ElectroCore gammaCore Sapphire SLC, Инструкция по эксплуатации

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64000-00154 Rev1
6. WARNINGS, PRECAUTIONS, POTENTIAL ADVERSE EFFECTS
Warnings indicate instructions, which, if not followed, may result
in serious injury or death to the device user or to the patient.
Precautions indicate instructions, which, if not followed,
may result in damage to the equipment or degradation in the
quality of treatment.
Warnings
• Safety and efficacy of gammaCore have not been evaluated in the following patients,
or situations:
o Patients with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
o Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease,
including congestive heart failure, known severe coronary artery disease, or recent
myocardial infarction (within 5 years)
o Patients with a history of abnormal baseline ECG, prolonged QT interval or arrhythmia
o Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
o Pediatric patients
o Pregnant women
o Patients with active cancer or cancer in remission
o Patients with an abnormal cervical anatomy
o Patients with a history of brain tumor, aneurysm, bleed or head trauma
o Patients with a history of syncope or seizures
• Contact your HCP if your symptoms continue or worsen.
• Treatment is intended to be given (administered) as directed by an HCP. Your HCP or Customer
Service must train you in the proper use of gammaCore.
Precautions
Before Use:
• You must carefully read the gammaCore Instructions for Use.
• Only use gammaCore as described in the Instructions for Use, or as otherwise directed by the HCP.
• The use of more than 24 stimulations per day has not been evaluated in controlled clinical trials.
Do not use more than 24 stimulations in a 24-hour period.