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       IRRA

flow

 Laser Leveler User Manual  

7000494 Rev C, USA

 

 

 

The IRRA

flow

 Laser Leveler has been labeled with the following symbols:

 

 

Safety Regulations 

4.1.

 

General Safety Regulations and Warnings

 

Device is not MRI compatible. 

Do not attach other pieces (other than those specified) to the system. 

Do not touch parts that could result in excessive leakage currents and the 
patient at the same time. 

All specified cleaning and disinfection procedures must be performed. 

Contraindication: 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 equipment 
should be observed to verify that they are operating normally. 

Contraindication:  Use  of  accessories,  transducers  and  cables  other  than 

those specified or provided by the manufacturer of this equipment could 

 

 

Serial number 

 

Laser Warning/Rating Label 

 

Store within given temperature range 

 

Transport/ship  within given 
temperature range 

 

Humidity Range Limitations 

 

 

 

Laser symbol  

 

Laser aperture location

 

 

Unique Device Identifier (UDI) 2D 
Barcode, unique to each device 

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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