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Table of Contents
2 Presentation 2 Accessories that come with the product 3
Symbols 4 Warnings / Attention 7 Installation / Connection to the
power network 8 General information 8 Diadynamic Currents 10
Monophase Currents 12 Microcurrents 13 Display Language 14 Controls
& Control Functions 15 Operation 16 Operation Mode : Diadynamic
22 Operation Mode : Monophase 28 Operation Mode : Microcurrents 30
Protocols 31 Indications & Contraindications 33 Electrode
Application 34 Preventive maintenance, preservation and cleaning 35
Corrective maintenance 36 Technical Characteristics 39 Manufacturer
declaration and orientation 43 Considerations 44 European
Representative 45 Bibliographical reference
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Presentation
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 60601-2-10:2002, which make it a safe and highly
reliable equipment.
Accessories that come with the device
4 Conductive rubber (Silicone) electrodes 4 Sponges pad 4
Polarized cables for electrode 1 Three-pole cable 1 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:
[email protected]
Symbols
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Symbols on the equipment
Means equipment off
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
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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Symbols on the packaging
Fragile. Handle with care
Keep in a dry place
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.
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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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
Turn on the equipment through the
ON/OFF switch
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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
exceeding 2 effective mA/cm2 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.
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.
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).
On/Off Switch
Fuse box
Power cable connector
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General Information
The NEUROMED 4084 is a functional neuromuscular
electrostimulator, Microcontrolled with the functions :
o Diadynamic Currents DF, MF, LP, SP, iD SP
o Monophase Square, Exponential, Ultra Exciting, Direct and
Interrupted
o 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.
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)
It is a fast alternance between a second MF course and a second
of the current DF. CP has as strong re-absorption effect.
iD SP ( Isodynamic Short Periods )
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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.
Monophase ( Faradic )
Monophase / Faradic 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 ives an indicat ion of the level of muscular t issue
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.
Exponential Monophase Current.
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Galvanic current
Direct Galvanic Current
Direct galvanic current, applied constantly without rest
interval.
Interrupted Galvanic Current
Interrupted galvanic current, and modulation of direct galvanic
current, at the frequency of 8 KHz, with working cycle of 90%.
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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effect is the absence of pain that can arise from just the first
treatment and that can last for several hours.
Tp = 2 mS / Tr = 5 mS
(2) Trabert, H. Ultra-Reizstrom, neues ein therapeutisches
Phnomen, Elektromedizin 2, 1957 (7).
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.
Microcurrents
Microcurrent is a rectangular monophase waveform selected
manually or with alternate polarity.
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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Display language
NEUROMED 4080 allows accessing three display languages:
Portuguese English Spanish
If you wish to change the current language, follow the steps
below:
1. Connect the power cable of the NEUROMED 4080 to the power
network.
2. 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. After the equipment issues a double beep, release the Menu
key
5. The display will show the accessible languages: ENGLISH
PORTUGUESE SPANISH
6. Select the language desired through the keys
7. Press the key
8. The equipment will exit the language selection mode,
displaying the Main menu.
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Controls
Control functions
Decrease
Moves to next field
Increase
Moves to previous
field
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Control of intensity of channels 1 and 2.
Figure : 1 Figure : 2
Enables the funct ion chosen
Enables the main menu screen
Enables the NEUROMED outputs
Disables the NEUROMED outputs
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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The display will show the Initial Screen:
Fol low the screen:
Use the keys to select the modes: .
or
or
1. Diadynamic
o In the screen Dyadinamics ,
o Use the keys to enable selection of the DIADYNAMIC modes (DF,
MF, LP, SP or CP Id ).
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Or
Or
Or
1.1 DF
o Select the Diadynamic DF mode.
o Press the key to enable the Diadynamic DF mode. The Diadynamic
DF parameter set screen will be displayed.
o Through the and keys, set the parameters Polarity and Timer
:
o
Settings : 1 minute to 60 minutes, in steps of 1 minute.
o
Settings : + V , + P or Automatic ( AUTO )
Polarity
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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
, the output settings of channels will be enabled.
o Use the key of the channel to set the intensity.
1.2 MF
o Select the Diadynamic MF mode.
o Press the key to enable the Diadynamic MF mode. The parameter
set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
Polarity
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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
, the output settings of channels will be enabled.
o Use the key of the channel to set the intensity.
1.3 LP
o Select the Diadynamic LP mode.
o Press the key to enable the Diadynamic LP mode. The parameter
set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
Polarity
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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
, the output settings of channels will be enabled.
o Use the key of the channel to set the intensity.
1.4 CP
o Select the Diadynamic SP mode.
o Press the key to enable the Diadynamic SP mode. The parameter
set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
Polarity
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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
, the output settings of channels will be enabled.
o Use the key of the channel to set the intensity.
1.5 CP iD
o Select the Diadynamic CP iD mode.
o Press the key to enable the Diadynamic CP iD mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
Polarity
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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
, the output settings of channels will be enabled.
o Use the key of the channel to set the intensity.
2. Monophase
o Use the and keys to enable selection of the MONOPHASE modes
(Square, Exponential, UE, Direct and Interrupted ).
Or
Or
Or
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Or
2.1. Square
o Select the Square Monophase mode.
o Press the key to enable the Square Monophase mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : 20 uS to 2000 uS ( steps of 10 uS )
o Settings : 1 mS to 100 mS (in steps of 1 mS)
o
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Settings : + V , + P or Automatic ( AUTO )
o 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.
2.2. Exponential
o Select the Exponential Monophase mode.
o Press the key to enable the Exponential Monophase mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : 20 uS to 2000 uS ( steps of 10 uS )
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o Settings : 1 mS to 100 mS (in steps of 1 mS)
o Settings : + V , + P or Automatic ( AUTO )
o 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.
2.3. Ultra Exciting (UE)
o Select the Ultra Exciting Monophase mode
o Press the key to enable the Ultra Exciting Monophase mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
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o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
o 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.
2.4. Direct
o Select the Direct Monophase mode.
o Press the key to enable the Direct Monophase mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
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o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
o 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.
2.5. Interrupted
o Select the Interrupted Monophase mode.
o Press the key to enable the Interrupted Monophase mode. The
parameter set screen will be displayed.
o Through the and keys, set the parameters:
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o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : + V , + P or Automatic ( AUTO )
o 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.
3. Microcurrents
o Select the Microcurrents mode.
o Press the key to enable the Microcurrents mode. The parameter
set screen will be displayed.
o Through the and keys, set the parameters:
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o Settings : 1 minute to 60 minutes, in steps of 1 minute.
o Settings : 1 Hz to 200 Hz ( in steps of 1 Hz )
o Settings : + V , + P or Automatic ( AUTO )
o 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.
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4. Protocols
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.
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).
o In the main screen,
o select the option PROTOCOLS, through the keys ,
o Press the Key o The display shows the screen :
o Use the keys to select the mode desired. o User
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o Erase
o Record
o 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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Contraindications: Absence of sensitivity; Presence of metal
plates in the patient; Pacemaker; Spastic excitation in cerebral
spastic paresis; Electroporation.
MicroCurrents Indications:
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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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:
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.
Current Density
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According to Brazilian Standard NBR IEC 60601-2-10, the maximum
current density allowed is 2 mA RMS per cm2 . 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
cm2
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 maintenance, preservation and cleaning
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.
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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 Solutions
Equipment does not come on 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 of the stimulus is greater in
one electrode than in the other
Change the electrodes (silicone or adherent) because they have
become worn out
The intensity is increased to the maximum and the patient
reports little stimulation
Check the patient's sensitivity Change the electrodes (silicone
or adherent)
On increasing the intensity, after 10 mA, the intensity is
zeroed, and the letter m is displayed on the right side of the
intensity
Press the Start key and start the treatment again. Check
continuity of the electrode cable Check conductivity of the
electrodes
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
Press the Start key and start the treatment again. Check
conductivity of the electrodes.
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Check if there is short circuit in the electrode cable plug
Contact technical assistance,
Device comes on normally but the patient reports
non-stimulation
Check the coupling and continuity of the electrode cables with
the patient 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 : CARCI Brazil Models :
NEUROMED 4084 CDB Function and Application : Equipment for
Electrotherapy Power supply : 100230 V~ automatic ( 10%)
: 50 / 60 Hz Maximum Consumption : 100 VA ANVISA [National
Health Surveillance Agency] Registration : 10314290035
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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
--------------------------------------------------------------------------------------------------
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NEUROMED 4084 - CDB
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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 : 2 channels Output
characteristics : Constant Current Current Amplitude Range :
Depends on the waveform Current Amplitude Resolution : 1 mA Maximum
Amplitude ( Ipp) : 70 mA (charge of 500 Ohms) Timer : 0 - 60
minutes
Diadynamic Currents
Modes : DF, MF, SP, LP and iDSP Amplitude : 0 to 70 mA Polarity
: Positive, Negative or Automatic.
Monophase
Interrupted Galvanic : Frequency : 8000 Hz Work Cycle : 95%
Polarity : Positive, Negative or Automatic. Amplitude : 0 to 40
mA
Direct Galvanic Polarity : Positive, Negative or Automatic.
Amplitude : 0 to 40 mA
Square Monophase Phase Duration : 0.05 to 2000 uS ( steps of 10
uS ) Phase Interval : 1 100 ms ( steps of 1 mS ) Polarity :
Positive, Negative or Automatic. Amplitude : 0 to 40 mA
Exponential Monophase Phase Duration : 0.05 to 2000 uS ( steps
of 10 uS )
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 38
Phase Interval : 1 100 ms ( steps of 1 mS ) Polarity : Positive,
Negative or Automatic. Amplitude : 0 to 40 mA
Trbert Ultra Exciting Phase Duration : 2 mS Phase Interval : 5
mS Polarity : Positive, Negative or Automatic. Amplitude : 0 to 40
mA
Microcurrents Frequency : 1 Hz to 200 Hz ( steps of 1 Hz )
Polarity : Positive, Negative or Automatic. Amplitude : 0 to 40
mA
Equipment working conditions: Room temperature : +10C to +40C
Relative humidity : 0% to 80% Atmospheric pressure : 700 hPa to
1060hPa
Environmental conditions for transport and storage: Room
temperature : -10C to 60oC Relative humidity : 20% to 90%
Atmospheric pressure : 500hPa to 1060hPa
Optional Accessories:
Conductive rubber (Silicone) electrodes Code 04033 Sponges pad
Electrode cables
Yellow Code 21305G Green Code 21306G
Three-pole cable Code 14747G User manual 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.
-
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 39
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 :
- Meaning given to the verbal forms should and may
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 Electromagnetic
environment - orientation
RF Emission CISPR 11 Group 1
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.
RF Emission CISPR 11 Class B 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.
Harmonics emission IEC 61000-3-2 Class A
Voltage fluctuation / Flicker emission IEC 61000-3-3
Compliant
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 40
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 tests Test level of IEC 60601 Level of
compliance Electromagnetic
environment - orientation
Electrostatic discharge IEC 61000-4-2
6 kV contact 8 kV air
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%.
Immunity tests Test level of IEC 60601 Level of
compliance Electromagnetic
environment - orientation
Fast transients / Bursts IEC 61000-4-4
2 kV power supply line 1 kV signal input and output line
2 kV power supply line
Not applicable The quality of the power network would be that of
a typical hospital or commercial environment.
Surge IEC 61000-4-5
1 kV differential mode 2 kV ordinary mode
1 kV differential mode 2 kV ordinary mode
-
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 41
Voltage dips, short interruptions and voltage variations in the
power supply. IEC 61000-4-11
95% dip in Ut) For 0.5 cycle
40% Ut (60% dip in Ut) For 5 cycles
70% Ut (30% dip in Ut) For 25 cycles
95% dip in Ut) For 5 s
95% dip in Ut) For 0.5 cycle
40% Ut (60% dip in Ut) For 5 cycles
70% Ut (30% dip in Ut) For 25 cycles
95% dip in Ut) For 5 s
Magnetic fields of the network frequencies (50/60 Hz) IEC
61000-4-8
3 A/m 3 A/m
The magnetic fields of the network frequencies would be
characteristic levels of a typical commercial or hospital
environment.
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
tests Test level of IEC 60601
Level of compliance
Electromagnetic environment - orientation
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
3 V
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
Pd .17.1=
Pd .17.1= 80 MHz to 800 MHz
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 42
Pd .3.2= 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:
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.
-
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 43
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.
Declared maximum output power of the
transmitter (W)
Separation distance according to the transmitter frequency 150
kHz to 80
MHz
Pd 17.1=
80 MHz to 800 MHz
Pd 17.1=
800 MHz to 2.5 GHz
Pd 3.2= 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.
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.
This manual cannot be reproduced in whole or in part without the
written consent of Carci.
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 44
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: [email protected]
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: [email protected]
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
Email: [email protected]
WARRANTY CERTIFICATE IN ANNEX
-
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 45
Bibliographical references
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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,
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8. Besson, J.M., Chaouch, A., Peripheral and Spinal Mechanisms
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9. Carley, P., Wainapel, S., Electrotherapy for Acceleration of
Wound Healing; Low Intensity Direct Current. Arch. Phys. Med.
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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
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1988.
12. Howson, D.C., Peripheral Nerve Excitability, Implications
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NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 46
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
thirty-six Human Muscles. An Autopsy Study. Journal of Neurological
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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.
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Gustv Fischer Verlag, Stuttgart, 2e druk, 1973.
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NEUROMED 4084 - CDB
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27. Niele, R., Treatment Protocol for the Endomed CV 405. B.V.
Enraf-Nonius Delft, Holland, November 1988.
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29. Pouliart, C., De Elektrische Weerstand van de Huid. Belgisch
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Fasc. 2, pp 64-79, 1974.
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Physiological Reviews, Vol, 53, 4, pp 916-947, October 1973.
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Leerboek
NEUROMED 4084 - CDB
MU_4084_English_Version: 1.0.0 (032012) 48
der Fysische Therape in Engere Zin, Wetenschappelijke Uitgeverij
bunge, 3e druk, 1986.
Microcurrents
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T. 1989. Modern low voltage microcurrent stimulation: A
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Cheng, N., Van Hoff, H., and Bockx, E. 1982. The effect of
electric
currents on ATP generation protein synthesis, and membrane
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8. Bauer, W. 1983. Electrical treatment of severe head and neck
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9. Kirsch, D., and Lerner, F. Electromedicine: the other side of
physiology. FA: St. Lucie Press, 1998.
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