Hidrex DP450 User Manual

DP450

Tap Water Iontophoresis (TWI)

System

User Manual

(Included and optional accessories not shown)

DP450 Tap Water Iontophoresis System User Manual

Rev. 1.4 / 02-16-2017

2

Table of Contents

Table of Contents

2

Read Before Use

3
Your Safety is Important 3
Contraindications 4
Side Effects 4
Additional Important Safety Considerations 4

Intended Use / Mechanism of Action

5
Treatment Fundamentals 6
Polarity Reversal and the Efficacy of Treatments 6
Types of Current 7

System Components

8
Standard Accessories 9
Optional Accessories 8
Control Unit Side & Rear Panel Elements 9
Control Unit Front Panel Elements 10

Installation / Treatment Setup

11
Setup for Hands and Feet Treatment 11
Setup for Axillary (Armpits) Treatment 12

Conducting Treatments

12
Primary Parameter Setup (Setup Mode) 13
Begin Treatment (Programming Mode) 15
Important Advice for Conducting Treatments 17

Care and Maintenance

18
Special Remark 18
Multi-Patient Use 18
Care and Purification 19
Disinfection 20
Reconditioning 21

Troubleshooting

21
Error Checklist 21
Operational Check 21
Shipping the Device for Repair or Maintenance 22

Applicable Regulations and Legal Requirements

22
Symbol Legend / Manufacturer / Device Identification 23
Lifespan 23
Electromagnetic Compatibility 24
Waste Management and Packaging of Electronic Devices 26

Technical Data

26

Distribution/Trading

28

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DP450 Tap Water Iontophoresis System User Manual

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Read Before Use

Your HIDREX tap water iontophoresis device was designed to maximize
functionality and usability. System setup is easy, and the device is simple to
operate. This manual is intended to guide you through setup and programming,
familiarize you with the system’s features, and offer hints on the use of your new
therapy system.

Your Safety is Important

 This treatment system may only be powered by the HIDREX AC power

adapter (which can be identified by a HIDREX nameplate with Serial­No.). This power supply is especially designed for this device.

 In order to prevent burns during treatment, make sure the supplied tow-

els or pads cover the treatment electrodes at all times. Avoid direct con­tact with the metallic surface.

 Two devices may not be simultaneously used by one patient.

 Prior to treatment, remove any metallic jewelry (wedding bands, etc.)

which would otherwise come in contact with the water source (trays or
pads). Keeping such accessories on would lead to localized minor (elec­trical) burns that are secondary to increased current densities.

 Avoid application of current in excess of that which can be safely and

comfortably tolerated by the patient. Always treat carefully and observe
patient reaction.

(As a rule, avoid current intensity greater than 0.5-1.0 milliamperes per
square inch of active electrode area.)

 The long term effects of chronic electrical stimulation have not been es-

tablished.

 Keep this device out of the reach of children.

 Caution: U.S. Federal law restricts this device to sale by or on the order

of a physician.

 WARNING: Potential systemic adverse effects may result from use of

this device. Drugs or solutions delivered with this device have the poten­tial to reach the blood stream and cause systemic effects. Carefully read
all labeling of the drug or solution used with this device to understand all
potential adverse effects and to ensure appropriate dosing information.
If systemic manifestations occur, refer to the drug or solution labeling for
appropriate action.

DP450 Tap Water Iontophoresis System User Manual

Rev. 1.4 / 02-16-2017

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Contraindications

The following conditions are considered contraindications for
iontophoresis, so treatment should not be administered unless otherwise
directed by your physician:

 Patient with a cardiac pacemaker;

 Patient with an ICD (implantable cardioverter/defibrillator);

 Pregnancy;

 Patient with a metal-containing intrauterine device (IUD);

 Metallic implants within the current path (arm or leg);

 Large skin defects/wounds that cannot be covered with petroleum jelly;

 Patients with impaired sensibility in their hands or feet (e.g. patients with

polyneuropathies);

 Potentially malignant lesions, acute localized infections, skin eruptions,

or swollen, broken, or inflamed areas;

 Any area where sensation is absent or impaired;

 Apply electrical current through or across the chest, brain, or sinuses;

 Patients with suspected or diagnosed heart problems or epilepsy.

Side Effects

Possible side effects or results of using this device include:

 Mild dysesthesia (tingling or burning)

 Short-term skin irritation (reddening) after treatment

 Erythema (skin redness, transient vesicles or blisters)

 Skin irritation or burns at the areas of electrode contact have been re-

ported with the use of electrical stimulators.

Additional Important Safety Considerations

⌦ Place the device on a firm level surface.

⌦ Make sure that the device is at room temperature before you power it

up.

⌦ You may remove the treatment area from the water source at any time,

but it is advisable to lower the dose to zero before you do so. In rare
cases, safe but uncomfortable electric shocks1 may result if the dose is
not reduced.

⌦ The system should not be operated in the vicinity of shortwave or

microwave medical diathermy devices. A minimum distance of 2
meters should be kept at all times.

1

These electric shocks are definitely uncomfortable, but harmless.

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DP450 Tap Water Iontophoresis System User Manual

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⌦ Prior to using AC wall power, check that your outlet meets the system’s

requirements of 110-230 V~ and 50-60 Hz.

⌦ Unplug the AC power adapter if a thunderstorm approaches or if you do

not intend to use the system for an extended period of time.

⌦ This device should only be used indoors. Do not expose the device to

rain or excessive moisture.

⌦ Do not use kerosene, thinner, alcohol, wax remover or any other

solvents.

⌦ Prior to cleaning the device, turn off the device and unplug all

connectors. For cleaning, use a soft cloth moistened with a mild
cleaning agent.

⌦ Prevent kinking of the cable and do not expose the cable to heat or

chemicals. If the cable is damaged, unplug it from the device and have it
checked by an authorized HIDREX repair center.

⌦ Never open the device; there are no control elements inside. The

system may only be serviced by an authorized HIDREX repair center.

⌦ Wash the supplied towels on a regular basis together with your regular

laundry (make sure to comply with the laundry instructions on the tag).

Intended Use / Mechanism of Action

Intended Use:

This tap water iontophoresis device is intended to treat
hyperhidrosis

1

(excessive sweating) affecting hands, feet and
underarms.
Any other use or usage beyond this scope is considered un­intended use and may have dangerous consequences.

Mechanism of Action:

During the HIDREX treatment, a current flows through the body regions that
are being treated. The water in the trays or pads mediates this current flow.
The skin areas in contact with the water will thereby secrete less sweat.

Although treatment success has been validated in numerous medical stud­ies, there is still no completely satisfactory scientific explanation for the
mechanism of action. Medical researchers believe that the electrical current
irritates the synapses between sweat-inducing nerves and sweat glands to
such an extent that sweat glands can no longer be stimulated. In other
words: the treatment does not affect the sweat glands directly, it only affects
the nervous input to these glands.

This effect explains why the original condition returns relatively quick­ly when the treatment is discontinued.

1

Additional indications include: Dyshidrotic dermatitis, palmoplantar pustolosis and acrocynosis.

DP450 Tap Water Iontophoresis System User Manual

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The treatment current can be adjusted according to your individual sensitivity.
There is no risk involved as the current cannot exceed certain maximum values.

Treatment Fundamentals

The HIDREX treatment concept comprises two treatment phases:

Phase 1: The initial phase (therapy initiation) is sometimes conducted

under a doctor‘s supervision. During this stage, patients learn to
administer treatments. For therapy initiation, at least

three weekly

treatments of approximately 15 minutes each should be
scheduled (not more than one treatment per day). Sweat
secretion will normalize after approximately 10 treatments.

Phase 2: Long-term treatment (maintenance therapy) is necessary

because the HIDREX treatment effect is reversible. Depending
on the severity of the condition, maintenance therapy involves
one to three weekly sessions of approximately 15 minutes each.

Polarity Reversal and the Efficacy of Treatments

It has been clinically documented that the area being treated with the anode (the
electrode that is attached to the red/positive cable) will produce slightly better
results initially than the area being treated with the cathode (the electrode that is
attached to the black/positive cable).

It is recommended to conduct all treatments in the initial treatment phase (Phase

1) without changing polarity until one side reaches an acceptable dryness level.
Once normal or acceptable dryness has occurred in one side of the treatment
area (for example, right hand), then it is advisable to reverse polarity and contin­ue the initial phase without changing polarity up to normal or acceptable dryness
has occurred in the other side of the treatment area (for example, left hand).

Once normal or acceptable dryness has occurred in both sides of the treatment
area (for example, both hands), then it is advisable to reverse polarity for each
treatment during the maintenance phase (Phase 2).

Polarity is reversed simply by changing which side of the treatment area is treat­ed by the anode or cathode (the electrodes with the red or black cable, respec­tively).

For example, on the first treatment in the maintenance phase, if the right hand
was treated with the anode and the left hand was treated with the cathode, then
on the next treatment, the right hand would be treated with the cathode, and the
left hand would be treated with the anode. This sequence would continue for
every treatment.

Remark: Failure to do this does not cause any harm or side effects, rather

results in only a slight loss of efficacy. Long-term treatment re­sults do not depend on the direction of current flow.

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DP450 Tap Water Iontophoresis System User Manual

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Only in the beginning of the initial phase (Phase 1), the anode
(red cable) is slightly more effective than the cathode (black
cable).

Hint: It is recommended NOT to reverse polarity within any given treat-

ment session.

Types of Current

The DP450 has several options for the type of current used during treatment:

-

DC: Direct Current (standard)

-

PC: Pulsed Current

PC is recommended as an option for treatment of underarms, or treatments
where the skin is more sensitive, or for the treatment of children.

Direct Current (DC):

In DC, the current (voltage) is being transmitted 100% of the time.

DC is the standard current of the device, and is the most efficient method of tap
water iontophoresis treatment available.

Due to user comfort preferences, this device gives the user the option to choose
PC as an alternative.

Pulsed Current (PC):

In PC, the current alternates its transmission between ON (the pulse) and OFF
(the pause) for equal lengths of time. The pulse and the pause are the same
duration

1

(equivalent to a pulse-width of 50).
PC can be practically imperceptible at certain voltages and allows a better com­fort level, but is typically slightly less effective.

Hint: Once selected for the treatment session, the pulse-width will remain the

same throughout the session. If the user desires to change the pulse­width for better comfort or more efficiency, then the treatment must be
stopped. Power must be cycled on the device to return to Setup Mode
to change the pulse-width.

1

for example, 50 microseconds ON and then 50 microseconds OFF, and then the cycle repeats

DP450 Tap Water Iontophoresis System User Manual

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Fig.: DP450

System Components

Your HIDREX therapy system is com­prised of a control unit and the accessories
explained in the following sections.

Standard Accessories

Optional Accessories

➱

Ergonomic treatment trays

✃

Axillary Treatment Kit1

1

Axillary Treatment Kit includes a pair of small electrodes (AX electrodes) and a pair of pads (each

pad consists of a sponge cushion with a leather cover)

AC

A

dapter

➴

➷

✃

➱

➘

Hard Shell Case

➴

2 treatment electrodes (covered in the picture)

➷

2 towels

➮

➬

Cable Set

➘

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DP450 Tap Water Iontophoresis System User Manual

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Control Unit Side & Rear Panel Elements

1 Control unit main ON/OFF switch (main power switch)
2 Jacks for connecting the cable set to the treatment electrodes
4 Connector for AC adapter (12V DC)

12V DC

+

4

2

1