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IRRA

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 Laser Leveler User Manual 

   

 

 

      13 

7000494 Rev C, USA

 

 
 
 
 

 

 

Appendix 

10.1.

 

Laser Technical Specifications 

Wavelength 

630-680 nm 

Divergence 

1.6 mrad 

Pulse Pattern 

Square 

Max Output 

< 1 mW 

Class 

Class 2 

 

10.2.

 

Electromagnetic Compatibility 

Electromagnetic compatibility tests have been performed with a 2.5 m power 
cable. 

Guidance and manufacturer’s 

declaration 

 electromagnetic emissions

 

The  IRRA

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  Control  Unit,  and  IRRA

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  Tube  Set  is  intended  for  use  in  the 

electromagnetic  environment  specified  below.  The  customer  or  the  user  of  the 
IRRA

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 CNS system should assure that it is used in such an environment. 

Standard  

Description 

IEC 60601-1-2 4

th 

ed 

Cispr 11/EN55011 

RF Emissions 

Group 1, Class B 

IEC61000-4-2 

ESD 

8 kV contact, 15 kV air 

IEC61000-4-3 

Radiated RF 

Immunity 

80-2700MHz :3 V/m ordinary, 10V/m home 

healthcare, 80% AM, 1 kHz 

385MHz :27 V/m, PM,18Hz 

450MHz :28 V/m, FM+/-5kHz dev, 1 kHz sine  

710, 745, 780MHz :9 V/m, PM, 217 Hz 

810, 870, 930MHz :28 V/m, PM, 18Hz 

1720, 1845, 1970MHz :28 V/m, PM, 217 Hz 

2450MHz :28 V/m, PM, 217 Hz 

5240, 5500, 5785MHz :9 V/m, PM, 217 Hz 

IEC61000-4-8 

Magnetic Immunity 

30 A/m,  50 Hz 

Table B-1 Electromagnetic compatibility 

 

Содержание IRRAflow

Страница 1: ...IRRAflow Laser Leveler 7000494 Rev C USA IRRAflow Laser Leveler REF ICLS 010 User Manual 0344...

Страница 2: ...ls 7 3 1 IRRAflow Laser Leveler Symbols 7 Safety Regulations 8 4 1 General Safety Regulations and Warnings 8 Environmental and Handling Conditions 10 Installation Procedure 10 Instructions for Use 11...

Страница 3: ...activated after pushing on the switch and automatically turns off after 20 seconds IRRAS only accepts responsibility for the equipment s safety usability and performance if the equipment is used in a...

Страница 4: ...the IRRAflow catheter in use Users must read this manual carefully prior to using the IRRAflow Laser Leveler for the first time so that the features are thoroughly understood Warning Failure to follo...

Страница 5: ...Aflow Laser Leveler The laser leveler generates a laser mark to assist in setting the height of the control unit The laser leveler has a power button and auto shuts off after approximately 20 seconds...

Страница 6: ...a product box as show in Figure 2 below This product box includes Laser Leveler Shoulder screw Push on cap Allen wrench Instructions for use The device does not include software It is non sterile can...

Страница 7: ...IRRAflow Control Unit such that the zero point of the Control Unit is at the same elevation as the patient s auditory meatus or ear canal prior to beginning treatment Labels 3 1 IRRAflow Laser Leveler...

Страница 8: ...aindication Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equi...

Страница 9: ...n 30 cm 12 inches to any part of the Laser Leveler including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result This is not a toy keep away fr...

Страница 10: ...g IP22 Power Source 3 6V Battery Do not place the device near heating equipment nor expose to direct sunlight Elevated temperatures can result in shortened battery life and degrade performance Install...

Страница 11: ...o the control unit The treatment normally occurs at the bedside but anywhere with direct line of sight to the patient s head may work Rotate the body of the device towards desired target location away...

Страница 12: ...propyl alcohol or 70 ethyl alcohol solution No liquid may be allowed to be directly poured or sprayed onto the Laser Leveler during cleaning or disinfecting as this may damage the equipment No liquid...

Страница 13: ...gnetic environment specified below The customer or the user of the IRRAflow CNS system should assure that it is used in such an environment Standard Description IEC 60601 1 2 4th ed Cispr 11 EN55011 R...

Страница 14: ...4 Rev C USA 10 3 Laser Levelers and Manual Please contact your local distributor if you wish to order Laser Levelers or a replacement manual IRRAflow Laser Leveler Ref no ICLS 010 Laser Leveler User m...

Страница 15: ...ured By Address IRRAS USA Inc 11975 El Camino Real Suite 304 San Diego CA 92130 USA URL http www IRRAs com E mail address US customerservice IRRAs com Phone 1 800 946 0458 EC Representative Address Eu...

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