ENT and Plastic Surgery Products Catalog 2013 Distributed in the US by: surgical products Office: 513.321.0055 Fax:513.321.0797 [email protected] www.acemedicalco.com I CLEANING & STERILIZATION The methods discussed have been validated for cleaning and sterilizing medical devices distributed by Invotec International and other fine surgical instrument suppliers. They have been developed using standard equipment and practices common to most health care facilities. Manual cleaning methods, steam and ETO sterilization were used as much as possible. The Sterilization Guidelines presented are based on type of product, placed into specific categories. CATEGORY TYPE OF PRODUCT Instruments with rough surfaces Applicators, burs, rasps, brushes, curettes Instruments with sliding hinges Adenotomes, forceps, punches, rangers Instruments with screw pivot hinges Scissors, specula, retractors, calipers Instruments whose surfaces that can be marred, scored, or Mallet heads, cutting blocks, Instruments made of or having scratched. Optim® or Delrin® surfaces, specula, mixing bowls. Instruments with lumens and channels Suction tips, cannulas, needles. RECOMMENDED CLEANING SUPPLIES • Enzyme solution (i.e. Klenzyme®), detergent (Manu-Klenz®) lukewarm water, soft bristle brush, and a clean soft towel. • Detergents: Proteolytic enzymatic detergents with a pH range between 6.0 and 8.0 should be used. These detergents have nonionic surfactants. Detergents should be used in a concentration level recommended by the manufacturer. NOTE: Undiluted detergents and those with pH's greater than 8.0 can strip the coloration from metal instruments. • Ultrasonic Cleaners designed for fine cleaning of medical devices. CLEANING PROCEDURE • Soak for a minimum of two (2) minutes in enzyme solution • Rinse thoroughly under lukewarm water • Manually clean with a soft bristle brush while immersed in a detergent solution, paying close attention to crevices and hard-to-clean areas. • If using a power washer, close adherence to washer manufacturers’ procedures should be followed. • Rinse thoroughly under lukewarm water • Dry with a clean soft cloth • Visibly examine for damage, rust deposits, and cleanliness. STERILIZATION RECOMMENDATIONS PREVACUUM PREVACUUM GRAVITY GRAVITY CHEMICAL CHEMICAL PERACETI GAS DEVICE TYPE EO WRAPPED UNWRAPPED UNWRAPPED WRAPPED DISINFECTANT STERILANT C ACID PLASMA Rough Surfaces YES YES YES YES YES YES YES YES YES Sliding Hinges YES YES YES YES YES YES YES YES YES Lever Hinges YES YES YES YES YES YES YES YES YES Screw Pivot YES YES YES YES YES YES YES YES YES Lumens YES YES YES YES YES YES YES NO YES Sterilization YES YES YES YES YES YES YES NO NO Trays Steam Sterilizable YES YES YES YES YES YES YES YES YES Endoscopes A “NO” indicates Invotec International does not have the data to support the recommendation of the specific method of sterilization for a given category. II CYCLE PARAMETERS Prevacuum cycle (wrapped and unwrapped): Three (3) preconditioning pulses with a minimum exposure time of 4 minutes at 270˚F (132˚C). Gravity cycle (wrapped): 270˚F (132˚C) with a minimum exposure time of 15 minutes. Gravity cycle (unwrapped): 270˚F (132˚C) with a minimum exposure time of 10 minutes. ETHYLENE OXIDE CYCLE STERILANT TEMPERATURE HUMIDITY PRECONDITIONING CONCENTRATION EXPOSURE 100% EO 131˚F (55˚C) 65-75% 1 hour 725 mg/l 120-360 minutes Aerate a minimum of 12 hours at 131˚F (55˚C) LIQUID CHEMICAL CYCLE CONCENTRATION OF EXPOSURE FOR EXPOSURE FOR TEMPERATURE GLUTARALDEHYDE DISINFECTION STERILIZATION 2.4% 77˚F (25˚C) 45 minutes 10 hours PLEASE NOTE: • Implants are sold as one-time use items and not intended for re-sterilization. • Most reusable instruments are sold nonsterile. These devices should be placed into suitable packaging for the sterilization process (i.e., central supply wrap (CSR), autoclave bags, paper/Tyvek® pouches, dedicated sterilization trays and sterilized prior to use. • All instruments should be examined and cleaned prior to sterilization. III aCCEssORiEs RR && RHinOLOgy anD COsmETiC suRgERy Swiss Therapy™ cold therapy 1 CC Ss A a Chin implants 2 CC CC Malar implants 3 Implantable silicone blocks 3 Nasal dorsal implants 4-5 DD Silicone sheeting, tubing and blocks 6 isis Septal buttons 6 Internal nasal splints 7-8 External nasal splints 9 OO Sponge Dressing and packing 10-11 TT OO Gelatin packing 12 A a CC CC Gel Dressing 13 Silicone epistaxis balloon 14 Rhinology knives and blades 15 OO Ss Ss DisPOsaBLE suCTiOns Rhinologic and Otologic 19-21 TT nn OTOLOgy Dressing and packing 25 EE Burs - Ultrabur Drill 26 LALa RR Myringotomy knives & ENT blades 27-28 A a TT CC Myringotomy kits & specula 29 CC nn Ventilation tubes 30-32 Otovent® middle ear auto inflation 33 OO Ss PP EE CC OssiCuLaR PROTHEsis Incus 37-38 ac aC cC Incus-Stapes 39 Partial 40-41 Total 42-43 RR HH Serenocem 44 i ini in Canal Wall 45 ss Caps and Shoes 45 Stapes 46-47 Bucket Handles 48 PP Nitinol Stapes 49-50 SBsB Instrumentation 51 Trials 52 Accessories 53 OO tT OO LaRyngEaL Tracheal t-tubes 57 in in ss Disposable adenoid curettes 57 Surface electrodes 57 LL aa sPECiaLTy PRODuCTs Lighting systems 61-64 rR in in Micro electro dissection needle 65 ss Ophthalmic sponge packing 65 Cotton tipped applicators 66 OO RR Anti-fog 66 OO // nn Headrest 66 aa ss Sterilization trays 67 in in ss RHinOLOgy insTRumEnTs Telescopes 71-72 Forceps 73-81 Antrum punches, back biters and kerrisons 82-87 Nasal Scissors 88-92 Knives and blades 93 Osteotomes, chisels and saws 94-97 Elevators and probes 98-99 Septum instruments 100-101 Curettes 102-103 Speculas 104-106 Retractors, hooks 107-110 Rasps 111-113 Sinus Suction Tips 114-115 Mallets 116 Needle Holders, Wire twisters 117-120 Tissue thumb forceps 121 Miscellaneous nasal and sinus 122-124 Measuring instruments 125 PaRanasaL, skuLL BasE, PiTuiTaRy insTRumEnTs Retractors 129 Forceps 130-131 OTOLOgy insTRumEnTs Tuning FORks Tuning Forks 135 ExTERnaL EaR CanaL insTRumEnTs Ear Speculum 136-137 Ear Curettes 138 Loops & Hooks 139-141 Probes 141 Tympanum Perforators 142-143 Ear Catheters 144 Air Bags 145 Powder Blower 145 miDDLE EaR insTRumEnTs Instrument Set 146 Suctions 147-148 Elevators 149-150 Snares 151 Rongeurs 152 Ear Forceps 153-158 Ear Scissors 159 Malleus Forceps 160 Needles/picks 161 Hooks 162-163 Tympanoplasty Knives 164-167 RR Micro Elevators 168-169 &C&C Ss Stapes Curettes 170 A a CC Footplate Drill 171 CC Mobilizers 172 Measuring & Cutting 173 DD isis LaRyngEaL insTRumEnTs OO TT OO A a miCRO LaRyngOsCOPy Operating Largyngoscopes 177-178 CC CC Scissors and Forceps 179-185 Micro Knives and Elevators 186-187 Suctions 188-189 OO Injection Needles 190 Ss Ss LasER miCRO suRgERy Suctions and Protectors 191-192 BROnCHO-EsOPHagOsCOPy Forceps 193-196 LALa RR Suctions 197 A a CC Accessories 198 CC sS PP EE a a ORO-nasOPHaRyngEaL insTRumEnTs Cc Cc Adenotomes 201 Adenoid Currettes 202-204 RHRH Laryngeal Mirrors 205-206 i ini in ss Mouth Gags - Tongue Depressors 207-213 Retractors 214-216 Tongue Spatulas 217-219 Nasopharynx Forceps 220-223 PP Ss Tonsil Artery Forceps 224-225 BB Tonsil Seizing Forceps 226-227 Tonsil Knives 228-229 Tonsil Screws 230 OO tT Tonsil Dissectors 231-232 OO Tonsil Scissors 233-234 in in ss Tonsil Snares 235-237 Tonsiltome 238 Tonsilletomy Instruments 239-240 LL aa Tonsil Needles 241 rR in in Suctions 242-243 ss Tonsil Accessories 244 OO RR OO // nn aa ss in in ss RHInOLOGY & COSMETIC aCCEssORiEs RR && Swiss Therapy™ CSCs A a Chin Implants CC CC Malar Implants Implantable Silicone Blocks Nasal Dorsal Implants D Silicone Sheeting, Tubing, Blocks is Septal Buttons Internal Nasal Splints External Nasal Splints O T Sponge Dressing and Packing O A Gelatin Packing C C Gel Dressing Silicone Epistaxis Balloon Rhinology Knives and Blades O S S L A R A C C S P E a c c R H i in s P S B O t O in s L a r in s O R O / n a s in s