Functional Cosmetics Company SweatStop DE20 User manual

Tabwater Iontophoresis Device
SweatStop® DE20
EN
Instruction Manual

2
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

3
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.

4
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.

5
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.

6
EN SweatStop® DE20
Description and number Image
Device in etui / box
Order number: DE 20
Accumulator
(rechargeable battery)
(4x Baby NiMH 1,2 V 2500 mAh)
Order number: A 0012
Charger
Charger for series of 4 NiMH accumulators
Order number: A 0011
Cables for electrodes
Order nomber: Z 0066
Tubs for tap water
Order number: Z 3000
Electrodes in sponges for the treatment of
hands and feet
Order number: Z 1000
User manual
Order number: B 0020
Scope of delivery
Depending on your prescription, the scope of delivery may differ or include other accessories.

7
EN
SweatStop® DE20 – Revison 002b – 2019-12-09
SweatStop® DE20
(2)
(3)(3)
(6)
(9)
(5)
(1)
(4)
(8)
(7)
(1) On / Off switch with
current controller
(2) Diverter for type of
current
(3) Outlet sockets for
electrodes
(4) LED, indicator
“weak battery”
(5) Digital display
(6) LED, indicator
“empty battery”
(7) Charging socket
(8) Battery compartment
(9) Code control
(3) Sockets to connect cables to electrodes
(7) Charging socket for charger
Structure and basic functions of the DE20

8
EN SweatStop® DE20
After the predefined treatment time of 20 minutes, the current flow will be interrupted auto-
matically. The text „treatment over“ will appear on the display. To switch off the device, turn the
button (1) back until it locks into place with a click.
The treatment time of 20 minutes begins once the circuit is first closed (displayed value > 0,00) and
will not be started anew if the circuit is momentarily interrupted to make adjustments.
2. Diverter for type of current
You may either choose direct current (DC) or pulsed current (PC). In “pulsed current” mode, the
ratio between pulse and pause is 1:1. This means that the efficient PC value is nearly half of the
displayed current value. Due to its decreased percentage of direct current, the pulsed current
allows more precise increments (5 mA PC is equivalent to 2,5 mA DC). Due to the interruptions in
the current, pulsed currents feel more comfortable for some patients.
3. Outlet sockets for electrodes
Two outlets: “Red“ - Anode (+) and “Black“ - cathode (-). Plug in the cables according to their
colours to connect the device with the electrodes. Change the polarity each time you start the
therapy, unless otherwise recommended by your doctor. The pole reversal can be carried out by
plugging the red cable into the black socket and the black cable into the red socket.
4. LED indicator “weak battery”
When this yellow LED lights up, it indicates that the accumulators are weak and must be re-
charged soon. You will be able to conduct 2 more treatment sessions before needing to recharge
the accumulators.
Stufe 12345678910
GS [mA] 2 4 6 8 10 12 14 16 18 20
PS [mA] 3 6 9 12 15 18 21 24 27 30
1. On / Off switch with current controller
To start the device, switch on clockwise until you hear a click.
Continue turning to control the amperage: turn clockwise to increase the value, anti-clockwise to
lower it.
This function is only available when the electric circuit is closed. When the circuit is interrupted,
the display will show “0,00” until the circuit is closed. Then, the current will slowly be raised until
it reaches the selected value.
The values 1-10 denote 10-100 % of the maximum value: in direct current mode, the maximum
value is 20 mA; 30 mA for pulsed current mode.

9
EN
SweatStop® DE20 – Revison 002b – 2019-12-09
SweatStop® DE20
5. Digital display
During normal usage, the display shows the current value measured in mA (milliampere), as well
as the chosen current type (PC or DC). Additionally, it shows messages such as “treatment over”.
6. LED indicator “empty battery”
When this red LED lights up, it indicates that the accumulators are empty. You will have to re-
charge the accumulators before being able to use the device again.
7. Charging socket
The charging socket is located on the right side of the device (7). You may only use the supplied
charger, since it is adjusted to the accumulators built into the device. Connecting the device to the
wrong charger may lead to severe damage.
If the DC plug of the charger is inserted, the circuit will be interrupted and the device will be
deactivated.
8. Battery compartment
The device has a battery compartment (8) for four rechargeable
batteries / accumulators of the cell type LR (Baby / C). 4 NiMH accumulators are part of the delivery
scope. The charging duration depends on the capacity of the batteries and the charger – new cells
(standard equipment, 4x 2500 mAh) take approximately 11-12 hours to charge.
9. Code control
The number of all completed treatments will be saved. This code status has replaced the “therapy
diary” in order to offer an alternative proof for a regular trial phase to health insurances.
Trial phase under prescription by health insurance
Code status
Many health insurances want to make sure that the device is actually
needed before they take over the costs. Often, a therapy diary or the
questionnaire provided by AAM (including code) is used as proof of
the therapy sessions. The code status indicates the number of treat-
ments you conducted. By demand of certain health insurances, the
number of completed sessions was coded to impede a possible deception. In order to read the
code status on the display, insert a pointy object, e.g. a screwdriver (2-3 mm in diameter) into the
hole on the left side (9)* to press the code switch. Keep it pressed down and switch on the device
– after a few moments, a four-letter figure will appear on the display. The code switch can now
be released.
*Insert horizontally if you own the version in the etui; insert slantwise from above if you own the version in the plastic case.

10
EN SweatStop® DE20
Safety features
• Anti-overtreatment
As a result of a successful treatment, the electric resistance of the skin rises up. To avoid an over-
treatment, the system monitors the conductivity of the skin. The displayed message “max” signals
that the predefined resistance has been met. If a second, higher limit is reached, the system will be
locked and won’t even start. Since these limits have been adjusted to the “average patient“, they
may not fit your individual situation.
If the hyperhidrosis is not relieved and the device won’t start due to the protective function, please
don’t hesitate to contact us so that we can find an individual solution for your situation.
• Maximum current strength
The current strength is controlled by the device and cannot be increased above the maximum
values of 20 mA (direct current - DC) and 30mA (pulsed current – PC). To give you the best possible
feedback, the display always shows the real current value.
• Disconnecting the device from the current supply (240V/ 110V)
When the DC plug of the charger is plugged into the charging socket of the device, the treatment
cannot be conducted. The DC plug disconnects the electric circuit. For this reason, the treatment is
only possible when the charger is disconnected.
• Protection against accidental change of current type
Switching between pulsed current and direct current is impossible during the operation of the
device. An accidental change between the current types cannot occur during the treatment. When
the device is started, the position of the button is saved and will be upheld until the end of the
treatment session even if the current type is changed.
• Anti pasture fence effect
To avoid electric shocks by the adjusted voltage when submerging the hands or feet, the controls
will only be started once the current is closed (= hands or feet are submerged). The current will
now rise gradually. If the circuit is interrupted during the treatment, the value will be reset to zero.
Once the treatment is continued, the current will gradually rise to the chosen value.