英语翻译5.1\x05产品的预期用途、预期目的是什么?如何使用?预期用途：临床上用于孕妇生产时剪、夹脐带用.使用方法：临床孕妇生产完婴儿后,由医生使用脐带剪,剪断婴儿与母体的连接脐带

英语翻译5.1\x05产品的预期用途、预期目的是什么?如何使用?预期用途：临床上用于孕妇生产时剪、夹脐带用.使用方法：临床孕妇生产完婴儿后,由医生使用脐带剪,剪断婴儿与母体的连接脐带
英语翻译
5.1\x05产品的预期用途、预期目的是什么?如何使用?
预期用途：临床上用于孕妇生产时剪、夹脐带用.
使用方法：临床孕妇生产完婴儿后,由医生使用脐带剪,剪断婴儿与母体的连接脐带并夹紧被剪断的2端.
5.2\x05医疗器械是否预期和患者或其他人员接触、如何接触、接触时间长短?
与患者接触：剪断脐带时与脐带接触,剪断时刀片接触到脐带内动脉和静脉；脐带夹夹紧脐带2端时与脐带外表接触,接触时间为短暂.
与医生接触：医生用手操作.为外表接触,接触时间为短暂.
5.3\x05在医疗器械中包含有何种材料和（或）组分或与其共同使用、或与医疗器械接触?
脐带夹采用尼龙材料制作；刀架、刀片垫采用尼龙材料制作；刀片采用不锈钢材料制做.4个部件组装在一起使用；
5.4\x05是否有能量给予患者或从患者身上获取?
没有能量从患者身上获取.
5.5\x05是否有物质提供给患者或从患者身上提取?
无
5.6\x05是否由医疗器械处理生物材料然后再次使用?
不是,产品为一次性使用,使用后由专门的医疗垃圾回收处理部门处理.
5.7\x05医疗器械是否以无菌形式提供或准备由使用者灭菌,或用其他微生物控制方法灭菌?
产品预期为一次性使用,不得重复使用；
产品的包装采用聚乙烯纸塑袋包装,经过验证,产品在规定的储存条件下储存有效期限为36个月；
产品采用环氧乙烷灭菌.
5.8\x05医疗器械是否预期由用户进行常规清洁和消毒?
产品由我公司经过环氧乙烷灭菌后出厂.
5.9\x05医疗器械是否预期改善患者的环境?
不是
5.10\x05医疗器械是否进行测量?
不是
5.11\x05医疗器械是否进行分析处理?
不是
5.12\x05医疗器械是否预期和医药或其他医疗技术联合使用?
不是
5.13\x05是否有不希望的能量或物质输出?
不存在
5.14\x05医疗器械是否对环境敏感?
产品采用纸塑袋包装保证产品无菌,应储存在湿度不超过80%无腐蚀性气体且通风良好的室内,产品的有效期限为36个月.
5.15\x05医疗器械是否影响环境?
否
5.16\x05医疗器械是否有基本消耗品或附件?
无
5.17\x05是否需要维护和校准?
否
5.18\x05医疗器械是否有软件?
否
5.19\x05医疗器械是否有储存寿命限制?
有寿命限制
5.20\x05是否有延迟和（或）长期使用效应?
否
5.21\x05医疗器械承受何种机械力?
有,医生使用器械时手指的握力.
5.22\x05是什么决定医疗器械的寿命?
包装袋和产品材料的老化.
5.23\x05医疗器械是否预期一次性使用?
是
5.24\x05医疗器械是否需要安全的退出运行或处置?
产品采用医用级塑料制造,产品不含有毒性,材料经过合理的处理后可回收利用.
5.25\x05医疗器械的安装或使用是否要求专门的培训?
产品为通用型器械,不需要专门的培训.
5.26\x05是否需要建立或引入新的生产过程?
不需要
5.27\x05医疗器械的成功使用,是否决定性的取决于人为因素,例如使用者接口?
如果在使用之前,产品包装破损,产品被污染了,使用者没有留意或不知情可能会感染患者患处.
4.27.1 医疗器械是否有连接部分或附件?
无
4.27.2医疗器械是否有控制接口?
无
4.27.3医疗器械是否显示信息?
否
4.27.4医疗器械是否由菜单控制?
否
5.28\x05医疗器械是否预期为移动式或便携式?
不涉及

英语翻译5.1\x05产品的预期用途、预期目的是什么?如何使用?预期用途：临床上用于孕妇生产时剪、夹脐带用.使用方法：临床孕妇生产完婴儿后,由医生使用脐带剪,剪断婴儿与母体的连接脐带
5.1 the products intended use, the expected purpose is? How to use?
Expected application: used for pregnant women cut when clinically production, clip with umbilical cord.
Method of use: clinical pregnant women finish production after the baby, by doctors use umbilical cord cut, cut off the baby and maternal connection umbilical cord and clamping was cut out of the two.
5.2 medical equipment is expected and patients or other personnel contact, how to contact, contact time length?
With the patient contact: umbilical cord contact with umbilical cord, cut the umbilical cord in contact with the inside arteries and veins; Umbilical cord clip clip tightly with the umbilical cord 2 appearance umbilical cord contact, for a short time.
And the doctor contact: the doctor operated by hand. Appearance for contact, for a short time.
5.3 in medical equipment contains what material and (or) or with the common use, components or and medical equipment contact?
The umbilical cord clip nylon material production; Knife blade pad, the nylon material production; The blade of stainless steel materials produced. Four assembly together use;
5.4 if there is energy gives patients or from patients get?
No energy from the patients get.
5.5 if there is provided to patients or material from the extraction of patients?
no
5.6 by medical devices are handling biological materials and then use again?
No, the product for the disposable use, after use of medical waste by special recycling department processing.
5.7 medical devices to provide or whether sterile form prepared by the user sterilization, or in other microbial control method sterilization?
Products for a one-time use expected, and shall not be repeated use;
The packaging of the polyethylene paper-plastic bag packaging, after verification, the products stipulated in the storage conditions storage is valid for 36 months;
Products using epoxy ethane sterilization.
5.8 medical equipment is expected by users for regular cleaning and disinfection?
The product by my company after epoxy ethane after sterilization factory.
5.9 medical equipment is expected to improve the patient's environment?
not
5.10 medical instrument measured whether?
not
5.11 medical instrument is analyzed with?
not
5.12 medical equipment is expected and medical or other medical technology joint use?
not
5.13 if there is no hope of energy or material output?
Does not exist
5.14 medical devices to the environment is sensitive?
The paper plastic bag packaging products ensure product aseptic, should be stored in the humidity of no more than 80% of no corrosive gas and ventilated good indoor, the product is valid for 36 months.
5.15 medical equipment would not affect the environment?
no
5.16 medical equipment whether basic consumables or accessories?
no
5.17 if need maintenance and calibration?
no
5.18 medical equipment is a software?
no
5.19 medical equipment is a storage life limit?
Life is limited
5.20 if there is a delay and (or) long-term use effect?
no
5.21 medical equipment under what mechanical force?
Have, doctors use equipment of fingers grip.
5.22 is what decision of medical devices life?
Packing materials and products of aging.
5.23 medical equipment is expected the disposable use?
is
5.24 medical equipment whether need safety exit operation or disposal?
Product USES the medical level plastic manufacturing, products do not contain toxic, material with reasonable processing can be recycled.
5.25 medical equipment in the installation or use whether to ask special training?
The product is general-purpose devices, do not need special training.
5.26 if need to build or introducing new production process?
Don't need
5.27 the success of the medical devices use, whether it is a decisive depends on human factors, such as the user interface?
If before use, the product packing damage, the product is polluted, didn't notice or unsuspecting users could get infected patients affected part.
4.27.1 medical equipment if there is a connection or accessories?
no
4.27.2 medical equipment whether control interface?
no
4.27.3 medical equipment whether display information?
no
4.27.4 medical equipment is of menu control?
no
5.28 medical equipment is expected as a mobile or portable?
Don't involve