Requirements specification for PressCise : A study of the material mechanical properties of the No.14001 bandage

Abstract: Varicose veins is a condition, which affects numerous people. The condition is mostly not harmful but aesthetically unappreciated. Therefore many people choose to have them surgically removed. After the surgery is completed, the leg is bandaged, this for creating an ideal healing environment, without any complications occurring. It is important that a uniform pressure is distributed evenly along the bandaged leg, because high or low pressure can cause complications which prolongs healing. During the bandaging it is difficult to achieve an even pressure since the pressure varies due to the shape of the leg and who is bandaging the leg. PressCise has developed a compression bandage with a guide along the bandage, so that each bandaging will give the same pressure upon the leg. The bandage is designed after a specific mathematical formula that is derived from the law of Laplace. This means that no matter how thick or thin the leg is at different points, the pressure will distribute itself evenly over the entire bandaged leg. PressCise aims to obtain a CE-mark for the product before a launch. An analysis of demands and a wide test study therefor needs to be carried out. Demands and requirements for the product from different laws and regulations have been observed in order to determine which tests are necessary to execute. At this stage PressCise also needs to evaluate different parameters. To begin with, they need to see how the bandage behaves in different types of treatments, and secondly they need to evaluate the properties in order to give the correct information concerning usage and durability advices. In this report, a survey of the competitors was conducted in order to estimate which standards and tests the competitors are marketing their products with. An examination of the requirements of the product from the PressCise, CE marking and laws will be study, to see which demands and regulations lies upon the bandage. In this report a minor test study will be executed, where the product will go through a washing test, an abrasion test and a hysteresis test. The report will conclude with a requirement specification for the current product and its launching.