24965 Patient Connector DRAFT Technical Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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Contents 1 Introduction to the 24965 Patient Connector . . . 1.1 Explanation of packaging and product symbols 1.2 Description . . . . . . . . . . . . . . . . . . . . . 1.3 Intended use . . . . . . . . . . . . . . . . . . . . 1.4 Contraindications . . . . . . . . . . . . . . . . . 1.5 Warnings . . . . . . . . . . . . . . . . . . . . . . 1.6 Precautions . . . . . . . . . . . . . . . . . . . . . 1.7 Regulatory compliance . . . . . . . . . . . . . . 1.8 Patient Connector functions . . . . . . . . . . . 1.
1 Introduction to the 24965 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. Caution Consult instructions for use Ingress protection Use only with specified power supply Type BF applied part Humidity limitation Non-ionizing electromagnetic radiation Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.
Accessories China RoHS Bluetooth connection Follow instructions for use (blue) Low battery Keep dry ACMA (Australian Communications and Media Authority and the New Zealand Ministry of Economic Development Radio Spectrum Management standards) symbol for Australia and New Zealand For US audiences only ETL Listed Mark Technical Conformity (Ministry of Internal Affairs and Communications) mark for Japan Transit temperature Storage temperature Security key Patient Connector Telemetry 1.
1.3 Intended use The patient connector is a portable electronic device using low frequency inductive telemetry to communicate with Medtronic implanted heart devices. The patient connector uses Bluetooth technology to transmit implanted heart device data to a Medtronic Mobile app for further processing. 1.4 Contraindications There are no known contraindications for the use of this device. 1.5 Warnings These warnings apply in general to using the patient connector settings.
Use of unapproved power supply – Use only the Medtronic-supplied power supply with the patient connector. Use of an unapproved power supply may damage equipment or impact user or patient safety. 1.6 Precautions Attaching the tether kit – Do not overtighten the screw when attaching the tether kit. Autoclaving – Do not autoclave the patient connector. Damaged equipment – If the case of the patient connector is cracked or if any of the connectors are damaged, contact your Medtronic representative.
normal use. However, electronic devices are susceptible to many environmental stresses 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 cause physical damage to the unit. This may impair device function. Even if the unit works immediately after being dropped, operational damage may have occurred that may not be observed until some future time.
1.9.2 What to do if you suspect the patient connector has been compromised Discontinue use of the patient connector if it does not behave as expected. Contact your Medtronic representative for further assistance. 1.10 Compatible components The following compatible components are available for the patient connector: • Power supply • Tether kit • Medtronic Model 6177 sterile sleeve Contact your local Medtronic representative to order them. Warning: Use the Medtronic-supplied components only.
Patient Connector – Provides the communication link between the app and the patient’s implanted device. The patient connector contains a radio-frequency (RF) transmitter and receiver. It must be held over the implanted device during a communication session. Mobile device (not supplied) – When running the Medtronic app and paired with the patient connector, provides the user interface to communicate and program the implanted device, depending on the app installed.
2.1.1 Indicator lights Figure 2. 1 Telemetry Status 2 Bluetooth Connection Status 3 Battery Status Table 1. Table with title and rules above and below header Icon Indicator Color Telemetry Status Green Bluetooth Connec- Blue tion Status Battery Status Amber 2.
2.2.1 Charging the patient connector battery 1. Open the power supply connector cover located on the bottom edge of the patient 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 patient connector. Use of an unapproved power supply may damage equipment or impact user or patient safety. 2.2.2 Downloading the app 1. Make sure the mobile device is connected to the Internet. 2.
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 app The patient connector uses a Bluetooth connection to communicate with the mobile device. You will need to pair each patient connector to the mobile device. You can have up to 20 patient connectors paired to one app. 1. 2. 3. 4. 5. 6. Enable Bluetooth on the mobile device, if it is not enabled. Open the app. Touch CONTINUE in the app.
3 Conducting a patient session 3.1 Position the patient connector For an implantable device, the patient connector should be held directly against the patient’s skin. The face of the patient connector must be parallel to and typically within 5 cm of the implantable device. Optimum position of the patient connector may not be directly centered over the implantable device. The distal end of the patient connector should be placed over the device with the device under the antenna.
1. Disinfect the patient connector by using a 10% bleach and water solution and a sterile saturated gauze pad or sponge. 2. Wipe down all external surfaces and maintain a wet or damp exposure time of 15 minutes. 3. Allow to air dry approximately 5 minutes or until dry. 4.2 Software updates Software updates will be pushed automatically to the patient connector when you start a communication session. Updates can take up to 5 minutes.
Table 2. Patient Connector specifications (continued) Electrical safety requirements per IEC 60601-1:2005, Clause 8.7 Touch leakage current ≤0.1 mA Patient leakage current A.C. ≤0.1 mA Patient auxiliary current ≤ 0.01 mA D.C. Patient auxiliary current ≤0.1 mA A.C.
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