Enraf Nonius TENSMED S82 User manual

INSTRUCTIONS FOR USE
14. September 2020
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TENSMED S82

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DEAR CUSTOMER
THANK YOU FOR CHOOSING THIS PRODUCT. WE REMAIN AT YOUR ENTIRE
DISPOSAL FOR ANY ASSISTANCE OR ADVICE YOU MAY NEED
The device has been manufactured in compliance with applicable technical standards
and has been certified, in compliance with Directive 93/42/EEC as amended by directive
2007/47 on medical devices, by the Notified Body Kiwa Cermet Italia, Via Cadriano 23,
40057 Granarolo Dell’Emilia (BO) Italy (n. 0476), in order to ensure product safety.

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Table of contents
TECHNICAL FEATURES......................................................................................................................... 5
Device .............................................................................................................................................. 5
Use conditions .................................................................................................................................5
Technical features of the currents NMES and TENS:.................................................................. 5
EQUIPMENT .......................................................................................................................................... 6
INTENDED USE...................................................................................................................................... 6
CONNECTIONS ................................................................................................................................... 7
Accessories ...................................................................................................................................... 7
LABELLING AND SYMBOLS ................................................................................................................. 7
WARNINGS AND CONTRAINDICATIONS........................................................................................10
Mandatory behavior....................................................................................................................10
Warnings before use ....................................................................................................................11
Warnings during the use ..............................................................................................................11
SIDE EFFECTS AND CONTRAINDICATIONS .....................................................................................12
Contraindications .........................................................................................................................12
MAINTENANCE AND CLEANING.....................................................................................................13
Maintenance and cleaning of the device ..............................................................................13
Accessories Use and storage of the electrodes and the cables..........................................13
INSTRUCTIONS FOR USE ....................................................................................................................15
ELECTROSTIMULATION......................................................................................................................18
Electrostimulation advantages...................................................................................................18
Mechanism of the muscular contraction .................................................................................18
TENS.................................................................................................................................................20
Incontinence programs...............................................................................................................21
Warnings.........................................................................................................................................21
Maintenance.................................................................................................................................21
PROGRAM LIST ..................................................................................................................................22
TREATMENT DESCRIPTIONS ..............................................................................................................25
WARRANTY ........................................................................................................................................27
FREQUENTLY ASKED QUESTIONS .....................................................................................................28

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TECHNICAL FEATURES
Device
Size: 130 X 80 X 20 mm
Weight: 220 g.
Case: in ABS
Protection level: IP 22
Storage and transportation
temperature: from -10°C to 45°C
Max. relative humidity: 30% - 75%
Medical device
classification class: IIa
The values indicate the limits allowed if the product or its accessories are not in the original
package.
Made in PRC.
Charger
Tipo: Switching Power Adaptor
Model: DK7-065-0200-EU
Input: 100-240Vac - 50-60Hz - 0,06 A
Output: 5,8 Vdc - 200 mA
Polarity:
Batteriy pack: Ni-MH AAA 4,8V 800 mAh
Made in PRC.
Use conditions
Temperature: from 0°C to 35°C
Max. relative humidity: from 15% to 93%
Atmospheric pressure: from 700 hPa to 1060 hPa
Technical features of the currents NMES and TENS:
Channels available: channel 1-2
Constant current: Yes
Intensity: 0-100 mA p.p. per channel
Wave form: Rectangular, biphasic, symmetric, compensated
Working frequency: 1-150 Hz
Recovery frequency: 1-150 Hz
Pulse width (single phase): 50-400 µs (total pulse time: 100-800 µs)
Working time: from 1 to 30 seconds
Recovery time: from 0 to 1 minute
Frequency modulation range: continuous variation from 1 to 150 Hz
Min. modulation time: 3 seconds
Pulse width modulation range: continuous variation from 50 to 400 µs
Min. Time: 1 minute
Max. Time: 100 minutes

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EQUIPMENT
A B C D E F G H
The electrostimulator is supplied complete of cables and electrodes to use: therefore, opening the
package, it is necessary to check that the basic equipment is complete. If some elements should
be missing, contact immediately the authorized retailer where you purchased the product.
Control carefully the integrity of the device and its electrodes.
A. Device
B. 2 colored electrode connection cables (for NMES and TENS treatments)
C. 1 bag containing 4 reusable self-adhesive electrodes (50 x 50 mm)
(It is suggested to use these electrodes for small areas such as upper limbs, calves, cervical
areas…)
D. 1 bag containing 4 reusable self-adhesive electrodes (50 x 90 mm).
(It is suggested to use these electrodes for big areas such as thighs, abdomen and glutei...).
E. Charger (see technical features)
F. Carrying bag
G. User manual in English (printed)
H. CD with user manual in English, German, French, Spanish, Italian
The device can be used with some optional accessories. For purchase information, contact your
Enraf-Nonius dealer or visit www.enraf-nonius.com.
INTENDED USE
The after sales service is guaranteed for 5 years. We suggest having a check of the device every 2
years for the maintenance and to ensure the safety. The numbers of treatments depends on the
battery charge.
The electrostimulators are designed to be used in the following operating environments:
- domestic environment;
- general pain treatments;
- beauty and sport purposes.
The Tensmed S82 is intended to be used, and shall only be used, by or under the supervision of
professional users in physiotherapy, rehabilitation and adjacent areas.

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It is important to read the following instructions carefully before using your
Tensmed S82. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
Should the use of this device lead to an undesirable event such as death or
serious injury to the user, the manufacturer and the competent authority of the
Member State MUST be informed without delay!
CONNECTIONS
Accessories
Cable connections
One or two cables may be used depending on whether you have chosen to use one or two
channels of the unit.
To connect the cable connector to the device, plug it into the appropriate inlet in the upper part
of the unit.
The inlets are situated exactly under the correspondent channel (left or right). Insert the cable at
the channel you want to use.
Electrode application
Take the electrodes from the original package; all new electrodes have a seal on the package.
Be sure that the device is off. To start, connect the two cable plugs to the electrodes, then
disconnect the electrodes from their position and apply them on the skin. To place the electrodes
correctly, see the pictures included in this manual.
After the use, place the electrodes in their original position again.
ATTENTION: do not unplug the electrodes if the unit is working.
LABELLING AND SYMBOLS
It refers to the manufacturer name and address
Warning
This symbol on your device indicates that it complies with the directives on medical
devices (93/42/CEE 47/2007CEE). The number of the notified unit is 0476.
It indicates that this is a II class device.

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It indicates that this device has type BF parts.
WEEE symbol (Waste of Electrical and Electronic Equipment). Recycling symbol. The
WEEE symbol used for this product indicates that the device may not be disposed of
as a household product. Properly dispose of the product to help protect the
environment. For more information on recycling this product, contact the local
competent department, the household waste management company or the store
in which the product was purchased.
It indicates the optimal temperatures for the storage and transportation of the
product.
It indicates that the product has been produced respecting the directive
2011/65/EEC.
It informs the operator that before using the device he must read the manual.
IP22
It indicates the water protection degree
It informs the operator of a compulsory conduct
It refers to the pressure of the environment where the device is stored
It refers to the humidity of the environment where the device and its accessories are
stored.
It refers to the manufacturing date
Use indoor
Device

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Charger
Electrodes
Clean and degrease the skin.
Do not apply the electrode on wounds or injured skin.
Connect the cable connector to the electrode connector.
Remove the electrode.
Apply on the skin.
Start the program.
At the end, put the electrode back in the package.
Electrodes are for personal use.
It refers to the production lot
It indicates the product code
It refers to product certification and indicates that
complies with directive 93/42/CEE + 47/2007CEE.
It indicates the storage temperature of the electrodes
It refers to the expiry date

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Do not remove the electrode by grabbing the connector.
Electrodes should not touch each other.
Do not apply the electrodes on the temples, the neck and in a transthoracic way.
Do not leave the electrodes in the car.
Display
PANEL/KEYBOARD
WARNINGS AND CONTRAINDICATIONS
Mandatory behavior
For safety reasons, the device must be used in the prescribed manner and within the limits of use
explained in this manual.
The manufacturer declines any responsibility due to a different use from what it is indicated in this
manual.
No part of this manual (texts and photos) may be reproduced by electronic or mechanical
manner without the prior written authorization of the manufacturer.
It is suggested not to carry out treatments in presence of skin wounds.
If the package, the cable or the connector of the power supply unit show signs of wear or
damage, replace it instantly.
Time
Program no.
Working and resting
phase time
Channel intensity
Increase/decrease
intensity button and
change parameters
during the setup
RIGHT button to move
to the next phase
LEFT button to move
to the previous phase
Fn button to modify the
treatment time and to access
the programming function
Pause time
P+ / P- / OK button to move
inside the menu and
increase/decrease the
intensity
Battery
Switching ON/OFF
and Confirm button
Working phase

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The unit should be connected to the mains by its power supply unit. Before starting the treatment,
make sure that the power system specifications comply with the directives in force within your
country. Make sure that the power supply unit will be in a comfortable position and that it will be
easy to be removed.
Warnings before use
We suggest avoiding the use of the device together with other electronic devices, especially with
those used to maintain vital functions. For a correct use of the Electromedical device, make
reference to the tables attached. If it is necessary to use the device near or together with other
devices, pay attention to its working.
It is recommended to read carefully the entire operating manual before using the device;
keep carefully this operating manual;
The device can emit current value above 10mArms;
Before each use always check the integrity of the unit. This is a fundamental requirement for
carrying out therapies, do not use the unit if either the buttons or cables are defective or
malfunctioning;
It must be used only by people over 18 who are able to understand and take action;
It should not be used for purposes other than neuromuscular stimulation as described in this
manual;
It must be used following the indications and under the physician or physiotherapist’s control;
It must be used with the supplied electrodes intended for transcutaneous neuromuscular
stimulation;
It must be kept out of the reach of children;
ECG monitoring devices may not operate properly when electrostimulation is working;
Do not use the device in trans-thoracic modality because it may cause cardiac arrhythmia,
imposing its frequency over the heart one. Do not stimulate the pectoral and dorsal muscles
simultaneously;
If there is any health problem, it must be used only after seeing a doctor;
A simultaneous connection of the patient to a high frequency electrosurgery device can
cause burns where the electrodes are placed and the electrostimulator can result damaged;
After turning on the device, make sure that in the display the software version and the model
of the device appear, it means that the device is working and it is ready to be used. If not, or in
the display all the segments do not appear, turn it off and on again. If the problem persists,
contact the service center and do not use the device;
An unexpected switching-off of the device means that the battery has run-down. Charge it
according to the instructions in the paragraph: how to charge the batteries.
Warnings during the use
While using the electrostimulator some warnings should be followed:
In case of damaged cables, they must be replaced with original parts and no longer used;
Use only the electrodes supplied by the company;
The device must be kept out of the reach of any pet that could damage it and contaminate it
with parasites;
Pay particular attention when the current density for every electrode is above 2mA/cm2
(effective value);

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The cables of the electrostimulation should not be wrapped around people's neck to avoid
any risk of strangulation and suffocation;
The mobile and fixed radio communications devices could influence the functioning of the
electromedical device: see the tables attached to this manual. Preventative measures to take
using the device for incontinence treatments.
Patients with extra-urethral incontinence should not be treated with the electrostimulator;
Patients suffering excessive incontinence due to evacuation problems should not be treated
with the electrostimulator;
Patients with severe urinary retention to the upper urinary passages should not be treated with
the stimulator;
Patients with total peripheral denervation of the pelvic floor should not be treated with the
stimulator;
Patients suffering of a total/subtotal prolapse of the uterus/vagina should be stimulated with
extreme care;
Patients with infections to the urinary passages should be treated for these symptoms before
starting the stimulation treatment;
Before removing or touching the probe it is necessary to turn off the stimulator or to regulate
the intensity of both the channels on 0,0 mA;
The treatment is a personalized medical prescription: do not borrow the stimulator to other
persons.
SIDE EFFECTS AND CONTRAINDICATIONS
Isolated incidents of skin irritation may occur in subjects with high epidermal sensitiveness. In case
of an allergic reaction to the electrode gel, suspend the treatment and contact a specialist.
If during the treatment signs of tachycardia and extrasystole appear, suspend the treatment and
contact your physician.
Contraindications
Do not use the device in the following cases:
-Stimulation of the front part of the neck (carotid sinus);
-Pacemaker weavers;
-Patients with tumor diseases (see your oncologist);
-Stimulation of the brain region;
-Pains whose etiology is unknown;
-Sores and dermatological diseases;
-Severe traumas;
-Stimulation on recent scars;
-Pregnancy;
-It is strictly forbidden to use the electrostimulator in the ocular area;
-Near body areas with metallic implants or infratissue metals (prostheses, osteosynthetic devices,
coils, screws, orthopedic plates), when using monophasic current, interferential, or continuous
current, ionophoresis.

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It is recommended to use the device with caution in people with capillary fragility, as an excessive
stimulation could cause capillary ruptures.
MAINTENANCE AND CLEANING
Maintenance and cleaning of the device
In case of real or alleged malfunction, do not tamper with the device or try to repair it yourself.
Do not intervene on the device and do not open it. Only specialized and authorized centers
can repair it;
Avoid violent impacts that may cause damage and malfunctions to the device even if
undetectable immediately;
Use this device in a dry environment and in an open space (not wrapped in any materials);
Clean the device and accessories only with disinfectant with sodium hypochlorite or
quaternary ammonium salt diluted with distilled water equal to 0,2-0,3%.
After cleaning/disinfecting it, dry the device and its accessories with a clean cloth;
Always use the device and its accessories with clean hands;
It is recommended to use the device in a clean room, to avoid the contamination of the
device with dust and dirt;
It is recommended to use the device in a ventilated space, with regular air change;
It is recommended to clean/disinfect the parts after every use.
Accessories
Use and storage of the electrodes and the cables.
After using the multi-purpose single patient and/or single-use electrodes, they must be stored
using their plastic film and placed in the plastic bag.
Avoid that the electrodes touch each other or that they overlie one over the other.
Once the package has been opened, the electrodes can be used for 25-30 applications.
The electrode must be always used with clean hands and they must be replaced if they are not
perfectly in contact with the skin.
If using non self-adhesive electrodes it is suggested to clean the surface with proper cleansers that
respect the requirements described in the manual.
The electrodes must be stored in their bag and in an environment that respects the requirements
described in the manual.
After the end of a treatment, unplug the cables from the connectors and clean them carefully
with proper cleansers that respect the requirements described in the manual.
After cleaning and drying them, they must be folded up and placed in the plastic bags supplied
with the cables.
Battery: how to charge the batteries
The device is supplied with a set of rechargeable nickel-metal hydrate batteries (4,8V 800mAh).
When in the display the battery to be charged icon appears, we suggest recharging the device,
as after the appearance of this symbol the electroestimulator autonomy is limited and could not
allow the execution of a complete program.
To charge the batteries, turn off the electrostimulator and disconnect the electrodes, then
connect the elctrostimulator to the charger provided by inserting the plug in the appropriate inlet.

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We suggest charging the device for 8-12 hours to obtain the greater duration of the battery pack.
A possible increase in the temperature in the battery area during the charge is normal.
Do not use a different charger from the one provided with the device. To replace the electro-
stimulator batteries, contact an authorized service center.
Disposal of the device
Do not throw the device or part of it in the fire, but dispose of the product in the
specialized centers and respecting the directives in force within your country.
When the product has to be disposed of, the user can give it back to the retailer
when purchasing a new unit.
A correct separate waste collection or following what above mentioned contribute to avoid
possible negative effects on environment and health and promote the reuse and/or recycle of
materials of which the device is composed. The illegal disposal of the product by the user involves
the application of the administrative fines according to the current regulations.

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INSTRUCTIONS FOR USE

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Programming
By pressing the Fn button for 2 seconds in the starting screen, you will have the possibility to
program the device through 6 ways ( PED1 –PED6 ).
To move from a parameter to the next one press OK.
PED1:
It is possible to set the values of frequency and pulse width.
Frequency: from 1 to 150 Hz in steps of 1 Hz.
Pulse width: from 50 to 250 µs in steps of 10 µs.
Default values: 100 Hz / 200 µs.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
PED2:
It is possible to regulate the pulse width with a frequency set at 100 Hz (fixed).
Pulse width: from 50 to 250 µs in steps of 10 µs.
Default value: 200 µs.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
PED3:
It is possible to set the frequency values.
Frequency: from 1 to 150 Hz in steps of 1 Hz.
Default value: 100 Hz
The pulse width is automatically modulated from 100 µs to 250 µs and can not be set.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
PED4:
It is possible to set the values of frequency and pulse width.
Frequency: from 1 to 150 Hz in steps of 1 Hz.
Pulse width: from 50 to 320 μs in steps of 10 μs.
Default values: 30 Hz / 250 µs.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
Work-rest program: tup = 1 s; thold = 5 s; tdown = 1 s; toff = 5 s.
The work-rest program is fixed and can not be modified.
PED5:
It is possible to set the frequency values.
Frequency: from 1 to 150 Hz in steps of 1 Hz.
Default value: 30 Hz
The pulse width is automatically modulated from 100 µs to 320 µs and can not be set.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
tUP
tHOLD
tDOWN
tOFF
5 s
5 s

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PED6:
It is possible to set the values of tHOLD e tOFF.
From 1 to 30 s in steps of 1 s.
Time values for tUP and tDOWN are fixed (at 1 s) and can not be modified).
It is possible to set the frequency values from 1 to 150 Hz in steps of 1 Hz.
Value of the pulse width set on 300 µs (fixed).
Default values: tHOLD = 2 s; tOFF = 10s; 30 Hz.
Treatment time can be set from 5 to 100 min. in steps of 5 min. (default value: 20 min.)
ELECTROSTIMULATION
Electrostimulation advantages
The electro stimulation does not want to replace physical activity but it must be considered as an
integrating treatment.
According to the aims it will be useful:
-To the sportsmen/sportswomen, in order to integrate the normal training and to increase
performances
-To who wants to intervene on some imperfections
-To who suffers from some pathologies
-To who has suffered from a trauma or in the rehabilitation.
The electro stimulation is a technique that provokes a muscular contraction completely similar to
the volunteer one, using electrical TENS impulse. There are two different ways of use:
1. Muscular stimulation (ideal for the development of the force and for aesthetic treatments)
2. The stimulation to nervous ends (ideal for the treatments against the pain).
Types of muscle
The muscle can be subdivided in three different types: streaked or voluntary muscle; cardiac
muscle and smooth or involuntary muscle.
The voluntary muscle includes the skeletal muscle that gives movement to the skeleton and the
cutaneous muscle that acts on facial expressions.
The cardiac muscle and the smooth muscle are not voluntarily controlled. The most part of the
muscles of the human body belongs to the category of streaked or voluntary muscles, with
approximately 200 muscles for every side of the body (approximately 400 in total).
Skeletal muscles are the target of the NMES.
Mechanism of the muscular contraction
The skeletal muscle exercises its functions through the mechanism of the contraction.
When the muscular contraction happens, the movement of the articulations is produced and
consequently the movement of the skeleton, too.
tUP
tHOLD
tDOWN
tOFF
1…. 30 s
1…. 30 s

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The muscle contracted in the following way: when a person decides to make a movement, an
alteration of the electric potential in the motor center of the brain and an electric impulse is
transmitted to the muscle that has to move.
The electrical impulse is transmitted as a change of potential (voltage); an electrical impulse
crosses the motor nerve to the muscle that must be stimulated. After the reception of the impulse,
Ca ions are freed by the reservoirs causing the approach of actin and myosin. The result is that the
distance between the bands Z diminishes causing therefore the muscular contraction.
The energy demanded for the contraction is supplied by the supply of sugars and fats stored in
the human body. In other words, the electrical stimulation is not a directed energy resource but it
works as an instrument that triggers the muscular contraction. The same type of mechanism is
activated when the muscular contraction is produced by the NMES.
They assume in other words the same role of a natural impulse transmitted by the motor nervous
system. Normally the muscle relaxes and returns to its original state them at the end of the
contraction.
Isotonic and isometric contractions
The isotonic contraction reveals when, in a movement of our body, the interested muscles
produce a state of constant tension. The isotonic contraction reveals when, in a movement of our
body, the interested muscles produce a state of constant tension. Instead, when the joint heads
of a physical segment are blocked and the musculature produces a tension, we talk about an
isometric contraction.
In the event of the electro stimulation an isometric contraction is preferred because it fosters to
obtain a more effective control.
The distribution of the different types of fibers in the muscle
The relationship between the two main categories (type I and the type II) can vary in sensitive
way. There are muscular groups that are typically constituted by fibers of type I, like the soleus,
and there are muscles that have only fibers of type II like the orbicular muscle. But in the most part
of the cases we have a simultaneous presence of various types of fibers.
The studies lead on the distribution of fibers in the muscle have put in evidence the strait
relationship that exists between the motoneuron (tonic or phasic) and the functional features of
fibers from it innervate and have demonstrated as to a specific motor activity
(and sports in particular) can determine a functional adaptation of the fibers and a modification
of the metabolic features of the same ones.
Motor unit
Contraction type
Fiber type
Stimulation frequencies
Tonic
ST slow contraction
I a
10 - 50 Hz
Phasic
FTa fast contraction
II a
50 - 70 Hz
Phasic
FTb fast contraction
II b
80 - 120 Hz
In order to make a tissue pass from the phase of rest to the one of excitation, by means of an
induced electrical stimulus (impulse of the electrostimulation), some conditions are necessary:

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-the current amount
-the duration of the stimulus that must be adapted to the corporeal district that is wanted to be
stimulated.
From this consideration, for the excitation of a tissue, the relationship between the duration and
the intensity of the stimulus is particularly important and not only the value of the peak of the
intensity. This relationship varies according to the muscular district.
Stimulation intensity
The current intensity necessary to obtain muscular contraction is personal and depends on the
position of the electrodes, the underlying adipose tissue layer, sweating, the presence of hair on
the area to be treated, etc.. For these reasons, the same current intensity can generate different
feelings from person to person, from day to day, and from the right side to the left side of the
body. During different sessions, it will be necessary to regulate the intensity in order to obtain the
same level of contraction because of the accommodation phenomena. The current intensities
recommended in the different phases are proposed as indicative values, and each person should
modify these levels according to his/her personal needs.
Moderate intensity: the muscle does not tire, not even during prolonged treatments. The
contraction induced is tolerable and pleasant. This is the first level on the graphic
representation of intensity.
Intermediate intensity: the muscle is visibly contracted but the stimulation does not cause the
joints to move. This is the second level on the graphic representation of intensity.
Elevated intensity: the muscle is contracted substantially. The muscular contraction will cause
the extension or bending of the limb if this is not blocked. This is the third level on the graphic
representation of intensity.
Maximum intensity: the muscle is contracted maximally. This is an intense treatment that should
be performed only after having executing different applications at lower
In the descriptions of the treatments, the best levels of intensities are recommended.
NOTE: The recommended levels of current are only indicative.
TENS
Transcutaneous Electrical Nerve Stimulation (TENS) is a selective stimulation of the large fibers of
the peripheral nerves favoring the closing of the gate entrance for the pain pulses and increasing
the release of endorphin substances, reducing in this way the pain intensity. Therefore with TENS
we want to treat the severe and chronic pain due to the main musculoskeletal pains.
Moderate
Maximal
High
Intermediate
from 10 mA to 20 mA
on the verge of the tolerance limit, always under the threshold of
pain.
from 20 mA to 30 mA
above 30 mA