MU_Tensmed_4034_4044_ENG_Rev05_092009

Tensmed

TENSMED II 4044 TENSMED IV 4034

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Ref. 4034 e 4044

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User Manual

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English

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Revisao: 05

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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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Symbols


Packaging symbols

Device symbols

IPX0

Device is off

Caution fragile. Handle with care

Device is on

Keep in a dry place

This symbol indicates the device causes physiological effects and that the user should check the user’s manual before using it.

This side up. This symbol indicates the right transport position

BF type applied part

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

Class II equipment

Minimum and maximum temperature limits for transportation and storage.

Not protected from harmful water penetration WARNINGS 1. This device can only be operated by qualified personnel; 2 . T h e e l e c t r od o d e a p p l i ca c a t i o n c l os o s e t o th th e t h o r a x m a y increase the risk of heart fibrillation; 3. Simultaneous connections of a PATIENT to a high frequency surgical DEVICE may result in burns where the STIMULATOR electrodes were applied and possible damages to the stimulator; 4 . S h o r t - d i s t an a n c e o p e r a ti t i o n ( f o r in in s t a n c e : 1 m ) f r o m a shortwave or microwave therapy DEVICE may produce instability at the STIMULATOR output; 5. We recommend special attention for current densities of any electrode exceeding 2 mA effective currents/cm2;

Manufacturer Identification Product Manufacture Date Product Serial Number

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

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


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 Right

Moves Field to Left

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

Figura 02.

▲ 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 intensity control: Key Key ▲ increments channel 1 intensity. Key ▼ reduces channel 1 intensity. ��

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8. Channel 2 intensity control: Key ▲ increments channel 2 intensity. Key ▼ reduces channel 2 intensity.

TENSMED II 4044 TENSMED IV 4034 Mode

Fr Hz P uS Timer

Values of Parameters: 1. 2.

3.

4.

Mode  Continous, Burst, VIF, VLP, VTF. Fr Hz = Frequency  1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200 Hz. P uS = Pulse Width  50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 1990, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400 uS. Timer = Timer  1 to 60 minutes, in 1 minute steps.

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

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:

VLP Mode: Mode

Fr Hz P uS Timer

Mode Fr Hz P uS Timer

VLF Mode: Mode

Followed by the screen:

Fr Hz P uS Timer

Mode Fr Hz P uS Timer T imer

4. Use ◄ or ► to select the Frequency (Fr Hz), as illustrated below: 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

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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. 7. Channel 1 intensity control: Key ▲ increments channel 1 intensity. Key ▼ reduces channel 1 intensity. ��

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Electrostatic discharge IEC 61000-42 Immunity tests

Fast transients / Blasts IEC 61000-44 Surge IEC 61000-45

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Test level of IEC 60601

Compliance level

± 2 kV power ± 2 kV power supply line ± 1 kV signal supply input and Not applicable output line ± 1 kV ± 1 kV differential differential mode mode ± 2 kV ± 2 kV common common mode mode


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

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

<5% Ut (>95% Ut reduction) For 0.5 cycle

Voltage failures, short interruptions and voltage variations in power supply. IEC 61000-411

<5% Ut (>95% Ut reduction) For 0.5 cycle

40% Ut 40% Ut (60% Ut (60% Ut reduction) reduction) For 5 cycles For 5 cycles 70% Ut (30% Ut reduction) For 25 cycles <5% Ut (>95% reduction) For 5 s

70% Ut (30% Ut reduction) For 25 cycles

<5% Ut Ut (>95% Ut reduction) For 5 s

Magnetic The magnetic fields of fields of utility utility frequencies frequencies should be levels of 3 A/m 3 A/m (50/60 Hz) typical hospital or IEC 61000-4commercial 8 environment. Note: Ut is the utility voltage C.A before the test level application. MANUFACTURER’S 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.

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Immunity tests

Test level of IEC 60601

Conducted RF

3 Vrms 150 kHz to

Compliance level

3V

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Electromagnetic environment - instructions

Portable and mobile devices of RF communications should not 37

MU_Tensmed_4034_4044_ENG_Rev05_092009

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