Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Contents 1 Introduction to the 24967 Patient Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1 Explanation of packaging and product symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2 CE mark of conformity . . . . . . . . . . . . . .
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 1 Introduction to the 24967 Patient Connector 1.1 Explanation of packaging and product symbols Refer 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 complies with applicable European Union Acts.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Transit temperature Storage temperature Security key 24970A Device manager 24967 Patient connector 249701 Power supply (for the 24970A base) 249705 Power cord (for the 24970A base) 249651 Power supply (for the 24967 patient connector) 249672 Tether Kit 249702 USB Cable 249671 Weight Kit 1.2 CE mark of conformity 2017 1.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 1.4 Intended use The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices. 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 environment 1.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 • You cannot install periodic updates and security enhancements that maintain the security of the Medtronic app because the mobile device is unable to access the Internet. • You cannot send downloaded Medtronic implantable device data to the CareLink Network. To use the Medtronic app, you must also enable Bluetooth wireless technology on your mobile device.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 2 Setup and configuration 2.1 Contents of package The package contains: • • • • Model 24967 Patient Connector MENB1020A0500XXX Power Supply (Medtronic re-order number: 249651) Model 249652 Tether Kit Literature 2.2 System components Figure 1.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 2.2.1 Indicator lights Figure 2. Patient connector indicator lights 1 Telemetry status 2 Bluetooth connection status Table 1.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 2.4 Setup This section describes how to: • • • • Power on the patient connector Power off the patient connector Download the app Attach the optional tether kit 2.4.1 Powering on the patient connector 1. Locate the button on top of the patient connector. Figure 3. Locate the patient connector button 1 Patient Connector button 2. To power on the patient connector, press and release the button.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 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.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 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 may damage equipment or impact user or patient safety. 2.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 7. Locate the security key code on the back of the patient connector. Figure 4. Patient Connector security key 1 Security key symbol 2 Security key code 8. 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.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 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 when communication is established with the implantable device. The telemetry status light is brighter when there is a stronger signal. 4.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) Condition 502386-031 Action Result that nothing physical is blocking the signal between the patient connector and the mobile device. 4 Maintaining the patient connector 4.1 Cleaning and disinfecting the 24967 patient connector 4.1.1 Cautions and notes for cleaning and disinfecting Cautions: • Clean and disinfect the patient connector as needed according to your organization’s policies.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 3. Unwrap the blue weight from around the patient connector and fully extend the cord. 4.1.3 Cleaning the patient connector 1. 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.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 e. If the optional tether kit is installed to secure the power supply cord or USB cable, wipe the cord or cable for approximately 1 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 connector 1.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 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 patient connector inside a plastic bag or container. Seal the bag or container to reduce evaporation. 6.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 4.1.5 Reassembling the patient connector 1. 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.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 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.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 7. Wrap the blue weight around the patient connector and insert the screw into the screw hole. Use the Medtronic-supplied wrench to tighten it. 4.3 Software updates Software updates will be pushed automatically to the patient connector when you start a communication session in the app. Updates can take up to 5 minutes.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Table 2. Patient connector specifications (continued) Power 15 W IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) Ingress This product complies with international electrical safety rating IP2X with regard to ingress of dust, other foreign objects, and water as required by IEC 60601-1. Physical dimension and weight Length 16.7 cm Width 7.3 cm Depth 3.0 cm Weight 0.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 • 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 EIRP Guidance and manufacturer’s declaration—electromagnetic emissions The 24967 patient connector is intended for use in the electromagnetic environment specified below.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Guidance and manufacturer’s declaration—electromagnetic immunity The 24967 patient connector is intended for use in the electromagnetic environment specified below. The customer or the user of the 24967 patient connectorshould assure that it is used in such an environment.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) 502386-031 Recommended separation distances between portable and mobile RF communications equipment and the 24970A base Note 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 from structures, objects, and people.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.
Printing instructions: doc #163256 Category: Size-selectable pkg Size: 8.5 x 11 in (216 x 279 mm) Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Authorized Representative in the European Community Medtronic B.V.