WARNINGS AND PRECAUTIONS
Wa i g
-
Read these instr ctions caref ll to ens re proper se of the Paras m de ice.
-
Do not inhale or s allo small parts.
-
Do not rap the lead ire aro nd the neck.
-
Do not appl stim lation in the bath or sho er or hile sleeping.
-
Do not get the Paras m de ice et.
-
Do not appl stim lation hile dri ing, operating machiner , or d ring an acti it in hich
electrical stim lation can p t the patient at risk of inj r .
-
Do not appl stim lation o er open o nds or rashes, or o er s ollen, red, infected, or inflamed
areas or skin er ptions (e.g., phlebitis, thrombophlebitis, aricose eins).
-
Do not appl stim lation o er, or in pro imit to, cancero s lesions.
-
Do not appl stim lation o er the patient s neck or mo th beca se this co ld ca se se ere
m scle spasms res lting in clos re of the air a , diffic lt in breathing, or ad erse effects on
heart rh thm or blood press re.
-
Do not appl stim lation across the patient s chest, beca se the introd ction of electrical c rrent
into the chest ma ca se rh thm dist rbances to the patient s heart, hich co ld be lethal.
-
Do not appl electrodes near the thora beca se the introd ction of electrical c rrent ma
increase the risk of cardiac fibrillation.
-
Stim lation sho ld not be applied across or thro gh the head, directl on the e es, co ering the
mo th, on the front of the neck, (especiall the carotid sin s), or from electrodes placed on the
chest and the pper back or crossing o er the heart.
-
Use this de ice onl ith the electrodes, and accessories recommended b the man fact rer as
sing others ma be nsafe.
-
Potential ha ard from sim ltaneo s connection of a patient to a high freq enc s rgical ME
eq ipment and the de ice that ma res lt in b rns and possible damage to the de ice.
-
Operation in close pro imit (e.g. 1 m) to a short a e or micro a e therap ME eq ipment ma
prod ce instabilit in the stim lator o tp t.
-
The long-term effects of the chronic se of the de ice ha e not been e al ated.
-
Contact o r healthcare pro ider (HCP) if o r s mptoms orsen.
-
Electronic monitoring eq ipment s ch as EKG alarms ma not operate properl hen the
Paras m de ice is in close pro imit hile being sed.
C
ai dica i
:
-
Patients ith an acti e implantable medical de ice, s ch as a cardiac pacemaker, hearing aid
implant, or an implanted metallic or electronic de ice
-
Patients ith a histor of baseline cardiac disease or atherosclerotic cardio asc lar disease,
incl ding congesti e heart fail re (CHF), kno n se ere coronar arter disease or recent
m ocardial infarction ( ithin 5 ears).
-
Patients ith diagnosed brad cardia.
-
Patients ho ha e had s rger to c t the ag s ner e in the neck (cer ical agotom ).
-
Patients diagnosed ith narro ing of the arteries (carotid atherosclerosis).
-
Patients hose pain s ndromes are ndiagnosed.
-
Pediatric patients.
-
Pregnant omen.
[P
IFU P
3
Содержание PK01
Страница 1: ...Parasym tVNS Device Instructions For Use...
Страница 2: ...P IFU P 1...
Страница 7: ...I c i F U e P IFU P 6...
Страница 8: ...P IFU P 7...
Страница 10: ...P IFU P 9...
Страница 23: ...Version SA 6 1 www parasym co P IFU P 22...