OrthoHeal PVT. LTD. Healing Comfortably > INTRODUCING % FlexiOH™ he NextGeneration johilizaton AWARDS AND RECOGNITION oe SUPPORTED BY co INDUSTRIAL INNOVATION AWARDS 2016 ok sia ¥y : ‘ Ov XBCIL BistESIEN = BE DiracFlexiOH™ The NextGeneration Bone Immobilizaton Technology FlexiOH™ is the first of its kind- an orthopedic cast that has the rigidity to hold the fractured part as well as it ensures proper skin ventilation. FlexiOH" comes as an easy to fix wearable material on the fractured part. After wearing, light ‘treatment completes the curing process and making the FlexiOH™ cast rigid. This process is quick and hardly takes 10 minutes. After course of therapy, FlexiOH™ can be removed without use of any other external cast cutter/spreader. Design and material of FlexiOH™ are engineered to provide superior comfort to patient. A foam, which is in contact with the skin, is biocompatible (ISO 10993-10 certified) and provides cushioning against hardened polymer. The cast is so designed that the intermittent hollow spaces facilitate circulation of air and evaporation of ‘sweat / water from the skin surface. Radiolucency of FlexiOH™ does not interfere with the radiological imaging and diagnosis. INTENDED USE * Non-displaced / * Minimally displaced / * Buckle fracture of Distal Radius Fracture * Carpal Bone Fracture other than Scaphoid / Trapezium * As a Removable splintSOLUTIONS FlexiOH™ provides these robust solutions for major issues related to conventional casts : Ensuring proper ventilation to the skin that prevent skin infections, Facilitating washing of the fractured part with water without any damage to the cast/skin. Ensuring that day to day activities done with ease because of light weight of the cast. without use of any other external cast | d | Zip system makes easy to apply and remove cutter/spreader. TECHNICAL SPECIFICATION Materials: Silicon rubber (USP IV), Light curable resin and Nitrile rubber foam Weight ~300 gms /~10.5 02 Curing System: RizyCure™ Light System. Direct sunlight UltimateTensile Strength: 1.25 KN (410%) Ultimate Compression Strength: | 3.5 kN (#10%) SIZE CHART SRLS) ay | ally | at Palm Circumference: | 175mm | 190mm | 215mm Wrist Circumference: | 169mm | 170mm | 190mm ‘Arm Circumference: | 215mm | 235mm | 285mm FlexiOH Length: 255mm 305mm 355mm. Notes * Measurements are gen of Short Arm Cast which fits best on adults. * Circumference sizes given are minimum, it can be stetched up to 15% to fit larger circumference. RizyCure” The Portable Rechargable Light Device Rizycure™ is the handheld light system which is high intensity portable blue light, developed by OrthoHeal Private Limited. Rizycure™ is visible blue light device, specially designed to cure FlexiOH™- an innovative orthopedic cast. It is very easy to.use and has been made for the doctors’ convenience. One full charged, Rizycure™ Light System can cure 3-4 FlexiOH” cast in a row without recharging. Once it indicates half battery, you need to charge it again for ~120 minutes for uniform intensity. APPLICATION OF RIZYCURE™ LED LIGHT SYSTEM Use of RizyCure™ Light System is to cure FlexiOH™ cast with high intensity uniform blue light, which gives deep and smooth curing. You need to just expose the uncured region moving slowly and firmly over every comers and regions and make sure that it has been cured properly and becomes rigid. Recommended time to cure the cast with light is 4-5 minutes. Before using of RizyCure”, check the battery level indicator. Press ON/OFF button to operate the Light Use only provided charger with RizyCure™ Light System. It is recommended that after curing 3-4 FlexiOH™, Charge again before using itPRECAUTIONS: TECHNICAL SPECIFICATION If you determine that the RizyCure™ Weight of ight 156 gms becomes hot or you observe change in sé color or shape, switch it off immediately. Cink ofcheer, a The device must not be used again and | Dimensionoflight_| 138mm x 67mm x22mm needs to be replaced. Equipment class Class * Do not use RizyCure™ while connected to Battery ype Liion 18650 3.7¥/2000mAn the charger or in case of low intensity/ LOW terycharging time | Approx 120 minute/2 Hrs battery . * Do not open the RizyCure™ Light System or _|_Batterylife psd cya} charger. Output Power ~3 Watt * Keep away from children / Do not let | Lightintensty 2030 mW/em2 children to play with this. Wenlenh Sa eae * Use goggles while using Rizycure™ to avoid Light chargerinput__| 110V-240vAC.S0H2 eye fatigue. Light charger Output __| DC 5V-1Amp(max) SAFETY GUIDELINE Operation control ON/OFF © Before switching “ON” light, put on Z87 +EN166 standard (yellow colour) goggles i i (yellow colout) gogal Protection from shock | Type ® provided with the Rizycure™ Light system. — Do not see the light directly with naked | OPetatng end Storage 010 108" (010 40°C) 10810 95% temperature relative huity(non condensin * eyes as it may create slight discomfort for " Reese oecenues See few minutes. 1060-hPa) atmospheric pressure. Operating life of light | Approx. 35 minutesAPPLICATION PROCESS STEPS: Take FlexiOH™ cast from the kit and place it in such a way that thumb holds it like an anchor. Pull the cast / splint toward patient's body and adjust the thumb hold to patent's comfort level. Pull FlexiOH™ cast / splint from both side to wrap it over the hand. It is quite flexible to pull from both zipper line closer to apply zipper. To start zipping process, insert insertion pin into retainer box. To do this zipper line needs to be aligned close to each other. Now start zipping with the help of puller attached with the retainer box. Take care of below skin and hair follicles for smooth zipping process, After zipping, expose FlexiOH™ cast with RizyCure™ light device or into direct sunlight for about 4-5 minutes. Try to expose cast uniformally so that the cast / splint can be 100% cured.sf BIOMAY BIOMEDICALS PVT. LTD. hs] Ey | TECHSUPPORT RELIABLE SERVICES ACKNOWLEDGEMENT (Fcct Bim If MEDIA PARTNERS #startupindia Se ¢! iS as Flex]0H™ has been developed under the Department of Biotechnology Government of India supported by School of AT Iernational Biodesign Programme (SiB), whichis being Implemented st All India Institute of Medical Sciences (AIMS),