Operating Room Product Portfolio Tony Phelps CONFIDENTIAL AND PROPRIETARY - FOR INTERNAL USE ONLY. NOT FOR PUBLIC DISPLAY OR COPYING UnoVac, HandyVac, MiniVac and OP-Flex are trade marks of Unomedical a/s. Realize the possibilities is a trade mark of ConvaTec Inc. All other trade marks are the property of their respective owners. © 2012 ConvaTec Inc. AP-013148-MM EM Operating Room Product Overview Operating Room Wound Drainage Systems UnoVac™ System HandyVac™ System CONFIDENTIAL & PROPRIETARY Suction Systems Passive Drainage High Vacuum Standard OP-Flex™ Range OP-Flex ™ Flexible Yankauer System 1 High Vacuum System HandyVac ™ ATS System Wound Drainage Systems HandyVac™ System CONFIDENTIAL & PROPRIETARY UnoVac™ System Passive Drainage System 2 Wound Drainage Drainage systems may be used to drain fluid, mostly blood, from surgical wounds after an operation. Low Vacuum Passive Drainage High Vacuum (except close to intestine and glands) CONFIDENTIAL & PROPRIETARY 3 Why do we need wound drainage? The process of facilitating and collecting post-operative bloodshed in order to avoid haematomas. Without drainage the fluid; • Is a medium for infection • Prolongs the healing process • Causes pain to the patient A key element in infection control and in facilitating the healing and mobilization process. CONFIDENTIAL & PROPRIETARY 4 The ideal wound drainage system Removes blood effectively Reduces the risk of wound infection Gentle to the tissue CONFIDENTIAL & PROPRIETARY 5 What Are Wound Drainage Systems? A sterile, single-use medical device consisting of:•Catheter – different types, sizes, materials (PVC or Silicone) • Trocar (usage optional) • Connecting Tube • Receptacle – Bottle / Bag • Bellows CONFIDENTIAL & PROPRIETARY 6 Where are they used? Predominantly where surgical procedures are performed; • Theatres – All specialities • Day Surgery Units • Recovery Wards will need to have stock of spare receptacles for replacement CONFIDENTIAL & PROPRIETARY 7 Types of Drainage Systems Low vacuum • HandyVac™ System • UnoVac™ System • MiniVac™ System Initial vacuum pressure • 50 – 120mmHg CONFIDENTIAL & PROPRIETARY 8 HandyVac™ System: Low vacuum system CONFIDENTIAL & PROPRIETARY 9 HandyVac™ System Hanger Bellows Connector 125 ml Clamp Bag Trocar 700 ml With/without bottom outlet CONFIDENTIAL & PROPRIETARY Drain 10 Non-Return Valves – infection prevention Non-Return Valve No reflux of fluids CONFIDENTIAL & PROPRIETARY 11 Suction Efficiency Excellent suction curve (invitro) - 25/65 mmHg Suction Pressure as a Function of Suction Amount HandyVac System with 700 ml bag. Ref nr. 400977182 • Minimises risk of hole closure • Minimises risk of tissue damage • Used for head, back and abdominal surgery Data on file. Test report: Suction pressure as a function of suction amount. 26 th September 2007. CONFIDENTIAL & PROPRIETARY 12 HandyVac™ System Low vacuum drain Initial vacuum pressure • 65mm Hg Bellows capacity • 125ml Bag • 700ml Drain Sizes • Ch 8,10,14,18 Bags with or without taps Two non-return valves (NRV) • Bag NRV prevents reflux • Drip chamber NRV – eliminates need for clamps Redon spiral drain CONFIDENTIAL & PROPRIETARY 13 HandyVac™ System Competitors Bellovac™ System Abdovac™ System Exudrain™ Mini System CONFIDENTIAL & PROPRIETARY 14 HandyVac™ System Competitors Redax™ Silicone System Redax™ System LowVac™ Plus System CONFIDENTIAL & PROPRIETARY 15 The UnoVac™ System CONFIDENTIAL & PROPRIETARY 16 UnoVac™ System Bag Bellows Protective cap 300 ml 600 ml Filter Trocar Ulmer drain CONFIDENTIAL & PROPRIETARY 17 How to establish the vacuum Press with two thumbs No clamps needed Simple and time saving CONFIDENTIAL & PROPRIETARY 18 Non-Return Valves – Infection prevention 2 Non-Return Valves CONFIDENTIAL & PROPRIETARY 19 What are the advantages of the UnoVac™ System? Low or passive drainage Supplied as a closed hygienic system With profuse secretion it is possible to change the bag Constant suction level Easy visual control of remaining vacuum High capacity of 900 ml ( bellows 300 ml / bag 600 ml) CONFIDENTIAL & PROPRIETARY 20 Suction Efficiency Suction Pressure as a Function of Suction Amount UnoVac™ System Excellent suction curve (invitro) - 110/95 mmHg to 50/60mmHg • Minimises risk of hole closure • Minimises risk of tissue damage Almost full Start • Suction Peak- almost full Passive drainage Data on file. Test report: Suction Curves at 15 ºC and 25 ºC . 6 th February 2001. CONFIDENTIAL & PROPRIETARY 21 Low Vacuum – MiniVac™ System Small 30ml bellows Initial suction vacuum • 80 mmHg Sizes • Ch 6 Redon spiral PVC drain • Ch 8 Ulmer PVC drain Used primarily in • Faciomaxillary (MaxFax) • Head & Neck surgery • Hand surgery CONFIDENTIAL & PROPRIETARY 22 MiniVac™ System Competitors Mini-Exuvac™ System (Minimed/procar3e/GB-UK) Exudrain™ Mini System (Astratech) Red-0-pak™ System (Vygon) Mini Redovac™ System (B.Braun) LOW VAX™ System (Athrodax) CONFIDENTIAL & PROPRIETARY 23 High Vacuum CONFIDENTIAL & PROPRIETARY 24 High Vacuum System Initial vacuum pressure • Above 400mmHg 600ml bottle • Drain sizes Ch 10,12,14,16,18 400ml bottle • Drain sizes Ch 10,12,14,16 Non Return Valve • 600ml bottles only Redon spiral drain CONFIDENTIAL & PROPRIETARY 25 High Vacuum - Competitors Redovac™ System (B.Braun) PREVAX™ / Econovax™ Systems (Athrodax) Drenofast™ (Nikomed) Safe-t-Vac™ System (Pro-Care/Minster/Meddis/GBUK) Medinorm™ System (Summit) CONFIDENTIAL & PROPRIETARY 26 Passive drainage Passive No negative pressure • gravity only (25mmHg) Ulmer drain Soft 90cm tube 700ml drainage bag Sizes Ch 20,24,28 CONFIDENTIAL & PROPRIETARY 27 Passive Drain - Competitors Robinson System (Portex) Drentech System (Summit) CONFIDENTIAL & PROPRIETARY 28 Drains 29 Unomedical Range of Drains Single use solid trocar PVC or Silicone drains Different perforations Detectable X-ray line Black indicator marks CONFIDENTIAL & PROPRIETARY 30 Wound Drain Perforations Corrugated drain Spiral drain Redon drain Slit drain Ulmer drain CONFIDENTIAL & PROPRIETARY Silicone drain 31 Silicone vs. PVC Silicone is inert (does not react with tissue),soft and pliable. Enviromental issues with PVC – clorinated by-products of incineration. Silicone: the most researched and tested material for implantable applications. CONFIDENTIAL & PROPRIETARY 32 Flat Drain Radiopaque Multiple narrow ducts provide fluid entry at any point CONFIDENTIAL & PROPRIETARY 33 Features of Round Drains Offers multiple drainage routes to resist clogging Four continuous channels provide greater tissue contact area than regular perforated drains Smaller, more flexible tube Constructed of silicone with solid center designed for strength and flexibility CONFIDENTIAL & PROPRIETARY Due to channel design, removal may be less traumatic to surrounding tissues in comparison to designs with holes 34 Filter Flow System Various OP-Flex™ Range of Suction Systems Flexible Yankauer Standard CONFIDENTIAL & PROPRIETARY 35 Suction in Surgery CONFIDENTIAL & PROPRIETARY 36 Why is suctioning neeeded in surgery? During operations it is necessary to remove blood and fluid in order to maintain an unobstructed view of the operating are and organs. The surgeon uses suction handles (linked to vacuum) of different kinds to keep the area free of blood and fluids to have a clear view of the surgical field. The production of a vacuum or partial vacuum in a cavity or over a surface - so that the external atmospheric pressure forces the surrounding fluid or blood, into the suction handle – through the tubing to the canister on the floor. CONFIDENTIAL & PROPRIETARY 37 The handle is THE tool for the surgeon CONFIDENTIAL & PROPRIETARY 38 How does a vacuum source work? An operation suction set consists of a suction handle and a connecting tube. The connecting tube is connected to a canister which can be either reusable or disposable. The canister is connected to a vacuum source having a vacuum of 2-400 mmHg mm/Hg CONFIDENTIAL & PROPRIETARY 39 Historic Overview - Yankauer Developed approximately 1907 by Dr. Charles Yankauer, the Yankauer Suction Instrument has become the most common suction instrument in the world. It's primary use is to aspirate fluid and debris from either a surgical site or orifice, e.g. the mouth. CONFIDENTIAL & PROPRIETARY 40 Yankauer Tips Conventional yankauer – all surgeries Tapered yankauer – narrow cavities Flattened yankauer – between nerves and muscle fibres Sump yankauer – delicate tissue Super Flow – AAA or trauma Poole – delicate tissue CONFIDENTIAL & PROPRIETARY 41 OP-Flex™ Suction Handles Tapered Flattened Conventional Sump Poole CONFIDENTIAL & PROPRIETARY 42 OP-Flex™ Range Ergonomic Suction handle Different tips available CONFIDENTIAL & PROPRIETARY With/without Vacuum control Detachable – easy to change 43 OP-Flex suction handles are supplied both with and without vacuum control When the hole is uncovered there is no suctioning. CONFIDENTIAL & PROPRIETARY When the hole is covered suctioning takes place. 44 Detachable Handles CONFIDENTIAL & PROPRIETARY 45 Relieving Eyes Relieving eyes Designed to minimise the risk of tissue damage CONFIDENTIAL & PROPRIETARY 46 OP-Flex Connecting Tube Anti-kink connectors • Unrestricted flow through the system • Full maneuverability in all positions. • Cut -to-fit connector at the distal end to enable a fit to all canisters CONFIDENTIAL & PROPRIETARY 47 Anti-kink Connector Unrestricted flow through the system with no risk of stopping the suctioning due to kinking. Full maneuverability in all positions which is very important as the surgeon will often have very limited space CONFIDENTIAL & PROPRIETARY 48 Cut-to-fit Connector - Universal To enable a fit to all canisters CONFIDENTIAL & PROPRIETARY 49 OP-Flex™ Flexible Yankauer Handle Ergonomic handle Non-slip safe-grip groove. Flexible bendable tip Precise handling & maximizes protection of internal organs. Transparent material Easy observation of blood. Integrated basket Increases the safety of loosing the tip. CONFIDENTIAL & PROPRIETARY Integrated universal connector Secures firm connection to suction tube. 50 Competitors Tyco Dahlhausen Pennine Astra 55 The OP-Flex™ FilterFlow Suction Set CONFIDENTIAL & PROPRIETARY 57 What is included in the Op-Flex™ FilterFlow Set? FilterFlow handle containing a filter. One extra filter included. 3 tips packed in set •1 short bent •1 long bent •1 long straight Indication Intra femoral suctioning. OP-Flex connecting tube. Single packed filters are available in boxes of 20 CONFIDENTIAL & PROPRIETARY 58 FilterFlow Filter Patented filter system prevents inconvenient and time-consuming blockages. The patented cross-flow filter allows fluids to pass through with minimal damage, yet traps debris that could clog conventional suction sets. CONFIDENTIAL & PROPRIETARY 59 he OP-Flex™ Frazier Suction Handle With/without Vacuum control 2 different lengths Graduated connector Malleable Tip with stylette X-Ray line CONFIDENTIAL & PROPRIETARY 60 Where are Frazier Handles used? Neurological surgery Plastic surgery Cardiac surgery Ear-Nose-Throat Other operation field where a small suction handle is used to access CONFIDENTIAL & PROPRIETARY 61 Close up features Flexible due to the stylette Vacuum control CONFIDENTIAL & PROPRIETARY Easy to connect to tubing 62 Disarp™ - Disposable Abdominal Retracting Pad Unique UnoMedical product X-ray detectable 45 cm and 25 cm lengths The Disarp™ Device was developed to protect and retract soft tissue during surgery in order to keep the operating field visible, clean and free of blood and fluids. CONFIDENTIAL & PROPRIETARY 63 Benefits of the Disarp™ Device Can be bent into desired position. Can be placed in small areas in the operation field. Excellent absorption of blood and fluids. X-ray detectable. Absorption capacity of short Disarp 100ml. Absorption capacity of long Disarp 200ml. CONFIDENTIAL & PROPRIETARY 64 Retractorpads™ – Competitor CONFIDENTIAL & PROPRIETARY 65 Inserting the Disarp™ Device CONFIDENTIAL & PROPRIETARY 66 Decision Makers in the Hospital – OR products Surgeon Nurse Economic Decision Maker X Clinical Decision Maker X X Economic Influencer X X Clinical Influencer X X Economic Gatekeeper Clinical Gatekeeper CONFIDENTIAL & PROPRIETARY X Purchaser Tender X X X X X X X 67