1
Pre-installation
CPI Canada Inc.
Use and disclosure is subject to the restrictions on the title page of this CPI document.
Page 1-8
CMP 200
®
X-Ray Generator Service Manual Ch # 901476-01 Rev. C
1.1.6
Electromagnetic Compatibility (EMC)
In accordance with the intended use, some models of this series of X-ray generators comply with the
European Council Directive concerning Medical Devices. The CE marking affixed to compliant products
signifies this. One of the harmonized standards of this Directive defines the permitted levels of
electromagnetic emission from this equipment and its required immunity from the electromagnetic
emissions of other devices.
It is not possible, however, to exclude with absolute certainty the possibility that other high frequency
electronic equipment, which is fully compliant to the EMC regulations, will not adversely affect the
operation of this generator. If the other equipment has a comparatively high level of transmission power
and is in close proximity to the generator, these EMC concerns (the risk of interference) may be more
pronounced. It is therefore recommended that the operation of equipment of this type such as mobile
telephones, cordless microphones and other similar mobile radio equipment be restricted from the vicinity
of this X-ray generator.
1.1.7 RoHS
Compliance
CMP 200
®
/ CMP 200
®
DR
产品中有毒有害物质或元素的名称及含量
Table of hazardous substances’ name and concentration.
有毒有害物质或元素
Hazardous substances’ name
部件名称
Component Name
铅
(Pb)
汞
(Hg)
镉
(Cd)
六价铬
(Cr(VI))
多溴联苯
(PBB)
多溴二苯醚
(PBDE)
Generator X
O O X
O
O
Console X
O
O X
O
O
O:
表示该有毒有害物质在该部件所有均质材料中的含量均在
SJ/T11363-2006
标准规定的限量要求以下
X:
表示该有毒有害物质至少在该部件的某一均质材料中的含量超出
SJ/T11363-2006
标准规定的限量要求
•
此表所列数据为发布时所能获得的最佳信息
•
由于缺少经济上或技术上合理可行的替代物质或方案，此医疗设备运用以上一些有毒有害物质来实
现设备的预期临床功能，或给人员或环境提供更好的保护效果。
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.
