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Summary of Contents for Parasym PK01
- Page 2 IFU P...
- Page 3 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.
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Page 4: Warnings And Precautions
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. - Page 5 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.
- Page 6 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...
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- Page 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. IFU P...
- Page 10 IFU P...
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Page 11: Electrode Placement
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. IFU P... - Page 12 (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.
- Page 13 F d g After setup repeat for each treatment session Ensure electrode has a firm connection to the left tragus (See p.8 image). 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. Adjust from here aiming to feel a comfortable pulsing.
- Page 14 cha ge f e 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.
- Page 15 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 Check the batteries are inserted correctly. Replace batteries.
- Page 16 Ce e Our Help Centre has answers to most common questions. You can access this at: www.parasym.co hc IFU P...
- Page 17 S 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 hello@parasym.co and your message will go through to our support team.
- Page 18 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.
- Page 19 (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...
- Page 20 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:...
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Page 21: Product Warranty Information
Ca i If batter leakage occ rs and comes incontact ith the skin or e es, ash thoro ghl ith lots of ater and seek medical ad ice. Wa i g: Do not adj st or position the adaptor pl g near the mains po er o tlet. Don t se near acti e HF s rgical eq ipment or the RF shielded room of an ME s stem for magnetic resonance imaging, here the intensit of EM dist rbances is high. - Page 22 al f Wa e Elec ical a d Elec ic P d c (WEEE) One of the pro isions of the E ropean Directi e 2002 / 96 / CE is that an thing electrical or electronic sho ld not be treated as domestic aste and simpl thro n a a .
- Page 23 Version SA.6.1 www.parasym.co IFU P...
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