75. www.clearsurgical.com

76. Oplight 180 TM

78.  Illumination of surgical cavities can be provided by:  overhead lamps  headlamps  non-self retaining retractors with fiber optic cable attachment  theatre staff holding and directing a torch.  Preferred method is fibre optic cable that connects to a retraction system. Current Situation Oplight 180 TM

79. Current Situation Oplight 180 TM

80.  Top down illumination can create shadows within the cavity.  Light may not reach the deepest part of the incision.  Retractor systems take time to set up.  Extra retractors can clutter the incision area.  Fibre optic cables can clutter the operating field.  Safety implication of the fibre optic cable Current Situation Oplight 180 TM

81. Solution  Two functions in a single device  Design of conventional self-retaining retractor with battery powered light source  Reduce shadowing  Light source in both sides  Single use  Reduces risk of cross contamination between patients Oplight 180 TM

82. A single patient use self retaining retractor with in-built cold light source. The Illuminated Retractor holds open and directly illuminates a surgical cavity.

83. Oplight 180 TM

84. Market sample ProcedureUKEUUSROW Breast Axillary45,000280,000220,000135,000 Hernia85,000535,000500,000250,000 Fem-Pop6,50040,00035,00019,000 Appendectomy40,000270,000210,000130,000 Others- cholecystectomy, splenectomy, pancreatic surgery, pelvic, colorectal and more Oplight 180 TM

85. Design Development

86. Oplight 180 TM Final Design Comparison

87. Oplight 180 TM  Apparatus is Class 2a sterile medical device  ISO13485  Electronics  Medical EMC Standard EN60601  LED safety guidelines  IEC/EN 62471  ANSI IESNA RP 27 Regulatory

89. Cannulated Reduction Forceps

92. Clinical Uses  General Trauma Equipment  Specialist Equipment including Radiolucent Implants  Interaction with locking plates  External Fixation - pin & wire placement including Circular Frames with ‘Olive’ wires  Syndesmotic injuries including Endobuttons  AC joint injuries  Elective Surgery - Implant alignment

93. Femur

94. Hip

95. Finger