MU_Fesmed_4052_4054_ENG_Rev02_092009

FESMED

4052 4054

USER MANUAL

Eng l ish

Version: 2

FESMED II 4052 FESMED IV 4054

MU_4052_4054_ENG_Rev:02_092009 1

Table of Contents 02 .............Presentation 02 .............Accessories supplied with the device 03 .............General Information 04 .............Symbols 05 ............Attention 09 .............Display Language 10 .............Controls 11 .............Control Functions 12 .............Operation Modes 12 .............TENS Operation Mode 14 .............FES Operation Mode 16 .............FESMED IV 4054 Device Operation 24 .............FESMED II 4052 Device Operation 32 .............Protocols 34 .............Indications 35 .............Contraindications 36 .............Electrode Application 38 .............Preventive Maintenance, Conservation and Cleaning 38 .............Corrective maintenance 39 .............Technical Data 42 .............Declarations 46 .............Final Considerations 47..............European Representative 47 .............References


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Presentation

Carci is proud to congratulate you for the acquisition of a high technology and security equipment. Where we are sure this equipment will satisfy the highest quality standards.

FESMED II - 4052 and FESMED IV 4054 devices were designed according to NBR IEC 60601.1:1994 + amend 1:1997, NBR IEC 60601-1-2:2006 and NBR IEC 60601-2-10:2002 safety rules, which makes them a safe and reliable product.

Accessories supplied with the device

FESMED IV 4054 08 Silicone electrodes and 1 gel tube or 08 Self-adhesive electrodes 3x5cm 04 Electrode cables 01 Three-pole power cable 01 Users Manual

FESMED II 4052 04 Silicone electrodes and 1 gel tube or 04 Self-adhesive electrodes 3x5cm 02 Electrode cables 01 Three-pole power cable 01 Users Manual

To buy optional accessories, please verify the codes at page 41, Additional Accessories .

If you have any doubt, please contact: Technical Assistance Department Rua lvares Fagundes, 359 So Paulo SP Brasil -CEP 04338-000 Tel.: (0XX11) 5621 7024 / 5622 8205 e-mail : [email protected]


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General Information

FESMED is a microprocessor-controlled neuromuscular electrostimulator, with TENS and FES functions.

F E S The functional electrical stimulation is a form of electrotherapy that can produce muscle contractions with functional objectives. The movements produced by FES technique are fully controllable and provide the patient a positive psychological attitude , as he/she uses his/her own muscles, which contributes to his/her physical and emotional rehabilitation.

The regular application of the neuromuscular electrostimulation (NMES) with FES has proved to be efficient in the treatment of patients with motor deficiencies caused by different neurological pathologies. Some results that may be obtained with the utilization of this technique are: reduced muscle spasticity, muscle strengthening and improved gait pattern.

The equipment allows, for instance, quadriceps stimulation, foot dorsiflexion movement and gait monitoring, among other resources.

T E N S Chronic pain - continued and debilitating pain, as those associated with rheumatism, arthritis, sciatic nerve, among others, do not have the purpose of indicating any eminent damage, but that we have a damage resulting from the pathology itself. The treatment of chronic pains using narcotics and other drugs always brings inconvenient side effects, almost always causing as many problems as the pain itself. TENS (Trancutaneous Electric Nerve Stimulation) promotes a simple, safe and effective solution to chronic pain problems.


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Symbols Device symbols

Device is off

Device is on

This symbol indicates the device causes physiological effects and that the user should

check the users manual before using it.

BF type applied part

IPX0 Not protected from harmful water penetration

Class II equipment

Manufacturer Identification

Product Manufacture Date

Product Serial Number

European Representative

CE marking and identification of the notified agency


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Packaging symbols

Caution fragile. Handle with care

Keep in a dry place

This side up. This symbol indicates the right transport position

Maximum piling. Indicates the maximum number of boxes that can be piled. The quantity is

indicated in the middle square.

Minimum and maximum temperature limits for transportation and storage.

ATTENTION

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 treatment modality available, as well as the indications, contraindications, warnings and precautions. Consult other resources to obtain further information on the application of electrotherapy.


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5. Operating sequence

Connect equipment to the power network

Turn on equipment through the

ON/OFF switch

Set the therapy parameters

Connect the electrode cables

to the patient

Set the current intensity desired

After the end of the time selected,

remove the electrodes from

the patient

Turn on the equipment through the

ON/OFF switch


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WARNINGS:

1. Never turn on the ON/OFF key of FESMED while one or more cables of the electrodes are connected to the patient and to FESMED.

2. This equipment is intended for use by health professionals only. 3. This equipment can cause radiofrequency or interrupt operation of

nearby equipment. 4. The use of accessories not specified by the manufacturer can

result in increase in EMISSIONS or decrease in IMMUNITY of the equipment.

5. The use of replacement parts not specified by the manufacturer, in technical assistance, can result in increase in EMISSIONS or decrease in IMMUNITY of the equipment.

6. We recommend not using this equipment piled or very close to other equipment.

7. Short-distance operation (e.g. 1 m) from a shortwave or microwave therapy EQUIPMENT can produce instability in the STIMULATOR output;

8. Application of electrodes near the thorax can increase the risk of cardiac fibrillation;

9. Simultaneous connections of a PATIENT to a high-frequency surgical EQUIPMENT can result in burning where the STIMULATOR electrodes are applied and possible damage to the stimulator;

10. We recommend that the current densities for any electrode exceeding 2 effective mA/cm2 may require special attention from the user;

11. Do not place the equipment on soft base that can cover the lower vents.

12. Keep this device out of reach of children. 13. This equipment is not suitable for use in the presence of mixture of

anesthetics inflammable with air, oxygen or nitrous oxide.


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Electrical Installation/Connection

For a perfect device operation, we suggest electrical installations according to the following rules:

Brazil: NBR 5410/1990 Low-voltage electrical installations; NBR13534/1995 Electrical installations at medical locations -

Safety requirements. Other Countries:

IEC 60364-7-7 (10/2002) Electrical Installations medical locations;

Or another related norm applicable in the utilization country.

Connect one end of the power cable to the three-pole socket on the rear panel and the other end to the wall outlet.

Figure 01 Your equipment uses switched power supply and operates at any volt

supply between 100 and 240VCA, 50 or 60Hz.

In case the protection fuse is blown, replace only with another one of the indicated rating:

Fuses should be 1.0A 250V 20AG


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Remove the fuse compartment cover with the help of a screwdriver (insert the tip into the fuse compartment groove, press down slightly and rotate counterclockwise).

Display Language

FESMED offers display configuration in three possible idioms: Portuguese English Spanish

If you want to change the current language, follow the steps below:

1. Connect FESMED power cable to the utility power supply. 2. Turn on the device the unit will perform a display test and the

screen below will appear:

3. After that, press and hold the following key:

4. After a double beep is heard, release Menu key. 5. The display will show the language options:

ENGLISH PORTUGUESE ESPANOL

6. Select the idiom using the arrow keys:

7. Press the following key:

FESMED 405X

SN.: 00001 Rev.: X.Y


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8. The unit will exit the language selection mode, and the Main Menu will be displayed.

Controls

F e s m e d I I 4 0 5 2

F e s m e d I V 4 0 5 4


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Control Functions

Intensity control for channels 1 and 2 of Fesmed II 4052

Intensity control for channels 1, 2, 3 and 4 of Fesmed IV 4054

NEXT FIELD

PREVIOUS FIELD

INCREASES SETTING DECREASES SETTING


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A c t i v a t e s t h e s e l e c t e d f u n c t i o n

D i s p l a ys t h e m a i n m e n u

E n a b l e s F e s m e d o u t p u t s

D i s a b l e s F e s m e d o u t p u t s

Operat ion Modes

FESMED 4052 and Fesmed 4054 can operate as stimulators with both FES and TENS Techniques.

TENS

The wave form of TENS mode is the Balanced Symmetrical Two-Phase Wave, as illustrated below:

The configurable parameters are: Frequency and Pulse Width.

Frequency settings are: - 1 to 10 Hz, in steps of 1 Hz - 10 to 50 Hz, in steps of 5 Hz

T


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- 60 to 200 Hz, in steps of 10 Hz

Pulse Width settings are: - 50 uS to 400 uS, in steps of 10 uS.

In TENS mode, the application method can be selected:

CONTNUO BURST VIF VLP VLF

CONTNUO (Continuous) In the operation mode, the device presents output continuous frequency signal and variable pulse duration. The Frequency value may be set between 1Hz and 200Hz, being: from

1Hz to 10Hz in steps of 1Hz; from 10Hz to 50 Hz in steps of 5 Hz and from 50 Hz to 200 Hz in steps of 10 Hz).

The pulse duration may be set between 50 s and 400 s, in steps of 10 s.

BURST In this operation mode, the device presents output continuous signal, modulated by 2Hz frequency. The output frequency is fixed at 100Hz, being modulated (interrupted)

by 2 Hz frequency. The pulse duration may be set between 50 s and 400 s, in steps of 10 s. VIF In this operation mode, the device presents output signal with automatic variation of Frequency and Pulse Width, i.e., the selected settings for frequency and pulse width present variation of +25% within a period of 3 sec., then returning to the original setting, and variation of 25%, within a period of 3 sec., then returning to the original setting. This cycle is repeated indefinitely. The frequency value may be set between 5Hz and 170Hz, being: from

5Hz to 10Hz in steps of 1Hz; from 10Hz to 50 Hz in steps of 5 Hz and from 50 Hz to 170 Hz in steps of 10 Hz).

The pulse width value may be set between 70 s and 370 s, in steps of 10 s.


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VLP In this operation mode, the device presents output signal with automatic variation of pulse width, i.e., the selected setting for pulse width presents variation of +25% within a period of 3 sec., then returning to the original setting, and variation of 25%, within a period of 3 sec., then returning to the original setting. This cycle is repeated indefinitely. The frequency is fixed according to the selected setting (adjustable

between 1Hz and 200Hz). The pulse duration varies +/- 25% of the selected setting (adjustable

between 70 s and 370 s).

VLF In this operation mode, the device presents output signal with automatic variation of frequency, i.e., the selected setting for frequency presents variation of +25% within a period of 3 sec., then returning to the original setting, and variation of 25%, within a period of 3 sec., then returning to the original setting. This cycle is repeated indefinitely.

The frequency varies +/- 25% of the selected value (adjustable between 5 and 170Hz).

The pulse duration is fixed according to the selected setting (adjustable between 50 s and 400 s).

FES

The wave form of FES mode is the Balanced Symmetrical Two-Phase Wave, as illustrated below:

T

The configurable parameters are: Frequency and Pulse Width.

Frequency settings are:


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- 1 to 10 Hz, in steps of 1 Hz - 10 to 50 Hz, in steps of 5 Hz - 60 to 200 Hz, in steps of 10 Hz

Pulse Width settings are: - 50 uS to 600 uS, in steps of 10 uS.

In FES mode the slope-up, holding, slope-down and stimulation slope rest times can be selected as illustrated in the figures below:

The selected settings are:

Slope-up Time: 0 to 9 seconds Holding: 1 to 30 seconds Slope-down: 0 to 9 seconds Rest: 1 to 30 seconds

T = Perodo

t

Freqncia = 1T

(Hz)I(mA)

Frequency

Period

Slope-down Time Rest Time

Slope-up Time

Holding Time


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In FES mode, the application form can be selected: SINCRONO. (synchronous)

All channels are enabled at the same time.

SEQUENCIAL (sequential)

Channel 1 is enabled first, followed by channel 2, and then successively.

ALTERNADO (alternate) The channels are enabled independently. Channels 1, 2, 3 and 4 are enabled and disabled sequentially.

RECIPROCO (reciprocal) (Fesmed IV 4054 only) In Fesmed II 4052, channels 1 and 2 are enabled alternately. In Fesmed IV 4054, channel pairs 1 & 2 and 3 & 4 are enabled alternately.

Device Operation:

A) FESMED IV - Model 4054 Turn on the unit using the ON / OFF switch on the rear panel.

The display will show the information:

Then, the unit enters the OPERATION MODE:

FESMED 4054 SN.: 00XXX Rev.: X.Y

TENS Normal Burst FES VIF VLP PROTOCOLOS VP


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Use the arrow keys to select FES mode.

Or PROTOCOLS mode.

O p e r a t i o n M o d e : T E N S

On the initial screen:

Use the arrow keys

to select the menu of TENS modes:

Use the arrow keys to select TENS modes: Normal, Burst, VIF, VLP or VP

TENS Normal Burst FES VIF VLP PROTOCOLS VP

TENS Normal Burst FES VIF VLP PROTOCOLOS VP

TENS Synchron Sequential FES Alternate Reciprocal PROTOCOlS

TENS

FES

PROTOCOLS


TENS Normal Timer 10 m 00 s

Frequency 100 Hz Pulse Widt 100 uS 0 0 0 0


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Press t o enable the selected mode.

Use the arrow keys to select Timer:

Use the arrow keys to set the desired time.

Use the arrow keys to select Frequency:

Use the arrow keys to set the desired time.












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Use the arrow keys to select Pulse Width:

Use the arrow keys to set the desired Pulse Width.

Press to enable the output channels.

Sada Acionada (Output Enabled) will be displayed and the selected time will be decreased every second.

To disable the outputs, press . Use the intensity control keys to increase or decrease the intensity:

The intensity controls are independent. After increasing or decreasing the intensity of any channel, the intensities of the other channels will be reset to zero. If there is no intensity alteration within 6 seconds, the intensities from reset channels will return to the intensity setting. After the set time is expired, a sound warning will be heard, and the intensities will be reset to zero.



TENS Normal Timer 15 m 00 s Out put ON Frequency 150 Hz Pulse Widt 200 uS 0 0 0 0

TENS Normal Timer 15 m 00 s Output ON Frequency 100 Hz Pulse Widt 200 uS 0 0 0 0


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To start a new therapy, select the desired time, check whether the Frequency and Pulse Width parameters are correct; otherwise, change the

settings and press .

O p e r a t i o n M o d e : F E S


Use the arrow keys to select FES operation mode

Use the arrow keys to select the menu for FES modes:

Use the arrow keys to select FES modes: Sincrono, Sequencial, Alternado or Reciproco.

TENS

PROTOCOLS


TENS Synchron Sequential FES Alternate Reciprocal PROTOCOLS

TENS Synchron Sequential FES Alternate Reciprocal PROTOCOLS

FES Synchron Timer 10 m 00 s

Frequency 100 Hz Pulse Widt 100 uS Slope / \ __ 0 : 1 : 0 : 1 s 0 0 0 0


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Use the arrow keys to set the time.


Use the arrow keys to set the Frequency value:












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Use the arrow keys to set the Pulse Width value.

Use the arrow keys to select SLOPE parameters and

the arrow keys to set the slope-up time, from 0 (zero) to 9 seconds.

Use the arrow keys to select the holding time setting, and

the arrow keys to set the slope holding time, from 1 to 30 seconds.

Use the arrow keys to select the slope-down parameter, and










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the arrow keys to set the slope-down time, from 0 (zero) to 9 seconds.

Use the arrow keys to select the slope rest parameter, and

the arrow keys to set the slope rest time, from 1 to 30 seconds.



To disable the outputs, press .





FES Synchron Timer 14 m 59 s Output ON Frequency 180 Hz Pulse Widt 400 uS Slope / \ __ 9 : 30 : 9 : 30 s 0 0 0 0


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Use the intensity control keys to increase or decrease the intensity:

The intensity controls are independent. After increasing or decreasing the intensity of any channel, the intensities of the other channels will be reset to zero. If there is no intensity alteration within 6 seconds, the intensities from reset channels will return to the intensity setting.

After the set time is expired, a sound warning will be heard, and the intensities will be reset to zero. To start a new therapy, select the desired time, check whether the Frequency and Pulse Width parameters are correct; otherwise, change the


B ) FESMED II - Model 4052

Turn on the unit using the ON / OFF switch on the rear panel.

The display will show the information:

Then, the unit enters the OPERATION MODE:

FES Synchron Timer 14 m 59 s Output ON Frequency 180 Hz Pulse Widt 400 uS Slope / \ __ 9 : 30 : 9 : 30 s 0 0 0 0

FESMED 4052

SN.: 00XXX Rev.: X.Y



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Use the arrow keys to select FES mode.

Or the PROTOCOLS mode.

O p e r a t i o n M o d e : T E N S


Use the arrow keys to select the menu of TENS modes:



TENS Synchron Sequential FES Alternate

PROTOCOLS

TENS

FES

PROTOCOLS



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Use the arrow keys to select TENS modes: Normal, Burst, VIF, VLP or VP.








Frequency 100 Hz Pulse Widt 100 uS 0 0












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Use the arrow keys to set the Pulse Width value:





After the set time is expired, a sound warning will be heard, and the intensities will be reset to zero.



TENS Normal Timer 15 m 00 s Output ON Frequency 150 Hz Pulse Widt 200 uS 0 0

TENS Normal Timer 15 m 00 s Output ON mA Frequency 150 Hz Pulse Widt 200 uS 0 0


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To start a new therapy, select the desired time, check whether the Frequency and Pulse Width parameters are correct; otherwise, change the


O p e r a t i o n M o d e : F E S


Use the arrow keys to select FES operation mode.

Use the arrow keys to select the menu of FES modes:

Use the arrow keys to select FES modes: Sincrono, Seqencial or Alternado.



PROTOCOLS



Frequency 100 Hz Pulse Widt 100 uS Slope / \ __ 0 : 1 : 0 : 1 s 0 0


PROTOCOLS


PROTOCOLS


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Use the arrow keys to set Frequency.













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Use the arrow keys to set the Pulse Width value.

Use the arrow keys to select SLOPE parameters, and

the arrow keys to set the slope-up time, 0 (zero) to 9 seconds.

Use the arrow keys to select the holding parameter, and

the arrow keys to set the slope holding time, 1 to 30 seconds.

Use the arrow keys to select the slope-down parameter,

and the arrow keys to set the slope-down time, 0 (zero) to 9 seconds.












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Use the arrow keys to select the rest parameter, and

the arrow keys to set the slope rest time, 1 to 30 seconds.

Press to enable the output channels. Output ON (Output Enabled) will be displayed and the selected time will be decreased every second.





FES Synchron Timer 14 m 59 s Output ON Frequency 180 Hz Pulse Widt 400 uS Slope / \ __ 9 : 30 : 9 : 30 s 0 0

FES Synchron Timer 14 m 59 s Output ON Frequency 180 Hz Pulse Widt 400 uS Slope / \ __ 9 : 30 : 9 : 30 s 0 0


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After the set time is expired, a sound warning will be heard, and the intensities will be reset to zero. To start a new therapy, select the desired time, check whether the Frequency and Pulse Width parameters are correct; otherwise, change the


Pro tocols

A) Protocol Selection

On the main screen,

use the arrow keys to select PROTOCOLOS.

Press .

Use the arrow keys to select the desired PROTOCOL.

Press to enable the selected protocol.

Or press to Return to the main menu.

PROTOCOLS STP TO DEL XXXXX FES YYYYY ZZZZZ

TENS

FES

PROTOCOLS



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B) Store Protocol

To store a protocol, select the desired parameters in FES or TENS mode. Ex.: FES Protocol, Alternate mode, FESMED IV.

Press . The storing screen will be displayed:

Use the arrow keys and to select a letter.

Press to confirm or to delete.

To record the protocol entered, press .

Note : The Fesmed allow you to record more than 30 Protocols in your memory.

1 2 3 4 5 6 7 8 9 0 a b c d e f g h i j k l m n o p q r s t u v w x y z , . Stp to DEL

teste gravar------

FES Alternate Timer 15 m 00 s



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C) Delete Protocol

On the initial screen, use the arrow keys to select PROTOCOLOS.

Press .

Use the arrow keys to select the desired PROTOCOL.

Press a to delete the selected protocol.

The following screen will be displayed:

Press to confirm, or to keep the previous protocol.

Press to return to the main menu.

Indications FES The functional electrical stimulation may be widely used as an aid in clinical treatments of neuromuscular system and skeletal muscle problems. In the presence of inactivity in peripheral nerve excitability, an external source of

PROTOCOLS STP TO DEL XXXXX FES YYYYY ZZZZZ

PROTOCOLS STP TO DEL XXXXX FES YYYYY Delet. ? ZZZZZ Enter= YES Menu = NO


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excitation may therapeutically induce the individual to a functional reaction, if the patients present difficult voluntary movements. The more common candidates to neuromuscular electrical stimulation (NMES) are: patients recovering from central nervous system lesions, with difficult gait and cranial traumas; patients after orthopedic surgeries, such as those with arthritis who have received prosthesis or athletes who have had tendon problems. The electrical stimulation may also be used in denervated muscles, in the following programs: Muscle strengthening through strength and force programs; Maintenance or increase of movement amplitude (stretching and

contracting), including contracting correction; Facilitation and reeducation of voluntary motor functions; Orthostatic training, including replacements of traditional orthesis; Control of chronic and acute edemas; Control of temporary inhibition of muscle spasms.

TENS Acute or chronic painful processes (overcoming the pain until its cause is securely identified): cervical-dorsal-lumbar pains lumbar sciatic pains, trigeminal neuralgias brachialgias surgical wound pains headache and articulation pains patients submitted to surgery and required to mobilize corporal

segments traumatized during surgical operation pulmonary re-expansion after thorax or abdomen surgery limb mobilization in cases of segment amputations bursitis traumatized limbs, plus hundreds of acute or chronic painful conditions.

Contraindications FES There are few specific contraindications for the therapeutic utilization of electrical stimulation. One of them is the presence of heart pacemaker. The


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presence of superficial electrical stimulation in any part of the body may cause interference in the pacemaker demand control circuit. Patients with heart problems; Pregnancy, mainly in the first three months. TENS No contraindications for TENS utilization are known so far. However, the following applications should be avoided: patients with Heart or Brain Pacemaker; patients with heart problems; patients with epilepsy; lumbar and abdominal regions - in the first three months of pregnant

patients; carotid arteries in the breast region.

Note: TENS should be applied only in case of diagnosed pains; otherwise, we could be hiding a pathological symptom of the body.

Electrode Application

Attention:

The utilization of non-specified accessories by the manufacturer, which is not allowed, may affect the patient and the correct device operation.

Before the Treatment: Check for contraindications with the patient. Test the heat sensitivity of the area to be treated. Clean the area to be treated with a solution of neutral soup and

water.

Conductive Rubber (Silicone) Electrode

We recommend the utilization of conductive rubber (silicone) electrodes, combined with conductive gel or moist sponge. The utilization of gel or properly moistened sponges ensures low impedance between the skin and Fesmed stimulator. After the treatment, electrodes and sponges can be easily cleaned.


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For securing electrodes with gel, or moist sponges, to the patients skin, a medical adhesive tape or elastic band may be used.

Self-Adherent Electrode

The utilization of self-adherent electrodes is characterized by the easy contact with the skin, due to its malleability. The thin adherent gel layer enables low impedance between the skin and Fesmed stimulator. If, during the application, the patient informs the stimulation is very weak, it is an indication that the electrodes should be replaced. They should also be replaced if the display shows M on the right side of the intensity indicator and if intensity reading is zero.

Electrolytic Effect

Electrolysis occurs under the electrodes, when types of currents with CC component are applied. FESMED is equipped with null CC component. In the electrolytic effect, due to the high concentration of electrolytes caused by ion migration under the electrodes, we recommend the silicone electrode utilization with sufficient gel, and properly moistened sponges, or new self-adherent electrodes, in order to keep the lowest electrolytic effect.

Current Density

According to NBR IEC 60601-2-10, the maximum admissible current density is 2 mA RMS / cm2. FESMED output is limited to 50 mA RMS, with load of 500 Ohms. In order to check whether the current density has exceeded the maximum admissible value or not, divide the output current (in mA) by the effective electrode area (in cm2).

Electrode connection and disconnection reactions

FESMED presents constant current at the current output, which may cause unpleasant reactions if the electrodes are not correctly attached to the skin or if skin contact has been lost. Be sure the output is reading 0 (zero) mA when attaching or removing electrodes.


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Preventive maintenance, conservation and cleaning

We recommend FESMED inspection and calibration once a year. Be sure to always turn off the device from the outlet before cleaning it.

Avoid wetting the electrical contacts of wires and connectors. Use moistened cloth with water and soap to clean the device housing. Keep a regular control over the power source and the power cable,

ensuring they present no defects. When disconnecting the electrode cable from the device, always pull it

by the plug, avoiding cable rupture. Always remove carefully the electrodes from the patient in order to

avoid damages. Inspect electrode cables regularly, checking for cable rupture to plugs.

Special care to adherent or silicone electrodes

For a longer electrode durability: When using silicone electrodes, always clean the plug contacts,

avoiding residues that make electrical contact more difficult. After using silicone electrodes, wash them with running water and dry

them. Keep electrodes in a fresh and dry place. After using adherent electrodes, remove them carefully from the

electrode cable, moisten them with water and keep them in their envelope, in a fresh and dry place.

Corrective maintenance Important Notes: The corrective maintenance of this device, besides those prescribed above, should be performed only by CARCI authorized professionals. Electrical connections, circuits and part list are not supplied to end consumers. If required, contact CARCI Authorized Technical Service. Problems Solutions

The device does not turn on. See if the power cable is connected to the

wall outlet. Check for blown fuse.

The patient says the stimulation Change the silicone or adherent electrodes, for they are worn out.


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sensation is higher with an electrode than with another.

The intensity is at maximum setting and the patient feels little stimulation.

Check the patients sensitiveness. Change the silicone or adherent

electrodes.

When increasing the intensity (above 10 mA), the Beep start, and the lettler M is displayed on the right side of the intensity.

CAUSE: Low level current detected when applied in the patient.

Check the electrode connection into the device

Check the electrode cable continuity. Check the conductivity of the electrodes. Press the key Start and begin a new

treatment Increase the intensity, above 10mA, and

according with patient sensibility, until the patient describe the stimulation. The Beep should stop and the letter m will not be displayed

When increasing the intensity, it is reset to zero, the message ERROR OUT is indicated on display, and the letter M is displayed on the right side of the intensity.

CAUSE: It means current excess.

Press the key Start and begin a new treatment

Check the conductivity of the electrodes. Check for short circuit in the electrode

cable plug. Contact the technical support.

The device is on as usual, but the patient says there is no stimulation.

Check the electrode connection into the device

Check the attachment and continuity of the electrode cables to the patient.

Check the conductivity of the electrodes.

Technical Data

Made by : CARCI Brazil Models : FESMED II 4052 and FESMED IV 4054 Function and Application : Electrotherapy device Power supply : 100230 V~ automatic ( 10%)

: 50 / 60 Hz Maximum Consumption : 25 VA ANVISA registration : AM-10314290017


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

Classification according to NBR IEC 60601.1 and NBR IEC 60601.2.10 rules:

- Type of protection against electrical shocks:..................... class II - Protection level against electrical shocks of the applied part: BF type - Protection level against harmful water penetration: IPX0 - Disinfection methods: see preventive maintenance - Safety degree of application in the presence of anesthetic mixture inflammable with air, oxygen or nitrous oxide: not applicable - Operation mode: continuous ----------------------------------------------------------------------------------------------------

Fuse : 1.0 A 250 V 20 AG Dimensions : 31 x 6 x 18 (WxHxD) (cm) Weight : 2.6 kg Overcurrent protection Direct current component = Zero

F E S M o d e P r o g r a m m i n g

Common parameters to both channels: Slope-up/slope-down time : 0 to 9 s Slope retaining time : 1 to 30 s Slope rest time : 1 to 30 s Parameters of channels: Pulse duration : 50 to 600 us Pulse frequency : 1 to 200 Hz

T E N S M o d e P r o g r a m m i n g

Parameters of channels: Pulse frequency : 1 to 200Hz Pulse duration : 50 to 400 us Operation modes:

Contnuo : adjustable frequency and duration Burst : Ton : 1s - Toff : 1s with adjustable frequency and

duration VIF : adjustable and variable frequency and duration VF : adjustable and variable frequency, adjustable

duration VLP : adjustable and variable duration, adjustable

frequency Synchronous output in both channels.


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Operating conditions of the device: Ambient temperature : +10C to +40C Relative humidity : 0% to 80% Air pressure : 700 hPa to 1060hPa

Environmental conditions for transport and storage: Room temperature : -10C to 60oC Relative humidity : 20% to 90% Air pressure : 500hPa to 1060hPa

Accessories

FESMED IV 4054 Silicone electrodes 3 x 5 cm Code 04033 Electrode cables

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

Three-pole power cable Code 14747G Users Manual Code 10395G Contact gel Code 7000/200

FESMED II 4052 Silicone electrodes 3 x 5 cm Code 04033 Electrode cables

Green Code 21306G Blue Code 20307G

Three-pole power cable Code 14747G Users Manual Code 10395G Contact gel Code 7000/200

Note: In case of accessory replacement, only those recommended by CARCI should be used. The use of accessories not specified by CARCI may affect the equipment safety. CARCI shall not be responsible if that occurs.

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


MU_4052_4054_ENG_Rev:02_092009 42

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

Declarations

MANUFACTURERS DECLARATION AND INSTRUCTION ELECTROMAGNETIC EMISSIONS

FESMED should be used in the electromagnetic environment described as follows. FESMED purchaser or operator should be aware that the device operation is being

done in such environment.

Emission tests Compliance Electromagnetic environment - instructions

RF Emission CISPR 11 Group 1

FESMED uses RF energy only for its internal functioning. This way, its RF emission is very low and it is not probable that it causes any interference in another electronic device nearby.

RF Emission CISPR 11 Class B FESMED is intended for utilization in all establishments,

including household applications and those directly connected to the utility power supply that provides for constructions of household purposes.

Harmonic Emission IEC 61000-3-2 Class A

Voltage Floating / Flicker Emission IEC 61000-3-3

According to

MANUFACTURERS DECLARATION AND INSTRUCTION ELECTROMAGNETIC IMMUNITY

FESMED should be used in the electromagnetic environment described as follows. FESMED purchaser or operator should be aware that is operating the device in

such environment.


MU_4052_4054_ENG_Rev:02_092009 43

Immunity tests Test level of IEC 60601 Compliance

level Electromagnetic

environment - instructions

Electrostatic discharge IEC 61000-4-2

6 kV contact 8 kV air

6 kV contact 8 kV air

The floor should be made of wood, concrete or ceramic. If covered with synthetic material, the relative air humidity should be min. 30%.

Fast transients / Blasts IEC 61000-4-4

2 kV power supply line 1 kV signal input and output line

2 kV power supply

Not applicable

The electrical system quality should be that of a typical hospital or commercial environment.

Surge IEC 61000-4-5

1 kV differential mode 2 kV common mode

1 kV differential mode 2 kV common mode

Voltage failures, short interruptions and voltage variations in power supply. IEC 61000-4-11

95% Ut reduction) For 0.5 cycle

40% Ut (60% Ut reduction) For 5 cycles


95% Ut reduction) For 5 s

95% Ut reduction) For 0.5 cycle



95% Ut reduction) For 5 s


MU_4052_4054_ENG_Rev:02_092009 44

Magnetic fields of utility frequencies (50/60 Hz) IEC 61000-4-8

3 A/m 3 A/m

The magnetic fields of utility frequencies should be levels of typical hospital or commercial environment.

Note: Ut is the utility voltage C.A before the test level application.

Conducted RF IEC 61000-4-6

Irradiated 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 devices of RF communications should not be used closer to any FESMED part - including cables - than the distance recommended as calculated through the equation applicable to the transmitter frequency. Recommended 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 max. output power of the transmitter in watts (W), according to the transmitter manufacturer, and d is the recommended distance in meters (m). The field generated by fixed RF transmitters, as determined through an on-site electromagnetic field studya, should be lower than the compliance level in each frequency rangeb. Interferences may occur in the neighboring area of the equipment with the following symbol:


MU_4052_4054_ENG_Rev:02_092009 45

NOTE 1: within the of 80 MHz and 800 MHz, the highest range frequency should be applied. NOTE 2: This procedure may not be applicable to all situations. The electromagnet propagation is affected by absorption and reflection of structures, objects and people. a. The intensity of fields generated by fixed transmitters, such as telephone radio-

base (mobile/wireless) and land mobile radio stations, amateur radio stations and AM, FM and TV radiobroadcast stations cannot be theoretically identified with precision. In order to evaluate the electromagnetic environment caused by fixed RF transmitters, a study on the site electromagnetic field should be taken into account. If the field intensity measured at the site where FESMED is used exceeds the compliance level above, FESMED should be checked for normal operation. If abnormal performance is observed, additional measures should be taken, such as FESMED reorientation or reallocation;

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

Distances recommended between portable and mobile RF communications devices and FESMED

FESMED should be used in electromagnetic environment where RF disturbances are controlled. FESMED purchaser or operator can help prevent electromagnetic

interferences by keeping the minimum distance between portable and mobile (transmitter) RF communications devices and FESMED, as recommended below,

according to the maximum output power of the communications equipment.

Declared value of max. output power of the transmitter (W)

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 11.70 cm 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 value of max. output power not listed above, the recommended distance (d in meters) may be determined through the equation applicable to the transmitter frequency, where P is the max. output power of the transmitter in watts (W), according to the transmitter manufacturer.


MU_4052_4054_ENG_Rev:02_092009 46

NOTE 1: between 80 MHz and 800 MHz: the highest frequency distance should be applied. NOTE 2: this procedure may be applied to all situations. The electromagnet propagation is affected by absorption and reflection of structures, objects and people.

Fina l Considera t ions

Carcis policy is to continuously improve the quality of its products. Carci reserves the right to make changes in the product project and specifications, as well as add and improve its products, which should not incur any obligation to install such changes in products already manufactured. The text, illustrations and specifications contained in this manual are based on information available at the printing moment. All rights reserved. This manual should not be reproduced wholly or partly, without Carcis authorization in writing.

Manufacturers Information CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. CGC: 61.461.034/0001-78 I.E. : 110.182.450.113 Rua lvares Fagundes, 359 So Paulo SP Brazil 04338-000 Tel.: (0XX11) 3346 2100 E-mail: [email protected] web site : www.carci.com.br

Carci registration at the Health Department: MS-1.03.142-9

For Technical Support: Departamento de Assistncia Tcnica Rua lvares Fagundes, 359 So Paulo SP Brazil 04338-000 Tel.: (0XX)11 5621 7024 / 5622 8205 e-mail : [email protected]

Technical Professional in Charge: Orlando Orlandi Melo de Carvalho - CREA 5061377287/D


MU_4052_4054_ENG_Rev:02_092009 47

European Representative

OBELIS SA 34, Av. de Tervuren, bte 44 B 1040 Brussels , BELGIUM Tel: (32) 2.732.59.54 Fax: (32) 2.732.60.03

E-mail: [email protected]

W ARRANTY CERTIF ICATE IN ANNEX

Re ferences

1. Clinical Electro Physiology 2nd edition Andrew J. Robinson / Lynn Snyder Mackler Williams & Williams - 1995

2. Introduction to surface Electromyography Jefgfrey R. Cram / Glenn S. Kasman Aspen - 1998

3. Estimulao Eltrica Funcional FES e REABILITAO Sergio Lianza Editora Atheneu - 1993

4. Eletroterapia de Clayton 10a edio Editora Manole Ltda. 1998. 5. Electrical Muscle Stimulation (EMS) Clinical Manual Toshihiro

Morinaga M.S., R.P.T. Kyoto University College of Allied Medical Sciences First Edition 1998.

6. Neuromuscular Electrical Stimulation A practical Guide 3rd Edition 1993.

7. Bertrand Sr. Method of determining optimal stimulation sites for transcutaneous electrical nerve stimulation. Physical Therapy 64:924-928, 1984.

8. Bohm E. Transcutaneous electrical nerve stimulation in chronic pain after peripheral nerve injury. Acta Neurochir (Wien) 40:277-283, 1978.

9. Fried T, Johnson R, McCracken W: Transcutaneous electrical nerve stimulation: Its role in the control of Chronic pain. Arch Phys Med Rehab 65:228-231, 1984.


MU_4052_4054_ENG_Rev:02_092009 48

10. Goldner Jl, Nashold Bs Jr, Hendrix PC: Peripheral nerve electrical stimulation. Clin Orthopedic 163:33-41,1982.

11. Hanson P, Ekblon A: Transcutaneous electrical nerve stimulation (TENS) as compared to placebo TENS for the Relief of acute oro-facial pain. Pain 15:157-165, 1983.

12. Harvie KW: A major Advantage in the control postoperative Knee pain. Orthopedics 2:1-2, 1979.

13. Mannheimer C, Lun S, Carisson C-A The effect of transcutaneous electrical nerve stimulation (TENS) on joint pain in patients with rheumatoid arthritis, Scand J Rheumatol 7:13-16, 1978.

14. Miler Jones CHM: Forum: Transcutaneous nerve stimulation in labor. Anesthesia 35:372-375, 1980.

15. Pike PHM: Transcutaneous electrical stimulation: Its use in management of postoperative pain. Anesthesia 33: 165-171, 1978.

16. McClean, D, Owen, H Gray C and Wallace D (1986). TENS post-operative analgesia a plasma beta-endorphin concentration, Proceedings of Anesthetic Research Society, British Journal of Anesthesia, 58,121P-122P.

17. Eriksson, M B E, Sjolund, B H and Nielzen, S (1979), Long-Term results of peripheral conditioning stimulation as an analgesia measure in chronic pain, Pain, 6, 335-347.

18. Wolf, C J (1984), Transcutaneous and implanted nerve stimulation, in Wall, Pd and Melzak, R (eds) The Textbook of Pain, Churchill Living stone, Edinburgh, chapter 3d1, pages 679-690.

19. Wolf SL, Gersh MR., Rao VR: Examination of electrode Placements and stimulating parameters in treating chronic pain with conventional transcutaneous electrical nerve stimulation (TENS). Pain 11:8-47,1981.

20. Moore DE, Blacker HM: How effective is TENS for Chronic Pain. Am J Nurs 83:1175-1177,1983.

21. Schomburg FL, Carter-Baker SA: Transcutaneous electrical nerve stimulation for postolaparotomy pain. Physiotherapy 63:188:193, 1983.

22. Taylor Ag, West Ba Simon B, et al: How effective is TENS for acute pain. Am J Nurs 83:1171-1174, 1983.

23. Solomon RA, Viernistein MC, Long DM: Reduction of postoperative pain and narcotic use by transcutaneous electrical nerve stimulation. Surgery 87:142-146.


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24. Sodipo Joa, Adedeji SA, Olumide O: Postoperative pain relief by TENS. Am J Chin Med 8:190-194, 1980.

25. Riley JE: The impact of TENS on the post-cesarean patient. Journal of Obstetrics, Gynecology, and Neonatal Nursing 11:325-329, 1982.

26. Erkola R Pikkola P, Kanto J: Transcutaneous nerve stimulation for pain relief during labor: A controlled Study. Ann Chir Gynaecol 69:273-277, 1980.

27. Jones M C M H: Transcutaneous nerve stimulation in labor. Anesthesia 35:372-375,1980.

28. Satisteban AJ: The role of Physical agents in the treatment of spine pain. Clin Orthorp 179:24-30,1983.

29. Taylor P, Hallett M, Flaherty L: Treatment of osteoarthitis of the knee with transcutaneous never stimulation. Pain 11:233-240, 1981.

30. Winnem MF, Amundsen T: Treatment of phantom limb pain with transcutaneous electrical nerve stimulation. Pain 12:299-300,1982.

31. Kahn J: Transcutaneous electrical nerve stimulation for no united fractures: A clinical report. Physiotherapy 62:950-844, 1982.

32. Gersh MR, Wolf SL, Rao VR: Evaluation of transcutaneous electrical nerve stimulation for pain relief in peripheral neuropathy: A clinical documentation. Physiotherapy 60:48-52, 1980.

33. Melzak R, Vetere P, Finch L: Transcutaneous electrical nerve stimulation for low back pain: A comparison of TENS and Massage for pain and range motion. Physiotherapy 63:489-493, 1983.

Documents

MU_Fesmed_4052_4054_ENG_Rev02_092009