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WARNINGS AND PRECAUTIONS

Wa i g

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Read these instr ctions caref ll  to ens re proper  se of the Paras m de ice.

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Do not inhale or s allo  small parts.

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Do not  rap the lead  ire aro nd the neck.

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Do not appl  stim lation in the bath or sho er or  hile sleeping.

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Do not get the Paras m de ice  et.

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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 .

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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).

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Do not appl  stim lation o er, or in pro imit  to, cancero s lesions.

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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.

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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.

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Do not appl  electrodes near the thora  beca se the introd ction of electrical c rrent ma
increase the risk of cardiac fibrillation.

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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.

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Use this de ice onl   ith the electrodes, and accessories recommended b  the man fact rer as

sing others ma  be  nsafe.

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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.

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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.

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The long-term effects of the chronic  se of the de ice ha e not been e al ated.

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Contact  o r healthcare pro ider (HCP) if  o r s mptoms  orsen.

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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

:

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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

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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).

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Patients  ith diagnosed brad cardia.

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Patients  ho ha e had s rger  to c t the  ag s ner e in the neck (cer ical  agotom ).

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Patients diagnosed  ith narro ing of the arteries (carotid atherosclerosis).

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Patients  hose pain s ndromes are  ndiagnosed.

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Pediatric patients.

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Pregnant  omen.

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Содержание PK01

Страница 1: ...Parasym tVNS Device Instructions For Use...

Страница 2: ...P IFU P 1...

Страница 3: ...ease make sure you have read all the precautions warnings and safety information followed by the guidance for proper setup If in doubt as to the suitability of the Parasym device consult your doctor b...

Страница 4: ...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 r...

Страница 5: ...The de ice casing is cracked dented or appears to be damaged Discontin e se if o e perience Lightheadedness di iness or chest pain E cessi e skin irritation Caring for Yo r De ice Do not p ll lead ir...

Страница 6: ...ght headedness di iness Fatig e Shortness of breath headaches Abnormal heart rh thm S eating Fatig e Tinnit s Diarrhea If o do not e perience a response to treatment ithin one month cons lt o r health...

Страница 7: ...I c i F U e P IFU P 6...

Страница 8: ...P IFU P 7...

Страница 9: ...E ec de P ace e Connect the electrode to the tragus of the left ear running the cable behind the neck over the right shoulder P IFU P 8...

Страница 10: ...P IFU P 9...

Страница 11: ...e Placement 3 1 Clip the electrode to your left tragus See diagram on Page 8 Make sure this is a good connection with both gold plates in rm contact with the skin 4 Push the Power Button 5 You can now...

Страница 12: ...t time each day using the treatment at the same time each day for consistency Daily treatment sessions with the Parasym device may be used as often as necessary but for most people it is best to treat...

Страница 13: ...ion 03 Adjust from here aiming to feel a comfortable pulsing If you experience any pain lower the Intensity right away If the sensation is sharp you may need to adjust the placement of your earpiece 0...

Страница 14: ...e fee he a d g e You should be able to feel a mild tingling or pulsing sensation at your tragus although it is common to become used to this sensation N e The tragus is a sensitive area and it is impo...

Страница 15: ...e ec ed This is likely to be the power save function If no buttons are pressed and the intensity level is zero the unit will power o automatically after a few minutes The e a f e cha e Check the Inte...

Страница 16: ...V He Ce e Our Help Centre has answers to most common questions You can access this at www parasym co hc P IFU P 15...

Страница 17: ...ut to us via our support messaging widget on our website www parasym co and we ll get right back to you You can also email us directly at hello parasym co and your message will go through to our suppo...

Страница 18: ...the device in water 4 D use any cleaning solution other than soap and water Te g Pa a Parasym can be tested by making sure the batteries are in the device correctly pressing the power button where th...

Страница 19: ...lder as shown in the image on page 8 N e the safety and e cacy of the Parasym device has not been established in individuals with Implantable medical devices a history of cardiac disease diagnosed nar...

Страница 20: ...as m PK01 O tp t Ma im m 36 mA a erage al e P lse Width100 S across 500 Ohm load RMS Val e 6 08mA P lse Width From 50 S to 250 S adj stable P lse rate From 1H to 30H Adj stable Wa eform Paras m Propri...

Страница 21: ...es lt in increased electromagnetic emissions or decreased electromagnetic imm nit of this eq ipment and res lt in improper operation Portable RF comm nications eq ipment incl ding peripherals s ch as...

Страница 22: ...r retailer ill be able to tell o here o r nearest facilit is The collection facilities ill send items for treatment reco er and rec cling so b sing them o ll help to sa e reso rces and minimi e the ef...

Страница 23: ...Version SA 6 1 www parasym co P IFU P 22...

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