Diatermed II

4022

User Manual

English

Revision : 09

Carci Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. Made in Brazil

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T ab le o f Contents

Presentation 2 Accessories 2 General Information 3 Symbols 4 Installation 6 Warnings and Recommendations 9 Physic Principles of Shortwave 12 Continuous and Pulsed mode shortwave 13 Description of Diatermed II 16 Controls 17 Control Functions 18 Equipment Operation 20 Use of Intensity and Tunning Controls 20 Protection Devices 21 Therapeutic Effects 21 Indications 22 Contraindications 23 Preservation and Preventive Maintenance 24 Corrective Maintenance 25 Schiliephakes Electrode 26 Adjusting the Electrode Skin distance 27 Technical Features 29 Optinal Accessories 30 Declarations 31 Final Considerations 35 Bibliographic References 36 European Representative 36

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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. DIATERMED II - 4022 device was designed according to NBR IEC 60601.1:1994 + amend 1:1997, IEC 60601-1-2:2006 and IEC 60601-2-3:1997 safety rules, which makes them a safe and reliable product. Accessories supplied with the device DIATERMED II 4022 01 User manual 01 Three-pole power cable 03 Fuses 20 AG - 3 A (for use at 220 V ~ ) 03 Fuses 20 AG - 5 A (for use at 127 V ~ ) 02 Electrode boards in silicone (12 x 17 Cm) 02 Silicone cables for connection with electrode boards 04 Woo Separation (12 x 17 Cm) 02 Cotton packs for electrode boards To buy optional accessories, please verify the codes at page 26, 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 : sat@carci.com.br

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GENERAL INFORMATION

The references to the clinic use of high frequency electric currents were tested for the first time in 1890. drsonval caused a high frequency current of 1A to pass through his assistants and his own body. Although he knew that similar electrical intensities at low frequencies were potentially fatal, drsonval described only a sensation of heat (Guy, 1984). Following works led to the development of inductive and capacitive methods for the application of high frequency currents in the body, generating a non-superficial heat (Guy, 1984). These methods became known as diathermy, from the Greek word that means heating by means of.

Diatermed II 4022 is a high frequency equipment (27,12 MHz) for Diathermy through Short Waves, operating in Continuous and Pulsed modes.

This equipment may be used with plate electrodes or Schliephakes electrodes (optional). Plate electrodes and the connection cables are made or vulcanized silicon rubber (unique in the national market). The quality of the raw material employed in our electrodes and cables provide a safe and comfortable application.

Schliephakes electrodes (optional) may be adjusted in the distance electrode-skin, which allows the movement of the concentration of heat generated.

It is a modern equipment, built with high quality electronic components. The project was based on the security requirements provided by NBR IEC 60.601.1

Finally, we congratulate you for purchasing this equipment. Quality, Technology and Reliability assure that Diatermed II 4022 with Continuous and Pulsed Short Waves is a safe and highly reliable equipment.

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Equipment symbols

Equipment off

Equipment on

This equipment has physiological effects. Consult instructions manual.

Applied part is type BF

IPX0

Not protected from harmful water penetration

Manufacturing date

Serial number

Manufacturer identification

Non-Ionizing Radiation Emission

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Cord switch

CE Mark and certifying body identification

European Representative

Symbols on the pack

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 marked in the intermediary square.

Minimum and maximum temperature

limits for transport and storage.

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Electrical Installation / Connection

WARNINGS

1. This device can only be operated by qualified personnel; 2. The electrode application close to the thorax may increase the risk of heart fibrillation;

3. Simultaneous connections of a PATIENT to a ELECTRICAL STIMULATOR THERAPY DEVICE may result in burns where the STIMULATOR electrodes were applied and possible damages to the stimulator;

4. C om b i na t i o n t h e r a p y Since the DIATERMED radiates an electromagnetic field that can affect electronic circuits inside equipment in the direct vicinity, you are strongly advised against any sort of combination in treatment whereby. 5. Short-distance operation (for instance: 1 m) from a ELECTRICAL TIMULATOR THERAPY DEVICE may produce instability at the STIMULATOR output;

6. Do note place the device on a soft surface that may block the bottom ventilation openings.

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.

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Electric power connection The 115/230V switch key, the fuses and the power cord connector are located on the back of the package shell.

A: 115/230Vac Switch Key B1 and B2: Fuse Port C: Power cable connector

Take out the lid of the fuse Holder with the help of a Screw driver. Take the fuse out and replace it by other of the same specification.

Install the fuses in the fuse ports B1 and B2, in accordance with the local electric network.

For 115Vac - use fuses type 5A - 250V size: 20 AG

For 230Vac - use fuses type 3A - 250V size: 20 AG

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Select the operational voltage according to the local electric network through the key A

Connect the three-pole power cable to connector C

Your equipment is ready to work. Notes:

This device is equipped with a special electronic line filter, which is intended to avoid that part of the noise signals generated by this equipment interferes in other equipment. The connection of the ground cable is critical for the correct operation of the circuit.

ALTHOUGH THIS EQUIPMENT MAY OPERATE IN BOTH 115Vac AND 230Vac.

WE SUGGEST THAT IT BE CONNECTED TO THE 230V NETWORK

This equipment generates high frequency magnetic fields that cross walls, ceilings, floors, etc. Such magnetic fields may cause interferences in electronic devices installed in the surroundings. In order to mitigate such interference, you must:

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Install other electronic equipment at least 5 meters away.

Use a good quality grounding

Use the 230V electric network

The interference may be mitigated to acceptable levels by means of a metallic and grounded screen placed inside the treatment box.

In cases where the interference is more severe, install a Faraday cage (electromagnetic shielding).

Warnings and Recommendations

This equipment should be operated only by qualified personnel in accordance

with the laws of the country of use; Never use other output cables than those supplied with the equipment and

approved by CARCI because there may be performance degradation and security equipment.

Do not wrap the cord in order to shorten it, it may damage the appliance

through induced currents;

Keep the electrode cables parallel. Do not cross or approach them, because there will be loss of power, damaging the unit.

The function of certain implanted electrical devices such as pacemakers, can be negatively affected during treatment with short-wave therapy. If in doubt, should be heard the recommendations of the physician responsible for patient;

The function of other equipment connected to a patient can be negatively

affected by the operation of short-wave equipment;

Patients usually should not be treated with short-wave therapy when they have reduced their sensitivity to heat the treatment area, unless the physician responsible for patient to be informed;

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The short-wave therapy should not be applied to patients through clothing. Conductive material should be eliminated from the treatment area;

Body of patients who have metal implants (medullary pins, for example) should normally be excluded from the treatment area, unless special techniques are used;

Hearing aids should be removed from the patient for treatment;

The patient must not come into contact with conductive parts that are connected to land or have an appreciable capacitance to ground and that can lead to unwanted paths represent current and radiofrequency. In particular, should not be used beds or chairs with metal frame;

The connection cables associated with the applicator should be positioned so

that a patient contact or conductive objects or absorbing power is avoided. It is recommended that the equipment operator to inspect the insulation of your

cords and applicators to check for possible damage; Do not dispose of such equipment or fittings in the trash at the end of its useful

life. There are substances in the equipment that may be harmful to nature, if not treated properly. In need of disposal of the equipment or its accessories, refer to the material CARCI, which will follow up accordingly.

Important observations:

This equipment is not adequate for use in the presence of an anesthetic mixture capable of inflammation in contact with the air or nitrous oxide.

Furniture and Clothing

Metal parts in furniture can cause concentrations in the intensity of the electromagnetic Field. Therefore, use only wood furniture free of metal. For all treatments with shortwave is advisable to strip the site to be treated in the patient and apply a towel between the skin and the electrode.

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Electromagnetic Interference.

The Diatermed II 4022 produces an electromagnetic field which is intended to generate thermal and biological effects in tissues and joints of the human body. In the open air, the strength of the electromagnetic field generated from electrodes, cables and treated patient is reduced in quadratic form with distance. This electromagnetic field can affect the electronics equipments placed in the neighborhood. For medium and low frequency physiotherapy equipments, this modulation can become perceptible to the patient as well. The susceptibility to electromagnetic interference of equipments from different manufacturers can be very different. This is due to the fact that some manufacturers are still insufficiently shielding their equipment against external electromagnetic fields. In the event of interference, we recommend contacting the manufacturer.

It is recommended attention to the following items in order to minimize possibility of electromagnetic interference

The greater the distance between the short-wave equipment and other equipment, lower electromagnetic interference. Place your shortwave unit and the patient in treatment, at least 8 meter from other electronic equipment. Make sure there are no metal oblong conductors objects in the vicinity, because they act as antennas (specially objects with a length of about 5,5 meters). Use a separate group of electric power (phase) for the shortwave equipment. Keep power cords away. The high frequency will be considerably reduced when the shortwave equipment is installed in a Faraday Gage.

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PHYSIC PRI NCIPLES o f SHORT WAVES High Frequency Electrotherapy

The high frequency electrotherapy is defined as the therapeutic use of electromagnetic oscillations with frequencies superior to 300 KHz. Such high electromagnetic frequency oscillations do not cause the depolarization of the nerve fibers, but the electromagnetic energy may turn into thermal energy inside the body tissue. Therapy by Short Waves is a form of high frequency electrotherapy.

Electromagnetic radiations with frequencies between 10 MHz and 100 MHz are known as short waves. The frequency employed in the Short Waves diathermy is 27.12 MHz.

The relation between frequency and wavelength comes from the following equation:

V = . f Where: V is the propagation speed of light in vacuum (300,000 Km/s)

f is the frequency (in this case, 27.12 MHz) is the wavelength

The heat produced by the Short Waves therapy is based on the principle that dipolar molecules found in living tissues are made basically of water and some proteins. These molecules are also affected by the electric fields. The positive pole of the molecule lines up towards the negative pole of the electric field and, this way, the alternate field of Short Waves Diathermy cause the rotation of such molecules, since the electric field between the electrodes is rapidly altered (about 27 million times per second). The heat resulting from the frictional drag between adjacent molecules describes this process as a reasonably efficient method of heating.

The heat is generated according to the following equation: Q = I 2. R t Where: Q heat in Joule

I current amplitude R ohmic resistance t time in seconds

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CONTINUOUS and PULSED Mode SHORT WAVES

Continuous Mode Short Waves

When Short Waves are continuously applied for a certain period of time, the dipolar molecules of the tissue initiate a continuous oscillating movement, which generates energy by the frictional drag between adjacent molecules, which is then transformed into heat.

Pulsed Mode Short Waves

The pulsed Short Waves consist of the application of a series of pulse trains with a specific frequency and duration.

Figure 4 exemplifies the emission of Short Waves in pulsed mode. High frequency (27.12 MHz) is modulated by a low frequency (selected according to the type of treatment). The duration of the pulse trains is always constant in 400 ms.

Continuous Short Waves

20 minutes period

27.12 Mhz

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Figure 4

The intensity of this energy is directly proportional to the modulation frequency in the pulsed mode, that is, the lower the modulation frequency, the lesser is the total energy amount, and vice versa.

As in:

T = 1 / f Where: T is the time in milliseconds (ms) F is the frequency in Hertz (Hz)

The Pulse Duration is steady (400 ms). The conclusion is that, for the same intensity, if the modulation frequency is increased the energy applied is also increased, which causes the median power to increase in the same proportion.

The median power is obtained through the following equation:

Pm = (Pp x Tp x Fp) Where: Pm is the median power Pp is the peak power Fp is the modulation frequency

Brief discharge of Short Waves Resting period between Short Wave

discharges

Beginning of the treatment End of the treatment

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The chart below illustrates the parameters required to calculate the median power:

In Diatermed II, the pulsed mode frequencies (Fp) are: 45, 70, 85, 115, 145, 175, 200, 230, 300 and 400 Hz

The maximum peak power (Pp) in pulsed mode is 250 Watts (obtained with intensity at the maximum position and tuning at 100%)

The pulse duration (Tp) is 400 ms (400 x 10 6 seconds).

Therefore, the median power for the lowest frequency, which is 45 Hz, will be:

Pm (45 Hz) = 250 x 400x10 6 x 45 Pm (45 Hz) = 4,5 Watts

And for the highest frequency, which is 400 Hz, it will be:

Pm (400 Hz) = 250 x 400 x 10 6 x 400 Pm (400 Hz) = 40 Watts

Pulse time

400 mts

Pulse frequency

median power

Maximum peak power

Pulse Recurrence Frequency

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DESCRIPT ION OF DIATERMED I I

Diatermed II 4022 Short Waves may be used with plate electrodes (17x12 cm) or round electrodes of Schliephake type.

The plate electrodes come with two 0.8 cm thick distancing felt pads and a cloth cover to involve them, which is intended to increase the electrode-skin distance.

Schliephake type electrodes (optional) are available in two sizes with emission area measuring 85 cm2 and 130 cm2. These electrodes may have the electrode-skin distance adjusted from 0 to 2.5 cm.

Next to the electrode outputs there is a place to install the support for Schliephakes electrodes, as indicated in figure 6 A.

For a more efficient use of Diatermed II 4022, the electrode cables (plates and Schliephake) are of connection type, which allows the combination of electrodes to be used according to the application. These electrodes combination may be: two plates, two Schliephake, one plate and one Schliephake; always associating the electrode-skin distance in order to better distribute the heat and the deep heat production.

There is a security device (figure 6B) located on the top of the right side, in which the patient may activate a protection system pulling a cord and interrupting immediately the equipment operation.

A: Place to install the support for Schliephakes electrodes B: Cord switch

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Controls

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1. On/Off Key 2. Operation Indicator Led 3. INTENSITY and RESET LOCK Intensity Control 4. Timer Reset Key 5. Treatment Time Selection Key 6. Continuous/Pulsed Modes Selection Key 7. Active Pulse Mode Indicator Led 8. Active Continuous Mode Indicator Led 9. Pulse Mode Frequency Selection Key 10. Tuning Indicator 11. Tuning Controller

Control Funct ions

1. On/Off Key Starts the equipment;

2. Operation Indicator Led - Indicates that the equipment is operating;

3. Reset Lock and Intensity Control; Enables the controlling of the equipment output intensity RESET LOCK it is a system used to protect the patient every

time the equipment is turned of or restarted. In order to avoid any injury to the patient, every time the equipment

is turned on or at the end of a treatment section, or after the patient security key is activated, the intensity control must be set back to the minimum intensity position (Reset Lock), and then the timer must be reset by pushing the control button (4).

This equipment will not allow the output circuit to be energized if the intensity control is set to the minimum intensity position (Reset Lock) and the Reset button (control 4) is pressed.

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4. Timer Reset Key Resets the timer to start a new time counting. Every time the timer gets to the end of the selected time, a buzzer produces a repeated signal to indicate the end of the time. To restart it and perform a new time counting, the intensity control must be set back to the Reset Lock position and then the Reset button must be pressed.

5. Treatment Time Selection Key Selects the treatment time from 10 to 30 minutes, with 5-minute intervals.

6. Continuous/Pulsed Modes Selection Key enables the selection of continuous or pulsed modes.

7. Active Pulse Mode Indicator Led.

8. Active Continuous Mode Indicator Led.

9. Pulse Mode Frequency Selection Key: the modulation frequencies for the pulsed mode are: 45 Hz, 70 Hz, 85 Hz, 115 HZ, 145 Hz, 175 Hz, 200 Hz, 230 Hz, 300 Hz and 400 Hz.

10. Tuning Control enables the equipment output circuit to be tuned to the maximum transference to the patient. To use this control, place the electrodes on the patient, select the desired intensity and turn this control to the right or to the left, until the point at which the leds indicating %TUNING (control 11) display the maximum indication (higher number of leds on). At this point the equipment will be tuned.

11. Tuning Indicator This equipment allows you to view the maximum energy transference to the patient circuit obtained through the tuning control (control 10). The percentage values indicated in this function are related to the equipment output power.

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Equipment Operat ion

1. Place the plate or Schliephake electrodes on the patient. 2. Set the INTENSITY control (3) to the Reset Lock position. 3. Select the treatment time through control (5). 4. Select pulsed or continuous mode through control (6). 5. If pulsed mode is chosen, select the desired frequency through control

(9). 6. Turn the equipment on through control (1). 7. Press the Reset button (4). 8. Turn the INTENSITY control (3) to the desired position. 9. Through TUNING (control 11), tune the equipment for the maximum

energy transference to the patient. The maximum tuning will be indicated by %TUNING (control 10).

10. At the end of the treatment time, a repeated sound will be heard and the output circuit will be turned off.

11. Return the intensity control (3) to the Reset Lock position. 12. Turn the equipment off through the ON/OFF control (1). Use of Intensi ty and Tun ing Controls

1. If the operation mode selected is continuous, the intensity to be used through the INTENSITY control (3) will be obtained by the sensation of light and pleasant heat, not causing discomfort to the patient. Through the TUNING control (11), the maximum energy transference to the patient is adjusted and can be seen through the %TUNING control (10).

2. If the operation mode selected is pulsed, the intensity to be used through the INTENSITY control (3) and TUNING control (11) must be obtained by having the %TUNING control (10) indicating over 80%.

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Protect ion Devices Diatermed II 4022 has protection systems to deactivate the patient circuit that are activated when: a) Control (6) is modified from the programmed function; b) The B Patient Protection Key (figure 6 - cord) is activated by the

patient or therapist at any moment; c) Momentary power failure.

Upon occurrence of any of the items above, check for the reason for which the device was activated. To retake the application: a) Check if the patient has the electrodes placed b) Return the INTENSITY control (3) to the Reset Lock position c) Press the Reset control button (4) d) Turn the INTENSITY control (3) until the desired position e) Tune the equipment by the TUNING control (11) to the maximum

energy transference to the patient (indicated by the %TUNING control (10)).

T HERAPEUT IC EFFECT S Increase of blood flow Reinforces the healing of inflammations Increases the extensibility of deep collagenous tissues Decreases the articular rigidity Relief for muscular pains and spasms

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Ind icat ions

The indications presented by the literature are based on biophysics researches, which mostly coincide with those originated by the empiricism developed by the clinical practices. These indications are fundamentally based on the capacity of Short Waves to heat deep tissues.

Short Waves have been used successfully as an adjuvant therapy in the following general cases (non-exhaustive list): Indications for Pulsed Short Wave Therapy

A- Post-Traumatic Diseases: Contusion Contracture Rupture Fracture Hematoma Lacerations It is very important that the treatment of these disease and wounds starts as soon as possible.

B- Postoperative diseases: Post-operation of the mandible Post-operation of foot and thigh.

C- Inflammations : Chronic osteitis Bursitis Sinusitis

D- Peripheral Circulatory Diseases

E- Internal Organ Diseases

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Indications for Continuous Short Wave therapy: Inflammatory processes, Distensions, Sprains, Luxations, Fractures, Trauma of soft tissues in general, boils, Cellulite, Neuralgia, Neuritides, Hemiplegia, Otitis, Mastitis, Sinusitis.

CONTRAINDICATIONS TO THE USE OF DIATHERMY In all these years a large number of contraindications for short wave therapy were identified. Some are clearly documented, others are based on suppositions. Others depend on dose or on location. For these reasons, the contraindications are divided into: Absolute Contraindications MALIGNANT TUMORS IMPLANTED ELECTRONIC DEVICE PACEMAKERS AND HEARING AIDS PREGNANCY TUBERCULOSIS FEVER RHEUMATOID ARHTRITIS - Relative Contraindications IMPLANTED METALS HEAT SENSITIVITY PROBLEMS SEVERE ARTERIAL AND VENOUS CIRCULATORY PROBLEMS such as ARTERIOSCLEROSIS,THROMBOSIS, ETC.

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Do not apply locally (with exception of submitis dose) since it is difficult for the tissue in question to adapt to the supplied heat. ACUTE INFECTIOUS DISEASES , ACUTE INFLAMMATIONS - Unproven Contraindications (but Particularly traditional) OSTEOPOROSIS TISSUES THAT DIVIDE RAPIDLY - HEMOPHILIA USE OF ANTICOAGULANT DRUGS General note:- Short wave diathermy must be used with precaution on areas of sensorial affectation. Special care is also needed for debilitated patients, since the dosimeter depends largely on the sensation of heat felt on the part of the patient. Pain is an indicator that excessive heat is being produced.

The Short Waves therapy is contraindicated in the following cases (non-exhaustive list):

Preservat ion and Prevent ive Maintenance

We recommend that your Diatermed II be inspected and calibrated

once a year. Be sure that the device is unplugged from the main energy source

before cleaning the equipment. Use only a cloth dampened in water and soap to clean the equipment

cover. Do not clean by pulverization or immersion. Control regularly the energy source and the power cable connection to

the electric network. Do not coil the power cable to make it shorter, for it may harm the equipment by causing induced currents.

Always keep the electrode cables parallel. Do not cross them or put them too close, otherwise there will be loss of power, which reduces the life of the valves.

Control regularly the electrode cable connections to the equipment and the plates (or Schliephake).

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Corrective Maintenance

Problems Solutions

Equipment does not turn on

Check if the power cable is connected to the electric network

Check for the integrity of the power cable

Check if the fuses are burned out

Power On Indicator lights up but the timer do not start

Contact the technical assistance

Equipment turns on, but the Tuning % control does not work

Check the fuse A (figure 7) of 1,0 A, located under the equipment (red cover) and replace it.

If the failure remains, contact the technical assistance.

Tuning % Indicator does not exceed 60 %

Check the integrity of the electrode cables (cable continuity).

Check the cable connection to the electrodes (plates or Schliephack)

Check the electrode-skin distance, increasing or decreasing it.

If it does not resolve the problem, contact the technical assistance.

Patient reports heating in only one electrode

Check the electrodes and cables. Check the electrode-skin distance. Check the cable connection to the

equipment.

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A Fuse Protecion Holder for Valves (tubes). Localized at Equipment base 1,0A 250V~ ( 20 AG )

Picture 7

Schl iephakes Elect rode

The Schliephakes electrode is an optional accessory. After the installation of the Schliephakes electrodes (installation guide goes with the Schliephakes electrode) follow the details of the electrode support fixation below:

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To connect Diatermed II with the Schliephakes electrodes, use the plate electrode cables as indicated in the figures below:

Adjust ing the Elect rode-Skin D istance

The Schliephakes electrodes of Diatermed II 4022 have a graduation for the electrode-skin distance from 0.0 cm to 2.5 cm. To achieve the desired distance, hold the electrode as indicated in the figure and spin it counter clockwise, until the distance indication appears, as indicated in figure 12. Each indication is equivalent to a distance of 0.5 cm.

Figure 12

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The following illustrations demonstrate the distribution of the heat concentration by varying the electrode-skin distance:

A) Big electrode-skin distance, with electrodes of the same size, the field lines are deep.

B) Small electrode-skin distance with electrodes of the same size, the field lines are superficial.

C) Big electrode-skin distance, with electrodes of different sizes, the field lines concentrate in the smaller electrode.

D) Different electrode-skin distance, with electrodes of the same size, the field lines concentrate in the electrode closer to the skin.

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Techn ica l Features Operation Frequency : 27.12 MHz 1% Type of therapy mode : Continuous and Pulsed Maximum Power in the Patient Circuit (Phantom Load)

o Continuous Mode : 240 Watts 10 % o Pulsed Mode : 300 Watts 10 %

Pulsed Mode Parameters: Pulse Width : 0.4 ms. ( 5 %) Pulse Frequency : 45, 75, 85, 115, 145, 175,

200, 230, 300, 400Hz (5%) Timer : 10 to 30 minutes (10%)

With 5-minute intervals Mains Supply : 115 / 230 Volts 10 %

50/60 Hz ---------------------------------------------------------------------------------------------------- Classification according to NBR IEC 60601.1 and NBR IEC 60601.2.3 rules: - Type of protection against electrical shocks:..................... class I - 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 ---------------------------------------------------------------------------------------------------- Fuses : 5A 20AG for 115 Volts

3A 20AG for 230 Volts Maximum Consumption : 370 VA Dimensions : 49 x 74 x 30 (W x H x L) Cm Gross Weight : 33 Kg UMDNSTM Classification : 11-248 Equipment Working Conditions:

Environmental temperature : 5C to 40C Relative humidity : 20% to 80% Atmospheric pressure : 700 to 1060hPa

Environmental conditions for transportation and storage:

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Environmental temperature : 5C to 50oC Relative humidity : 20% to 80% Atmospheric pressure : 500 to 1060hPa

Optional Accessories User manual Code 13921G Schliepack Electrode Code 4024S Complete Set of Articulate arms (Schliephake elec.) Code 05548 Circular Electrode for Schliephake (17 cm ) Code 13918G Circular Electrode for Schliephake (13 cm ) Code 13919G Circular Electrode for Schliephake (8,5 cm ) Code 13920G Fuse 1,0A 250V 20AG Code 10308G Three-pole power cable Code 14747G Fuses 20 AG - 3 A (for use at 220 V ) Code 13735G Fuses 20 AG - 5 A (for use at 110 V) Code 13736G Electrode boards in silicone (12 x 17 Cm) Code 10266G Silicone cables for connection with electrode boards Code 14641G Woo Separation (12 x 17 Cm) Code 10275G Cotton packs for electrode boards Code 10349G 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. Electric Schemes, circuits and lists of parts are not provided to final consumers. Should it be required, contact Carcis Authorized Technical Assistance.

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MANUFACTURERS DECLARATION AND INSTRUCTION

ELECTROMAGNETIC EMISSIONS DIATERMED II 4022 should be used in the electromagnetic environment described

as follows. DIATERMED II 4022 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

DIATERMED II 4022 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

DIATERMED II 4022 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

DIATERMED II 4022 should be used in the electromagnetic environment described as follows. DIATERMED II 4022 purchaser or operator should be aware that is

operating the device in such environment.

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%.

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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 70% Ut (30% Ut reduction) For 25 cycles 95% Ut reduction) For 5 s

95% Ut reduction) For 0.5 cycle 40% Ut (60% Ut reduction) For 5 cycles 70% Ut (30% Ut reduction) For 25 cycles 95% Ut reduction) For 5 s

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-

3 Vrms 150 kHz to 80 MHz

3 V

Portable and mobile devices of RF communications should not be used closer to any DIATERMED II

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6 Irradiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

4022 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:

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-

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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 DIATERMED II 4022 is used exceeds the compliance level above, DIATERMED II 4022 should be checked for normal operation. If abnormal performance is observed, additional measures should be taken, such as DIATERMED II 4022 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 DIATERMED II 4022 DIATERMED II 4022 should be used in electromagnetic environment where RF

disturbances are controlled. DIATERMED II 4022 purchaser or operator can help prevent electromagnetic interferences by keeping the minimum distance between portable and mobile (transmitter) RF communications devices and DIATERMED II

4022, 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. 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.

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Fina l Considerat ions Carci has striven its best efforts regarding the quality of its products. Carci reserves itself the rights to perform any changes in design and specifications, as well as add items and improve its products without any obligation to install such additions or improvements in products previously manufactured.

The texts, illustrations and specifications included in this guide are based on information available by the time of printing. All rights reserved.

This manual cannot be totally or partially reproduced without previous written consent by Carci.

Manufacturer Data

CARCI Indstria and Comrcio de Aparelhos Cirrgicos and Ortopdicos Ltda. Corporate Taxpayer Registration (CNPJ) no.: 61.461.034/0001-78 State Registration (I.E.) no.: 110.182.450.113 Address: Rua lvares Fagundes, 359 So Paulo-SP - Brazil - CEP 04338-000 Telephone: (55 11) 3346-2100 Fax: (55 11) 3270-8027 e-mail : carci@carci.com.br web site : www.carci.com.br

Registration of Carci with the Ministry of Health: MS-1.03.142-9 For Technical Assistance: Departamento de Assistncia Tcnica [Technical Assistance Department] [Address] Rua lvares Fagundes, 359 So Paulo [City] SP [State of So Paulo] Brazil CEP [Zip Code] 04338-000 Telephone: (55 11) 3272 0724 e-mail: sat@carci.com.br

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Technician in Charge: Orlando Orlandi Melo de Carvalho Registered in CREA/SP under number 5061377287/D The Regional Council of Engineering, Architecture and Agronomy

Bibliograph ic References

Eletroterapia de Clayton -Sheila Kitchen and Sarah Bazin, Editora Manole, 10 edio.

Thermal Agents in Rehabilitation - Susan L. Michlovitz, Contemporary Perspectives in Rehabilitation, 3 Edition.

Principles and Practice of Electrotherapy - Joseph Kahn, PhD, PT. 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: mail@obelis.net

W AR R AN T Y C E R T I F I C A T E AT T A C H E D