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MNPG127-02 

Pag. 17 

 

Appendix C – ELECTRO-MAGNETIC COMPATIBILITY TABLES 

 

Guidance and manufacturer’s declaration – electromagnetic emissions 

 FOR ALL ME EQUIPMENT 

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

Emissions test 

Compliance 

Electromagnetic environment – guidance 

RF Emissions 
CISPR 11 

Group 2 

The 

ME 

EQUIPMENT 

must 

emit 

electromagnetic  energy  in  order  to  perform 
its  intended  function.  Nearby  electronic 
equipment may be affected.  

RF Emissions 
CISPR 11 

Class A 

The ME EQUIPMENT is suitable for use in all 
establishments, 

other 

than 

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 

Voltage fluctuations/ 
flicker emissions 
IEC 61000-3-3 

Complies 

 

 

 

 

 

 

 

 

 

 

Guidance and manufacturer’s declaration – electromagnetic immunity 

FOR ALL ME EQUIPMENT

 

The ME EQUIPMENT is intended for use in the electromagnetic environment specified below.  

The customer or the user of the ME EQUIPMENT should assure that it is used in such an environment.  

Immunity test 

IEC 60601  

Test level 

Compliance level 

Electromagnetic environment –

guidance 

Electrostatic discharge 
(ESD) 
IEC 61000-4-2 

± 6kV 

contact 

± 6kV 

contact 

Floors should be wood, concrete 
or ceramic tile.  
If floors are covered with 
synthetic material, the relative 
humidity should be at least 30 %. 

± 8kV air 

± 8kV air 

Electrical fast 
transient/burst 
IEC 61000-4-4  

± 2kV for 

power 

supply lines 

± 2kV per 

power 

supply lines 

Mains power quality should be 
that of a typical commercial or 
hospital environment 

± 8kV for 

input / output lines 

NOT APPLICABLE 

Sovra-tensioni  
IEC 61000-4-5 

± 1kV 

line(s) to line(s) 

± 1kV 

line(s) to line(s) 

Mains power quality should be 
that of a typical commercial or 
hospital environment 

± 2kV line(s) to 

earth

 

± 2kV line(s) to 

earth

 

Voltage dips, short 
interruptions and 
voltage variations on 
power supply input 
lines 
IEC 61000-4-11 

<5% U

(>95% buco in U

T

per 0.5 cicli 

<5% U

per 0.5 cicli 

Mains power quality should be 
that of a typical commercial or 
hospital environment. If the user 
of the ME EQUIPMENT requires 
continued operation during power 
mains interruptions, it is 
recommended that the ME  
EQUIPMENT be powered from an 
uninterruptible power supply or a 
battery. 

<5% UT 

(>95% dip in UT) for 

0.5 cycles 

<5% UT 

for 0.5 cycles 

70% UT (30% dip in 
UT) for 25 cycles

 

70%  UT    for  25 
cycles

 

<5%  UT  (>95%  dip 
in  UT) for 5 sec

 

<5% UT for 5 sec

 

Power frequency 
(50/60Hz) magnetic 
field 
IEC 61000-4-8 

3 A / m 

3 A / m 

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

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

 

 

Summary of Contents for LA500

Page 1: ...I A C E R Srl MNPG127 02 06 06 17 LASER THERAPY...

Page 2: ......

Page 3: ...E 8 INDICATIONS 8 CONTRA INDICATIONS 8 DEVICE DESCRIPTION 9 PATIENTS PREPARATION 9 HOW TO USE IT 9 Therapeutic indications 11 MAINTENANCE 13 HANDLES CLEANING 13 WORKING PROBLEM 13 ELECTROMAGNETIC INTE...

Page 4: ...important information and useful tips for operating the equipment CAUTIONS The CAUTION message appears before operations which if not correctly performed may cause damage to the machine and or its acc...

Page 5: ...t use the equipment in places where it might get wet Before operating the machine carefully check the correctness of the connections according to the instructions Do not use accessories other than the...

Page 6: ...ecution of different procedures from those specified in this user manual can cause the exposition to dangerous radiation The operator has the responsibility to verify that the issuing head remains wel...

Page 7: ...er production of ATP The applications of the I TECH LA500 laser produce a number of effects on the treated tissues 1 increase in hematic flow vasodilatation of capillaries and arteries 2 biostimulatio...

Page 8: ...ensitive to laser radiation and can be permanently damaged from direct or reflected laser beams The special safety glasses must be worn by both patient by the operator pregnancy the laser is contraind...

Page 9: ...of the patient for the therapy carry out the following operations 1 wash the skin using soap and mild soap or alcohol where the head of the laser will be positioned 2 dry well the skin HOW TO USE IT...

Page 10: ...ent time last 3 minutes Select the operation mode CONTINUOS or CYCLE using the buttons on the right side of the front panel picture below With CYCLE mode it is possible to select the ON time from 1 to...

Page 11: ...ition upper picture Take away the key from the machine to avoid the use by unauthorized personnel Please do not switch off the device unplugging the cable from the power socket to avoid any type of da...

Page 12: ...ITIS 0 3 66 sec 264 sec BAKER S CYST 0 3 66 sec 264 sec DE QUERVAIN SYNDROME 0 2 100 sec 400 sec OEDEMA 0 3 66 sec 264 sec HEMATOMA 0 3 66 sec 264 sec EPICONDYLITIS 0 4 50 sec 200 sec HERNIATED DISC 0...

Page 13: ...ent HANDLES CLEANING The laser handle is very weak and it needs a daily cleaning The following advices are absolutely important to not damage the lens and the laser probe It is suggested to 1 Remove t...

Page 14: ...that the socket works properly The power cable is not inserted correctly into the connector of the device Insert correctly the plug and the cable in the connector of the device The power cable is wor...

Page 15: ...B Output channels 1 Class of isolation parts applied according to the rule EN 60601 1 I BF Protection level against the liquids penetrations according to the rule EN 60601 1 IPX0 Command of execution...

Page 16: ...that the product shall not be disposed of as domestic waste The user must dispose of scrap equipment by taking it to a recognized centre of recycling of electrical and electronic equipment Appendix B...

Page 17: ...ctrostatic discharge ESD IEC 61000 4 2 6kV contact 6kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30...

Page 18: ...th 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 ME EQ...

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Page 21: ...nd warehouse 30030 MARTELLAGO VE Via S Pertini 24 A Tel 0039 041 5401356 Fax 0039 041 5402684 Cod Fisc P IVA IT 00185480274 R E A VE N 120250 M VE001767 e mail iacer iacer it Internet www itechmedical...

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