MU 4084-CDB English Version 1.0.0

NEUROMED 4084 - CDB

MU_4084_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 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

NEUROMED 4084 - CDB


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

NEUROMED 4084 - CDB


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 4084 - CDB


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 4084 - CDB


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 4084 - CDB


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 4084 - CDB


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 4084 - CDB


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)

NEUROMED 4084 - CDB


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 )

NEUROMED 4084 - CDB


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.

NEUROMED 4084 - CDB


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.

NEUROMED 4084 - CDB


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.

NEUROMED 4084 - CDB


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.

NEUROMED 4084 - CDB


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 ).

NEUROMED 4084 - CDB


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

NEUROMED 4084 - CDB





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.




Polarity

NEUROMED 4084 - CDB





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.




Polarity

NEUROMED 4084 - CDB





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.




Polarity

NEUROMED 4084 - CDB





2. Monophase

o Use the and keys to enable selection of the MONOPHASE modes (Square, Exponential, UE, Direct and Interrupted ).

Or

Or

Or

NEUROMED 4084 - CDB


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 Settings : 20 uS to 2000 uS ( steps of 10 uS )

o Settings : 1 mS to 100 mS (in steps of 1 mS)

o

NEUROMED 4084 - CDB


Settings : + V , + P or Automatic ( AUTO )




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 Settings : 20 uS to 2000 uS ( steps of 10 uS )

NEUROMED 4084 - CDB


o Settings : 1 mS to 100 mS (in steps of 1 mS)





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.


NEUROMED 4084 - CDB







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.


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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.


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3. Microcurrents

o Select the Microcurrents mode.

o Press the key to enable the Microcurrents mode. The parameter set screen will be displayed.


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o Settings : 1 Hz to 200 Hz ( in steps of 1 Hz )





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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

NEUROMED 4084 - CDB


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

NEUROMED 4084 - CDB


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

NEUROMED 4084 - CDB


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

NEUROMED 4084 - CDB


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.

NEUROMED 4084 - CDB


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

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

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

NEUROMED 4084 - CDB


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 )

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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


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


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

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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.

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


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.

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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.

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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: [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

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Bibliographical references

Low, Medium and Polarized Currents 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.

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

11. Hoogland, R., Strengthening and Stretching of Muscles using Electrical Current. B.V. Enraf-Nonius Delft, Holland, December 1988.

12. Howson, D.C., Peripheral Nerve Excitability, Implications for Transcutaneous Electrical Nerve Stimulation. Physical Therapy, Vol. 58, 12, December 1978.

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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 Science, 18, pp. 111-129.

15. Kaada, B., Vasodilation induced by Transcutaneous Nerve Stimulation in Peripheral Ischemia. European Heart Journal, 3, pp 303-314, 1982.

16. Khan, J., Use of Iontophoresis in Peyronies Disease. Physical Therapy, 7, July 1982.

17. Kloth, L.C., Feedar, J.A., Acceleration of Wound Healing with High Voltage, Monophasic, Pulsed Current. Physical Therapy, 68, pp 503-508, 1988.

18. Kots, Y.M., Lectures and Laboratory Periods. Symposium on Electrostimulation of Skeletal Muscles. Concordia University, Montreal/Quebec, Canada, December 6th-15th, 1977.

19. Kovanen, V., Suominen, H., Heillinen, E., Collagen of Slow Twitch and Fast Twitch Muscle Fibres in Different Types of Rat Skeletal Muscle. Eur. J. Appl. Physiol., 52, pp 235-242, 1984.

20. Kuo, K.H.M., Clamann, H., Coactivation of Synergistic Muscles of Different Fibre types in Fast and Slow Contractions. American Journal of Physical Medicine, vol.60, 5, pp 219-238, 1981.

21. Kousemaeker, E.A.M., Aarts, N.J.M., Duy, A. Van der, De Behandeling van Slecht Genezende Wonden met Behulp Xanthinolnicotinaat. Nederlands Tijdschrift voor Fysiotherapie, 6, pp 174-178, 1974.

22. Levine, J.D., Codere, T.J., Basbaum, A.I., Proceedings of the Vth World Congress on Pain. Elsevier Science Publishers B.V. (Biomedical Division), 1988.

23. Lullies, H., Trincker, D., Taschenbuch der Physiologie II, Gustv Fischer Verlag, Stuttgart, 2e druk, 1973.

24. Lullies, H., Elektrophysiologische voraussetzungen der Elektrodiagnostik and Elektrotherapie. Elektromedizin. Band 6, 2, 1961.

25. Lundeberg, T., Kjartansson, J., Samuelsson, J., Effect of Electrical Nerve Stimulation on Healing of Ischaemic Skin Flaps. The lancet, pp 712-714, September 1988.

26. Melzack, R., Wall, P.D., Pain Mechanisms: A New Theory. Science 150, pp 971-979, November 1965.

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27. Niele, R., Treatment Protocol for the Endomed CV 405. B.V. Enraf-Nonius Delft, Holland, November 1988.

28. Ottoson, D., Lundeberg, T., Pain Treatment: A Practical Manual by Transcutaneous Electrical Nerve Stimulation. Springer Verlag. Berlin, 1988.

29. Pouliart, C., De Elektrische Weerstand van de Huid. Belgisch Tijdschrift voor Reumatologie en Fysische Geneeskunde, Vol 29, Fasc. 2, pp 64-79, 1974.

30. Pronk, N., Het Twee (Vier) Cellenbad by de Behandeling van Hyperhydrosis Palmoplantaris. Nederlands Tijdschrift voor Fysiotherapie, Vol 96, 6, pp 120-121, 1986.

31. Sato, A., Schmidt, R.F., Somatosympathetic Reflexes: Afferent Fibres, Central Pathways, Discharge Characteristics. Physiological Reviews, Vol, 53, 4, pp 916-947, October 1973.

32. Sjlund, B.H., Eriksson, M.B.E., Endorphins and Analgesia Produced by Peripheral Conditioning Stimulation. Advances in Pain Research and Therapy, vol 3, 1979.

33. Steuernagel, O., Skripten zur Elektrotherapie, Band II. Heidelberger Reprographie A. Grosch KG, Eppelheim b. Heidelberg, 1978.

34. Stralen, C.J.C. van, Transcutane elektrische prikkeling bij Claudicatio Intermittens. Nederlands Tijdschrift voor Fysiotherapie, Vol. 94, nr. 11, blz. 226, 1984.

35. Wheeler, P.C., Wolcott, L.E., Morris, J.L, Spangler, M.R., Neural Considerations in the Healing of Ulcerated Tissue by Clinical Electrotherapeutic Application of Weak Direct Current. Findings and Theory. Neuro-Electric Reasearch, 1970.

36. Wolcot, L.E., Gault, W.R., Gatens, P., Acceleration of Healing Rate in Ischaemic Skin Ulcers with Low Intensity Direct Current (LIDC). Lecture on June 14th, Las Vegas, 1972.

37. Wolf, S.L., Perspectives on Central Nervous System Responsiveness to Transcutaneous Electrical Nerve Stimulation. Physical Therapy, Vol, 58, 12, December 1978.

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

39. Zimmermann, M., Pain Mechanisms and Mediators in Osteoarthritis. Seminars in Arthritis and Rheumatism, vol 18m 4, suppl. 2, pp 22-29, 1989.

40. Zutphen, H.C.F. van, Stralen, C.J.C. van, Pls, P., Bernards, J.A., Kolle, L.F.J.Th.M., Rens, P.P.Th.G. van, Nederlands Leerboek

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der Fysische Therape in Engere Zin, Wetenschappelijke Uitgeverij bunge, 3e druk, 1986.

Microcurrents

1. Micro-Current Therapy Ushers In A New Era. PA: ICN.Publications, 1989.

2. Kirsch, D., and Lerner, F. Electromedicine: the other side of physiology. FA: St. Lucie Press, 1998.

3. Mylon-Tech Research Results. http://www.mylontech.ca 4. Wing, T. 1989. Modern low voltage microcurrent stimulation: A

comprehensive overview. Chiropractic Economics. 37: 265-271. 5. Cheng, N., Van Hoff, H., and Bockx, E. 1982. The effect of electric

currents on ATP generation protein synthesis, and membrane transport in rat skin. Clin. Orthop. 171: 264-272.

6. Becker, R. The Body Electric. NY: William Morrow and Co, Inc., 1985.

7. Delitto, A., Strube, M., and Shulman, A. 1992. A study of discomfort with electrical stimulation. Physical Therapy. 72: 410-424.

8. Bauer, W. 1983. Electrical treatment of severe head and neck cancer pain. Arch Otolaryngol. 109: 382- 383.

9. Kirsch, D., and Lerner, F. Electromedicine: the other side of physiology. FA: St. Lucie Press, 1998.

10. Becker, R. 1995. The basis for microcurrent electrical therapy in conventional medical practice. Journal of Advancement in Medicine. 8 (2).

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MU 4084-CDB English Version 1.0.0