GE CRxFlex Operating Manual page 11

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The table showing the distribution of hazardous substances and its concentration to be
complaint to RoHS directive is shown below:
Component
Name
Metal Parts
Plastic Parts
Elastomere Parts
Electromechanical
Components
Cables and Cable
Assemblies
Printed Circuit Boards
and PCB Assemblies
Optical Glasses
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous
materials for this part is below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the
homogeneous materials used for this part is above the limit requirement in SJ/T11363-2006.
Data listed in the table represents best information available at the time of publication
Applications of hazardous substances in this medical device are required to achieve its
intended clinical uses, and/or to provide better protection to human beings and/or to
environment, due to lack of reasonably (economically or technically available substitutes.
CRxFlex Operating Manual V1.1
Table of hazardous substances' name and concentration
Hazardous substances' name
Pb
Hg
O
O
O
O
O
O
X
O
X
O
X
O
X
O
.
Cd
CrVI
O
X
O
O
O
O
O
O
O
O
O
O
O
O
PBB
PBDE
O
O
X
X
X
X
X
X
X
X
X
X
O
O
11

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