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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 specified 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 environment - 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:                                      

 

 

Содержание 80000650

Страница 1: ...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 info easytechitalia com Direct line of Easytech technical support 39 348 2316323 1936 ...

Страница 2: ...itten 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 ...

Страница 3: ...nical 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 ...

Страница 4: ... 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...

Страница 5: ...edical 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 ...

Страница 6: ...ly 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 ...

Страница 7: ...s 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 ...

Страница 8: ... 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 ...

Страница 9: ...ended for use in the electromagnetic environment specified 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 co...

Страница 10: ...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 m...

Страница 11: ...and reflection from structures objects and people a Field strength 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 consider...

Страница 12: ...ut power P of transmitter W From 150kHz to 80MHz d 1 2 P From 80MHz to 800MHz d 1 2 P From 800MHz to 2GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 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...

Страница 13: ...line in the case of devices for applications other than cardiology For patients with hypotension long term applications or applications on the cervical vertebrae or spine may cause low arterial pressure in this case it is necessary to suspend the application until the pressure returns to normal values and then reduce the duration of treatment or lengthen the interval between one session and anothe...

Страница 14: ...must supervise the treatment during various stages in order to guarantee its prompt intervention in case of need the operator must use the equipment in accordance with the instructions contained in this manual avoiding any action which might reduce the level of safety for himself and or for the patient Patients with prostheses or other metal implants in the event that the application must take pla...

Страница 15: ...tions It is equipped with A touch screen This is the operator interface for controlling the device which allows the selection of the operating mode the operating parameters treatment activation B a power adjustment knob C one connector for connecting a reference electrode identified with a band in yellow colour D one connector for connecting a capacitive electrode identified with a band in blue co...

Страница 16: ... surface EasyTech provides electrodes of different shape and size Resistive electrodes a circular electrodes with a flat surface and three different sizes of diameter 35mm 55mm 75mm b cylindrical wedge shaped electrode optional c adhesive pad with clamp connector optional d Kit TMA optional Capacitive electrodes circular electrodes are available with flat surface and three different sizes of diame...

Страница 17: ...36 Figure 3 2 Capactive Electrode Figure 3 3 Resistive Electrode Figure 3 4 Return Plate Passive Electrode Figure 3 5 Elbow pipes The optional electrodes are shown in the figures 3 6 3 7 3 8 Figures 3 6 Functional Resistive Electrode Figures 3 7 Return Plates ...

Страница 18: ...rode and the skin and between skin and return plate it s valid only for the steel return plate because the disposables ones are pre soaked with a conductive gel Easytech invites to use the type of cream that comes with the device tested and EC marked The cream is made with standard ingredients tested in applications identical to the present The label on the package shows the list of ingredients ...

Страница 19: ... supplied n 1 T Care Compact Unit n 1 User Manual n 1 Resistive Handpiece n 3 Resistives Electrodes complete with cover D 75 D 55 D 35 n 1 Capacitive Handpiece n 3 Capacitive Electrodes complete with cover D 75 D 55 D 35 n 1 Return Plate n 1 Conductive Cream 100 ml n 2 Adhesive Reference plate 136 cm2 n 1 Plastic Case with foam padding n 1 Backpack ...

Страница 20: ...ightness 130x72mm Working frequencies 500 kHz 5 Output power RES at 82 ohm 200 W Output power CAP at 1000 ohm 250 VA Maximum output voltage on the resistive electrode open circuit 340 Vpp Maximum output voltage on the capacitive electrode open circuit 500 Vpp Power supply voltage and frequency 100 230 Vca 50 60 Hz Maximum power consumption 350 W Electric protection 2 Fuses of 4 A Dimensions WxDxH ...

Страница 21: ...5 35 LUMBAR HERNIATED DISC 20 MIN CAP 50 RES 50 500 KHz CAP 20 30 RES 10 15 EPICONDYLITIS 20 MIN CAP 50 RES 50 500 KHz CAP 20 25 RES 15 20 GONARTROSIS 20 MIN CAP 50 RES 50 500 KHz CAP 20 30 RES 15 25 ACUTE ACHILLES TENDINOPATHY 15 20 MIN CAP 100 500 KHz 5 10 CHRONIC ACHILLES TENDINOPATHY 15 20 MIN CAP 50 RES 50 500 KHz CAP 25 35 RES 20 35 Energy delivery can be made in two way 1 Continuous 2 Pulse...

Страница 22: ...you select see Figure 4 1 and Figure 4 2 resistive or capacitive mode of operations the energy output mode You can have continuous mode symbol or pulsed mode symbol the working frequency 500 kHz the treatment duration from 10 sec to 60 minutes or the energy set 1 to 999 KJ You set one of the two parameters after selecting the mode of operation time or energy the frequency for the pulsed mode The s...

Страница 23: ... area to be treated 2 give the start command 3 Set the power to be delivered1 in of the maximum The start command can also be given through the button on the knob When the treatment begins see Figure 4 3 the timer starts counting backwards indicating the time residual it is also activated an audible signal beep In the time mode the treatment will stop when the timer reaches 0 In the energy mode tr...

Страница 24: ...annot tolerate the heat generated with the set power level eg for simple hypersensitivity you can put the unit in Pause press in order to stop the timer and change the setting Reached the new value press start and resumes processing from where it was stopped When the treatment is active a LED inside the handpiece lights up at the resistive electrode the led colour is red orange for capacitive one ...

Страница 25: ...t power language setting Italian English French German Spanish Dutch Portuguese other volume setup for sounds produced during treatment The adjustment can be made on 8 levels display contrast adjustment The other parameters shown on the display are used by Easytech service The vertical arrows are used for selecting a row the horizontal ones to change a parameter press OK to confirm the change ESC ...

Страница 26: ...5 3 How to place the Electrodes The position of the reference electrode and the mobile one depend on pathologies to be treated a layer of conductive cream must always be used between the surface of each electrode and the skin in order to reduce the electrical resistance in the contact area and to facilitate movement of the electrodes on the skin it is always recommended to use the cream provided w...

Страница 27: ...he effect of resistive diathermy is to generate heat in deep areas therefore it is impossible to measure the temperature achieved for this reason we must consider the patient s response The mobile electrode should be maintained still or be moved slowly with a massage Important the entire electrode surface should rest flat on the patient s skin to avoid a concentration of current on a small area wh...

Страница 28: ... flat on the patient s skin to avoid a concentration of current on a small area which could have harmful effects Treatment is started with a low power level which is then increased until the patient doesn t feel a warm sensation the value of power must be reduced as soon as the patient perceives excessive heat 5 6Checks to be performed during the treatment During treatment the operator should chec...

Страница 29: ...cant damage before it takes place the normal patient s defensive reaction distancing from the applicator In case of failure the only instance in which the risk may be modest but important for the patient can occur when the patient is desensitized to the thermic sensation but this is just one of the cases where it is foreseen that the operator uses a special care The actions of the user and of the ...

Страница 30: ...ic rule it is recommended an annual inspection by a specialized laboratory which can also make the performance at home The interval of a year is the most commonly used for devices of this class however periodic checks can be performed in accordance with the choices of quality policies by each Center The reference standard for the electrical safety testing is EN 62353 As already suggested in the se...

Страница 31: ...setting consists instead in a series of actions to ensure that the machine measure correctly again when the error is not caused by the presence of a fault but only by a drift or by the replacement of a component In the event that it is instead a failure first will be performed the repairing replacement of a component then the calibration and the setting if necessary Repairs and settings are carrie...

Страница 32: ...0 C Relative Humidity 0 75 Atmospheric Pressure 700 1060 mbar 8 2 Packaging In the case of shipping by courier you should create a package that can guarantee protection from shocks or falls There are no particular instructions except the obvious expedients to prevent damage the device can be regarded as a television 9 UNIT DISPOSAL AT THE END OF ITS LIFECYCLE The device no longer usable must be di...

Страница 33: ...witch Non ionizing radiation It is located on the device plate Type BF Applied Part Classification According CEI EN 60601 1 Code This number is just an example Read User Manual The device that is no longer usable must be disposed of in accordance with current regulation for electrical and electronic equipment WEEE Directive 2012 19 UE Production year Manufacturer ...

Страница 34: ...Easytech s r l User Manual T CaRe Compact rev D Pag 34 di 36 ...

Страница 35: ...Easytech s r l User Manual T CaRe Compact rev D Pag 35 di 36 ...

Страница 36: ...s r l Via della Fangosa 32 50032 Borgo S Lorenzo Firenze Italy Tel 39 055 8455216 Fax 39 055 8454349 E Mail info easytechitalia com www easytechitalia com Direct line of Easytech technical support 39 348 2316323 ...

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