Clark Paula E, Okenfuss Charles R, Campbell Margaret
Eli Lilly and Company, Indianapolis, Indiana, USA.
J Diabetes Sci Technol. 2010 Mar 1;4(2):353-6. doi: 10.1177/193229681000400216.
The HumaPen Luxura HD insulin pen (Eli Lilly and Company, Indianapolis, IN) was originally designed to deliver accurate doses in half-unit increments from 1 to 30 units. Laboratory testing examined the accuracy of the initial 0.5-unit dose within a 95/95% tolerance interval with respect to a specification of +/-0.5 unit (+/-0.005 ml).
After priming, operators recorded the first 0.5 unit. Data were analyzed using k-value targets.
While examining 577 half-unit doses per device lot, test temperature, operator, or test liquid, at least 95% of the doses were accurate with 95% confidence. All data points were within +/-0.5 unit (+/-0.005 ml).
Dose accuracy of the initial half-unit is achieved with the HumaPen Luxura HD insulin pen.
优伴笔畅易型胰岛素笔（礼来公司，印第安纳波利斯，印第安纳州）最初设计用于以0.5单位的增量准确注射1至30单位的剂量。实验室测试在95/95%的公差区间内检查了初始0.5单位剂量相对于±0.5单位（±0.005毫升）规格的准确性。
在进行预充后，操作人员记录首个0.5单位剂量。使用k值目标对数据进行分析。
在检查每批设备577个0.5单位剂量时，无论测试温度、操作人员或测试液体如何，至少95%的剂量在95%置信度下是准确的。所有数据点均在±0.5单位（±0.005毫升）范围内。
优伴笔畅易型胰岛素笔可实现初始0.5单位剂量的准确性。
