TensCare mynd Manual
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Summary of Contents for TensCare mynd

  • Page 2 Dear Customer, Thank you for choosing Mynd. TensCare stands for high-quality, thoroughly tested products for the applications in the areas of gentle electrotherapy, muscle toning, continence management and pain relief during labour. Please read these instructions for use carefully and keep them for later use, be...
  • Page 3: Table Of Contents

    GEL PAD ADVICE ....13 CONTENT ........14 UNIT INFORMATION ...... 14 5.1. CONTROLS......14 5.2. OPERATING INSTRUCTIONS SETTING UP AND USING MYND ... 17 6.1. CHARGING THE BATTERY . 17 6.2. PREPARING FOR SESSION 21 6.3. TREATMENT SESSION ..23 6.4.
  • Page 4 SYMBOLS USED TYPE BF APPLIED PART: 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”. Temperature Limitation: indicates the temperature limits to which the medical device can be safely...
  • Page 5 Manufacturer Symbol Date of Manufacture: indicates the date which the medical device was manufactured. This is included within the serial number found on travel case, either “E/Year/Number” (YY/123456) or “E/Month/Year/Number” (MM/YY/123456). CE Mark This medical device is indicated for home use. This medical device is not water resistant and should be protected from liquids.
  • Page 6: Intended Use

    INTENDED USE MYND is a medical device designed to be used in the home healthcare environment for the treatment and prevention of frequent episodic and chronic migraine headaches. It is suitable for use by all who can control device understand instructions.
  • Page 7 May also affect body worn monitoring devices. Do not use MYND if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.
  • Page 8 Do not place electrode pads on broken skin. electrode pads could encourage infection. Do not use MYND in close proximity (less than meter) short wave microwave therapy equipment as it may produce instability in MYND output.
  • Page 9 CAUTIONS: Do not ignore any allergic reaction to the electrode pads: skin irritation develops, stop using MYND, as a small number of users may have an adverse reaction to the gel Trigeminal neuralgia and Ophthalmic shingles make facial...
  • Page 10 Changing only maintenance the patient should perform. Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons. If necessary, we will provide circuit diagrams, component part lists or other information that will assist authorized service personnel to repair the device.
  • Page 11 Neck pain: At the start of treatment you may tense your neck muscles when you are using MYND, and this can lead to an aching neck. If this happens, try resting your head on a pillow during treatment. Note: Electrode pads supplied...
  • Page 12 Caution: Keep the device away from sunlight, as long-term exposure to sunlight may affect the rubber causing it to become less elastic and crack. Caution: Keep the device away from lint and dust, as long-term exposure to lint or dust may affect the socket Caution: Temperature &...
  • Page 13: Programmes

    Note: Some migraine patients develop Allodynia with their migraine attacks. This makes any skin stimulation, including MYND, feel painful. Programme 2 - Prevention Maximum intensity 20 mA (Peak) (across load resistance of 500 Ω)
  • Page 14: Gel Pad Advice

    Programme 2 is designed to prevent migraines and will last for 20 minutes. This programme should be used once a day. Regular helps reduce frequency of migraine attacks. 3.2. GEL PAD ADVICE Gel pads are reusable but for single • patient use.
  • Page 15: Content

    CONTENT The pack contains: 1 x MYND unit 3 x Reusable gel pads 1 x Charging cable 1 x Travel case 1 x Mirror 1 x Instruction manual 1 x Quickstart guide UNIT INFORMATION CONTROLS 5.1. INTENSITY ON/OFF INTENSITY DOWN...
  • Page 16: Operating Instructions

    LEDs light will switch off. Note: Always check unit is OFF before applying or removing the MYND device from forehead. Note: Always clean forehead before using device. PROGRAMME CONTROL ON/OFF button also programme select button. MYND has two pre-set programmes.
  • Page 17 Every time the unit is switched on, the programme 1 is automatically selected. If you wish to change to programme 2 press and release the ON/OFF button. Programme 2 selection will be indicated by two short beeps. To change back to programme 1, press and release the ON/OFF button.
  • Page 18: Setting Up And Using Mynd

    Each LED gets brighter as the intensity increases. The minimum and maximum intensities are as follows: Minimum intensity – one dim LED Maximum intensity – three bright LEDS SETTING UP AND USING MYND 6.1. CHARGING THE BATTERY MYND powered built-in rechargeable Li-ion battery. A separate charging cable with universal USB plug is included in the kit.
  • Page 19 When the battery is low, the central LED will flash white. This would start about 4 hours before the battery is empty (4 hours on stand-by). Warning: Use only the charging cable supplied. Use of other chargers could be hazardous and will negate the warranty.
  • Page 20 Rated input voltage shall • exceed 250 V Classification of protection against • electric shock: Class II IP classification: at least IP21 • The adapter need to comply with • IEC 60601-1 or IEC 60950-1 Battery Life The battery life will last approximately 22 hours at 50% maximum output intensity.
  • Page 21 If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots water immediately seek medical attention. Do not replace with your own batteries. Changing lithium batteries or fuel cells incorrectly can lead to unacceptable risks.
  • Page 22: Preparing For Session

    2) For first use, remove one of the gel pads from its foil packaging. 3) Remove the blue plastic liner from the gel pads and apply to the rear of the MYND device.
  • Page 23 4) Remove the clear plastic liner from the rear of the device. Be careful to ensure the gel pads remain stuck to the device. 5) Place the clear plastic liner back in the travel case. The blue liner can be disposed of.
  • Page 24: Treatment Session

    Note: Gel pads are for single patient use. The gel is a peelable hydrogel (water based). Warning: Ensure that MYND is switched OFF before applying and removing the device. 6.3. TREATMENT SESSION 1) Press and hold the ON/OFF button on...
  • Page 25: After Your Treatment Session

    Be careful to avoid contact with silver electrodes. Wipe dry. Do not immerse your MYND device in • water. Do not use any other cleaning •...
  • Page 26: Emc

    Storage life of an unopened pack of • self-adhesive gel pads is 2 years. This may be affected by very high temperatures or very low humidity. The unit has no fixed shelf life. • Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be...
  • Page 27: Accessories

    Simply print a postage-paid PACKETPOST RETURNS label from our website www.tenscare.co.uk, attach this to an envelope or padded bag with the unit enclosed, and post it back to us. Upon receipt, we will process your old device for components recovery and recycling to help conserve the world’s...
  • Page 28: Warranty

    TensCare, by telephone using a credit or debit card, or through the TensCare website. The following replacement parts may be ordered from TensCare www.tenscare.co.uk +44(0) 1372 723434. E-MYND Pack of 3 MYND gel pads WARRANTY This warranty refers to the unit only.
  • Page 29 Otherwise, we will quote for any repair which will be carried out on acceptance of our quotation. The benefits conferred by this warranty are in addition to all other rights and remedies in respect of the product, which the consumer has under the Consumer Protection Act 1987.
  • Page 30 For hygiene reasons, please do not include used gel pads or charging cable. Send only the MYND unit. Please return the unit with the following details: Name: • Address: • Postcode: • Telephone: • Email: • Model: • Date of purchase: •...
  • Page 31: Troubleshooting

    TROUBLESHOOTING If your MYND device is not working properly, please check the following: Problem Possible Solution causes The white Flat battery. Charge LEDs do not battery. turn on section 6.1. Intensity is not Increase sensation strong enough. strength. Sudden If you remove...
  • Page 32: General Specification

    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/docum ents/36683/attachments/1/translations/e n/renditions/pdf GENERAL SPECIFICATION Waveform Alternated mono-phasic rectangular Amplitude 20 mA (Peak) zero to peak +ve in 40 steps.
  • Page 33 Environmental specifications: Operating: Temperature: 5℃ to 40℃ Humidity: 15 % to 90 %, non- condensing Atmospheric pressure: 700hPa to 1060hPa Temperature: -10℃ to 60℃ Storage: Humidity:15 % to 75% Atmospheric pressure: 700hPa to 1060hPa Battery storage temperature: -10℃ ~+60℃ (≤ 1 month) -10℃...
  • Page 34 @TensCareLtd TensCare Limited @tenscareltd EC Declaration of Conformity TensCare Ltd. hereby declare that an examination of the production quality assurance system has been carried out following the requirements of the UK national legislation according to Annex V of the Directive 93/42/EEC on medical devices.

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