Dr. Honle idromed 5 PS User manual

Rev. 06/2016
Instructions for use
idromed®5 PS
Item no. 111001 –EU-plug / silver
Item no. 111501 –EU-plug / white
Item no. 111003 –UK-plug / silver
Item no. 111503 –UK-plug / white
Please read these instructions carefully
before beginning treatment!

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INSTRUCTIONS FOR USE
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PART I –GENERAL SAFETY AND COMPLIANCE INFORMATION..........................................................3
1. Important notes for your safety ................................................................................................................... 3
1.1 General safety instructions............................................................................................................................. 3
1.2 Responsibility of staff ..................................................................................................................................... 5
1.3 Use in home treatment................................................................................................................................... 5
1.4 Hazards when using this device ...................................................................................................................... 6
1.5 Intended use ................................................................................................................................................... 6
1.6 Symbols and warnings on the equipment ...................................................................................................... 7
2. Areas of application, indications, contraindications, side effects and environment ..................................... 8
2.1 Areas of application ........................................................................................................................................ 8
2.2 Indication ........................................................................................................................................................ 8
2.3 Contraindications............................................................................................................................................ 8
2.4 Side effects ..................................................................................................................................................... 9
2.5 Environmental conditions............................................................................................................................... 9
PART II - OPERATING INSTRUCTIONS FOR THE IDROMED® 5 PS .....................................................10
3. Scope of delivery, description and setup.....................................................................................................10
3.1 Scope of delivery........................................................................................................................................... 10
3.2 Description.................................................................................................................................................... 11
3.3 Setting up the device .................................................................................................................................... 12
4. Performing therapy.....................................................................................................................................13
4.1 Preparing treatment ..................................................................................................................................... 13
4.2 Types of treatment ....................................................................................................................................... 14
4.3 Treatment of hyperhidrosis of the hands and/or feet.................................................................................. 14
4.4 Treatment of hyperhidrosis in the armpits................................................................................................... 17
4.5 Tips and information..................................................................................................................................... 18
4.6 Cleaning and Maintenance ........................................................................................................................... 19
PART III - MAINTENANCE AND SERVICE ..........................................................................................20
5. Maintenance...............................................................................................................................................20
6. Service ........................................................................................................................................................20
7. Troubleshooting..........................................................................................................................................21
8. Warranty and liability .................................................................................................................................23
9. Ordering spare parts ...................................................................................................................................23
PART IV - TECHNICAL DATA, EMC, DISPOSAL..................................................................................24
10. Specifications of the idromed®5 PS.............................................................................................................24
11. Electromagnetic Compatibility ....................................................................................................................27
12. Disposal ......................................................................................................................................................29
PART V –PRODUCT AND USER VIDEO ............................................................................................29

idromed®5 PS
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Part I –General Safety and Compliance Information
Dear Sir or Madam,
You have purchased an idromed®5 PS, the iontophoresis device for treatment of
excessive sweating (hyperhidrosis) of the hands, feet and armpits. We hope that you will
be satisfied with the idromed®5 PS. You will help assure your own satisfaction by
carefully reading and observing all the following instructions before using the device.
Sincerely yours,
Dr. Hoenle Medizintechnik GmbH
1. Important notes for your safety
Please read these instructions before using the idromed®5 PS and observe them
carefully.
1.1 General safety instructions
In case of contraindications as described in section 2.3, idromed®5 PS
should not be used or only in consultation with the attending physician.
Using the device and another high frequency surgical device at the
same time can cause burns under the electrodes.
Operation in close proximity (less than 1m) to a medical device for short
wave or microwave therapy can cause fluctuations in the output levels
of idromed®5 PS.
Application of the electrodes on or near the chest may increase the risk
of ventricular fibrillation.
Use extra caution when operating with effective current densities of
more than 2 mA/cm² on any electrode surfaces.

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The therapy should not be applied: on or through the head; directly to
the eyes; inside the mouth; on the front of the neck (especially the
carotid sinus); or with electrode surfaces attached on the chest and
upper back or across the heart.
During treatment, the circuit must always be closed, i.e. there must be
at least one hand or foot in each tray.
Conductive objects (e.g. metal, water conduits, etc.) must not be
touched during treatment.
All hand and foot jewellery, including wrist watches, must be removed
before treatment.
Damage to the stratum corneum (minor injuries, scratches, etc.) on the
palms, soles of the feet, nail folds or armpits, as well as areas that are
susceptible to eczema, must be covered with Vaseline or a fatty
ointment, since conductivity is elevated in these areas. Please cover
only these areas!
Adjustment of the current should be performed individually for each
user. The current is optimal when the treatment does not cause stitches
or burning. The current levels specified are maximum permitted levels.
Wet the sponge pockets very thoroughly inside and out, but not to the
point that they drip water. Do not wring! If the sponge bags are too dry
there is considerable risk of burns!
Warning: direct skin contact with the metal electrodes can cause
burns! During axillary treatment, the electrodes must be kept steady,
with even pressure; otherwise there may be error messages or power
fluctuations in the display.
Never short metal electrodes!

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The device may only be connected to a fixed wall socket with protective
contact. The device may not be operated via extension cable or via
splitters!
The device must not be used in conjunction with other household
appliances.
Compliance to all important safety instructions is a prerequisite for safe and trouble-free
operation of the idromed®5 PS.
This manual contains all necessary instructions to operate the device properly. The
manual, particularly the safety instructions, must be observed by anyone working with the
device. Also, all applicable local rules and regulations for accident prevention must be
obeyed.
1.2 Responsibility of staff
Individuals in clinical facilities or doctors’ offices who are to work with idromed®5 PS
must, before they begin, agree to:
observe the regulations on occupational safety and accident prevention.
read the chapters on safety and the warnings in this manual and continually
observe them during operation.
Apart from adhering to the instructions for use, no further technical requirements are
needed for its operation.
1.3 Use in home treatment
This medical device was also developed for the treatment of patients in a home setting.
The following minimum requirements apply to patients using the appliance independently:
The user must be able to read these usage instructions independently and
understand them. No further technical qualifications are necessary.
The minimum age for use of idromed®5 PS is 12 years. Children under 12 may
use the medical device for therapeutic purposes only in consultation with the
attending physician and under adult supervision.

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1.4 Hazards when using this device
The idromed®5 PS is built to a state-of-the-art standard incorporating the established
safety regulations. The equipment may only be used
as intended
in a perfectly safe setting, and
with the enclosed original accessories from the manufacturer.
Improper use can endanger the health of the user or other persons, or damage the
equipment or other material.
Malfunctions that could affect safety must be corrected immediately.
1.5 Intended use
The idromed®5 PS is an iontophoresis device for the treatment of hyperhidrosis of the
hands, feet and armpits.
If the patient operates this medical device during its application completely and without
assistance, then the patient becomes the operator.
The user may only operate the device in accordance with all the user and safety
information in this manual.
Any other use, or use beyond its specifications, is regarded as improper and can be
dangerous.
Dr. Hoenle Medizintechnik GmbH cannot be made liable for injury or damage caused by
improper use of this device.

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1.6 Symbols and warnings on the equipment
+
Anode
Cathode
On/off switch
(pressure switch)
Safety Class II devices
Application part type BF
IP
21
Protection class against ingress
of dirt and water
Manufacturer’s name and
address
Observe instructions for use
CE mark with symbol of the
designated authority
Do not dispose of with
household waste!
(See also Chapter 10)
See warnings in instruction
manual

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2. Areas of application, indications, contraindications, side effects
and environment
2.1 Areas of application
With the idromed®5 PS, depending on the indication, long-term iontophoresis therapy
can be performed using tap water and a pulsed direct current (pulsed DC). Affected body
parts, such as hands and feet, are placed in trays filled with tap water. During treatment,
direct current flows through the extremities. During axillary treatment, the current flows
through wet sponge bags. This current flow causes a normalization of perspiration. (See
Part II - operating instructions, page 9).
2.2 Indication
According to the latest findings, treatment of the following indications is promising:
Hyperhidrosis of the hands, feet and armpits
Multiple therapy-resistant Verrucae-Vulgares on hands or foot soles
Dyshidrotic hand or feet eczema
Sudeck’s syndrome
Gramnegative infections of the interstitial spaces between the toes, the keratoma
sulcatum and fungal infections (mycoses), possibly resulting from the
hyperhidrosis.
2.3 Contraindications
In cases of the following contraindications, the idromed®5 PS should not be used or
only after consultation with the attending physician:
Cardiac arrhythmia
Electronically controlled implants (e.g. pacemakers)
Metal implants in the area of the current flow
Metal-containing (coil) intrauterine implants
Pregnancy
Large skin defects
Insensitivity to pain stimuli

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2.4 Side effects
In very rare cases, side effects can occur during treatment. Please see the following
notes:
Side effect
Notes
Skin reaction (redness, very rarely
blistering) especially along the waterline
Reactions are temporary and normally
resolve without additional treatment
after 1 hour.
Dry, cracked skin
Can be minimized by the use of cream.
Distressing pain in areas with injuries or
rashes
Cover injuries or inflamed areas of the
skin with Vaseline.
2.5 Environmental conditions
The idromed®5 PS is designed to be used in dry rooms with an ambient temperature of
15 °C to 30 °C (59 °F to 86 °F).
Do not operate in rooms with more than 85% humidity.
Always protect the device against chemical vapors and never operate it in potentially
explosive areas.

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Part II - Operating Instructions for the idromed® 5 PS
3. Scope of delivery, description and setup
3.1 Scope of delivery
Basic treatment set:
1 x idromed®5 PS
tap water iontophoresis device
(Basic unit) made from Terluran®.
1 x Power adapter
(24 V AC/DC ADAPTER, type: UE24WCP1-240030SPA)
or
(12 V AC/DC ADAPTER, type: KNW24U20A-120B0-I4410VL)
2 x aluminium plate electrodes (nickel-free)
2 x electrode cables
2 x plastic grids
2 x foam edge protectors
1 x shock-resistant PVC case
whose two separable case shells also serve
as treatment trays
1 x patient’s diary

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1 x instructions for use
Optional accessories: (see Chapter 8 “Ordering spare parts”)
2 x nickel-free armpit electrodes with sponge
pockets for treating the armpits
2 x large treatment trays, plus
2 x plastic cover mats for large treatment trays
3.2 Description
The basic treatment set consists of the components described in section 3.1 “Scope of
delivery".
The two halves of the supplied protective case serve as treatment trays. Mount the
idromed®5 PS following the steps described below.
Remove label and protective film from the electrodes prior to first use!
For proper implementation of treatment and for your own safety, the
device may only be operated with the enclosed original accessories from
the manufacturer. Accessories from other manufacturers are not
compatible with idromed®5 PS!

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3.3 Setting up the device
1
The idromed®5 PS should be used on a flat, stable base (table) close to
a wall socket.
Position the idromed®5 PS so that it is easy to connect and/or disconnect
the AC adapter.
Open the case and take out all the supplied components.
Place all parts on the table and set the packaging material aside.
2
The case halves serve as treatment trays.
Before treatment the two case shells must be
separated (for easy emptying after treatment).
To do this, open the case completely, place it on a flat
surface and pull the two halves gently apart in the
direction indicated by the arrow.
3
The edge protection prevents uncomfortable pressure on
the forearms.
Attach the edge protection to the case edges.
4
The connectors for the electrode cable are on the outside
left of the idromed®5 PS.
Connect the electrode cable marked (+) with the jack
marked (+) on the device, and the electrode cable
marked (-) with the jack marked (-).
5
Cover each electrode with one of the supplied plastic
grids.
Now connect each electrode cable to the
corresponding electrode tray.
Place one electrode in each tray.

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6
Write down in your medical record with which
polarity each hand or foot is treated. This will help
you change the polarity for the next treatment.
7
Fill the two treatment trays with tap water, high
enough that the front finger joints or toe joints are
barely covered.
8
Now connect the power cord to the side of the
idromed®5 PS case and plug the AC adapter into
a properly rated outlet (100 - 240V~ / 50 - 60Hz).
The light on the power adapter will turn green.
The device is now ready for use.
4. Performing therapy
4.1 Preparing treatment
Remove all jewellery from around areas of treatment. Thoroughly clean the body parts to
be treated, to remove any possible grease or cosmetic residue. If the body parts to be
treated have any damage to the stratum corneum (minor injuries, scratches, eczema),
cover these with Vaseline or a fatty ointment.
Observe all warnings and safety instructions listed in Chapter 1.1
"General safety instructions". Failure to comply may result in injury!

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4.2 Types of treatment
The treatment should take place once a day to start. The therapy time is 15 minutes. A
normal level of hidrosis is usually reached after 10-15 applications, meaning that moisture
development of the skin is normalized.
Treatment example:
First week every day / second week every 2nd day / after the third week only one –two
times per week.
The suppression of perspiration at the positive terminal (+ anode) is much more
pronounced than at the negative terminal (- cathode). In order to achieve an optimal
therapeutic response, you should change the polarity after every 5 treatments.
Simply swap the connections of the electrodes (exchange the positive and negative
connections).
The current level should be adjusted individually for each user. The following specified
current levels are the maximum permitted levels. In general, however, the levels to be
used are significantly lower.
The maximum allowable levels are as follows:
For the treatment of hands: 15 mA
For the treatment of feet or hands and feet: 25 mA
For the treatment of armpits: 5 mA
Too high a current can cause an unpleasant stinging or burning in the
current-carrying extremities during treatment. If this occurs, the current
level should be set lower; otherwise there is risk of burns!
4.3 Treatment of hyperhidrosis of the hands and/or feet
Do not turn off the device during treatment.
Direct skin contact with the metal electrodes can cause burns!

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Position the treatment trays according to whether you want hands and feet treated
at the same time or individual hand or foot treatments:
Fig (1):
Fig (1) left
shows the positioning if
simultaneous hand and
foot treatment is to take
place. For this situation,
use one tray for the
hands and one tray for
the feet.
Fig (2) on the top right
shows the positioning if
only the hands are being
treated.
Fig (3) on the bottom
right
shows the positioning if
only the feet are being
treated.
Fig (2):
Fig (3):
Set the rotary switch so that the indentation is level
with the dot (●) on the case before switching on the
device.
Turn on the device by pressing down the dark gray
knob that regulates the current.
Experience has shown that the desired therapeutic
levels can best be adjusted to comfort from this
setting.
After switching on, the device will perform a self-test
automatically. This process takes a few seconds.
In the display you can read the maximum levels of the
current selected for therapy.

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Set amperage by rotating the knob to a minimum level
(for hand treatment approx. 4 mA and for feet approx. 9
mA).
This level can be increased by turning the knob to the
right and decreased by turning to the left.
Connect the circuit by putting a hand or a foot in each
of the water-filled trays.
If you experience a stitching or burning sensation, the current is set too
high and must be decreased until the feeling ceases.
If no stitching or burning occurs at maximum amperage, the treatment
should be carried out with the maximum allowable amperage for each area.
To set the amperage, hands or feet can safely be taken from the treatment trays even
with the power on.
Please dry off your hands before you adjust the amperage on the device!
The therapy time is 15 minutes. The remaining session
time can be seen on the display.
If therapy is interrupted, the device stores the remaining treatment session time.
If the therapy was interrupted, hands and/or feet may be put back into the trays.
The therapy will continue automatically.
After the treatment period, remove hands and/or feet from the treatment trays.
Dry your hands thoroughly.
Turn off the device by pressing the knob downwards.
After each treatment, disconnect all cables. Drain the water from the trays and dry the
trays, electrodes and cable with a cloth.

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4.4 Treatment of hyperhidrosis in the armpits
For treatment of the armpits please use the two optional
electrodes together with the sponge pockets
(See Chapter 8 “Ordering spare parts”).
Do not turn off the device during treatment.
Soak the sponge pockets in a water bath through dipping
in, pressing and again dipping in. Press some water from
the sponge bags, just enough that they no longer drip (do
not wring!).
The more water stays in the sponge pockets, the better the
current will transfer to the areas undergoing treatment.
If the sponge bags are too dry there is considerable risk of burns!
Attention! Direct skin contact with the metal electrodes can cause burns!
Put the electrodes completely into the wet sponges.
Use the two electrode cables to connect the electrodes to
the positive and negative poles of the device.
Set the rotary switch so that the indentation is level with
the dot (●) on the case before switching on the device.
Turn on the device by pressing down the dark grey knob
that regulates the current.
Experience has shown that the desired therapeutic levels
can best be adjusted to comfort from this setting.
After switching on, the device will perform a self-test
automatically. This process takes a few seconds.
In the display you can read the maximum levels of the current
selected for therapy.

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Set amperage by rotating the knob to a minimum level of the
maximum permissible current intensity (approx. 3 mA).
This level can be increased by turning the knob to the right
and decreased by turning to the left.
Connect the circuit by squeezing a sponge electrode under
each armpit.
Throughout the entire treatment period keep the sponge
electrodes under your armpits steadily and with even
pressure; otherwise error messages or power fluctuations
may occur in the display.
The therapy time is 15 minutes. The remaining time is readable
on the display.
If therapy is interrupted, the device stores the remaining treatment session time.
If the therapy was interrupted, the sponges with the electrodes may be put back
under the armpits.
The therapy will continue automatically.
If you experience a stitching or burning sensation, the current is set too high
and must be decreased until the feeling ceases.
If no stitching or burning occurs at maximum amperage, the treatment should
be carried out with the maximum allowable amperage for each area.
After the treatment period, remove the sponge electrodes from under your armpits.
Dry your hands thoroughly!
Turn off the device by pressing the knob downwards.
After each treatment, disconnect all cables. Rinse the sponge bag thoroughly and let it
dry. Clean the electrodes and cable with a cloth.
4.5 Tips and information
To simplify the treatment, use the same treatment amperage in mA once it is determined.
Maximum current and maximum voltage adhere to safety standards that are defined by
the DIN EN 60601-1 code. Keep the circuit closed during treatment and follow the
treatment instructions. Make sure that the device is not turned off during ongoing
treatment.
For optimal treatment results, please switch the polarity after 5 treatments. Simply swap
the electrode terminals (plus ↔ minus).

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Make sure that the water you are using has not been treated by a water softener. This
reduces the conductivity of the water, which means the treatment can only be partially
effected or not at all. If only softened tap water is available, use mineral water or soda
water to perform the treatment instead.
If you see this message in the display, please call our
customer service.
Note the number that follows the hash sign (#) in the
message and inform our staff.
You will find our customer service contact information in
Chapter 6 “Service”.
4.6 Cleaning and Maintenance
Drain the water from the trays after every treatment and dry the trays, electrodes and
cable with a cloth.
Disinfect the treatment set (case, plate electrodes and cover mats) with a commercial
disinfectant if needed. Discoloration of the electrode surfaces may occur after the first
therapy sessions and is normal.
Wipe the device with a damp cloth only when needed.
Make sure no water gets into the device.
Never use abrasives or solvents such as alcohol, acetone or benzene.
The plate electrodes and plastic grids need to be cleaned regularly with a usual vinegar
based solution.
Rinse the sponge bag thoroughly, clean them with water and let them not dry in the sun
or on a radiator.
Note for doctors’ offices:
Dr. Hoenle Medizintechnik recommends the disinfectant Sani-Cloth Active®cleaning
cloths by Ecolab. This product was tested in a long-term trial and can be recommended.
Service
required
#1234

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Part III - Maintenance and Service
5. Maintenance
The manufacturer recommends a safety inspection by our customer service at regular
intervals (every 2 years). All accessories must be included in maintenance and safety
inspections.
Maintenance on this device may not be carried out while the medical device
is being used. A maintenance check may only be carried out by
Dr. Hoenle Medizintechnik GmbH, or a person or institution authorized by
Dr. Hoenle Medizintechnik.
Maintenance on this device may not be performed by the operator or user.
6. Service
If you notice a problem with your idromed®5 PS, please start by reading Chapter 7
“Troubleshooting”. If you cannot resolve the fault this way, please call the following
contacts for assistance.
For questions about operation, service, and spare parts orders, please contact us
at:
Main Office:
Dr. Hoenle Medizintechnik GmbH
Dornierstrasse 4 Phone: [phone]
D-82205 Gilching, Germany Fax: [phone]-50
Email: [email protected]
Website: www.drhoenle.de
If the medical device is defective or if customer service recommends that you
return the device, please send it to the following address:
Branch (production site):
Dr. Hoenle Medizintechnik GmbH
Thura Mark 8+10
D-06780 Zoerbig, Germany