MU 4082-IfC English Version 1.0.0

NEUROMED 4082 IFC

MU_4082-IFC_English_Version:1.0.0 (032012) 1

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 Interferential Current 11 Display Language 12 Controls & Control Functions 13 Operation 14 Operation Mode : Two pole Interferential 16 Operation Mode : Manual Vector Interferencial 17 Operation Mode : Automatic Vectos Interferential 19 Operation Mode : Isoplanar Interferential 21 Protocols 24 Indications & Contraindications 25 Electrode Application 26 Preventive maintenance, preservation and cleaning 27 Corrective maintenance 29 Technical Characteristics 32 Manufacturer declaration and orientation 35 Considerations 36 European Representative 37 Bibliographical reference

NEUROMED 4082 IFC


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 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 60601-2-10:2002, which make it a safe and highly reliable equipment.

Accessories that come with the device

4 Conductive rubber (Silicone) electrodes 1 Gel Tube 2 Cables for electrode 1 Three-pole cable 1 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: [email protected]

NEUROMED 4082 IFC


Symbols

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

NEUROMED 4082 IFC


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

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

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 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.

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.

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

NEUROMED 4082 IFC


General Information

The NEUROMED 4082 is a functional neuromuscular electrostimulator, Microcontrolled with the functions :

o Interferential Current Two-pole, Manual Vector, Automatic and Isoplanar.

Interferential Current

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.

1 beat frequency cycle

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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

NEUROMED 4082 IFC


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

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.

NEUROMED 4082 IFC


Display language

NEUROMED 4082 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 4082 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.

NEUROMED 4082 IFC


Controls

Control functions

Control of intensity of channels 1 and 2.

Decrease

Moves to next field

Increase

Moves to previous

field

NEUROMED 4082 IFC


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.

The display will show the Initial Screen:

NEUROMED 4082 IFC


Use the keys to select the current types.

1. Interferential : Use the and keys to enable selection of the interferential modes : Two-pole, Manual Vector, Automatic Vector or Isoplanar Vector

1.1. Two-pole Interferential

o Select the Two-pole Interferential mode.

NEUROMED 4082 IFC


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

o Through the and keys, set the parameters:

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

o

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

o

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

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

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

Carrier Frequency

Frequency Modulation

Frequency Variation

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key , the output settings of channels 1 and 2 will be enabled.

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

1.2. Manual Vector Interferential

o 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.


o

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

NEUROMED 4082 IFC


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

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


o Settings : Rise/fall : 0 s to 9 s (steps of 1 s) Sustaining/Rest : 1 s to 30 s (steps of 1 s)


key , the output settings of channels 1 and 2 will be enabled.


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

1.3. Automatic Vector Interferential

o Select the Automatic Vector Interferential mode

Carrier Frequency


Frequency Variation

NEUROMED 4082 IFC


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

o


o

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




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

Carrier Frequency


Frequency Variation

Speed

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)


key , the output settings of channels 1 and 2 will be enabled. The time selected will decrease.


o The will move according to the speed selected.

1.4. Isoplanar Interferential

o Select the Isoplanar Interferential mode

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

NEUROMED 4082 IFC



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




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

o 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

, the output settings of channels 1 and 2 will be enabled.


o The will move according to the speed selected.

Speed

Carrier Frequency


Frequency Variation

NEUROMED 4082 IFC


2. 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).

2.1 Select Protocol

o In the main screen,

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o Select the option PROTOCOLS, through the keys ,

position the cursor in the option SELECT, press the key

o The display will show the screen:

o Use the keys to select the desired protocol.

o Use the keys to change the cursor to the right; and

to select or delete the protocol.

o Press the key to confirm.

2.2 Save Protocol

o Example : For the therapy

NEUROMED 4082 IFC


o Press the key o The screen will be showed

o Use the and keys to change the cursor to select the letter to write..

o Press the key to confirm, or to erase.

o Press the key to save the protocol.

2.3 Erase Protocol

o In the Protocols screen:

NEUROMED 4082 IFC


o Use the keys to select the desired protocol to erase.

o Press the key to confirm.

o Press the key 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.

NEUROMED 4082 IFC


Contraindications:

Muscular injuries, tendinitis; Dysfunctions in acute joints (arthritis, bursitis combined with heat)

and functional lesion; Unconsolidated fibers; Forms of spasticity;

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 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

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

According to Brazilian Standard NBR IEC 60601-2-10, the maximum current density allowed is 2 mA RMS per cm2 . 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 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

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.

Special cares for adherent or 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.

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.

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.

Problems Solutions

NEUROMED 4082 IFC


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. 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

NEUROMED 4082 IFC


Technical characteristics

Origin : CARCI Brazil Models : NEUROMED 4082 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

-------------------------------------------------------------------------------------------------

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 : 4 channels Output characteristics : Constant Current Current Amplitude Range : Depends on the waveform Current Amplitude Resolution : 1 mA Maximum Amplitude ( Ipp) : 140 mA (charge of 500 Ohms) Timer : 0 - 60 minutes

Interferential

NEUROMED 4082 IFC


Automatic Vector Interferential Frequency : 2, 4, 6, 8 and 10 kHz Frequency Modulation (AMF) : 10 to 150 Hz (steps of 10 Hz) Frequency Spectrum : 10 to 100 Hz (steps of 10 Hz) Ramp rise/descent time: 0 to 9 (steps of 1s) Ramp sustaining time: 1 to 30 s (steps of 1s) Ramp rest time : 1 to 30 s (steps of 1s) Vector Speed : 1 to 9 S Amplitude: 0 - 140 mA

Isoplanar Interferential Frequency : 2, 4, 6, 8 and 10 kHz Frequency Modulation (AMF) : 10 to 150 Hz (steps of 10 Hz) Frequency Spectrum : 10 to 100 Hz (steps of 10 Hz) Ramp rise/descent time : 0 to 9 (steps of 1s) Ramp sustaining time : 1 to 30 s (steps of 1s) Ramp rest time : 1 to 30 s (steps of 1s) Vector Speed : 1 to 9 S Amplitude : 0 - 140 mA

Two-pole Interferential Frequency : 2, 4, 6, 8 and 10 kHz Frequency Modulation (AMF) : 10 to 150 Hz (steps of 10 Hz) Frequency Spectrum : 10 to 100 Hz (steps of 10 Hz) Ramp rise/descent time : 0 to 9 (steps of 1s) Ramp sustaining time : 1 to 30 s (steps of 1s) Ramp rest time : 1 to 30 s (steps of 1s) Amplitude : 0 - 140 mA

Exponential 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

Trbert Ultra Exciting Phase Duration : 2 mS Phase Interval : 5 mS Polarity : Positive, Negative or Automatic. Amplitude : 0 to 40 mA

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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 Electrode cables

Yellow Code 21305G Green Code 21306G Blue Code 20307G Purple Code 21308G

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.

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

NEUROMED 4082 IFC


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

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

NEUROMED 4082 IFC


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

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


95% dip in Ut) For 5 s

95% dip in Ut) For 0.5 cycle



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.

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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

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

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;

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

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

NEUROMED 4082 IFC


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.

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

NEUROMED 4082 IFC


Fax: (32) 2.732.60.03

Email: [email protected]

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Bibliographical references

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10. Hogenkamp, M., Mittelmeijer, E., Smits, I., Stralen, C. Van, Interferential Therapy. B.V. Enraf-Nonius Delft, Holland, May 1990.

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38. Yaksh, T.L. Substance-P Release from Knee Joint Afferent Terminals: Modulation by Opiods. Brain Research, 458, 319-324, 1988.

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