patient connector1. Locate the button on the top of the patient connector.2. Press and release the button.3. Complete the task.4. The patient connector will turn off after 1 minute of inactivity. If the patientconnector is not yet paired, it will turn off after 2 minutes. You can also hold thebutton down for 3 seconds to turn the patient connector off manually.2.2.5 Attaching the tether kitThe tether kit provides a way to attach the patient connector to the power cord. Thisis an optional configuration.1. Locate the plug over the power supply cover on the bottom of the patientconnector.2. Use the Medtronic-supplied Allen wrench to remove the screw.3. Slide the cable retainer over the power supply plug of the power cord.4. Attach the power supply plug side of the power cord to the patient connector.5. Insert the screw into the bottom of the cable retainer and tighten the screwusing the Allen wrench.Caution: Do not overtighten the screw when attaching the tether kit.Warning: Use the Medtronic-supplied components only. Use of unapprovedcomponents may reduce device effectiveness or impact user or patient safety.2.2.6 Troubleshooting potential interferenceTo address possible harmful interference between the patient connector and otherdevices, which would result in reduced quality of service, you are encouraged totake one or more of the following measures to address the situation:• Reorient or relocate the devices.• Increase the separation between the patient connector and the devices.• Connect the equipment to an outlet on a different circuit.• Consult Medtronic for help.13M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
3 Conducting a patient session3.1 Position the patient connectorFor an implantable device, the patient connector should be held directly against thepatient’s skin. The face of the patient connector must be parallel to and typicallywithin 5 cm of the implantable device. Optimum position of the patient connectormay not be directly centered over the implantable device. The distal end of thepatient connector should be placed over the device with the device under theantenna. For best telemetry performance, do not use the patient connector close tosources of electrical noise.3.2 Communicating with an implanted device1. Touch the app icon to open it.2. Follow the instructions in the app to start communicating with the device.3. If the patient connector isn’t already on, turn on the patient connector bypressing the button.4. Hold the patient connector over the implanted device until the communicationis complete. Communication can take up to 5 minutes.5. Follow the instructions in the app to complete the task.4 Maintaining the patient connector4.1 Cleaning and disinfecting the 24965 Patient ConnectorCaution: Do not immerse the patient connector in water or cleaning agents. Severedamage to the device may occur. Do not use automated machine washers. Do notsterilize the patient connector by ethylene oxide, gamma radiation, orsteam-sterilization (autoclave). Damage may occur using these methods.Caution: Turn the power off on the patient connector. Disconnect the power supplycord or unplug the power supply from the wall socket if the cable retention kit is used.Do not expose the patient connector to ethers, acetone, or chlorinated solvents.These solvents may damage the housings or labels.Cleaning10% Bleach method1. Before disinfection, clean the patient connector thoroughly using a 10% bleachand water solution and a dampened sterile gauze pad or sponge.2. Wipe down to remove all visible soil.3. Allow to air dry approximately 5 minutes or until dry.DisinfectingUse one of the methods below:70% Isopropyl method1. Disinfect the patient connector by using a 70% isopropyl alcohol and a sterileprep pad, saturated gauze pad or sponge.2. Wipe down all external surfaces and maintain a wet or damp exposure time of15 minutes.3. Allow to air dry approximately 5 minutes or until dry.10% Bleach method14M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
1. Disinfect the patient connector by using a 10% bleach and water solution anda sterile saturated gauze pad or sponge.2. Wipe down all external surfaces and maintain a wet or damp exposure time of15 minutes.3. Allow to air dry approximately 5 minutes or until dry.4.2 Software updatesSoftware updates will be pushed automatically to the patient connector when youstart a communication session. Updates can take up to 5 minutes. You must waituntil the update is complete before you can continue with the session.4.3 SpecificationsTable 2. Patient Connector specificationsStandards (The patient connector complies with the following:)Radio frequency wireless specifications and applicable standardsEMC EN / IEC 60601-1-2EN 300 328EN 301 489EN 302 195EN 55022 Class BEN 55024 Class BRadio FCC CFR 47RSS-210R&TTE Directive 1999/5/ECPatient safety UL/CUL 60601-1, Type BF applied partEN 60601-1, Class 2, continuous operation, TypeBFAC power requirementVoltage 100–240 VAC nominalFrequency 50/60 Hz nominalBatteryType Li-polymer, rechargeableCapacity 1500 mAhCharge duration Standby: 15 daysOperating: 2 hours (typical)Voltage 3.7 VPower supplyAC/DC adapter in 100–240 VAC @ 50/60 Hz100-240 VAC 0.5A 50-60 HzAC/DC adapter out 5 V @ 5.3 A5 VDC 3 AElectrical safety requirements per IEC 60601-1:1988, Clause 19Enclosure leakage current ≤ 0.1 mAPatient leakage current A.C. ≤ 0.1 mAPatient auxiliary currentD.C.≤ 0.01 mAPatient auxiliary currentA.C.≤ 0.1 mA15M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
Table 2. Patient Connector specifications (continued)Electrical safety requirements per IEC 60601-1:2005, Clause 8.7Touch leakage current ≤0.1 mAPatient leakage current A.C. ≤0.1 mAPatient auxiliary currentD.C.≤ 0.01 mAPatient auxiliary currentA.C.≤0.1 mAIEC 60529 Degrees of Protection Provided by Enclosures (IP Code) - AMD7643: July 1993; AMD 10931: August 2000Ingress This product complies with international electricalsafety rating IP22 with regard to ingress of dust,other foreign objects, and water as required by IEC60601-1.Physical dimension and weightHeightWidthDepthWeight14 cm7.2 cm3.2 cm.18 kgTemperature limitsOperatingStorageTransport15 °C to 35 °C- 20 °C to 60 °C- 30 °C to 70 °CHumidity limitsOperatingStorageStorage Transport75%95% at 35 °C93% at 35 °CAltitudeMaximum 3000 mConnectivity and controlsBluetooth 2.1 and 4.0Frequency range 2.4 GHzOutput power Less than 10 mW EIRPExpected service life5 years4.3.1 Expected service lifeThe patient connector has an expected service life of 5 years. If you noticedecreased operational time between battery charges or the battery no longer holdsits charge, contact Medtronic to get a replacement patient connector.4.3.2 Disposal of the patient connectorReturn the patient connector to Medtronic for proper disposal.16M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03XSL-Stylesheet J - Size-selectable packagemanual 24-JAN-2014
Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAwww.medtronic.com+1 763 514 4000Medtronic USA, Inc.Toll-free in the USA (24-hour technicalconsultation for physicians and medicalprofessionals)Bradycardia: +1 800 505 4636Tachycardia: +1 800 723 4636Europe/Middle East/AfricaMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerland+41 21 802 7000Technical manualswww.medtronic.com/manuals© 2014 Medtronic, Inc.M999999A 2014-11-20*M999999A*

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