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Summary of Contents for CEFALY Technology Dual

  • Page 1 D U A L...
  • Page 2: Programme

    Copyright © 2018 CEFALY Technology, 4102 Seraing - Belgium Texte original français : Département Médical CEFALY Technology (Seraing, Belgique) Revue et validation : Département R&D CEFALY Technology (Seraing, Belgique) ref. 34077 - Version 02 - EN 02 - 06.07.2018...
  • Page 4: Table Of Contents

    1. Safety precautions 2. Contraindications 3. Side effects INDICATIONS FUNCTIONAL PRINCIPLE DIRECTIONS FOR USE 1. Practical use Preparing the session 1. Cleansing and degreasing the skin 2. Removing an electrode 3. Positioning the electrode 4. Positioning the Cefaly ® Dual device...
  • Page 5 Selecting and starting the programme 1. Programme 1 2. Programme 2 During the session 1. Conducting the session 2. Controlling the intensity 3. Link a new session 4. Interrupting the session 5. Accidental interruption: defective electrode After the session 1. Removing the device 2.
  • Page 6: Safety Precautions, Contraindications And Side Effects

    Cefaly ® apart from the forehead. Dual. The Cefaly Dual is meant to be used by a person ‚ ® Implanted electronic device in the head. ‚ from the age of 15 (having the required education Trigeminal neuralgia.
  • Page 7: Side Effects

    This prohibits the use of Cefaly ® Dual while driving or during a dangerous activity that Pain during the session needs to be alert and focused. A portion of people may perceive the sensation...
  • Page 8 Headache after the session Neck pain Very rarely a headache can occur at the end of a Some subjects, especially in the early stages of use, preventive treatment session (Programme 2). This is tend to unconsciously contract neck muscles during a casual and fleeting but prevents some patients from session.
  • Page 9: Indications

    INDICATIONS Cefaly Dual is designed to prevent and treat frequent However, a part of migraine patients (+/- 10%) ® episodic and chronic migraines. suffer from allodynia during migraine attacks. It is a hypersensitivity that makes normal sensations felt Programme 1 is designed to treat the migraine attack, as painful.
  • Page 10: Functional Principle

    V1. Trigeminal nerve stimulation using Programme 1 of the Cefaly Dual (high frequency) induces a sedative effect ® on the nervous system that causes headache pain relief during migraine attacks.
  • Page 11: Directions For Use

    DIRECTIONS FOR USE 1. PRACTICAL USE Preparing the session Before first use, make sure to charge the Cefaly Dual (see p. 22). ® 1. Cleansing and degreasing the skin It is essential to cleanse and degrease the skin thoroughly Then cleanse the skin on the forehead (see Figure 2).
  • Page 12: Removing An Electrode

    2. Removing an electrode 3. Positioning the electrode Remove an electrode from its plastic support, holding Use a mirror to correctly position the electrode (see it by one of its two tips (see Figure 3). The quality of Figure 4). the treatment depends on the quality of the electrodes.
  • Page 13: Positioning The Cefaly ® Dual Device

    4. Positioning the Cefaly Dual device ® Two magnets allow to fix the device on the electrode. The pointed part is placed downwards with the lower Hold the device and bring the rear side of the device edge placed exactly on the horizontal line that joins with the two magnets against the central part of the both eyebrows (see Figure 5).
  • Page 14: Selecting And Starting The Programme

    7). For the central button to be functional, the Cefaly ® battery charge is too low and you must therefore first Dual needs to detect that the device is placed on an charge the Cefaly Dual. ®...
  • Page 15: During The Session

    Our limit automatically. is purely psychological as we are capable, for most people, of tolerating the full intensity of Cefaly Dual, ® 2. Controlling the intensity in other words it is possible to let it run for sixty...
  • Page 16: Link A New Session

    4. Interrupting the session To interrupt the session before its programmed end, just remove the Cefaly Dual which will stop at once when ® it loses contact with the electrode (see Figure 8). Four series of 3 successive beeps indicate the disconnection 5.
  • Page 17: After The Session

    This unintentional spontaneous interruption means that 2. Detaching and stowing the electrode either the skin has not been cleansed thoroughly or Detach the electrode from your skin by holding one the electrode has been positioned incorrectly or is no of its tips (see Figure 9). Replace the electrode on its longer intact, or may even mean that the two magnets transparent plastic support sheet.
  • Page 18: Sensations

    This difference of sensation is mainly the attack. These patients can therefore only use the felt during the first minutes of the session when the Cefaly Dual in prevention (Programme 2), between the intensities are low. ® migraine attacks.
  • Page 19: After The Session

    DISTRIBUTION OF THE SESSIONS AND the whole of the forehead and the front part of the THEIR EFFECTIVENESS skull. The Cefaly Dual increases the intensity very ® gradually. After 14 minutes, the intensity stabilises Treating attacks and remains constant until the treatment session is...
  • Page 20: Preventive Treatment

    Preventive treatment After several months, once an improvement has been noticed, you can try reducing the number of sessions Programme 2 should be used once or twice a day carried out. In case this dose reduction is inadequate, outside the attacks. A daily session of 20 minutes is start increasing the number of sessions again.
  • Page 21: Warranty

    WARRANTY The CEFALY Technology company warrants the This warranty does not cover damage caused by purchaser of the Cefaly Dual device against faulty shocks, falls and other knocks, which are likely to ® workmanship and defective components. The damage the device. The warranty does not apply to...
  • Page 22: Technical Aspects

    It is therefore connector on the rear side of the recommended to charge the battery at least every 5 sessions. Cefaly Dual device. ® Power supply: a rechargeable 3.7 V Lithium-ion Polymer battery. The device is charged thanks to the provided cable and power adapter.
  • Page 23 Prepare™ wipe. ® Transport and storage conditions: -5°C to +35°C Temperature: The Cefaly Dual device does not require any maintenance ® Relative humidity: 45% to 75% operation. It is not necessary to disinfect or sterilize the Atmospheric pressure: 500 hPa to 1060 hPa device between uses on different patients.
  • Page 24 preventing any galvanic direct Electrode shelf life: Electrode can be reused as long Compensated constant current as it correctly sticks to forehead. If you take care of component cleansing correctly the forehead skin before each ses- Stimulation parameters: sion, placing the electrode back on its support, placing Programme 1 Programme 2 the support back in the sachet and storing it correctly, the...
  • Page 25 Dual. Also, do not use the ® tion manual. Cefaly ® Dual in close proximity (less than 1 meter) to short wave or microwave therapy equipment as it may produce This standardized symbol, applied on the electrode instability in the Cefaly Dual output.
  • Page 26 List of Cables and Accessories before applying Cefaly ® Dual. The only accessories to be used with the Cefaly Dual are the ® Any electrode for which the current density is above 2 mA/ Cefaly electrode and the charging system provided with the ®...
  • Page 27 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS The Cefaly Dual device is intended for use in the electromagnetic environment specified below. The customer or the user of ® the Cefaly Dual device should assure that it is used in such an environment.
  • Page 28 The Cefaly Dual device is a patented model and is protected Copyright © 2018 CEFALY Technology, 4102 Seraing - Belgium ® by an international patent. Cefaly is a trademark that has ® been registered internationally. All rights reserved. This manual may not be reproduced in any...

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