Professional Documents
Culture Documents
Table of Contents
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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
4
4
4
1
1
Symbols
MU_4084_English_Version: 1.0.0
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Means equipment on
Class II Equipment
Manufacturer Identification
MU_4084_English_Version: 1.0.0
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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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Connect
equipment to the
power network
Turn on
equipment
through the
ON/OFF switch
Connect the
electrode cables
to the patient
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Turn on the
equipment
through the
ON/OFF switch
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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Diadynamic Currents
Monophase
Other Countries :
On/Off Switch
Power cable
connector
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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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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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.
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Galvanic current
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.
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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Display language
Controls
Control functions
If you wish to change the current language, follow the steps below:
1.
2.
3.
4.
6.
7.
8.
5.
Moves to
next field
Decrease
Increase
Moves to
previous
field
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Fo l lo w th e s c r e e n:
Figure : 1
Figure : 2
Use the
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
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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Or
Or
Or
1.1
DF
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
Press the
key to enable the Diadynamic MF mode.
The parameter set screen will be displayed.
Through the
o
Settings : 1 minute to 60 minutes, in steps of 1 minute.
Polarity
o
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and
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1.4 CP
o
Press the
key to enable the Diadynamic SP mode. The
parameter set screen will be displayed.
Through the
1.3 LP
o
Press the
key to enable the Diadynamic LP mode. The
parameter set screen will be displayed.
Through the
and
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o
and
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2.
1.5 CP iD
o
Monophase
Press the
key to enable the Diadynamic CP iD mode.
The parameter set screen will be displayed.
Through the
and
Use the
a nd
keys to enable selection of the
MONOPHASE modes (Square, Exponential, UE, Direct and
Interrupted ).
Or
Or
Polarity
Or
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Or
2.1.
Square
o
Press the
key to enable the Square Monophase mode.
The parameter set screen will be displayed.
2.2.
o
Through the
and
Exponential
Press the
key to enable the Exponential Monophase
mode. The parameter set screen will be displayed.
Through the
o
o
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and
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o
o
2.3.
2.4.
Direct
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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and
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o
o
2.5.
Interrupted
3.
Microcurrents
Press the
key to enable the Interrupted Monophase
mode. The parameter set screen will be displayed.
Through the
and
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Press the
key to enable the Microcurrents mode. The
parameter set screen will be displayed.
Through the
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and
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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
o
o
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o
o
o
o
Use the
User
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Erase
Record
MicroCurrents
Indications:
Use the
to confirm.
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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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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
Use a cloth wet with water and soap to clean the cabinet of your
device
Current Density
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and
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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
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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
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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
2 channels
Constant Current
Depends on the waveform
1 mA
70 mA (charge of 500 Ohms)
0 - 60 minutes
Diadynamic Currents
Modes
Amplitude
Polarity
: 1 100 ms ( steps of 1 mS )
: Positive, Negative or Automatic.
: 0 to 40 mA
: 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
: 8000 Hz
: 95%
: Positive, Negative or Automatic.
: 0 to 40 mA
Direct Galvanic
Polarity
Amplitude
Square Monophase
Phase Duration
Phase Interval
Polarity
Amplitude
Exponential Monophase
Phase Duration
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Polarity
Amplitude
Monophase
Interrupted Galvanic :
Frequency
Work Cycle
Polarity
Amplitude
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Room temperature
Relative humidity
Atmospheric pressure
: -10C to 60 C
: 20% to 90%
: 500hPa to 1060hPa
Optional Accessories:
Code 04033
Code 21305G
Code 21306G
Code 14747G
Code 10395G
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Immunity 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
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Electrostatic
discharge
IEC 61000-4-2
Immunity tests
6 kV contact
8 kV air
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
Level of
compliance
Electromagnetic
environment - orientation
2 kV power
supply line
Not applicable
1 kV
differential
mode
2 kV ordinary
mode
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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
3 A/m
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.
d = 1.17. P
3 V/m
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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.
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
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Microcurrents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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