无菌医疗器械包装泄漏测试仪 XL0681-D
English name：Aseptic medical device packaging leakage tester
Model： XL0681-D
Product brand：
远梓
适用方向：针对包装产品密闭测试端加装冒泡法的物理装置来验证气压泄漏的大小。
Application direction: A physical device with bubbling method is installed on the closed test end of the packaged product to verify the size of the air pressure leak..
仪器特点
采用7英寸K600+内核/点阵式65色 800*480分辨率触摸屏显示，PLC控制系统动态显示加载力值；操作界面可选：中文/英文/中英文切换；数字闭环控制。触控操作显示屏进行选择，并可由机载打印机打印出测试结果。
Using 7-inch K600+ core/dot-matrix 65 color 800*480 resolution touch screen display, PLC control system dynamically displays the loading force value; Operation interface Optional: Chinese/English/English switch; Digital closed loop control. The touch-operated display makes the selection and the test results can be printed by the on-board printer.
仪器参数
执行标准：yy0681.5-2010无菌医疗器械包装试验方法。
测试参数与要求：
1、对透气性材料和非透气性材料给出了两个不同的试验方法两个方法的主要差异在于对透气材料给出了浸透时间试验灵敏度控制非透气性包装的程序
2、启动检测程序，正气压在0～10K P a 可调范围内,精度为：±1%，分辨率：0.01Kpa
保压时间：0～10min误差不大于±0.5s
预调好测试气压,此时设备因恒压输气,平缓的抽
离针阀手柄,在针阀手柄和膜片位移过程中不能有泄漏气压的现象。
3、用穿孔器在包装上穿一个孔，穿孔宜尽量位于包装的中央，孔的大小宜能插入空气源和压力检测器，能使空气泄漏为最小，如有必要用胶带和橡胶垫作为穿孔部位的封堵器来密封插入部位。向样品中插入实验气源和压力监测器。将包装浸没在水下约2.5cm.向包装内施加空气，缓慢对包装充气大于或等于最小试验压力。检验整个包装上显示破损区域的气泡流，检验时间依据包装的大小而定，从小中取出包装，标出所有观察到的破损区域
4、透气性包装的程序和非透气性程序一致，不同的是透气包装材料应与样品施加阻隔剂，包装浸没在水下至少5s之后才开始施加空气 。
发货清单：主机1台、有机玻璃水槽、合格证1份、操作说明书1份、打印纸1卷
电源：AC90V-240V/50Hz
数据保存：机载针式打印机/可U盘导入电脑存储
净重：15kg 外形尺寸：300×240×240（mm）
服务：可定制非标仪器
仪器终身免费依国家标准规定升级服务、终身维
Executive Standard: yy0681.5-2010 sterile medical device packaging test method.
Test parameters and requirements:
1. Two different test methods are given for breathable materials and non-breathable materials. The main difference between the two methods is that the permeation time test sensitivity control procedure of non-breathable packaging is given for breathable materials
2, start the detection program, positive gas pressure in the adjustable range of 0 ~ 10KPa, accuracy: ±1%, resolution: 0.01Kpa
Pressure holding time: 0 ~ 10min error is not more than ±0.5s
The test air pressure is pre-adjusted, and the equipment is pumped gently due to constant pressure gas transmission
When the needle valve handle is removed, there should be no leakage of air pressure during the displacement of the needle valve handle and the diaphragm.
3, with a perforator in the package through a hole, the hole should be located in the center of the package as far as possible, the size of the hole should be able to insert the air source and pressure detector, so that the air leakage is minimal, if necessary, with tape and rubber pad as the perforator to seal the insertion part. Insert the experimental air source and pressure monitor into the sample. Submerge the package under about 2.5cm of water. Apply air into the package and slowly inflate the package at or above the minimum test pressure. Inspect the entire package for a stream of bubbles showing damaged areas. The inspection time depends on the size of the package. Remove the package from the small center and mark all observed damaged areas
4, breathable packaging procedures and non-breathable procedures are consistent, the difference is that breathable packaging materials should be applied with the sample barrier agent, packaging immersed in water at least 5s before starting to apply air.
Delivery list: 1 host, plexiglass sink, 1 certificate, 1 operating manual, 1 roll of printing paper
Power supply: AC90V-240V/50Hz
Data storage: on-board needle printer/U disk can be imported into th
售后服务
整机质保壹年
上门培训维修
七天质量问题全款退换货服务
仪器软件终身免费依国家标准规定升级服务、终身维护
The whole machine quality guarantee one year
door-to-door training maintenance
seven days quality problem full-money return service
instrument software life-long free according to the national standard upgrade service, life-long maintenance
