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Table of Contents
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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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1
2
1
1
MU_4082-IFC_English_Version:1.0.0 (032012)
Symbols
Symbols on the equipment
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
ATTENTION / WARNINGS
MU_4082-IFC_English_Version:1.0.0 (032012)
Connect
equipment to the
power network
Turn on
equipment
through the
ON/OFF switch
Connect the
electrode cables
to the patient
MU_4082-IFC_English_Version:1.0.0 (032012)
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.
MU_4082-IFC_English_Version:1.0.0 (032012)
Interferential Current
Two-pole,
Manual Vector,
Automatic and
Isoplanar.
Interferential Current
On/Off Switch
General Information
Other Countries :
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).
MU_4082-IFC_English_Version:1.0.0 (032012)
MU_4082-IFC_English_Version:1.0.0 (032012)
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).
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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3.
4.
6.
7.
8.
5.
Control functions
Moves to
next field
Decrease
Increase
Moves to
previous
field
11
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Figure : 1
Figure : 2
E na b les t h e f u nc t io n c hos e n
Use the
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.
13
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Press the
key to enable the Two-pole Interferential
mode. The Two-pole mode set screen will be displayed.
key
be enabled.
o
o
Through the
and
o Press the
key to enable the Manual Vector
Interferential mode. The Manual Vector mode set screen will
be displayed.
Carrier Frequency
o
Settings : 10 Hz to 150 Hz ( steps of 10 Hz )
Frequency Variation
o
Settings : 10 Hz to 100 Hz ( steps of 10 Hz )
Through the
parameters:
and
o
Set : 1 minute to 60 minutes, in steps of 1 minute.
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o Press the
key to enable the Automatic Vector
Interferential mode. The Automatic Vector mode set screen
will be displayed.
Frequency Modulation
Frequency Variation
key
be enabled.
Through the
parameters:
and
o
Set : 1 minute to 60 minutes, in steps of 1 minute.
Carrier Frequency
o Use the
keys to move the
to the desired position.
Frequency Modulation
Frequency Variation
Speed
Set : 1 s to 15 s (steps of 1 s)
o
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Through 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
o
o
The
selected.
o
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
Press the
key to enable the Isoplanar Interferential
mode. The Isoplanar mode set screen will be displayed.
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The
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Protocols
Attention
o
Use the
Use the
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
2.2
21
to confirm.
Save Protocol
o
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Select Protocol
o
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22
o
o
Use the
Use the
and
select the letter to write..
to confirm, or
2.3
to erase.
MU_4082-IFC_English_Version:1.0.0 (032012)
to confirm.
to return to the main menu..
Erase Protocol
o
23
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24
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.
Self-Adhesive Electrode
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Preventive
cleaning
maintenance,
preservation
and
Use a cloth wet with water and soap to clean the cabinet of your
device
MU_4082-IFC_English_Version:1.0.0 (032012)
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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.
MU_4082-IFC_English_Version:1.0.0 (032012)
Problems
Solutions
27
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: 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
4 channels
Constant Current
Depends on the waveform
1 mA
140 mA (charge of 500 Ohms)
0 - 60 minutes
Interferential
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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
: 2 mS
: 5 mS
: Positive, Negative or Automatic.
: 0 to 40 mA
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: 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
Room temperature
Relative humidity
Atmospheric pressure
: -10C to 60 C
: 20% to 90%
: 500hPa to 1060hPa
Optional Accessories:
Emission tests
Compliance
RF Emission
CISPR 11
Group 1
RF Emission
CISPR 11
Class B
Harmonics emission
IEC 61000-3-2
Class A
Voltage fluctuation /
Flicker emission
IEC 61000-3-3
Compliant
Immunity tests
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Level of
compliance
MU_4082-IFC_English_Version:1.0.0 (032012)
Electromagnetic
environment - orientation
32
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
<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
3 A/m
MU_4082-IFC_English_Version:1.0.0 (032012)
d = 1.17. P
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
d = 2. 3. P
3V
3 V/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
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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.
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
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)
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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)
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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.
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