Easytech T CaRe Compact Manuale utente

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. 055 8455216 – fax 055 8454349

e-mail: [email protected]

Direct line of

Easytech technical support

+39 348 2316323

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. +39 0558455216, fax +39 0558454349.

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

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

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

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

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

Magnetic power frequency field

should be that of a typical

commercial or hospital

environment.

NOTE:U

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

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

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:

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