医学行业参考翻译范文
中医范文 西医范文 医疗器械范文
西医范文:
此范文为英译中
原文:
Home Diagnostics, Inc. is committed to providing its customers with the highest quality
diabetes management products. Over the life of a product, HDIs R&D Team works continuously
on manufacturing improvements. As a result of these on-going efforts, the TrueTrack Smart
System (TTSS) Test Strip will be modified. Modification of the TTSS Test Strip involves
implementation of a manufacturing process that results in longer potential shelf-life.
Shelf-life is an important product feature to our customers, and HDI is committed to further optimizing this feature. Extension of a product’s shelf-life requires extended, real-time studies, which must meet specific quality guidelines before product labeling can be changed.Based upon the studies being conducted, HDI anticipates being able to offer its customers an extended product shelf-life on TTSS Test Strips in the near future. In the meantime,production lots of the modified TTSS Test Strips will be available to our customers prior to completion of these studies.
Multi-patient facilities using blood glucose monitors are required to conduct quality control testing using a minimum of two Glucose Control levels. Glucose Control solutions are expected to provide glucose results that approximate both ‘normal’ and ‘above normal’glucose levels. TTSS currently offers two Glucose Control levels (Level 1 & Level 2).
Because the modified TTSS Test Strip yields higher Glucose Control results, a new Glucose
Control level (Level 0) and its corresponding range of values will appear on the test strip vial label of the modified test strip lots only. The current references of “Low” and “High,” for Level 1 and Level 2 Glucose Control respectively, will also be eliminated.
The chart below provides typical Glucose Control results for both the current and modified
test strips when using Glucose Control levels 0, 1 and 2. It should be noted that while Glucose Control yields higher results when used with the modified test strips, this modification has no effect on blood glucose results.
译文:
Home Diagnostics, Inc. 家庭诊断公司立志于为它的客户提供最高质量的糖尿病治疗产品。除了产品生
产以外,HDIs 的研发队伍还不断地从事产品生产的改进工作。这些坚持不懈的努力使得TTSS(TrueTrack Smart System血糖监测)的试验带得到了改良。TTSS试验带的改良包含能使其拥有更长存
放期的生产程序改进的执行。
存放期是一个重要的产品特性,HDI许诺为更进一步地优化这个特性而努力。产品存放期的延长需要长期
的、实时的研究,并且这些研究必需在产品标签能够更换之前符合特定的质量指标。在这些研究的基础上,HDI 期望能够在不久的将来为它的客户提供延长的产品存放期的TTSS试验带。同时,这些批改良的TTSS试验带的生产能使我们的客户优先享受这些完成的研究。
使用血糖监测的多容量设备是使用最小的两个葡萄糖对照级别进行质量对照试验所必需的。葡萄糖对照溶液被期望能提供接近“正常”和“正常以上”的葡萄糖检测结果。目前TTSS提供两个葡萄糖对照级别(级别1和级别2)。因为改良的TTSS试验带能产生更高的葡萄糖对照检测结果,所以一个新的葡萄糖对照级别(级别0)以及其相应值的范围将只在改良试验带批次的包装瓶的标签上出现。通用的级别1和级别2葡萄糖对照的“低”和“高”的参照也将被取消。
下图提供使用葡萄糖对照级别0,1和2 时通用的和改良的试验带的典型葡萄糖对照结果。应该注意的是当使用改良试验带产生更高的葡萄糖对照结果时,这个改良对血糖检测结果没有影响。