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Medtronic CareLink Programmer

Indications, Safety, and Warnings

Medtronic CareLink Monitor/Medtronic CareLink Network

Intended Use

The Medtronic CareLink® Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.

Contraindications

There are no contraindications for the Medtronic CareLink Monitor.

Warnings and Precautions

The Medtronic CareLink® Monitor must only be used for interrogating compatible Medtronic implantable devices. The Medtronic CareLink Monitor is intended for use within the prescribing country.

The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic's website at www.medtronic.com

Paceart System

Intended Use

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.

Contraindications

There are no known contraindications for the Paceart System.

Precautions

See the Paceart Manuals for more detailed information regarding precautions and use of the system. For further information regarding Paceart, please call Medtronic at 1 (800) 722-3278 and/or consult Medtronic's website at www.paceart.com.

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