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IRRA

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 Laser Leveler User Manual 

   

 

 

      3 

7000494 Rev C, USA

 

 
 
 
 

 

 

Please note the components included in this package are meant to be used 
in conjunction with the IRRA

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 Control Unit and IRRA

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 instructions for 

use. The Laser Leveler is attached to the IRRA

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 Control Unit for height 

positioning, 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 accordance with its intended use, and 

the  equipment  is  used  in  accordance  with  the 
product documentation. 

 

 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

WARNING 

Read all instructions and warnings prior to use. 

Users of the IRRA

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 Laser Leveler shall be trained medical personnel with 

training and experience in neurosurgical medical care. 

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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