浓缩清洗液CE技术文档（全套）

IVDD Technical File General Information Page 1 of 2 根据/According to 欧盟指令 98/79/EC Council Directive 98/79/EC (体外诊断设备/IVDD)制造商制造商/Manufacturer:（名称及地址，联系人；电话，传真或电子邮件）(Name and address,contact person;telephone,fax or e-mail)深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 联系人：胡亚军先生 电话：+86 755 86368398 传真：+86 755 26525016 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China Contact Person:Mr.Hu Yajun Tel:+86 755 86368398 Fax:+86 755 26525016 设计场所设计场所/Design facility(ies):(名称及地址/Name and address)生产场所生产场所/Manufacturing facility(ies):(名称及地址/Name and address)深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China 深圳市雷诺华科技实业有限公司 中国广东省深圳市南山区高新技术产业园区科技南二路 W2-B 栋一层东 LABNOVATION TECHNOLOGIES,INC.1F,W2-B Building,Keji 2nd Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,PR China 产品类别产品类别/Product category:产品产品/Product:体外诊断设备/IVDD 清洗液（血细胞分析仪用）DETERGENT FOR HEMATOLOGY ANALYZERS USE 分类分类/Classification:IVDD,non-self-testing device and other than those covered by List A and List B in Directive 98/79/EC.产品总述产品总述/General Description 血液细胞分析仪用清洗液，与全自动或半自动血液分析仪设备配套使用。用于体外诊断。Detergent For Hematology Anaalyzers Use,used with automated and semi-automated hematology devices,for in vitro diagnostic use。生产（销售）历史生产（销售）历史/Product(Sales)history:2001 年起/Since 2001 产品更改计划产品更改计划/Planned Variants:无/None 认可认可/Existing Approvals:FDA exempt,according to TITLE 21-FOOD AND DRUGS,SUBCHAPTER H-MEDICAL DEVICES,PART 864 HEMATOLOGY AND PATHOLOGY DEVICES,Subpart A-General Provisions,864.9-Limitations of exemptions from section 510(k)of the Federal Food,Drug,and Cosmetic Act.IVDD Technical File General Information Page 2 of 2 签署人声明/The undersigned declares:履行被认证通过的质量体系的职责和义务/to fulfill the obligations arising from the quality system as approved.保持被认证通过的质量体系的有效性和足够性/to maintain the approved quality system in such way that it remains adequate and effective.质量体系显著变更或计划显著变更时通知签约认证机构，TUV 莱茵技术监护（深圳）有限公司/to inform the contracted Notified Body,TUV RHEINLAND GROUP,of and plan for substantial changes to the quality system.建立并保持系统过程以获得设备生产后阶段的经验，并通过适当的方式进行必要的改进/to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action.在得知以下情况时立即通知主管当局/to notify the competent authorities of the following incidents immediately on learning of them:I.设备系统性失效，以及任何不充分的指导说明可能导致患者或使用者死亡，或导致其健康严重损害/any malfunction or deterioration in the characteristics and/or performance of a device,as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;II.任何与设备特性或性能相关的技术的或医疗的原因，导致如（I）中所述的情况，而由制造商召回产品/any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph(I)to systematic recall of devices of the same type by the manufacturer.日期日期/Date:2017.04.14 公司代表：公司代表：Name of company representative:胡亚军胡亚军/Hu Yajun 1/4 Product Application GuideProduct Application Guide Procedure:Labnovation Reagent Installation Action necessary:When switching to Labnovation reagents Instruments:All,that are not specified separately Date:2017/04/14 Attention,important information!This procedure,described below,is not suitable for changing from cyanide reagents to non cyanide,or from non-cyanide reagents to cyanide.Use the following procedure,for fully automatic instruments when there is no other description available.This way of changing solution can take up to an hour,but you can be sure,that the system is purged with the newly installed reagents.IT IS NECESSERY TO BE DONE ONLY ONCE,WHEN YOU FIRST INSTALL THE LABNOVATION REAGENTS ON YOUR INSTRUMENT.1.Remove all the reagent aspiration tubes from the currently used reagent boxes/bottles.2.Wipe the tubes surface with a lent free tissue,and then rinse with distilled water.Put the tubes into the LABNOVATION reagent boxes/bottles.3.Run at least 50 backgrounds.Check for the acceptable values.At first high background counts can be seen,that should lower to normal after a few runs.4.Run all three levels of a dedicated commercial control.Check for the acceptable values.5.Recalibrate the unit if necessary.Important information:Labnovation reagents are developed as a system,where the particular components work together.Using different brand solutions together,the quality of the result is not guaranteed.LABNOVATION TECHNOLOGIES,INC.1F,W2-B Bldg.,Keji 2 Road South,Hi-Tech Industrial Park,Shenzhen 518057,Guangdong,China Tel:+86 755 86368328 Fax:+86 755 86368318 2/4 NO.Product Applicable Analyzer Cat#1 EZ 清洗液 EZ-CLEANER Ruby，CD3700，3500，3000，CD3200，CD1800,1700,1600,1500,1400,1300，CD1200 33-40-E001 2 清洗液 CD5 DETERGENT CD5 CD3700，3500，3000 L-99321-01 3