Safety Information; Warnings; Precautions - Somatics Thymatron System IV User Manual

Thymatron System IV Instructions for Use
®

SAFETY INFORMATION

Please read the following important safety requirements before using the Thymatron® System IV ECT
Instrument.

WARNINGS

Various medical conditions are associated with substantially increased risk from ECT, including
risk of death. These include unstable or severe cardiovascular conditions (recent myocardial
infarction, unstable angina, poorly-compensated congestive heart failure, severe valvular cardiac
WARNING
disease), vascular aneurysms susceptible to rupture with increased blood pressure, increased
intracranial pressure, recent cerebral infarction, severe chronic obstructive pulmonary disease, asthma,
pneumonia and anesthesia risk level ASA 4 or 5. Pulmonary risks of ECT associated with general anesthesia
and neuromuscular blocking agents include hypoxemia, hypoventilation, aspiration, and upper-airway
obstruction.
ECT device use may be associated with disorientation, confusion, and memory problems.
WARNING
When used as intended this device provides short term relief of symptoms. The long-term safety
and effectiveness of ECT treatment has not been demonstrated, and long-term follow-up may be
needed.
WARNING
Some patients who were suicidal before receiving ECT eventually committed suicide after
receiving ECT, including after receiving ECT with a Thymatron® device.
WARNING
Administering ECT to a patient with an implanted DBS device can damage the DBS device or
cause it to malfunction and cause injury to the patient.
WARNING

PRECAUTIONS

For patients with brain tumor, brain aneurysm, myocardial infarction, coronary insufficiency,
heart failure, or aortic aneurysm medical specialists in Neurology or Cardiology should be
CAUTION consulted to determine additional precautions needed, if any.
Do not remove the top or bottom covers of the Thymatron® System IV. There are no user
serviceable parts inside. Any servicing must be performed by qualified service personnel.
CAUTION
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