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INSTRUCTIONS FOR USE
Classification and Standards
Classification
Technical and Quality Assurance
Standards
IEC 60601-1 Classification According to
Degree Protection against Electrical
Shock
IEC 60601-1 Classification According to
Degree Protection against Electrical
Shock
IEC 60601-2-46 Classification According to
Degree of Protection against Dust and
Fluid Intrusion
Mode of Operation
Applied Parts (in accordance with IEC 60601-1)
Rail Top
Positioning supports (such as pads,
C-Flex® Head Positioning System, and
disposables)
4.3
Declarations:
Device does not contain any hazardous substances as referred in directive 2011/65/EU.
Materials used in the construction of the device contain CAS # 7439-92-1, Lead. The
concentration of Lead is less than 0.1% concentration by weight of the overall product
and therefore is in compliance with 1907/2006 REACH directive.
4.4
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Document Number: 80028190
Version: E
IEC 60601 Ed. 3 for Class 1 Type B
instrument
IEC 60601-2-46 Ed. 2.0 relevant sections
IEC 60601-1-2 relevant sections
IEC 60601-1-6 relevant sections
Class I equipment
Type B applied part
IPX 4
2 minutes ON/18 minutes OFF
Flat Top
Flat Top pad
Page 66
English
Standard
Issue Date: 16 MAY 2022
Ref Blank Template: 80025117 Ver. F
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