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NEUROMED 4084 - CDB

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NEUROMED 4084 - CDB


Presentation

Presentation
Accessories that come with the product
Symbols
Warnings / Attention
Installation / Connection to the power network
General information
Diadynamic Currents
Monophase Currents
Microcurrents
Display Language
Controls & Control Functions
Operation
Operation Mode : Diadynamic
Operation Mode : Monophase
Operation Mode : Microcurrents
Protocols
Indications & Contraindications
Electrode Application
Preventive maintenance, preservation and cleaning
Corrective maintenance
Technical Characteristics
Manufacturer declaration and orientation
Considerations
European Representative
Bibliographical reference

Carci has the honor of congratulating you in your purchase of a high-tech


equipment of intrinsic safety, which we are certain will meet the most
demanding quality standards.
NEUROMED 4080 is an equipment for functional muscular stimulation of
medium and low frequency, intended for all areas of electrotherapy, which
was developed observing the safety standards NBR IEC 60601-1:1994 +
amendment 1:1997, NBR IEC 60601-1-2:2006, and NBR IEC 60601-210:2002, which make it a safe and highly reliable equipment.

Accessories that come with the device

4
4
4
1
1

Conductive rubber (Silicone) electrodes


Sponges pad
Polarized cables for electrode
Three-pole cable
User manual

To purchase optional accessories, consult the codes on page 38,


'Accessories' item.
In case of doubts, please contact:
Technical Assistance Department
Rua lvares Fagundes, 359 So Paulo SP Brazil -CEP [zip code]
04338-000
Phone: (0XX11) 5621 7024 / 5622 8205
email: sat@carci.com.br

Symbols
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NEUROMED 4084 - CDB

NEUROMED 4084 - CDB


Symbols on the packaging

Symbols on the equipment


Means equipment off

Fragile. Handle with care

Means equipment on

Keep in a dry place

This symbol shows that the equipment


causes physiological effects and that the
user must check the instruction manual
before using it.

This side up. This symbol shows the correct


transport position
Maximum piling. Shows the maximum
number of boxes that can be piled. The
quantity is marked in the intermediary
square.

Applied part type BF

Minimum and maximum temperature limits


for transport and storage.

Class II Equipment

Manufacturer Identification

Product Manufacturing Date

Product Serial Number


European Representative
CE Mark and identification of the notifying
body

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ATTENTION / WARNINGS
1. Read, understand and practice the operation and precaution
instructions. Know the limitations and dangers associated with
use of any electrical stimulation device.
2. Do not expose the device to direct sunlight radiated from a heat
radiator, excessive quantities of dust, humidity, vibrations and
mechanical shocks.
3. In the case of liquid infiltration, disconnect the device from the
power network and contact the Authorized Technical Assistance.
4. Before administering any treatment on a patient, you must
become acquainted with the operational procedures for each
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NEUROMED 4084 - CDB


treatment modality available, as well as the indications,
contraindications, warnings and precautions. Consult other
resources to obtain further information on the application of
electrotherapy.
5. Operating sequence

Connect
equipment to the
power network

Turn on
equipment
through the
ON/OFF switch

Set the therapy


parameters

Connect the
electrode cables
to the patient

Set the current


intensity desired

After the end of


the time selected,
remove the
electrodes from
the patient

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Turn on the
equipment
through the
ON/OFF switch

NEUROMED 4084 - CDB

WARNINGS:
1. Never turn on the ON/OFF key of Neuromed while one or more
cables of the electrodes are connected to the patient and to
Neuromed.
2. This equipment is intended for use by health professionals only.
3. This equipment can cause radiofrequency or interrupt operation
of nearby equipment.
4. The use of accessories not specified by the manufacturer can
result in increase in EMISSIONS or decrease in IMMUNITY of the
equipment.
5. The use of replacement parts not specified by the manufacturer,
in technical assistance, can result in increase in EMISSIONS or
decrease in IMMUNITY of the equipment.
6. We recommend not using this equipment piled or very close to
other equipment.
7. Short-distance operation (e.g. 1 m) from a shortwave or
microwave therapy EQUIPMENT can produce instability in the
STIMULATOR output;
8. Application of electrodes near the thorax can increase the risk of
cardiac fibrillation;
9. Simultaneous connections of a PATIENT to a high-frequency
surgical EQUIPMENT can result in burning where the
STIMULATOR electrodes are applied and possible damage to the
stimulator;
10. We recommend that the current densities for any electrode
2
exceeding 2 effective mA/cm may require special attention from
the user;
11. Do not place the equipment on soft base that can cover the lower
vents.
12. Keep this device out of reach of children.
13. This equipment is not suitable for use in the presence of mixture
of anesthetics inflammable with air, oxygen or nitrous oxide.

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Installation/Connection to the power network
For a perfect functioning of your equipment, we suggest that the electrical
installations be according to the following standards:
 Brazil :

NBR 5410/1990 Low-voltage electrical installations;


NBR13534/1995 Electrical installations in health establishments
- Safety requirements.

NEUROMED 4084 - CDB


General Information
The NEUROMED 4084 is a functional neuromuscular electrostimulator,
Microcontrolled with the functions :

Diadynamic Currents

Monophase







 Other Countries :

IEC 60364-7-7 (10/2002) Electrical Installations medical


locations;
Or another related standard applied in the country of use.

Connect the power cable to the three-pole connector located in the


posterior panel and connect it to the power socket.
Fuse box

On/Off Switch

Power cable
connector

Your equipment uses switched power sully and operates in any


voltage between 100V~ and 240V~ 50 or 60Hz.

In case the protective fuse burns, replace it only be the value


indicated: the fuses must be of 1.0A 250V~ 20AG

Remove the cover of the fuse box using a screw driver (insert the screw
driver in the groove of the fuse box, apply a little pressure and turn it
counterclockwise).
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DF, MF, LP, SP, iD SP


Square,
Exponential,
Ultra Exciting,
Direct and Interrupted

Microcurrents

Diadynamic Currents
Diadynamic currents were introduced by Bernard (1) and won an
important position in the history of physiotherapy. They are currently
unfairly deemed as outdated compared to TENS or Interferential currents.
Diadynamic Currents are used mainly to reduce pain and improve
blood circulation.
Bernard uses the term Diadynamic currents, which refer to a monophase
(MF - Monophas fixe) or double phase (DF - Diphas fixe) rectified
alternating current. The frequency was derived directly from the power
source, resulting in sinusoidal pulses with a duration of 10 ms. This time,
10-ms phase will mainly depolarize thick fibers. Stimulation of the thin
fibers can only be obtained with greater current amplitude.
(1) Bernard, Pierre D.
La diadynamique thrapie,
Paris, Editions Physio ', dated 1962.
ATTENTION:
Diadynamic Currents are monophase currents that produce electrolysis
subproducts. These subproducts can result in burning beneath the
electrodes. Always use a correctly wet sponge / electrode combinations to
absorb these products during the treatment.
The available variations are as follows:
MF (Monophas fixe)
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It is a single sinusoidal phase rectified current with a frequency of 50 Hz.
MF is a vibration waveform that easily induces the contractions.

NEUROMED 4084 - CDB


Is identical to SP, except that the amplitude of the current in the MF
phase is 12.5% smaller than during the DF phase.
Usually, a lower frequency is experienced to be more aggressive than a
higher frequency. IDSP prevents this difference in the sensation.

DF (Diphas Fixe)
It is a dual sinusoidal phase rectified current with a frequency of 100 Hz.
DF is usually experienced with a fast vibration. It is a pleasant waveform
that is often used as an introduction to SP or LP.

LP (Long Periods)
It is a slow alternance between six seconds of MF and six seconds of DF.
In the DF phase, the intervals between the MF pulses are filled with
additional pulses gradually with the increase and decrease in amplitude.
LP is suaver than SP.

SP (Short Periods)

Monophase ( Faradic )
Mo n op h as e / F aradic currents are often used for muscular stimulation
applications that are based on previous diagnosis. The diagnostic
objective is the obtainment of information on the sensitivity of the
neuromuscular device for electrical stimulation. This g i v es a n
i nd ic at i on of t he le v e l of m us c u lar t is s u e enervation. With this
technique, the ratio between amplitude and the duration of the current
phase of a rectangular and triangular pulse is plotted in a power / duration
curve. The power / duration curve is recorded by observing the amplitude
of the current required in phase of various values of duration (varying
from 0.01 to 1000ms) that produce contraction of a muscle or muscular
group that is just perceptible (that is only visible or palpable). In case of
reduced sensitivity or absence in electrical stimulation, the power /
duration curve gives an indication of the current waveform, phase
duration and amplitude of the electrical stimulation current to be used in
any therapy that can be applied.

Square Monophase Current.

It is a fast alternance between a second MF course and a second of the


current DF. CP has as strong re-absorption effect.

Exponential Monophase Current.

iD SP ( Isodynamic Short Periods )

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NEUROMED 4084 - CDB

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effect is the absence of pain that can arise from just the first treatment
and that can last for several hours.

Galvanic current

Tp = 2 mS / Tr = 5 mS

Direct Galvanic Current

(2) Trabert, H.
Ultra-Reizstrom, neues ein therapeutisches Phnomen,
Elektromedizin 2, 1957 (7).

Direct galvanic current, applied constantly without rest interval.

ATTENTION:
Monophase currents are currents that produce electrolysis subproducts.
These subproducts can result in burning beneath the electrodes. Always
use a correctly wet sponge / electrode combinations to absorb these
products during the treatment.
Interrupted Galvanic Current
Interrupted galvanic current, and modulation of direct galvanic current, at
the frequency of 8 KHz, with working cycle of 90%.

Microcurrents
Microcurrent is a rectangular monophase waveform selected manually or
with alternate polarity.

Trabert Ultra-Exciting.
The 2-5 or "Ultra-exciting current was introduced by Trbert.(2) . The 2-5
faradic current is a rectangular pulsated current with a phase duration of 2
ms and a phase interval of 5 ms. These configurations are the standard
configurations for the faradic current rectangular waveform and result in a
pulse frequency of approximately 143 Hz. Trabert did not provide any
explanation for the choice of these parameters. However, many workers
have adopted the treatment and it is still applied with success. A notable
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Many therapists prefer Microcurrent therapy because of the low current


amplitudes used. Alternate polarity can be used for the average of the DC
component, reducing electrolysis formation.

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NEUROMED 4084 - CDB

NEUROMED 4084 - CDB

Display language

Controls

NEUROMED 4080 allows accessing three display languages:


 Portuguese
 English
 Spanish

Control functions

If you wish to change the current language, follow the steps below:
1.
2.

Connect the power cable of the NEUROMED 4080 to the


power network.
Turn on the device - the equipment will conduct a test of the
display, presenting the Main screen.

3.

Next, press the key and keep it pressed

4.

6.

After the equipment issues a double beep, release the Menu


key
The display will show the accessible languages:
ENGLISH
PORTUGUESE
SPANISH
Select the language desired through the keys

7.

Press the key

8.

The equipment will exit the language selection mode,


displaying the Main menu.

5.

Moves to
next field

Decrease

Increase

Moves to
previous
field

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NEUROMED 4084 - CDB


Control of intensity of channels 1 and 2.

NEUROMED 4084 - CDB


The display will show the Initial Screen:

Fo l lo w th e s c r e e n:

Figure : 1

Figure : 2

Use the

keys to select the modes: .

or
E na b les t h e f u nc t io n c hos e n
or
E na b les t h e m a in m enu s c r ee n

E na b les t h e N EU RO M ED o u tp uts

1. Diadynamic
o

In the screen Dyadinamics ,

Use the
keys to enable selection of the
DIADYNAMIC modes (DF, MF, LP, SP or CP Id ).

D is ab l es t he N E UR O M ED ou tp u ts

Modes of operation
Operation of the device:

Press the ON/OFF at the back of the device. (Figure 1 page 7).
ATTENTION: Never turn on the ON/OFF key of Neuromed
while one or more cables of the electrodes are connected to
the patient and to Neuromed.

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o

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key

Or

, the output settings of channels will be enabled.


o

Or

Use the key of the channel to set the intensity.

Or

1.1

DF

Select the Diadynamic DF mode.

Press the
key to enable the Diadynamic DF mode.
The Diadynamic DF parameter set screen will be displayed.

Through the
Polarity and Timer :

and

1.2

MF

Select the Diadynamic MF mode.

Press the
key to enable the Diadynamic MF mode.
The parameter set screen will be displayed.

Through the

keys, set the parameters

o
Settings : 1 minute to 60 minutes, in steps of 1 minute.

Polarity

Settings : + V , + P or Automatic ( AUTO )

o
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and

keys, set the parameters:

Settings : 1 minute to 60 minutes, in steps of 1 minute.


Polarity

Settings : + V , + P or Automatic ( AUTO )

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NEUROMED 4084 - CDB


o

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key
, the output settings of channels will be enabled.

, the output settings of channels will be enabled.


o
o

Use the key of the channel to set the intensity.

Use the key of the channel to set the intensity.

1.4 CP
o

Select the Diadynamic SP mode.

Press the
key to enable the Diadynamic SP mode. The
parameter set screen will be displayed.

Through the

1.3 LP
o

Select the Diadynamic LP mode.

Press the
key to enable the Diadynamic LP mode. The
parameter set screen will be displayed.

Through the

and

Settings : 1 minute to 60 minutes, in steps of 1 minute.


Polarity

Settings : + V , + P or Automatic ( AUTO )

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keys, set the parameters:

keys, set the parameters:

o
o

and

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Settings : 1 minute to 60 minutes, in steps of 1 minute.


Polarity

Settings : + V , + P or Automatic ( AUTO )

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NEUROMED 4084 - CDB


o

NEUROMED 4084 - CDB

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key

, the output settings of channels will be enabled.


o

Use the key of the channel to set the intensity.

Use the key of the channel to set the intensity.

2.

1.5 CP iD
o

, the output settings of channels will be enabled.

Monophase

Select the Diadynamic CP iD mode.


o

Press the
key to enable the Diadynamic CP iD mode.
The parameter set screen will be displayed.

Through the

and

keys, set the parameters:

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Use the
a nd
keys to enable selection of the
MONOPHASE modes (Square, Exponential, UE, Direct and
Interrupted ).

Or

Or

Polarity

Or

Settings : + V , + P or Automatic ( AUTO )

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NEUROMED 4084 - CDB

NEUROMED 4084 - CDB


Settings : + V , + P or Automatic ( AUTO )

Or

2.1.

, the output settings of channels will be enabled.

Square
o

Select the Square Monophase mode.

Press the
key to enable the Square Monophase mode.
The parameter set screen will be displayed.

2.2.
o

Through the

After setting the parameters, connect the electrode cable in output


1, 2 or both, to the electrodes in the patient. Press the key

and

Exponential

keys, set the parameters:

Select the Exponential Monophase mode.

Press the
key to enable the Exponential Monophase
mode. The parameter set screen will be displayed.

Through the

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Settings : 20 uS to 2000 uS ( steps of 10 uS )

Settings : 1 mS to 100 mS (in steps of 1 mS)

o
o
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Use the key of the channel to set the intensity.

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and

keys, set the parameters:

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Settings : 20 uS to 2000 uS ( steps of 10 uS )

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NEUROMED 4084 - CDB

o
o

NEUROMED 4084 - CDB

Settings : 1 mS to 100 mS (in steps of 1 mS)

Settings : + V , + P or Automatic ( AUTO )


After setting the parameters, connect the electrode cable in output
1, 2 or both, to the electrodes in the patient. Press the key

, the output settings of channels will be enabled.


o

2.3.

Use the key of the channel to set the intensity.

Settings : + V , + P or Automatic ( AUTO )


After setting the parameters, connect the electrode cable in output
1, 2 or both, to the electrodes in the patient. Press the key
, the output settings of channels will be enabled.

2.4.

Ultra Exciting (UE)

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Use the key of the channel to set the intensity.

Direct

Select the Ultra Exciting Monophase mode

Select the Direct Monophase mode.

Press the
key to enable the Ultra Exciting Monophase
mode. The parameter set screen will be displayed.

Press the
key to enable the Direct Monophase mode.
The parameter set screen will be displayed.

Through the

Through the

and

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keys, set the parameters:

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and

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keys, set the parameters:

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NEUROMED 4084 - CDB

o
o

NEUROMED 4084 - CDB

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Settings : + V , + P or Automatic ( AUTO )


After setting the parameters, connect the electrode cable in output
1, 2 or both, to the electrodes in the patient. Press the key

, the output settings of channels will be enabled.


o

2.5.

Settings : + V , + P or Automatic ( AUTO )


After setting the parameters, connect the electrode cable in output
1, 2 or both, to the electrodes in the patient. Press the key
, the output settings of channels will be enabled.

Use the key of the channel to set the intensity.

Use the key of the channel to set the intensity.

Interrupted
3.

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Microcurrents

Select the Interrupted Monophase mode.

Press the
key to enable the Interrupted Monophase
mode. The parameter set screen will be displayed.

Through the

and

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Select the Microcurrents mode.

Press the
key to enable the Microcurrents mode. The
parameter set screen will be displayed.

Through the

keys, set the parameters:

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and

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keys, set the parameters:

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NEUROMED 4084 - CDB

NEUROMED 4084 - CDB


4.

Protocols

Settings : 1 minute to 60 minutes, in steps of 1 minute.

Attention
Before applying the treatment protocols, the operator must be informed of
the content of this manual as well as operation of this equipment and all
aspects related to the patient's treatment.

Settings : 1 Hz to 200 Hz ( in steps of 1 Hz )

Liability Limitations
o
o

Settings : + V , + P or Automatic ( AUTO )


After setting the parameters, connect the electrode cable in output
1, 2 or both, to the electrodes in the patient. Press the key
, the output settings of channels will be enabled.

Use the key of the channel to set the intensity.

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Under no circumstance will Carci Ind. e Com., or its suppliers and/or


dealers, be held liable for any indirect, special, incidental damage caused
by use or inability to use the product, including, without being limited to
damages due to loss, or every and any other damage or commercial loss,
and regardless of the legal or equal theory (contract, complaint or other
mode) on which the claim is based.
Carci shall not be held liable for any consequence resulting from
inaccurate information provided by its personnel, or errors included in this
manual and/or other adjunct documentation (including commercial
documentation).
o

In the main screen,

select the option PROTOCOLS, through the keys

o
o

Press the Key


The display shows the screen :

o
o

Use the
User

keys to select the mode desired.

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Contraindications:
Absence of sensitivity;
Presence of metal plates in the patient;
Pacemaker;
Spastic excitation in cerebral spastic paresis;
Electroporation.

Erase

Record

MicroCurrents
Indications:

Use the

keys to change the cursor to the right; and

to select or delete the protocol.

o Press the key

to confirm.

Indications & Contraindications


Polarized Currents
Indications:
Traumatisms, arthropathies, myalgias
Muscular Paresis
Edemas (due to vasomotor effect)
Arthritis
Hydrate and soften sites with progression of fibrosis.
Cutaneous diseases
Neuralgias

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Acute and chronic pain


Inflammation - edema
Synovitis
Musculoskeletal dysfunctions
Premenstrual syndrome
Sports lesions luxations, stretches and contusions
Arthritic conditions - Osteoarthritis (OA)
Lumbosciatalgia
Temporo-mandibular dysfunctions (TMDs)
Fibromyalgia (FMS)
Plantar fascitis
Tennis elbow
Carpal tunnel syndrome (CTS)
Fractures Bone calcification
Cicatrization of wounds ischemic ulcers

Contraindications:
In painful syndromes where the etiology is not established:
Pregnancy
Pacemaker users
Directly on infected wounds
On malignant or benign tumors
On the ocular globe
On the carotid
Osteomyelitis
On the laryngeal musculature
In the presence of topical substances containing metallic ions

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NEUROMED 4084 - CDB


Electrode Application
Attention:
The connection of accessories not specified by the manufacturer can
affect the patient and correct operation of the equipment, which is not
allowed.

Before the Treatment:

NEUROMED 4084 - CDB


According to Brazilian Standard NBR IEC 60601-2-10, the maximum
2
current density allowed is 2 mA RMS per cm .
The NEUROMED 4084 output is limited to 50 mA RMS, with charge of
500 Ohms.
To check if the current density did not exceed the maximum allowed,
divide the output current in mA by the effective area of the electrode in
2
cm

Electrode connection and disconnection reactions

Check if the patient fits any other contraindication.


Heat sensitivity test of the area to be treated.
Clean the area to be treated with aqueous solution with neutral
soap.

Conductive Rubber (Silicone) Electrode


The use of conductive rubber (silicone) electrode is recommended, in
combination with wet sponge. The use of gel or duly wet sponges
assures low impedance between the skin and the NEUROMED 4084
stimulator. The electrodes and sponges can easily be cleaned after
treatment.
To fix the electrodes with gel, or wet sponges, with the patient's skin,
sticky tape of medical use or rubber band can be used.

Electrolytic Effect
Electrolysis occurs under the electrodes, when the types of currents with
DC component are applied.
NEUROMED 4084 has DC component.
In the electrolytic effect, due to the high concentration of electrolytes
caused by the migration of ions occurring under the electrodes, we
recommend that the sponges be duly wet in order to have minimal
electrolytic effect.

NEUROMED has Constant Current in the current output, which can cause
unpleasant reactions if the electrodes are not correctly coupled to the
skin, or if there is loss of contact with the skin.
Ensure that the output is marking 0 (zero) mA when placing or removing
the electrodes.

Preventive
cleaning

maintenance,

preservation

We recommend that the NEUROMED be inspected and


calibrated once a year

Always ensure that the device is disconnected from the power


supply before cleaning. Avoid wetting the electric contacts of the wires
and connectors

Use a cloth wet with water and soap to clean the cabinet of your
device

Regularly control the power supply and power cable, assuring


that there are no defects.

On disconnecting the power cable from the device, always


remove it from the plug, thus preventing the wire from breaking

Always remove the electrodes from the patient with care so as


not to damage them.

Regularly inspect the cables of the electrodes, checking if there is


no breakage of the cable with the plugs.

Current Density

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and

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NEUROMED 4084 - CDB




NEUROMED 4084 - CDB


Check if there is short circuit in
the electrode cable plug
Contact technical assistance,

Special cares for silicone electrodes

Cares for longer lasting electrodes:


When using silicone electrodes, always clean the contacts
of the plugs, preventing residues that render electric contact difficult.
After using the silicone electrodes, wash them with running water and
dry them, keeping in a fresh and dry place.

Corrective maintenance
Problems
Equipment does not come on

Solutions
Check if the power cable is
connected to the power network
Check if the fuse(s) is(are) not
burnt

Patient reports that the sensation Change the electrodes


of the stimulus is greater in one (silicone or adherent) because
electrode than in the other
they have become worn out
Check the patient's sensitivity
The intensity is increased to the Change the electrodes (silicone
maximum and the patient reports or adherent)
little stimulation
On increasing the intensity, after
10 mA, the intensity is zeroed,
and the letter m is displayed on
the right side of the intensity

On increasing the intensity, it is


zeroed, and the letter
M is
displayed on the right side of the
intensity. This means that there
was excess current
MU_4084_English_Version: 1.0.0

Press the Start key and start the


treatment again.
Check continuity of the electrode
cable
Check
conductivity
of
the
electrodes
Press the Start key and start the
treatment again.
Check
conductivity
of
the
electrodes.

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35

Check
the
coupling
and
Device comes on normally but continuity of the electrode cables with
the
patient
reports
non- the patient
stimulation
Check
conductivity
of
the
electrodes
Important notes:
Corrective maintenance of this equipment, in addition to the prescriptions
above, must be conducted by the CARCI authorized technical assistance
only.
Electric diagrams, circuits and parts lists are not supplied to end
consumers. If needed, contact the Carci Authorized Technical Assistance.

Technical characteristics
Origin
Models
Function and Application
Power supply

: CARCI Brazil
: NEUROMED 4084 CDB
: Equipment for Electrotherapy
: 100230 V~ automatic ( 10%)
: 50 / 60 Hz
Maximum Consumption
: 100 VA
ANVISA [National Health Surveillance Agency]
Registration
: 10314290035
------------------------------------------------------------------------------------------------ Classification according to the standards NBR IEC 60601.1 and
NBR IEC 60601.2.10:
- Type of protection against electric shock:...............................
class II
- Level of protection against electric shock of the part applied:
type BF
- Level of protection against harmful water penetration:
IPX0
- Disinfection methods :
see preventive maintenance
- Level of application safety in the presence of an anesthetic mixture
inflammable with air, oxygen or nitrous oxide: not suitable
- Mode of operation:
continuous
-------------------------------------------------------------------------------------------------MU_4084_English_Version: 1.0.0

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NEUROMED 4084 - CDB

Fuse
: 1,0 A 250 V 20 AG
Dimensions
: 31 x 6 x 18 (LxHxD) (cm)
Weight
: 2.6 kg
Excess current protection
Continuous component of current equal to Zero

Neuromed Output Parameters:


Output channels :
Output characteristics :
Current Amplitude Range :
Current Amplitude Resolution :
Maximum Amplitude ( Ipp) :
Timer :

2 channels
Constant Current
Depends on the waveform
1 mA
70 mA (charge of 500 Ohms)
0 - 60 minutes

Diadynamic Currents
Modes
Amplitude
Polarity

: DF, MF, SP, LP and iDSP


: 0 to 70 mA
: Positive, Negative or Automatic.

: 1 100 ms ( steps of 1 mS )
: Positive, Negative or Automatic.
: 0 to 40 mA

Trbert Ultra Exciting


Phase Duration
Phase Interval
Polarity
Amplitude

: 2 mS
: 5 mS
: Positive, Negative or Automatic.
: 0 to 40 mA

Microcurrents
Frequency
Polarity
Amplitude

: 1 Hz to 200 Hz ( steps of 1 Hz )
: Positive, Negative or Automatic.
: 0 to 40 mA

Room temperature
Relative humidity
Atmospheric pressure

: +10C to +40C
: 0% to 80%
: 700 hPa to 1060hPa

Environmental conditions for transport and storage:

: 8000 Hz
: 95%
: Positive, Negative or Automatic.
: 0 to 40 mA

Direct Galvanic
Polarity
Amplitude

: Positive, Negative or Automatic.


: 0 to 40 mA

Square Monophase
Phase Duration
Phase Interval
Polarity
Amplitude

: 0.05 to 2000 uS ( steps of 10 uS )


: 1 100 ms ( steps of 1 mS )
: Positive, Negative or Automatic.
: 0 to 40 mA

Exponential Monophase
Phase Duration

: 0.05 to 2000 uS ( steps of 10 uS )

MU_4084_English_Version: 1.0.0

Phase Interval
Polarity
Amplitude

Equipment working conditions:

Monophase
Interrupted Galvanic :
Frequency
Work Cycle
Polarity
Amplitude

NEUROMED 4084 - CDB

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37

Room temperature
Relative humidity
Atmospheric pressure

: -10C to 60 C
: 20% to 90%
: 500hPa to 1060hPa

Optional Accessories:

Conductive rubber (Silicone) electrodes


Sponges pad
Electrode cables
Yellow
Green
Three-pole cable
User manual

Code 04033
Code 21305G
Code 21306G
Code 14747G
Code 10395G

Note: In case of accessory replacement, only use those indicated by


CARCI. The use of accessories not specified by CARCI can compromise
equipment safety. CARCI will not be held liable for such procedure.
MU_4084_English_Version: 1.0.0

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NEUROMED 4084 - CDB

NEUROMED 4084 - CDB


MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC IMMUNITY

Terminologies and Definitions:


For purposes of the standard NBR IEC 60601-1:1994 + amendment
1997, the following conditions apply, used in the Manufacturer
Declarations & Orientations :

NEUROMED is intended to be used in the electromagnetic environment specified below.


The buyer and operator of NEUROMED would assure that it is being used in such
environment.

- Meaning given to the verbal forms should and may

Immunity tests

should means that compliance with the requirement or test in


question is mandatory in order to comply with the Standard.

would means that compliance with the requirement or test in


question is strongly recommended, but not mandatory in order to
comply with the Standard.

may means that compliance with the requirement or test in


question is only a particular way of obtaining compliance with the
Standard.

MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC EMISSIONS


NEUROMED is intended to be used in the electromagnetic environment described below.
The buyer and operator of NEUROMED would assure that it is being used in such
environment.
Emission tests

Compliance

RF Emission
CISPR 11

Group 1

RF Emission
CISPR 11

Class B

Harmonics emission
IEC 61000-3-2

Class A

Voltage fluctuation /
Flicker emission
IEC 61000-3-3

Compliant

MU_4084_English_Version: 1.0.0

Electromagnetic environment - orientation


NEUROMED uses RF energy for its internal
operation only. Thus, its RF emission is very
low and not likely to cause any interference in
another nearby electronic equipment.

Electrostatic
discharge
IEC 61000-4-2

Immunity tests

Test level of IEC


60601

6 kV contact
8 kV air

Test level of IEC


60601

Fast transients /
Bursts
IEC 61000-4-4

2 kV power
supply line
1 kV signal
input and output
line

Surge
IEC 61000-4-5

1 kV
differential mode
2 kV ordinary
mode

Level of
compliance

Electromagnetic
environment - orientation

6 kV contact
8 kV air

The floor must be made of


wood, concrete or ceramic. If
the floor is covered with
synthetic
material,
the
relative humidity of the air
must be at least 30%.

Level of
compliance

Electromagnetic
environment - orientation

2 kV power
supply line
Not applicable
1 kV
differential
mode
2 kV ordinary
mode

The quality of the power


network would be that of a
typical
hospital
or
commercial environment.

NEUROMED is intended to be used in all


establishments, including homes and those
connected directly to the public power network
that supplies power to constructions with
domestic purposes.

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39

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NEUROMED 4084 - CDB

Voltage dips,
short
interruptions and
voltage
variations in the
power supply.
IEC 61000-4-11

Magnetic fields
of the network
frequencies
(50/60 Hz)
IEC 61000-4-8

<5% Ut
(>95% dip in Ut)
For 0.5 cycle

<5% Ut
(>95% dip in
Ut)
For 0.5 cycle

40% Ut
(60% dip in Ut)
For 5 cycles

40% Ut
(60% dip in Ut)
For 5 cycles

70% Ut
(30% dip in Ut)
For 25 cycles

70% Ut
(30% dip in Ut)
For 25 cycles

<5% Ut
(>95% dip in Ut)
For 5 s

<5% Ut
(>95% dip in
Ut)
For 5 s

3 A/m

d = 2. 3. P

Note: Ut is the voltage of the AC network before applying the test level.
MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC IMMUNITY
NEUROMED is intended to be used in the electromagnetic environment specified below.
The buyer and operator of NEUROMED would assure that it is being used in such
environment.
Immunity
Test level of
Level of
Electromagnetic environment tests
IEC 60601
compliance
orientation

Conducted
RF
IEC 610004-6

3 Vrms
150 kHz to 80
MHz

Radiated RF
IEC 610004-3

3 V/m
80 MHz to 2.5
GHz

3V

800 MHz to 2.5 GHz

Where P is the maximum output power of


the transmitter in watts (W), according to
the transmitter manufacturer, and d is the
recommended separation distance in meters
(m).
The field generated by fixed RF
transmitters, as determined by an
electromagnetic field study in the sitea,
would be lower than the level of
compliance in each frequency range. b
There may be interference in the equipment
surroundings with the following symbol:

The magnetic fields of the


network frequencies would
be characteristic levels of a
typical
commercial
or
hospital environment.

3 A/m

NEUROMED 4084 - CDB

NOTE 1: in the range of 80 MHz and 800 MHz, the highest frequency of the range is
applied.
NOTE 2: this procedure cannot be applied in all situations. The electromagnetic
propagation is affected by absorption and reflection of structures, objects and people.
a. The intensity of the fields generated by fixed transmitters, such as cell sites for
telephones (mobile/wireless) and land mobile radios, amateur radios, AM, FM and
TV radio broadcasting stations cannot be theoretically prognosed with precision. To
evaluate the electromagnetic environment due to the fixed RF transmitters, a study of
the electromagnetic field in the site would be considered. If the field intensity
measured in the site where NEUROMED is used exceeds the level of compliance
above, the NEUROMED would be observed to verify if it is operating normally. If
abnormal performance is observed, additional measures may be required,, such as
reorientation or reallocation of the NEUROMED;
b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be less
than 3 V/m.

Portable and mobile RF communication


equipment would not be used closer to any
part of the NEUROMED, including
cables, other than the separation distance
recommended, calculated from the equation
applicable for the transmitter frequency.
Recommended separation distance

d = 1.17. P
3 V/m

MU_4084_English_Version: 1.0.0

d = 1.17. P

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80 MHz to 800 MHz

41

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NEUROMED 4084 - CDB

Separation distances recommended between portable and mobile RF communication


equipment and NEUROMED
NEUROMED is intended for use in an electromagnetic environment in which RF
disorders are controlled. The buyer or operator of the NEUROMED may help prevent
electromagnetic interference by keeping a minimum distance between portable and mobile
RF communication equipment (transmitters) and NEUROMED as recommended below,
according to the maximum output power of the communication equipment.
Separation distance according to the transmitter frequency
Declared maximum
150 kHz to 80
80 MHz to 800
800 MHz to 2.5
output power of the
MHz
MHz
GHz
transmitter (W)

d = 1.17 P

d = 1.17 P

d = 2.3 P

0,01
11.70 cm
11.7 0cm
23.00 cm
0,1
37.00 cm
37.00 cm
72.70 cm
1
1.17 m
1.17 m
2.30 m
10
3.70 m
3.70 m
7.27 m
100
11.70 m
11.70 m
23.00 m
For transmitters with declared maximum output power not listed above, the recommended
separation distance (d in meters) may be determined using the equation applicable to the
transmitter frequency; where P is the maximum output power of the transmitter in watts
(W) according to its manufacturer.
NOTE 1: at 80 MHz and 800 MHz, the separation distance for the highest frequency is
applied.
NOTE 2: this procedure may be applied in all situations. The electromagnetic propagation
is affected by absorption and reflection of structures, objects and people.

NEUROMED 4084 - CDB


Manufacturer Data
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CGC [Corporate Taxpayer's Roll]: 61.461.034/0001-78
I.E. [State Tax ID] : 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP [zip code]
04338-000
Phone: (11) 3346 2100
Fax.: (11) 3270 8027
email: carci@carci.com.br
website : www.carci.com.br
Carci Registration at the Ministry of Health : MS-1.03.142-9
For Technical Assistance :
Technical Assistance Department
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP [zip code]
04338-000
Phone: (0XX11) 5621 7024
email: sat@carci.com.br
Technical Responsible:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

European Representative
OBELIS SA
34, Av. de Tervuren, bte 44
B 1040 Brussels , BELGIUM
Phone: (32) 2.732.59.54
Fax: (32) 2.732.60.03

Final considerations
It has been Carci's policy to continuously improve the quality of its
products. Carci reserves the right to make changes in the design and
specifications, as well as to add and improve its products, without being
obliged to install them in already manufactured products.
The text, illustrations and specifications contained in this manual are
based on information available during the printing.
All rights reserved.

Email: mail@obelis.net
WARRANTY CERTIFICATE IN ANNEX

This manual cannot be reproduced in whole or in part without the written


consent of Carci.

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NEUROMED 4084 - CDB


Bibliographical references
Low, Medium and Polarized Currents
1. Frampton, VM (1994) Transcutaneous electrical nerve stimulation
and Chronic Pain, in Wells, PE, Frampton, VM, Bowsher, D (eds)
Pain Management by Physiotherapy. Butterworth Heinemann,
London.
2. Johnson, MI, Ashton, CH, Thompson, JW (1991a) An indepth
study of long term users of transcutaneous electrical nerve
stimulation (TENS). Implications for clinical use of TENS Pain
44: 221- 229.
3. Johnson, MI, Ashton, CH, Thompson, JW (1991b) The
consistency of pulse frequencies and pulse patterns of
transcutaneous electrical nerve stimulation (TENS) used by
chronic pain patients. Pain 44: 231- 234.
4. Tulgar, M, McGlone, F, Bowsher, D, Miles, JB (1991)
Comparative effectiveness of different stimulation modes in
relieving pain. Part I A Pilot Study. Pain 47: 151 155.
5. Alberts, P.D., Bakker, M., Spierversterking door Middel van
Middenfrequente Wisselstromen. Nederlands Tijdschrift foor
Fysiotherapie 10:318 et seq. 1977.
6. Bernards, J.A., Bouman, L.N., Fysiologie van de Mens. Bohn,
Scheltema en Holkema, Utrecht, 5e herziene druk, 1988.
7. Bernard, Pierre D., La therapie Diadynamique Paris, Editions
"PHYSIO", 1962.
8. Besson, J.M., Chaouch, A., Peripheral and Spinal Mechanisms of
Nociception. Physiological Reviews 67, 1. January 1987.
9. Carley, P., Wainapel, S., Electrotherapy for Acceleration of
Wound Healing; Low Intensity Direct Current. Arch. Phys. Med.
Rehab., 66, pp 443-446. 1985.
10. Hogenkamp, M., Mittelmeijer, E., Smits, I., Stralen, C. Van,
Interferential Therapy. B.V. Enraf-Nonius Delft, Holland, May
1990.
11. Hoogland, R., Strengthening and Stretching of Muscles using
Electrical Current. B.V. Enraf-Nonius Delft, Holland, December
1988.
12. Howson, D.C., Peripheral Nerve Excitability, Implications for
Transcutaneous Electrical Nerve Stimulation. Physical Therapy,
Vol. 58, 12, December 1978.
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NEUROMED 4084 - CDB


13. Janda, V., Muskelfunktionsdiagnostik, Muskeltest Untersuchung
Verkrzter Muskeln, Untersuchung der Hypermobilitt. Verlag
Acco, Leuven, Belgi, 1979.
14. Johnson, M.A., a.o., Data on Distribution of Fibre Types in thirtysix Human Muscles. An Autopsy Study. Journal of Neurological
Science, 18, pp. 111-129.
15. Kaada, B., Vasodilation induced by Transcutaneous Nerve
Stimulation in Peripheral Ischemia. European Heart Journal, 3, pp
303-314, 1982.
16. Khan, J., Use of Iontophoresis in Peyronies Disease. Physical
Therapy, 7, July 1982.
17. Kloth, L.C., Feedar, J.A., Acceleration of Wound Healing with
High Voltage, Monophasic, Pulsed Current. Physical Therapy, 68,
pp 503-508, 1988.
18. Kots, Y.M., Lectures and Laboratory Periods. Symposium on
Electrostimulation of Skeletal Muscles. Concordia University,
Montreal/Quebec, Canada, December 6th-15th, 1977.
19. Kovanen, V., Suominen, H., Heillinen, E., Collagen of Slow Twitch
and Fast Twitch Muscle Fibres in Different Types of Rat Skeletal
Muscle. Eur. J. Appl. Physiol., 52, pp 235-242, 1984.
20. Kuo, K.H.M., Clamann, H., Coactivation of Synergistic Muscles of
Different Fibre types in Fast and Slow Contractions. American
Journal of Physical Medicine, vol.60, 5, pp 219-238, 1981.
21. Kousemaeker, E.A.M., Aarts, N.J.M., Duy, A. Van der, De
Behandeling van Slecht Genezende Wonden met Behulp
Xanthinolnicotinaat. Nederlands Tijdschrift voor Fysiotherapie, 6,
pp 174-178, 1974.
22. Levine, J.D., Codere, T.J., Basbaum, A.I., Proceedings of the Vth
World Congress on Pain. Elsevier Science Publishers B.V.
(Biomedical Division), 1988.
23. Lullies, H., Trincker, D., Taschenbuch der Physiologie II, Gustv
Fischer Verlag, Stuttgart, 2e druk, 1973.
24. Lullies, H., Elektrophysiologische voraussetzungen der
Elektrodiagnostik and Elektrotherapie. Elektromedizin. Band 6, 2,
1961.
25. Lundeberg, T., Kjartansson, J., Samuelsson, J., Effect of
Electrical Nerve Stimulation on Healing of Ischaemic Skin Flaps.
The lancet, pp 712-714, September 1988.
26. Melzack, R., Wall, P.D., Pain Mechanisms: A New Theory.
Science 150, pp 971-979, November 1965.

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NEUROMED 4084 - CDB


27. Niele, R., Treatment Protocol for the Endomed CV 405. B.V.
Enraf-Nonius Delft, Holland, November 1988.
28. Ottoson, D., Lundeberg, T., Pain Treatment: A Practical Manual
by Transcutaneous Electrical Nerve Stimulation. Springer Verlag.
Berlin, 1988.
29. Pouliart, C., De Elektrische Weerstand van de Huid. Belgisch
Tijdschrift voor Reumatologie en Fysische Geneeskunde, Vol 29,
Fasc. 2, pp 64-79, 1974.
30. Pronk, N., Het Twee (Vier) Cellenbad by de Behandeling van
Hyperhydrosis Palmoplantaris. Nederlands Tijdschrift voor
Fysiotherapie, Vol 96, 6, pp 120-121, 1986.
31. Sato, A., Schmidt, R.F., Somatosympathetic Reflexes: Afferent
Fibres, Central Pathways, Discharge Characteristics.
Physiological Reviews, Vol, 53, 4, pp 916-947, October 1973.
32. Sjlund, B.H., Eriksson, M.B.E., Endorphins and Analgesia
Produced by Peripheral Conditioning Stimulation. Advances in
Pain Research and Therapy, vol 3, 1979.
33. Steuernagel, O., Skripten zur Elektrotherapie, Band II.
Heidelberger Reprographie A. Grosch KG, Eppelheim b.
Heidelberg, 1978.
34. Stralen, C.J.C. van, Transcutane elektrische prikkeling bij
Claudicatio Intermittens. Nederlands Tijdschrift voor
Fysiotherapie, Vol. 94, nr. 11, blz. 226, 1984.
35. Wheeler, P.C., Wolcott, L.E., Morris, J.L, Spangler, M.R., Neural
Considerations in the Healing of Ulcerated Tissue by Clinical
Electrotherapeutic Application of Weak Direct Current. Findings
and Theory. Neuro-Electric Reasearch, 1970.
36. Wolcot, L.E., Gault, W.R., Gatens, P., Acceleration of Healing
Rate in Ischaemic Skin Ulcers with Low Intensity Direct Current
(LIDC). Lecture on June 14th, Las Vegas, 1972.
37. Wolf, S.L., Perspectives on Central Nervous System
Responsiveness to Transcutaneous Electrical Nerve Stimulation.
Physical Therapy, Vol, 58, 12, December 1978.
38. Yaksh, T.L. Substance-P Release from Knee Joint Afferent
Terminals: Modulation by Opiods. Brain Research, 458, 319-324,
1988.
39. Zimmermann, M., Pain Mechanisms and Mediators in
Osteoarthritis. Seminars in Arthritis and Rheumatism, vol 18m 4,
suppl. 2, pp 22-29, 1989.
40. Zutphen, H.C.F. van, Stralen, C.J.C. van, Pls, P., Bernards, J.A.,
Kolle, L.F.J.Th.M., Rens, P.P.Th.G. van, Nederlands Leerboek
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der Fysische Therape in Engere Zin, Wetenschappelijke
Uitgeverij bunge, 3e druk, 1986.

Microcurrents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

Micro-Current Therapy Ushers In A New Era. PA: ICN.Publications,


1989.
Kirsch, D., and Lerner, F. Electromedicine: the other side of
physiology. FA: St. Lucie Press, 1998.
Mylon-Tech Research Results. http://www.mylontech.ca
Wing, T. 1989. Modern low voltage microcurrent stimulation: A
comprehensive overview. Chiropractic Economics. 37: 265-271.
Cheng, N., Van Hoff, H., and Bockx, E. 1982. The effect of electric
currents on ATP generation protein synthesis, and membrane
transport in rat skin. Clin. Orthop. 171: 264-272.
Becker, R. The Body Electric. NY: William Morrow and Co, Inc.,
1985.
Delitto, A., Strube, M., and Shulman, A. 1992. A study of discomfort
with electrical stimulation. Physical Therapy. 72: 410-424.
Bauer, W. 1983. Electrical treatment of severe head and neck
cancer pain. Arch Otolaryngol. 109: 382- 383.
Kirsch, D., and Lerner, F. Electromedicine: the other side of
physiology. FA: St. Lucie Press, 1998.
Becker, R. 1995. The basis for microcurrent electrical therapy in
conventional medical practice. Journal of Advancement in
Medicine. 8 (2).

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