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!

idromed®5 PS
INSTRUCTIONS FOR USE
Rev. 06/2016 Page 2
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
INSTRUCTIONS FOR USE
Rev. 06/2016 Page 3
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.

idromed®5 PS
INSTRUCTIONS FOR USE
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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!

idromed®5 PS
INSTRUCTIONS FOR USE
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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.

idromed®5 PS
INSTRUCTIONS FOR USE
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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.

idromed®5 PS
INSTRUCTIONS FOR USE
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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

idromed®5 PS
INSTRUCTIONS FOR USE
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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

idromed®5 PS
INSTRUCTIONS FOR USE
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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.

idromed®5 PS
INSTRUCTIONS FOR USE
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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