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TENSMED II 4044

TENSMED IV 4034

Tensmed
Content

Ref. 4034 e 4044

User Manual

English
Revisao: 05
































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

MU_4034_4044_ENG_Rev05_092009

TENSMED II 4044
TENSMED IV 4034

TENSMED II 4044
TENSMED IV 4034

Presentation

General Information

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.

What is Pain?

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

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.

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 : sat@carci.com.br

MU_4034_4044_ENG_Rev05_092009

MU_4034_4044_ENG_Rev05_092009

TENSMED II 4044
TENSMED IV 4034
Symbols

TENSMED II 4044
TENSMED IV 4034
Packaging symbols

Device symbols
Caution fragile. Handle with care

Device is off

IPX0

Device is on

Keep in a dry place

This symbol indicates the device causes


physiological effects and that the user should
check the users 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.

Manufacturer Identification

2.
Product Manufacture Date

3.

Product Serial Number


4.
5.

MU_4034_4044_ENG_Rev05_092009

This device can only be operated by qualified


personnel;
The electrode application close to the thorax may
increase the risk of heart fibrillation;
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;
Short-distance operation (for instance: 1 m) from
a shortwave or microwave therapy DEVICE may
produce instability at the STIMULATOR output;
W e recommend special attention for current
densities of any electrode exceeding 2 mA
2
effective currents/cm ;

MU_4034_4044_ENG_Rev05_092009

TENSMED II 4044
TENSMED IV 4034
6.

Do note place the device on a soft surface that


may block the bottom ventilation openings.

Using TENS a s 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.

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.

TENSMED II 4044
TENSMED IV 4034

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

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)


CONT
ROLE
CENTRAL
Central
Control

Action
S
ISTEMA
System
DE
AO

NervousNERVOS
FibersAS
FIBRRAS
Type
TIPOIIIIand
E IIIIII

Gelatin
SUBS
TNCIA
Substance
GELAT
INOSA

Nervous
FibersAS
FIBRRAS
NERVOS
Type
IV
TIPO IV

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

MU_4034_4044_ENG_Rev05_092009

Transmission
CLULA
Cell SORA
TRNAMIS
(Laminae
(LAMINAV)
V)

Gate
Control
System
SISTEMA
DE CONT
ROLE
DA PORTA

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.

MU_4034_4044_ENG_Rev05_092009

TENSMED II 4044
TENSMED IV 4034
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
Thick

Thin

A
A
A
A
B
C

Afferent
I
II
III
III
IV

Speed
M/s
70 120
50 70
30 50
< 30
3 14
<3

Diameter
m
12 22
5 12
5 12
25
13
0.1 1.3

TENSMED II 4044
TENSMED IV 4034
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:

I
T

Summary of nervous fibers (Erlanger and Gasser)

Endorphin release theory (Sjolund and Eriksson)

Continuous
Mode
Modo Contnuo

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).

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:

Operation modes

The unit has the following stimulation modes:



CONTINUOUS

BURST

VIF

VLP

VLF

0
Modo Burst

Burst Mode
Burst
Burst
Mode
Mode

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TENSMED II 4044
TENSMED IV 4034

TENSMED II 4044
TENSMED IV 4034

VIF

VLF

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.

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 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.

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

0
VIF Mode
VIF Mode
Modo
VIF

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.

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.

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10

TENS APPLICATION FOR ACUTE PAIN


Author Diagnosis

Electrode
Placement

Pulse
Pulse
Intensity
Duration Frequency

Treatment
Frequency
***********

*******

********

********

Hz

ref. 15

after
laparotomy

parallel to
incision

120-340

10-100

ref. 16

after
laparotomy

parallel to
incision

80

40

ref. 18

after
laparotomy

parallel to
incision

128-200

10-100

ref. 17

after
surgery

parallel to
incision

**********

**********

MU_4034_4044_ENG_Rev05_092009

*******

0-90 V
Constant in
Comfortable first 48 hours
Comfortable

60 min. each
4 hours

0-135 mA
Constant in
Comfortable first 48 hours
*******

Constant in
first 48 hours

11

TENSMED II 4044
TENSMED IV 4034
ref. 19

after
above and
Caesarian
below incision
section

ref. 20

delivery
pain

ref. 21

delivery
pain

ref. 5

paraesp.
T10-L1,S2-S4

**********

toothache on pain region

250-400

**********

**********

200

80-100

**********

**********

100

20-35 mA

Constant or 30
min. 4 times a
day
st

20-25 V
Comfortable

During 1
stage of
delivery

Comfortable

During 1st
stage of
delivery

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
13
to Wolf and Colleagues , 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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TENSMED II 4044
TENSMED IV 4034
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


Electrode
Pulse
Pulse
Treatment
Intensity
Placement Duration Frequency
Frequency

Author

Diagnosis

*******

**********

***********

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

ref.23

backache

backache
central part

ref.24

knee
osteoarthritis

on knees

ref.25

phantom limb
pain

ref.26
ref.27

paravertebral maximum
************

2/abr
4/ago

motor level 30 - 61 min.


tolerance

30 min. 2 x
a week

************ Comfortable Comfortable

30-60 min.
a day

stump or
central limb

************

15 min. 2 x
a day

fracture

on fracture

300

Neuro-peripheral
pain

on painful
region

200

MU_4034_4044_ENG_Rev05_092009

*********

************

sensor level sensor level


110

26-28 mA

30-60 min.
3-4 x a day
cont. 8-10
hours a day

13

TENSMED II 4044
TENSMED IV 4034
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 painrelated trigger points or roots.
7. Segmentally related myotonia

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TENSMED II 4044
TENSMED IV 4034
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)
MU_4034_4044_ENG_Rev05_092009

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TENSMED II 4044
TENSMED IV 4034
4. Pain in the lower part of the back, with L5 root pain in the left leg

5&6
7.
8.

Right leg position for amputation below the knee


After-surgery TENS for abdominal region
Backache with bilateral pain in the legs

TENSMED II 4044
TENSMED IV 4034
9.
10.
11.
12.

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

Controls
A) TENSMED II 4044
Increment / Changes
Field

Moves Field to
Right

Moves Field to
Left

Decrement /
Changes Field

MU_4034_4044_ENG_Rev05_092009

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17

TENSMED II 4044
TENSMED IV 4034
1. UP Key

2. DOWN Key

3. LEFT Key

4. RIGHT Key

TENSMED II 4044
TENSMED IV 4034

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.

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.

Figura 02.

MU_4034_4044_ENG_Rev05_092009

18

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.
MU_4034_4044_ENG_Rev05_092009
19

TENSMED II 4044
TENSMED IV 4034
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 W idth  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:
Mode

Fr Hz

VLP Mode:
Mode

Fr Hz

P uS Timer

P uS Timer

VLF Mode:
Mode

Followed by the screen:


Mode

Fr Hz

Fr Hz

P uS Timer

P uS Timer

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.

Mode

Fr Hz

P uS Timer

The main screen will remain on the display:


MU_4034_4044_ENG_Rev05_092009

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MU_4034_4044_ENG_Rev05_092009

21

TENSMED II 4044
TENSMED IV 4034

TENSMED II 4044
TENSMED IV 4034

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


below:

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


the stimulation intensity.

Mode

Fr Hz

P uS Timer

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.

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:
Mode

Fr Hz

P uS Timer

Fr Hz

P uS Timer

Increment / Changes
Field

9. Use or to select the desired time, as illustrated below:


Mode

Fr Hz

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

8. Use or to select Timer, as illustrated below:


Mode

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.

Moves Field to
Right

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.
MU_4034_4044_ENG_Rev05_092009

22

Moves Field to
Left

Decrement /
Changes Field
MU_4034_4044_ENG_Rev05_092009

23

TENSMED II 4044
TENSMED IV 4034
1. UP Key

2. DOWN Key

3. LEFT Key

4. RIGHT Key

TENSMED II 4044
TENSMED IV 4034

5. START Key

6. STOP Key

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

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.

Figura 03.

MU_4034_4044_ENG_Rev05_092009

24

MU_4034_4044_ENG_Rev05_092009

25

TENSMED II 4044
TENSMED IV 4034

TENSMED II 4044
TENSMED IV 4034

8. Channel 2 intensity control: Key increments channel 2 intensity. Key


reduces channel 2 intensity.
9. Channel 3 intensity control: Key increments channel 3 intensity. Key
reduces channel 3 intensity.
10. Channel 4 intensity control: Key increments channel 14 intensity.
Key reduces channel 4 intensity.

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

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 W idth  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

Mode

Fr Hz

P uS Timer

VIF Mode:

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

VLP Mode:
Mode

Fr Hz

P uS Timer

P uS Timer

VLF Mode:
Mode

Followed by the screen:


Mode

Fr Hz

Fr Hz

P uS Timer

P uS Timer

MU_4034_4044_ENG_Rev05_092009

26

MU_4034_4044_ENG_Rev05_092009

27

TENSMED II 4044
TENSMED IV 4034
4. Use or to select the Frequency (Fr Hz), as illustrated below:
Mode

Fr Hz

P uS Timer

Fr Hz

P uS Timer

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


Mode

Fr Hz

9. Use or to select the desired time, as illustrated below:


Mode

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


below:
Mode

TENSMED II 4044
TENSMED IV 4034

P uS Timer

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.
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.

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


below:
Mode

Fr Hz

P uS Timer

8. Use or to select Timer, as illustrated below:


Mode

Fr Hz

P uS Timer

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

MU_4034_4044_ENG_Rev05_092009

28

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
MU_4034_4044_ENG_Rev05_092009
29

TENSMED II 4044
TENSMED IV 4034

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.

MU_4034_4044_ENG_Rev05_092009

30

TENSMED II 4044
TENSMED IV 4034
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

31

TENSMED II 4044
TENSMED IV 4034
Nothing happens when the keys
are pressed.
Patients says the stimulation
sensation is greater in one
electrode than in the other.

Contact
assistance.

the

authorized

Change the (silicon or adherent)


electrodes, as they might be worn
out.

TENSMED II 4044
TENSMED IV 4034
- 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
 Pulse duration
 BURST mode
 Modulation
 Frequency
 Pulse duration

The intensity is increased to the Check the patients sensitivity.


maximum and the patient reports Change the (silicon or adherent)
little stimulation.
electrodes.

Check the electrode cable


The unit turn on as usual, but the
continuity.
patient says that there is no
Check
the
electrode
stimulation.
conductivity.

Frequency and Pulse Duration:


Registration number in Anvisa

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
TM
UMDNS
Classification
13-782





: 100 to 240vac 50/60hz


: 12 VA
: 1A 250V 20AG
: 50 / 60 Hz
: 23.5 x 8.0 x 17.0
: 650 grams
: Four independent channels
: Two independent channels
: Asymmetrical 2-Phase

: 100 mA 10 % (RL = 500 )


: 1 to 60 minutes ( 1% ), in
1-min ute steps

: 2 Hz 1%
: 100Hz 1%
: 50 s to 400 s 1 %

Technical Data
Specifications:
Power supply
Maximum consumption
Fuse
Operating frequency
Dimension
(WxHxD) cm
Weight
Channels Tensmed IV 4034
Channels Tensmed II 4044
Pulse form
Rectangular
Maximum intensity per channel
Digital timer

: 1 to 200 Hz 1 %
: 50 s to 400 s 20 %

: AM-10314290033

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

MU_4034_4044_ENG_Rev05_092009

32

MU_4034_4044_ENG_Rev05_092009

33

TENSMED II 4044
TENSMED IV 4034
Acessories

Important Notes:

TENSMED IV 4054

Silicone electrodes 3 x 5 cm
Electrode cables
Yellow
Green
Blue
purple
2-Pole Power Cable
Users Manual
Contact Gel 200ml

Code 04033
Code 14635G
Code 09852G
Code 14644G
Code 14634G
Code 17394G
Code 17813G
Code 7000/200

TENSMED II 4052

Silicone electrodes 3 x 5 cm
Electrode cables
Green
Blue
2-Pole Power Cable
Users Manual
Contact Gel 200ml

Code 04033
Code 09852G
Code 14644G
Code 17394G
Code 17813G
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:
o
Ambient temperature
: -10 to 50 C
Relative humidity
: 20 to 90%
Air pressure
: 500 to 1060 hPa

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

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.
Electromagnetic
Emission tests
Compliance
environment - instructions
FESMED uses RF energy
only
for
its
internal
functioning. This way, its RF
RF Emission
Group 1
emission is very low and it is
CISPR 11
not probable that it causes
any interference in another
electronic device nearby.
RF Emission
CISPR 11

Class B

Harmonic Emission
IEC 61000-3-2

Class A

Voltage Floating /
Flicker Emission
IEC 61000-3-3

According to

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.

MANUFACTURERS DECLARATION AND INSTRUCTION


ELECTROMAGNETIC IMMUNITY

Applicable Norms:

TENSMED II 4044
TENSMED IV 4034

34

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.
Electromagnetic
Immunity
Test level of
Compliance
environment tests
IEC 60601
level
instructions
MU_4034_4044_ENG_Rev05_092009

35

TENSMED II 4044
TENSMED IV 4034
Electrostatic
discharge
IEC 61000-42

6 kV contact
8 kV air

Immunity
tests

Test level of
IEC 60601

Fast
transients /
Blasts
IEC 61000-44

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

Surge
IEC 61000-45

1
kV
differential
mode

2
kV
common mode

The floor should be


made of wood, concrete
6 kV
or ceramic. If covered
contact
with synthetic material,
8 kV air
the relative air humidity
should be min. 30%.
Electromagnetic
Compliance
environment level
instructions
2 kV power
supply
Not applicable

1
kV
differential
mode

2
kV
common
mode

The electrical system


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

TENSMED II 4044
TENSMED IV 4034

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

Magnetic
fields of utility
frequencies
(50/60 Hz)
IEC 61000-48

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

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

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

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

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

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

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

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

Ut

3 A/m

3 A/m

Ut
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
Conducted
RF
MU_4034_4044_ENG_Rev05_092009

36

Test level
of
IEC 60601
3 Vrms
150 kHz to

Compliance
level
3V

MU_4034_4044_ENG_Rev05_092009

Electromagnetic
environment - instructions
Portable and mobile devices of
RF communications should not
37

IEC 610004-6

Irradiated
RF
IEC 610004-3

80 MHz
3 V/m
80 MHz to
2.5 GHz

3 V/m

TENSMED II 4044
TENSMED IV 4034

TENSMED II 4044
TENSMED IV 4034

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:
d = 1,17. P

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.

d = 1,17. P
MHz

80 MHz to 800

d = 2,3. P

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
a
electromagnetic field study ,
should be lower than the
compliance level in each
b
frequency range .
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

38

Distance according to the transmitter frequency

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

150 kHz to 80
MHz

80 MHz to 800
MHz

800 MHz to 2.5


GHz

d = 1,17 P

d = 1,17 P

d = 2,3 P

0.01
0.1
1
10
100

11.70 cm
37.00 cm
1.17 m
3.70 m
11.70 m

11.70 cm
37.00 cm
1.17 m
3.70 m
11.70 m

23.00 cm
72.70 cm
2.30 m
7.27 m
23.00 m

MU_4034_4044_ENG_Rev05_092009

39

TENSMED II 4044
TENSMED IV 4034
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 : carci@carci.com.br
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 : sat@carci.com.br
Technician in Charge:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D
MU_4034_4044_ENG_Rev05_092009

40

TENSMED II 4044
TENSMED IV 4034
REFERENCES
1. Bertrand Sr. Method of determining optimal stimulation sites for
transcutaneous electrical nerve stimulation. Physical Therapy 64:924928, 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 postoperative 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 11:847,1981.
MU_4034_4044_ENG_Rev05_092009

41

TENSMED II 4044
TENSMED IV 4034
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

42

TENSMED II 4044
TENSMED IV 4034
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 10 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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43

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