gbo Medizintechnik Sonostat User Manual Download Page 32

32

 

 

Sonostat

 

 gbo Medizintechnik AG

 

Version 1.2 

Guidance and manufacturer’s declaration — electromagnetic immunity 

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

Immunity test 

IEC  60601-  test 
level 

Compliance 

level 

Electromagnetic 

environment – guidance 

 

 

 

Portable  and  mobile  RF  communications 
equipment should be used no closer to any 
part  of  the  equipment,  including  cables, 
than the recommended separation distance 
calculated  from  the  equation  applicable  to 
the frequency of the transmitter. 
 

Recommended separation distance: 

Conducted RF,  
IEC 61000-4-6 

3 V

rms

 

150 kHz to 80 MHz 

3 V

eff

 

d=1,2 P 
 

Radiated RF,  
IEC 61000-4-3 

3 V/m 
80 MHz to 2,5 GHz 

3V/m 

d=1,2 P 
for 80 MHz to 800 MHz 

 

 

 

d=2,3 P 
for 800 MHz to 2,5 GHz 

 

 

 

Where  P  is  the  maximum  output  power 
rating of the transmitter in watts according 
to the transmitter manufacturer and d is the 
recommended 

separation 

distance 

in 

meters (m). 
 
Interference  may  occur  in  the  vicinity  of 
equipment  marked  with  the  following 
symbol: 

 

 

Recommended  separation  distances  to  portable  and  mobile  RF  communication 
equipment 

The equipment is intended to be operated in an electromagnetic environment, where radiated RF 
interference  is  controlled.  The  user  can  help  in  avoiding  interferences  by  means  of  meeting 
minimum  separation  distances  between  portable  and  mobile  RF  communication  equipment 
(transmitters) according to the maximum output power of the communication equipment. 

Rated power of 

the transmitter 

(W) 

Separation distance according to the transmission frequency 

(m) 

150 kHz to 80 

MHz 

d=1,2 P 

80 MHz to 800 

MHz 

d=1,2 P 

800 MHz to 2,5 GHz 

d=2,3 P 

0,01 

0,12 

0,12 

0,23 

0,1 

0,38 

0,38 

0,73 

1,2 

1,2 

2,3 

10 

3,8 

3,8 

7,3 

100 

12 

12 

23 

 

 

 

Summary of Contents for Sonostat

Page 1: ...Sonostat User manual...

Page 2: ...no responsibility for errors or omissions All rights reserved No part of this manual may be reproduced in any form or by any means electronic mechanical or otherwise without the prior written permiss...

Page 3: ...3 3 Settings 15 4 THERAPY 16 4 1 General guidelines for ultrasound therapy 16 4 2 Choice of therapy by own therapy 17 4 3 Choice of therapy by indications 17 4 4 Choice of therapy by individual setti...

Page 4: ...4 Sonostat gbo Medizintechnik AG Version 1 2 10 ACCESSORIES 28 11 TROUBLESHOOTING 29 12 APPENDIX 30 INDEX 33...

Page 5: ...ostat 5 gbo Medizintechnik AG Version 1 2 Warnings and Notes Warning Warnings which must be observed by all means Attention Observe the instructions for use Note Information that will facilitate the w...

Page 6: ...spective temperature Energy flow and temperature in the treated tissue is determined by absorption and reflection of ultrasound and is therefore highly tissue specific c Piezoelectric effect primary a...

Page 7: ...asonic frequency the lower the penetration of the ultrasound Accordingly we recommend the use of 3 3 MHz at near surface indications In addition the Sonostat offers indication programs By selecting th...

Page 8: ...rapy device belongs to class IIa Warning Note for use in the clinical area The unit is not designed to be operated in places with the inherent risk of explosions If it is used in dangerous areas of an...

Page 9: ...card slot located to the right of the display This port is intended for service purposes only 2 3 Placing out of operation In order to place the device out of operation just disconnect it from the ma...

Page 10: ...a the control panel of the touch screen 3 1 Overview 3 1 1 Touchscreen display The touch screen should be operated with a distinct pressure of the fingertip Sharp objects are unsuitable for operation...

Page 11: ...power 3 1 3 The ultrasonic heads The treatment heads can be connected to the right or left side of the device The treatment head has an LED lamp signaling the following states Importance Color Type He...

Page 12: ...e device displays the home screen Button Direct help Button head heater Button settings Button Head left Button Head right Selection Favourite list Selection Own therapies Selection Indications Detail...

Page 13: ...with hatched Treatment area Indication list in alphabetical order Range selection to restrict the list of indications Return to the Home screen without loading of the indication Return to the Home sc...

Page 14: ...press the button to which you want information This opens an information window on the screen which provides information about the selected key The information window can be closed by pressing in the...

Page 15: ...ilable in the Settings menu Display Setting the language Calibration of the touch screen Audio Setting the system sounds like the therapy end sound error tone etc The sounds can be heard and assigned...

Page 16: ...forget that there may be sensitive organs close by see chapter 7 Contraindications The upper limit of the permissible intensity is generally signaled by the occurrence of periosteal pain provided the...

Page 17: ...setting are changed as desired The set therapy parameters may also be stored in the Favorites list 4 5 Choice of therapy from the favorites list The Favorites list can be filled by the user as desired...

Page 18: ...ansducer is indicated by a green LED on the transducer housing and through a graphical representation on the screen In case of bad coupling of the transducer the LED flashes green Warning Do not forge...

Page 19: ...the back side of the Sonostat The device s internal flow path is activated only for the selected ultrasound head Warning Observe the operating instructions of the connected electrical stimulation ther...

Page 20: ...ent intensity so that the patient experiences a significant irritant effect on the stimulation current therapy unit by turning the intensity knob If the patient feels a pain reduce the stimulation cur...

Page 21: ...gulation has to be observed in particular Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is mandatory to have the device checked at 12 months intervals by the m...

Page 22: ...suitable for wipe disinfection It is important to ensure that no liquids get into the unit Do not wet plugs or sockets The device must not be sprayed for cleaning or disinfecting The device and its ac...

Page 23: ...control If the patient and or the patient cable is in the direct range of a high frequency short wave or micro wave therapeutic device damage to the device or an injury to the patient cannot be exclu...

Page 24: ...tronic devices Malignant tumors Oncological diseases at all stages Feverish conditions Active tuberculosis regardless of the stage and the localization Pregnancy Vascular disease of the extremities th...

Page 25: ...hildren Sexual organs Front of the neck carotid artery and thyroid End prosthesis Body parts with silicone implants or metal implants not directly sonicate the larynx in the treatment not directly son...

Page 26: ...und head Application part of Type BF floating Stimulation current input for combination therapy Max 120Veff max 100 mAeff This appliance is labeled in accordance with European Directive 2002 96 EC on...

Page 27: ...operation Continuous operation Protection class I Protection class of housing IP X0 Dimensions 27 cm 19 3 cm 28 cm W H D Weight 4 9 kg without accessories Display 10 1 TFT LCD with touch screen Envir...

Page 28: ...Article no Ultrasound head 2 5 cm 032 0 3010 Equipment trolley basic rack Sonostat additional module Holder for ultrasound gel bottle 026 0 3000 026 0 3050 026 0 3020 The picture shows the trolleys fo...

Page 29: ...orized by the manufacturer Further errors symptom cause and action The device cannot be switched on no display is shown Please check the mains plugs and sockets If necessary contact your service agent...

Page 30: ...acturer is 10 years Sonostat is an electronic device For its disposal the according regulations for electronic devices have to be observed On request the manufacturer will provide you with further tec...

Page 31: ...test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or...

Page 32: ...z to 800 MHz d 2 3 P for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distanc...

Page 33: ...isposal of equipment 21 H Home screen 12 I indication 13 installation 8 Intended use 6 M mains voltage 8 Maintenance 21 O Operation 10 Overview 10 own therapies 13 P Power regulator 11 S Safety checks...

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