Hidrex GS400 User Manual

Deckblatt
Rev. 1.0 / 2011-10-10
2
Table of Contents
Table of Contents
................................................................................................ 2
Read Before Use
.................................................................................................. 3
Your safety is important - Contraindications ......................................................... 3
Additional important safety considerations ........................................................... 4
Intended Use / Mechanism of Action
............................................................ 5
Treatment Fundamentals ........................................................................................... 5
System Components
........................................................................................... 6
Standard Accessories ................................................................................................. 6
Optional Accessories ................................................................................................... 7
Controls on the Casing Panels .................................................................................. 7
Front Panel Controls .................................................................................................... 8
Installation / Treatment Setup
......................................................................... 9
Setup for Treating Hands and Feet .......................................................................... 9
Setup for Axillary Treatment (Armpits) ................................................................. 10
Treatment Setup for Special Applicators ............................................................. 10
Conducting Treatments
................................................................................... 11
Primary Parameter Setup (Setup Mode) ............................................................... 11
Begin Treatment (Treatment Mode) ...................................................................... 13
Important Advise for Conducting Treatments ..................................................... 16
Side Effects .................................................................................................................. 17
General Information
.......................................................................................... 17
Special Remark ........................................................................................................... 17
Care and Maintenance .............................................................................................. 17
Operational Check ...................................................................................................... 18
Symbol Legend ............................................................................................................ 19
Error Checklist ............................................................................................................. 19
Shipping the Device for Repair or Maintenance .................................................. 20
Applicable Regulations and Legal Requirements
.................................. 20
Reconditioning and Disinfection ............................................................................. 20
Technical Safety Inspection .................................................................................... 21
Lifespan ......................................................................................................................... 21
Electric-Magnetic Compatibility .............................................................................. 21
Entsorgung von Verpackung und Elektro-Altgeräten ........................................ 22
Technical Data
.................................................................................................... 23
Distribution / Trading .................................................................................................. 23
User Manual Tap Water Iontophoresis System GS400
Rev. 1.0 / 2011-10-10
3
Read Before Use
Your HIDREX 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 the setup procedure, familiarize you with the system’s features, and will offer hints on the use of your new therapy system.
Your safety is important - Contraindications
Important:
Under no circumstances should you use iontophoresis if any of the following conditions apply:
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 petrolatum Patients with impaired sensibility in their hands or feet (e.g. patients
with polyneuropathies)
Warning:
The treatment system may only be powered by the HIDREX wall
adapter (to recognize at HIDREX nameplate with Serial-No.). This power supply is especially designed for this device.
In order to prevent burns during treatment, make sure the supplied
towels 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 jewellery (wedding bands etc.)
which would otherwise be immersed in the water bath. Keeping such accessories on would lead to localized minor (electrical) burns sec­ondary to increased current densities.
Rev. 1.0 / 2011-10-10
4
Additional important safety considerations
Place the treatment device on a firm level surface.
Make sure that the treatment device is at room temperature before
you power it up.
You may remove your hands or feet from the treatment water bath at
any time, but it is advisable to lower the dose to zero before you do so. In rare cases, uncomfortable electric shocks1 may result if the dose is not reduced.
The system may 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.
Prior to using wall power, check that your outlet power meets the sys-
tem’s requirements of 110-230 V~ and 50-60 Hz.
Unplug the wall power adapter if a thunderstorm approaches or if you
do not intend to use the treatment system for an extended period of time.
This treatment device may only be used indoors. Do not expose the
system to rain or excessive moisture.
Prior to cleaning the system, turn the device off and unplug all
connectors. For cleaning, use a soft cloth moistened with a mild cleaning agent.
Do not use kerosene, thinner, alcohol, wax remover or any other
solvents.
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 the HIDREX Company.
Never open the device; there are no control elements inside. The
system may only be serviced by the HIDREX Company.
Wash the supplied towels on a regular basis together with your
regular laundry (make sure to comply with the laundry instructions on the tag).
1
These electric shocks are definitely uncomfortable, but absolutely harmless.
User Manual Tap Water Iontophoresis System GS400
Rev. 1.0 / 2011-10-10
5
Intended Use / Mechanism of Action
During HIDREX treatment, a current flows through the body regions un­der treatment. The water bath mediates this current flow. The skin areas inside the treatment 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!
The treatment current can be adjusted according to your individual sensitivity. There is no risk involved as the current cannot exceed certain maximum values.
Remark: In general, HIDREX treatment results do not depend on the
direction of current flow. The anode (red), however, is slightly more effective than the cathode (black). Current direction should therefore be reversed on a regular basis – but not with­in one treatment session.
Important: The HIDREX iontophoresis unit GP450 is intended to treat
hyperhidrosis affecting hands, feet, face, necks / back and arm pits. Any other use or usage beyond this scope is con­sidered unintended use and may have dangerous conse­quences.
Treatment Fundamentals
HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis1 (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis.
The HIDREX treatment concept comprises two treatment phases:
1
Additional indications include: Dyshidrotic dermatitis, palmoplantar pustolosis and acro-
cynosis.
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Phase 1: The initial phase (therapy initiation) is conducted under a doctor‘s
supervision. During this stage, patients learn to administer treatments. For therapy initiation, 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 indicated because
the HIDREX treatment effect is reversible. Patients should conduct maintenance therapy sessions by themselves at home and with their own unit. Depending on the severity of the condition, maintenance therapy involves one to three weekly sessions of approximately 15 minutes each.
System Components
Your HIDREX therapy system compris­es a control unit and the accessories explained in the following chapters.
Standard Accessories
Fig.: Control Unit GS400
Hard Shell Case Treatment electrode
(covered in the picture)
Towel Dual connecting cable set Safety wall adapter
(Fig. similar)
  
User Manual Tap Water Iontophoresis System GS400
Rev. 1.0 / 2011-10-10
7
Optional Accessories
Ergonomic treatment tray Axillary applicators
1
(Fig.: Model AX 1)
Face mask
2
Nape or back applicator (not shown)
2
Set DUO allows simultaneous treatment of hands and feet (not shown)
3
Controls on the Casing Panels
Therapy system main ON/OFF switch (main power switch) Jacks for connecting the dual connecting cable set (treatment electrodes) Connector for safety wall adapter (12V DC)
1
includes a pair of sponge cushions with leather covers respectively a pair of sponge
pouches and special small electrodes (AX electrodes)
2
made of foam and come equipped with hook and loop tapes (used with the AX elec-
trodes)
3
includes 2 additional electrodes each, towels, and a dedicated cable set
12V DC
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