indications, safety, and warnings CareLink SmartSync Device Manager

Brief Statement

CareLink SmartSync™ 24970A Base and associated apps:

Intended Use

The device manager is intended to be used to interrogate and program Medtronic implantable devices and conduct a cardiac lead analysis session during Medtroinic heart device implant or invasive troubleshooting. The base provides the analyzer and ECG hardware for use during device implant, invasive troubleshooting, and implanted device follow-up procedures. The base also provides a charge cradle and USB port to charge the patient connector. Additionally, the USB port is used to transmit data between the patient connector and the device manager app. The base is intended for use by healthcare professionals or Medtronic representatives in a clinical or hospital environment.

Contraindications

Do not use the base as an external pulse generator (EPG) outside of  the implant procedure. In addition the patients age and medical condition may dictate the pacing modes and lead analysis appropriate for the patient.

See the CareLink SmartSync 24970A Technical Manual before using the CareLink SmartSync device manager for detailed information regarding the procedure, indications, or intended uses, contraindications, warnings, precautions, and potential adverse events. 

CareLink SmartSync™ 24967 Patient Connector and associated apps:

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.

Precautions

Contraindications — There are no known contraindications for the use of this device.

Security — Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Install periodic updates for the medtronic apps used with the patient connector. These updates help keep the interface between the tablet and the patient connector secure. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector fails, 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 adverse events.