WARNINGS AND PRECAUTIONS
Waig
- Read these instrctions carefll to ensre proper se of the Parasm deice.
- Do not inhale or sallo small parts.
- Do not rap the lead ire arond the neck.
- Do not appl stimlation in the bath or shoer or hile sleeping.
- Do not get the Parasm deice et.
- Do not appl stimlation hile driing, operating machiner, or dring an actiit in hich
electrical stimlation can pt the patient at risk of injr.
- Do not appl stimlation oer open onds or rashes, or oer sollen, red, infected, or inflamed
areas or skin erptions (e.g., phlebitis, thrombophlebitis, aricose eins).
- Do not appl stimlation oer, or in proimit to, canceros lesions.
- Do not appl stimlation oer the patients neck or moth becase this cold case seere
mscle spasms reslting in closre of the aira, difficlt in breathing, or aderse effects on
heart rhthm or blood pressre.
- Do not appl stimlation across the patients chest, becase the introdction of electrical crrent
into the chest ma case rhthm distrbances to the patients heart, hich cold be lethal.
- Do not appl electrodes near the thora becase the introdction of electrical crrent ma
increase the risk of cardiac fibrillation.
- Stimlation shold not be applied across or throgh the head, directl on the ees, coering the
moth, on the front of the neck, (especiall the carotid sins), or from electrodes placed on the
chest and the pper back or crossing oer the heart.
- Use this deice onl ith the electrodes, and accessories recommended b the manfactrer as
sing others ma be nsafe.
- Potential haard from simltaneos connection of a patient to a high freqenc srgical ME
eqipment and the deice that ma reslt in brns and possible damage to the deice.
- Operation in close proimit (e.g. 1 m) to a shortae or microae therap ME eqipment ma
prodce instabilit in the stimlator otpt.
- The long-term effects of the chronic se of the deice hae not been ealated.
- Contact or healthcare proider (HCP) if or smptoms orsen.
- Electronic monitoring eqipment sch as EKG alarms ma not operate properl hen the
Parasm deice is in close proimit hile being sed.
Caidicai:
- Patients ith an actie implantable medical deice, sch as a cardiac pacemaker, hearing aid
implant, or an implanted metallic or electronic deice
- Patients ith a histor of baseline cardiac disease or atherosclerotic cardioasclar disease,
inclding congestie heart failre (CHF), knon seere coronar arter disease or recent
mocardial infarction (ithin 5 ears).
- Patients ith diagnosed bradcardia.
- Patients ho hae had srger to ct the ags nere in the neck (cerical agotom).
- Patients diagnosed ith narroing of the arteries (carotid atherosclerosis).
- Patients hose pain sndromes are ndiagnosed.
- Pediatric patients.
- Pregnant omen.
