Medtronic 24967 24967 User Manual MAPS ID 502387 043

Medtronic, Inc. 24967 MAPS ID 502387 043

User Manual

24967Patient ConnectorTechnical ManualCaution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the propertyof their respective owners.CareLink, Medtronic
Contents1 Introduction to the 24967 Patient Connector ............................................................... 41.1 Explanation of packaging and product symbols .......................................................... 41.2 Description ......................................................................................... 61.3 Intended use ....................................................................................... 61.4 Contraindications ................................................................................... 71.5 Warnings .......................................................................................... 71.6 Precautions ........................................................................................ 71.7 Regulatory compliance .............................................................................. 81.8 Patient Connector functions .......................................................................... 81.9 IT network, mobile device, and data information ......................................................... 82 Setup and configuration ................................................................................. 102.1 Contents of package ................................................................................ 102.2 System components ................................................................................ 102.3 Compatible accessories ............................................................................. 112.4 Setup ............................................................................................ 122.5 Charging the patient connector battery ................................................................ 132.6 Pairing the patient connector with the app ............................................................. 142.7 Troubleshooting potential interference ................................................................. 153 Conducting a patient session ............................................................................ 153.1 Positioning the patient connector ..................................................................... 153.2 Communicating with an implantable device ............................................................ 153.3 Troubleshooting .................................................................................... 164 Maintaining the patient connector ....................................................................... 174.1 Cleaning and disinfecting the 24967 patient connector .................................................. 174.2 Replacing the patient connector nose, cable, and weight ................................................. 214.3 Software updates .................................................................................. 234.4 Specifications ..................................................................................... 235 Electromagnetic compatibility declaration ................................................................ 243
1 Introduction to the 24967 Patient Connector1.1 Explanation of packaging and product symbolsRefer to the package label and product to see which symbols apply to this product.Consult instructions for use at www.medtronic.com/manuals.Conformité Européenne (European Conformity). This symbol means that the device fully complieswith applicable European Union Acts.Ingress protectionUse only with specified power supplyClass II ME equipment equipmentType BF applied partType CF applied partHumidity limitationNon-ionizing electromagnetic radiationDo not dispose of this product in the unsorted municipal waste stream. Dispose of this productaccording to local regulations. See http://recycling.Medtronic.com for instructions on proper dis-posal of this product.Direct currentManufacturerDate of manufactureAuthorized representative in the European communityFor US audiences onlyCaution: Federal law (USA) restricts this device to sale by or on the order of a physician4
Re-order numberSerial numberPackage contentsProduct documentationAccessoriesMagnetic Resonance (MR) UnsafeBluetooth connectionWireless communication enabledTelemetry enabledCaution: Strong magnetFollow instructions for use (blue)Low batteryKeep dryACMA (Australian Communications and Media Authority) and the New Zealand Ministry of Eco-nomic Development Radio Spectrum Management compliance mark for Australia and New Zea-landSystem meets the applicable Canadian and U.S. IEC safety standardsTechnical Conformity (Ministry of Internal Affairs and Communications) mark for JapanOperating temperature5
Transit temperatureStorage temperatureSecurity key24970A Device manager24967 Patient connector249701 Power supply (for the 24970A base)249705 Power cord (for the 24970A base)249651 Power supply (for the 24967 patient connector)249672 Tether Kit249702 USB Cable249671 Weight Kit1.2 DescriptionThe 24967 Patient Connector telemetry head (referred to from now on as the patient connector), pairs with Medtronic apps on yourmobile device to interrogate and/or program implantable Medtronic devices.The patient connector includes these features:• Low frequency inductive telemetry to communicate with implantable Medtronic devices.• Bluetooth® wireless technology to communicate with implantable Medtronic devices and the apps running on the mobile device.1• Integration with the Medtronic 24970A Base for charging (not included).1.3 Intended useThe patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronicdevices. The patient connector uses Bluetooth technology to transmit that data to a Medtronic app for further processing.The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment1The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any such use of those marks by Medtronicis under license.6
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 more information related to specific implantable devicemodels, see the reference guides for the implantable device and the software.Battery exposure – Exposing the patient connector to cold temperatures may result in a loss of performance and shortened patientconnector service life.Connection of external devices – Additional equipment connected to medical electrical equipment must comply with the respectiveIEC or ISO standards. All configurations must comply with the requirements for medical electrical systems, see IEC 60601-1 and IEC60601-1-1. Anyone connecting additional equipment to medical electrical equipment configures a medical system and is thereforeresponsible that the system complies with the requirements for medical electrical systems. Local laws take priority over the abovementioned requirements. If in doubt, consult your local Medtronic representative or the technical service department.Damage due to impact – Do not use the patient connector if it has sustained impact damage. Internal components may be damagedor exposed. Use of damaged equipment may impact user or patient safety.Magnetic Resonance (MR) Unsafe – The patient connector is MR Unsafe. Do not bring the patient connector into Zone 4 (magnetroom), as defined by the American College of Radiology.Modification of equipment – Do not modify this equipment. Modifications may reduce system effectiveness and impact user orpatient safety. Modifying the patient connector without the approval of Medtronic could void the user’s authority to operate theequipment.Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of thepatient connector. Although the patient connector has been approved, there is no guarantee that it will not receive interference or thatany particular transmission from the patient connector will be free from interference.Unauthorized use – The patient connector can be used with any compatible mobile device onto which the app is installed.Inappropriate programming could result if untrained persons obtain the patient connector and a patient with a Medtronic implantableheart device allows them to use it with the patient’s device.Use of unapproved power supply – Use only the Medtronic-supplied power supply with the patient connector. Use of anunapproved power supply may damage equipment or impact user or patient safety.1.6 PrecautionsAttaching the tether kit – Do not overtighten the screw when attaching the tether kit.Autoclaving – Do not autoclave the patient connector.Damaged equipment – Periodically, inspect the patient connector, connection port, and cord for damage. If the case of the patientconnector is cracked, or if the power supply connector is damaged, contact your Medtronic representative. Replace the power supplyif there is damage to it. Dispose of the damaged power supply according to local 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 anyaccessories in any liquid or clean them with aromatic or chlorinated hydrocarbons.Maintenance and service – Do not modify or do any maintenance or service on the patient connector while you are using it. Doingany of these tasks on the patient connector while it is in use can lower its effectiveness. Contact Medtronic at the number on the backcover of this manual if your patient connector is not working properly.Product and packaging labels and information – If labels or information appear to be missing from the product or packaging,contact your local Medtronic representative at the address and telephone number located on the back cover of this document.Security – Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm topatients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-rangecommunication to protect patient information. If the patient connector should fail, there is no risk of patient harm.Sterility – The patient connector is not sterile and cannot be sterilized. For applications in which a sterile environment must bemaintained, place the patient connector inside of the Medtronic Model 6177 sterile sleeve.Use of wireless devices – The patient connector incorporates radio-frequency (RF) communications components which may affectother devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluatedand authorized by the responsible organization. RF interference may affect device performance.Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmfulinterference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment mustbe evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in aparticular installation.7
If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct theinterference by one or more of the following measures:• Reorient or relocate the patient connector and other devices.• Increase the separation between the patient connector and other devices by at least 2 m (approximately 6 feet). Other devicesinclude, but are not limited to, cellular phones, computer screens, wireless network devices, and ‘walkie-talkies’.• Turn off any interfering equipment.1.6.1 Environmental precautionsTo ensure safe and effective operation, use the patient connector with care to avoid damage to the patient connector fromenvironmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to the patientconnector under normal use. However, the patient connector is susceptible to many environmental stresses including, but not limitedto, the following examples.• The patient connector is designed to be used indoors in a clinical or hospital environment.• Do not drop or mishandle the patient connector or damage may occur. Damage can impair the functionality of the patientconnector. Even if the patient connector works immediately after being dropped, operational damage may have occurred that maynot be observed immediately.• Do not spill fluid on the patient connector. Fluid incursion can occur and cause damage to the patient connector.• The patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as acarpeted floor, discharge any charge collected on your body before touching the patient connector.• Do not open the case of the patient connector. The patient connector is constructed to minimize risk from environmental factors.Opening the case of the patient connector can make it susceptible to environmental factors and can expose the patient or userto hazardous voltage or current.• Do not expose the patient connector to rapid temperature changes. Rapid temperature changes may affect proper operation ofthe patient connector. If the patient connector is exposed to rapid temperature changes, allow the temperature to stabilize beforeusing it.• Do not store or operate the patient connector for prolonged periods of time in high humidity. Prolonged storage or operation of thepatient connector in high humidity can affect proper operation.If the patient connector is damaged, contact Medtronic at the telephone number on the back cover of this manual.Other environmental factors can impair the performance of the patient connector. Always use good health management practices toprevent environmental damage to the patient connector.1.7 Regulatory compliance1.7.1 US Federal Communications Commission (FCC)This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not causeharmful interference, and (2) this device must accept any interference received, including interference that may cause undesiredoperation.1.8 Patient Connector functionsThe patient connector communicates with an implantable device. The patient connector also communicates with the Medtronic apprunning on a mobile device.1.9 IT network, mobile device, and data information1.9.1 Required IT network characteristics and configurationThe use of the patient connector requires your network to have Internet access for the following purposes:• Download and install the Medtronic app from the app store.• Download and install Medtronic app updates and software updates for the patient connector.• Register, download, and install app configuration files from the Medtronic Application Services (MAS), if the Medtronic app allowsit.• Send data to the CareLink Network, if the Medtronic app allows it.Failure to provide IT network access results in the following effects:• You cannot install or update the Medtronic app because the mobile device is unable to access the Internet.• You cannot install periodic updates and security enhancements that maintain the security of the Medtronic app because themobile device is unable to access the Internet.• You cannot send downloaded Medtronic implantable device data to the CareLink Network.8
To use the Medtronic app, you must also enable Bluetooth wireless technology on your mobile device. The patient connectorcommunicates with the Medtronic app installed on the mobile device through a Bluetooth connection.Failure to provide Bluetooth wireless communication access prevents the patient connector from communicating with the Medtronicapp. If Bluetooth connectivity is disabled, the patient connector cannot interrogate, analyze or program Medtronic implantabledevices.Follow your organization’s processes and policies to configure your network and your mobile device.1.9.2 Supported mobile devices and technical specificationsFor a list of supported mobile devices and their specifications, including network connectivity specifications, go to the followingwebsite:www.medtronic.com/249671.9.3 Intended information flowsData is sent for processing through the system components in the following sequential order:• Implantable device• 24967 patient connector• Medtronic app running on the mobile deviceSystem logs are sent for processing through the system components in the following sequential order:• 24967 patient connector• Medtronic app running on the mobile device• Internet• Medtronic Application Services (MAS)During installation and updates, the app sends clinic registration and device manager system credentials to Medtronic ApplicationServices via the Internet for authentication. In response, Medtronic Application Services returns configuration files to the app via theInternet to install or update the app and component software as needed.All information in transit is protected for security.1.9.4 Precautions when connecting to your IT networkConnecting this system to an IT network that includes other equipment could result in unforeseen risks to patients, operators, or thirdparties. Changes to your IT network, such as adding, disconnecting, and upgrading equipment or changing network configurationscould also introduce additional risks. Analyze, evaluate, report, and control any risks identified.1.9.5 Data transmissionsThe patient connector uses Bluetooth wireless technology to communication with the Medtronic app installed on the mobile device.Data transmission rates over Bluetooth connections are highly dependent on the environment in which the patient connector andmobile device are used. Transmission rates may degrade based on electrical interference from other radio emitters, distance betweenthe patient connector and the mobile device, and wireless or cellular settings on the mobile device. Maximum data throughput in anideal environment is 2.1 Mbit/s with a latency of 5 to 10 ms.All data transmitted between the patient connector and the app is encrypted for data privacy. Data integrity is maintained throughstandard communication protocols for error detection.1.9.6 SecurityData in the Medtronic app is protected by application level encryption. The app does not provide data protection for data exported toanother destination. Data exported from the app should be handled in accordance with your clinic’s security policy for data handlingand storage.To protect the system, Medtronic recommends you implement the following security measures:• Use the Medtronic app and system components only on a managed, trusted network.• Secure your network with anti-virus software or a firewall, in line with your IT department’s policies.• To help protect patient health information, implement security measures such as a passcode and PIN to protect the mobile device.• Ensure security certificates match before connecting to Medtronic Application Services for app updates.If you suspect a cybersecurity event has occurred, stop using the app (if possible) and contact your IT Security or Biomedicaldepartment for information on how to confirm and respond to the suspected incident.9
2 Setup and configuration2.1 Contents of packageThe package contains:• Model 24967 Patient Connector• MENB1020A0500XXX Power Supply (Medtronic re-order number: 249651)• Model 249652 Tether Kit• Literature2.2 System componentsFigure 1. Patient connector components1 Weight (blue)2 Patient connector3 Tether kit4 Power supplyPatient connector – Provides the communication link between the app and the patient’s implantable device. The patient connectorcontains a radio-frequency (RF) transmitter and receiver. It must be placed over the implantable device during a communicationsession. The patient connector has a blue counter weight, and when it is unwrapped and placed over the patient’s shoulder can holdthe patient connector in place hands-free.Mobile device (not included) – When running the Medtronic app and paired with the patient connector, provides the user interfaceto communicate with the implantable device, depending on the app installed.Power supply – Connects to an AC power outlet to charge the patient connector battery.Tether kit – Semi-permanently connects the patient connector to the power cord. Contains a Torx wrench, screw, and cable retainer.Warning: Do not modify this equipment. Modifications may reduce system effectiveness and impact user or patient safety. Modifyingthe device without the approval of Medtronic could void the user’s authority to operate the equipment.10
2.2.1 Indicator lightsFigure 2. Patient connector indicator lights1 Telemetry status2 Bluetooth connection status3 Battery statusTable 1. Patient connector icons and indicator lightsIcon Indicator Color State DescriptionTelemetry status Amber Solid The patient connector is out of range ofthe implanted device.Green Solid The patient connector is actively commu-nicating with the implanted device. Thelight becomes brighter when the signalfrom the implanted device is stronger.Bluetooth connection sta-tusBlue Flashing The patient connector is broadcasting itsstatus or is being paired with the mobiledevice.Blue Solid The patient connector is connected to themobile device.Battery status Amber Solid The patient connector battery is low.Green Flashing The patient connector battery is charg-ing.Green Solid The patient connector battery is fullycharged.2.3 Compatible accessoriesThe following compatible accessories are available for the patient connector:• MENB1020A0500XXX power supply (Medtronic re-order number: 249651XX), 2 m (approximately 6.5 feet)• Model 249672 tether kit• Model 6177 sterile sleeve (not included)• Model 24970A Base (not included)• Model 249702 USB cable, approximately 3 m (10 feet) (not included)Contact your local Medtronic representative to order them.Warning: Use the Medtronic-supplied components only. Use of unapproved components may reduce device effectiveness or impactuser or patient safety.11
2.4 SetupThis section describes how to:• Power on the patient connector• Power off the patient connector• Download the app• Attach the optional tether kit2.4.1 Powering on the patient connector1. Locate the button on top of the patient connector.Figure 3. Locate the patient connector button1 Patient Connector button2. To power on the patient connector, press and release the button.The Bluetooth connection status light flashes when the patient connector is turned on.2.4.2 Powering off the patient connectorIf the patient connector is not charging and has not been paired with the app, it powers off automatically after 5 minutes of inactivity.If the patient connector is not charging and has been paired with the app, for example after a patient session, it powers off automaticallyafter 15 minutes of inactivity.If the patient connector is charging, the Bluetooth radio turns off automatically after 5 minutes of inactivity.2.4.3 Downloading the app1. Make sure the mobile device is connected to the Internet.2. Navigate to the app store and locate the app.3. Tap the app download button to download the app onto the mobile device.4. Install the app.5. Tap the app icon to open it.6. Follow the instructions in the app to complete the installation.2.4.4 Attaching the optional tether kitThe tether kit provides a way to semi-permanently attach the patient connector to the power supply cord. This is an optionalconfiguration.1. Locate the power supply connector cover on the bottom of the patient connector.2. Use the Medtronic-supplied wrench to remove the screw.12
3. Remove the power supply cover from the patient connector.4. Plug the power supply into the patient connector.5. Slide the cable retainer over the power supply plug of the power cord.6. Insert the screw into the bottom of the cable retainer and tighten the screw using the Medtronic-supplied wrench.Caution: Do not over tighten the screw when attaching the tether kit.Warning: Use the Medtronic-supplied components only. Use of unapproved components may reduce patient connectoreffectiveness or impact user or patient safety.2.5 Charging the patient connector batteryCaution: Charge the patient connector before use. If the patient connector is not adequately charged before beginning a procedure,you may not be able to complete that procedure.Charge the patient connector using the Medtronic-supplied power supply.There are two additional ways to charge the patient connector using the 24970A base. For more information on charging, refer to theinstructions for use provided with the 24970A base. Contact your Medtronic representative for details.Notes:• The patient connector and power supply form a medical electrical system when connected.• If you need to disconnect the patient connector from the AC power mains, the power supply is the power disconnect at the mainsoutlet.• Position the patient connector so that it can be easily disconnected or unplugged from the wall.• The third conductor in the power supply plug, if present, is a functional earth connection.• If the operational time between charges decreases or the patient connector internal rechargeable battery no longer retains acharge, contact Medtronic for a replacement2.5.1 Charging using the power supplyConnect the power supply to the patient connector and to an AC power outlet (AC mains) to charge the patient connector.13
1. Open the power supply connector cover located on the bottom edge of the patient connector.2. Connect the power supply cord to the patient connector.3. Plug the power supply into the AC power outlet (AC mains).Warning: Use only the Medtronic-supplied power supply to power the patient connector. Use of an unapproved power supply maydamage equipment or impact user or patient safety.2.6 Pairing the patient connector with the appThe patient connector uses a Bluetooth connection to communicate with the app running on the mobile device. You will need to paireach patient connector to the mobile device.1. Enable Bluetooth on the mobile device, if it is not enabled.2. Open the app.3. Follow the instructions in the app to continue.4. Enter the patient connector model number, if you are prompted. The model number is located on the back of the patientconnector.5. Turn on the patient connector by pressing the button when prompted by the app. The Bluetooth connection status light on thepatient connector flashes when it is being paired with the mobile device, and is solid when communication is established with themobile device.6. When prompted by the app, select the patient connector you want to use from the list.14
7. Locate the security key code on the back of the patient connector.Figure 4. Patient Connector security key1 Security key symbol2 Security key code8. Enter the security key code and follow the instructions in the app to continue.9. Accept the Bluetooth pairing request on the mobile device.10. Complete the configuration steps in the app.2.7 Troubleshooting potential interferenceInterference between the patient connector and other electronic equipment can result in reduced quality of service. Reduced qualityof service could result in slow data transmission speeds or poor communication strength.For more information on app-specific error messages see the instructions for use provided with the Medtronic app.To address possible interference between the patient connector and other electronic equipment, take one or more of the followingmeasures:• Reorient or relocate the electronic equipment.• Increase the separation between the patient connector and the electronic equipment.• Connect the electronic equipment to an outlet on a different circuit, if the patient connector is plugged into the outlet for charging.• Move the patient connector and mobile device closer together.• Consult Medtronic for help.3 Conducting a patient session3.1 Positioning the patient connectorThe patient connector can either be balanced over the patient’s shoulder using the blue weight for hands-free use or held over theimplanted device. The patient connector, blue weight, and cord come into physical contact with the patient during normal use of thedevice. Use the Model 6177 sterile sleeve if sterility is a concern.1. For hands-free use, unwrap the blue weight and cord from the patient connector and place the weight over the patient’s shoulder.2. Position the patient connector over the implantable device.Note: The bottom of the patient connector must be parallel to and typically within 5 cm of the implantable device.3. Verify that the green telemetry status light on the patient connector is on. The telemetry status light will become brighter whenthe signal from the device is stronger. This indicates better telemetry.For best telemetry performance, do not use the patient connector close to sources of electrical noise or interference.3.2 Communicating with an implantable deviceTo ensure good Bluetooth communication, make sure the mobile device is no further than 2 m (6.5 feet) from the patient connectorduring the patient session.Caution: Charge the patient connector before use. If the patient connector is not adequately charged before beginning a procedure,you may not be able to complete that procedure.Note: Place the Model 6177 sterile sleeve over the patient connector if the patient connector is being used in a sterile environment.15
1. Tap the app icon to open it.2. If the patient connector isn’t already on, turn on the patient connector by pressing the button.3. Place the patient connector over the implantable device. The telemetry status light on the patient connector is green whencommunication is established with the implantable device. The telemetry status light is brighter when there is a stronger signal.4. Follow the instructions in the app to start communicating with the implantable device.5. Leave the patient connector over the implantable device until the communication is complete. Communication can take up to 5minutes.Caution: Only use the patient connector to communicate with the intended implanted device. Avoid placing the patientconnector over an unintended active implanted device. Placing the patient connector over an unintended active implanteddevice could interfere with that device, potentially affecting its operation.6. Follow the instructions in the app to complete the task.3.3 TroubleshootingAn error or an informational message displays in the app if there is a problem with the patient connector. The message may have ananimated demo with directions on how to resolve the condition. Refer to the app online help for additional information about specificerror codes. For some conditions, contact Medtronic using the information found on the back cover of this manual.3.3.1 Patient connector battery statusIf the patient connector needs to be recharged, the following condition occurs:Condition Action ResultThe battery status light on the patient con-nector is amber.Recharge the patient connector battery. When the patient connector is charging thebattery status light flashes green. Whenthe battery is fully charged the battery sta-tus light is solid green.3.3.2 Patient connector positionPosition the patient connector correctly over the implantable device to communicate with it. If you do not position the patient connectorproperly over the implantable device, the following condition may occur:Condition Action ResultThe telemetry status light is amber. Reposition the patient connector over theimplantable device.If the implantable device is implanted in thepatient, additional implanted devices mayinterfere with the communication betweenthe patient connector and the patient’simplanted device. If the patient has morethan one implanted device and you areunable to communicate with the patient’simplanted device, reposition the patientconnector closer to the patient’s implanteddevice.When the telemetry status light turnsgreen, the patient connector is communi-cating with the implantable device. Thetelemetry status light is brighter when thecommunication from the device is stron-ger.The telemetry status light is off. Confirm that the implantable device is aMedtronic device. The patient connectoronly works with Medtronic implantabledevices.Reposition the patient connector over theMedtronic implantable device.When the telemetry status light turnsgreen, the patient connector is communi-cating with the implantable device. Thetelemetry status light is brighter when thecommunication from the device is stron-ger.3.3.3 Bluetooth connection lostThe patient connector pairs with a mobile device to send data. If the patient connector loses the Bluetooth connection with the mobiledevice, the following condition occurs:Condition Action ResultThe Bluetooth connection status indicatorlight flashes.Check that Bluetooth is enabled on themobile device. Enable Bluetooth on themobile device if it is not enabled.Move the mobile device closer to thepatient connector and confirm that the bluelight on the patient connector is on. CheckThe Bluetooth connection status light is on.When the blue light is on, Bluetooth hasestablished a connection between thepatient connector and the mobile device.16
Condition Action Resultthat nothing physical is blocking the signalbetween the patient connector and themobile device.4 Maintaining the patient connector4.1 Cleaning and disinfecting the 24967 patient connector4.1.1 Cautions and notes for cleaning and disinfectingCautions:• Clean and disinfect the patient connector as needed according to your organization’s policies. Use only the recommendedmethods to clean and disinfect the patient connector. Depending on the level of contamination, such as exposure to blood or bodyfluid, Medtronic recommends cleaning and disinfecting the patient connector promptly after use to minimize drying and crosscontamination.• Use only recommended cleaning and disinfecting methods on the patient connector. Using other cleaners, solvents, ordisinfectants (such as bleach, ethers, acetone, or chlorinated solvents) may damage the patient connector plastic, circuitry, ormetal components.• Do not immerse the patient connector in water or cleaning agents. Do not use automated machine washers. Severe damage tothe patient connector may occur.• Do not sterilize the patient connector by ethylene oxide, gamma radiation or steam-sterilization (autoclave). Severe damage to thedevice, housing, or labels may occur using these methods.Notes:• The patient connector is designed to withstand normal cleaning and disinfecting over its product life.• The disinfecting procedure below has been tested and shown to achieve a log 4.8 or greater reduction in pathogens. If yourorganization or application requires a higher level of disinfection, place the patient connector inside a sterile barrier (such as theMedtronic Model 6177 sterile sleeve).• During procedures in a sterile environment or when cross contamination is a concern, place the patient connector inside a sterilebarrier (such as the Medtronic Model 6177 sterile sleeve).• The power cord, USB cable, and optional tether kit accessories cannot be disinfected effectively. If these accessories becomecontaminated, discard the accessory and contact Medtronic for a replacement. When using the optional tether kit to secure theUSB cable or power cord, place the patient connector inside of the Medtronic Model 6177 sterile sleeve to limit patient contact andreduce device exposure to contamination.4.1.2 Preparing the patient connector1. If the patient connector is connected plugged into a power source, unplug it. If you are using the optional tether kit to secure thecord to the patient connector, only unplug the cord from the power source.2. The patient connector powers off automatically in 5 min when it is not connected to a power source. Wait 5 min for the patientconnector to power off.The LED lights turn off when the patient connector powers off.17
3. Unwrap the blue weight from around the patient connector and fully extend the cord.4.1.3 Cleaning the patient connector1. Clean the patient connector thoroughly using one of the following cleaning methods:• A 70% isopropyl alcohol prep pad.• A sterile gauze pad or sponge dampened with 70% isopropyl alcohol.2. Wipe all external surfaces of the patient connector to remove all visible soil.a. Wipe the blue weight and its cord.b. Wipe all sides of the patent connector, including the cord retention channel and cable power supply connector cover oroptional tether kit.c. Wipe the top of the patient connector.d. Wipe the bottom of the patient connector.18
e. If the optional tether kit is installed to secure the power supply cord or USB cable, wipe the cord or cable for approximately1 m (3 feet) extending from the patient connector.3. Allow to air dry approximately 5 minutes or until dry. Leave the blue weight fully extended until it is dry.4.1.4 Disinfecting the patient connector1. Follow the steps in the previous section to thoroughly clean all external surfaces of the patient connector.You do not need to allow the patient connector to dry if you are disinfecting it after cleaning.2. If the optional tether kit is installed, remove the tether kit and unplug the USB cable or power cord. Reinstall the cable connectorport cover to seal the connector port contacts.The USB cable, power cord, and optional tether kit accessories cannot be disinfected effectively. If these accessories becomecontaminated, remove them from the patient connector and discard. Contact Medtronic for a replacement.3. Disinfect the patient connector with one of the following materials:• Several 70% isopropyl alcohol prep pads, or sterile gauze pads or paper wipes dampened with 70% isopropyl alcohol.• Several 1.4% hydrogen peroxide wipes.4. Fully wrap all external surfaces of the patient connector with the damp prep pads, sterile gauze pads, or wipes.a. Wrap the blue weight and its cord lengthwise to completely cover both.19
b. Wrap all sides of the patient connector to completely cover it.5. To maintain a wet or damp exposure time of 15 minutes and reduce evaporation, place all wrapped components of the patientconnector inside a plastic bag or container. Seal the bag or container to reduce evaporation.6. After 15 minutes have elapsed, remove all wrapped components of the patient connector from the plastic bag or container.7. Remove the damp prep pads, paper wipes, or sterile gauze from the exterior of the patient connector and all its components.8. Safely discard the damp prep pads, paper wipes, or sterile gauze according the policies and procedures of your organization.9. Allow to air dry approximately 5 minutes or until dry. Leave the blue weight fully extended from its cord during drying.20
4.1.5 Reassembling the patient connector1. Rewrap the blue weight around the patient connector and secure it in the top of the retention channel.2. Install a new replacement tether kit with a new USB cable or power supply, if needed. This is an optional configuration.4.1.6 Additional resourcesFor additional information about cleaning and disinfecting the patient connector, contact Medtronic Instruments Technical Services:• Phone: +1 800 638 1991• Email: tshelp@Medtronic.comFor more information and resources on cleaning and disinfecting medical devices, visit the CDC and HICPAC websites.4.2 Replacing the patient connector nose, cable, and weightYou can replace the patient connector nose, cable, and weight if they become damaged. Contact your Medtronic representative toorder the replacement parts.1. Locate the screw on the nose of the patient connector.2. Use the Medtronic-supplied wrench to loosen and remove the screw.21
3. Unwrap the blue weight from around the patient connector and fully extend the cord.4. Remove the nose, the cable, and the weight.5. Thread the cable with the weight through the hole in the nose.6. Place the new nose on the patient connector and line up the screw hole.22
7. Wrap the blue weight around the patient connector and insert the screw into the screw hole. Use the Medtronic-supplied wrenchto tighten it.4.3 Software updatesSoftware updates will be pushed automatically to the patient connector when you start a communication session in the app. Updatescan take up to 5 minutes. You must wait until the update is complete before you can continue with the session.4.4 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 55011 Class BEN 55024 Class BRadio FCC CFR 47Patient safety UL/CUL 60601-1, Type BF applied partEN 60601-1, Class 2, continuous operation, Type BFAC 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 VPatient connector charger specificationsPower supplyModel MENB1020A0500XXX power supply (Medtronic re-order number 249651)Voltage in 100-240 VAC 0.5A at 50-60 HzVoltage out 5 VDC 3 AElectrical shock protection class Class IIIntended duty ContinuousUSB cableModel 249702 USB cableVoltage 5 V 0.8 APower 4W24970A charge cradleModel 24970AVoltage 5 V 3.0 APower 15 WIEC 60529 Degrees of Protection Provided by Enclosures (IP Code)Ingress This product complies with international electrical safety rating IP2X with regard toingress of dust, other foreign objects, and water as required by IEC 60601-1.23
Table 2. Patient connector specifications (continued)Physical dimension and weightLengthWidthDepthWeight16.7 cm (6.6 in)7.3 cm (2.9 in)3.0 cm (1.2 in)0.25 kg (0.55 lbs)Temperature limitsOperatingStorageTransport10°C to 35°C (50°F to 95°F)15°C to 30°C (59°F to 86°F)- 30°C to 55°C (-22°F to 131°F)Humidity limitsOperatingStorageTransport8%-80%15%-93% at 35°C (95°F)15%-93% at 35°C (95°F)AltitudeMaximum 3000 mConnectivityLow frequency inductive telemetryFrequency range 150-200 kHzModulation frequency Frequency shift key, phase shift key, On/Off keyingOutput power 30 dBµA/m @ 10 mBluetooth wireless technology 2.1 and 4.0Frequency range 2.4-2.483 GHzModulation frequency Gaussian frequency shift keyOutput power Less than 10 mW EIRP4.4.1 Expected service lifeThe patient connector including the internal battery has an expected service life of 5 years. If you notice decreased operational timebetween battery charges or the battery no longer holds its charge, contact Medtronic to get a replacement patient connector.4.4.2 Disposal of the patient connectorReturn the patient connector to Medtronic for proper disposal. Contact Medtronic at the address or telephone number on the backcover for information on returning the patient connector.5 Electromagnetic compatibility declarationThe following list of accessories were included in the system demonstrating compliance with the requirements of IEC 60601-1-2 2007clauses 7 and 8:Accessory Maximum lengthMENB1020A0500XXX Power Supply(Medtronic re-order number: 249651)2 m (approximately 6.5 feet)Use of accessories other than what is specifically listed may result in increased emissions or decreased immunity of the 24967 patientconnector.The 24967 patient connector needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed andused according to the EMC information provided in the accompanying documents.The 24967 patient connector should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary,the 24967 patient connector should be observed to verify normal operation in the configuration in which it will be used.The 24967 patient connector contains RF transmission and receiving capabilities. Consequently, it is possible that other equipmentmay interfere with the 24967 patient connector even if that other equipment complies with CISPR emission requirements. Thefollowing is a technical summary of the RF communication properties:Transmitting and receiving:• Frequency of operation: 150 kHz to 200 kHz, 2400 MHz to 2483.5 MHz• Modulation characteristics: 18K0M1D or 74K4F1D, FHSS, DTS• Field strength: less than 30 dBµA/m @ 10 m, less than 10 mW EIRP24
Guidance and manufacturer’s declaration—electromagnetic emissionsThe 24967 patient connector is intended for use in the electromagnetic environment specified below. The customer or the user ofthe 24967 patient connector should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment—guidanceRF emissionsCISPR 11Group 1 The 24967 patient connector uses RF energy only for its internal func-tion. Therefore, its RF emissions are very low and are not likely to causeany interference in nearby electronic equipment.RF emissionsCISPR 11Class BHarmonic emissionsIEC 61000-3-2Class A The 24967 patient connector is suitable for use in all establishments,including domestic establishments and those directly connected to thepublic, low-voltage power supply network that supplies buildings usedfor domestic purposes.Voltage fluctuations/flicker emissionsIEC 61000-3-3CompliesGuidance and manufacturer’s declaration—electromagnetic immunityThe 24967 patient connector is intended for use in the electromagnetic environment specified below. The customer or the user ofthe 24967 patient connector should assure that it is used in such an environment.Immunity test IEC 60601 Test level Compliance level Electromagnetic environment—guid-anceElectrostatic discharge (ESD) ±6 kV contact ±8 kV contact Floors should be wood, concrete, orceramic tile. If floors are covered with syn-thetic material, the relative humidity shouldbe at least 30%.IEC 61000-4-2 ±8 kV air ±15 kV airElectrical fast transient/burst ±2 kV for power supplylines±2 kV for power supplylinesMains power quality should be that of a typ-ical commercial or hospital environment.IEC 61000-4-4 ±1 kV for input/ outputlines±1 kV for input/ outputlinesSurge ±1 kV differentialmode±1 kV differentialmodeIEC 61000-4-5 ±2 kV common mode ±2 kV common modeVoltage dips, short interruptions, andvoltage variations on power supplyinput linesIEC 61000-4-11<5% UT(>95% dip in UT)for 0.5 cycle<5% UT(>95% dip in UT)for 0.5 cycleMains power quality should be that of a typ-ical commercial or hospital environment. Ifthe user of the 24967 Patient Connectorrequires continued operation during powermains interruptions, it is recommended thatthe 24967 Patient Connector be poweredfrom an uninterruptible power supply or abattery.Note:UT is the AC mains voltage prior toapplication of the test level.40% UT(60% dip in UT)for 5 cycles40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles70% UT(30% dip in UT)for 25 cycles<5% UT(>95% dip in UT)for 5 s<5% UT(>95% dip in UT)for 5 sPower frequency (50/60 Hz) mag-netic field3 A/m 30 A/m Power frequency magnetic fields should beat levels characteristic of a typical location ina typical commercial or hospital environ-ment.IEC 61000-4-825
Guidance and manufacturer’s declaration—electromagnetic immunityThe 24967 patient connector is intended for use in the electromagnetic environment specified below. The customer or the user ofthe 24967 patient connectorshould assure that it is used in such an environment.Immunity test IEC 60601 Test level Compliance level Electromagnetic environment—guid-ancePortable and mobile RF communicationsequipment should be used no closer to anypart of the 24967 patient connector, includ-ing cables, than the recommended separa-tion distance calculated from the equationapplicable to the frequency of the transmit-ter.Recommended separation distanceConducted RF 3 VRMS (volts root-meansquare)10 V d = 0.35√PIEC 61000-4-6 150 kHz to 80 MHzRadiated RF 3 V/m 10 V/m d = 0.35√P for 80 MHz to 800 MHzIEC 61000-4-3 80 MHz to 2.5 GHz d = 0.70√P for 800 MHz to 2.5 GHzwhere P is the maximum output power rat-ing of the transmitter in watts (W) accordingto the transmitter manufacturer and d is therecommended separation distance inmeters (m).Field strengths from fixed RF transmitters,as determined by an electromagnetic sitesurvey,a should be less than the compliancelevel in each frequency range.bInterference may occur in the vicinity ofequipment marked with the following sym-bol:Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fromstructures, objects, and people.aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AMand FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due tofixed RF transmitters, consider an electromagnetic site survey. If the measured field strength in the location in which the 24967 patient connectorisused exceeds the applicable RF compliance level above, observe the 24967 patient connectorto verify normal operation. If abnormal performanceis observed, additional measures may be necessary, such as re-orienting or relocating the 24967 patient connector.bOver the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.Recommended separation distances between portable and mobile RF communications equipment and the 24970A baseThe 24967 patient connector is intended for use in an electromagnetic environment in which radiated RF disturbances are con-trolled. The customer or the user of the 24967 patient connector can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equipment (transmitters) and the 24967 patient connector asrecommended below, according to the maximum output power of the communications equipment.Rated maximum output power oftransmitterSeparation distance according to frequency of transmitter150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzd = 0.35 √P d = 0.35 √P d = 0.70 √P0.01 W 0.035 m 0.035 m 0.070 m0.1 W 0.11 m 0.11 m 0.22 m1 W 0.35 m 0.35 m 0.70 m10 W 1.1 m 1.1 m 2.0 m100 W 3.5 m 3.5 m 7.0 mFor transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can beestimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of thetransmitter in watts (W) according to the transmitter manufacturer.26
Recommended separation distances between portable and mobile RF communications equipment and the 24970A baseNote 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fromstructures, objects, and people.27
Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAwww.medtronic.com+1 763 514 4000Medtronic USA, Inc.Toll-free in the USA (24-hour technical consultation for physicians andmedical professionals)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© 2016 MedtronicM966328A001 C2016-08-16*M966328A001*

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