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Summary of Contents for Paingone Qalm

  • Page 2 QUICKSTART GUIDE STEP ONE: Before use ensure to STEP TWO: Remove clean your forehead with a coloured plastic liner from the damp cloth and soapy water. gel and dispose of it. STEP THREE: Apply the sticky STEP FOUR: Place the device gel on the device and then on your forehead 1cm above remove the clear plastic liner.
  • Page 3 STEP FIVE: Press and hold the STEP SIX: To change the power button for 3 seconds to programme, press switch the device on. release the power button. STEP SEVEN: Regulate STEP EIGHT: After use re-apply output intensity with the clear plastic liner to the increase decrease gel pads and store the device...
  • Page 4: Table Of Contents

    CONTENT .................... 10 UNIT INFORMATION ................10 5.1. CONTROLS ................10 5.2. OPERATING INSTRUCTIONS ........... 11 SETTING UP AND USING QALM ............12 6.1. CHARGING THE BATTERY ............12 6.2. PREPARING FOR SESSION ............. 14 6.3. TREATMENT SESSION .............. 15 6.4.
  • Page 5 SYMBOLS USED Attention! Please follow the instructions in the user’s instructions for use. TYPE BF EQUIPMENT: Equipment providing a degree of protection against electric shock, with isolated applied part. Indicates that this device has conductive contact with the end user. This symbol on the unit means “Refer to instructions for use”.
  • Page 6 Date of Manufacture: indicates the date which the medical device was manufactured. This is included within the serial number found on the travel case, either as “E/Year/Number” (YY/123456) or “E/Month/Year/Number” (MM/YY/123456). CE Mark 0197 This medical device is indicated for home use. This medical device is not water resistant and should be protected from liquids.
  • Page 7: Intended Use

    It is suitable for use by all who Do not use QALM on can control the device and any other areas apart understand the instructions. from the forehead. Use on the chest or neck may affect heart...
  • Page 8 If so the patient should electrode pads: If a skin reduce the intesity. irritation develops, stop using QALM, as a small number Headache after of users may have an adverse Programme Very reaction to the gel...
  • Page 9 QALM, and this can lead to an Caution: Keep aching neck. If this happens, try device away from lint resting your head on a pillow and dust, as long-term during treatment.
  • Page 10: Programmes

    • After use, always replace the migraine attacks. This makes any clear plastic liner on top of skin stimulation, including QALM, the gel pads on the device. feel painful. Keep the device and gel pads in the travel case.
  • Page 11: Content

    The pack contains: • The shelf life of an unopened packet of gel pads is 2 years. 1 x QALM unit This can be affected by very 3 x Reusable gel pads high temperatures or very 1 x Headband low humidity.
  • Page 12: Operating Instructions

    Note: Always check unit programme gives a different is OFF before applying sensation. or removing the QALM STRENGTH CONTROLS device from the forehead. The buttons marked ˄, ˅ are the strength controls. Note: Always clean the...
  • Page 13: Setting Up And Using Qalm

    BATTERY You may feel nothing over the first few stages of increase. Continue pressing until QALM is powered by a built-in sensation strong rechargeable Li-ion battery. A comfortable. Further increases separate charging cable with during use may be necessary if...
  • Page 14 To charge the battery: acid, become hot, explode or ignite and cause injury and /or Connect the USB cable to a damage. mobile phone tablet charging socket or PC USB port. Do not pierce, open, disassemble or use in a Whilst the battery is charging, humid the central LED light will flash...
  • Page 15: Preparing For Session

    The 3) Remove the yellow plastic yellow liner can be disposed of. liner from the gel pads and apply to the rear of the QALM 6) Place the device in the centre device. of your forehead, roughly 1 cm...
  • Page 16: Treatment Session

    If you wish to change to programme 2 press A fabric headband is included and release the ON/OFF button. with your QALM device. This is You will hear two short beeps. provided for your convenience and can be used to help keep...
  • Page 17: After Your Treatment Session

    Wipe dry. white LED light is switched off. If it is not, hold down • Do not immerse your QALM ON/OFF button device in water. switch off. Remove the • other...
  • Page 18: Disposal Of Waste Electrical And Electronic Products (Weee)

    To comply with the Directive, and their base stations, walkie- you can return your old Qalm talkies can affect this equipment unit for disposal (postage not and should be used no closer covered). Please return in an...
  • Page 19: Warranty

    available from your supplier or damaged in transit; lack of distributor (see back cover for responsible care; is dropped; if contact details). the unit has been immersed in water; if damage occurs by reason of failure to follow the written instructions Replacement electrode pads booklet enclosed;...
  • Page 20: Troubleshooting

    TROUBLESHOOTING If your QALM device is not working properly, please check the following: Problem Possible causes Solution The white LEDs Flat battery. Charge battery. See section do not turn on 6.1. No sensation Intensity strong Increase strength. enough. Sudden change...
  • Page 21: General Specification

    GENERAL SPECIFICATION Waveform Alternated mono-phasic rectangular Amplitude 17 mA zero to peak +ve in 34 steps. (over 500 Ohm load) +/- 10% Batteries Built-in lithium-ion battery Weight Dimensions 120 x 38 x 11 mm Safety Classification Internal power source. Designed for continuous use. No special moisture protection.
  • Page 22 European Medical Device Regulation requires that any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority in your country. This can be found at https://ec.europa.eu/docsroom/documents/36683/attachments/1/tra nslations/en/renditions/pdf EC Declaration of Conformity EasyMed lnstruments Co., Ltd.

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