Nurosym
™
Instructions for Use
Privileged and confidential | Parasym Ltd | 1
Page 1: ...Nurosym Instructions for Use Privileged and confidential Parasym Ltd 1 ...
Page 2: ...recautions warnings and safety information followed by the guidance for proper setup If in doubt of the suitability of the Nurosym device consult your doctor before use The Nurosym Neuromodulation device is intended to provide non invasive Auricular VNS delivered through the tragus The Nurosym device is indicated for the treatment of symptoms associated with Depression Anxiety Pain and Insomnia Pr...
Page 3: ...Cable 1 RC01 Earpiece 1 RE01R Carry Case 1 RFC01 Instruction for use 1 3 2 Do not use accessories and detachable parts not specified or authorized by the manufacturer as it may cause damage to the unit or danger to the user or patients Privileged and confidential Parasym Ltd 3 ...
Page 4: ...laced on the chest and the upper back or crossing over the heart Use this device only with the earpiece and accessories recommended by the manufacturer as using others may be unsafe Potential hazard from simultaneous connection of a patient to a high frequency surgical ME equipment and the device that may result in burns and possible damage to the device Operation in close proximity e g 1 m to a s...
Page 5: ...liquids Keep Nurosym away from steam as moisture may damage the device Store Nurosym in a safe location out of reach of children Do not place the unit close to excessive heat Do not open or take apart the case or attempt to repair or modify the device There are no user serviceable parts If the device is not working contact Nurosym support Keep the unit away from sources of high magnetic fields suc...
Page 6: ...tment within one month consult your health care practitioner authorized Nurosym distributor or Parasym Ltd IF IN DOUBT CONSULT YOUR DOCTOR OR HCP Environmental Conditions Temperature Operating 5 40 Storage 25 70 R H ambient Operating 15 93 RH Storage 0 93 RH Altitude Operating 700hPa to 1060hPA Storage 500hPa to 1060hPA At least 30min is required for the device to warm from the minimum storage tem...
Page 7: ...Device Diagrams Stimulator Unit Earpiece electrode Earpiece placement Charging cable Privileged and confidential Parasym Ltd 7 ...
Page 8: ...Display and controls Privileged and confidential Parasym Ltd 8 ...
Page 9: ...1 Plug charging cable into Nurosym Device Make sure the device is fully charged before first use Privileged and confidential Parasym Ltd 9 ...
Page 10: ...2 Insert earpiece lead into Nurosym Device Privileged and confidential Parasym Ltd 10 ...
Page 11: ...3 Clip the earpiece to the tragus of the right ear Wrap the malleable wire behind the ear Privileged and confidential Parasym Ltd 11 ...
Page 12: ...conds The display will show the number of minutes for your session Notes The treatment time is displayed Adjust by pressing and press ENTER to confirm session duration you will then progress to choosing intensity level Step 5 Privileged and confidential Parasym Ltd 12 ...
Page 13: ...e 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 D Each user s preferred Intensity level will vary and more Intensity is not necessarily better E Once you find a comfortable level press ENTER to begin your session You may want to adjust the level again during your session...
Page 14: ...6 Nurosym is on The blue LED light indicates that the device is on and delivering current Privileged and confidential Parasym Ltd 14 ...
Page 15: ...nge Intensity during a session Press any button to wake the device 1 Double press the Enter Button to unlock the device 2 Amend Intensity by buttons 3 Confirm by pressing Enter This will resume the session Privileged and confidential Parasym Ltd 15 ...
Page 16: ... power button minus button for 5 seconds 3 The screen will flash twice This indicates the device has been reset Session Time Pressing any button will wake the device to show the display During a session the display will show how long is left in minutes Here the display shows 30 minutes remaining Privileged and confidential Parasym Ltd 16 ...
Page 17: ...ing there is 30 minutes left of a recommended 60 minutes session All LEDs will be displayed at the beginning of the session and will gradually decrease throughout the session proportional to the time remaining When the device is paused the rightmost LED will flash and the blue light will turn off to indicate no current being delivered The session will resume and the blue light will turn back on Pr...
Page 18: ...ill indicate a low battery with the below example When the device is powered on Lo will be shown on the display with a single flashing LED to indicate low battery When the battery symbol on the LCD screen flashes it is time to charge the battery Privileged and confidential Parasym Ltd 18 ...
Page 19: ...ry Failure to follow these instructions could cause the lithium ion battery to leak acid become hot explode or ignite and cause injury and or damage Do NOT expose to temperatures over 60 C 140F Do NOT put store or leave it near sources of heat in direct strong sunlight in a high temperature location in a pressurized container or in a microwave oven Warning Do not use accessories and detachable par...
Page 20: ...on during my session 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 Note The tragus is a sensitive area and it is important not to over stimulate with too high an intensity or for too long a period of time Warning It is recommended not to use the device for more than 60 minutes at a time Will I still need to tak...
Page 21: ...ssion has ended the device will power off automatically If the device is paused it will power off automatically after 5 minutes There is no stimulus simulation Check the intensity is set above zero Check the lead wire is inserted into the port correctly firmly in the socket Check the position of the earpiece with the skin ensuring both metal plates are firmly pressed against the skin Speak to one ...
Page 22: ...an 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 earpiece is not connected to the unit 3 Do not immerse the device in water 4 Do not use any other cleaning solution than soap and water Expected Service life Nurosym has been designed to last for more than 5 years but is guaranteed for 2 years Damage to...
Page 23: ... in use The patient can maintain the device and its accessories according to the user manual Note the safety and efficacy of the Nurosym device has not been established in individuals with Implantable medical devices diagnosed narrowing of the arteries carotid atherosclerosis bradycardia an abnormally low resting heart rate pregnant women and pediatric patients Discontinue use if you experience Li...
Page 24: ... ME system for magnetic resonance imaging where the intensity of EM disturbances is high Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than th...
Page 25: ...ach position on off is stable position CE Mark with Notified Body Reference 0197 IP22 Protected against access to hazardous parts with a finger and the jointed test finger of 12 mm Ф 80 mm length shall have adequate clearance from hazardous parts and protected against solid foreign objects of 12 5 mm Ф and greater Protected against vertically falling water drops when the enclosure is tilted up to ...
Page 26: ...ny repairs to the device or accessories Please contact the retailer for repair Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty WARNING Do not modify this device without authorization of the manufacturer Only our authorized service agents should carry out repairs to the device European Representative Parasym OÜ Majaka 26 11412 Tallinn Estoni...
Page 27: ...Privileged and confidential Parasym Ltd 27 ...
