Human Tecar HCR 1002 User manual

Unibell Srl
via Indipendenza, 27 - 23885 Calco (LC) - Italy
T. +39 039991131
info@humantecar.com humantecar.com
HCR 1002
USER MANUAL

humantecar.com
© 2016 UNIBELL srl - All rights reserved
English language text.
Any duplication, reproduction, storage and transmission of this publication in any form (electronic, mechanical, by photocopying,
translation or any other means), is expressly prohibited, unless authorized in writing by Unibell Srl.

3
INDEX
1INTRODUCTION
1.1 device presentation
1.2 acronyms and symbol
2DEVICE DESCRIPTION
2.1 components of device
2.2 control unit
2.3 handpieces
2.4 active electrodes
2.5 indifferent (or neutral) electrodes
2.6 radio remote control
2.7 complementary accessories – electrolytic emulsion
3INTENDED USE
3.1 operating principle
3.2 intended use and applications
4INSTALLATION PROCEDURE
4.1 installation
4.2 environmental conditions for transport and service
4.3 placing
4.4 mains power connection
4.5 setup menu
5HOW 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
6TECHNICAL SPECIFICATIONS
6.1 classification
6.2 technical data
6.3 life expectancy
7CLEANING 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
8GENERAL SAFETY NOTE
8.1 general warnings and precautions
8.2 warnings and contraindications to treatment
9MAINTENANCE
9.1 training and educational programs for technicians
9.2 required equipment for technicians
9.3 routine maintenance work
9.4 emergency maintenance work
10 PACKAGING AND LABELING
10.1 packaging
10.2 transport
10.3 label
11 DISPOSAL AT END OF LIFE
12 WARRANTY
13 SAFETY TESTS PERFORMED
13.1 list of guidelines and technical standards applied
13.2 electromagnetic compatibility

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.
4
USER MANUAL HCR 1002

1INTRODUCTION
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.
5

Photos and drawings in this publication are intellectual property of Unibell Srl.
All rights reserved - Reproduction prohibited.
6
USER MANUAL HCR 1002

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 eects on tissue of this energy transfer are prevalently temperature-related
owing to the Joule eect, and biochemical eects 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 sta, physicians and/or physiotherapists.
It can be used in clinics and doctor’s oces – 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.
7

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
8
USER MANUAL HCR 1002

9
2DEVICE 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:
16577 Control Unit: HCR 1002
16579 Power cord
16607 Power filter
16458 High-impedance CAP electrode, flat, thermodynamic Ø 30 mm
16459 High-impedance CAP electrode, flat, thermodynamic Ø 40 mm
16460 High-impedance CAP electrode, flat, thermodynamic Ø 55 mm
16461 High-impedance CAP electrode, flat, thermodynamic Ø 65 mm
16462 High-impedance CAP electrode, flat, thermodynamic Ø 80 mm
16469 High-impedance CAP electrode, flat, thickened and lymphodynamic (for face) Ø 55 mm
16463 High-impedance CAP electrode, convex, thermodynamic Ø 30 mm
16464 High-impedance CAP electrode, convex, thermodynamic Ø 40 mm
16465 High-impedance CAP electrode, convex, thermodynamic Ø 55 mm
16466 High-impedance CAP electrode, convex, thermodynamic Ø 65 mm
16467 High-impedance CAP electrode, convex, lymphodynamic Ø 40 mm
16468 High-impedance CAP electrode, convex, lymphodynamic Ø 55 mm
16470 Low-impedance RES electrode Ø 35 mm
16472 Low-impedance RES electrode Ø 50 mm
16473 Low-impedance RES electrode Ø 65 mm
16474 Low-impedance RES electrode Ø 90 mm
16475 Loop-shaped handpiece for CAP electrodes
16476 Pencil handpiece for CAP electrodes
16477 Loop-shaped handpiece for RES electrodes
16478 Pencil handpiece for RES electrodes
16479 Cylindrical indifferent (or neutral) electrode
16480 Flat indifferent (or neutral) electrode
16489 Radio remote control
16449 Remote control battery
16580 User Manual
The device is provided with a series of complementary accessories tested for use with this equipment:
Code Description Q.ty
15682 Electrolytic Emulsion

10
Frontal panel
ADisplay showing treatment parameters
BControl panel, split into three distinct areas:
• Treatment commands
• Configuration commands
• On and off buttons
CHandpiece connection
Rear panel
D Power plug with fuse compartment and
power switch
EEquipotential bonding bar
F Ventilation fan
GLabel
B
C
A
E
GD
F
USER MANUAL HCR 1002
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:
Treatment display
Display showing the treatment parameters previously set and current parameters measured by
machine in real time.
Serial Number - fw:
X2BC345609AB -1.32
HCR 1002

RESET
START
STOP
+
_
CAPRES
RF
Control panel
TREATMENT SETUP ON-OFF
ON - OFF
SETUP
TREATMENT
TIMER
MENU
Handpiece Encoder regulating power of treatment
ROTATION: increasing (clockwise rotation) and
decreasing (anti-clockwise rotation) output power.
PRESSED: interrupting treatment.
Yellow LED indicating mechanical failure
11
Selecting duration of treatment in Setup Menu
Saving the preset time interval as default duration
Button enabled when treatment is on standby.
Buttons for increasing and decreasing duration of
treatment
May be used to increase and decrease values of parameter
selected in Setup Menu.
Green power LED
LIT UP AND STEADY: power cable connected and rear
power switch ON.
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
Button enabled when treatment is on standby.
Navigation buttons in Setup Menu
Increasing and decreasing value of selected parameter.
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 for Start/Stop treatment
Button to Reset treatment
Button enabled when machine is on treatment standby.
Button selecting treatment with RES/CAP
electrodes
Button enabled when machine is on treatment standby.
+
_
CAPRES
RESET
START
STOP
RF

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.
USER MANUAL HCR 1002
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.
13
HANDPIECES & CAP ELECTRODES
INDIFFERENT FLAT ELECTRODE
HANDPIECES & RES ELECTRODES
INDIFFERENT CYLINDRICAL ELECTRODE

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
+_
USER MANUAL HCR 1002

15
3INTENDED 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.

4INSTALLATION 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
USER MANUAL HCR 1002

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

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
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.
4.5 SETUP MENU
18
Press “Setup Menu” key for configuration display.
USER MANUAL HCR 1002

19
In order to connect device to power, position the switch on the rear panel
onto “I”.
The green LED above the ON/OFF switch on the front control panel will light up.
Press the ON/OFF switch for three seconds.
The display screen will turn off while the green LED will remain lit.
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.
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.
5OPERATING METHODS
5.1 SWITCHING ON AND OFF
Switching on
Functioning
Switching off
WARNING
The green LED above the ON/OFF switch on the front control panel will light up.
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.
I
0
I
0

5.2 SETTING TIME OF TREATMENT
20
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.
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.
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.
USER MANUAL HCR 1002
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