I-tech CR200 User guide

MNPG428-00 Edition 01/03/2022

CR200

USER MANUAL

MNPG356 Rev.1 of 15/01/2022

Tecar Therapy

CR200

IACER Srl 43 MNPG356-01

INFORMATION ON THE USER MANUAL 47
MANUFACTURER 48
DECLARATION OF CONFORMITY 48
CLASSIFICATION 49
INTENDED PURPOSE AND SCOPE OF USE 49
TECHNICAL SPECIFICATIONS 49
DEVICE DESCRIPTION AND CONTROLS 52
LABELLING 55

Pack contents 56

NOTES 57
INTRODUCTION TO THE TECHNOLOGY 58

General information 58
Endothermic therapy 58

CONTRAINDICATIONS 60
WARNINGS 61
USE OF DEVICE 62

List of programmes 69

MAINTENANCE 71
TROUBLESHOOTING 73
DISPOSAL INFORMATION 75
WARRANTY 76

Support 77
Spare parts 77

SOUND ENERGY EMITTED 78
INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES 78

Contents

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Technical information

Information on the user manual

This user manual is addressed to:

- the machine user;

- the owner;

- supervisors;

- those in charge of moving it;

- installers;

- users;

- maintenance staff.

This document provides information for the installation and correct use of the
CR200 Tecar Therapy device.
This manual acts as indispensable reference guide for the user: before installing
and using the machines, it is essential to carefully read the contents of the manual
and keep it always at hand for quick reference.
Failure to comply, even partially, with the recommendations contained herein may
lead, in addition to malfunctions, also to damage to the equipment, and
invalidation of the warranty.
However, by closely following the instructions and recommendations provided by
the manufacturer, you will be assured of the best results as well as the availability
of a fast and efficient technical support service if needed.
The limits of this user manual are:

the user manual can never replace adequate user experience;

−

− the user manual, for particularly demanding tasks, can be only considered

a reminder of the main operations.
The user manual is to be considered part of the equipment and must be kept for
future reference until the final dismantling of the equipment. The user manual
must be available for consultation near the machine and stored correctly.
This user manual reflects the state of the art at the time of marketing and cannot
be considered inadequate only because it is subsequently updated on the basis of
new experience. The manufacturer reserves the right to update its products and
the related manuals without the obligation to update previous products and
manuals.

The company is relieved of any liability in the main cases of

- improper use of the machine;

- use contrary to the specific national regulations;

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:

- incorrect installation;

- power supply faults;

- serious failure to comply with scheduled maintenance;

- unauthorised modifications or operations;

- use of spare parts or materials not specific to the model;

- total or partial failure to follow the instructions;

- exceptional events.

If any further information is needed, contact the manufacturer directly.

Manufacturer

I.A.C.E.R.S.r.l.

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel.: [phone] • Fax: [phone]

IACER S.r.l. is an Italian manufacturer of medical devices (CE certificate no.
0068/QCO-DM/168-2020 issued by the Notified Body no. 0068 MTIC InterCert
S.r.l.).

Declaration of conformity

I.A.C.E.R.S.r.l

Via S.Pertini 24/A – 30030 Martellago (Ve), Italy

hereby declares under its own responsibility that the products

CR200

UMDNS code: 11244

Batch:

Serial No.:
are designed and built-in compliance with Directive 93/42/EEC concerning
medical devices (implemented in Italy with Legislative Decree46/97), as
amended by Directive 2007/47/EC (Legislative Decree37/2010) and
subsequent amendments/additions.
The devices are classified class IIb, according to Annex IX, rule 9 of Directive
93/42/EEC (and subsequent amendments/additions) and are marked

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MASSIMO MARCON

Martellago, 15/05/2020

Mains power supply

110-240 V, 50-60 Hz, ±10%

Maximum power consumption:

260 W

The conformity of the products in question with the Directive 93/42/EEC
has been verified and certified by the Notified Body:

0068 - MTIC InterCert S.r.l.

Via Giacomo Leopardi 14, 20123 Milan, Italy

Certif. No.:

0068/QCO-DM/168-2020

according to the certification process provided for in Directive 93/42/EEC,
Annex II (excluding point 4).

_________________ _______________________

Place, date Legal Representative

Classification

CR200 devices assume the following classifications:

• class IIb device (Directive 93/42/EEC, Annex IX and subsequent

amendments);

• class I, with applied parts BF (EN 60601-1);

• active therapeutic device, non-invasive.

Intended purpose and scope of use

CR200 is an electromedical device that delivers Tecar therapy treatments, with the
aid of handpieces/applicators that allow the administering of the treatment.
The use of this device is reserved to operators who, by virtue of their professional
training, ensure adequate use and total safety for the patient.
In actual fact, the operator must be suitably qualified to be able to use these
machines, and must have passed an appropriate training course, or must operate
under the aegis of a doctor who is adequately qualified to use the machine under
safe conditions for the person subjected to treatment.
This machine can be used in a hospital environment, provided it is used by
personnel qualified in this regard and in compliance with what is stated in the user
manual.

Technical specifications

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Maximum power supplied by the machine:

160 W

230 Vac

3.5 A-T - 5 x 20 mm

115 Vac

3.5 A-T - 5 x 20 mm

Backlit LCD touch-screen display for viewing,
checking operating parameters and setting
them for treatment purposes.

Programmable treatment time

Up to 60 minutes

Electrode holder handpiece

Emission frequency of the handpiece
Modulation

1÷100 Hz (in "Custom" mode)

Resistive, made of AISI 316L

Capacitive, made of

paint

35 mm diameter

60 mm diameter

Adjustable power

0-100%

Double time-delay safety fuse
on the mains (T):

Handpieces supplied

7 inch, 1024*600 resolution

of resistive type

Electrode holder handpiece
of capacitive type

Type of electrodes used

Electrode diameter

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500 kHz

steel

aluminium and coated in rilsan

35 mm
diameter

60 mm
Classification according to directive 93/42/EEC

II B

Insulation class/parts applied according to EN

Ingress protection rating according to EN
60601-1

2 Independent

Stored protocols

34

External dimensions (Width x Height x Depth):

27 x 12 x 30.5 cm

Machine body weight:

3 kg

ambient

(+10 ÷ +40) °C

relative

(10 ÷ 80) % non-condensing

ambient

(-25 ÷ +70) °C

relative

(0 ÷ 93) % non-condensing

Electrode working area

9.61 cm2

60601-1

Output channels

diameter

28.26 cm2

I / BF

IP20

(1 output channel
for capacitive use,
1 output channel
for resistive use)
1 channel for bipolar handpiece
(to be used as an alternative to
the other 2)
1 channel for return plate

Conditions of use

Storage/transport conditions

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Rear panel

Full-colour touch screen display

Encoder knob

Plate connector

Handpiece connectors

Atmospheric
pressure

The service life of the device is set at 3 years.

Device description and controls

(500 ÷ 1060) hPa

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Cooling fan

ON/OFF switch

Power supply socket

Fuse Holder

Return Plate

Bipolar handpiece

Capacitive handpiece

Resistive handpiece

REAR PANEL

OUTPUT PANEL

ACCESSORIES

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Description

Code

Supplied

Optional

Schuko plug power cable

CVAL REA

1

User manual

MNPG356

1

Capacitive handpiece

MAN-CAP REA

1

Kit 2 electrodes for capacitive
treatments (diameters 35, 60 cm)

ELCAP35 REA
ELCAP60 REA

Resistive handpiece

MAN-RES REA

1

Kit 2 electrodes for resistive
treatments (diameters 35, 60 cm)

ELRES35 REA
ELRES60 REA

CAVO+ELRIT/N

REA

CAVO+ELRIT/N

REA XL

Bottle of conductive cream

CREMA-TEC

1

Bipolar handpiece*

MAN-BIP REA

\

X

Handpieces with resistive and capacitive electrodes (see below)

Return Plate

The device is equipped with a mains power cable, and is compatible with the
following kit of accessories supplied:

Steel return plate 12x17 cm

Steel return plate 17x24 cm

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1

1

1

\ X

Symbol

Meaning

*not included in the medical CE certification.

The assembly of the accessories is simple and intuitive: a colour is associated with
the corresponding connector + handpiece + electrode system (in the case of
resistive and capacitive handpiece). he division of colours is shown on the previous
page under "Output panel":

- White: return plate.

- Black: bipolar output.

- Grey: capacitive output.

- Green: resistive output.

In the event of installation problems or difficulties, contact IACER S.r.l.'s technical
support service.

Labelling

Product certification issued by notified body No. 0068.

Manufacturer data.

Warning, see the documents accompanying the product

Date of manufacture (MM-YYYY).

Consult the user manual.

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Symbol

Meaning

SN

Device serial number

RF output signal (label placed near the handpiece

sensitive device (label located near the

RIT

BIP

CAP

RES

WEEE directive for the disposal of electronic and electrical
waste.

Type BF applied part according to IEC 60601-1.

Fuses used on the machine

connectors)

Electrostatic­handpiece connectors)

Return plate output

Bipolar handpiece output

Capacitive handpiece output

Resistive handpiece output

Pack contents

The pack contains:

• User manual;

• 1 mains power cable;

• 1 resistive handpiece;

• resistive electrodes kit (diameter 35mm, 60mm);

• 1 capacitive handpiece;

• capacitive electrodes kit (diameter 35mm, 60mm);

• 1000ml bottle of conductive cream;

• steel plate.

Check the contents of the pack. If any item is missing, contact your authorised
I.A.C.E.R. S.r.l. dealer immediately.

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Notes

PRELIMINARY NOTES

The installation of the device is quick and easy.

USE

Interactions with the device take place via the touchscreen. During therapy it is
possible to increase or decrease the therapy using the encoder.

MAINTENANCE

For optimal use of the device and to ensure its maximum performance, it is
recommended to carry out maintenance correctly according to the timings and
ways recommended.

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How to use the device

Introduction to the technology

General information

IACER Srl has recently developed a complete series of devices, accessories and
equipment, designed and built according to the highest quality standards,
adopting cutting-edge technologies in full compliance with the directives and
standards in force.
Particular attention has been paid to design, ease of operation, functionality and
safety. The result is a compact unit with which it is possible to interface via a large
display.
The multiple possibilities of therapeutic applications, together with guaranteed
patient and therapist safety (the unit complies with international standards), make
the machine a high-quality device.
These machines have been designed and manufactured so that their use, if it takes
place under the conditions and for the uses intended, does not compromise the
health and safety of patients, users and third parties, taking into account the
benefit provided to the patient.
These machines are not reserved for diagnosis, prevention, monitoring,
compensation for injury or handicap, replacement or modification of the anatomy,
control of conception, support of vital functions but allow you to treat particular
conditions and actually reduce the disease/condition.
No special intervention is required in case of failure of the medical device, only
normal maintenance/repair operations.

Endothermic therapy

The endothermic therapy system is a recently introduced therapeutic method
within physical therapy.It allows you to stimulate biological structures and natural
reparative and anti-inflammatory processes from the inside through the
application of energy, exploiting a form of interaction between electromagnetic
energy and the tissue, which refers to the electrical concept of the capacitor.This
device consists of 2 facing elements (called plates) separated by an insulating
material, connected to an electric generator which creates a potential difference
(p.d.) between the 2 plates.This causes electric charges to attract and repel each
other concentrating near the 2 elements.In this way there is a positive increase in
the charge density in one plate and negative in the other.
The mobile electrode and the fixed return plate must be positioned in such a way
as to create a circuit between them.

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The current generator works in the field of long wave radio frequencies of 0,5 MHZ,
with a variable power up to a maximum of 160W.
In this way there is no external energy emission, but there is only an endogenous
or internal development at a biological tissue level produced by the movement of
ions and electrolytes, induced by the attraction and repulsion forces that are
generated between the 2 plates of the capacitor.

APPLICATION TECHNIQUES

Capacitive/resistive tecar therapy (acronym of Capacitive and Resistive Energy
Transfer) is a therapy that stimulates the body's natural repair processes,
shortening the recovery time.
Diathermy through the electromagnetic energy/tissue interaction produces an
increase in temperature which occurs inside the tissues in a uniform and controlled
way. This electromagnetic interaction gives rise to the appearance of an ionic flow
with a micro-hyperemia which ultimately favours the release of endogenous
"substances" (especially cortisol and endorphins) which are used to reduce pain,
oedema and inflammation.
CR200 therefore stimulates the increase in blood flow directly, thanks to the
increase in temperature and indirectly through the demand for oxygen by the
treated tissues; the increase in blood promotes the increase of normal immune
defences and stimulates tissue regeneration.
CR200 works in two modes:

- if you work in capacitive mode, there will be an increase in charge density

near the area below the mobile electrode and above all at the superficial
soft tissue level.

- if you work in resistive mode, the concentration of charges and therefore

the biological effect occurs in the tissues with the highest resistance that
are interposed between the mobile electrode and the return plate.

HOW IT WORKS

In order for the phenomenon of the increase in charge density to occur, the two
capacitor plates must be connected to an electric generator which has the task of
supplying the plates with charges.
A real current is thus established, which in the accumulation phase goes from the
generator to the capacitor. As the capacitor accumulates charges, the flow
decreases until it is zero when the capacitor is fully charged.
After this initial phase, if the polarity of the generator is inverted, there will be a
current in the opposite direction which will charge the capacitor with polarity

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opposite to the previous one. If the generator cyclically reverses polarity there will
be a flow in both directions i.e. an alternating current.
The transfer by capacitive contact is carried out through a capacitive electrode
treated with an insulating coating which mobilises the ionic charges in the
subcutaneous tissues.
Rresistive transfer takes place by means of a non-insulated resistive electrode
which mobilises the charges making them concentrate in the areas of greater
depth and resistance.
The capacitive mode therefore acts specifically on soft tissues (superficial muscles,
vascular and lymphatic circulatory system, adipose tissue), whereas the resistive
mode acts on the tissues with greater resistance (bone, cartilage, tendons, deep
muscles).
The mobile electrode (capacitive or resistive) and the plate are positioned so that
the circuit created includes the area to be treated.
For a better transfer of energy to the tissues on the part to be treated, a cream is
used that prevents the interposition of air between the electrode and the body
surface and which favours a homogeneous interaction of the body with the applied
parts of the device.
CR200 is a device manufactured according to the MED 93/42/EEC directive (and
subsequent amendments) relating to medical devices.

Contraindications

Tecar therapy treatments cannot be administered in cases of people with:

− bleeding;

− tumors;

− phlebitis, thrombi and arteriopathies;

− decreased sensitivity in the area to be treated;

− metal prostheses;

− pacemaker;

− hearing aids;

− insulin pumps;

− intrauterine devices;

− fever or infections;

− ongoing pregnancies;

− epilepsy;

− or on children under 14 years.

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Warnings

- The customer is responsible for damage resulting from inadequate

packaging.
case of return to the company.

- Do not use the device in places where it could get wet.

- Carefully check that the connections are in accordance with the instructions

provided before operating the machine.
To avoid any risk of electric shock, the device must only be connected to

-

mains with protective grounding systems.

- Do not use accessories other than the original ones supplied: these could

damage the machine and invalidate the warranty. In the event of installation
problems or difficulties, contact IACER S.r.l.'s technical support service.

- If you use an extension lead that the machine shares with other devices,

check that the total current consumption of the connected devices does not
exceed the maximum current allowed for that type of cable and that it is not
in any case greater than 15A.

- It is not possible to define a suggested number of sessions to evaluate the

effectiveness of the treatment, since they are linked to the power delivered
to the patient undergoing treatment, as well as to the minutes of therapy.The
doctor/healthcare professional must decide the number of therapeutic
sessions to which the patient is subjected according to the specific needs, in
order to guarantee the patient receives effective treatment over time that is
carried out under completely safe conditions.
Check the condition of the power supply cable and the connection cable to

-

the handpiece/applicator often: these must not be damaged or worn.

- It is a class A device in terms of emissions.The device can be used in a hospital

environment provided that it is duly taken into account that the device could
cause disturbance to electronic devices placed in the immediate vicinity.

- No modification of this device is permitted.

- The use of accessories, transducers and cables, other than those specified or

supplied by the manufacturer, could lead to higher electromagnetic
emissions or a decrease in the electromagnetic immunity level of the device,
with consequent incorrect operation.

- The device is not intended for outdoor use.

- The device is not intended for use in the domestic settings.

Keep the original packaging of the machine: it must be reused in

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USE

- It is possible to provide a digital copy of the device's user manual upon

request.

- The device should not be used in close proximity to other equipment and, if

it is necessary to use it near other equipment, the electro-medical device
must be monitored to check the normal operation in the configuration in
which it is used.

- If the electro-medical device, interacting with another device, causes or

receives detected interferences, the user is encouraged to limit such
interference by adopting one or more of the following measures:

• reorient or relocate the receiving device;

• increase the distance between the devices;

• connect the device to a socket of a circuit different from the device(s)

that cause the interference;

• contact the manufacturer or your local technician for assistance.

- Portable and mobile radio communication equipment may affect the

operation of the device.

Use of device

- The perfect functionality of the device is guaranteed if you comply with the

installation and use standards indicated, and only use original accessories and
spare parts.

- In the event of installation problems or difficulties, contact IACER S.r.l.'s

technical support service.

- The correct transport position of the machine requires that the device is

handled only by holding the sides of the machine body with both hands.

: avoid handling the device by the handpiece/electrode holder tabs.

N.B.

- Before connecting the cable to the mains plug, check that the device has not

been damaged during transport and make sure that the characteristics of the
electricity supply on the available power socket meet the nameplate data
shown on the back of the machine.

- The device must only be connected to compliant systems.

- If extension leads are used, check the presence and integrity of the protective

earth conductor.

- Connect the equipment directly to the wall socket, possibly without using

extension leads. Failure to comply with this warning could result in hazardous
electric shocks to people and alter the operation of the machine.

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- The manufacturer is only responsible for the fundamental safety, reliability

and performance of the device if:

• the electrical system of the premises complies with the appropriate

regulations;

• the device is used in accordance with the instructions for use.

GENERAL INFORMATION

- In order to guarantee the operation of the machine in conditions of absolute

safety for the patient, it is advisable to subject the machine to a cycle of routine
checks (at least 2 years) to be carried out by the manufacturer.

- It is recommended to leave the machine on standby for 5 minutes after each

cycle of therapy.

- It is absolutely forbidden to use the device in the presence of flammable

anaesthetic mixtures and oxygen-rich environments. In case of non­compliance with the indication provided, IACER Srl shall not be held
responsible for any accidents.

- It is absolutely forbidden to cover the rear vent: doing so may not allow the

machine to work safely. In case of non-compliance with the indication
provided, IACER Srl shall not be held responsible for any accidents.

- It is important to draw the operator's attention to the need to check the

correctness of the electrical installation of the equipment before operating the
mains switch.

- Before beginning treatment, the operator must make sure that the patient

removes any metal objects worn, so as to avoid triggering hazardous radio
frequency coupling phenomena.

- Tecar therapy treatments must be administered, under the strict control of the

operator, to "conscious" patients, capable of interacting with the operator with
regard to the electrical forces transmitted by the machine.

- It is advisable to suspend the therapeutic treatment if issues should appear

during its administering.

UNPACKING

The device is packed and prepared for shipping with its box, complete with filling
material, designed for safe storage and transport.
To unpack the machine, place the box on a flat, solid surface and remove the upper
polystyrene part.
Carefully remove the appliance.

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INSTALLATION

The installation of the CR200 device is quick and easy.
The recommended environmental characteristics for installation are the following:

- ambient temperature: +10° to +40°C;

- Relative humidity 10 to 80% non-condensing;

- avoid direct exposure to sunlight, chemicals and vibrations.

CONNECTIONS

On the rear of the machine there is the built-in mains power supply module, which
includes the three-pole connector for the power cable, the removable fuse holder
with two fuses (see technical specifications) and the double-pole main switch.
Insert the three-pole female plug of the power cable into the built-in module,
checking that it is perfectly inserted inside the connector.
If extension leads are used, check the presence and integrity of the protective
earth conductor.
Failure to comply with this warning could result in hazardous electric shocks to
people and alter the operation of the machine.
To connect the applied parts, proceed as described: connect the steel plate to the
corresponding connector. Identify the desired mobile handpiece (resistive or
capacitive) for therapy and the associated electrode.The connector + handpiece +
electrode system can be identified by a dedicated colour.The description of the
corresponding colours and outputs is given in the "Output panel" section, in the
chapter relating to the description of the device.
If you need to use the bipolar handpiece, this is the only one that requires you to
disconnect the steel plate. Please note that this handpiece is only intended to be
used in "Custom" mode. This applicator does not fall under the medical CE
certification of the device, as it is suitable only for aesthetic purposes.
After carrying out the checks for correct installation and assembly, turn on the
main power switch, checking that the display comes on correctly.
N.B

: only connect the applied parts necessary for the treatment when using the

device.

OPERATION

The user-device interface is achieved by a large, clear touchscreen display: it
displays all the operational messages relevant for the operator, the operating

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status of the machine during normal therapeutic activity, any error, visual and
acoustic.
The following sections describe how the device menu is divided.

Therapy selection

Within the "Therapy Selection" menu, you can choose from 2 types of pre-set
programmes (Rehabilitation, Sport) or decide to manually set the therapy
specifications (Custom).

Figure 7

PRE-SET PROGRAMMES

When you choose one of the first 2 submenus shown in Figure 1, a screen will open
displaying the list of available programmes. The programme list screen is shown
below (Figure 2):

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Figure 8

Using the touchscreen, you can scroll through the available pre-set programmes.
For further information on the therapeutic protocols present, please refer to the
following chapter "List of programmes".
Once the desired programme has been selected, you can decide to start the
therapy or to return to the list of available programmes, as shown in the following
figure.

Figure 9

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Once the programme has started, it is possible to pause the treatment at any
time.In the case of programmes that involve the use of both electrodes (resistive
and capacitive), the specific duration of the individual treatment phases are given,
in the predetermined order.

CUSTOM

When you press the button for the "Custom" programme, the following screen
appears.

Figure 10

Before starting the therapy, it is possible to choose the type of treatment
(capacitive/resistive/bipolar), as well as the duration, the carrier frequency and
the modulation.

WARNING

The selected therapy parameters can be stored by pressing the "Save" button. The
menu relating to free memory slots will then open, as shown below in Figure 5.

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: when setting the duration of the therapy, avoid 0:00.

Figure 11

Once the desired memory slot has been selected, the device will ask you to enter
a name in order to save the Custom programme.

Figure 12

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Time (min) and mode

1

Phantom limb

500

15 C + 15 R

2

Knee arthrosis

500

15 R + 10 C

3

Arthrosynovitis

500

10 R + 10 C

4

Bursitis

500

10 R + 20 C

5

Neck pain

500

15 R + 10 C

6

Whiplash syndrome

500

10 R + 20 C

7

Chondropathy

500

10 R + 10 C

8

Muscle contracture

500

5 R + 15 C

9

Contusion

500

20 R + 10 C

10

Muscular sprain

500

20 R + 10 C

11

Sprain

500

12 R + 12 C

12

Muscle distraction

500

10 R + 20 C

13

Joint pain

500

10 R + 10 C

14

Oedema

500

20 R + 10 C

15

Epicondylitis

500

10 R + 10 C

Each programme saved in free memory slots can be called up via the "Load" button
in the "Custom programme" menu (see Figure 4).

After starting the programme, you can adjust the power (initially set to 0) using
the encoder knob. To increase the power output, turn the knob clockwise.To
decrease the power, turn the knob in the opposite direction.
At the end of the therapy, press the "BACK" button until you reach the main menu,
then turn off the device using the switch on the rear panel. Finally unplug the
power plug from the socket.

The proposed preset programmes are the result of operational experience gained
over many years supporting expert professional users. The following section ("List
of programmes") contains the list of available protocols, by category.

List of programmes

REHABILITATION

No. Programme CarrierFrequency

(kHz)

(Capacitive/Resistive)

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Time (min) and mode

16

Epitrochleitis

500

10 R + 10 C

Anterior cruciate ligament
(ACL)

18

Lymphoedema

500

15 C

19

Low back pain

450

10 C + 10 R

synovitis)

21

Muscle tear

500

10 R + 20 C

22

Acute tendinitis

500

10 R + 10 C

23

Chronic tendinitis

500

10 R + 10 C

24

Rotator cuff tendinopathy

500

25 C + 15 R

(kHz)

1

Muscle contracture

500

5 R + 15 C

2

Contusion

500

20 R + 10 C

3

Muscle recovery

500

10 C + 10 R + 5 C

4

Sprain

500

12 R + 12 C

5

Hematoma

500

20 R + 10 C

6

Tendon injury

500

10 R + 10 C

7

Superficial massage*

500

10 R + 10 C

8

Deep massage*

500

10 R + 10 C

10

Muscle tear

500

10 R + 20 C

No. Programme CarrierFrequency

17

20 Meniscopathy (meniscal

(kHz)

500 15 C + 15 R

500 10 R + 10 C

SPORT

No. Programme CarrierFreq.

(Capacitive/Resistive)

Time (min) and mode
(Capacitive/Resistive)

9 Muscle sprain 500 20 R + 10 C

*Treatment not covered by medical CE

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Device care

Maintenance

CR200 Tecar therapy devices do not require particular maintenance operations,
except for routine maintenance and cleaning of the applicator handpieces, with
the aim of ensuring the best operating conditions, to guarantee the effectiveness
of the treatment and patient safety.
External cleaning of the equipment must only be done with a soft cloth moistened
with hot water, or using non-flammable cleaning liquids. The front control panel
can also be cleaned in the same way.
The handpieces/applicators, in particular the treatment head, must be periodically
cleaned with
Carefully put away the handpieces/applicators at the end of each treatment.
Contact IACER Srl authorised centres for information on original accessories and
spare parts.
Do not spray, nor pour liquids on the external container of the devices, nor on the
ventilation slots.
Do not immerse the machine in water.
After cleaning the outside of the box, make sure all parts are dry before putting
the device back into operation.
Under no circumstances must the device be disassembled for cleaning or checking
purposes: there is no need to clean the machines internally, and in any case this
operation must be done exclusively by IACER Srl specialised and authorised
technical personnel.
More specifically:

- handle the handpiece-applicator with care: rough handling can negatively

-

- Under no circumstances must the device be disassembled for cleaning or

- Do not use thinners, detergents, acid solutions, aggressive solutions or

water and denatured alcohol.

influence its performance and characteristics.
Under no circumstances are unauthorised technical personnel allowed to
open and/or disassemble the handpiece/applicator: such tampering, in
addition to damaging the characteristics of the handpiece, immediately
invalidates the warranty.

checking purposes: there is no need to clean the machine internally, and
in any case this operation must be done exclusively by IACER Srl
specialised and authorised technical personnel.

flammable liquids to clean the machine exterior and accessories. The use
of these substances, coupled with improper use of the accessories,

IACER Srl 71 MNPG356-01

besides irreparably damaging the appliance, also invalidates the
warranty.

- For optimal use of the device and to ensure its maximum performance, it

is recommended to carry out maintenance correctly according to the
timings and ways recommended.

- To correctly replace the fuses on the machine, follow the instructions

below:

6. use a screwdriver to open the fuse box, taking care to insert the

screwdriver into the slot created on the fuse box and levering it
outwards

7. remove the fuse-holder structure by sliding it along the guide

8. remove the inserted fuses and replace them with new ones

9. insert the fuse-holder structure in the fuse box, sliding it towards

the guide

10. close the plastic door of the fuse box

− It is recommended to carry out routine maintenance every year,

checking:

• the intensity of any leakage currents;

• the continuity, and therefore the integrity, of the earth conductor;

• the correctness of the insulation resistance value

in order to guarantee the electrical safety of the device and to make sure that
it operates under the guaranteed safe conditions. For such operations, we
recommend contacting a qualified technical service centre or alternatively
IACER Srl or one of its authorised centres.

WARNING!

For safety reasons, before carrying out any maintenance and cleaning

-

operations on the device, it is NECESSARY to turn off the device using the
switch on the rear panel and disconnect the power cable from the power
socket.

- It is recommended to carefully clean the machine and accessories supplied

before using it in contact with the patient.

- It is useful to draw the operator's attention to the need for routine

maintenance of the handpieces/applicators, to be carried out by the
manufacturer.

- Cleaning and disinfection must always be done before carrying out the

therapeutic treatment on the patient.

IACER Srl 72 MNPG356-01

PROBLEM

POSSIBLE CAUSE

SOLUTION

Mains plug not inserted correctly

Check the operation of the

Mains cable not correctly

device.

Insert the plug and cable

connector of the appliance.

Mains cable worn and broken.

Replace the mains cable.

The switch is off.

Operate the mains switch.

The LCD display

Replace the missing,

- Do not spray or pour liquids on the external container of the device, on the

ventilation slots, on the LCD display or on the fan grille.IACER Srl will not be
held responsible for any damage occurring if the machine has been used
without carrying the maintenance operations described above.

- Check the condition of the power supply cable and the connection cables of

the applicators/accessories applied to the patient often: these must not be
damaged or worn.
It is advisable to have the fuses replaced by personnel with adequate

-

technical expertise and training, in order to carry out the operation safely.

- Do not open the device: there are high electric voltages inside which can be

dangerous.

- Only technical personnel authorised by the manufacturer can access the

internal parts of the device. For repairs and further information it is necessary
to contact IACER Srl or its authorised service centres.

Troubleshooting

CR200 Tecar therapy machines have been designed and built adopting advanced
technological solutions, quality components, for continuous use that is always
efficient and reliable.
If, however, there is a problem with operation, it is recommended to consult the
following guide before contacting an authorised service centre.

The LCD display

on the front

panel does not

turn on: the

device does not

work.

on the front

IACER Srl 73 MNPG356-01

inserted in the connector of the

Defective or blown fuse or fuses.

in the power socket.

power socket.

correctly into the

defective or blown fuse (s).

PROBLEM

POSSIBLE CAUSE

SOLUTION

panel does not

The LCD display

Some controls

Defective buttons or keys.

Carefully check the output

Handpiece-applicator cable

Replace the defective
handpiece-applicator which
shows clear signs of wear in

the treatment head and on

the cable.

Fault in the electronic circuit of

Contact an IACER Srl

The device works

Not perfectly efficient connection

Perform the maintenance

cable and the connector of

turn on: the

device does not

work.

on the front

panel does not

turn on.

on the front

control panel do

not work
properly.

The device does

not activate

during delivery.

Electronic control circuit failure.

Defective components on the

electronic control board.

Electronic control circuit failure.

Bad connections in the output

circuit applied to the patient

broken or incorrectly connected

Output cables are worn and/or

have loose contact.

Contact an IACER Srl

service centre.

Contact an IACER Srl

service centre.

Contact an IACER Srl

service centre.

connections are correct

and not damaged.

as normal, but

there is a

noticeable drop

in the

effectiveness of

the treatment.

IACER Srl 74 MNPG356-01

the power generator.

of the handpiece-applicator

output circuit.

service centre.

operations described.

Install and position the

device as described.

Check the condition of the

the handpiece-applicator.

PROBLEM

POSSIBLE CAUSE

SOLUTION

Mechanical damage (due to falls

Check the perfect

Electronic circuit of the generator

Possible failure of the appliance's

or hard knocks) on the

handpiece-applicator, in

particular on the radiating head.

not perfectly calibrated.

power generator circuit.

When the conditions listed below occur, disconnect the device from the electrical
system and contact IACER Srl's technical support service:

• the cable or the built-in rear power supply module is worn or damaged;

• liquid has entered the device;

• the device has been exposed to rain.

-

Only technical personnel authorised by the manufacturer can access the

internal parts of the device.

- For repairs and further information it is necessary to contact I.A.C.E.R.Srl or

its authorised service centres.

WARNING!

− DO NOT OPEN the unit, there are HIGH ELECTRIC VOLTAGES inside which

can be DANGEROUS.

adherence of the parts

applied on the surface

involved in the treatment.

Contact an IACER Srl

service centre.

Disposal Information

CR200 Tecar therapy devices, in line with operating and safety requirements, have
been designed and built to have a minimal negative impact on the environment.
The criteria followed are those of minimising the amount of waste, toxic materials,
noise, unwanted radiation and energy consumption.
Careful research into optimising machine performance guarantees a significant
reduction in consumption, in accordance with the subject of energy saving.

This symbol indicates that this product should not be
disposed with other household waste.

IACER Srl 75 MNPG356-01

Correct disposal of obsolete equipment, accessories and especially batteries, helps
to prevent possible negative consequences on human health and the
environment.
The user must dispose of the equipment to be scrapped by taking it to the
collection centre indicated for the subsequent recycling of electrical and electronic
equipment.
For more detailed information on the disposal of obsolete equipment, contact
your local council, waste disposal service or shop where you purchased the
product.

Warranty

I.A.C.E.R.Srl guarantees the quality of its devices, when used in accordance with
the instructions provided in this manual, for a period of 12 months from the date
of purchase.
During the warranty period, defective products will be repaired or replaced at the
company's discretion.
Replacement of the device itself is not part of the warranty.
The warranty does not cover malfunctions or damage resulting from

- inadequate placement and installation;

- incorrect use or that not in compliance with the instructions given in this

manual;

- improper or inadequate maintenance by the user;

- operation that does not comply with the environmental specifications

indicated for the product;

- unauthorised opening of external enclosures;

- tampering and/or unauthorised modifications;

- use of non-original accessories.

The warranty is provided ex I.A.C.E.R. srl's registeredoffice.
If a return is necessary, follow the packing instructions below and attach a copy of
the purchase receipt.
It is advisable to insure the shipment.
Before shipping the machine due to a suspected fault, it is recommended to
carefully consult the MAINTENANCE and TROUBLESHOOTING chapters: issues are
largely attributable to poor maintenance or minor technical problems that the user
can easily resolve.
A simple phone call to I.A.C.E.R Srl's Technical Service can be of great help in
solving any problem.
Instructions for packing and returning the device:

:

IACER Srl 76 MNPG356-01

6. disconnect the power and connection cables with handpieces, applicator

devices, etc .;
thoroughly clean and disinfect all accessories and parts of the machine

7.

that have been in contact with the patient.
For obvious hygiene reasons, in order to guarantee adequate health
protection of technical personnel (workplace safety law, Legislative
Decree81/2008),
receiving them will not be checked;

8. disassemble the accessories and any mechanical supports;

9. reuse the original box and materials for packaging;

10. attach to the shipment the Support Request Form including the reasons

for the request for inspection/service, the type of failure or malfunction:
such information will help technicians and significantly reduce repair
times.

appliances deemed hygienically unsafe by the staff

Support

The manufacturer is the only point of contact for technical support regarding the
device.For all technical support matters, please contact:

I.A.C.E.R.S.r.l.

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel.: [phone] • Fax: [phone]

Technical documentation concerning repairable parts may be provided, but only
with prior company authorisation and only after giving proper training to the
maintenance personnel.

Spare parts

Original spare parts for this device can be ordered at any time from the
manufacturer. To order them contact:

I.A.C.E.R.S.r.l.

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel.: [phone] • Fax: [phone]

In order to preserve the warranty, guarantee operation and safety of the product,
it is recommended to only use original spare parts supplied by the manufacturer
(also see the Warnings paragraph).

IACER Srl 77 MNPG356-01

Sound energy emitted

The sound energy emitted by the CR200 device during normal use (except for the
audible alarm signals) does not exceed the following levels:

-

80dBA for 24 h cumulative exposure over 24 h; to this value is added a deviation
of 3dBA when the total duration of exposure is halved over 24 h (for example
83dBA for 12 h over 24 h);

-

a sound pressure level of 140dBC (peak) for pulse energy or noise impact.

Interference and electromagnetic compatibility tables

The CR200 Tecar therapy device has been designed and built in compliance with
EN 60601-1-2:2015 and the current ELECTROMAGNETIC COMPATIBILITY
DIRECTIVE 2014/30/EC, with the aim of providing reasonable protection from
harmful interference in residential, civil and hospital settings.
All the necessary measurements and checks were carried out at I.A.C.E.R. srl's in­house testing, measurement and inspection laband specialised external centres.
Upon request, customers may view the reports on EMC measurements at the
company.
Based on their operating principle, the CR200 tecar therapy devices do not
generate significant radio frequency energy and have an adequate level of
immunity to radiating electromagnetic fields. Under these conditions, harmful
interference cannot occur to radioelectric communications and to the operation
of electro-medical devices used for monitoring, diagnosis, therapy and surgery, to
the operation of electronic office devices such as computers, printers, copiers,
faxes, etc. and to any electrical or electronic appliance used in such environments,
provided that they comply with the ELECTROMAGNETIC COMPATIBILITY directive.
In any case, to prevent any problem with interference, it is recommended to
operate any therapy device at an appropriate distant from critical equipment for
monitoring patients' vital functions and to use caution in therapeutic applications
on patients with pacemakers.

CR200.All rights reserved. CR200 and the logo are the exclusive property
of I.A.C.E.R. Srl and are registered trademarks.

IACER Srl 78 MNPG356-01

is recommended that

Campo magnetico a

30 A/m

30 A/m

I campi magnetici a

Nota_e UT è la tensione di rete in c.a. prima dell’applicazione del livello di prova

frequenza di rete
(50/60 Hz)

Power frequency
(50/60 Hz)
magnetic field

IEC 61000-4-8

<5% UT

(>95% buco in_dip

)

in U

T

per_for 5 sec

<5% UT

(>95% buco in_dip

)

in U

T

per_for 5 sec

the CR200 be powered
from an uninterruptible
power supply or a
battery

frequenza di rete
dovrebbero avere livelli
caratteristici di una
località tipica in
ambiente commerciale
o ospedaliero.

Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment

UT is the a.c. mains voltage prior to application of the test level

IACER Srl 202 MNPG428-00

GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA –

La CR200 è prevista per funzionare nell’ambiente elettromagnetico sotto specificato. Il

Prova di immunità

Livello di prova

Livello di

Ambiente elettromagnetico –

Gli apparecchi di

PER GLI APPARECCHI ED I SISTEMI CHE NON SONO DI SOSTENTAMENTO DI FUNZIONI
VITALI

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
– FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING

cliente o l’utilizzatore della CR200 deve garantire che esso venga usato in tale
ambiente.

The CR200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CR200 should assure that it is used in such an environment.

Immunity Test

IEC 60601

IEC 60601 test

level

conformità

Compliance

level

Guida

Electromagnetic environment -

Guidance

comunicazione a RF portatili e
mobili non dovrebbero essere
usati più vicino a nessuna parte
della CR200 compresi i cavi,
della distanza di separazione
raccomandata calcolata con
l’equazione applicabile alla
frequenza del trasmettitore

Portable and mobile RF
communications equipment
should be used no closet to any
part of the CR200, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the
transmitter.

IACER Srl 203 MNPG428-00

Distanza di separazione

3 Veff_Vrms

P

V

d











=

1

5,3

P

V

d











=

1

12

P

E

d











=

1

12

raccomandata

Recommended separation
distance

RF condotta

Conducted RF

IEC 61000-4-6

da 150 kHz a
80 MHz

150 kHz to 80
MHz

6 Veff_Vrms

da 150 kHz a
80 MHz per
banda ISM

150 kHz to 80
MHz for ISM
band

3 Veff_Vrms

([V

] V)

1

6 Veff_Vrms

([V

] V)

1

for ISM band

RF irradiata

Radiated RF

IEC 61000-4-3

IACER Srl 204 MNPG428-00

3 V/m

da 80 MHz a
2,7 GHz

3V/m

[E

] V/m

1

da 80 MHz a

800 MHz

80 MHz to 800
MHz

80MHz to 2,7

P

E

d











=

1

7

RF irradiate per

P

E

d











=

1

6

ove P è la potenza massima

dispositivi di
comunicazione
radio

Radiated RF to RF
wireless
communication
equipment

IEC 61000-4-3

GHz

3 V/m

da 80 MHz a 6
GHz

80 MHz to 6
GHz

3V/m

[E

] V/m

1

da 800 MHz a

2,7 GHz

800 MHz to 2,7
GHz

da 80 MHz a

6 GHz

80 MHz to 6 GHz

IACER Srl 205 MNPG428-00

nominale d’uscita del
trasmettitore in Watt (W)
secondo il costruttore del
trasmettitore e d è la distanza
di separazione raccomandata in
metri (m).

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 metres (m).

Note_s:

Le intensità di campo dei
trasmettitori a RF fissi, come
determinato da un’indagine
elettromagnetica
potrebbe essere minore del
livello di conformità in ciascun
intervallo di frequenza

Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey
should be less than the
compliance level in each
frequency range

Si può verificare interferenza in
prossimità di apparecchi
contrassegnati dal seguente
simbolo:

a

del sito

b

.

b

a

,

Interference may occur in the
vicinity of equipment marked
with the following symbol:

IACER Srl 206 MNPG428-00

(1) A 80 MHz e 800 MHz; si applica l’intervallo di frequenza più alto.

a Le intensità di campo per trasmettitori fissi come le stazioni base per

At 80 MHz and 800 MHz, the higher frequency range applies.

Queste linee guida potrebbero non applicarsi in tutte le situazioni. La propagazione
elettromagnetica è influenzata dall’assorbimento e dalla riflessione di strutture,
oggetti e persone.

These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

radiotelefoni (cellulari e cordless) e radiomobili terrestri, apparecchi di radioamatori,
trasmettitori radio in AM e FM e trasmettitori TV non possono essere previste
teoricamente e con precisione. Per valutare un ambiente elettromagnetico causato da
trasmettitori RF fissi, si dovrebbe considerare un’indagine elettromagnetica del sito. Se
l’intensità di campo misurata nel luogo in cui si usa un CR200, supera il livello di
conformità applicabile di cui sopra, si dovrebbe porre sotto osservazione il
funzionamento normale della CR200. Se si notano prestazioni anormali, possono
essere necessarie misure aggiuntive come un diverso orientamento o posizione della
CR200.

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 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
CR200 is used exceeds the applicable RF compliance level above, the CR200 should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the CR200.

b L’intensità di campo nell’intervallo di frequenza da 150 kHz a 80 MHz
dovrebbe essere minore di [V1] V/m

Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than [V1] V/m.

IACER Srl 207 MNPG428-00

DISTANZE DI SEPARAZIONE RACCOMANDATE TRA APPARECCHI DI

La CR200 è prevista per funzionare in un ambiente elettromagnetico in cui sono sotto

Potenza di uscita

Distanza di separazione alla frequenza del trasmettitore (m)

0,01

0,12

0,2

0,12

0,23 – 0,1

0,38

0,63

0,38

0,73 – 0,2 – – – –

0,9 1 1,20

2,0

1,20

2,30 – 1,8 – – – –

2,7

RADIOCOMUNICAZIONE PORTATILI E MOBILI PER LA CR200 CHE NON SONO DI
SOSTENTAMENTO DELLE FUNZIONI VITALI

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT THE CR200 THAT ARE NOT LIFE-SUPPORTING

controllo i disturbi irradiati RF. Il cliente o l’operatore della CR200 possono contribuire a
prevenire interferenze elettromagnetiche assicurando una distanza minima fra gli
apparecchi di comunicazione mobili e portatili a RF (trasmettitori) e la CR200 come sotto
raccomandato, in relazione alla potenza di uscita massima degli apparecchi di
radiocomunicazione.

The CR200 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CR200 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the CR200 as recommended
below, according to the maximum output power of the communications equipment.

massima del
trasmettitore
specificata

Rated maximum
output power of
transmitter

W

IACER Srl 208 MNPG428-00

Separation distance according to frequency of transmitter (m)

150 kHz
to

80 MHz

150 kHz
to

80 MHz
(ISM
band)

Da 80
MHz to
800
MHz

800
MHz to
2,7 GHz

Da 80 MHz to 6 GHz

(to RF wireless radio
communication
equipment)

2 – – – –

2,8

10

3,80

6,3

3,80

7,30 – 100

12,00

20

12,00

23,00

–

Per i trasmettitori specificati per una potenza massima di uscita non riportata sopra, la

Nota_e

distanza di separazione raccomandata d in metri (m) può essere calcolata usando
l’equazione applicabile alla frequenza del trasmettitore, ove P è la potenza massima
d’uscita del trasmettitore in Watt (W) secondo il costruttore del trasmettitore

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be determined using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

(1) A 80 MHz e 800 MHz, si applica l’intevallo della frequenza più alto.

At 80 MHz and 800 MHz, the separation distance for the higher frequency

range applies.

(2) Queste linee guida potrebbero non applicarsi in tutte le situazioni. La
propagazione elettromagnetica è influenzata dall’assorbimento e dalla riflessione di
strutture, oggetti e persone.

These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

IACER Srl 209 MNPG428-00