easytech T CaRe Compact User manual

Easytech s.r.l. –T CaRe Compact User’s Manual rev. D Pag. 1 di 36
T CaRe Compact
Mod. 80000650
User’s Manual
EASYTECH s.r.l.
Via della Fangosa, 32 – 50032 Borgo San Lorenzo (FI) – Italy
tel. [phone] – fax [phone]
e-mail: [email protected]
Direct line of Easytech technical support :
[phone]
1936

Easytech s.r.l. –T CaRe Compact User’s Manual rev. D Pag. 2 di 36
No part of this publication may be reproduced, in any form or by any means, without
the express written authorization from Easytech s.r. l., via della Fangosa, 32, Borgo
San Lorenzo (Florence), tel. [phone], fax [phone].
Easytech s.r.l . reserves the right to revise this publication and make changes to it
without prior notice.
Version 02/03/2020
Title: T CaRe COMPACT User’s Manual
Internal Revision MusTCareCOMPACT _GB_BN_ D (Based on MusTCareCOMPACT_IT_BN_C)

Easytech s.r.l. –T CaRe Compact User’s Manual rev. D Pag. 3 di 36
INDEX
1. INTRODUCTION ....................................................................................................................... 4
1.1 T CaRe Compact intended use ........................................................................................ 4
1.2 Applied standards ............................................................................................................ 4
2. PRESCRIPTIONS FOR SAFETY ............................................................................................. 6
2.1 Easytech responsibilities ............................................................................................... 6
2.2 Warnings concerning installation, maintenance and regular inspections ......... 6
2.3 Precautions for use ......................................................................................................... 7
2.4 Warnings regarding electromagnetic interference .................................................. 8
2.5 EMC tables......................................................................................................................... 8
2.6 Special prescriptions for the operator ..................................................................... 13
2.7 Special prescriptions for the patient ........................................................................ 13
2.7.1 Contraindications ....................................................................................................... 13
2.7.2 Particular caution ................................................................................................... 14
2.8 Safety devices ................................................................................................................ 14
3. DESCRIPTION OF THE DEVICE ........................................................................................... 15
3.1 Control Unit ..................................................................................................................... 15
3.2 Electrodes ........................................................................................................................ 16
3.3 Sales Configuration ....................................................................................................... 19
3.4 T CaRe Compact Technical Characteristics ............................................................ 20
4. USING T CARE COMPACT ................................................................................................... 21
4.1 Knob for power adjust .................................................................................................. 21
4.2 Operations with user interface ................................................................................... 21
4.3 Treatment ........................................................................................................................ 22
4.4 Manual Settings .............................................................................................................. 22
4.5 Set-up commands ........................................................................................................ 25
5. GUIDELINES FOR TREATMENT WITH T CARE PLUS .................................................. 26
5.1 Preparing the treatment............................................................................................... 26
5.2 Placing the patient ......................................................................................................... 26
5.3 How to place the Electrodes ...................................................................................... 26
5.4 Operating in Resistive Mode ........................................................................................ 27
5.4.1 Using of Manual Treatment Kit (TMA Kit – Optional) ........................................ 27
5.5 Operating in Capacitive Mode ..................................................................................... 28
5.6 Checks to be performed during the treatment ..................................................... 28
6. MALFUNCTIONS .................................................................................................................... 29
7. MAINTENANCE ....................................................................................................................... 30
7.1 Cleaning the exterior ..................................................................................................... 30
7.2 Periodic inspection and life cycle of the unit ......................................................... 30
7.3 Calibration and settings (by the Easytech Technical Service) .......................... 31
7.4 Fuses replacement ........................................................................................................ 31
8. TRANSPORT ............................................................................................................................ 32
8.1. Environmental and condition for transportation and storage ........................... 32
8.2. Packaging ......................................................................................................................... 32
9. UNIT DISPOSAL AT THE END OF ITS LIFECYCLE ....................................................... 32
10. LABELS ................................................................................................................................ 33

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 4 di 36
1. INTRODUCTION
1.1 T CaRe Compact intended use
T CaRe Compact is a device for capacitive - resistive diathermy ( endothermy) to be used in
the area of physical rehabilitation; it is an active therapeutic medical device class IIb
(according to the definitions of Directive 93/42/EEC, as amended in accordance with the
Directive 2007/47/EC).
It is a device to be used under medical supervision.
With T CaRe Compact it is possible to treat arthritis, edema (traumatic or inflammatory
origin), bruising, muscle or joint injuries and to perform analgesics and myorelaxant
treatments.
The results achievable with the use of T CaRe Compact are: analgesic effect, increased
vascularization in the treated area with consequent acceleration of the recovery processes,
increased lymphatic drainage, reduction of inflammatory states.
Operation of T-Care Compact is based on the principle of energy transfer obtained through
the use of endogenous energy, which is achieved through the recall in the area to be treated
of electrical charges (ions) present in the tissues.
The adopted model of reference is that of the condenser, in fact, T-Care operates on the
basis of technologies that use a generator at a frequency between 400 and 1000 KHz
connected to a movable electrode and a reference electrode, which make up the two
armatures of the condenser, among which the biological tissue is interposed becoming an
electrical conductor of the second class. The energy supply provided by the generator
produces a concentration of electrical charges in the most resistive points (the less
vascularized ones) of the tissue, hence involving the muscles, bones, tendons and ligaments.
The interaction caused determines bio-stimulation as an increase in energy transformations
(ATP production) and oxygen consumption that activate the arterial and lymphatic
microcirculation, as well as an increase of endogenous temperature with consequent
dilation of blood vessels and increase in flow blood.
1.2 Applied standards
The device T CaRe Compact is made in accordance with Directive 93/42/EEC and
subsequent amendments, applying the current version of the standards listed below:
 EN 60601-1:
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
With reference to this Norm, the device is classified as Class I Type BF applied part;
 EN 60601-1-2:
Medical electrical equipment. Part 1: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests.
 EN 60601-1-6:
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance - Collateral standard: Usability
 EN 60601-2-6:
Medical electrical equipment - Part 2: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
 EN 62304:
Medical device software – Software life-cycle processes

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 5 di 36
 EN ISO 14971:
Medical devices - Application of risk management to medical devices
 EN ISO 10993-1 :
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process
 EN ISO 15223-1
Medical Devices - Symbols to be used with medical devices labels, labelling and
information to be supplied – Part 1: General Requirements
 EN 1041
Information supplied by the manufacturer of medical devices
 ISO 13485
Medical devices – Quality management systems – Requirements for regulatory
purposes

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 6 di 36
2. PRESCRIPTIONS FOR SAFETY
The device has been developed in accordance with the laws and regulations in force,
however, the safe use, both for the patient and the operator, is not guaranteed if you do not
observe the prescriptions for installation, for use and periodic inspections. In the following
paragraphs are detailed the warnings and requirements grouped by specific topics.
2.1 Easytech responsibilities
Easytech declines any responsibility concerning the safety and functionality of T CaRe
Compact if:
 installation, modifications, maintenance and inspections are not carried out by
personnel authorized by Easytech ;
 the device has been installed in a room with an electrical system that is not
compliant with the requirements of current standards;
 the device is not used for the intended use or it is not used in accordance with the
instructions provided in this manual.
2.2 Warnings concerning installation, maintenance and regular inspections
 The installation site must be fitted with an electric system that is compliant with the
requirements of current standards.
 ATTENTION: to prevent the risk of electrical shocks, this device must only be connected
to grounded power supply.
 Make sure that the type of supply complies with that indicated on the device label.
 Before installing the device, verify that the packaging and its content are not damaged.
 Only use the power cord supplied with T CaRe Compact or the spare power cords
supplied by Easytech . Although it is possible to purchase similar cables that offer good
performances, their characteristics are not suitable to guarantee the compliance with
standards according to which the device has been manufactured. In particular:
leads with an inadequate section or an excessive length, and ever worse both all
the same have as a consequence that the machine is not in compliance with the
requirements of electrical safety.
Furthermore, as quoted in standard EN 60601-1-2 regarding electromagnetic
compatibility:
"the use of cable other than those specified ....... may increase emissions and
reduce the immunity of the device ".
 Do not use adaptors, multiple sockets or extensions to connect the device to the main
power supply.
 Do not place heavy or sharp objects above the power cord in order not to damage it.
 Do not place T CaRe Compact near to heat sources or expose it to direct sun light. Install
the device in an adequately ventilated room.
 Avoid installation in rooms with rapid temperature excursions or where humidity, dust,
chemical vapours and vibrations are present.
 For information concerning electromagnetic interferences, refer to paragraph 2.5. Avoid
in particular installation of the device close to potential sources of electromagnetic

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 7 di 36
interferences (like portable or mobile radio-communication devices or medical devices
that generate electromagnetic energy for therapeutic and diagnostic purposes) which
would exceed the limits recommended in the standards and thus affect the immunity of
the device.
 For information on how to perform maintenance, calibration and regular inspection
operations, refer to Chapter 7.
 WARNING: all device’s modifications are prohibited
 WARNING: do not modify this device without express consent and authorization of the
manufacturer
 WARNING: when a modification is applied, it’s necessary to perform tests and trials
adequate to demonstrate the security of the device for continue use.
2.3 Precautions for use
The device must be used only by qualified personnel who has achieved at least a High
School Diploma and a Bachelor Degree in Physiotherapy (Short cycle).
It is useful a good level of knowledge in the use of physical means in physiotherapy and
some experience gained from other similar products related to musculoskeletal disorders
and in general relevant rehabilitative treatments, in order to understand the potential of the
device in question.
An adequate knowledge of the local language is required.
Only slight visual or sensory impairments are admitted. Also a slight motor impairment is
permitted provided that the correct positioning of the device with respect to the patient is
guaranteed.
 Do not replace the electrodes while the device is operating.
 Do not open for any reason the device’s closure housing.
 For cleaning or maintenance operations, always refer to chapter 7.
 Do not spill or spray liquid on the device, handpiece included.
 Do not obstruct the ventilation holes or insert objects into them.
 Check frequently the condition of the apparatus by simple visual examination and in
particular check the power cord and its connectors (verify that the plug contacts are not
blackened, that there are no signs of overheating, mechanical deformation or breakage,
sheath worn ...). This simple and rapid operation, far from being exhaustive, may, however,
in many cases foresee forthcoming failures.
 If the device has fallen to the ground or the external casing is damaged or you reasonably
suspect that the performance of the device has degraded, disconnect it from the power
supply and contact the technical support of Easytech .

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 8 di 36
2.4 Warnings regarding electromagnetic interference
T CaRe Compact produces electromagnetic energy for emitting it for therapeutic purposes.
The device is manufactured in accordance with the laws and the standards in force and, if
used according to guidelines included in this manual, it radiates only very small quantities of
electromagnetic energy like any other electronic device not used for telecommunications.
Normally, therefore, it will not disturb other equipment nor produce radiation potentially
dangerous for people, whether they are the patient, the operator or third parties.
T CaRe Compact is manufactured so as to be immune from noise due to other equipment,
provided that the latter complies with the standards and, in the case intentionally it emits
electromagnetic radiation (for therapeutic use or for telecommunications), it is maintained a
suitable distance to avoid interference.
2.5 EMC tables
What mentioned above in a qualitative way, is better specified and quantified by the
following tables, prescribed by the standard EN 60601-1-2 and comprehensive of all types of
electromagnetic interference that may cause incompatibility between several units in a given
location.
The first table concerns the emissions of T CaRe Compact to other devices; the other three
relate to the ability of T CaRe Compact not to be affected by external disturbances; the last
table shows the separation distance required between RF communication devices and T
CaRe Compact . On the contrary a significant degradation in device performance may occur.
The following Warning should be noted:
"Portable RF communication devices (including peripheral devices such as antenna cables
and external antennas) should not be used within 30 cm (12 inches) from T Care Compact ,
including cables. Otherwise, the device may suffer degraded performance. "
The following tables are based on the test results, according to clause 6 of the EN 60601-1-2
standard.
In relation to the essential performances, the device does not provide immediate support for
the patient, certainly not life support. Therefore, there are no essential "therapeutic"
performances to be maintained in critical situations.
WARNING
T Care Compact is a Class A product. In a residential environment this device may cause
radio interference in which case the user may be required to take adequate
countermeasures.

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 9 di 36
Guidance
and manufacturer's declaration
–
Ele
ctromagnetic Emissions [tab.1/60601
-
1
-
2]
T CaRe Compact is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such an environment.
Emission test
Conformity
E
lectromagnetic Environment
-
guidance
RF Emissions
Cispr 11 Group 2 T Care must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF Emissions
Cispr 11 Class A
T-Care is suitable for use in all establishments, excluded domestic
establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
T CaRe Compact is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
T CaRe Compact is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Tabella 2-1 – EMC, Emissions
Guidance and manufacturer's declaration
–
Electromagnetic Immunity [tab.2/60601
-
1
-
2]
The device is intended for use in the electromagnetic environment spe
cified below. The customer or
the user should assure that it is used in such an environment.
Immunity test
Test level
EN 60601-1-2 Compliance Level Electromagnetic Environment -
guidance
Electrostatic
discharge
(ESD)
EN 61000-4-2
±8kV contact
±2-4-8-15 kV air
4 kV indirect contact
±8kV contact
±2-4-8-15 kV air
4 kV indirect contact
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Burst/Fast
Transient
EN 61000-4-4
±2kV power supply
lines
±2kV power supply
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
EN 61000-4-5
±0,5-1kV differential
mode
±0,5-1-2kV common
mode
±0,5-1kV differential
mode
±0,5-1-2kV common
mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
EN 61000-4-11
Voltage reduction 100%
(10ms)
Voltage reduction 30%
(500 ms)
Voltage reduction 100%
(5000 ms)
Voltage reduction 100%
(10ms)
Voltage reduction 30% (500
ms)
Voltage reduction 100%
(5000 ms)
Mains power quality should be that
of a typical commercial or hospital
environment. If the user requires
continued operation during power
mains interruptions, it is
recommended that the device be
powered from an uninterruptible
power supply or a battery.
Power frequency
magnetic field
EN 61000-4-8
30 A/m 30 A/m Magnetic power frequency field
should be that of a typical
commercial or hospital
environment.
NOTE:U
T
is the a.c. mains voltage prior to
application of the test level
Tabella 2-2 – EMC, Immunity

Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 10 di 36
Guidance and manufacturer's declaration
–
Electromagnetic Immunity [tab.4/60601
-
1
-
2]
The
device is intended for use in
the electromagnetic environment speci
fied below. The customer or
the user should assure that it is used in such an electromagnetic environment.
Immunity test
Test level
EN 60601-1-2
Compliance
Level
Electromagnetic environme
nt
-
guide
RF conducted
EN 61000-4-6
3 Veff from
150kHz to
80MHz
6 Veff from
6,765MHz to
6,795MHz, from
13,553MHz to
13,567MHz, from
26,957MHz to
27,283MHz, from
40,66MHz to
40,70MHz
3 Veff from
150kHz to
80MHz
6 Veff from
6,765MHz to
6,795MHz, from
13,553MHz to
13,567MHz,
from 26,957MHz
to 27,283MHz,
from 40,66MHz
to 40,70MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1,2 .√P from 150kHz to 80MHz
d = 1,2 .√P from 80 MHz to 800 MHz
d = 2,3 .√P from 800 MHz to 2,5 GHz
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)
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey a, should be less than
the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment
marked with the following symbol:
RF radiated
EN 61000-4-3
3 Veff from
150kHz to
80MHz
6 Veff from
6,765MHz to
6,795MHz, from
13,553MHz to
13,567MHz, from
26,957MHz to
27,283MHz, from
40,66MHz to
40,70MHz
3 Veff/m2 from
80MHz to
2700MHz
27 Veff/m2 from
380MHz to
390MHz
28 Veff/m2 from
3 Veff from
150kHz to
80MHz
6 Veff from
6,765MHz to
6,795MHz, from
13,553MHz to
13,567MHz,
from 26,957MHz
to 27,283MHz,
from 40,66MHz
to 40,70MHz
3 Veff/m2 from
80MHz to
2700MHz
27 Veff/m2 from
380MHz to
390MHz
28 Veff/m2 from
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1,2 .√P from 150kHz to 80MHz
d = 1,2 .√P from 80 MHz to 800 MHz
d = 2,3 .√P from 800 MHz to 2,5 GHz
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)
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey a, should be less than
the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment
marked with the following symbol: