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I.A.C.E.R. Srl 

21 

                    MNPG207-02 

EMC tables 

Electromagnetic emission 

Emission test 

Compliance 

Electromagnetic environment – 

guidance 

RF emissions 
Cispr 11 

Group 1 
 
 

ORTHOMAG  uses  RF  energy  only  for 
its  internal  function.  Therefore,  its  RF 
emissions  are  very  low  and  are  not 
likely  to  cause  any  interference  in 
nearby electronic equipment 

RF emissions 
Cispr 11 

Class B 

ORTHOMAG  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. 
 

Harmonic emissions 
IEC 61000-3-2 

Class A 
Complies 
 

The  ORTHOMAG  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 
 
 
 

Voltage fluctuations/ 
flicker emissions 
IEC 61000-3-3  

Complies 

Electromagnetic immunity  

ORTHOMAG is  intended  for  use  in  the  electromagnetic  environment  specified  below. 
The  customer  or  the  user  of  ORTHOMAG  should  assure  that  is  used  in  such 
environment. 
Immunity test  

Test 

level 

EN 

60601-1-2 

Compliance level 

Electromagnetic 
environment 

– 

guidance  

Electrostatic 
discharge (ESD) 
EN 61000-4-2 

±

 6kV contact 

±

 8kV air 

±

 6kV contact 

±

 8kV air 

Floors  should  be 
wood,  concrete  or 
ceramic  tile.  If  floor 
are  covered  with 
synthetic 

material, 

the  relative  humidity 
should  be  at  least 
30%  
 

Electrical 

fast 

transient/burst 
IEC 61000-4-4 

± 2kV for power 
supply lines 

± 2kV per power 
supply lines  

Mains  power  quality 
should  be  at  that  of 
a typical commercial 
or 

hospital 

environment. 

Impulses 
EN 61000-4-5 

±

1kV 

differential 

mode 

±

1kV 

differential 

mode 

Mains  power  quality 
should  be  at  that  of 
a typical commercial 
or 

hospital 

environment.  

Summary of Contents for ORTHOMAG

Page 1: ...USER MANUAL MNPG207 02 Edition 02 12 2016 Magnetotherapy model ORTHOMAG I A C E R Srl www itechmedicaldivision com...

Page 2: ...I A C E R Srl Via S Pertini 24 A 30030 Martellago VE ITALY Tel 39 041 5401356 Fax 39 041 5402684 e mail iacer iacer it www itechmedicaldivision com...

Page 3: ...r 5 Declaration of conformity 5 Specifications 6 Technical features 7 Labelling 8 Label details 8 Symbols description 8 Kit contents 9 How to use 10 Warnings 10 Contraindications and side effects 12 H...

Page 4: ...rticular for the osteoporosis Pulsed electromagnetic fields induce biological modifications on biological membrane in order to re establish correct cellular functions According to different authors ex...

Page 5: ...bility that ORTHOMAG is manufactured in conformity with Directive 93 42 EEC MDD dated 14 June 1993 D Lgs 46 97 dated 24 February 1997 Attuazione della Direttiva 93 42 CEE concernente i dispositivi med...

Page 6: ...or when mixed with any flammable agents and in environments with high concentrations of oxygen Continuous operating mode equipment Equipment not suited to be used in external Purpose Clinical purpose...

Page 7: ...e of the device and its accessories 3 years Technicalfeatures Power supply Battery charger DC 3 7V Lithium battery 12V 1A Max absorbed current 300 mA therapy mode Insulation class CEI EN 60601 1 II Ap...

Page 8: ...etails Label 1 Label 2 DC INPUT 12V 1A Symbolsdescription Attention consult operating instructions Product subject to WEEE regulations concerning separate waste collection of electronic equipment Clas...

Page 9: ...e protected against solid foreign diameter 12 5mm and against dripping water vertical when the device is kept at 15 from the normal operating position Only domestic use Kitcontents ORTHOMAG kit N 1 OR...

Page 10: ...o not open the device in case of problems contact the manufacturer Orthomag is a medical device Keep it out of children and animal s reach Do not use the device in case of anomalies or malfunctions Me...

Page 11: ...ay from other devices that may interfere or prevent the safe use of the device and its accessories connected The manufacturer is considered responsible for the performance reliability and safety of th...

Page 12: ...tes viral in acute phase illnesses mycosis cardiopathic subjects tumours serious arrhythmias or pacemaker carriers children metallic prosthesis carriers acute infections epileptics different medical p...

Page 13: ...device switches off When using the device with battery the program duration is guaranteed up to 3 hours How to use the device with the power supply adapter Connect the applicator to the Orthomag Place...

Page 14: ...field is still emitted until the device is switched off Therapeutic indications average time of therapy 2 4 hours per day To discontinue therapy and switch off the device press and hold the power but...

Page 15: ...tor allows a perfect contact with the body The image below gives some of the possible applications for the most common diseases treated with magnetic therapy such as cervical osteoarthritis and or joi...

Page 16: ...I A C E R Srl 16 MNPG207 02...

Page 17: ...device from the charger Remove the belt clip by pushing it down lightly Open the battery compartment Pull out the battery Insert the new battery please use only battery provided by the manufacturer Cl...

Page 18: ...carefully using a sponge soaked in solution of water and alcohol 20 We recommend to disconnect the applicator from the device before cleaning the it Pay attention to respect the temperature humidity a...

Page 19: ...AG please follow these instructions Check the mains socket integrity by connecting a working device to the same socket Check the connection with working wall mount charger and applicator Check the cor...

Page 20: ...0030 Martellago VE Tel 041 5401356 Fax 041 5402684 You can get any technical documentation on spare parts but only prior business authorization Spareparts For original spare parts contact the National...

Page 21: ...er supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electromagnetic immunity ORTHOMAG is intended for use in the electrom...

Page 22: ...r of the ORTHOMAG requires continued operation during power mains interruptions it is recommended that ORTHOMAG be powered from an uninterruptible power supply or a battery Mains power electromagnetic...

Page 23: ...han the complicance level in each frequency rage Interference may occur in the vicinity of equipment marked with the following symbol Recommended separation distances between portable and mobile commu...

Page 24: ...g to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propaga...

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