The Qalm device is a medical device designed for the treatment and prevention of frequent episodic and chronic migraine headaches. It is intended for home healthcare use and is suitable for individuals who can control the device and understand its instructions. Children aged 8 and above may use it under adult supervision, though its effectiveness for users under 18 has not been established. The device should only be used for its intended purpose.
Function Description
The Qalm device operates by delivering electrical stimulation to the forehead to alleviate and prevent migraines. It features two pre-set programmes: Programme 1 for treating existing migraine attacks and Programme 2 for migraine prevention. Programme 1 has a duration of 60 minutes and should be applied when a migraine is present or at its first signs. Programme 2 lasts 20 minutes and is recommended for daily use to reduce the frequency of migraine attacks. The device is powered by a built-in rechargeable Li-ion battery, which can be charged using a supplied USB cable connected to a mobile phone, tablet charging socket, or PC USB port. A low battery is indicated by a flashing white central LED, which starts approximately 4 hours before the battery is empty.
Usage Features
Before each use, the forehead must be cleaned with a damp cloth and soapy water to ensure proper adhesion and stimulation from the device. Make-up removal products should be avoided as they can leave a greasy film on the skin. For first-time use, a gel pad should be removed from its foil packaging, and its yellow plastic liner removed before applying it to the rear of the Qalm device. The clear plastic liner from the gel should then be removed. The device is placed on the forehead, approximately 1 cm above the eyebrows.
To switch the device ON, the ON/OFF button must be pressed and held for 3 seconds, accompanied by a long beep and the illumination of white LED lights. The device automatically turns OFF at the end of a session (60 minutes for Programme 1, 20 minutes for Programme 2), indicated by a long beep. Manual turn-off is also achieved by pressing and holding the ON/OFF button for 3 seconds.
The ON/OFF button also functions as the programme selector. Programme 1 is automatically selected upon powering on. To switch to Programme 2, the ON/OFF button is pressed and released, indicated by two short beeps. Pressing and releasing the ON/OFF button again will switch back to Programme 1, indicated by a single beep. A safety feature ensures that the strength level reverts to zero whenever a new programme is selected, as each programme provides a different sensation.
The output intensity is regulated using the increase (^) and decrease (v) buttons. Pressing and releasing these buttons adjusts the intensity in steps of 0.5 mA. Holding them down allows for faster adjustment. Reaching maximum or minimum intensity is indicated by three quick beeps. Users may not feel sensation during the initial stages of intensity increase; it is advised to continue pressing until the sensation is strong but comfortable. Further increases may be necessary as the body adapts. The device has 34 strength levels, indicated by three LEDs at the bottom, which get brighter as intensity increases.
The gel pads are reusable but for single-patient use. Their conductivity depends on their condition and stickiness. They should be replaced when they lose adhesion. After use, the clear plastic liner must be re-applied to the gel pads, and the device stored in its travel case. A fabric headband is included to help keep the device firmly in place, though its use is optional.
Maintenance Features
The device should be cleaned at least once a week by wiping it with a damp cloth and a mild soap and water solution, avoiding contact with the silver electrodes. It should be wiped dry. The Qalm device should not be immersed in water or any other cleaning solution besides soap and water.
For storage, the device must always be kept in its travel case when not in use. The storage life of an unopened pack of self-adhesive gel pads is 2 years, but this can be affected by extreme temperatures or humidity. The unit itself has no fixed shelf life.
The built-in lithium-ion battery should be recharged yearly, regardless of usage, to minimize capacity reduction. Only the supplied charging cable should be used, as other chargers could be hazardous and void the warranty. The device should not be pierced, opened, disassembled, or used in humid or corrosive environments. It should not be exposed to temperatures above 60°C (140°F) or stored near heat sources, in direct sunlight, in high-temperature locations, in pressurized containers, or microwave ovens. Immersion in water or seawater, or application to wet skin, is prohibited. Short-circuiting should also be avoided. In case of battery leakage, contact with skin or eyes should be thoroughly washed with water. Batteries must be disposed of responsibly according to local government guidelines and never thrown into fire due to explosion risk.
The device should not be modified without manufacturer authorization, as this could affect safe operation and invalidate the warranty. Long-term exposure to sunlight can affect the rubber, making it less elastic and prone to cracking. The device should also be kept away from lint and dust, which can affect the socket.