Chapter 9
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning.
Please note: The designation of 10 years EFUP is not to be equated with the durability, use- duration or any
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
部件名称
Component Name
有毒有害物质或元素
Hazardous substances name
铅 | 汞 | 镉 | 六价铬 | 多溴联苯 | 多溴二苯醚 |
(Pb) | (Hg) | (Cd) | (Cr(VI)) | (PBB) | (PBDE) |
x
o
o | o | o | o |
O:
X:
∙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
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
∙Data listed in the table represents best information available at the time of publication
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