MEDICAL Where everything connects SafeT™ Stopcocks Lipid and drug Compatibility evaluation By Eldad Ohayon, Elcam Medical | Revision 2a, January 2020 Introduction The need for a more reliable stopcock increases in an ever-advancing industry objective towards a safer and efficient care-giving environment. Addressing lipid-induced cracking is one way to reach these objectives. Lipid and chemical induced cracks and leakages are considered under-reported adverse wan* • jj v\ \ - events or mistakenly attributed to other circumstances. Resin manufacturers have long been exploring options for a more robust resin that can better handle lipids and other aggressive solutions commonly administered, mainly through the IV route. As an answer to this need and as part of our continuous effort to enhance patient and caregiver safety, Elcam Medical is now incorporating the Eastman Tritan™ copolyester - a new, robust resin that can help minimize chemical and lipid-induced cracking in a new line of stopcocks - the Elcam Medical SafeT™ stopcocks. The SafeT™ stopcocks have been tested and proven to be resistant to 10 different drugs including lipid and other aggressive substances and IPA (propranolol). (Elcam-Medical Document # 099094). The abstract of this study is hereby described. Experiment Setup and Methods Three types of stopcocks with identical body design made of 3 different raw materials - Tritan, Polysulfone (PSU), and Polycarbonate (PC) - were exposed to 10 different drugs and one external alcohol-based disinfectant. • Fusid • Nimodipine • Vancomycin • Cyclosporine • Heparin • Noradrenaline • Phenytoin Sodium/ • Intralipid • Propofol • Actrapid Natrium • IPA The chosen drugs cover a range of clinical applications, with an emphasis on drugs which are known to be aggressive as well as various common drugs used to treat diabetes, blood pressure etc. The stopcocks were subjected to exposure periods of 48 and 96 hours in order to examine them under frequent and maximal product use durations. Overall 2112 stopcocks in 66 groups (3 types of stopcocks x 11 types of drugs x 2 exposure times), with each test group containing 32 stopcocks, were tested (66 groups x32 units per group). All tested stopcocks were naturally aged for one year and underwent 80kGy radiation and 2 cycles of Ethylene Oxide (EtO) sterilization. Fax: 972-4-698-0777 Baram 1386000, Israel | [email protected] 'Z Elcam MEDICAL Where everything connects 0 Elcam Devices § Elcam Stopcocks S Elcam Compo

" Elcam SafeT™ Stopcocks Lipid and drug Compatibility evaluation The tested stopcocks were assembled together in a chain formation and fastened with an applied torque of 20 In^Oz. Exposure testing was conducted by filling the chain of stopcocks with the tested solution/drug. Stopcock handles were adjusted in such a manner that the liquid reached all the passes including the side port. A visual test using a magnifier and a leakage test were conducted once the exposure times to the drugs (after 48 and 96 hours) were completed. 4 of the Tritan groups (2 from each time frame) were also tested after...

Figure 1 Results of stopcocks exposure to Intralipid Intralipid 4 70%_ Table 1 Type of drug tested - Test Results Fax: 972-4-698-0777 Baram 1386000, Israel | [email protected] 'Z Elcam MEDICAL Where everything connects □ Elcam Devices El Elcam Stopcocks El Elcam Components

SafeT™ Stopcocks Lipid and drug Compatibility evaluation Results of stopcocks exposure to Phenytoin sodium Percentage of failed parts Percentage of failed parts Results of stopcocks exposure to Cyclosporine Exposure time (hours) 96 Exposure time (hours) Conclusions The Tritan stopcocks withstood exposure to all drugs and disinfectants tested in this trial. The Polycarbonate stopcocks withstood all the materials except for Phenytoin Sodium / Natrium and Cyclosporine, and continue to be limited for use with Intralipid for up to 24 hours. The Polysulfone stopcocks withstood exposure to most of the...