Contraindications include but are not limited to:
- Users with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Users with a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Users who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
The safety and efficacy of Pulsetto have not been evaluated in the following users or situations:
- Users with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
- Users 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)
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Users with a history of abnormal baseline ECG, prolonged QT interval, or arrhythmia
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Users who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
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Pediatric users
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Pregnant women
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Users with active cancer or cancer in remission
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Users with an abnormal cervical anatomy
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Users with a history of brain tumor, aneurysm, bleed or head trauma
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Users with a history of syncope or seizures