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10               

 

 

       IRRA

flow

 Laser Leveler User Manual  

7000494 Rev C, USA

 

 

 

 

Environmental and Handling Conditions 

Laser Leveler 
Operation Temperature range 

+10 to +40°C 

Operation 
Air humidity 

15 

 90% 

Operation 
Ambient pressure 

70 

 106 kPa 

Storage and transport 
Temperature range 

+2 to +50 °C 

Storage and transport 
Air humidity 

15 

 90% 

Storage and transport 
Ambient pressure 

50 

 106 kPa 

IP Rating 

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. 

 

Installation Procedure 

 

The IRRA

flow

 Laser Leveler device is provided with a mounting 

screw for use with the The IRRA

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 CNS control unit.  

 

Contraindication: This device is not designed to be 
installed or used other than indicated.  

 

Clean and disinfect device per section 10.  

 

Remove black cap from the head of the shoulder screw. Insert 
shoulder screw into the device as shown.    

 

Summary of Contents for IRRAflow

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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