MU_Tensmed_4034_4044_ENG_Rev05_092009

Tensmed

Ref. 4034 e 4044

User Manual

English

Revisao: 05

TENSMED II 4044 TENSMED IV 4034

MU_4034_4044_ENG_Rev05_092009 1

Content 02 .............Presentation 02 .............Accessories supplied with the device 03 .............General Information 04 .............Symbols 05 .............Warnings 06 .............Electrical Installation / Connection 07 .............Using TENS as therapy 08 .............Operation modes 11 .............Using TENS for acute pain 12 .............Using TENS for chronic pain 14 .............Types of Electrodes 14 .............Electrode positioning 15 .............Electrode application 17 .............Tensmed II = Controls 19 .............Tensmed II = Control functions 20 .............Tensmed II = Unit operation 23 .............Tensmed IV = Controls 25 .............Tensmed IV = Control functions 26 .............Tensmed IV = Unit operation 29 .............Indications 30 .............Contraindications 30 .............Preventive maintenance and conservation 31 .............Precaution Instructions 31 .............Corrective maintenance 32 .............Technical data 34 .Acessories 34 .............Applicable Normas 40 .............Final considerations 41 .............References 43 .............General literature


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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. TENSMED II - 4044 and TENSMED IV 4034 devices were designed according to NBR IEC 60601.1:1994 + amend 1:1997, IEC 60601-1-2:2007 and IEC 60601-2-10:2002 safety rules, which makes them a safe and reliable product.

Accessories supplied with the device TENSMED IV 4054 08 Silicone electrodes and 1 gel tube or 08 Self-adhesive electrodes 3x5cm 04 Electrode cables 01 2-Pole Power Cable 01 Users Manual

TENSMED II 4052 04 Silicone electrodes and 1 gel tube or 08 Self-adhesive electrodes 3x5cm 02 Electrode cables 01 2-Pole Power Cable 01 Users Manual To buy optional accessories, please verify the codes at page 34, 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 What is Pain? Pain is an alert mechanism of our body. When there is a malfunction or if our body suffers any aggression, the pain appears to warn us. Without the pain sensation, the brain could not be alerted to these possible dangers or damage occurrence. Chronic pain - continued pain, degrading when associated with rheumatism, arthritis, sciatic nerve, among others; its purpose is not to warn of any eminent damage, but to indicate we have a problem resulting from our own pathology. The treatment of chronic pains by means of narcotic and other drugs always cause those inconvenient side effects, almost always provoking so many problems as the pain itself. The Transcutaneous Electric Nerve Stimulation TENS provides a simple, safe and effective solution for 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

Class II equipment

IPX0

Not protected from harmful water penetration

Manufacturer Identification

Product Manufacture Date

Product Serial Number


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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 marked in the intermediary square.

Minimum and maximum temperature limits for transportation and storage.

WARNINGS 1 . T h i s d e v i c e c a n o n l y b e o p e r a t e d b y q u a l i f i e d

p e r s o n n e l ; 2 . T h e e l e c t r o d e a p p l i c a t i o n c l o s e t o t h e t h o r a x m a y

i n c r e a s e t h e r i s k o f h e a r t f i b r i l l a t i o n ; 3 . S i m u l t a n e o u s c o n n e c t i o n s o f a P A T I E N T t o a h i g h

f r e q u e n c y s u r g i c a l D E V I C E m a y r e s u l t i n b u r n s w h e r e t h e S T I M U L A T O R e l e c t r o d e s w e r e a p p l i e d a n d p o s s i b l e d a m a g e s t o t h e s t i m u l a t o r ;

4 . S h o r t - d i s t a n c e o p e r a t i o n ( f o r i n s t a n c e : 1 m ) f r o m a s h o r t w a v e o r m i c r o w a v e t h e r a p y D E V I C E m a y p r o d u c e i n s t a b i l i t y a t t h e S T I M U L A T O R o u t p u t ;

5 . W e r e c o m m e n d s p e c i a l a t t e n t i o n f o r c u r r e n t d e n s i t i e s o f a n y e l e c t r o d e e x c e e d i n g 2 m A e f f e c t i v e c u r r e n t s / c m 2 ;


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6 . D o n o t e p l a c e t h e d e v i c e o n a s o f t s u r f a c e t h a t m a y b l o c k t h e b o t t o m v e n t i l a t i o n o p e n i n g s .

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 connector on the rear panel and one end to the power supply outlet

Figure 01.

Your equipment can operate with any voltage between 100 and 230VAC, 50 or 60Hz.

In case of blown fuse, change it for another protection fuse of the same value, as indicated:

Fuse: 1A 250V 20AG


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Using TENS as a therapy TENS (Transcutaneous Electrical Nerve Stimulation) has been used for many years as a pain relief method, with several studies (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) confirming the treatment effectiveness. TENS is based on the gate control theory of pain, developed by Melazack and Wall in 1965. According to this theory, stimuli of a certain frequency and form, through a competition mechanism, would be able to block the passage of nociceptive stimuli to the upper integration centers through the marrow.

Gate control theory of pain (Melzack and Wall)

SUBSTNCIAGELATINOSA

CLULA TRNAMISSORA

(LAMINA V)

CONTROLE CENTRALSISTEMA

DE AO

SISTEMA DE CONTROLE DA PORTA

FIBRRAS NERVOSASTIPO II E III

FIBRRAS NERVOSASTIPO IV

This theory is based on the association that stimuli from thick myelinated nervers produce a marrow-level inhibition. This inhibition blocks the pain stimulus transmission to the brain, conveyed by thin unmyelinated nerves.

Central Control

Nervous Fibers - Type II and III

Nervous Fibers - Type IV

Gelatin Substance

Transmission Cell

(Laminae V)

Gate Control System

Action System


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In other words, through a selective stimulus of nerves Type II and III, the stimulus transmission is inhibited by nerves Type IV. Stimulus of nerves Type IV is not desirable in this process. This theory shows one of the main starting points for the pain treatment.

Category Efferent Afferent Speed M / s Diameter

m

Thick A A A

I II III

70 120 50 70 30 50

12 22 5 12 5 12

Thin A

B C

III -

IV

< 30 3 14

< 3

2 5 1 3

0.1 1.3

Summary of nervous fibers (Erlanger and Gasser) Endorphin release theory (Sjolund and Eriksson) The chronic pain always comes with the patients endorphin system hypoactivity or increased consumption of released endorphins. The utilization of pulse trains of TENS allows to stimulate the central nervous system, in such way to provoke the release of endogen substances, thus obtaining an analgesic effect as a result. According to Sjolund and Eriksson, endorphins are released if we apply low-frequency modulated (interrupted) 100Hz frequency, usually between 2 Hz and 5 Hz (in BURST mode). Operation modes The unit has the following stimulation modes: CONTINUOUS BURST VIF VLP VLF


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CONTINUOUS In this operation mode, the unit outputs a continuous frequency signal and variable pulse duration. The frequency value setting range is 1Hz to 200Hz, being: from 1Hz to

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

The pulse duration setting range is 50 s and 400 s, in 10 s steps. The figure below illustrates the CONTINUOUS mode:

BURST In this operation mode, the unit outputs a continuous signal modulated by a 2Hz frequency. The output frequency is fixed at 100Hz and modulated (interrupted) by

a 2Hz frequency. The pulse duration setting range is 50 s to 400 s, in 10 s steps. The figure below illustrates the BURST mode:

I

0 T

Modo Burst

I

0 T

Modo ContnuoContinuous Mode

Burst Mode Burst Mode Burst Mode


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VIF In this operation mode, the unit outputs a signal of Frequency and Pulse Width automatic variation. That is, the adjusted frequency and pulse width values present a +25% variation in a 3 second period, returning to the original value, and a 25% variation in a 3 second period, returning to the original value. This cycle is indefinitely repeated. The frequency setting value is 5Hz to 170Hz, being: from 5Hz to 10Hz in

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

The pulse width setting value is 70 s to 370 s, in 10 s steps.

I

0 T

Modo VIF

VLP In this operation mode, the unit outputs a signal of pulse width automatic variation. That is, the adjusted pulse width value presents a +25% variation in a 3 second period, returning to the original value, and a 25% variation in a 3 second period, returning to the original value. This cycle is indefinitely repeated. The frequency is fixed, according to the selected value, which can be set

between 1Hz and 200Hz. The pulse duration presents a variation of + / - 25% of the selected

value, which can be set between 70 s and 370 s.

VIF Mode VIF Mode


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VLF In this operation mode, the unit outputs a signal of frequency automatic variation. That is, the adjusted frequency value presents a +25% variation in a 3 second period, returning to the original value, and a 25% variation in a 3 second period, returning to the original value. This cycle is indefinitely repeated. The frequency presents a variation of + / - 25% of the selected value,

which can be set between 5 and 170Hz. The pulse duration is fixed, according to the selected value, which can

be set between 50 s and 400 s.

Using TENS for acute pain One of the various successful applications of TENS is its after-surgery utilization for pain control. The electrodes are places near the incision and the treatment is continuously used in the first 48 to 72 hours after the surgery. In cases of acute pain caused by traumatisms, contusions, lesions, etc., the utilization of TENS to relieve the pain is also highly indicated.

TENS APPLICATION FOR ACUTE PAIN

Author Diagnosis Electrode Placement Pulse

Duration Pulse

Frequency Intensity Treatment Frequency

******* ******** ******** Hz ******* ***********

ref. 15 after laparotomy parallel to incision 120-340 10-100

0-90 V Comfortable

Constant in first 48 hours

ref. 16 after laparotomy parallel to incision 80 40 Comfortable

60 min. each 4 hours

ref. 18 after laparotomy parallel to incision 128-200 10-100

0-135 mA Comfortable


ref. 17 after surgery

parallel to incision ********** ********** *******



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ref. 19 after

Caesarian section

above and below incision 250-400 80-100 20-35 mA

Constant or 30 min. 4 times a

day

ref. 20 delivery pain paraesp.

T10-L1,S2-S4 ********** ********** 20-25 V

Comfortable During 1st stage of delivery

ref. 21 delivery pain ********** ********** ********** Comfortable During 1st stage of delivery

ref. 5 toothache on pain region 200 100 2-3 X sensor level 30 min.

Using TENS for chronic pain The utilization of TENS to treat Chronic Pains has been studied by many researchers. Among the studies that have been conducted, special regards to Wolf and Colleagues13, who determined the TENS response in 114 patients that presented lesions in peripheral nerves, muscular and skeletal traumas and secondary pains of peripheral neuropathies. The electrodes were systematically placed on the pain side, over nervous routes or peripheral nerves. The applications lasted 30 to 45 minutes. The intensity utilized was such to produce a painful, but comfortable, sensation. After the application, the patients were interviewed and the following data were obtained: 72.0% of the patients with peripheral neuropathies; 28.5% of the patients with lesions in peripheral nerves; 22.0% of the patients with radicular pains ; 38.4% of the patients with muscular and skeletal pains;

reported a relief of over 60% of the pain. In another investigation, 98 patients with pain in the paravertebral region, headache and other types of pain symptoms (14), employed TENS in their homes, placing electrodes beside the painful region and using intensity at comfortable levels.


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Twelve days after the application: 69.0% of the patients with pain in the paravertebral region; 40.0% of the patients with headache; 60.0% of the patients with other pain types;

reported a relief of over 50% of the pain.

TENS APPLICATION FOR CHRONIC PAIN

Author Diagnosis Electrode Placement Pulse

Duration Pulse

Frequency Intensity Treatment Frequency

******* ********** *********** Hz ******** ***********

ref.13 Varied beside the painful region 100 50-100 sub-motor

level 30-45 min. 3-5 times a

week

ref.14 Varied Varied mid scale 10-100 comfortable 30-60 min. a day

ref.22 column pain paravertebral maximum 2/abr motor level 30 - 61 min.

ref.23 backache backache central part ************ 4/ago tolerance

30 min. 2 x a week

ref.24 knee osteoarthritis on knees ************ Comfortable Comfortable

30-60 min. a day

ref.25 phantom limb pain stump or

central limb ************ ********* ************ 15 min. 2 x

a day

ref.26 fracture on fracture 300 sensor level sensor level 30-60 min. 3-4 x a day

ref.27 Neuro-peripheral pain on painful

region 200 110 26-28 mA cont. 8-10

hours a day


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Types of Electrodes Conductive silicon: The silicon electrode utilization requires the use of

conductive gel and securing tapes. Adherents: The application of this type of electrode is performed

directly on the skin, so the conductive gel and securing tapes are not required.

Electrode Positioning It is essential to position the electrodes as correctly as possible to obtain the desired results. There are many possibilities of placing the electrodes. The most common are:

1. Alternate The channels are placed alternately when the stimulus is linear, in order to ensure a higher paresthesia distribution in the painful region. 2. Bilateral The electrodes are placed in both sides of an articulation or region; 3. Contralateral When there are no conditions to stimulate an end or either side of the body, the stimulus of the same nerve can be contralateral. The contralateral stimulus does not present the same efficiency as the ipsilateral stimulus, but in cases without normal stimulus conditions, it should be used. 4. Cross This is the case when the stimulus occurs with more than one channel, then crosses the painful region, thus concentrating the current perception on the painful region. 5. Distal At least one electrode is placed near the painful region in order to ensure the parenthesia perception. 6. Linear It involves the proximal and distal placement, as in sites referring to pain-related trigger points or roots. 7. Segmentally related myotonia


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When the stimulation is intolerable at the pain site, the electrodes should be placed in distant muscular groups, but stimulated by the same marrow levels as in the painful region. 8. Proximal The electrodes are placed above the lesion level. This method is efficient for peripheral nerve lesions, marrow lesions and phantom limb pains. 9. High cervical region The electrodes are placed behind the ear and immediately over the mastoid process. 10. Remote The electrodes are places in regions segmentally related or not to the painful area. A remote site may be located proximally, distally or contralaterally to the painful region. A strong stimulation is usually used in these remote areas. 11. Not related sites Good results can be obtained through the stimulation of: superficial regions of sciatic, median and ulnar nerves; column bottom and top ends; transcranial and high cervical regions. 12. Transcranial Stimulation in both temporal cavities. The exact point is 2.5 cm before and above the ear.

Electrode application 1. Connect the electrode to the output cable of the channel that you may

want to use; 2. If this is a silicon electrode, apply a thin gel film on the electrode and

place it on the application site, use adhesive tape (micro pore or similar) to secure the electrode. If this is an adherent electrode, remove it from the protection and place it on the application site.

The illustrations below show the electrode placement diagrams for some application types:

1. Median nerve irritation (lower part) caused by carpus tunnel compression

2. Lumbar region pain 3. Brachial plexus lesion with anesthesia below the elbow (C5T1)


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4. Pain in the lower part of the back, with L5 root pain in the left leg

5 & 6 Right leg position for amputation below the knee 7. After-surgery TENS for abdominal region 8. Backache with bilateral pain in the legs


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9. Post-hepatic neuralgia 10. Obstetric application of TENS for the pain control during delivery 11. Hypersensitive scar on the right knee 12. Neck pain

Controls A) TENSMED II 4044

Increment / Changes Field

Moves Field to Left

Moves Field to Right

Decrement / Changes Field


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1. UP Key

2. DOWN Key

3. LEFT Key

4. RIGHT Key 5. START Key

6. STOP Key

7. CH 1 and CH 2 Intensity control for channels 1 and 2 of Tensmed II 4044.

Figura 02.


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Control Functions 1. UP Key

Changes MODE parameter and increment values of Frequency (Fr Hz), Pulse Width (P uS) and Timer (minutes).

2. DOWN Key Changes MODE parameter and decrement values of Frequency (Fr Hz), Pulse Width (P uS) and Timer (minutes)

3. LEFT Key Allows navigation through parameters to the left: MODE, Fr Hz, P uS and TIMER.

4. RIGHT Key Allows navigation through parameters to the right: TIMER, P uS, Fr Hz and MODE.

5. START Key Enables the outputs, allowing intensity values to be incremented and decremented.

6. STOP Key Interrupts the application, placing output intensities at zero, and stops the TIMER.

7. Channel 1 intensity control: Key increments channel 1 intensity. Key reduces channel 1 intensity.


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Values of Parameters: 1 . M o d e C o n t i n o u s , B u r s t , V I F , V L P , V T F . 2 . F r H z = F r e q u e n c y 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 ,

1 0 , 1 5 , 2 0 , 2 5 , 3 0 , 3 5 , 4 0 , 4 5 , 5 0 , 6 0 , 7 0 , 8 0 , 9 0 , 1 0 0 , 1 1 0 , 1 2 0 , 1 3 0 , 1 4 0 , 1 5 0 , 1 6 0 , 1 7 0 , 1 8 0 , 1 9 0 , 2 0 0 H z .

3 . P u S = P u l s e W i d t h 5 0 , 6 0 , 7 0 , 8 0 , 9 0 , 1 0 0 , 1 1 0 , 1 2 0 , 1 3 0 , 1 4 0 , 1 5 0 , 1 6 0 , 1 7 0 , 1 8 0 , 1 9 9 0 , 2 0 0 , 2 1 0 , 2 2 0 , 2 3 0 , 2 4 0 , 2 5 0 , 2 6 0 , 2 7 0 , 2 8 0 , 2 9 0 , 3 0 0 , 3 1 0 , 3 2 0 , 3 3 0 , 3 4 0 , 3 5 0 , 3 6 0 , 3 7 0 , 3 8 0 , 3 9 0 , 4 0 0 u S .

4 . T i m e r = T i m e r 1 t o 6 0 m i n u t e s , i n 1 m i n u t e s t e p s .

Unit Operation TENSMED II 1. Connect the unit to the power supply using the power cable provided

with Tensmed. Turn on the unit (ON/OFF switch, on the rear panel of the unit (Figure 1, page 7).

2. The display will show the following information: Mode Fr Hz P uS Timer

Followed by the screen: Mode Fr Hz P uS Timer

Note: NS.:00001 is Tensmed IV serial number. The same number is on the external label placed on the unit. The main screen will remain on the display:


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Mode Fr Hz P uS Timer

3. Use or to change Tensmed IV application mode, as described below:

Burst Mode: Mode Fr Hz P uS Timer

VIF Mode: Mode Fr Hz P uS Timer

VLP Mode: Mode Fr Hz P uS Timer

VLF Mode: Mode Fr Hz P uS Timer

4. Use or to select the Frequency (Fr Hz), as illustrated below: Mode Fr Hz P uS Timer


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5. Use or to change the Frequency value (Fr Hz), as illustrated below:


6. Use or to select the Pulse Width (P uS), as illustrated below:


7. Use or to change the Pulse Width value (P uS), as illustrated below:


8. Use or to select Timer, as illustrated below: Mode Fr Hz P uS Timer

9. Use or to select the desired time, as illustrated below: Mode Fr Hz P uS Timer

10. Connect the cables of the electrodes from the channels to be used to the electrodes on the patient. (Figure 02 Page20)

11. To start the treatment, press START. The Timer will start flashing, indicating the time counting.


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12. Use the control keys of channels CH 1 or CH 2 to increase or decrease the stimulation intensity.

13. TENSMD II allows the application to be interrupted by pressing STOP. The intensities of the channels being used will be reset and the time will be interrupted.

14. In order to resume the application, press START, and use the control keys of channels CH 1 or CH 2 to increase or decrease the stimulation intensity.

15. When the preset time expires, the unit will issue a sound, informing that the time has expired, and the intensities of the channels being used will be reset.

B) TENSMED IV 4034

Note: The Current intensity in the patient circuit should be very comfortable. Ask the patient to report the stimulation sensation in order to adjust the ideal intensity value.

This value varies from person to person, as each patient has particular sensitivity and tissue impedance characteristics, as well as other factors that may influence the intensity sensation.

Increment / Changes Field

Moves Field to Left

Moves Field to Right

Decrement / Changes Field


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1. UP Key

2. DOWN Key

3. LEFT Key

4. RIGHT Key 5. START Key

6. STOP Key

7. CH 1, CH 2, CH 3 e CH4 Intensity control for channels 1, 2, 3 and 4 of Tensmed IV 4034

Figura 03.


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Control Functions 1. UP Key

Changes MODE parameter and increment values of Frequency (Fr Hz), Pulse Width (P uS) and Timer (minutes).

2. DOWN Key Changes MODE parameter and decrement values of Frequency (Fr Hz), Pulse Width (P uS) and Timer (minutes)

3. LEFT Key Allows navigation through parameters to the left: MODE, Fr Hz, P uS and TIMER.

4. RIGHT Key Allows navigation through parameters to the right: TIMER, P uS, Fr Hz and MODE.

5. START Key Enables the outputs, allowing intensity values to be incremented and decremented.

6. STOP Key Interrupts the application, placing output intensities at zero, and stops the TIMER.



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Values of Parameters: 1 . M o d e C o n t i n o u s , B u r s t , V I F , V L P , V T F . 2 . F r H z = F r e q u e n c y 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 1 0 ,

1 5 , 2 0 , 2 5 , 3 0 , 3 5 , 4 0 , 4 5 , 5 0 , 6 0 , 7 0 , 8 0 , 9 0 , 1 0 0 , 1 1 0 , 1 2 0 , 1 3 0 , 1 4 0 , 1 5 0 , 1 6 0 , 1 7 0 , 1 8 0 , 1 9 0 , 2 0 0 H z .

3 . P u S = P u l s e W i d t h 5 0 , 6 0 , 7 0 , 8 0 , 9 0 , 1 0 0 , 1 1 0 , 1 2 0 , 1 3 0 , 1 4 0 , 1 5 0 , 1 6 0 , 1 7 0 , 1 8 0 , 1 9 9 0 , 2 0 0 , 2 1 0 , 2 2 0 , 2 3 0 , 2 4 0 , 2 5 0 , 2 6 0 , 2 7 0 , 2 8 0 , 2 9 0 , 3 0 0 , 3 1 0 , 3 2 0 , 3 3 0 , 3 4 0 , 3 5 0 , 3 6 0 , 3 7 0 , 3 8 0 , 3 9 0 , 4 0 0 u S .

4 . T i m e r = T i m e r 1 t o 6 0 m i n u t e s , i n 1 m i n u t e s t e p s .

Unit Operation TENSMED IV 1. Connect the unit to the power supply using the power cable provided

with Tensmed. Turn on the unit ON/OFF switch, on the rear panel of the unit (Figure 1, page 7).

2. The display will show the following information: Mode Fr Hz P uS Timer

Followed by the screen: Mode Fr Hz P uS Timer


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Note: NS.:00001 is Tensmed IV serial number. The same number is on the external label placed on the unit. The main screen will remain on the display: Mode Fr Hz P uS Timer

3. Use or to change Tensmed IV application mode, as described below:

Burst Mode: Mode Fr Hz P uS Timer

VIF Mode: Mode Fr Hz P uS Timer

VLP Mode: Mode Fr Hz P uS Timer

VLF Mode: Mode Fr Hz P uS Timer


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4. Use or to select the Frequency (Fr Hz), as illustrated below: Mode Fr Hz P uS Timer

5. Use or to change the Frequency value (Fr Hz), as illustrated below:


6. Use or to select the Pulse Width (P uS), as illustrated below: Mode Fr Hz P uS Timer

7. Use or to change the Pulse Width value (P uS), as illustrated below:


8. Use or to select Timer, as illustrated below: Mode Fr Hz P uS Timer


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9. Use or to select the desired time, as illustrated below: Mode Fr Hz P uS Timer

10. Connect the cables of the electrodes from the channels to be used to the electrodes on the patient.

11. To start the treatment, press START. The Timer will start flashing, indicating the time counting.

12. Use the control keys of channels CH 1, CH 2, CH 3 or CH 4 to increase or decrease the stimulation intensity.

13. TENSMD IV allows the application to be interrupted by pressing STOP. The intensities of the channels being used will be reset and the time will be interrupted.

14. In order to resume the application, press START, and use the control keys of channels CH 1, CH 2, CH 3 or CH 4 to increase or decrease the stimulation intensity.

15. When the preset time expires, the unit will issue a sound, informing that the time has expired, and the intensities of the channels being used will be reset.

Indications Acute or chronic pain processes (minimizing the pain until its cause is safely identified): Lumbar and cervical pains Lumbar and sciatic pains, trigeminal neuralgias Brachial pains Surgery injury pains

Note: The Current intensity in the patient circuit should be very comfortable. Ask the patient to report the stimulation sensation in order to adjust the ideal intensity value.

This value varies from person to person, as each patient has particular sensitivity and tissue impedance characteristics, as well as other factors that may influence the intensity sensation.


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Migraine headaches and articulation pains Patients submitted to surgery and that need to immobilize body

traumatized segments during the surgery Pulmonary re-expansion after thorax or abdomen surgery Limb immobilization Cases of segment amputations Bursitis Traumatized limbs and hundreds of over acute or chronic pain states.

Contraindications So far, no contraindications have been reported concerning TENS utilization. However, the following applications should be avoided: Patients with Cardiac or Brain Pacemaker; Patients with Heart Diseases; Patients with epilepsy; Lumbar and abdominal regions in patients in the three first gestation

months; Region over carotid breasts. Not diagnosticated pain.

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

Preventive maintenance and conservation We recommend to inspect and adjust Tensmed IV once a year. Be sure the unit is disconnected from the power supply before

cleaning. Avoid wetting the electrical contacts of wires and connectors. Use a damp cloth with water and soap to clean the cabinet of your unit. Inspect the power supply and the power cable regularly, check for

defects. When disconnecting the electrode cable from the unit, remove it by the

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

avoid damages.


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Special care with adherent or silicon electrodes For improved durability of the electrodes: When using silicon electrodes, always clean the plug contacts, avoiding

residues that obstruct electrical contacts. After using silicon electrodes, wash them with running water and dry

them. Store them in a fresh and dry place. After using adherent electrodes, remove them from the electrode cable

carefully, moist them with water and store them in the envelope in a fresh place.

Precaution Instructions

Be familiarized with this manual. Keep updated about the progress in TENS therapy and take all adequate precautions;

Do not use TENS equipment near Shortwave or Microwave equipment in operation;

Keep this equipment out of childrens reach; All Technical Assistance service performed on your unit should be

executed by properly Authorized and Qualified Staff; Always clean the electrode cable terminals.

Corrective maintenance

Problems Solutions

The unit does not turn on Check whether the power cable is connected to the power supply outlet Check whether the fuse is blown

The equipment turns on, but the display does not show the

INITIAL screen.

Turn off the unit. Wait for 30 seconds and turn it on again. If the failure remains, please contact the authorized assistance.


MU_4034_4044_ENG_Rev05_092009 32

Nothing happens when the keys are pressed.

Contact the authorized assistance.

Patients says the stimulation sensation is greater in one electrode than in the other.

Change the (silicon or adherent) electrodes, as they might be worn out.

The intensity is increased to the maximum and the patient reports

little stimulation.

Check the patients sensitivity. Change the (silicon or adherent) electrodes.

The unit turn on as usual, but the patient says that there is no

stimulation.

Check the electrode cable continuity. Check the electrode conductivity.

Technical Data Specifications: Power supply : 100 to 240vac 50/60hz Maximum consumption : 12 VA Fuse : 1A 250V 20AG Operating frequency : 50 / 60 Hz Dimension (WxHxD) cm : 23.5 x 8.0 x 17.0 Weight : 650 grams Channels Tensmed IV 4034 : Four independent channels Channels Tensmed II 4044 : Two independent channels Pulse form : Asymmetrical 2-Phase

Rectangular Maximum intensity per channel : 100 mA 10 % (RL = 500 ) Digital timer : 1 to 60 minutes ( 1% ), in

1-min ute steps Frequency and Pulse Duration: Registration number in Anvisa : AM-10314290033 -------------------------------------------------------------------------------------------------------

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


MU_4034_4044_ENG_Rev05_092009 33

- Type of protection against electrical shocks: class II - Protection level against electrical shocks of the applied part: F 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 ----------------------------------------------------------------------------------------------------

CONTINUOUS mode Frequency : 1 to 200 Hz 1 % Pulse duration : 50 s to 400 s 20 %

BURST mode Modulation : 2 Hz 1% Frequency : 100Hz 1% Pulse duration : 50 s to 400 s 1 %

VIF mode Frequency : 5 to 170 Hz 1% Frequency Modulation : 25% in 6 seconds Pulse Duration : 70 to 370 s 1 % Pulse Duration Modulation : 25% in 6 seconds

VLP mode Frequency : 1 to 200 Hz 1% Pulse duration : 70 to 370 s 1 % Pulse Duration Modulation : 25% in 6 seconds

VIF mode Frequency : 5 to 170 Hz 1% Frequency Modulation : 25% in 6 seconds Pulse Duration : 50 to 400 s 1 %

Safety and protection class : Class II - applied part BF type acc. to NBR IEC 60601-1 :1994 + amend 1:1997, NBR IEC 60601-1-2:2006 and NBR IEC 60601-2-10:2002

UMDNSTM Classification 13-782


MU_4034_4044_ENG_Rev05_092009 34

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

Yellow Code 14635G Green Code 09852G Blue Code 14644G purple Code 14634G

2-Pole Power Cable Code 17394G Users Manual Code 17813G Contact Gel 200ml Code 7000/200

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

Green Code 09852G Blue Code 14644G

2-Pole Power Cable Code 17394G Users Manual Code 17813G Contact Gel 200ml Code 7000/200 Equipment Operating Conditions: Ambient temperature : +15 to +40C Relative humidity : 0 to 80% Air pressure : 700 to 1060 hPa Environmental conditions for transport and storage: Ambient temperature : -10 to 50oC Relative humidity : 20 to 90% Air pressure : 500 to 1060 hPa

Appl icab le Norms: NBR IEC 60.601-1: 1988 (Electrical Medical Equipment Part 1

General safety prescriptions) ISO 780: 1997 Packing Graphic Symbols for storage and transport

packing identification.


MU_4034_4044_ENG_Rev05_092009 35

Important Notes:

This unit is not adequate to the use in the presence of oxygen or nitrous oxide flammable anesthetic mixture.

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. Immunity

tests Test level of IEC 60601

Compliance level

Electromagnetic environment - instructions


MU_4034_4044_ENG_Rev05_092009 36

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%.

Immunity tests

Test level of IEC 60601

Compliance level

Electromagnetic environment - instructions

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


MU_4034_4044_ENG_Rev05_092009 37

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

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.

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 the device

operation is being done in such environment.

Immunity tests

Test level of

IEC 60601 Compliance

level Electromagnetic

environment - instructions

Conducted RF

3 Vrms 150 kHz to

3 V

Portable and mobile devices of RF communications should not


MU_4034_4044_ENG_Rev05_092009 38

IEC 61000-4-6

Irradiated RF IEC 61000-4-3

80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V/m

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:

NOTE 1: within the of 80 MHz and 800 MHz, the highest range frequency


MU_4034_4044_ENG_Rev05_092009 39

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


MU_4034_4044_ENG_Rev05_092009 40

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.

Final Considerations The continuous product quality improvement has been Carcis policy. Carci reserves the right to make changes in the project and specifications, as well as add and improve its products, with no resulting obligation to install them in already manufactured products. The text, illustrations and specifications contained in this manual are based on information that was available on the printing occasion. All rights reserved. This manual cannot be reproduced, fully or partially, without the authorization in writing by Carci.

Manufacturers Data CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. CNPJ 61.461.034/0001-78 I.E. : 110.182.450.113 Rua lvares Fagundes, 359 So Paulo SP Brasil 04338-000 Tel.: (0XX11) 3346 2100 e-mail : [email protected] web site : www.carci.com.br Carci Registration at the Department of Health: MS-1.03.142-9 For Technical Assistance: Departamento de Assistncia Tcnica Rua lvares Fagundes, 359 So Paulo SP Brasil 04338-000 Tel.: (0XX11) 5621 7024 / 5622 8205 e-mail : [email protected] Technician in Charge: Orlando Orlandi Melo de Carvalho - CREA 5061377287/D


MU_4034_4044_ENG_Rev05_092009 41

REFERENCES 1. Bertrand Sr. Method of determining optimal stimulation sites for

transcutaneous electrical nerve stimulation. Physical Therapy 64:924-928, 1984.

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

3. 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.

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

5. 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.

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

7. 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.

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

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

10. 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.

11. 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.

12. 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.

13. 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.


MU_4034_4044_ENG_Rev05_092009 42

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

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

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

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

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

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

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

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

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

23. 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. 24. Taylor P, Hallett M, Flaherty L: Treatment of osteoarthitis of the knee with transcutaneous never stimulation. Pain 11:233-240, 1981. 25. Winnem MF, Amundsen T: Treatment of phantom limb pain with transcutaneous electrical nerve stimulation. Pain 12:299-300,1982. 26. Kahn J: Transcutaneous electrical nerve stimulation for no united fractures: A clinical report. Physiotherapy 62:950-844, 1982. 27. 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.


MU_4034_4044_ENG_Rev05_092009 43

General literature Zahl, K, Bray, C Taylor, L, Bagshaw, R J, Young, M L, Davis, R A a

Smith, D S (1988). Does transcutaneous electrical nerve stimulation provide pain relief after lumbar laminectomy, Anesthesia and Analgesia, 67, S264.

Augustinsson, P L-E, Bohlin, P Bundsen, P, Carlsson, C-A, Forssman, L, Ajoberg, P and Tyreman, N O (1977). Pain relief during labor by transcutaneous electrical never stimulation, pain 4,58-65.

Robson, E (1979), Transcutaneous nerve stimulation for pain relief in labor, Anesthesia, 34, 357-361.

Melzack, R and Wall, P D (1965). Pain mechanisms: A new theory, Science, 150, 971-979.

Pike, P M H(1978). Transcutaneous electrical stimulation, Anesthesia, 33, 165-171.

Eletroterapia de Clayton 10a edio Sheila Kitchen e Sarah Bazil

Eletroterapia Carlos Lucema Ed. Lovise 1990

Electroterapia e Actinoterapia Pauline M. Scott. - Ed. JIMS 1972.

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MU_Tensmed_4034_4044_ENG_Rev05_092009