HCR 1002

USER MANUAL
HCR 1002
Unibell Srl T. +39 039991131

via Indipendenza, 27 - 23885 Calco (LC) - Italy info@humantecar.com humantecar.com
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© 2016 UNIBELL srl - All rights reserved
English language text.

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INDEX
1 INTRODUCTION
8 GENERAL SAFETY NOTE
1.1 device presentation 8.1 general warnings and precautions
1.2 acronyms and symbol 8.2 warnings and contraindications to treatment
2 DEVICE DESCRIPTION 9 MAINTENANCE

2.1 components of device 9.1 training and educational programs for technicians
2.2 control unit 9.2 required equipment for technicians
2.3 handpieces 9.3 routine maintenance work
2.4 active electrodes 9.4 emergency maintenance work
2.5 indifferent (or neutral) electrodes
2.6 radio remote control
2.7 complementary accessories – electrolytic emulsion
10 PACKAGING AND LABELING
10.1 packaging
10.2 transport
3 INTENDED USE
10.3 label
3.1 operating principle
3.2 intended use and applications
11 DISPOSAL AT END OF LIFE
4 INSTALLATION PROCEDURE
12 WARRANTY
4.1 installation
4.2 environmental conditions for transport and service
4.3 placing 13 SAFETY TESTS PERFORMED
4.4 mains power connection 13.1 list of guidelines and technical standards applied
4.5 setup menu 13.2 electromagnetic compatibility
5 HOW TO USE

5.1 switching on and off
5.2 setting time of treatment
5.3 connecting accessories
5.4 applying electrodes
5.5 treatment
5.6 end of treatment
5.7 precautions for use
5.8 warnings and precautions in using accessories and
applied parts
6 TECHNICAL SPECIFICATIONS
6.1 classification
6.2 technical data
6.3 life expectancy
7 CLEANING AND DISINFECTION

7.1 classification of device for hygiene and safety
7.2 recommended products
7.3 general procedure for cleaning and disinfection
7.4 cleaning the device
7.5 cleaning the electrode holder handpieces
7.6 cleaning RES electrodes
7.7 cleaning indifferent electrodes, flat and cylindrical
7.8 cleaning CAP electrodes
7.9 decontamination

USER MANUAL HCR 1002
Please read the present user guide before using

device, with particular attention to the warnings,
precautions and operating instructions marked
with this symbol.
DOCUMENTATION PROVIDED
Operating instructions for the present device are supplied
either in paper form than in electronic format PDF (Portable
Document Format). Reading files in PDF format requires
an electronic visualization tool and PDF reader software.
Instructions are also accessible from www.humantecar.com.
You are advised to visit said internet site regularly, in order
to consult and/or download the most updated version of the
operating instructions.
It is also recommended user print andor download all

documents or portions of documents that may be needed
in case of emergency or failure to access the Internet or
malfunction of your electronic viewing device, computer,
tablet etc.
All hard copies or electronic documentation relative to HCR
device should be preserved for the entire lifespan of your
equipment. In case of loan or sale, said documentation should
be supplied together with device.

1 INTRODUCTION
Dear Customer,
we would like to thank you for choosing HUMAN TECAR® and trust you will derive great professional
satisfaction from using the present device, HCR 1002.
The device was designed and manufactured in accordance with current CE requirements and in
compliance with the harmonized technical norms for medical devices as detailed in the CE Declaration
of Conformity relative to the device itself and/or paragraph 13.
The present user guide contains all technical and functional instructions necessary for the correct
installation and use of the device, so as to obtain the best possible performance.
The manufacturer shall not held liable for any damage deriving from improper use of device.
Improper use is understood to be any use save the one provided for and described in detail in the
present user guide, and/or use of device by unqualified personnel a/o following functional or structural
alterations to device or any kind of maintenance that is not provided for in the present user guide or
that is unauthorized.
Notes
The information, technical specifications and illustrations contained in the present publication are not
to be held as legally binding.
The manufacturer reserves the right to amend and ameliorate the technical features of the device in
question without varying the present instructions, unless the situation requires it. The manufacturer
also reserves the right to modifythe present user guide without previous notice.
The manufacturer pursues a policy of constant improvement of its products, so that some of the
instructions, specifications and illustrations appearing in the user guide may differ slightly from the
actual product purchased.

Photos and drawings in this publication are intellectual property of Unibell Srl.
All rights reserved - Reproduction prohibited.

1.1 DEVICE PRESENTATION
The technology
HCR 1002 is a scientifically and technologically advanced device, whose technical and therapeutic
principles are based on the use of high-frequency variable alternating current, with direct low-impedance
diathermic application mode (Resistive Electric Transfer - RES) and insulated high-impedance
diathermic application (Capacitive Electric Transfer - CAP).
The trademarks
TECAR® and TECARTERAPIA® are internationally registered trademarks belonging to UNIBELL Srl and
used as brands to cover an ample range of devices and functional cosmetics.
The terms “tecar” and “tecarterapia”, improperly used to define therapeutic treatment with devices
technologically similar to the present device, do not define either the technical and functional peculiarities
nor the performance of other devices; they should be exclusively used to define the characteristics and
performance of this specific tool belonging to the HCR series of devices and identified by the HUMAN
TECAR® brand.
The physiological effects and therapeutic use

The physiological effects on tissue of this energy transfer are prevalently temperature-related
owing to the Joule effect, and biochemical effects on metabolism, as they typically do not stimulate
neuromuscular activity and do not determine electrolytic phenomena or consequent depolarization.
Local increase in body temperature, moreover, reactivates micro-capillary circulation in depth,
consequently increasing blood flow and lymphatic circulation and thus eliminating catabolites and/or
supplying nutrients, as well as increasing oxygenation of tissues.
The device is a physiotherapeutic tool used in rehabilitation from conditions better detailed further
below.
Required skills
HCR 1002 is for the exclusive use of healthcare staff, physicians and/or physiotherapists.
It can be used in clinics and doctor’s offices – for physiotherapeutic and rehabilitation purposes in
general – and in hospitals, though not necessarily in a hospital context. Necessary precautions should
be taken, as detailed in paragraph 13.

1.2 ACRONYMS AND SYMBOLS
This user guide uses graphic symbols and conventional acronyms that also appear on the device itself.
Following is their list and corresponding meanings:

Operating instructions
Means you need to consult user guide before using the device

Instructions
Means instructions are supplied electronically

Warning
Indicates a situation where failure to follow instructions may lead to malfunction or failure of device or
damage to user and/or patient

Electrical safety classification for applied parts

Type BF applied part

equipotential bonding bar

Alternating current

Fuse

Equipment complying with the requirements laid down by European directives

The number appearing beside the CE Mark indicates the Notified Body designated to assess conformity

Warning: separate disposal

European Directive regarding waste of electric and electronic equipment (WEEE)

Warning: possible emissions of non-ionizing radiation

Manufacturer

Date of Manufacture stated by year (yyyy)

Code number assigned to device by manufacturer

Serial number assigned to device by manufacturer

In the present user guide, points out specific warnings, precautions or operating instructions


2 DEVICE DESCRIPTION
This section synthetically describes how the device operates, solely focusing on the basic aspects so as
to assist user in employing the device correctly.
2.1 COMPONENTS OF DEVICE
The device is made up of a control unit and of essential accessories.

List of parts:

Code Description Q.ty
16576 HCR 1002 - sales kit - complete with: 1
16577 Control Unit: HCR 1002 1

16579 Power cord 1
16607 Power filter 1
16458 High-impedance CAP electrode, flat, thermodynamic Ø 30 mm 1
16469 High-impedance CAP electrode, flat, thickened and lymphodynamic (for face) Ø 55 mm 1
16463 High-impedance CAP electrode, convex, thermodynamic Ø 30 mm 1
16467 High-impedance CAP electrode, convex, lymphodynamic Ø 40 mm 1
16468 High-impedance CAP electrode, convex, lymphodynamic Ø 55 mm 1
16470 Low-impedance RES electrode Ø 35 mm 1
16475 Loop-shaped handpiece for CAP electrodes 1
16476 Pencil handpiece for CAP electrodes 1
16477 Loop-shaped handpiece for RES electrodes 1
16478 Pencil handpiece for RES electrodes 1
16479 Cylindrical indifferent (or neutral) electrode 1
16480 Flat indifferent (or neutral) electrode 1
16489 Radio remote control 1
16449 Remote control battery 2
16580 User Manual 1
The device is provided with a series of complementary accessories tested for use with this equipment:
Code Description Q.ty

15682 Electrolytic Emulsion 1

2.2 CONTROL UNIT
The case of control unit consists of a mold made of ABS (thermoplastic polymer), housing the
memory cards and all electrical and electronic components.
It comprises a front panel or user interface and a rear panel for connection, laid out as follows:
A B
Frontal panel
A Display showing treatment parameters
B Control panel, split into three distinct areas:
• Treatment commands
• Configuration commands
• On and off buttons
C Handpiece connection
G D
Rear panel
D Power plug with fuse compartment and
power switch
E Equipotential bonding bar
F Ventilation fan
G Label
F E
Treatment display
Display showing the treatment parameters previously set and current parameters measured by
machine in real time.
HCR 1002
Serial Number - fw: X2BC345609AB -1.32
10

Control panel
TREATMENT SETUP ON-OFF
RESET
RF START
STOP RES CAP
_ +
Green power LED

LIT UP AND STEADY: power cable connected and rear
power switch ON.
ON - OFF OFF: power cable not connected or rear
power switch OFF.
On/Off Switch
Active for shutdown solely when device is on standby.
Menu selection key in setup

Select parameter you want to configurate / confirm
MENU Button enabled when treatment is on standby.
Navigation buttons in Setup Menu
Increasing and decreasing value of selected parameter.
SETUP
Selecting duration of treatment in Setup Menu
Saving the preset time interval as default duration
Button enabled when treatment is on standby.
TIMER Buttons for increasing and decreasing duration of
_ +
treatment
May be used to increase and decrease values of parameter
selected in Setup Menu.
LED signalling RES/CAP treatment selected

LIT UP AND STEADY:
electrode selected with power output
BLINKING LIGHT:
electrode selected without power output
OFF:
RES/CAP treatment mode not selectet.
Button selecting treatment with RES/CAP

RES CAP electrodes
Button enabled when machine is on treatment standby.
TREATMENT START
STOP Button for Start/Stop treatment
Button to Reset treatment

RESET
Button enabled when machine is on treatment standby.
Handpiece Encoder regulating power of treatment

ROTATION: increasing (clockwise rotation) and
RF
decreasing (anti-clockwise rotation) output power.
PRESSED: interrupting treatment.
Yellow LED indicating mechanical failure
11

Connection electrodes
In order to make things easier for user and ensure safety of device, the connectors for high-impedance
capacitive electrode handpieces, for low-impedance resistive electrode handpieces and indifferent, flat
or cylindrical electrode, have been distinguished as follows:
by color
White: connector for low-impedance RES electrode handpiece
Black: connector for indifferent, flat or cylindrical electrode
Gray: connector for high-impedance CAP electrode
By key input, which prevents accidentally inverted connections.

Connector fastening to device is fast type.
2.3 SMART-USE HANDPIECES
The device employs specifically designed smart-use, ergonomic, grip-friendly handpieces (loop-shaped
and pencil-shaped) for better handling, easier use, increased efficiency and precision during treatment.
The magnetic fastening system of handpiece to electrode facilitates and speeds up replacement.
Another way to facilitate user is the difference in color and inlet hole of electrode shaft where it in inserted
into handpiece, in order to avoid erroneous insertion for a given treatment:

Handpiece for RES electrode - gray/white - white cable
Handpiece for CAP electrode - black/white - gray cable
2.4 ACTIVE ELECTRODES
These are applied parts to patient.

Depending on the intended effect, two types of electrodes are available, differing in size, shape and
characteristics of materials used.
High-impedance CAP electrodes

Made of distinct conductive materials for lymphodynamic and thermodynamic electrodes, these are
coated with a special, insulating component. High-impedance electrodes have a specific working life
that depends on frequency of use and on maintenance.
Low-impedance RES electrodes

Made of stainless steel, they do not deteriorate and their working life is as long as the device itself lasts.
12

2.5 INDIFFERENT (OR NEUTRAL) ELECTRODES
They are applied parts to patient.

Made of stainless steel, they have distinctive shapes, plate or cylinder, and are chosen by user according
to type of treatment and body part treated:
Flat indifferent electrode
comes into contact with body parts and its outer edges are coated with silicone rubber to avoid
slipping.

Cylindrical indifferent electrode
is meant to be gripped by user.
HANDPIECES & CAP ELECTRODES HANDPIECES & RES ELECTRODES
INDIFFERENT FLAT ELECTRODE INDIFFERENT CYLINDRICAL ELECTRODE
13

2.6 RADIO REMOTE CONTROL
Allows remote control of the following:
Switching device on and off

Increasing and diminishing output power + _
2.7 COMPLEMENTARY ACCESSORIES
Electrolytic Emulsion
Electrolytic emulsion is recommended for best performance of device.o.
The product performs various actions:
conductive - thus maximizing the affinity of electrode and biological tissue during treatment;
mechanical - per facilitare lo scorrimento degli elettrodi attivi;
moisturizing - to maintain the skin supple and well hydrated.
The product was designed to ensure proper and ideal conductivity and viscosity, high skin tolerance
and non-corrosive towards the capacitive electrodes’ insulator.
Note
Composition, storage conditions, shelf life, instructions for use and contraindications of the electrolytic emulsion
are listed on package label and data sheet of product.
14

3 INTENDED USE
3.1 OPERATING PRINCIPLE
HCR 1002 produces an alternating current at a specific and unique frequency (0.447 MHz), which is
applied to the area to be treated by means of moveable active electrodes.
The active electrodes are placed so they adhere to tissue to be treated and moved by operator all the
time – with the operator-dependent device active.
The device issues the energy applied and trasfers it to the patient only when the circuit is closed, i.e.
when the active electrode and the indifferent electrode are both in contact with tissue.
The transfer of energy from the active to the indifferent electrode, through the tissue to be treated, is
successful only through the interposition of the electrolytic emulsion.
Depending on the type of electrodes used, we will also have two different modes:
• Resistive Electric Transfer - RES
• Capacitive Electric Transfer - CAP
The physiological effects on tissue of this energy transfer are prevalently temperature-related owing to
the Joule effect, and biochemical effects on metabolism, as they typically do not stimulate neuromuscular
activity and do not determine electrolytic phenomena or consequent depolarization.
Local increase in body temperature, moreover, reactivates micro-capillary circulation in depth,
consequently increasing blood flow and lymphatic circulation and thus eliminating catabolites and/or
supplying nutrients, as well as increasing oxygenation of tissues, making use of device functional to
massage techniques.
3.2 INTENDED USE AND APPLICATIONS
HCR 1002 is a device for diathermy, tecartherapy.

It is non-invasive device and should come into contact with patient only temporarily, at the epidermal
level on undamaged, healthy skin. The device is employed in all those cases where it is necessary to
obtain a physiological increasement of the micro and macro-circulation and of tissue temperature.
The operator can use it with great flexibility thanks to its focused, local action and capacity to induce
micro-macrometrical physiological changes in temperature in a specific district, and at the same
time, therefore, causing a temperature difference between that district and another, more or less
contiguous area. It also gives the opportunity to act in more or less extensive areas of the body
selected according to whether the objective is acting on local districts, regional or segmental ones.
Thanks to these variations, vital functions are rebooted and a new balance is rapidly established, whose
main objective is precisely the “functional recovery” that will lead to a reduction of symptoms and
rehabilitation.
The present device is a physiotherapeutic tool for rehabilitation from conditions including:
• Musculoskeletal injuries such as muscle contractions, strains and elongations, acute and chronic
tendonitis, distortion, synovitis,bursitis;
• Treatment of articular diseases, both degenerative and inflammatory (arthrosis and arthritis);
• Treatment oof inflammation of the limbs and of the spinal cord, characterized by pain and functional
limitation (neck pain, back pain, lumbago, brachialgia i.e. pain in the arms, lumbar radiculopathy or
sciatica, pain of the ischium and cruralis etc.);
• Treatment of injuries from functional overloading, typical of sports and professional activities (tennis
elbow, jumper’s knee, pitcher’s shoulder, carpal tunnel syndrome, metatarsalgia i.e. metatarsal pain
or “stone bruise”, plantar fasciitis or jogger’s heel, etc.);
• Treatment of DOMS (Delayed Onset Muscle Soreness), occurring after eccentric exercise (exercise
consisting of lengthening contractions of the muscle) or muscle fatigue, and treatment of conditions
that require facilitating muscle relaxation;
• Besides, thanks to a technique that makes use of the mobilization of fluids from topical temperature
differences in tissue on the one hand, and on the other, from the induced increment of tissue
oxygenation, the device is suited to physiotherapeutic treatment of superficial edema from venous
and lymphatic stasis.
• The topical increment in microcirculation leads to a trophic action (i.e. stimulation of cell
reproduction and enlargement by nurturing and causing growth) that is recommended in treating
peripheral vascular disorders such as diabetic feet etc.
15

4 INSTALLATION PROCEDURE
4.1 INSTALLATION
Unpacking
The present device has already been tested and subsequently packaged by manufacturer, in order to
ensure in-transit integrity.
It has also been assembled in all its parts, save for accessories.
Unpacking and installation procedures may be carried out by user. They require no special training; it is
sufficient to comply with the following instructions.
Remove device and accessories from the respective housings, inspecting them to verify there has been
no in-transit damage.
Bear in mind that compensation claims will only be acknowledged if notified immediately.
To this end, claimant should send a written communication detailing the anomalies encountered and the
machine’s serial number (as shown on the identification plate), addressed to manufacturer, distributor
or authorized service facility. Please follow instructions reported in warranty clauses.
In case of extreme climatic conditions (heat, cold, humidity), it is advisable to let several hours go by
after setup, before starting up device for the first time.

Cleaning and disinfection
When the device is first installed, it is advisable to clean and disinfect the entire device, including accessories,
following instructions in the corresponding chapter.
4.2 ENVIRONMENT CONDITIONS OF TRANSPORT AND SERVICE
The present device is sensitive to ambient conditions such as temperature and humidity, since it
houses electronic circuits and electromechanical components.
It is generally advisable to follow the following instructions:
Condition for Storage and Transport Service

Temperature - 40 °C e + 70 °C + 10 °C e + 30°C
Relative Humidity 10% e 75% without condensation 30% e 75%
Atmosheric Pressure 50 kPa e 106 kPa 70 kPa e 106 kPa
Maximum Altitude Use - Less than 2000m
16

4.3 PLACING
HCR 1002 should be placed on a flat-topped, solid and stable surface, with a capacity adequate to
device’s weight (ideally, above 50kg/m2) and sufficiently large to guarantee an unobstructed working
surface and a safety margin against unexpected shocks and jolts (ideally, 800 mm wide and 600 mm
deep).
Being fed to the alternating mains voltage, it is potentially dangerous if improperly placed and used, i.e.
in a manner not conforming to the directions below. The device’s lower half is provided with slits for
adequate ventilation between interior and exterior.
The device must be used in medical environments (surgeries and clinics - physiotherapy and
rehabilitation centers in general - and hospitals). The device should not be used in the vicinity of
equipment influenced by RF (shortwave appliances, mobile phones, etc.). In case of interference,
turn it off. When used in a domestic environment, it is necessary to check possible RF interference
with portable appliances and make use of special precautions, better detailed in paragraph 13.
.
Place the appliance in a well ventilated room, taking care not to obstruct the ventilation slots located on
the rear and bottom side.
The appliance should be placed in such a way as to avoid shocks, jolts or falls that would damage its
protective sheathing (outer shell).
Do not place device close to sources of heat; do not expose it to direct sunlight or place it close to sources
of liquid, dusty environments, without protection.
The appliance is not suitable for use in inflammable environments or ones charged with inflammable
gaseous substances such as oxygen, nitrous oxide, anesthetic gases.
4.4 MAINS POWER CONNECTION
The device should be connected, by means of the cable supplied with product, to a regulatory compliant
power line provided with ground connection and having the characteristics indicated in the label.
Should warnings and instructions not be followed, this would be liable to put operator and patient
at risk or to cause a malfunction of the device itself.
In order to avoid any danger of electric shock, the present device should be exclusively connected to
grounded mains power.
Before connecting device, make sure that the mains power:

• Has a voltage suited to the values indicated in plate data;
• Is provided with adequate and functioning grounding to earth;
• Is compliant with regulations for electric installations of rooms used for medical purposes.
Do not tamper with the power cord or machine in an effort to adapt them to non-compliant power lines.
Do not connect other appliances to the same magnetothermic switch.
Do not position device in such a way that it will be difficult to disconnect device from mains power by
operating rear switch.
Make sure that the power cord is not hampering personnel or nearby devices, and that it cannot be
stepped on.
Use the supplied power filter by connecting it between the power plug and the network cable. Failing to
use it could create conducted electromagnetic emission disturbances.
17

4.5 SETUP MENU
Once the device is turned on, it is possible to define certain setup parameters, such as:
•
Brightness
•
Volume
• Acoustic signal at end of treatment session (active/disbled)
• Remote control: battery charge level
• Remote control: device/remote control connection
• Information on device
• Voice processing information (on / off)
• Return to home screen
Press “Setup Menu” key for configuration display.
Use “arrow keys” to select parameter to be set.

A white frame will appear around the selected icon.
Once icon is selected, press key for “Setup Menu” once more. A blue frame will
now appear around the icon.
You may now increase or diminish brightness and volume of device by using
“arrow keys”.
You may enable or disable end-of-session acoustic signal and see charge level of
remote control.
18

5 OPERATING METHODS
5.1 SWITCHING ON AND OFF
Switching on
In order to connect device to power, position the switch on the rear panel I
onto “I”.
The green LED above the ON/OFF switch on the front control panel will light up. 0
WARNING
The green LED above the ON/OFF switch on the front control panel will light up.
Functioning
Once the green LED is on, press the ON switch on the front control panel.
The display screen will light up and operational pages will appear in sequence,
including configuration pages for duration of treatment.
Switching off
Press the ON/OFF switch for three seconds. I

The display screen will turn off while the green LED will remain lit. 0
The device turns off only when in pause or standby handling mode
(blue flashing LED on RES or CAP).
Turn off power by positioning the switch present on the rear control panel onto “0”.
Green LED light will turn off.
WARNING
At the end of the day, turn device off not only by means of the ON/OFF switch but by positioning the
switch present on the rear control panel.
19

5.2 SETTING TIME OF TREATMENT
When the device is turned on, the display screen will show the default duration of
treatment session, default to 30 minutes.
Using the increase and decrease keys of treatment time to set the desired duration.
Time programmable machine, maximum of 90 minutes.
After approx. 10 seconds of inactivity of page, the display automatically goes on to

the subsequent page: Treatment, which by default is RES.
The duration of treatment may also be reset during the session itself:
when device is on standby, remaining time can be increased or decreased by
pressing the corresponding buttons.
By pressing TIMER button, the time set will be default time when new treatment
starts.
By pressing START/STOP or RES button, you force device to go onto RES

electrode treatment page.
By pressing CAP button, you go to CAP electrode treatment page.
20

5.3 CONNECTING ACCESSORIES
Connect the electrode handpieces to unit control, then connect electrodes in their respective seatings,
CAP, RES and neutral.
Insert electrodes into the corresponding handpiece.
The device is provided with both hardware and software safety systems for erroneous insertions.
In case of incorrect connection, the signal will appear on the display, as shown in the figures below:
RES 0:18:29
0:16:45
39 V 0,01 A 4587 Ω
VOLTAGE INTENSITY R-RESISTANCE
0:18:29 0:18:29
8V 0A 1819 Ω 0V 0A 0Ω
VOLTAGE INTENSITY Z - IMPEDANCE VOLTAGE INTENSITY Z - IMPEDANCE
Be very careful not to force insertion of connectors. Each connector is provided with a specific
insertion key which only allows access to the right connector.
Beware you do not force electrode insertion into the wrong handpiece. Each handpiece has a
distinctive hole, with different diameters for CAP or RES electrodes.
If connector is not correctly inserted, this will be signaled on the display screen of device. Repeat
operation, connecting cable afresh. If signal on display persists, call technical support.
21

5.4 APPLYING ELECTRODES
It is essential for electrodes to be used and applied in the correct manner.

The neutral indifferent electrode should always be placed in contact with the body of patient. To minimize
interface resistance between the electrode and skin of the patient, a suitable conductive emulsion should
be placed between electrode and body tissue.
Recommended positioning of neutral electrode, depending on body area being treated with active
electrode, is shown in the following illustration.
Active electrodes (CAP/RES) must be operated by user, who will have to slide them over the area being
treated with continuous circular movements. Treatment is operational only when the active electrode is
in contact with body tissue. When the user raises the electrode handpiece, power release is interrupted.
22

5.5 TREATMENT
RES 0:16:45 0:14:25
100% 183 VA
39 V 0,01 A 4587 Ω 250 V 0,085 A 1372 Ω
VOLTAGE INTENSITY R-RESISTANCE VOLTAGE INTENSITY Z - IMPEDANCE
Select the operating mode
When device is switched on, default setting of treatment is with low-impedance

electrodes (RES).
By pressing RES button, you set treatment with RES low impedance electrode.
By pressing CAP button, you set treatment with CAP high impedance electrode.
In order to change over from RES mode to CAP mode or vice versa, the device
should be on standby.
The blue LED flashes on the selected mode. The machine is on standby: it does not
supply power and the clock timing treatment momentarily pauses.
To start or stop treatment, press the START / STOP button. When the device is
working, the blue LED is fixed; if it is flashing, the device in on standby.
Apply electrode to the area being treated, then turn the encoder knob clockwise to
increase the percentage of power output, or counterclockwise to decrease it.
The display shows, in distinct areas, the parameters set for treatment and, in the box
below, parameters registered by device during the treatment, updated in real time.
23

0:18:29 RES 0:16:45
20 V 0A 90000 Ω 30 V 0A 90000 Ω
VOLTAGE INTENSITY Z - IMPEDANCE VOLTAGE INTENSITY R-RESISTANCE
0:18:29 RES 0:16:45
20 V 0A 90000 Ω 30 V 0A 90000 Ω
VOLTAGE INTENSITY Z - IMPEDANCE VOLTAGE INTENSITY R-RESISTANCE
In case of treatment involving considerable increase in temperature, thus employing

higher power (above c. 5% of power), in order to ensure maximum safety to both
patient and operator, if the electrode shifts and is no longer in contact with the
biological tissue being treated, this information is shown on display (a red X shape
appears between the electrode symbol and tissue) and operator will need to restore
contact. The device memorizes output value at the time electrode/tissue contact
was interrupted, while reducing output power to a safe value. When electrode/tissue
contact is restored, the device will gradually restore output power to the memorized
value.If, however, contact is interrupted for more than 10 seconds, device will
automatically go on standby, at 0% power.
To resume treatment, press the START/STOP key again and bring the encoder
knob back to the value desired.
When the device is on standby, the remaining time-count for treatment can be
increased or diminished by operating the appropriate buttons.
At the end of treatment (Timer = 0:00:00) or when device is on standby, the

session will be terminated by pressing the RESET button, and summary page of
work done will be shown.
24

With every new start, the device verifies whether there is any connection problem with handpiece; should
there be a problem, it will be shown on the display and the machine will go on standby.
In order to ensure safety during treatment involving considerable increase in temperature, therefore an
output power above 5%, any time the active electrode is no longer in contact with the biological tissue being
treated, output power is reduced and, after a few seconds, the device goes on standby, at 0% power.
To increase safety and be able to act fast, the operator can also end treatment by pressing any button on the
control panel or pressing the encoder knob.
To increase safety and be able to act fast, the operator can also end treatment by pressing any button
on the control panel or pressing the encoder knob.
If the device does not power up, check whether the electrode is properly inserted into the handpiece and
whether there is any dust or dirt where the two connect. If so, clean the area and reinsert. If the device
still does not power up, contact technical support.
Operator should never simultaneously touch the metal connector where the indifferent electrode is
inserted into handpiece and patient during treatment.
5.6 END OF TREATMENT
DURATION OF TREATMENT
40 VA 80 VA AVERAGE POWER EMPLOYED

15 min. 25 min. TIME TAKEN
120 Ω 150 Ω INITIAL IMPEDANCE / RESISTANCE

1372 Ω 1350 Ω FINAL IMPEDANCE / RESISTANCE
The end-of-treatment display summarizes parameters of session by showing:
Total time of treatment;

Time of treatment using CAP electrodes and average power released;
Time of treatment using RES electrodes and average power released;
Impedance value/initial resistance and the final resistance;
The diagram shows a summary of CAP and RES treatment sequences effected.
If you want to start a new session: press the START/STOP or RESET keys again,
o
in which case the device will go back to treatment time setting mode.
To turn off device, it must be in RES or CAP modality and in standby.

Then press key for about 3 seconds.
25

5.7 PRECAUTIONS FOR USE
User Characteristics
The present equipment must be used by healthcare personnel, physician or physiotherapist, who are
professionally qualified to use medical devices.
It is important to ascertain that user is aware of and follows all the instructions indicated in the user
manual. Inobservance of the instructions, precautions and warnings indicated in user guide could lead
to damage in patient and user.
The manufacturer organizes specific training courses to facilitate awareness of equipment’s operational
characteristics, as well as keeping users up-to-date on the application techniques of device. Said
coursesare not mandatory but recommended.
The healthcare operator is responsible for treatment and for risks deriving from incompetence or lack
of training.
Initial checks
Before use, check accessories to verify the absence of damage, usury or malfunction.
Any damaged or defective part should not be used or handled, as it would be liable to damage patient
and user.
Preparing patient

As with all physical therapy, the patient’s informed consent to treatment and a corresponding medical
prescription are necessary.
The user should be aware of warnings, precautions and contraindications to treatment, as well as
possible side effects.
The person undergoing treatment should not come into contact with conductive parts during
treatment, for these might generate unwanted transmission lines that could damage subject and
user.
Therefore, the person undergoing treatment should not wear metallic objects.
Do not use beds or armchairs provided with metallic structures.

Should there be any metal portion, these should not be accessible to patient contact.
Body areas covered in thick hairs need to be shaved before treatment.
Positioning applied parts

Place electrodes as shown in chapter 5.4. In using them, bear in mind the precautions and warnings
indicated in the present user guide.
Never use device without having previously positioned the return electrode and without having applied
the electrolytic emulsion onto electrodes.
Omitting this precaution might lead to causing patient burns.
Place the electrode in contact with tissue prior to bringing power from zero to the desired value. If power
is increased before applying active electrode, this is liable to cause damage to device and/or patient.
26

Treatment
Treatment is actively user-dependent: during treatment, the user should always be present and
continuously monitor device as well as collect feedback from patient. In particular, if the patient
complains of discomfort, user will need to reduce power released until the discomfort vanishes. High
output power, above patient’s discomfort level, causes reddened skin and possible burns in the body
area treated.
Skin should be cleansed prior to treatment. Only Human Tecar electrolytic emulsion should be used.
Applying other conductive creams or products (e.g. cosmetics, essential oils, medications) is liable to
cause damage to device and/or patient.
Never use device in combination with other equipment on the same subject.
A prolonged and repeated use of device on an individual patient may lead to sensitization in particularly
susceptible subjects.
The user needs to wear CE-marked gloves when s/he applies electrolytic emulsion and in gripping
handpiece.
The four fundamental factors for outstanding treatment are:

Pressure
The suitable movement should ensure that contact resistance is the lowest possible. In order to obtain
minimal resistance, you need to exercise a certain pressure on electrode to establish better physical
contact and reduce interface resistance or impedance between the electrode and skin on the surface
of the body. This leads to greater intensity and the penetration level of current applied is consequently
increased. To give user an idea of what the movement should be like, compare pressure exerted to the
pressure necessary to erase with a large eraser.
Speed
With each circular movement, the electrode should advance with a slow and ceaseless progress
corresponding to 50% of its diameter. Again as an example, the movement should be similar to
erasing very slowly.
Output power applied / Temperature

Power released is regulated on the basis of the subject’s own sensation of “heat”: it is therefore subjective,
there is no set parameter. It varies depending on subject.
You need to select temperature that is high yet bearable; it should be perceived but should not cause
excessive discomfort. Before increasing intensity, you always need to check if the patient tolerates a
given temperature.
Duration and frequency of treatment

Duration of treatment session is set by user based on type of treatment, body area treated and electrodes
employed.
Duration of session ranges from few minutes (5/10) to a maximum of 30 minutes, alternating an initial
stage in RES mode (15 minutes) followed by a second stage in CAP mode (15 minutes).
The frequency of sessions ranges from 2/3 sessions to 20 or more, and it can be on a daily basis, every
other day, or even monthly in the case of maintenance treatment.
The duration of treatment, number of total sessions and their frequency depends on the type and
seriousness of the condition being treated and on the evolution of the therapeutic effects of treatment
itself, for these vary depending on characteristics of subject.
27

Alert Signal
YELLOW LED lit up: this indicates a device failure. In this case, you need to call technical support.
BLUE LED flashing: pause or standby.
BLUE LED steady: treatment in progress.
GREEN LED: powered device.
SOUND: indication of the end of treatment; Voice treatment information.

Image of detached electrode on display: Indicates that the active electrode is not adhering to the skin and,
if it persists, it means that there is an interruption of the signal due to defective contact of electrode where
it is connected to the handpiece. Remove, clean and reinsert. If image still persists, call customer service.
Image of detached cable on display: Indicates that the cable is not properly inserted. If image persists
after reinserting, call customer service.
5.8 WARNINGS AND PRECAUTIONS IN USING ACCESSORIES AND APPLIED PARTS
Handpieces
Before use, be sure to check the integrity of cables and connections.
Effecting substitution of the handpiece when the device is operational may cause damage to user and
to patient.
Do not apply tension or traction on connections between cables and connectors, handpieces and
indifferent electrodes. This could compromise correct operation of device.
The insertion connectors of handpieces to control unit are provided with distinct keys. Do not force
insertion: check that you are using the correct connection.
In turn, the handpieces have different-sized holes for inserting electrodes. Do not force insertion: check
that you are associating the correct electrode to a given diameter of hole.
Electrodes
Clean and sanitize electrodes previous to every session of treatment.
Correct cleaning and disinfection, as well as appropriate operational procedures, are indispensable to
prevent the spread of infection or cross-contamination.
Use a soft cloth to remove excess cream from electrodes.
For improved contact with skin and before starting treatment, you need to spread a light layer of electrolytic
emulsion onto area to be treated, where the active electrodes (CAP or RES) will slide, as well as onto the
neutral electrode (plate or cylindrical), which you will need to make as adherent as possible to body skin.
Before inserting, removing or replacing an electrode (RES or CAP), it is important to reset power to zero.
If the CAP or RES electrode does not work, you need to make sure the electrode shaft and the insertion
seat on handpiece have been properly cleaned.
28

High-impedance Electrodes (CAP)
Check integrity of electrode before treatment. Replace if broken.
Avoid shocks and jolts with sharp or pointed objects.
Clean and sanitize electrodes according to instructions in corresponding chapter. Using high
temperatures (over 90° C) or unsuitable detergents (alcohol) reduces working life of electrode and
deteriorates its coating.
Indifferent (or neutral) Electrodes

The neutral electrode, plate or cylindrical, must always be applied during treatment in order to allow
suitable passage of current and closure of circuit.
It is always essential to check whether the indifferent electrode perfectly adheres to body.
It is advisable to use the plate for treating larger-sized surfaces, in combination with active electrodes
having a diameter over 40 mm.
The neutral cylindrical electrode, on the other hand, is recommended only in special circumstances such
as facial treatment or certain specific areas.
Flat indifferent electrodes should not be flexed over their natural limits.
If the plate is bent out of shape, adherence to tissue is reduced, compromising safety and effectiveness
of treatment.
Remote Control
Replace batteries when the remote no longer works.
Scrap batteries must be disposed of in compliance with local and national laws in the proper containers.
Always use batteries of the correct voltage and type indicated for the remote control supplied.
Remote control must be operated exclusively by user and in the immediate vicinity of patient.
Electrolytic Emulsion
The electrolytic emulsion was designed and tested for use with the present device.
A different product might not be suited, thus:

• Causing deterioration of outside insulation layer of electrode;
• Causing burns;
• Reducing effectiveness of treatment owing to an improper coupling of electrode and body tissue; this
would be indicated by the absence or feebleness of subcutaneous heat sensation or, on the contrary,
by the overheating of skin surface.
It is good practice, before applying emulsion, to verify patient history and determine whether the subject
might be liable to sensitization to specific components of the product.
Make the usual checks and apply the usual limitations regarding exposure to products that might contain
the principle or principles responsible for said sensitization or allergy (mini patch test, controlled use
and suspension if necessary).
29

6 TECHNICAL SPECIFICATIONS
6.1 CLASSIFICATION
The device, according to the harmonized technical norms for safety evaluation EN 60601-1 and EN
60601-1-2, is classified as follows:
For type of protection against electrical hazard Class I Device
Level of protection against electrical hazards of applied parts Type BF Device

Electromagnetic compatibility Gruppo 1, Classe A
For type of protection agains penetration of water Common Device
For type of protection agains penetration of dust Common Device
For sterilization method Not applicable

For safety level in atmosphere containing inflammable Device not suited
For manner of use Device intended for continuous use
Mode of placement Portable Device
6.2 TECHNICAL DATA

Mains power supply and frequency 100 - 240 V 50 - 60 Hz
Input fuses 2 x T5A H 250V
Input power 380VA
Output frequency 0,447 MHz ± 0,002 MHz
Output voltage and power RES: 150V/300W ± 10% e ± 2W (a)

CAP: 600V/450VA ± 10% e ± 2W (b)
Standby consumption 1,1 W

Consumption in sleep mode 12 W
Size/Weight L 53 x P 27 x H 19 cm / Kg 7,5
Remote control: batteries 2 x alkaline batteries GP23A 12V
(a) Dummy load of 47 ohm

(b) Dummy load of 330pF, 235 ohm
30

Table of indicative values of impedance and load curves for the nominal power output
RES loads measured: 47Ω CAP loads measured: 330 pF/235Ω
% V (V) I (A) R (Ω) W % V (V) I (A) R (Ω) W
10% 15 0,26 58 4 10% 60 0,15 1400 3
20% 30 0,5 58 15 20% 120 0,09 1400 11
30% 45 0,73 60 33 30% 180 0,14 1300 25
40% 60 0,99 61 59 40% 240 0,19 1300 48
50% 75 1,23 61 92 50% 300 0,25 1200 75
60% 90 1,47 61 131 60% 360 0,30 1200 105
70% 105 1,70 61 179 70% 420 0,35 1200 150
80% 120 1,95 61 236 80% 480 0,4 1200 190
90% 135 2,1 59 290 90% 540 0,46 1150 250
100% 137 2,2 57 302 100% 600 0,50 1150 300
Means of separating device from mains power supply consists of the master control switch.
The present device avails itself of a redundant software-hardware system that runs both treatment parameters
and safety parameters such as limiting excessive output power and output overcurrent.
6.3 LIFE EXPECTANCY
The life cycle of the control unit of device, cables and networking anf RES electrodes is calculated to be approx.
5 years, in conditions of normal use and service.
The life cycle of handpieces dei manipoli is calculated to be approx. 2 years, in conditions of normal use.
The life cycle of high-impedance CAP electrodes, on the other hand, is calculated to be approx. 1 year, in conditions
of normal use.
Conditions of normal use mean installation, use and maintenance complying with instructions indicated in
the present user guide.
Should there be any anomaly or damage in equipment, handpieces, electrodes and external connection cables,
you immediately need to contact technical support authorized by manufacturer, and they will straightaway check
status and correct anomalies.
31

MANUALE D’ISTRUZIONE HCR 1002
7 CLEANING AND DISINFECTION

Correct cleaning and disinfection procedures, together with adequate operating procedures, are
essential to prevent the spread of infection or cross-contamination.
This paragraph lists the activities you need to carry out during normal use and maintenance, to ensure
device is correctly cleaned and disinfected.
7.1 CLASSIFICATION OF DEVICE FOR HYGIENE AND SAFETY
The device may be classified as “non-critical” since it is used on healthy skin, so that adequate cleaning
is sufficient, or low-level disinfection.
However, in those cases where subject’s condition is transmissible by direct contact, or in case of
accidental exposure to body fluids, it is recommended to disinfect with a higher-level disinfectant after
cleaning.
The device is not sterile on delivery, application parts do not need to be sterile, and it should not be
sterilized previous to use.
7.2 RECOMMENDED PRODUCTS
The choice of product and procedure takes into account the requirements of both cleaning and disinfection.
It also takes into account both the sensitivity of device to specific substances and the product’s disinfecting
effectiveness.
The use of solvents (acetone) is absolutely contraindicated, as are acidic or basic solutions (pH < 4.5 and
> 8.0), ethyl or isopropyl alcohol, chlorine-based and chlorine-derived products (bleach or household
bleach like Amuchina).
Thermal sanitizing by means of high temperatures, as well as sanitizing by radiation are absolutely
contraindicated, as are autoclave sterilization, thermochemical treatment in automatic machines and
dry cleaning with radiation-emitting equipment (UV rays).
Solely for low-impedance RES electrodes and neutral electrodes, is the use of ethyl or isopropyl
alcohol recommended.
The manufacturer will not be held liable for any damage caused by using disinfectants not recommended
in the present user guide.
We recommend using medical products with the CE mark for medical device or medical-surgical devices,
in particular for:
Detergents - polyenzymatic solutions or neutral surfactant-based solutions.
Disinfectants/decontaminating products - Biguanide (chlorhexidine) in polyenzymatic soapy solution
(mixed with detergent); alternatively, only for indifferent and resistive electrodes (stainless steel), you
may use ethyl alcohol, 70% v/v, or isopropyl alcohol.
Please comply with instructions provided by manufacturer in using product.
32

7.3 GENERAL PROCEDURE FOR CLEANING AND DISINFECTION
Cleaning and disinfection need to be carried out after each treatment (application).
If the product used only contains detergents or only disinfectants, steps to be taken are two: cleaning
and disinfecting, in two stages.
If the product used contains both detergents and disinfectants, the cleaning procedure will be all in one
stage.
Portions of device not in contact with patient should be cleaned at least once a day.
Portions of device that come into contact with patient should be thoroughly cleaned and disinfected at
the beginning and at the end of each application.
7.4 CLEANING THE DEVICE

Device must be accurately cleaned after each use.
In order to avoid damage of any kind to device and accessories, follow instructions carefully.
Once device has been turned off, unplug it from power socket.
The outer shell of device may be cleaned with a damp, soft cloth with a rinse-free cleansing solution (we
recommend using neutral, surfactant-based solutions and/or polyenzymatic solutions.

7.5 CLEANING THE ELECTRODE HOLDER HANDPIECES

After each treatment, remove residual cream from handpiece surface with a cloth.
Clean electrode holder handpieces with a cloth dampened with a neutral, surfactant-based solution
and/or a polyenzymatic solution.
Periodically eliminate dirt from slits and interstices with a cotton swab.
The device should be turned off for this operation, and power cable should be unplugged; handpieces
should preferably be disconnected from body of machine control unit.
7.6 CLEANING LOW-IMPEDANCE RES ELECTRODES
Low-impedance electrodes are made of steel and therefore present no particular contraindication to
products and procedures that are normally used in cleaning, sanitizing, disinfecting and decontaminating.
Remove excess cream from electrode.
Clean and disinfect with a soft cloth soaked in 70% ethyl alcohol or isopropyl alcohol.
The device should be turned off for this operation, and power cable should be unplugged; accessories
should preferably be disconnected from control unit.
33

7.7 CLEANING INDIFFERENT (OR NEUTRAL) ELECTRODES - FLAT AND CYLINDRICAL

Indifferent electrodes are made of steel and therefore present no particular contraindication to products
and procedures that are normally used in cleaning, sanitizing, disinfecting and decontaminating.
Clean and disinfect with a soft cloth soaked in 70% ethyl alcohol or isopropyl alcohol.
The device should be turned off for this operation, and power cable should be unplugged; accessories
should preferably be disconnected from control unit.
7.8 CLEANING HIGH-IMPEDANCE CAP ELECTRODES
Unlike steel electrodes, high-impedance electrodes, being coated with an insulating material, are
sensitive to certain substances or physical agents.
Clean and disinfect with a soft cloth soaked in a neutral, surfactant-based solution and/or a polyenzymatic
solution.
The device should be turned off for before this operation, and power cable should be unplugged;
accessories should preferably be disconnected from control unit.
7.9 DECONTAMINATION

Immerse surface of the tip of electrode or the neutral electrode in a decontaminating solution
(chlorhexidine aqueous solution, chlorhexidine soapy solution) for 5/10 minutes.
Rinse in lukewarm water.
Dry with a cloth or with a single-use wipe.
34

8 GENERAL SAFETY NOTES
8.1 GENERAL WARNINGS AND PRECAUTIONS
Carefully read all warnings and precautions listed in the present user guide and bearing the
symbol here shown.
THE MANUFACTURER, IMPORTER AND AUTHORIZED INSTALLER ARE RESPONSIBLE FOR THE
SAFETY, RELIABILITY AND CORRECT OPERATION OF DEVICE
only on the following conditions:
• That all operations of assembly, adjustment, modification, maintenance or repair work be carried out
by authorized personnel;
• That the electrical wiring of treatment rooms comply with local and national legal requirements;
• That the device be used following instructions contained in the present user guide.
THE MANUFACTURER WILL NOT BE HELD LIABLE FOR POSSIBLE DAMAGES

that may directly or indirectly affect persons or things as a consequence of inobservance of any or all of
the instructions specified in the user manual, in particular, the instructions, precautions and warnings
concerning use and maintenance of device.
In this regard, the manufacturer recommends attending training courses organized either by the
manufacturer or by accredited bodies.
The manufacturer is responsible for designing and manufacturing devices that comply with legal safety
standards in terms of general safety, electrical safety and electromagnetic compatibility.
The conformity certificate testifies safety compliance.
THE MANUFACTURER WILL NOT BE HELD LIABLE FOR SAFETY OF DEVICE

in the following cases:
• If device is tampered with and seal is broken;
• If device is altered without the express authorization of manufacturer;
• If device is subjected to maintenance in ways and instances not provided for in the present user guide;
• If maintenance is carried out by unauthorized technical personnel and/or by using non-original parts;
• If non-original accessories are used – in particular, using different cables may compromise current
values/voltage released by device or levels of immunity to other radiation.
• The failed use of the network filter that can affect the levels of conducted emission (emc).
I
35

8.2 WARNINGS AND CONTRAINDICATIONS TO TREATMENT
The present device is non-invasive. It is intended to come into contact with subject of treatment only
temporarily and only on healthy skin. The device does not replace or modify the body of patient.
The device must be used on wakeful and conscious subjects who can interact with operator and provide
feedback on the heat sensation deriving from treatment.
Nonetheless, there are certain precautions and contraindications to be considered:

The device should not be used on children below 12 years of age, pregnant women or women who are
breastfeeding.
Do not treat open wounds, eyes, intracavitary regions, soft tissues, mucous membranes and genital
areas. Before treatment, carefully study the area to be treated in order to verify the integrity of skin.

Before treatment, remove all metallic objects worn by subject (earrings, rings, bracelets, piercings).
Unless authorized by specialist physician, subjects with the following conditions are not recommended
to use device:
• Epilepsy
• Angina pectoris
• Cardio-vascular disfunctions
• Insensitivity to temperature
• Nervous infermities
• Neoplasms
• Subjects with pacemakers and active implants in general
• Coagulopathies and thrombophlebitis
The use of device is contraindicated in the following cases, unless specifically sanctioned by
subject’s physician:
• Prolonged applications in the cervical or paravertebral region may cause transitory alterations of
blood pressure.
• Individuals with hypotension, sometimes, owing to a prolonged session or during treatment of the
joints, may be subject to a sudden lowering of arterial blood pressure. In such cases, it is advisable
to reduce duration of sessions and/or prolong the interval between sessions.
• The presence of metal implants does not constitute a contraindication as long as over 50% of
implants’ surface is in contact with the organic substrate.
• Individuals affected by scarce sensitivity to temperature should undergo a preliminary test before
treatment.
• The use of device is not intended for treatment of body areas with open wounds or recent burns.
• The use of device is contraindicated for application on body orifices and vital points of the body.
• It is important to abstain oneself from treating individuals affected by internal infection with
encapsulation (abscess), as one may run the risk of spreading infection. In such cases, it is advisable
to consult one’s physician and undergo antibiotic treatment before treatment with device.
36

9 MAINTENANCE
WARNING - Do not modify this device without written authorization from manufacturer.
No maintenance work may be performed on device by user or third parties except as expressly
specified in the present user guide.
Should the device fail or malfunction, contact a qualified operator authorized by manufacturer.
Installation, repair work and modifications should be exclusively carried out by qualified personnel
authorized by manufacturer.
9.1 TRAINING AND EDUCATIONAL PROGRAMS REQUIRED FOR TECHNICIANS

The required training varies depending on type of maintenance.
In case of any routine operation on device, instructions contained in the present manual shall suffice
Any non-routine or correctiv maintenance work, on the other hand, may only be performed by
qualified technicians, trained and authorized by manufacturer.
9.2 REQUIRED EQUIPMENT FOR TECHNICIANS
Routine maintenance work on device is not particularly hazardous.

In cases of non-routine maintenance work, potential hazards should be assessed according to the
specific operation required.
In any case, the use of adequate personal protective equipment (PPE) is recommended.
9.3 ROUTINE MAINTENANCE WORK
General
Periodically verify there is no obstruction to the slits in lower portion of device, impeding proper
ventilation.
Cables and connectors
Before starting session, assess the status of cables and keep them clean, removing any residue of
conductive cream. Should you note any anomaly, replace them before breakage occurs.
Periodically verify that the electrical connection between connector and electrode holder handpiece
or neutral electrode is intact. This operation can be performed by means of a “Tester” (ohmmeter).
CAP electrodes
Previous to session, check electrode insulation status.
If borders of electrode look slightly worn, they point to normal wear and tear that may, however,
have compromised insulating characteristics. A dent on the contour of electrode, on the other hand,
is a clear sign the electrode has taken a shock or fall. In both cases, you will need to replace the
electrod.
Remote control
The only thing you need to remember is changing batteries when you notice the device no longer
responds to remote. Exclusively use batteries of the type and voltage indicated in kit supplied.
Dispose of scrap batteries at a recycling point in compliance with environmental safety standards
as established by law. If you should not use your batteries for a lengthy period of time, extract them
from their housing.
Cleanliness and hygiene
See corresponding chapter.
37

9.4 EMERGENCY MAINTENANCE WORK
Replacing fuses
The device is provided with two outer fuses as voltage surge protection. The device is provided with two
outer fuses as voltage surge protection. The outer fuses are located in
the connection plug of the power cord and may be replaced by competent personnel that will refer to the
values indicated in manual and identification plate data.
Replacing power cable
If the power cable fails or malfunctions, this must be replaced by an original cable.
Replacement of handpieces and indifferent electrode cables
In the event of cable connection failure, this must be replaced by an original cable.
Replacement of the power filter
In the event of power filter failure, this must be replaced by an original power filter.
Other
If you should notice any anomaly, do not use the device and immediately request technical support.
The device must be serviced exclusively by Technical Support authorized by manufacturer, failing which
warranty would lapse and/or would manufaturer’s liability.
Fuses should always be replaced while the device is disconnected to power supply and the ON/OFF
switch on the rear panel of device is turned off. Fuses should correspond to type and nominal value
specified in the identification plate data.
If the power cable should fail or malfunction, it should be replaced with an original cable. Using a different
cable would compromise the safety of device.
In the event power filter should fail, it should be replaced with an original power filter. Using a different
filter would compromise the safety of device.
The Manufacturer undertakes to supply, upon substantiated request, layout of circuits, component
lists, calibration instructions and/or any other information that will allow technicians to perform the
required repair work.
The device must not undergo calibration. However, manufacturer recommends calibration of power
released every two years, in order to guarantee maximum efficiency of device itself.
38

10 PACKAGING AND LABELING
Following are instructions concerning packaging, transport and labeling.
10.1 PACKAGING
The Manufacturer has packaged device in every one of its parts at the close of the production cycle.
The control unit has been inserted in apposite preformed holders, then placed in a cardboard box.
All accessories have been adequately bubble-wrapped and inserted in a cardboard box.
These two cardboard boxes, together with the user guide and statement of conformity, have been
placed in a shipping carton (60x34x34mm; m3 0.68).
Packages show international symbols providing for standard-compliant waste disposal as per the
norms of country of destination, as well as symbols for adequate handling during transport and storage.
1O.2 TRANSPORT
We recommend preserving all original packages and wrappings and repacking device every time you
need to transport it; on the other hand, if you need to shift it a small distance, handle device with care,
avoiding shocks, jolts and falls.
10.3 LABEL
This is applied to rear panel of device.
11 DISPOSAL AT END OF LIFE

In accordance with current European Directives concerning reduced use of hazardous substances in
electrical and electronic equipment and waste disposal, it is mandatory not to dispose of electrical and
electronic equipment as ordinary urban waste, but as special waste, separately disposed of.
At time of purchase of new equipment of an equivalent type, previous equipment that has reached end
of life will have to be returned to seller for disposal.
Also, at end of life for device and before disposal of same, batteries of remote control must be removed
and disposed of separately, at a specific recycling point for batteries.
39

12 WARRANTY
The Manufacturer guarantees that each device is free from material or manufacturing defects and that
it complies with the specific technical norms detailed in the declaration of conformity and/or at point 13.
This warranty is valid for a two-year period from date of purchase and covers material or manufacturing
defects.
The commercial guarantee is valid for one year from the date of purchase and covers the breaking of
device or its accessories not attributable to an improper use of the same. Improper use means not
following the instructions and warnings indicated in the present manual.
Warranty exclusion or cessation clauses

This warranty does not imply any obligation on Manufacturer’s part to replace device, even temporarily.
In no case can it be extended to cover compensation for damages, of whatsoever nature, incurred by
people or things as a consequence of suspension of use of warranted device.
Warranty does not cover parts that are defective due to negligence in use of device such as:
• Inobservance of operational instructions;
• Erroneous maintenance;
• Circumstances that are not derivable from material or manufacturing defects.
Warranty is void
• Should the device be tampered with; in particular, in the event of maintenance/repair work or
modifications carried out by unqualified personnel that has not been authorized by manufacturer
and/or with spare parts other than originals;
• Should serial number be erased, altered or removed;
• When the duration of warranty itself has expired.
To request technical support

To request technical support from manufacturer, distributor or authorized service center during period
covered by warranty, the owner must send written communication to manufacturer, distributor or
authorized service center specifying the serial number of device, which is indicated on the identification
plate, and the anomalies encountered.
If the owner deems it necessary to send the device on for examination or repair work, the accompanying
written communication should also specify the complete name of customer, customer’s address and
telephone number and purchase invoice number where applicable, as well as the name of distributor or
service center where purchase was made.
Technical support specifics

In case of warranty claims, spare parts and labor costs or expenses shall be borne by manufacturer if
repair work takes place on the manufacturer’s premises, while transport charges and hazards are the
responsibility of customer.
Should customer request Technical Support on his/her own premises, transport expenses, handling
charges, labor costs or expenses and call-out charge shall be debited on every call-out of technicians.
Should technicians not ascertain any flaw or quality defect, all expenses borne shall be borne by
customer, even during warranty period.
40

13 SAFETY TESTS PERFORMED

13.1 LIST OF DIRECTIVES, TECHNICAL STANDARDS AND REGULATIONS APPLIED
Here below are the main European Directives and Technical Standards applied.
In particular, electrical security and electromagnetic compatibility tests were performed complying
with the regulatory standards of:
CEI EN 60601-1; CEI EN 60601-1-2; CEI EN 60601-2-2
European Directive 93/42 / EEC and SMI EU Medical Device Directive transposed in Italy
by the Legislative Decree 46/97 and subsequent
amendments
European Directive 2011/65/EEC and SMI EU RoHS Directive, restriction on use of hazardous
substances in electrical and electronic equipment
Applied standards EN ISO 13485:2012; CEI UNI EN 14971:2012; UNI CEI

(indicative and non-exhaustive list both with EN 1041:2013; UNI CEI EN 15223-1:2012; UNI CEI EN
respect to norms and to revisions - manufacturer 980:2009; UNI EN ISO 10993-1:2010; UNI EN ISO 10993-
constantly verifies and integrates standards, 5:2010; UNI EN ISO 10993-10:2010; CEI EN 62304:2008;
norms and revisions, so that the present list may be
CEI EN 60601-1:2012; CEI EN 60601-1-2:2014; IEC
incomplete and/or not updated)
60601-2-2:2014; CEI EN 60601-1-6:2007; CEI EN
62366:2008.
13.1 ELECTROMAGNETIC COMPATIBILITY - EMC
The device complies with the collateral norm no. EN 60601-1-2 relative to electromagnetic compatibility.
EMC tests have not ascertained any hazard regarding interference of device with other electronic units.
The present device must be installed and operated on the basis of EMC information supplied in this
section.
Device may be affected by portable and mobile radiocommunications systems.
Device should not be used near or overlapping to other equipment in order to avoid interference in the
normal operating condition. If necessary, verify normal operation.
Device is designed for use by healthcare personnel on public or private medical floors. Using device in a
domestic setting or connected to the public power supply network may generate radio-interference or
affect operation of nearby equipment. In such cases, it may be necessary to adopt mitigation measures
of said effects, like repositioning or reorienting device.
The device cannot be equipped with cables and network filters other than those specified by the
manufacturer, although sold as replacement parts for internal components, as this condition may result
in increased emissions or decreased immunity of the EMC.
41

Following are the EMC assessment tables.

(Tables follow the numbering system detailed in EN 60601-1-2 for portions used in assessment).
Table 1 - For all EM equipment or system

This device is intended for use in the environment specified below. The customer or user of device
should ensure that it is used in such an environment.
EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT
RF Emissions Group 1 Device uses RF energy to perform; its RF emissions are

CISPR 11 very low and not likely to cause any interference in nearby
electronic equipment.
RF Emissions Device is designed for use by healthcare personnel

CISPR 11 Class [A] on public or private medical floors. Using device in a
domestic setting or connected to the public power
Harmonic emissions supply network may generate radio-interference or
EN 61000-3-2 Compliant affect operation of nearby equipment.
In such cases, it may be necessary to adopt mitigation
Voltage fluctuations/
measures of said effects, like repositioning or
flicker emissions Compliant
reorienting device.
EN 61000-3-3
Table 2 - For all EM equipment or system

This device is intended for use in the environment specified below. The customer or user of device
should ensure that it is used in such an environment.
IMMUNITY EN 60601-1-2 COMPLIANCE ELECTROMAGNETIC

TEST TEST LEVEL LEVEL ENVIRONMENT - GUIDANCE
2
Electrostatic ± 6 kV contact EN 60601-1-2 Floors should be wood, concrete
discharge (ESD) ± 8 kV air or ceramic tile. If floors are covered
EN 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical fast ± 2 kV for power EN 60601-1-2 Mains power quality should be
transient/burst supply lines that of a typical commercial or
EN 61000-4-4 hospital environment.
± 1 kV for input/output
lines > 3m
Surge ± 1 kV differential mode EN 60601-1-2 Mains power quality should be
EN 61000-4-5 ± 2 kV common mode that of a typical commercial or
hospital environment.
Voltage dips, short <5 % UT for 0,5 cycles EN 60601-1-2 Mains power quality should be
interruptions and (>95 % dip in UT) Not applicable that of a typical commercial or
voltage variations 40 % UT for 5 cycles hospital environment.
on power supply (60 % dip in UT)
input lines 70 % UT for 25 cycles
EN 61000-4-11 (30 % dip UT)
<5 % UT per 5 s
(>95 % dip in UT)
Power frequency 3 A/m EN 60601-1-2 The power frequency magnetic
(50/60 Hz) field should be that of a
magnetic field typical commercial or hospital
EN 61000-4-8 environment.
42

Table 4 - For all EM equipment or system that is not of sustenance to vital functions
This device is intended for use in the electromagnetic environment specified below. The customer or
user of device should ensure that it is used in such an environment.
IMMUNITY EN 60601-1-2 COMPLIANCE ELECTROMEGNETIC

TEST TEST LEVEL LEVEL ENVIRONMENT
Radiated RF 3 V/m [E1] V / m. Portable and mobile RF

EN 61000-4-3 80 MHz to 2.5 GHz 3 V/m communications equipment should
EN 60601-1-2 not be placed or used closer to any
part of the device, including cables,
than the recommended separation
distance calculated from the equation
applicable to transmitter frequency.
Recommended Separation Distance
d = 1.2√P 80 MHz to 800MHz
d = 2.3√P 800 MHz to 2.5GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey (a),
Coducted RF 3V± [V1] V
should be less than the compliance
EN 61000-4-6 150 kHz to 80 MHz 3V level in each frequency range (b).
EN 60601-1-2 Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note 1 - At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
any accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the device is used exceeds the
applicable RF compliance level above, one should check that the device operates normally. If any operational anomaly
is discovered, additional measures may be necessary, such as reorienting or repositioning the device.
b) Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V / m.
43

Table 6 - Recommended separation distances between portable and mobile RF

communications equipment and EM devices that are not used for sustaining vital functions
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. Customer or user of device can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and
the device as recommended below, according to the maximum output power of the communications
equipment.
RATED MAXIMUM OUTPUT POWER SEPARATION DISTANCE ACCORDING TO FREQUENCY

OF TRANSMITTER OF TRANSMITTER
W M
150 kHz 80 MHz 800 MHz
to 80 MHz to 800 MHz to 2.5 GHz
d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.20 1.20 2.30
10 3.80 3.80 7.30
100 12.00 12.00 23.00
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
44

REF. 16580 - 2016.10
Tecar, HumanTecar and Tecarterapia are registered trademarks of Unibell International Srl.
Unibell Srl
Via Indipendenza, 27 - 23885 Calco (LC), Italia
info@humantecar.com - humantecar.com

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USER MANUAL

Unibell Srl T. +39 039991131

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English language text.

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2 DEVICE DESCRIPTION 9 MAINTENANCE

7 CLEANING AND DISINFECTION

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Please read the present user guide before using

It is also recommended user print andor download all

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The physiological effects and therapeutic use

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1.2 ACRONYMS AND SYMBOLS

Electrical safety classification for applied parts

equipotential bonding bar

Equipment complying with the requirements laid down by European directives

Warning: separate disposal

Warning: possible emissions of non-ionizing radiation

Date of Manufacture stated by year (yyyy)

Code number assigned to device by manufacturer

Serial number assigned to device by manufacturer

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2.1 COMPONENTS OF DEVICE

The device is made up of a control unit and of essential accessories.

16577 Control Unit: HCR 1002 1

Code Description Q.ty

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2.2 CONTROL UNIT

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Green power LED

Menu selection key in setup

LED signalling RES/CAP treatment selected

Button selecting treatment with RES/CAP

Button to Reset treatment

Handpiece Encoder regulating power of treatment

Yellow LED indicating mechanical failure

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By key input, which prevents accidentally inverted connections.

2.3 SMART-USE HANDPIECES

Handpiece for CAP electrode - black/white - gray cable

2.4 ACTIVE ELECTRODES

These are applied parts to patient.

High-impedance CAP electrodes

Low-impedance RES electrodes

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They are applied parts to patient.

HANDPIECES & CAP ELECTRODES HANDPIECES & RES ELECTRODES

INDIFFERENT FLAT ELECTRODE INDIFFERENT CYLINDRICAL ELECTRODE

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2.6 RADIO REMOTE CONTROL

Allows remote control of the following:

Switching device on and off

2.7 COMPLEMENTARY ACCESSORIES

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3.2 INTENDED USE AND APPLICATIONS

HCR 1002 is a device for diathermy, tecartherapy.