TensCare SOMNUS Sleep Aid Device CES User Manual

TensCare SOMNUS Sleep Aid Device CES

Introduction

• Somnus uses Cranial electrotherapy stimulation (CES) to aid in falling asleep, reduce waking during the night and improve sleep quality to leave you feeling alert and refreshed the next day.
• The device generates very small electrical pulses that gently stimulate the cranial nerves via wearable ear clip electrodes. This non-invasive neuromodulation technique has evidence to help those who suffer from insomnia, as well as anxiety and depression.

Kit Contents

This product includes

• 1 x Somnus sleep aid device
• 2 x Ear clips
• 1 x Lead wire
• 1 x USB charging cable
• 1 x Instructions for use
• 1 x Certificate

Controls and Interface

1. Power button
2. Charging socket
3. Lead wire socket
4. Intensity increase/parameter selection button
5. Intensity decrease/parameter selection button
6. Time selection button
7. Display
8. Charging indicator

How to Use

1. Connect the ear clips to the ends of the lead wire. Insert the lead wire into the lead wire socket on the device.

2. Clamp each ear clip onto your earlobes.

3. Turn the device on by holding the power button for 5 seconds.

4. Select the session time by pressing the time selection button on the side of the device. The default session time will be set at 20 minutes. We recommend no more than 1 hour of stimulation per day.

5. Once the time has been selected, start the session by pressing the power button.

6. Increase intensity by pressing the increase intensity button.
   We recommend increasing the intensity slowly during the first use. The stimulation should provide a slight tingling sensation in the earlobes.

7. Complete the session.

8. Turn off the device by holding the power button for 5 seconds.

Note: The device will automatically go to sleep mode if there is no operation for 5 minutes, and it will automatically power off if there is no operation for 10 minutes.

When to Use
Initially, Somnus should be used daily, for 20-60 minutes before bed. Most people will experience the best results when applying stimulation within three hours of going to sleep.
After improvement in sleep, we recommend reducing use to two or three times a week, ideally in the morning. This can be possible after two weeks.
Note: A small percentage of people may find stimulation creates an alert state of mind, making it difficult to switch off. If so, apply stimulation earlier in the day.

Tips for Use

• If you cannot feel any sensation, it may be necessary to improve the conductivity of the ear clips. This can be done by carefully applying a small amount of water to the rubber ends of the ear clips, or by wiping with a disinfecting wet wipe.
• Over time adaption may occur and you will get used to the strength of the stimulation. It may be necessary to increase intensity throughout the session.
• Head dizziness during use is common. This is a physical indication that the stimulation is working. Dizziness can be relieved by reducing the intensity.
• CES stimulation can cause very vivid dreams. This is common and should return to normal within a week or two.
• Earclips should be cleaned before and after every use.

Charging

• When the battery is low, the screen displays a low battery prompt, and the device automatically powers off after ten seconds.
• Charge the unit by connecting the device to a power source using the Type-C USB charging cable provided. The charging indicator is blue during charging. When fully charged the indicator will turn green. Do not use the device whilst charging.
• A full charge takes approximately 1-2 hours. The battery will last approximately 20 hours once fully charged.
• To maximise the battery life it is recommended to fully charge the device at least once a month.

Safety Guidelines

Contraindications

• Do not use if you have a heart pacemaker, (or if you have a heart rhythm problem) or with any electronic medical devices.
• Using this unit with electronic medical devices may cause erroneous operation of the device. Electrical stimulation in the direct vicinity of an implanted device may affect some models.
• Pregnant women, people with sensitive skin, heart disease, abnormal blood pressure, malignant tumours, patients with cerebrovascular disease, patients with acute diseases or other people undergoing treatment, must consult a doctor before using this product.
• Do not use it if you have unresolved brain or facial injuries.
• Do not apply stimulation to any part of the body other than the ear lobes.

Warnings

• Do not permit use by children unable to understand the instructions or persons with cognitive disabilities, i.e., Alzheimer’s disease or dementia.
• Do not use it when driving or operating heavy machinery.
• Do not use or consult with your clinician before use if you have, in the area stimulation is being applied: active or suspected cancer or undiagnosed pain with a history of cancer. Stimulation directly through a confirmed or suspected malignancy should be avoided as it may stimulate growth and promote the spread of cancer cells.
• Stop using the device and consult a healthcare professional if you experience any adverse reactions from the device.
• Keep the device away from electromagnetic interference, please do not use the phone when using the device.
• Do not apply the ear clips to the earlobes if the skin is broken. This could encourage infection.

Cautions

• Caution should be used if you have a bleeding disorder as stimulation may increase blood flow to the stimulated region.
• Caution should be used if you have suspected or diagnosed epilepsy as electrical stimulation may affect seizure threshold.
• Do not immerse your device in water or place it close to excessive heat or humidity as this may cause it to cease to operate correctly.
• The accessory wires and ear clips of this product can only be used with this device, do not interconnect with other devices.
• If there is a slight tingling sensation of the earlobes, it can be relieved by reducing the intensity.
• If the device is damaged, discontinue use and return the unit (see Warranty section).
• There are no serviceable user parts. Do not attempt to open or modify the unit. This may affect the safe operation of the unit and will invalidate the warranty.
• 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.

Cleaning and Storage

• When cleaning the device, wipe it with a soft cloth or towel moistened with a little water, not with volatile objects.
• When cleaning the ear clip of the product, use medical alcohol to wipe and disinfect.
• When storing the product for a long time, please fully charge the battery of the device in advance.
• Please keep in a dry and ventilated place.
• Do not store in a place exposed to direct sunlight, high temperature, or humidity.

Troubleshooting

Technical Specification

• Model No: DS-CES03
• Power supply: 5V DC 1000mA
• Pulse frequency: 0.8-1.2Hz
• Pulse width: 200-1100ms
• Charging time: 1-2 hours
• Lithium battery: 3.7V DC 1000mAh
• Input power: 3W
• Waveform: Biphasic asymmetrical square

Warranty

• The product is warranted to be free from manufacturing defects for 1 year from the date of purchase.
• This warranty refers to the unit only and does not cover the ear clips, lead wires or charging cable.
• This warranty is void if the product is modified or altered, is subject to misuse or abuse; damaged in transit; lack of responsible care; is dropped; if the unit has been immersed in water; if damage occurs by reason of failure to follow the user manual; or if product repairs are carried out without authority from TensCare Ltd.
• Our goods come with guarantees that cannot be excluded under the UK consumer Law.
• You are entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality.

Before you send your unit for service please be sure to read the user manual and follow all the instructions

Should repair be needed within the warranty period, please return the device with the following details:

• Name:
• Address:
• Telephone:
• Email:
• Date of Purchase:
• Proof of Purchase:

Returns should be sent to the following address

CONTACT

• TensCare Ltd
• 9 Blenheim Road,
• Epsom, Surrey
• KT19 9BE, UK
• For more information, please call +44 (0) 1372 723 434.

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