Functional Cosmetics Company SweatStop DE20 User manual

Tabwater Iontophoresis Device
SweatStop® DE20
EN
Instruction Manual

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EN SweatStop® DE20
Index
Before operation.................................................................................................................................. 3
Intended use......................................................................................................................................... 3
Contraindications................................................................................................................................. 3
Warning ................................................................................................................................................ 4
Safety measures.................................................................................................................................... 4
Side effects / Accompanying symptoms ............................................................................................... 5
Scope of delivery.................................................................................................................................. 6
Structure and basic functions of the DE20 ......................................................................................... 7
- Trial under health insurance ............................................................................................................. 9
- Safety features ................................................................................................................................. 10
Application ......................................................................................................................................... 11
- Basics................................................................................................................................................. 11
- Preparation....................................................................................................................................... 12
- Hand treatment ............................................................................................................................... 13
- Foot treatment................................................................................................................................. 15
- Combined treatment of hand and feet.......................................................................................... 16
- Underarm treatment ....................................................................................................................... 18
Treatment interval ............................................................................................................................. 19
Power supply ...................................................................................................................................... 20
- Monitored battery / accumulator capacity...................................................................................... 20
- Charging the accumulator............................................................................................................... 20
- Notice ............................................................................................................................................... 21
Technical specifications...................................................................................................................... 21
Cleaning and maintenance................................................................................................................ 21
Storage and transportation............................................................................................................... 22
Disposal............................................................................................................................................... 22
Warranty, guarantee and lifetime .................................................................................................... 22
Signs and symbols .............................................................................................................................. 23
Contact................................................................................................................................................ 24
Guidance and manufacturer’s declaration of EMC .......................................................................... 24

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EN
SweatStop® DE20 – Revison 002b – 2019-12-09
SweatStop® DE20
Before operation
The manual should be read thoroughly before operating this device. Home treatment should be
conducted only after consulting a doctor/ dermatologist. This iontophoresis device was designed
for optimal functionality and usability. Its operation is simple and ergonomic. This manual is
intended to familiarize you with the system and its proper usage. Should there still be any questions
after reading the manual, please don’t hesitate to contact us.
The treatment with this device may also be a positive influence on the therapeutic effects of any
other adjunct therapy.
Intended use
The DE20 is intended to use tap water for the temporary reduction of excessive perspiration.
Specialised electrodes for different body parts are made available. The patient is the intended
operator of the iontophoresis device under the instruction or guidance of the clinician. The DE20
is intended to be used in medical facilities and in private homes by healthcare professionals as well
as non-professionals. The operation must be exclusively conducted in closed rooms. Any other use
is considered “unintended use“ at the risk of the user.
Contraindications
1. Do not use if you have any electronic implant, such as a cardiac pacemaker or ICD (implanted
cardioverter defibrillator).
2. Do not use if you have a suspected or diagnosed cardiac condition.
3. Do not use if you are or have recently been pregnant.
4. Do not use if you wear any metallic implant such as a metal-containing IUD (intrauterine device),
screws, plates or wires within the possible current path. Take off all metal jewellery before the
treatment.
5. Do not use if the body parts you wish to treat suffer from malign tumours, thrombosis, diabetes,
impaired sensitivity, inflammation, uncovered skin defects, fresh wounds or vascular disorders.

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EN SweatStop® DE20
Warning
1. The patient is the responsible user of this device and should only operate it under the instruction
or guidance of a medical professional.
2. The target population is over 18 years old and was given a medical prescription to use the
device.
3. Do not disassemble the device. If needed, return it for examination or repair.
4. CAUTION: All modifications of this equipment or its accessories are forbidden.
5. The medical device should not be used close to or on top of other electric equipment. Should
such a usage be strictly necessary, the medical device must be verified to conduct normal opera-
tion in the configuration in which it will be used.
6. CAUTION: The usage of accessories, chargers or cables other than those specified or provided by
the manufacturer of this equipment may negatively influence the electromagnetic emissions or
electromagnetic immunity of this equipment and result in a faulty operation.
7. CAUTION: Portable RF communications equipment (including peripherals such as antenna cables
and external antennae) should be used no closer than 30 cm (12 inches) to any part of the
medical equipment, including the cables specified by the manufacturer. Otherwise, the function
of the equipment might deteriorate.
8. Do not use the iontophoresis device near the active high frequency equipment and the RF-
shielded room of an MRI scanner, where the intensity of disturbances is extraordinarily high.
9. Use only with tap water. Liquids other than tap water are not allowed.
Safety measures
1. Keep away from children.
2. This device should only be used with the leads and cables provided by the manufacturer to
ensure the maximum clinical effectiveness. Using accessories which are not approved by the
manufacturer may cause damage or an unauthorised interference emission and loss of opera-
ting license.
3. To prevent burns during the treatment, make sure the electrodes are covered at all times. Direct
contact with the surface of the electrodes must be avoided at all times.
4. Any damage to the skin (minor injuries, scratches etc.) in the treatment area must be coated
with Vaseline or a fatty lotion before treatment to avoid further damages.
5. Two devices may not be used simultaneously on one patient.
6. Make sure that the device is at room temperature before operating it. If the device has been
stored in low temperatures, a condensation of the air humidity may lead to malfunctions or
damage of the device.
7. All jewellery worn in the treatment areas must be removed before starting the therapy. Due to
their increased current density, metal objects can cause local skin injuries.

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EN
SweatStop® DE20 – Revison 002b – 2019-12-09
SweatStop® DE20
8. This device is designed for indoor use only. Do not expose it to rain or humidity.
9. Caution should be used when treating areas of the skin that lack normal sensation (e.g. diabetic
patients). Note: watch out for skin irritations. Pause the treatment if necessary.
10. High currents do not lead to a more successful treatment, but can lead to skin irritation
instead. The current strength should be adjusted to the comfort of the patient. In cases of skin
irritation, stop the treatment and seek advice from your doctor.
11. If the treatment feels uncomfortable, reduce the current strength to a comfortable level or
stop the session.
12. If the treatment is ineffective or unpleasant, discontinue the sessions and seek advice from
your doctor.
13. Before operation, the patient must sit still and all cables must be plugged in firmly.
14. The mains plug is specified as a part of this medical equipment. Only use the adaptor supplied
by the manufacturer.
15. Do not submerge the device in water.
16. Dropping the device may cause damage.
Side effects / accompanying symptoms
• Skin irritations are one possible side effect of the intended usage. The treatment should be
stopped until the cause of the irritation can be determined.
• You will perceive every treatment differently. For this reason, the milliampere value should only
be used as a rough guidance. The current strength should be adjusted according to your personal
comfort level.
• Iontophoresis treatment stimulates the circulation, so a harmless reddening of the skin after the
treatment may occur.
• During the treatment you may experience tingling or stinging sensations. In this case, you should
reduce the current strength to a comfortable value.
• As a consequence of the treatment, the skin will become increasingly drier.
• If the treatment leads to skin that is too dry, chapped or cracked, stop the treatment and consult
your doctor.