indications, safety, and warnings CareLink SmartSync Device Manager

Brief Statement

Medtronic Model 24970A CareLink SmartSync™ Device Manager Base and associated apps:

Indications

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Contraindications

The base is not intended for use as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient’s age and medical condition may dictate the lead analyses appropriate for the patient.

See the CareLink SmartSync 24970A and Technical Manual and 24967 Patient Connector Technical Manual before using the CareLink SmartSync device manager for detailed information regarding the procedure, indications, or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Medtronic Model 24967 CareLink SmartSync™ Device Manager Patient Connector and associated apps: Indications

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.

Precautions

Security — Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.

See the CareLink SmartSync 24967 Patient Connector Technical Manual before using the CareLink SmartSync device manager for detailed information regarding the procedure, indications, or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.