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NEUROMED 4082 IFC

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Presentation

Presentation
Accessories that come with the product
Symbols
Warnings / Attention
Installation / Connection to the power network
General information
Interferential Current
Display Language
Controls & Control Functions
Operation
Operation Mode : Two pole Interferential
Operation Mode : Manual Vector Interferencial
Operation Mode : Automatic Vectos Interferential
Operation Mode : Isoplanar Interferential
Protocols
Indications & Contraindications
Electrode Application
Preventive maintenance, preservation and cleaning
Corrective maintenance
Technical Characteristics
Manufacturer declaration and orientation
Considerations
European Representative
Bibliographical reference

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NEUROMED 4082 IFC

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 4082 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
1
2
1
1

Conductive rubber (Silicone) electrodes


Gel Tube
Cables for electrode
Three-pole cable
User manual

To purchase optional accessories, consult the codes on page 31,


'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

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NEUROMED 4082 IFC

NEUROMED 4082 IFC


Symbols on the packaging

Symbols
Symbols on the equipment

Fragile. Handle with care


Means equipment off
Keep in a dry place

Means equipment on
This symbol shows that the equipment
causes physiological effects and that the
user must check the instruction manual
before using it.
Applied part type BF

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.
Minimum and maximum temperature limits
for transport and storage.

Class II Equipment

Manufacturer Identification

ATTENTION / WARNINGS

Product Manufacturing Date

Product Serial Number


European Representative
CE Mark and identification of the notifying
body

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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 4082 IFC


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 4082 IFC

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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NEUROMED 4082 IFC


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.

The NEUROMED 4082 is a functional neuromuscular electrostimulator,


Microcontrolled with the functions :

Interferential Current





Two-pole,
Manual Vector,
Automatic and
Isoplanar.

Interferential Current

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

General Information

 Other Countries :

NEUROMED 4082 IFC

Interferential Current is a form of medium-frequency wave, distributed


through two channels (four electrodes), where the currents cross
themselves in the body, in the area that needs treatment. The two
currents have interference between them at the crossing point, causing
intensity modulation
(the current intensity increases and reduces at a regular frequency).
In the interferential current, a carrier frequency of the medium
frequency is used to pass the low frequency stimulation (beat) through the
skin. The relatively low resistance of the skin to the carrier frequency
contributes toward the patient's comfort and is oftentimes associated with
this type of stimulation. Interferential Currents are all AC currents without
any DC residual component.

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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1 beat frequency cycle

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NEUROMED 4082 IFC


the isoplanar vector mode is mild and equally divided over the
treatment area.

Vector Interferential
In this method of therapy, four electrodes are used, and two modulated
currents are generated for each electrode pair (two channels). The
frequency of a channel is set in the carrier frequency, while the other
channel has a variable frequency, based on the beat frequency and
frequency modulation configurations. The Interference occurs when the
two currents cross in the tissue. The depth of modulation (which
determines the amplitude of the stimulation current) depends on the
direction of the currents, and can vary from 0 to 100%. The 100%
modulation occurs only in the diagonal (and therefore, in the intersection)
of both currents. It is obviously a theoretical situation, based on the
presupposition that the tissue is homogeneous. In reality, the tissue is
heterogeneous, such that the balance between both channels must be
used to obtain the 100-% modulation depth (Fig. 1).

Isoplanar Vector Model


Two-pole Interferential.
With the dipole vector technique, the currents of the two electrode pairs
are summed vectorially in the tissue. The effect is that stimulation
occurs only in direction of the resulting vector, which can be adjusted at
an interval of 360. Amplitude modulation occurs in the equipment and
the modulation depth is 100%.
Stimulation with 100% modulation occurs only in direction of the vector.
The advantage of this method is that the direction of stimulation can be
adjusted electronically after positioning the electrodes.
Automatic vector dipole
With the automatic vector dipole technique described above, it is turned
at an adjustable speed. If the increase in the current amplitude is
greater than the motor threshold, the tissue will contract and relax
rhythmically. The current automatic dipole vector is ideal for areas
where the mechanical pressure of massage is not desirable.

Figure 1
Isoplanar
The isoplanar vector technique is intended to increase the area where
effective stimulation occurs. Amplitude modulation occurs in the
equipment and a special phase relation between both channels
guarantees a 100% modulation depth between the four electrodes in all
the positions. Modulation depth is 100% over the complete treatment
area.
The advantage of this method is that positioning of the four electrodes
to effectively treat the affected tissue is less critical. The sensation of
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NEUROMED 4082 IFC


Display language

NEUROMED 4082 IFC


Controls

NEUROMED 4082 allows accessing three display languages:


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

Connect the power cable of the NEUROMED 4082 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.

Control functions
Moves to
next field

Decrease

Increase

Moves to
previous
field

Control of intensity of channels 1 and 2.


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NEUROMED 4082 IFC

Figure : 1

NEUROMED 4082 IFC

Figure : 2

E na b les t h e f u nc t io n c hos e n

Use the

keys to select the current types.

1. Interferential :

E na b les t h e m a in m enu s c r ee n

Use the
a nd
keys to enable selection of the
interferential modes : Two-pole, Manual Vector, Automatic Vector or
Isoplanar Vector

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

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.

o Select the Two-pole Interferential mode.

The display will show the Initial Screen:


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1.1. Two-pole Interferential

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NEUROMED 4082 IFC

NEUROMED 4082 IFC

Press the
key to enable the Two-pole Interferential
mode. The Two-pole mode set screen will be displayed.

key
be enabled.

, the output settings of channels 1 and 2 will

o Use the keys of the channels to set the intensity.

1.2. Manual Vector Interferential


o
o

o
o

Through the

and

keys, set the parameters:

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

Select the Manual Vector Interferential mode

o Press the
key to enable the Manual Vector
Interferential mode. The Manual Vector mode set screen will
be displayed.

Carrier Frequency

Settings : 2 KHz, 4 KHz, 6 KHz, 8 KHz & 10 KHz.


Frequency Modulation

o
Settings : 10 Hz to 150 Hz ( steps of 10 Hz )
Frequency Variation

o
Settings : 10 Hz to 100 Hz ( steps of 10 Hz )

Settings : Rise/fall : 0 s to 9 s (steps of 1 s)


Sustaining/Rest : 1 s to 30 s (steps of 1 s)
o

After setting the parameters, connect the electrode cables in


channels 1 and 2 to the electrodes in the patient. Press the

Through the
parameters:

and

keys, set the

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

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NEUROMED 4082 IFC


Carrier Frequency

o Press the
key to enable the Automatic Vector
Interferential mode. The Automatic Vector mode set screen
will be displayed.

Settings : 2 KHz, 4 KHz, 6 KHz, 8 KHz & 10 KHz.

NEUROMED 4082 IFC

Frequency Modulation

Settings : 10 Hz to 150 Hz ( steps of 10 Hz )

Frequency Variation

Settings : 10 Hz to 100 Hz ( steps of 10 Hz )

Settings : Rise/fall : 0 s to 9 s (steps of 1 s)


Sustaining/Rest : 1 s to 30 s (steps of 1 s)
o

After setting the parameters, connect the electrode cables in


channels 1 and 2 to the electrodes in the patient. Press the

key
be enabled.

, the output settings of channels 1 and 2 will

o Use the keys of the channels to set the intensity.

Through the
parameters:

and

keys, set the

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

Carrier Frequency

Settings : 2 KHz, 4 KHz, 6 KHz, 8 KHz & 10 KHz.

o Use the
keys to move the
to the desired position.

Settings : 10 Hz to 150 Hz ( steps of 10 Hz )

1.3. Automatic Vector Interferential


o

Frequency Modulation

Frequency Variation

Settings : 10 Hz to 100 Hz ( steps of 10 Hz )

Select the Automatic Vector Interferential mode

Speed

Set : 1 s to 15 s (steps of 1 s)

o
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NEUROMED 4082 IFC

NEUROMED 4082 IFC

Settings : Rise/fall : 0 s to 9 s (steps of 1 s)


Sustaining/Rest : 1 s to 30 s (steps of 1 s)
o
o

Through the

keys, set the parameters:

After setting the parameters, connect the electrode cables in


channels 1 and 2 to the electrodes in the patient. Press the

and

key
, the output settings of channels 1 and 2 will
be enabled.
The time selected will decrease.
Use the keys of the channels to set the intensity.

o
o
o

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


Carrier Frequency

Settings : 2 KHz, 4 KHz, 6 KHz, 8 KHz & 10 KHz.


Frequency Modulation

Settings : 10 Hz to 150 Hz ( steps of 10 Hz )


Frequency Variation

Settings : 10 Hz to 100 Hz ( steps of 10 Hz )


Speed

o
o

The
selected.

will move according to the speed

o
o

1.4. Isoplanar Interferential


o

Set : 1 s to 15 s (steps of 1 s)
Settings : Rise/fall : 0 s to 9 s (steps of 1 s)
Sustaining/Rest : 1 s to 30 s (steps of 1 s)
After setting the parameters, connect the electrode cables in
channels 1 and 2 to the electrodes in the patient. Press the key

Select the Isoplanar Interferential mode


enabled.

Press the
key to enable the Isoplanar Interferential
mode. The Isoplanar mode set screen will be displayed.

o Use the keys of the channels to set the intensity.

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, the output settings of channels 1 and 2 will be

The

will move according to the speed selected.

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NEUROMED 4082 IFC


2.

NEUROMED 4082 IFC

Protocols

o Select the option PROTOCOLS, through the keys


position the cursor in the option SELECT, press the key

Attention
o

The display will show the screen:

Use the

Use the

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.

Liability Limitations
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).

2.1

o Press the key

In the main screen,

2.2

21

to confirm.

Save Protocol
o

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keys to change the cursor to the right; and

to select or delete the protocol.

Select Protocol
o

keys to select the desired protocol.

Example : For the therapy

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NEUROMED 4082 IFC

o
o

Press the key


The screen will be showed

NEUROMED 4082 IFC

Use the

o Press the key


o Press the key

Use the
and
select the letter to write..

Press the key

to confirm, or

Press the key

to save the protocol.

2.3

keys to change the cursor to

to erase.

In the Protocols screen:

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to confirm.
to return to the main menu..

Indications & Contraindications


Indications :
Joint Sprain
Ligament lesion
Muscular contusion
Muscular distension
Traumatic Synovitis
Tendinitis
Myalgias
Radiculopathies ( lumbosciatalgias and cervicobrachialgias )
Post-operatory of Meniscectomy.

Erase Protocol
o

keys to select the desired protocol to erase.

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NEUROMED 4082 IFC


Contraindications:
Muscular injuries, tendinitis;
Dysfunctions in acute joints (arthritis, bursitis combined with heat)
and functional lesion;
Unconsolidated fibers;
Forms of spasticity;

NEUROMED 4082 IFC


The use of self-adhesive electrodes is characterized by the ease of
contact with the skin, due to their malleability. The thin layer of adherent
gel allows low impedance between the skin and the Fesmed stimulator.
If peradventure during the application the patient informs that the stimulus
is too weak, it is a sign that the electrodes must be changed. They must
be changed if the display shows the letter M on the right side of the
intensity indicator, and the intensity marks zero.

Current Density

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.

According to Brazilian Standard NBR IEC 60601-2-10, the maximum


2
current density allowed is 2 mA RMS per cm .
The NEUROMED 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

Before the Treatment:

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 conductor gel or wet sponge. The use of gel or duly wet
sponges assures low impedance between the skin and the NEUROMED
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.

Self-Adhesive Electrode

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Electrode connection and disconnection reactions


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

and

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
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NEUROMED 4082 IFC

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.

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.
After using the adherent electrodes, carefully remove them from the
electrode cable, wet them with water and keep in their envelope, in a
fresh and dry place.

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

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

Device comes on normally but


the
patient
reports
nonstimulation

Corrective maintenance
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.

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Equipment does not come on

Check the patient's sensitivity


The intensity is increased to the Change the electrodes (silicone
maximum and the patient reports or adherent)
little stimulation

Special cares for adherent or silicone electrodes

Problems

NEUROMED 4082 IFC

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.
Check if there is short circuit in
the electrode cable plug
Contact technical assistance,
Check
the
coupling
and
continuity of the electrode cables with
the patient
Check
conductivity
of
the
electrodes

Solutions
27

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NEUROMED 4082 IFC


Technical characteristics
Origin
Models
Function and Application
Power supply

: CARCI Brazil
: NEUROMED 4082
: 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
------------------------------------------------------------------------------------------------- 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 :

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

Interferential

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NEUROMED 4082 IFC


Automatic Vector Interferential
Frequency :
Frequency Modulation (AMF) :
Frequency Spectrum :
Ramp rise/descent time:
Ramp sustaining time:
Ramp rest time :
Vector Speed :
Amplitude:

2, 4, 6, 8 and 10 kHz
10 to 150 Hz (steps of 10 Hz)
10 to 100 Hz (steps of 10 Hz)
0 to 9 (steps of 1s)
1 to 30 s (steps of 1s)
1 to 30 s (steps of 1s)
1 to 9 S
0 - 140 mA

Isoplanar Interferential
Frequency :
Frequency Modulation (AMF) :
Frequency Spectrum :
Ramp rise/descent time :
Ramp sustaining time :
Ramp rest time :
Vector Speed :
Amplitude :

2, 4, 6, 8 and 10 kHz
10 to 150 Hz (steps of 10 Hz)
10 to 100 Hz (steps of 10 Hz)
0 to 9 (steps of 1s)
1 to 30 s (steps of 1s)
1 to 30 s (steps of 1s)
1 to 9 S
0 - 140 mA

Two-pole Interferential
Frequency :
Frequency Modulation (AMF) :
Frequency Spectrum :
Ramp rise/descent time :
Ramp sustaining time :
Ramp rest time :
Amplitude :

2, 4, 6, 8 and 10 kHz
10 to 150 Hz (steps of 10 Hz)
10 to 100 Hz (steps of 10 Hz)
0 to 9 (steps of 1s)
1 to 30 s (steps of 1s)
1 to 30 s (steps of 1s)
0 - 140 mA

Exponential 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

Trbert Ultra Exciting


Phase Duration
Phase Interval
Polarity
Amplitude

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

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NEUROMED 4082 IFC


Microcurrents
Frequency
Polarity
Amplitude

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

Equipment working conditions:

Room temperature
Relative humidity
Atmospheric pressure

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

Environmental conditions for transport and storage:

Room temperature
Relative humidity
Atmospheric pressure

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.

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

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.

Optional Accessories:

NEUROMED 4082 IFC

Conductive rubber (Silicone) electrodes Code 04033


Electrode cables
Yellow
Code 21305G
Green
Code 21306G
Blue
Code 20307G
Purple
Code 21308G
Three-pole cable
Code 14747G
User manual
Code 10395G

Emission tests

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.

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

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.

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.

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

MU_4082-IFC_English_Version:1.0.0 (032012)

31

Test level of IEC


60601

Level of
compliance

MU_4082-IFC_English_Version:1.0.0 (032012)

Electromagnetic
environment - orientation

32

NEUROMED 4082 IFC

Electrostatic
discharge
IEC 61000-4-2

Immunity tests

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

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

6 kV contact
8 kV air

Level of
compliance

Electromagnetic
environment - orientation

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
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

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

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%.

NEUROMED 4082 IFC

3 A/m

MU_4082-IFC_English_Version:1.0.0 (032012)

d = 1.17. P

The quality of the power


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

The magnetic fields of the


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

33

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

d = 1.17. P

80 MHz to 800 MHz

d = 2. 3. P

800 MHz to 2.5 GHz

3V

3 V/m

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:

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

MU_4082-IFC_English_Version:1.0.0 (032012)

34

NEUROMED 4082 IFC

NEUROMED 4082 IFC

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;
Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be less
than 3 V/m.

specifications, as well as to add and improve its products, without being


obliged to install them in already manufactured products.

Separation distances recommended between portable and mobile RF communication


equipment and NEUROMED

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

b.

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.

The text, illustrations and specifications contained in this manual are


based on information available during the printing.
All rights reserved.
This manual cannot be reproduced in whole or in part without the written
consent of Carci.

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

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
MU_4082-IFC_English_Version:1.0.0 (032012)

35

OBELIS SA
34, Av. de Tervuren, bte 44
B 1040 Brussels , BELGIUM
Phone: (32) 2.732.59.54
MU_4082-IFC_English_Version:1.0.0 (032012)

36

NEUROMED 4082 IFC


Fax: (32) 2.732.60.03
Email: mail@obelis.net
WARRANTY CERTIFICATE IN ANNEX

Bibliographical references
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.
MU_4082-IFC_English_Version:1.0.0 (032012)

37

NEUROMED 4082 IFC


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.
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.
MU_4082-IFC_English_Version:1.0.0 (032012)

38

NEUROMED 4082 IFC

NEUROMED 4082 IFC

24. Lullies, H., Elektrophysiologische voraussetzungen der


Elektrodiagnostik and Elektrotherapie. Elektromedizin. Band 6, 2,
1961.
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Electrical Nerve Stimulation on Healing of Ischaemic Skin Flaps.
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Science 150, pp 971-979, November 1965.
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by Transcutaneous Electrical Nerve Stimulation. Springer Verlag.
Berlin, 1988.
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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.
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Heidelberger Reprographie A. Grosch KG, Eppelheim b.
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Claudicatio Intermittens. Nederlands Tijdschrift voor
Fysiotherapie, Vol. 94, nr. 11, blz. 226, 1984.
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(LIDC). Lecture on June 14th, Las Vegas, 1972.
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38. Yaksh, T.L. Substance-P Release from Knee Joint Afferent


Terminals: Modulation by Opiods. Brain Research, 458, 319-324,
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Uitgeverij bunge, 3e druk, 1986.

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