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.
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.
CardioSight Reader
Intended Use
The Model 2020A CardioSight® Reader is intended for use in a clinical setting. The CardioSight Reader is indicated for use to interrogate compatible Medtronic implantable devices to collect patient and device data and send the information to the clinician. The 2020A CardioSight Reader cannot be used to change therapy.
Contraindications
There are no contraindications for the 2020A CardioSight Reader.
Warnings and Precautions
The CardioSight® Reader must only be used for interrogating compatible Medtronic implantable devices. Do not use a cellular phone while the antenna is positioned over the implanted device. The CardioSight Reader is designed for use in the continental United States, Alaska and Hawaii.
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.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.