Parasym PK01 User manual

Parasym™ tVNS Device
Instructions For Use

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he
Welcome to your new Parasym device.
These instructions show you how to set up your Parasym device and get
you on a schedule specific to you that you can use every day. Two AA
alkaline batteries are included so you can start straight away.
Before using your device please 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 before use.
The Parasm non-inasie Vags Nere Stimlator (VNS) is intended to proide non-inasie
Ariclar VNS deliered throgh the trags. The Parasm deice is indicated for the
management of smptoms associated ith depression, pain, aniet and insomnia.
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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.
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Pecai
Before Use:
- Yo mst read the Parasm Instrctions for Use before sing Parasm. Hoeer, reading the
Instrctions for Use ma not be enogh to fll eplain the safe and effectie se of the deice.
Ask or HCP or contact Parasm spport if o hae an qestions abot ho to se the deice
or reqire an frther clarification of these Instrctions.
- Onl se Parasm as described in these Instrctions for Use or as otherise directed b or
HCP.
- Remoe jeellr that ma interfere ith the electrode location (earrings etc.) before sing
Parasm.
- Alas carefll eamine the deice for an signs of damage or defects before se.
- Do not strip the batteries oter seal hen inserting (for risk of short-circiting), this can be
aoided b taking care hen inserting.
- Do not share or Parasm ith another person.
Do not se Parasm if:
- The skin on the trags is broken or cracked.
- 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ires to remoe the electrode.
- Keep Parasm aa from ater or other liqids.
- Keep Parasm aa from steam as moistre ma damage the deice.
- Store Parasm in a safe location ot of reach of children.
- Do not place the nit close to ecessie heat.
- Do not open or take apart the case, or attempt to repair or modif the deice. There are no ser
sericeable parts. If the deice is not orking, contact Parasm spport.
- Use onl the specified batteries: 2 1.5 olt AA Alkaline. Use of an other batter cold damage
the nit.
- Remoe the batteries from the nit, hen it is not sed for a long time.
- Keep the nit aa from sorces of high magnetic fields sch as TVS, microae oens and hi-fi
speakers, as these ma affect the LCD screen.
If the deice seems to malfnction, hen possible, contact Parasm spport for assistance. Parasm
spport cannot proide medical assistance.
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POTENTIAL RISKS AND COMPLICATIONS
Aderse effects are sall rare, mild and resole shortl after treatment is completed.
Tingling/pain/redness/itching at the site of electrode placement dring long term application
Brn at the stimlation site if sed continosl at a high intensit
Light-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 care practitioner,
athoried Parasm distribtor, or Parasm Ltd.
IF IN DOUBT CONSULT YOUR DOCTOR OR HCP.
Eieal Cdii:
Temperatre :
Operating: 5  40 ℃
Storage : -25  70 ℃
R.H.ambient :
Operating: 15%  93% RH
Storage : 0%  93% RH
Altitde :
Operating: 700hPa to 1060hPA
Storage : 500hPa to 1060hPA
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Ici F Ue
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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.
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Qc Sa Gde
1 Insert the two AA alkaline batteries
Take care doing this be careful not to strip the material covering the
batteries
2 Plug the lead included into the CH1 port.
3 Electrode 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 firm contact with the skin
4 Push the Power Button
5 You can now input the settings for your treatment (see next page)
Note: It is recommended to incorporate Parasym into your daily routine keeping the time
of day for each session consistent.
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Paa Seg
(a) Pulse Rate  20 H
(b) Pulse Width  200 
(c) Intensity  See ec be
(d) Recommended Time  60da
1. Adjust the settings with the corresponding  buttons to match the
display shown above. (Reference diagram on page 9)
2. The Parasym device can be used for 60 minutes per day. This can be
achieved by pressing the timer button to 60 min. The device will
automatically shut down after 60 minutes. Please find a convenient
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 between once
a day and twice a week. Results usually improve and last longer with
additional treatments.
3. Parasym will automatically power off after the session ends. If you end
your session early press the Power button to switch off the device.
Ne When the batteries are low the battery symbol will flash indicating
that the batteries should be replaced. Batteries typically last well over 1 year.
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Fdg  Ie ee
After setup repeat for each treatment session
01. Ensure electrode has a firm connection to the left tragus
(See p.8 image).
02. Slowly increase Intensity by one level per second. Take care not to
rush this process. Stop as soon as you feel a light tingling sensation.
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.
04. Each users preferred Intensity level will vary and more Intensity is
not necessarily better.
05. Once you find a comfortable level you can begin your session. You
may want to adjust the level again during your session this is normal
and can be done at any time.
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C Ie Qe
M a e chage fee hgh  eae
e  h 
It is common for sensory thresholds to change throughout a session
as well as between sessions. This is because the variables that affect
conductivity which causes perception of the stimulation and
establishes a sensory level can vary depending on time of day skin
conductivity and stress levels etc.
Shd I be ab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 important not to overstimulate
with too high an Intensity level or for too long a period of time.
W I  eed  ae edca
You and your healthcare provider (HCP) should discuss your ongoing
treatment routine including the use of any additional therapies andor
medications. It is important to always follow your HCPs
recommendations about your medications.
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Tbehg
If Parasym does not appear to be operating correctly refer below to
determine the cause. Should none of these measures correct the problem
please contact your supplier.
Paa de  fc a a
Check the batteries are inserted correctly.
Replace batteries.
Paa che  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off automatically
after a few minutes.
Thee    a f e chae
Check the Intensity is set above zero.
Check the lead is inserted into the unit correctly firmly in the socket.
Check the lead is in CH1 (when controlling channel 1).
Check the position of the earclip with the skin both metal plates
should be firmly pressed against the skin.
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V  He Cee
Our Help Centre has answers to most common questions. You can access
this at: www.parasym.cohc
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Sea  e f   ea
Reach out 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 [e-mail] and your message will
go through to our support team.
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Ceag ad Maeace
Replace batteries as soon as the flashing symbol appears. Care should be
taken to not get moisture in the internal circuitry or inside the battery
compartment.
1. Clean your device before use.
2. The case and lead wires can be cleaned by wiping with a damp cloth and
a solution of mild soap and water. Wipe dry. This must be done when the
device is switched off and the earclip electrode is not connected to the
unit.
3. D  immerse 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 the LCD screen should turn on
and remain on.
Teg he Eecde
The electrode can be tested before each treatment session with the
standard sensory and therapeutic threshold protocol found in the Quick
Start Section. Stimulation should be a constant tingling or pulsing sensation.
If this is intermittent there may be a fault in the lead. If there is a fault or if
the electrode is found to no longer work please contact Parasym Support.
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Ke   e
Do not raise the stimulation Intensity level to a level where there is
pain or discomfort on the tragus.
For safety reasons only use alkaline batteries in the device.
Turn Parasym off before applying or removing the electrode.
Make sure the earclip is plugged firmly into Channel 1 (the left
channel). Make sure that Intensity is set on Channel 1 (the left side of
the display).
To help take the weight off the connection and increase mobility you
can arrange the lead behind your neck and over the right shoulder (as
shown in the image on page 8).
Ne the safety and efficacy of the Parasym device has not been
established in individuals with: Implantable medical devices a history of
cardiac disease diagnosed narrowing of the arteries (carotid
atherosclerosis) bradycardia (an abnormally low resting heart rate)
pregnant women and pediatric patients.
Dce e f  eeece
Lightheadedness dizziness chest pain or excessive skin irritation
Reactions such as irritation at the stimulation site are rare If this does
occur and becomes unpleasant stop the stimulation The irritation or
discomfort should cease shortly after stopping stimulation If skin
irritation persists discontinue use and consult your doctor
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Oigial Acce
The nit mst be sed onl ith the original tpe of accessories.
Replacement earclip electrodes are aailable from or spplier.
List of Accessories:
 2 X 1.5 olt AA Alkaline
 1 X earclip electrode (Model: PREW)
Paa Secificai
Model:
Paras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 Proprietar
Mode:
CONSTConstant Stimlation
Treatment Timer:
Continos, 15min, 30min, 45min, 60min, 90min
Applied Part:
Earclip electrode: Gold plated metal
Electrode condctie area:
0.23 cm2
Epected serice life
5 ears
IP classification
IP22
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