TENStem eco

Dual-channel transcutaneous nerve stimulator

Art. No. 104725

Operating Instrucions Art. No. 100817-V02

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schwa-medico Operating Instructions - TENStem eco

Contents
Intended use............................................................................................................3
Important safety instructions..................................................................................3
Device description...................................................................................................4
Description of symbols............................................................................................4
Specifications..........................................................................................................5
Pulse forms..............................................................................................................5
Operating the device...............................................................................................6
Switching on the device..........................................................................................6
Mode of stimulation................................................................................................7
Locking the device...................................................................................................8
The Editing mode....................................................................................................8
Deleting the user programmes...............................................................................9
Operating parameters...........................................................................................10
Switching off the device.......................................................................................10
Changing the battery.............................................................................................10
Description of the programmes............................................................................11
General information..............................................................................................16
Readjustments, alterations and repairs................................................................16
Circuit diagrams, spare parts list and setting instructions..................................16
Warranty................................................................................................................16
Cleaning and maintenance...................................................................................17
Classification.........................................................................................................17
Technical checks....................................................................................................17
Combination..........................................................................................................17
Scope pf supply.....................................................................................................17
Accessories...........................................................................................................18
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schwa-medico Operating Instructions - TENStem eco

Intended use
The TENStem eco device was designed for transcutaneous muscle and nerve
electrostimulation. Please do not use this device for any other purpose.

Important safety
instructions
Please read the Operating Instructions carefully before using the device.

To ensure safe use of the device

• Only use the TENStem eco with original accessories.
• Keep the TENStem eco away from water or other fluids.
• Do not drop the TENStem eco, handle it incorrectly or expose it to extreme
temperatures or high humidity (only use at temperatures between 10 °C
and 40 °C and at a relative humidity below 90 %).
• Never use the TENStem eco when it is not functioning properly or when it
is damaged in any way.
• Store the TENStem eco in its original packaging after use to protect it from
damage and contamination.

Warning
Patients with an implanted electronic device (e. g. pacemaker) should not un-
dergo electrotherapy with the TENStem eco before consulting a doctor. The
TENStem eco may only be connected to one person at a time.

The TENStem eco should not be used besides or on other electronic appli-
ances in order to prevent interference. If this is not possible, the respective
device functions during operation need to be obtained in order to ensure a
conventional use.

Connecting the patient at the same time to a high-frequency surgical unit may
cause burns under the electrodes.
Operation near (e.g. 1 m) a short-wave or microwave device may cause fluctu-
ations in the baseline values of the electrotherapy device.
The minimum size of the electrodes should not be less than 2 cm2.
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schwa-medico Operating Instructions - TENStem eco

Device description
The TENStem eco was designed to stimulate human nerves and muscles.
The keys may be used to make all adjustments necessary. The display shows
the different operating modes.
6
1 Display (see a-f)
2 Menu keys
3 Modification keys
3A intensity channel 1
3B intensity channel 2 1
(These keys may be used to alter in-
tensity during stimulation and to alter
parameters in the editing mode.)
4 ON/OFF key
5 Battery compartment 2
6 Sockets
a f

b 3A 3 3B
c
e
4

d 5

a Battery charge
full empty
b) Display of selected programmme:
P = Standard programme U = Changed programme
c) Programme time
d) Intensity of each channel
e) Display of programme phases
f) Locking active: Only intensity adjustable

Description of symbols

Attention: Read Operation Instructions!

BF type application part. Protection against electric shock.

The year of construction of the product follows this symbol.

 5

schwa-medico Operating Instructions - TENStem eco

The article or order number of the product follows this symbol.

The serial number of the product follows this symbol.

This equipment is marked with the recycling symbol. It means that at the end
of the life of the equipment you must dispose of it separately at an appropriate
collection point and not place it in the normal domestic unsorted waste stream.
This will benefit the environment for all.

Conform with Council Directive 93/42/EEC of 14 June 1993 concerning medical

devices.

Specifications
Dual-channel nerve stimulator with electrically insulated channels, constant
current characteristic, output short circuit control element (AKS), 12 integrated
programmes and 12 user-defined programmes.

Output current 70 mA (with 1kΩ real)

Frequencies 0.5-120 Hz
Pulse width 60-300 µs
Current consumption 6 mA
Current supply 9 V battery
Dimensions approx. 115 mm x 60 mm x 30 mm
Weight approx. 130 g (without accessory)

Pulse forms
With 1kΩ load real

Current, Voltage
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Time

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 6 ���������������

schwa-medico Operating Instructions - TENStem eco

�����

With ANSI/AAMI standard load

Voltage
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Time
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Current

Time
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Change in output current depending on load

Current
Strom I
mA
80
60
40
20

Resistance R L
Widerstand
500 1000 1500 2000 2500
Ω

Operating the
device
Switching on the device
Switch on the device using the key. The TENStem eco starts with the pro-
gramme number which was active when the device was last switched off. If
locking (please refer to section entitled “Locking the device“) is active, the key
symbol appears in the upper right-hand corner of the display (see fig. ).

Activating the editing mode

Only if you switch on the TENStem eco pressing the key, you can activate
the standard programmes (please refer to section entitled “Editing mode“) and
make copies of them in the form of user programmes. However, this function is
only available if the device was not locked beforehand.
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schwa-medico Operating Instructions - TENStem eco

Resetting the operating parameters and deleting the user programmes

If you wish to delete the user programmes and return the operating time meter,
the cycle meter and the mean stimulation intensity to zero, keep the key on
the left and the key pressed down while switching on the device (please
refer to section entitled “Operating parameters“).

Mode of stimulation
Programme selection
Use the key to change to the next standard or user programme. However,
this is only possible with an unlocked device. The standard programmes 1 to 12
marked with a „P“ run initially, followed by the user programmes marked with
a „U“, if present. When the last programme has been reached, pressing the key
again returns the setting to Programme 1 (P1).

Starting stimulation
First, position the electrodes at the desired points of the body and connect
the electrode cables to the electrodes and the device. When the desired pro-
gramme has been selected using the key, or the locked device has been
started directly with the desired programme, the two keys may be used to
start stimulation (see fig. ).

Setting the intensity

You can use the modification keys to set the intensity of both channels
to a pleasant value at any time. The display shows the strength of current for
both channels, which may be varied from 0-70 mA. Intermediate values are
clearly marked by a dash behind the digit. If the electrodes are not correctly
connected to the device, the intensity is returned to zero starting from a current
of 8 mA.

Attention!
The TENStem eco from serial B up (from Serial no. 171770 B and from firmware
version 1.6) provides with an additional safety control. By push and hold the
modification knob the automatic adjustment will be stopped automatically
when reaching the intensity of 20 mA. To increase the intensity the knob has
to be released and pushed once again. This process will be repeated when
reaching 30, 40, 50 and 60 mA.The Intensity can be reduced in just one step
without releasing the intensity with the modification knob .

If you are in the run-down or pause phase in Programme 9 and you press one of
the modification keys, the working phase is started directly from the build-
up phase. There is no pause phase in Programme 7. The programmes then stay
in the work phase until none of the modification keys are pressed for 3
seconds. The programme run is not interrupted if you lower the intensity.
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schwa-medico Operating Instructions - TENStem eco

Displaying the stimulation parameters

Press the key to display the programme parameters in the upper left-hand
corner of the display during stimulation. The first value to appear is frequency
(see fig. ) and then pulse width (see fig. ) if you press the key once more.
The programme number is then displayed again (see fig. ). The remaining
stimulation time in minutes is shown in the middle of the display. A particular
feature of Programme 4 is that the frequency for channel 1 is shown in the
upper left-hand corner, and that for channel 2 in the upper right-hand corner
(see fig. ).

Stopping stimulation
Use the or keys to stop stimulation at any time. Stimulation stops au-
tomatically at the end of a programme.

Locking the device

Choose the programme desired for the patient using the key (please refer
to section entitled “Description of the programmes“). Lock the device by then
pressing the key on the left and also the key. A key appears in the up-
per right-hand corner of the display. All device functions apart from stimulation
with the selected programme are now no longer available. Use the same key
combination to unlock the device. A locked device cannot be started in the
editing mode.

Editing mode
Activating editing mode
Please switch on the device while pressing the key. An "E" on the right-
hand side of the display indicates the editing mode. However, this only works
if the device was not locked beforehand. Then use the key to select the
standard or user programme (see fig. ) that you wish to edit. The key is
then used to start editing the currently active standard or user programme. This
is shown by the fact that the "P" or "U" symbol before the programme number
changes to an "E".

Editing standard or user programmes

The parameters of each programme are used as the starting value. Press the
key to jump to the next parameter or to save the values. Use the
key to interrupt the editing process at any time without saving the altered
parameters. Various parameters may be processed, depending on the type of
programme. If not indicated otherwise, the frequency and the pulse width ap-
ply for both channels. Use the modification keys to adjust the values.
If you keep the keys pressed down, counting up or down of the parameter is
automatically continued.
 9

schwa-medico Operating Instructions - TENStem eco

Programme 1, 2, 3 (TENS):
1. Frequency: 0.5 Hz up to 120 Hz (fig. )
2. Pulse width: 60 µs up to 300 µs (fig. )
3. Total run time: 1 up to 99 min., timer off (fig. ).

Programme 4 (TENS):
1. Frequency channel 1: 80 Hz, 90 Hz, 100 Hz, 110 Hz, 120 Hz (fig. )
2. Frequency channel 2: 0.5 Hz, 1 Hz, 2 Hz, 5 Hz, 10 Hz
3. Pulse width: 60 µs up to 300 µs (fig. )
4. Total run time: 1 up to 99 min., timer off (fig. ).

Programme 5 (Adjustment):
1. Max. frequency: 2 + 10 Hz up to 120 Hz (fig. )
2. Min. frequency: 0.5 Hz up to max. frequency - 10 Hz (fig. )
3. Pulse width: Calculated according to the frequency
4. Total run time: 10 up to 99 min. (fig. )

Programme 6 (Han):
1. Total run time: 1 up to 99 min., timer off (Fig. )

Programme 7 (Burst), 9 (Muscle), 10 (Dynamic Massage),

11 (Dynamic Rub), 12 (Deep-TENS):
1. Frequency: 10 Hz up to 120 Hz (fig. )
2. Pulse width: 60 µs up to 300 µs (fig. )
3. Total run time: 1 up to 99 min., timer off (fig. )

Programme 8 (Modulation):
1. Max. frequency: Min. frequency 2 + 10 Hz up to 120 Hz (fig. )
2. Min. frequency: 2 Hz up to max. frequency - 10 Hz (fig. )
3. Pulse width: Calculated according to the frequency
4. Total run time: 1 up to 99 min., timer off (fig. )

To save the new programme, press the key once more after
processing the last parameter. A "U" symbol now appears before the
programme number on the display.

Deleting the user

programmes
To delete all user programmes, keep the key and the key on the
left pressed down when switching on the device. This will also return all
operating parameters to zero.
10

schwa-medico Operating Instructions - TENStem eco

Operating parameters
Description of parameters
These values are used to check the patient’s stimulation behaviour. The fol-
lowing information are recorded by the TENStem eco:
The stimulation time (see fig. ) is the total time during which stimulation was
carried out with the device. The cycles (see fig. ) mark how often the device
was switched on and concomitantly used for stimulation.The mean stimulation
intensity (see fig. ) is the mean value of all values for current set by the pa-
tient. This information is registered separately for the two channels. The values
are updated every minute during stimulation. However, only intensities above
4 mA are considered.

Calling up the parameters

Press the key on the left and the key at the same time. The stimulation
time in hours and minutes is first shown in the upper part of the display. The
number of cycles is shown in the lower part of the display.
After pressing the key, the mean stimulation intensity for channel 1 is shown
in the lower left part of the display, that for channel 2 in the lower right part.
Resetting operating parameters
To reset all the described values to zero, keep the key on the left and the
key pressed down when switching on the device. Please be aware that all
user programmes are also deleted.

Switching off the device

Use the key to switch off the device. If the battery voltage has fallen below
a critical value, or if no key is pressed for two minutes outside stimulation, the
device switches itself off automatically. This is signalled by a beep.

Changing the battery

The voltage of the battery in the device is displayed during operation by the
segments within the battery symbol. If the voltage falls below a critical value,
the TENStem eco switches itself off automatically and cannot be switched back
on again. You then need to insert a new battery into the device.
• Switch off the device.
• Take off the lid of the battery compartment.
• Remove the used battery from the compartment.
• Insert a new battery into the compartment.
• Please pay attention to the correct polarity.
• Put the lid of the battery compartment back on.
 11

schwa-medico Operating Instructions - TENStem eco

Description of the programmes

Programme 1
Name: Gate Control 1
Total run time = 30 min.
Parameter: Frequency channel 1 and 2 = 100 Hz
Pulse width = 200 µs
Symbol on the display:
Description: Both channels are continuously operated with the same
frequency and pulse width.

Intensity
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Pulse width
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Time
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Programme 2
Name: Gate Control 2
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�� Total run time = 30 min. �

Parameter: Frequency channel 1 and 2 = 80 Hz

Pulse width = 150 µs
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Please refer to programme 1 concerning description and symbols.

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Programme 3 ��
Name: Kaada
Total run time = 30 min.
Parameter: Frequency channel 1 and 2 = 2 Hz
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Pulse width = 250 µs
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Please refer to programme
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Programme 4 ��
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Name: Gate Control + Kaada

Total �������
run time = 30 min.
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Parameter: � Frequency channel 1 = 100 Hz���
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Frequency channel 2 = 2 Hz
Pulse width = 200 µs
Symbol on the display:
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12 ������������ ����������
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schwa-medico Operating Instructions - TENStem eco

������������

�
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��
Description: Channel 1 works continuously at a high frequency between
80 Hz and 120 Hz, whereas channel 2 operates at a low frequency between
0.5 Hz and 10 Hz.
Channel
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Intensity
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�� �

Channel
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Time
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Programme 5
Name:
���������� Adjustment �������
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�� Total run time = 30 min.
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Parameter Phase 1: Frequency channel 1 and 2 = 100 Hz ��
Pulse width = 150 µs
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Duration = 10 min.
Parameter Phase 2: Frequency
������� channel 1 and 2 = 2 Hz ������������
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� Pulse width = 200 µs ���
�� Duration��= 20 min. ��

Symbols on the display: Phase 1:

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Phase 2:
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Description:
�� The device stimulates as described already for �������
Programme 1.
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Phase 1 with a high frequency
������� first occurs in both channels. Then the
�� frequency
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is altered to a low value and the pulse width increased accordingly. The device ��
operates at this��frequency until the end of the programme (Phase 2).
Frequency
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Phase 1
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Phase 2
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Programme 6 ����������
�� �������
Name: ��� ������� ����� Han
Total run time = 30 min. ������� ������������
� ��
Parameter Phase 1: ���� Frequency
��� ���� = 100 �Hz
��
Pulse width = 150 µs
Durantion = 3 sec.
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schwa-medico Operating Instructions - TENStem eco ��
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Parameter
����������Phase 2: Frequency = 2 Hz
��
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Pulse width = 200 µs
������� ������������
Duration
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= 3 sec. ������������
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Symbols
�� on the display: Phase 1: ��
��
Phase 2:
Description: The device stimulates with a high frequency and a relatively low
������� �������
pulse width (phase� 1) respectively with a low frequency and a �������
relatively high
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pulse width (phase 2) alternately.
�� The duration
�� of the phases
�� is 3 sec. each.
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Frequency
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Phase
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������� Time
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Programme 7 �� �� ��

Name: Burst
������� Total run time = 30 min.
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Parameter:
��
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Frequency = 100 Hz
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�������� Pulse width = 150 µs
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����� Working
����� phase = 0.25 sec. ��

�� �������Pause phase = 0.25 sec.

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Symbols on the display: Working phase: �������
�
�
������� Pause phase:
���� ��� ���� � �������
�
Description: The device� stimulates � at a high frequency as in programme 1.
The difference in this case is that the pulses are switched on (working phase)
and off (pause phase) alternately for fractions of a second.

Pulses
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Working
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phase �����
phase
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Pause
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phase
Time
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 14

schwa-medico Operating Instructions - TENStem eco

Programme 8
Name: Modulation
Total run time = 30 min.
Parameter: Min. frequency = 2 Hz ➡ Pulse width = 200 µs
Max. frequency = 80 Hz ➡ Pulse width = 100 µs
Duration of modulation = 7.5 sec.
Symbols on the display: Build–up phase:
Run–down phase:
Description: In the build-up phase, frequency is increased within a few se-
conds in individual steps, starting from minimum and reaching maximum fre-
quency, the pulse width being adapted accordingly. This is followed by a run-
down phase in which the intensity is regulated back down to the minimum.

Frequency
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��
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Build-up
��������� Run-down
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phase
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phase

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�� Time
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Programme 9
������� Name:
������������ Muscle
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�� Total run time = 30 min.
�� ����
��� �
�� �����

Parameter: Frequency = 50 Hz
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�

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Pulse width = �������
250 µs
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Build–up phase = 2 sec.
Working phase = 5 sec.
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�� Run–down phase = 1 sec. �
� � �
Pause phase = 12 sec.
Symbols on the display: Build–up phase:
Working phase:
Run–down phase:

������������ Pause phase:
��
Description: During the build-up phase, intensity is continously increased
from zero to the��
set value. The device then stimulates at the set intensity
during the working phase. In the subsequent run-down phase, intensity is re-
������� ������� gulated back down to zero. The next build-up phase starts after the pulse-free
��� pause phase.
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Intensity
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e

R�u��� ase
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Working
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n-�d�
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phase
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ow
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�n
������� ���������� Time
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Programme 10 ��
Name: Gate Control dynamic 1
������� ������������ Total run time = 30 min.
�� �� �������
Parameter: Frequency = 80 Hz �
��� ��
�� Pulse width = 150 µs
Build–up phase = 1 sec.
�������
Run–down phase = 1 sec.
�������
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Symbols on the display: Build–up phase:
��
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�� Run–down phase: �������
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��� �
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Description: Basically, the�device works � like in

� the muscle mode but without
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�

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working and break times. During �����the build–up phase�����intensity is increased up
�

���
��

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to the set value. The run–down phase is following immediately, decreasing
intensity back to zero. The channels of the TENStem eco work alternately, i. e.
������������
������� �������
�� when �� channel 1 has reached�������
its maximum intensity, the intensity � of channel
� � �
2 is zero and vice versa.
������There
�����is a convenient massage effect owing to the
dynamic stimulation when placing the electrodes next to each other on the
�
�

������� painful area.

�
�
Intensity
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�� �

��

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�� �� Time
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Programme
� 11
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Name: Gate Control dynamic 2
��
�������Total run time = 30 min.
Parameter:
������ ����� Frequency = 80 Hz
�
�

Pulse width = 150 µs

������� Build–up phase = 0.2 sec.
�
� Run–down phase = 0.2 sec.
�������
Total run time = 30 min. �
 ��
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16

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schwa-medico Operating Instructions - TENStem eco

������� �������
�� �
� � �

Please refer to programme 10 concerning description and symbols.

Name: Deep-TENS
������������
�� Total run time = 30 min.
Parameter: Frequency = 100 Hz
��
Pulse width = 75 µs
Number of pulses = 4
������� ������� Pause between the pulses = 200 µs
���
�� �� Symbol in the display: �������
Description: The device works
�
as described
� �
under programme �1. In contrast,
Deep–TENS has four pulses in sequence with a break of 200 µs in between.

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��Intensity
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Time
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General information
������
���� Readjustments,
alterations and repairs
������� The manufacturer is only responsible for the safety and perfor-
�
���� � mance of the TENStem eco device when readjustments, alterations
and repairs are carried out by authorised individuals and when the
TENStem eco is used in accordance with the user instructions.

Circuit diagrams,
spare parts list and
setting instructions
Qualified technicians who are familiar with the technical features of the device
can be provided with circuit diagrams, spare parts list and setting instructions
by the manufacturer.

Warranty
We give a guarantee of 2 years from the date of purchase on the
TENStem eco device. This guarantee does not cover cables, electrodes and
the battery.
 17

schwa-medico Operating Instructions - TENStem eco

Cleaning and maintenance

No special cleaning or care agents are required for the TENStem eco. Clean
the TENStem eco with a soft, lint-free cloth. Please ensure that no moisture
gets into the device. If moisture does enter the device, a technical check must
be carried out before using the device again.

Classification
In accordance with Council Directive 93/42/EEC of 14 June 1993 concerning
medical device, the TENStem eco device is classified as being a Class IIa me-
dical device.

Technical checks
Technical checks on the device should be performed every 24 months.

These include:
1. Checking to see whether the operating instructions and the medical device
book are included in the accompanying documentation.
2. Checking the equipment for completeness.
3. Visual check:
- for mechanical damage
- for damage to all cables and connections
4. Functional safety:
- Checking the output signals with a load resistance of 1 kΩ real
(current and voltage)
- Checking the frequency
- Checking the pulse width

These technical checks may only be performed by individuals with appropriate

training. The results must be noted in the medical device book along with the
date and name of the person carrying out the check.

Combination
The TENStem eco may be used together with all accessories mentioned in the
chapter „Accessories“.

Scope of supply
104725 TENStem eco 1
602000 9V Alkaline battery 1
283400 Self-adhering electrode 50 x 50 mm 1
106351 Cable type 5.15 2
105510 Videobox 1
100817 Operating Instructions 1
100841 Short instruction sheet TENStem eco 1
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schwa-medico Operating Instructions - TENStem eco

Accessoires
Rubber electrodes
Technical Data
Compound: Silicone-carbon
Durability: approx. 12 months
Colour: Black
Manufacturer: Pierenkemper GmbH

Application
Spread 2-3 drops of the electrode gel evenly over the flat side of the electrode.
The electrode gel improves the conductivity of the electrode. Place the elec-
trodes on the relevant skin areas and secure the electrodes with a tape strip.
Do not apply to broken skin!
Because conductivity of the electrodes slowly decreases after approx. 6 months
of use, replace electrodes after approx. 12 months of intensive use.
Cleaning
Clean electrode surface with water and soap or appropriate disinfectant (e. g.
alcohol 70%) after every use.

Art. No. Article Quantity

107090 Rubber electrode, round 20 mm Ø 2

107060 Rubber electrode, round 25 mm Ø 2

107075 Rubber electrode, 40 x 28 mm 2

107035 Rubber electrode, 56 x 28 mm 2

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schwa-medico Operating Instructions - TENStem eco

Art. No. Article Quantity

107020 Rubber electrode, 75 x 30 mm 2

107055 Rubber electrode, 90 x 35 mm 2

Gummielektroden
2 Stück 35 x 90 mm

107011 Rubber electrode, 38 x 45 mm 2

107010 Rubber electrode, 48 x 48 mm 2

107 010 Gummielektroden
2 Stück 48 x 48 mm

107050 Rubber electrode, 70 x 65 mm 2

107070 Rubber electrode, 70 x 140 mm 2

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schwa-medico Operating Instructions - TENStem eco

Self-adhering electrodes
Technical Data
Compound: Conductive and bonding material
Durability: 80-150 treatments
Colour: Grey
Manufacturer: Pierenkemper GmbH

Application
Place self-adhering electrodes directly on appropriate skin treatment
area, no special preparation of electrode is necessary. See „Electrode mainte-
nance“ below to insure electrode’s effectiveness. Do not apply to broken skin!

Electrode maintenance
For hygienical reasons, self-adhering electrodes are for single patient use only.
After every treatment session, return electrodes to their original foil and store
them in their plastic bag. To increase longevity, store in cool area (i. e. refrige-
rator). With appropriate use and proper care the electrodes are applicable 80-
150 times. To renew adhesion of electrodes, place 2-3 drops of water on the
electrode’s adhesive surface and air dry a couple of seconds before placing on
treatment area.

Art. No. Article Quantity

281000 Stimex, round 32 mm Ø 4

282000 Stimex, round 50 mm Ø 4

283300 Stimex, 50 x 30 mm 4
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schwa-medico Operating Instructions - TENStem eco

Art. No. Article Quantity

283400 Stimex, 50 x 50 mm 4

283600 Stimex, 50 x 90 mm 2

283000 Stimex, 50 x 130 mm 2

283100 Stimex, 80 x 130 mm 2

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schwa-medico Operating Instructions - TENStem eco

Accessories

Art. No. Article Quantity

108000 Electrode gel 60 g

106351 Electrode cable type 5.15 1

109000 Tape (type silk) 1 roll

603110 Rechargeable battery 9 V NiCd 1

603000 Charger for 9 V rechargeable batteries 1

➟ Ni.Cd.Akku 9 Volt

602000 9 V Alkaline battery 1

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schwa-medico Operating Instructions - TENStem eco

schwa-medico
Medizinische Apparate Vertriebsgesellschaft mbH · Export Department
Wetzlarer Straße 41 - 43 · 35630 Ehringshausen
Phone +49 6443 8333-113 · Fax +49 6443 8333-119
E-Mail export@schwa-medico.de · www.schwa-medico.com

Manufacturer: Pierenkemper GmbH

Hörnsheimer Eck 19 · 35578 Wetzlar · Germany
www.pierenkemper.eu
Art.-Nr. 451600-0232