Modifications may impair the effectiveness of the Patient Assistant. Caution: To prevent the risk of infection, do not place the Patient Assistant in direct contact with your incision site until it is completely healed. Waiting to seek medical attention could be dangerous to your health. If your doctor has provided other instructions, follow them. If there is an emergency, call your local emergency number. Seek medical attention immediately if you are feeling ill and think you might need to go to the hospital.
Warning: The Patient Assistant is not intended to be used as an alarm system for situations where medical attention is needed. The Patient Assistant is used to initiate recording of cardiac event data in the device memory of the ICM.Ĭontraindications: There are no known contraindications for the use of this device. Indications: The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. Potential adverse events: Potential adverse events include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
#MEDTRONIC HEART MONITOR MANUAL#
This manual provides warnings, precautions, and guidance for health care providers who perform medical therapies and diagnostic procedures on patients with cardiac devices. For information about additional medical procedures that are likely to be sources of interference or to be hazardous, see the Medtronic Medical Procedure and EMI Precautions Manual for Health Care Professionals. We also recommend referencing the Medtronic MRI Resource Library website located at For detailed information on determining if a Reveal LINQ patient can undergo an MRI scan and for precautions related to the procedure, see the Reveal LINQ MRI Technical Manual. Medtronic recommends that cardiologists/radiologists validate any already implanted devices or leads by using the Reveal LINQ MRI Technical Manual. Magnetic Resonance Imaging (MRI): Although the Reveal LINQ ICM is considered conditionally safe for use in the MRI environment when used under specified conditions, other implanted devices or the patient’s individual medical condition might have an impact on safety and might require additional examination. For information to share with Reveal LINQ patients about sources of electromagnetic interference (EMI) in the home, at work, and in other environments that patients may need to avoid, see the Medtronic Reveal LINQ Medical Procedure and EMI Precautions Manual for Health Care Professionals.
Although most interference is filtered out, there are some signals in the environment that have similar characteristics to the signals emitted by the programming head or the Patient Assistant, or which could otherwise interfere with device function. The device should not be affected by the normal operation of electrical equipment such as cell phones, household appliances, electrical machine shop tools, microwave ovens, spark-ignited internal combustion engines, radio frequency transmitting systems, or microwave frequency transmitting systems. The device will function normally as soon as the patient moves away from the source of interference.
Since the device communicates with the programming head and Patient Assistant by means of radio frequency telemetry, certain types of electromagnetic interference (EMI) may cause temporary telemetry interruptions, trigger inappropriate episode detection, corrupt the data stored in memory, or result in an electrical reset of the device (see Section B.2 of the manual). However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.Īvoiding effects of electrical interference in the home, work, and other environments: The Reveal LINQ ICM is designed to monitor and store ECG data and to receive radio signals from the programming head and the Patient Assistant. patients who experience transient symptoms that may suggest a cardiac arrhythmia.Ĭontraindications: There are no known contraindications for the insertion of the Reveal LINQ ICM.patients with clinical syndromes or situations at increased risk of cardiac arrhythmias.Indications: The Reveal LINQ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: BRIEF STATEMENTS REVEAL™ INSERTABLE CARDIAC MONITORS Reveal LINQ™ (LNQ11)
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