AED IONOMAT 1 User manual

User guide in English / Manuel d’utilisations en anglais
A
AE ED D I IO ON NO OM MA AT T
USER MANUAL
27/12/18
Anglais / English
IONOMAT 1
1 General description and expected use of the IONOMAT ……………………..……….1 3
2 Contents of box ………………………………………………………………………………3

IONOMAT 1
Page 2sur 14
3 Product feature ……………………………………………………………………………….4
4 Unpacking the device and switching on the device …………………………...…………5
5 Hand perspiration treatment ……………………………………………………………….6
6 Treatment of foot tranpiration……………………………………………………………... 8
7 Underarm perspiration treatment ………………………………………………………….9
8 Warts treatment …………………………………………………………………………….11
8.1 Treatment of warts unilaterally (on one side) …………………………………………..11
8.2 Treatment of bilateral warts (both sides) …………………………………………………11
9 Cleaning and disinfection of the device ………………………………………………….12
9.1 Maintenance IONOMAT …………………………………………………………………..12
9.2 Disinfection ………………………………………………………………………………….12
9.2.1 Home use: ……………………………………………………………………………………12
9.2.2.2 Use in a professional environment: ………………………………………………………12
10 Storage of the device ………………………………………………………………….……13
11 Troubleshooting ……………………………………………………………….……………13
12 Possible errors identified ……………………………………………………….………….13
13 Recommendations for use……………………………………………………….……….. 13
14 Precaution for use ……………………………………………………………..……………14
14.1 Transport of IONOMAT 1……………………………………………………..………….. 14
14.2 Precautions ……………………………………………………………………………...…..14
14.3 Disposal………………………………………………………………………………...…… 14
14.4 Electromagnetic sensitivity ………………………………………………………...………14
14.5 Target user profile& Operating environment…………………………………...……… 15
14.6 Pictograms used on the IONOMAT 1 …………………………………………...………..15
14.7 Technical specifications …………………………………………………………...………..16
14.8 Device lifetime…………………………………………………………………...…………. 17
14.9 Storage conditions ……………………………………………………………...…………...17
15 Administrative information concerning the company ……………………...………..…17

IONOMAT 1
Page 3sur 14
1General description and intended use of IONOMAT 1
IONOMAT 1 is intended for the treatment of perspiration of the hands, feet or armpits by
ionophoresis, it also allows the treatment of warts of the feet and hands.
Iontophoresis is one of the most effective methods to combat sweating. It works with water to
transmit a small flow of 10 to 20 mA electrical current to the skin surface (through the feet or
hands placed on electrodes with 2 cm of ordinary water).
The electrical current released by the machine has one purpose: to microscopically thicken the
surface layer of the skin in order to block the production of perspiration.
The ionophoresis method consists of placing the areas to be treated (feet, hands, etc.) in tanks
containing water and operating the device.
For the armpits, it is a matter of placing small electrodes on wet sponges, putting them under
your arms and activating the machine.
The treatment of perspiration gives satisfactory results after a period of between 4 and 10
weeks, respecting the frequency of sessions indicated in this manual.
For the treatment of warts, one tablespoon of sodium salicylate is added to the water on the
affected side.
2 Contents of the box
→The Generator
→2 Cables with
crocodile clips
→Bins (2 or 3 litres)
→2 Cables with
crocodile clips
→Biocompatible
grids
→2 Storage Case
→2 Stainless steel
electrodes

IONOMAT 1
Page 4sur 14
2Product Features
Device name: IONOMAT 1
The medical device for the treatment of hypersudation by iontophoresis.
The functions are ensured by the electronic assembly allowing the production of a stable and
precise current.
It is strictly forbidden:
-To use accessories, spare parts, and equipment not described in this manual.
-To connect this unit to other equipment not described in this manual
-To modify this device
3User Manual
For assistance, if necessary, in the assembly, use or maintenance of the device, please
contact AED IONOMAT.
3.1 Unpacking the device and starting the device
1 Remove the medical device from its transport package.
The red wire must be connected to the red plug, the black wire must be connected to the
black plug.
Risk of Strangulation - Special attention should be paid to the use of cables
4) Once the generator and bins are positioned at your convenience, pour 2cm of tap water into
each tray (for hand and foot treatment)
Figure 1: Generator of IONOMAT 1
Screen
Ameprage adjustement
Time adjustement

IONOMAT 1
Page 5sur 14
Wet the sponges abundantly (for underarm treatment).
The device must be positioned so that you can easily access the mains plug to ensure separation
to the power supply.

IONOMAT 1
Page 6sur 14
4Hand perspiration treatment
1) Place on a coffee table: the generator in the middle,
On the left is a tray with the electrode covered with the biocompatible grid.
On the right the other tank with the electrode covered with the biocompatible grid.
2) Connect the electrodes to the cables with the clamps to the generator,
3) Plug in the generator, the green LED lights up and you read 00.0
Pour about 2 cm of water into the bins. (hands must not be fully immersed).
Sit comfortably on a chair in front of the table.
4) Adjust the current to the supported value according to the table of recommended values, start
with the minimum value, gradually increase over the sessions until the maximum value is easily
supported).
5) Turn the right knob to "IONO 20" and put your hands in the water immediately.
6) After 15 seconds, the current rises slowly and then stabilizes. It cancels out after 10 minutes
and then slowly increases again as it reverses.
7) After 20 minutes the device rings, you can then remove your hands and stop the ringing by
setting the right button to 0.
You can stop the treatment at any time by gradually removing the extremities
and finishing with a palm.
During the first use, it is recommended to use 20min to determine the
effectiveness of the treatment, switch to the 30 mn position in case of insufficient
effectiveness.
Children (From 7 years
old)
Women
Men
HANDS
2 à 8 mA
5 à 20 mA
8 à 25 mA
Frequency of sessions: In attack treatment 3 to 5 sessions the first week, then 2 sessions per week for
4 weeks and 1 maintenance session per week all year round.
Treatment of foot tranpiration
1) Place on a coffee table: the generator.
Place 1 tray on the floor on the left with the electrode covered with the biocompatible grid.

IONOMAT 1
Page 7sur 14
Place the other tray on the right side of the floor with the electrode covered with the
biocompatible grid.
2) Connect the electrodes to the cables with the clamps to the generator,
3) Plug in the generator, the green LED lights up and you read 00.0
Pour about 2 to 3 cm of water into the bins. (The feet should not be fully submerged).
Sit comfortably on a chair in front of the table.
4) Adjust the current to the supported value according to the table of recommended values, start
with the minimum value, gradually increase over the sessions until the maximum value is easily
supported)
5) Turn the right knob to "IONO 20" and put your feet in the water.
6) After 10 seconds, the current rises slowly and then stabilizes. It cancels out after 10 minutes and
then slowly increases again as it reverses.
7) After 20 minutes the device rings, you can then remove your hands and stop the ringing by
setting the right button to 0.
You can stop the treatment at any time by gradually removing the ends and ending with
the heel, or reset with the current adjustment knob.
During the first use, it is recommended to use 20min to determine the effectiveness of
the treatment, switch to the 30 mn position in case of insufficient effectiveness.
You will read 00.0 if one or both feet are not water.
Children (From 7 years
old)
Women
Men
Feets
3 à 10 mA
5 à25 mA
10 à 25 mA
Frequency of sessions: In attack treatment 3 to 5 sessions the first week, then 2 sessions per week for
4 weeks and 1 maintenance session per week all year round.
7 Underarm perspiration treatment
1) Connect the alligator clips to the width of the stainless steel armpit electrodes.
2) Thread the stainless steel underarm electrodes into the biocompatible sponges when
wet thoroughly.
3) Hold them under the arms horizontally, letting the crocodile clip extend well beyond
the arms, which should not touch the skin.

IONOMAT 1
Page 8sur 14
4) Set the right button to "Iono 20" and gradually increase to read between 3 and 6 on the
display.
When using, do not exceed 6 mA read on the display; a higher current may cause
small burns that heal spontaneously. Wait for complete recovery before resuming
treatment.
You will read 00.0 if the electrodes are not in place under the arms or are not
sufficiently wet.
Wet the biocompatible protective sponges thoroughly.
Children (From 7 years
old)
Women
Men
Underarms
1 à 3 mA
4 à 6 mA
4 à 6 mA
Frequency of sessions: In attack treatment 3 to 5 sessions the first week, then 2 sessions per week for
4 weeks and 1 maintenance session per week all year round.
Warts treatment
7.1 Treatment of warts unilaterally (on one side)
1) Add one tablespoon of sodium salicylate to the water on the electrode side connected
to the red cable, the other end is immersed in ordinary water
2) Use the "Lock" position of the right button.
3) Then refer to the instructions for the treatment of sweating on your hands or feet.
7.2 Treatment of bilateral warts (both sides)

IONOMAT 1
Page 9sur 14
1) Add one tablespoon of sodium salicylate to each tray.
2) Use the "Iono 30" position of the right button.
Then refer to the instructions for treating hand or foot perspiration.
Children (From 7 years
old)
Women
Men
Hands
2 à 8 mA
5 à 22 mA
8 à 25 mA
Feet
5 à 10 mA
8 à25 mA
12 à 25 mA
Frequency of sessions: Two sessions per week are necessary until the wart(s) disappears completely,
the skin must be clear
8 Cleaning and disinfection of the device
8.1 IONOMAT maintenance
Do not use acetone solvent
The cleaning of the device is limited to the external parts with a non-abrasive sponge
soaked in alcohol or a dry cloth
Never immerse the unit in water or clean it with ether.
Device :
- The cleaning of the device is limited to the external parts with a non-abrasive sponge
soaked in alcohol or a dry cloth.
- Never immerse the device in water or clean it with ether.
Accessories :
- Dry the electrodes.
- Dry the biocompatible grids
- Dry the bins after each use.
- Renew the electrodes every month with a scouring pad to maintain their shine.

IONOMAT 1
Page 10 sur 14
- Never put the cables in water or disinfectant.
8.2 Disinfection
8.2.1 Home use:
Treatment of hyperhidrosis:
- Disinfect the trays, biocompatible grids and electrodes every 10 sessions with diluted
bleach.
Warts treatment:
- Disinfect the trays, biocompatible grids and electrodes between each session with
diluted bleach.
8.2.2. Use in a professional environment:
Treatment of hyperhidrosis or warts:
- Disinfect the tubs and sponges and electrodes between each patient with water using the
recommended products: Streranios 2%, Hexanios G+R or Alcohol 70%.
- Refer to the instructions for the products used.
4.1 Storage of the Dispense
1) Once the treatment is complete, disconnect the medical device, empty the water from the
trays and dry the electrodes and trays
2) Store the device in its case (if applicable) in this order:
- Place the electrodes at the bottom of the case.
- Place over the bins
- Place the generator in the trays and surround the trays with the power cable and the cables
connecting the electrodes
Or store the device in a suitable place so as not to damage it.

IONOMAT 1
Page 11 sur 14
5Troubleshooting
Only AED IONOMAT personnel are authorized to carry out repairs to the
IONOMAT 1. For any incident, contact AED IONOMAT. In any case, unplug the power cord
from the wall outlet.
6Possible errors identified
Errors Identified Information
Handling
The generator does not display and the green
light does not light
Check the power supply of the device
Low battery on display
Voltage on insufficient area
Display "00.0" during treatment
Check that both ends are well immersed in
water
7Recommendations for use
The use of IONOMAT 1 is not recommended for patients meeting one of these criteria:
•Pregnant women
•Children under 7 years
•People with heart problems
•Persons with metallic prostheses and / or orthoses
•Persons with metallic IUDs
•Persons with injuries at the extremities
13 recautions for use
13.1 Transport of IONOMAT 1
The integrity of the transport is ensured by a transport package containing dunnage particles.
13.2 Precautions
•Carefully keep this user manual as it contains the information necessary for proper use
of the equipment,
•Before connecting the appliance to an outlet, check the values given in the appliance's
operating instructions (volts and Hz) and your distribution network,
•Medical device, fragile, to handle with precautions,
•Do not unscrew the visible nuts,
•Do not open the device,
•Do not place anything on the unit and do not bend the cables
•Always unplug the appliance after each use.
•Do not leave the cables within easy reach of children

IONOMAT 1
Page 12 sur 14
•For children, the treatment is the same, but it is necessary to respect the recommended
current values. We advise the presence of an adult during the treatment
13.3 Disposal
At the end of life, the device is to be placed in a suitable reprocessing center. Under no
circumstances should the device and disposable probe be disposed of with household waste or
disposed of in the environment.
Pursuant to European Directive 2002/96 / EC, this electrical appliance
must not be disposed of in household waste but must be brought to a
waste disposal facility for processing for recovery.
13.4 Electromagnetic Sensitivity
This device complies with the requirements of EN 60601-1-2 which describes electromagnetic
compatibility (EMC) requirements for medical devices. IONOMAT 1 requires precautions against
EMC.
Interference Hazards: The use of accessories, sensors and cables other than
those specified, with the exception of sensors and cables sold by the manufacturer as an
internal component replacement part, may lead to increased levels of interference.
emission or a decrease in immunity levels of IONOMAT 1.
Using IONOMAT next to other devices may cause interference. Especially in the vicinity of
RF communication with higher immunity levels than the values in Table 9 of EN 60601-1-
2.
13.5 Intended User Profile & User Environment
The device is intended to be used in an environment but medical and in patients' homes. It is
intended for several users:
•Practitioner (Dermatologist / Physiotherapist / Podiatrist): Person who is currently
using medical devices
•Patient: Person (> 7 years) using this medical device at home
13.6 Pictograms used on IONOMAT 1
Symbols
Mention
Symbols
Mention
Manufacture or place
of manufacture
Date of manufacture
Displays the relative
humidity limit
between which the
IONOMAT can be
safely exposed
Applied part of type
BF

IONOMAT 1
Page 13 sur 14
Do not use if damaged
packaging
Alternating current
Catalog Number
Serial number
User Manual
WARNING !
RoHS
Fragile
Do not throw in
household garbage
Keep out of direct
sunlight
Protect from moisture
Displays the
temperature limit
between which the
IONOMAT can be
safely exposed
IP 21
Protection sign
Connection to Class II
Power System
13.7 Technical Specifications
•Dimension of the generator: 220 x 155 x 70mm
•Generator weight: 0.8 kg
•Constant current generator
•Guaranteed current from 0mA to 25mA on a load of 2.2kohms
•Digital reading of current in mA and indication of polarity
•Residual ripple for 10mA 10mV nominal, warranty below 20mV
•15 s +/- 1 current-delaying device at start-up
•Slow ((1-exponential) growth of the current to reach the preset value
•Automatic zero reversal
•Automatic shutdown, power cancellation and ringing at the end of the cycle
•Casing, buttons made of insulating material

IONOMAT 1
Page 14 sur 14
•Sealing of the generator: IP 21
•Class IIa medical device,
•230 V / 50 Hz - 10VA
•2 fuses of 0.5A (not accessible)
•2 fuses of 0.1A (not accessible)
•IONOMAT 1 device does not have essential performance
•Cables 1m long and 0.75 sections
13.8 Device life
The lifetime of the device and its accessories is:
•Generator: 10 years
•Cables: 5 years
•2 x plastic trays (30 cm x 20 cm x 6 cm): 5 years
•2 x 3 cm plastic bins (34 cm x 23 cm x 7 cm): 5 years
•2 pairs of stainless steel feet / hand electrodes: 5 years
Maintenance must be performed every 5 years to ensure the performance and safety of the
device
13.9 Storage conditions
Storage conditions for IONOMAT 1 are described below.
Transport, Storage and Operation
Ambient temperature
0°C à + 38°C
Relative humidity
30% à 70%
Atmospheric pressure
850hPa à 1060hPa
14 Administrative information concerning the company
For any incident (operation or unforeseen event), please contact AED IONOMAT
-
AED IONOMAT
Adress : 5 rue des Genêts 34269 La Tour Sur Orb - FRANCE
0459
Telephone service from Monday to Friday only in the morning from 9am to 12pm.