Instructions for Aesculap models including: SterilContainer System
Aesculap SterilContainer™ System Instructions for Use (IFU) SOP-AIC-5001592 Rev. 06 Intended for US Only As of June 2020 Page 6 of 83 The System is designed to be processed on a daily basis and provide years of continual use.
Aesculap® SterilContainerTM System Instructions for Use Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities Instructions for Use Intended for US Only As of June 2020 SOP- AIC- 5001592 Rev. 06 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table of Contents 1.0 PURPOSE OF INSTRUCTIONS FOR USE .......................................................................................................................... 4 2.0 STERILCONTAINERTM SYSTEM ......................................................................................................................................... 4 3.0 STERILCONTAINERTM SYSTEM SERVICE ......................................................................................................................... 7 4.0 DECONTAMINATION AND CLEANING PROCESS........................................................................................................... 8 4.1 Wat er Qualit y..............................................................................................................................................................................................8 4.2 Det ergent Solut ions...................................................................................................................................................................................9 4.3 Decont aminat ion and M echanical Cleaning.......................................................................................................................................9 4.4 Decont aminat ion and M anual Cleaning ........................................................................................................................................... 10 5.0 INSPECTION PRIOR TO USE...........................................................................................................................................11 5.1 ................................................................................................................................... 12 5.2 6.0 6.1 Basket , Tray and Plat f orms Inspect ion Crit eria ............................................................................................................................... 14 PREPARATION AND ASSEMBLY OF STERILCONTAINERTM SYSTEM .......................................................................... 14 St erilCon .................................................................................................................................................... 15 6.2 Assembly of Surgical Inst rument at ion .............................................................................................................................................. 17 6.3 Loading of Basket , Lif t ing Plat f orm and Tray .................................................................................................................................. 17 6.4 Int ernal Process Indicat ors................................................................................................................................................................... 18 6.5 Ext ernal Process Indicat ors and Tamper Evident Seals................................................................................................................. 18 6.6 Cont ainer St orage and Transport at ion .............................................................................................................................................. 20 7.0 STERILCONTAINERTM SYSTEM STERILIZER CYCLE PARAMETERS -- STEAM AND ETO...........................................21 7.1 St eam and Et O St erilizat ion M odalit y Cycle Paramet ers ............................................................................................................. 22 8.0 STERILCONTAINERTM SYSTEM STERILIZER CYCLE PARAMETERS -- ASP STERRAD® .............................................. 29 8.1 STERRAD® St erilizat ion M odalit y Cycle Paramet ers...................................................................................................................... 30 9.0 STERILCONTAINERTM SYSTEM STERILIZER CYCLE PARAMETERS -- STERIS® V-PRO®............................................40 9.1 STERIS® St erilizat ion M odalit y Cycle Paramet ers .......................................................................................................................... 41 10.0 STERILCONTAINERTM SYSTEM STERILIZER CYCLE PARAMETERS -- STERIZONE®...................................................47 10.1 STERIZONE® St erilizat ion M odalit y Cycle Paramet ers.................................................................................................................. 48 11.0 ASEPTIC PRESENTATION ............................................................................................................................................... 52 11.1 .............................................................................................................................. 55 11.2 ................................................................................................... 55 12.0 STERILE CONTAINER VALIDATION SUMMARY ........................................................................................................... 55 12.1 Validat ion Test ing ................................................................................................................................................................................... 56 12.2 ............................................................................................................ 57 13.0 CUSTOMER VERIFICATION ............................................................................................................................................ 58 14.0 INDICATIONS FOR USE .................................................................................................................................................. 62 14.1 St eam and Et O St erilizat ion................................................................................ 62 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 2 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.2 PreVac IUSS St erilizat ion ................................................................................................................................. 63 14.3 JK / JN744 PreVac St eam, IUSS and Et O St erilizat ion ............................................................................. 63 14.4 TM Lid .............................................................................................................................................. 64 14.5 TM Pro Lid....................................................................................................................................... 64 14.6 Reusable Filt er ............................................................ 65 14.7 JS Series................................................................................................................................................................ 65 14.8 STERRAD® 100S.............................................................................................................................................. 71 14.9 .................................................................. 72 14.10 St eri STERRAD® 100NX EXPRESS Cycle.............................................................................................................. 72 14.11 STERRAD® 100NX DUO Cycle...................................................................................................................... 73 14.12 STERIS® V- PRO® 60 St eri .................................................................................................. 74 14.13 STERIS® V- PRO® maX Flexible Cycle .................................................................... 76 14.14 STERIS® V- PRO® 1 and V- PRO® 1 Plus ................................................................. 77 14.15 STERIZONE® VP4 ......................................................................................................... 78 14.16 S JS Series Et O, STERRAD®100NX DUO & STERIZONE® VP4 ...................................................................... 79 List of Figures ..........................................................................................................................................................4 ................................................5 Figure 3: PrimeLineTM Pro Lid Inspect ion Process ............................................................................................................................. 10 Figure 4: Filt ers f or Perf orat ed Bot t oms and Lids ............................................................................................................................ 15 Figure 5: Tamper Evident Locks............................................................................................................................................................. 19 Figure 6: Indicat or and Communicat ion Cards ................................................................................................................................. 19 Figure 7: Easy Ref erence Handout ....................................................................................................................................................... 55 List of Images Image 1: Single Use Processing Supplies, Filt ers, Tamper Evident Locks, Indicat or Cards........................................................6 Image 2: JK, JN and JM Lid Reusable Filt er Inspect ion................................................................................................................... 12 Image 3: Filt er Ret ent ion Plat es and Silicone Gasket s Inspect ion Process................................................................................ 13 Image 4: PrimeLineTM Lid Inspect ion Process..................................................................................................................................... 13 Image 5: Aluminum Lid w it h M et al Ret ent ion Plat e and Reusable Filt er.................................................................................. 16 Image 6: Aluminum Lid w it h M et al Ret ent ion Plat e and Single Use Filer Assembly.............................................................. 16 Image 7: PrimeLineTM Lid Inspect ion Process..................................................................................................................................... 16 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 3 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 1.0 Purpose of Instructions for Use The purpose of t his document is t o: Describe t he component s of t he Syst em, how each should be used, and w hich component s can be used t oget her in each of t he st erile processing modalit ies. Provide det ailed inst ruct ions on how t o use, decont aminat e, clean and process t he Syst em properly in dif f erent st erilizat ion modalit ies. Give guidance f or verif ying t he Syst em in your f acilit y and applicat ion. Inst ruct ions included in t his document are based on validat ion t est ing by Aesculap® in a medical device t est ing laborat ory using w orst case scenario. Each f acilit y should ensure t heir processing syst em provides similar result s. Personnel t raining and compet ency is required t o perf orm all phases of processing. Equipment , wat er supply, and pract ices all cont ribut e t o providing an ef fect ive reprocessing syst em and should be monit ored by t he facilit y. 2.0 SterilContainerTM System The Aesculap® Syst em is a reusable rigid cont ainer syst em used f or t he packaging, t ransport at ion, and st orage of inst rument s prior t o, during, and aft er st erilizat ion. It consist s of t he various sizes of cont ainer bot t oms, cont ainer lid, and basket opt ions, and Aesculap® accessories such as inst rument holders, basket s, f ilt ers, indicat or cards and t amper evident locks. The f irst t w o let t ers of t he part number are t he series name, and ident if y t he product f amily and at t ribut es of each bot t om and lid. See chart . Each cont ainer bot t om must ONLY be used w it h t he specif ic lid designed f or t hat series of cont ainer, and it should not be combined wit h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. Product Family Bottom Series Lid Series3, 5 SterilContainerTM SterilContainerTM S SterilContainerTM S2 JK JN Solid, Perf orat ed, Anodized Anodized JK PrimeLineTM4 PrimeLine Pro4 JK PrimeLine4 PrimeLine Pro4 JM Perf orat ed, Non- Anodized JM JS Perf orat ed, Anodized JS PreVac Steam X X X X X X X X PreVac IUSS X X X Gravity X X X EtO X X X X Low Temp STERRAD®1 Low Temp STERIS®2 Low Temp STERIZONE6 X X X X X X 1. See sect ion 8.0 Syst em St erilizer Cycle Paramet ers ASP STERRAD® f or more det ails on st erilizer cycle det ails. 2. See sect ion 9.0 Syst em St erilizer Cycle Paramet ers STERIS® V- PRO® f or more det ails on st erilizer cycle det ails. 3. JK, JN, JM , JS and PrimeLine Pro lids are made of aluminum. PrimeLine is made of High- Grade, Thermost able Plast ic. 4. PrimeLine and PrimeLine Pro lids have a reusable f ilt er and are only available f or JK and JN Series f ull- size, t hree- quart er size and half size cont ainers. 5. See 6.0 Preparat ion and Assembly of Syst em f or f ilt er modalit y compat ibilit y. 6. See sect ion 10.0 Syst em St erilizer Cycle Paramet ers STERIZONE® f or more det ails on st erilizer cycle det ails. Figure 1: SterilContainerTM System SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 4 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Throughout t his IFU document , ref erences t o t he Syst em include t he , S and t he S2 product families. Ref erences t o t he only include t he JK / JN Series of product s, ref erences t o S only include JM Series of product s, and ref erences t o S2 only include JS Series of product s. JJKK SSoolliidd BBoottttoomm JN Perforated Bottom JJSSPPeerrffoorraatteeddBBoottttoomm, IIddeennttiiffiieedd bbyy tthhee GGoolldd HHaannddllee && LLaattcchh The Syst em f ull, t hree- quart er and half size JK Series and JN Series have t hree lid opt ions. JK Series Aluminum Lids wit h M et al Ret ent ion Plat e JP1 Series PrimeLineTM Pro JP0 Series PrimeLine Aesculap® has perf ormed t he required validat ion t est s, including accept ed aerosol t est ing met hodology f or medical devices, and received FDA clearance f or it s st erile cont ainer product s w hen used in t he f ollow ing st erilizat ions modalit ies. The modalit ies f or each cont ainer series vary. Please refer t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®) and 9.0 (STERIS®) Cycle Paramet ers t o det ermine appropriat e cont ainer bot t om, lid, f ilt er, lock and indicat or card f or st erilizat ion cycle being used. Primary Name Which Includes May Also Be Referred to As Dynamic Air Removal PreVacuum St eam, PreVac St eam1,2 St eam St erilizat ion1 PreVacuum St eam Dynamic Air Removal PreVacuum Immediat e Use, PreVac IUSS1,2 Et hylene Oxide Hydrogen Peroxide Hydrogen Peroxide and Ozone Immediat e Use Gravit y Et hylene Oxide Gas Plasma Vapor Hydrogen Peroxide Ozone Gravit y1 Et O1 Low Temperat ure1, H2O2, STERRAD®3, STERIS®3, V- PRO®3 Low Temperat ure1 TS033, STERIZONE3, VP43 1. These t erms will be used t hroughout t he remainder of t he Inst ruct ions f or Use (IFU). 2. Aesculap® validat ions f or PreVac St eam can be applied t o St eam Flush Pressure Pulse (SFPP) wit h like cycles 3. M ay also be generically ref erred t o by t he st erilizer manuf act urer model name and/or cycle name. Figure 2: Sterilizations Modality Nomenclature and SterilContainerTM System Compatibility SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 5 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) The Syst em is designed t o be processed on a daily basis and provide years of cont inual use. When select ing a cont ainer syst em, make sure t he cont ainer and inst rument s mat ch t he applicat ion and st erilizat ion requirement s properly. - provides guidelines on how t o conduct an evaluat ion. Syst em Processing Supplies include single use paper and polypropylene f ilt ers, t amper evident locks and indicat or cards. See Sect ion 6.0 Preparat ion and Assembly of Syst em f or more inf ormat ion and f or f ilt er modalit y compat ibilit y. All Aesculap® f ilt ers, locks and indicat or cards have been designed and validat ed specif ically f or t he Syst em. They should not be used w it h ot her brand cont ainer syst ems. Aesculap® does not recommend using non- Aesculap® brand f ilt ers, locks and indicat or cards, and cannot guarant ee proper perf ormance w it h t hese product s. All processing supplies are shipped non- st erile. Image 1: Single Use Processing Supplies, Filters, Tamper Evident Locks, Indicator Cards Syst em accessories include t he f ollow ing: Ident if icat ion labels or t ags M at s Inst rument Organizat ion Syst em (IOS) Racks and scope holding plat f orm Inst rument st ringers Cont act an Aesculap® sales represent at ive or cust omer service f or more det ails on accessories. Notes: Each f acilit y should ensure it s processing syst em provides similar result s. Personnel t raining and compet ency is required t o perf orm all phases of manual processing. Equipment , w at er supply, and pract ices all cont ribut e t o providing an ef f ect ive reprocessing syst em and should be monit ored by t he f acilit y. Visit ww w .yout ube.com/Aesculapusa Syst em sect ion f or inf ormat ional videos on Syst em proper st erile reprocessing preparat ion. See AAM I ST79 f or more det ails and recommendat ions. Silicone inst rument holders, mat s and t he gasket in lid and f ilt er ret ent ion plat e are not made w it h nat ural rubber lat ex The Aesculap® reusable PTFE f ilt ers have been validat ed and are FDA cleared f or PreVac St eam and PreVac Immediat e Use St eam St erilizat ion (IUSS) f or up t o 2,200 cycles (decont aminat e w ash inspect - assemble st erilize use). Using a non- t oxic permanent marking pen, record t he dat e put int o service and t he est imat ed remove from service dat e, in mm/dd/yy f ormat . Calculat e t he remove f rom service dat e based on t he average expect ed reprocessing levels f or your f acilit y. Do not exceed 2,200 cycles. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 6 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Aesculap® basket s and accessories can be cleaned and st erilized f ollow ing accept ed indust ry guidelines and by using t he same processes as Aesculap® st erile cont ainer bot t oms. Aesculap® IOS pieces (IOS M ount ing Type B & C) and mat s are made of silicone and cut t ing t hem does not change t he charact erist ics of t he mat erial and/or it s f unct ion. Aesculap® Syst em only perf orms cont ainer t est ing w it h basket s and does not recommend using cont ainers w it hout basket s or w it h only mat s. The only except ion is t he JK187 and JN187 because of t heir size and height , a mat only is accept able. Aesculap® St erilit ® JF598 and JG600 are non- silicone lubricant s and do not require any addit ional PPE during use. w ill provide more precise applicat ion in small area. When applying oil, a reasonable amount should be used. For t he drops t his w ould be one or t w o drops, and f or t he spray it w ould be a light even coat ing of t he area t hat requires lubricat ion. Excess oil should be removed w it h a clear lint - f ree clot h af t er proper applicat ion. The oil should not cause build up when excess oil is removed and t he inst rument is cleaned properly. pH by it s def init ion specif ically requires a product t o be in a w at er- based solut ion t o be measured, w hich St erilit product s are not . Theref ore it does not have a pH. M SDS sheet s are available f or product s on Aesculap® websit e, w w w .Aesculap®usa.com/en/company/qualit y- assurance.ht ml. 3.0 SterilContainerTM System Service Like all reusable medical devices, t he Prior t o Use), and proper care and handling. Syst em requires inspect ion prior t o use (ref er t o Sect ion 5.0 Inspect ion The Aesculap® Syst em is a FDA Class II device t hat requires ext ensive t est ing and FDA 510(k) clearance. An Aesculap® t rained t echnician can service cont ainers t o t he original equipment manuf act urer dimensions and specif icat ions of t he original cont ainers used in t he validat ion and replace part s such as gasket s, f ilt er syst ems and handles w it h t he same Aesculap® component s. ONLY Aesculap® trained technicians are authorized to service the Aesculap® SterilContainerTM System. Using a non-Aesculap® service technician to service containers will void the Aesculap® Warranty on the container and may void any of the validation testing associated with Aesculap® containers. Aesculap® of fers a w ide variet y of cont ainer service programs t hat can be perf ormed by eit her our highly t rained t echnicians at our cent ral service facilit y in St . Louis, or by our mobile van service specialist s. All of t he service specialist s are Aesculap® employees w ho go t hrough ext ensive t raining on Aesculap® product s. Cont act an Aesculap® represent at ive or call cust omer service (1- 800- 214- 3392 or at scsr.us@ Aesculap®.com) f or more det ails. Notes: All product s being ret urned for maint enance/service must be t horoughly cleaned and decont aminat ed bef ore service. Ret ent ion plat es should be replaced w hen t hey show w ear, age and/or are damaged. The ret ent ion plat e on t he met al lids should not spin f reely when properly inst alled and in proper w orking condit ion. Not e t hat t he ret ent ion plat e may move a lit t le if signif icant amount of pressure is applied w hile t rying t o t w ist or t urn (especially w hen f ilt er is inst alled). The black PEEK feet on t he Aesculap® JF basket s assist in aligning t he JF basket s when st acking t hem in a cont ainer or during t he reprocessing process. These f eet may w ear and/or break overt ime depending on t he processing (number of t imes, chemicals, w at er qualit y), applicat ion (t ype of set ) and use (handling of t he product ). Inspect basket and f eet prior t o use. Replace if desired, using Aesculap® part number JF112210. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 7 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 4.0 Decontamination and Cleaning Process Follow f a policies, procedures, and AAM I ST79 recommended guidelines f or t he t ransport at ion of soiled inst rument s and cont ainers. Always wear appropriat e personal prot ect ive equipment (PPE) per t he healt hcare facilit y and procedures w hen t ransport ing and cleaning t he Syst em. DO NOT USE abrasive cleaners, met al brushes or abrasive cleaning pads. Use of abrasive product s can cause permanent damage t o cont ainer surfaces. Use of abrasive cleaners or pads w ill result in warrant y exclusion. If t he cont ainer and/or lid are soiled, t hey must be f ully cleaned. For cont ainers and/or lids t hat are not soiled and have been removed f rom t he operat ing room bef ore t he pat ient ent ered, t he f acilit y should det ermine best cleaning pract ice based on it s est ablished policy and procedures. Cont ainer, lids and basket s t hat may not be used or needed right away should be decont aminat ed and cleaned prior t o st orage. The Syst em should be st acked neat ly, eit her assembled or unassembled, in a dry, clean area. Notes: Thoroughly clean all Aesculap® cont ainer product s, basket s, accessories and replacement part s prior t o f irst use and af t er cont ainer service has been perf ormed. It ems are shipped nonst erile. Cleaning w ipes w it h pH range of 6.5 t o 8.5 t hat do not cont ain chlorides w ill not harm t he aluminum surf ace. The ef f ect iveness of w ipes in cleaning t he cont ainer syst em has not been evaluat ed by Aesculap®. The use of w ipes should be det ermined based on est ablished f acilit y policy and procedures. See cleaning w ipe manuf act urer Inst ruct ions f or Use and AAM I ST79. Aesculap® has no validat ion t est ing f or t he use of w ipes in t he decont aminat ion and cleaning process. Remove cont ainer bot t om and JK Series, JM Series and JS Series aluminum lid ret ent ion plat e(s) by pushing inw ard simult aneously on t he t w o but t ons on t he cent er sect ion of t he ret ent ion plat e. To replace cont ainer bot t om and JK Series, JM Series and JS Series aluminum lid ret ent ion plat e(s), press dow n evenly Aesculap® basket s may be processed in an ult rasonic cleaner. The ult rasonic cleaner may loosen basket accessors and Inst rument Organizat ion Syst em (IOS). Aesculap® has not evaluat ed t he use of bot t oms and lids in ult rasonic cleaners. 4.1 Water Quality Wat er qualit y is an import ant considerat ion in all st ages of medical device reprocessing and can cont ribut e t o providing an ef fect ive reprocessing syst em and should be monit ored by t he facilit y. AAM I TIR34:2014 out lines t he dif f erent t ypes of wat er and t he specif ic use of each. 4.1.1 Utility Water Ut ilit y w at er, per AAM I TIR34, is wat er as it comes f rom t he t ap t hat might require furt her t reat ment t o achieve t he specif icat ions. See AAM I TIR34 f or specif icat ions t able. This w at er is mainly used f or f lushing, washing, and rinsing. 4.1.2 Critical Water Crit ical wat er, per AAM I TIR34, is wat er t hat is ext ensively t reat ed (usually by a mult ist ep t reat ment process t hat could include a carbon bed, sof t ening, DI, and RO or dist illat ion) t o ensure t hat t he microorganisms and t he inorganic and organic mat erial are removed f rom t he w at er; a f inal submicron f ilt rat ion could also be part of t he t reat ment process. This wat er is recommended f or t he f inal rinse and st eam generat ion t o avoid discolorat ion or damage result ing f rom minerals f ound in ut ilit y wat er. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 8 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 4.2 Detergent Solutions Use det ergent in a w at er solut ion w here t he det ergent and w at er have a pH range of 6.5 t o 8.5 t o clean ef f ect ively and w it hout causing damage t o t he or S cont ainers. Notes: The use of ut ilit y w at er in mechanical w ashers may result in t he w at er having a high alkaline level w hich could be harmf ul t o t he cont ainer surf ace. Crit ical w at er should be used f or t he f inal rinse. If w hit e residue is observed on t he cont ainer, t his may have been caused by a high pH, alkaline cleaning solut ion. Check pH level of w at er and det ergent solut ion t hroughout t he process reduce t o a pH of 6.5 t o 8.5. The w hit e residue does not impact f orm, f it or funct ion. DO NOT USE solvent s such as acet one or benzene, w hich may be f ound in chemical drying rinses on t he PrimeLineTM and PrimeLine Pro Lids. Use of t hese product s can cause permanent damage t o lid surfaces and/or f ilt er housing, and result in w arrant y exclusion. 4.3 Decontamination and Mechanical Cleaning 1. Remove all remaining ext ernal process indicat ors and disposable locks. 2. Remove lid f rom bot t om of cont ainer. 3. Remove t he basket and any inst rument s from t he cont ainer. 4. Single Use Filt er a. Remove ret ent ion plat e(s). b. Remove single use f ilt er(s) and discard (if present ). c. Rinse visible debris f rom ret ent ion plat e(s). d. The met al ret ent ion plat e may be washed separat ely or inst alled during mechanical w ashing. 5. Reusable Filt er a. Remove ret ent ion plat e w hile leaving f ilt er in place. b. Rinse visible debris f rom ret ent ion plat e(s). c. Do not discard reusable f ilt er if in good w orking condit ion and w it hin recorded dat e. Reusable f ilt er may remain held in place by t he ret ent ion plat e during cleaning provided t here is no visible sign of w ear, damage and/or bioburden. The PTFE f ilt er mat erial is hydrophobic so blood and ot her liquids can be rinsed of f t he f ilt er if bioburden is observed. d. Replace ret ent ion plat e(s). 6. Rinse visible debris f rom all cont ainer component s. a. Crit ical wat er is recommended f or t he f inal rinse and st eam generat ion t o avoid discolorat ion or damage result ing from minerals f ound in ut ilit y w at er. b. For PrimeLineTM and PrimeLine Pro - Exclusively use crit ical w at er f or t he f inal rinse and make sure no residues f rom t he cleaning process remain on t he lid. 7. Place component s on w asher rack facing dow n t o avoid w at er collect ion. a. Fold t he lid handles t owards t he inside of t he lid t o avoid w at er collect ion and damage. b. Ret ent ion plat es should f ace away f rom t he direct f orce of pressurized washer jet s t o avoid damage during w ash cycles. 8. Af t er mechanical cleaning cycle a. Thoroughly dry (eit her w it h a sof t , dry clot h or air dry) all component s, and ret ent ion plat e and ret ent ion plat e housing (PrimeLineTM and PrimeLine Pro) bef ore proceeding t o preparat ion and packaging. b. If ret ent ion plat es were inst alled during mechanical washing, remove ret ent ion plat e(s) and dry area bet w een ret ent ion plat e and cont ainer. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 9 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) (From Aesculap® DOC1006) Remove f ilt er ret ent ion plat e by t urning count er clockwise. Ret ent ion plat e should be f ree of cracks and damage. Figure 3: PrimeLineTM Pro Lid Inspection Process Reusable f ilt er may remain inside lid during inspect ion. Check f ilt er int egrit y f or rips/t ears. Ret ent ion plat es may be inst alled during mechanical washing. Notes: Af t er cleaning, visually inspect and repeat t he cleaning process if a visually clean endpoint has not been achieved. DO NOT USE solvent s such as acet one or benzene, w hich may be f ound in chemical drying rinses on t he PrimeLineTM and PrimeLine Pro lids. Use of t hese product s can cause permanent damage t o lid surfaces and/or f ilt er housing, and result in w arrant y exclusion. The int egrat ed f ilt er syst em, and t he decont aminat ion, cleaning, inspect ion and asept ic present at ion process are t he same f or PrimeLineTM and PrimeLine Pro. To remove st erilizat ion adhesive t ape remnant of surf ace abrasions, w e recommend t he use of Aesculap®- Eloxal Cleaner (Cat alog number JG601). This is a non- abrasive cleaner. Apply t he cream, t he size of penny w it h a soft dry, non- lint ing clot h and rub t o polish t he surf ace. If needed, repeat w it h an increasing volume. Thoroughly remove all residual cleaning cream. Crit ical w at er is recommended for t he f inal rinse. Cleaner may cause discolorat ion and/or f ading of colored surf aces. DO NOT USE cleaner on PrimeLineTM lid, and PrimeLine Pro lid f ilt er housing and st ainless st eel covers. 4.4 Decontamination and Manual Cleaning Each f acilit y should ensure t heir processing syst em provides similar result s. Personnel t raining and compet ency is required t o perf orm all phases of manual processing. Equipment , w at er supply, and pract ices all cont ribut e t o providing an ef fect ive reprocessing syst em and should be monit ored by t he facilit y. 1. Remove all remaining ext ernal process indicat ors and disposable locks. 2. Remove lid f rom bot t om of cont ainer. 3. Remove t he basket and any inst rument s from t he cont ainer. 4. Single Use Filt er a. Remove ret ent ion plat e(s). b. Remove single use f ilt er(s) and discard (if present ). c. Rinse visible debris f rom ret ent ion plat e(s). d. The ret ent ion plat e should be w ashed separat ely. 5. Reusable Filt er a. Remove ret ent ion plat e w hile leaving f ilt er in place. b. Rinse visible debris f rom ret ent ion plat e(s). c. Do not discard reusable f ilt er if in good w orking condit ion and w it hin recorded dat e. Reusable f ilt er may remain held in place by t he ret ent ion plat e during cleaning provided t here is no visible sign of w ear, damage and/or bioburden. The PTFE f ilt er mat erial is hydrophobic, so blood and ot her liquids can be rinsed of f t he f ilt er if bioburden is observed. d. Replace ret ent ion plat e(s). 6. Rinse visible debris f rom all cont ainer component s. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 10 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) a. Crit ical wat er is recommended f or t he f inal rinse and st eam generat ion t o avoid discolorat ion or damage result ing from minerals f ound in ut ilit y w at er. b. For PrimeLineTM and PrimeLine Pro - Exclusively use crit ical w at er f or t he f inal rinse and make sure no residues f rom t he cleaning process remain on t he lid. 7. Use a soft sponge and det ergent , as described in Sect ion 4.2 Det ergent Solut ions, t o clean t he component s of t he . 8. Af t er manually cleaning a. Thoroughly dry (eit her w it h a sof t , dry clot h or air dry) all component s, and ret ent ion plat e and ret ent ion plat e housing (PrimeLineTM and PrimeLine Pro) bef ore proceeding t o preparat ion and packaging. b. If ret ent ion plat es were inst alled during washing, remove ret ent ion plat e(s) and dry area bet w een ret ent ion plat e and cont ainer. Notes: Af t er cleaning, visually inspect and repeat t he cleaning process if a visually clean endpoint has not been achieved. If t he cont ainer and/or lid are soiled, t hey must be f ully cleaned. For cont ainers and/or lids t hat are not soiled and have been removed f rom t he operat ing room bef ore t he pat ient ent ered, t he f acilit y should det ermine best cleaning pract ice based on it s est ablished policy and procedures. Cleaning w ipes w it h pH range of 6.5 t o 8.5 t hat do not cont ain chlorides w ill not harm t he aluminum surf ace. The ef f ect iveness of w ipes in cleaning t he cont ainer syst em has not been evaluat ed by Aesculap®. The use of w ipes should be det ermined based on est ablished f acilit y policy and procedures. See cleaning w ipe manuf act urer Inst ruct ions for Use and AAM I ST79. Aesculap® has no validat ion t est ing f or t he use of w ipes in t he decont aminat ion and cleaning process. DO NOT USE Alcohol w ipes alcohol w ill harm t he PrimeLineTM lid or PrimeLine Pro filt er housing. If component s are t oo large t o be immersed at t he f acilit y, t hen t he component s should be cleaned in a manner t hat w ill not produce aerosols. Please refer t o AAM I ST79 f or recommended pract ices. To remove st erilizat ion adhesive t ape remnant of surf ace abrasions, w e recommend t he use of Aesculap®- Eloxal Cleaner (Cat alog number JG601). This is a non- abrasive cleaner. Apply t he cream, t he size of penny w it h a soft dry, non- lint ing clot h and rub t o polish t he surf ace. If needed, repeat w it h an increasing volume. Thoroughly remove all residual cleaning cream. Crit ical w at er is recommended for t he f inal rinse. Cleaner may cause discolorat ion and/or f ading of colored surf aces. DO NOT USE cleaner on PrimeLineTM lid, and PrimeLine Pro lid f ilt er housing and st ainless st eel covers. DO NOT USE solvent s such as acet one or benzene, w hich may be f ound in chemical drying rinses on t he PrimeLineTM and PrimeLine Pro Lids. Use of t hese product s can cause permanent damage t o lid surfaces and/or f ilt er housing, and result in w arrant y exclusion. The int egrat ed f ilt er syst em, and t he decont aminat ion, cleaning, inspect ion and asept ic present at ion process are t he same f or PrimeLineTM and PrimeLine Pro. Aesculap® basket s and accessories can be cleaned and st erilized f ollow ing accept ed indust ry guidelines and by using t he same processes as Aesculap® st erile cont ainer bot t oms. 5.0 Inspection Prior to Use Inspect ion of t he cont ainer and it s component s must be conduct ed PRIOR TO EVERY USE. If any of t he condit ions described in t his sect ion are observed DO NOT USE t he or S cont ainer bot t om and/or lid. Cont act Aesculap® f or service. Using a non- Aesculap® service t echnician t o service cont ainers w ill void t he Aesculap® Warrant y on t he cont ainer and may void any of t he validat ion t est ing associat ed w it h Aesculap® cont ainers. See Sect ion 3.0 Syst em Service f or f ull det ails regarding service. Please ref er t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers t o det ermine appropriat e cont ainer bot t om, lid, f ilt er, lock and indicat or card f or st erilizat ion cycle being used. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 11 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Notes: Af t er cleaning, and bef ore use, visually inspect and repeat t he cleaning process if a visually clean endpoint has not been achieved. Remove cont ainer bot t om and JK Series and JM Series aluminum lid ret ent ion plat e(s) by pushing inw ard simult aneously on t he t w o but t ons on t he cent er sect ion of t he ret ent ion plat e. To replace cont ainer bot t om and JK Series and JM Series aluminum lid ret ent ion plat e(s), press dow n evenly on ret ent The met al ret ent ion plat e may be w ashed separat ely or inst alled during mechanical w ashing. Ret ent ion plat es should f ace aw ay f rom t he direct f orce of pressurized w asher jet s t o avoid damage during w ash cycles. 5.1 SterilContainerTM System Inspection Criteria 1. All cont ainer component s should be inspect ed and f ree from a. Observable cracking in aluminum and/or plast ic. b. Any misalignment and/or dent s in w hich t he lid and bot t oms do not adequat ely mat e. c. Any pit t ing in t he aluminum. 2. Lid silicone gasket should be inspect ed and f ree f rom any sign cracking or damage. 3. For met al ret ent ion plat es. a. Remove ret ent ion plat e by pressing in on t he t w o t abs and lif t ing. For reusable f ilt er, leave f ilt er in place during inspect ion. Reusable f ilt er may remain in place inside lid during inspect ion. Check f ilt er int egrit y f or damage. The ret ent ion plat e may be inst alled during mechanical washing. Image 2: JK, JN and JM Lid Reusable Filter Inspection b. M et al f ilt er ret ent ion plat e and silicone gasket should be inspect ed and f ree f rom: i. Any sign of cracking or damage. ii. Any misalignment or damage in w hich ret ent ion pin, f ilt er, ret ent ion plat e and/or gasket do not adequat ely mat e. c. Conf irm ret ent ion plat e is not bent by placing ret ent ion plat e on f lat surf ace t o check f or cont inuous cont act around edge. Not e t hat when perf orming t he inspect ion, t here w ill be a unif orm space bet ween t he out er most edge of t he ret ent ion plat e and t he surf ace since t he ret ent ion plat e has a raised gasket . SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 12 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) (From Aesculap® DOC1006) Remove f ilt er ret ent ion plat e by pressing in on t he t wo t abs and lift ing. Place ret ent ion plat e on f lat surf ace t o check f or cont inuous cont act around edge. Ret ent ion plat e gasket should be f ree of cracks or damage. Pin f or f ilt er ret ent ion plat e must be secure and f irm. The ret ent ion plat e may be inst alled during mechanical washing. Image 3: Filter Retention Plates and Silicone Gaskets Inspection Process d. Conf irm f ilt er ret ent ion pin is secure and f irm. e. Conf irm f ilt er ret ent ion plat e is secure and f irm on ret ent ion pin. f . Remove ret ent ion plat e f rom service if it does not meet crit eria above, and replace w it h Aesculap® part number JK100 round, JK098 rect angle. 4. For PrimeLineTM and PrimeLine Pro lids. (From Aesculap® DOC1006) Remove f ilt er ret ent ion plat e by t urning count er clockwise. Ret ent ion plat es should be f ree of cracks and damage. Image 4: PrimeLineTM Lid Inspection Process Reusable f ilt er may remain inside lid during inspect ion. Check f ilt er int egrit y f or rips/t ears. Check t hat f ilt er is w it hin use- by dat e. Ret ent ion plat e may be inst alled during mechanical washing. a. Remove ret ent ion plat e by t urning count er clockw ise. Leaving f ilt er in place. b. Inspect reusable f ilt er f or holes, t ears and rips. If observed, remove f ilt er f rom service and replace w it h Aesculap® part number JP050. c. Conf irm f ilt er is w it hin use- by dat e (< 2,200 cycles). Replace as needed. d. Filt er ret ent ion plat e(s) and f ilt er housing(s) should be inspect ed and f ree f rom: i. Any sign of cracking or damage. ii. Any misalignment or damage in w hich ret ent ion plat e, f ilt er and/or f ilt er housing do not adequat ely mat e. e. Conf irm f ilt er, ret ent ion plat e and f ilt er housing are secure and f irm. f . Remove ret ent ion plat e f rom service if it does not meet crit eria above, and replace w it h Aesculap® part number JP001204. g. Replace ret ent ion plat e by t urning clockw ise. h. Conf irm out side cover is secured f irmly. i. PrimeLineTM lid black cover may be replaced w it h Aesculap® part number JP001202. PrimeLine Pro lid should be serviced by Aesculap®. See 3.0 Syst em Service f or f ull det ails regarding service. Notes: SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 13 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) If w hit e residue is observed on t he cont ainer, t his may have been caused by a high pH, alkaline cleaning solut ion. Check pH level of w at er and det ergent solut ion t hroughout t he process reduce t o a pH of 6.5 t o 8.5. The w hit e residue does not impact f orm, f it or f unct ion. The S is made of non- anodized aluminum w hich undergoes a nat ural oxidat ion process. This oxidat ion process produces a very t hin layer on t he surf ace w hich may appear brow n or black. This oxidat ion process w ill cont inue unt il t he ent ire raw surf ace is oxidized. This brow n or black discolorat ion is part of t he nat ural processes. Please cont act an Aesculap® represent at ive f or more inf ormat ion, if needed. Ret ent ion plat es should be replaced w hen t hey show w ear, age and/or are damaged. The ret ent ion plat e on t he met al lids should not spin f reely when properly inst alled and in proper w orking condit ion. Not e t hat t he ret ent ion plat e may move a lit t le if signif icant amount of pressure is applied w hile t rying t o t w ist or t urn (especially w hen f ilt er is inst alled). Excessive removal and replacement of reusable f ilt er over cent er pin may cause t earing of t he cent er hole. M et al ret ent ion plat e may be w ashed separat ely or inst alled during mechanical w ashing. Ret ent ion plat es should f ace aw ay f rom t he direct f orce of pressurized w asher jet s t o avoid damage during w ash cycles. Using inspect ion and t est met hods ot her t han t hose out lined in t his IFU are not recommended and have not been validat ed by Aesculap®. The int egrat ed f ilt er syst em, and t he decont aminat ion, cleaning, inspect ion and asept ic present at ion process are t he same f or PrimeLineTM and PrimeLine Pro. If t he PrimeLineTM or PrimeLine Pro int ernal or ext ernal cover f alls of f aft er st erilizat ion and bef ore t he set is used, t he set can maint ain st erilit y if no ot her event relat ed incidence has occurred since it is a sealed f ilt er syst em. The broken dust cover should be replaced and/or t he lid should be serviced by Aesculap®. See Sect ion 3.0 Syst em Service f or f ull det ails regarding service. 5.2 Basket, Tray and Platforms Inspection Criteria Basket s, t rays and plat f orms should be inspect ed and f ree f rom: 1. Observable cracking and/or dent s 2. Any misalignment of sides, bot t om or handles 3. Any loose or w orn handles, part s, f eet , accessories or inst rument organizat ion syst em component s Notes: Basket s w it h or w it hout f eet maybe used w it h Syst em. Using basket s w it h f eet may help reduce t he possibilit y of scrat ching of basket on t he cont ainer bot t om. The black PEEK feet on t he Aesculap® JF basket s assist in aligning t he JF basket s when st acking t hem in a cont ainer or during t he reprocessing process. These f eet may w ear and/or break overt ime depending on t he processing (number of t imes, chemicals, w at er qualit y), applicat ion (t ype of set ) and use (handling of t he product ). Inspect basket and f eet prior t o use. Replace if desired, using Aesculap® part number JF112210. 6.0 Preparation and Assembly of SterilContainerTM System Inspect ion of t he cont ainer and it s component s must be conduct ed PRIOR TO EVERY USE. Please refer t o Sect ion 5.0 Inspect ion Prior t o Use t o learn how t o properly inspect a cont ainer and it s component s. Ensure all cont ainer component s are complet ely dry. Each cont ainer bot t om must ONLY be used w it h t he specif ic lid designed f or t hat series of cont ainer, and it should not be combined w it h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. Det ermine t he t ype of bot t om and lid being assembled and proceed t o t hat sect ion. Please refer t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers t o det ermine appropriat e cont ainer bot t om, lid, f ilt er, lock and indicat or card f or st erilizat ion cycle being used. All Aesculap® f ilt ers, locks and indicat or cards have been designed and validat ed specif ically f or t he Syst em. They should not be used w it h ot her brand cont ainer syst ems. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 14 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Aesculap® does not recommend using non- Aesculap® brand f ilt ers, locks and indicat or cards, and cannot guarant ee proper perf ormance w it h t hese product s. All processing supplies are shipped non- st erile. Filter Type PreVac Steam PreVac IUSS Gravity EtO Paper Filter w/ Indicator1 X1 X1 X1 X1 US751 Paper Filter w/o Indicator X X X X US994, US999 Polypropylene Filter w/o Indicator X X X M D344, M D355 Metal Retention Plate Lid PTFE Reusable Filter X X JK090, JK091 PrimeLineTM & PrimeLine Pro PTFE Reusable Filter X X JP050 1. Filt er cont ains a dual indicat or dot , which changes f rom blue t o brow n in st eam, and t o orange in Et O. Figure 4: Filters for Perforated Bottoms and Lids Low Temp X Notes: Visit ww w .yout ube.com/Aesculapusa St eril Syst em sect ion f or inf ormat ional videos on Syst em proper st erile reprocessing preparat ion. All inf ormat ion and st eps out lined in t his IFU should be follow ed. Aesculap® DOC1006 and DOC1007 may be used as a ref erence guide in Prep and Pack, and t he OR respect ively once personnel t raining and compet ency is achieved. The Aesculap®US756, US998, US992, JK092 and JK089 filt ers are designed f or t he Aesculap® generat ion 2 cont ainer, circa 1980s. The Generat ion 2 cont ainer f ilt ers have a diff erent size and shape compared t o t he current Syst em. 6.1 SterilContainerTM System Assembly 1. ONLY USE cont ainers and component s t hat have passed t he inspect ion crit eria out lined in Sect ion 5.0 Inspect ion Prior t o Use. 2. Please ref er t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers based on cont ainer syst em f or proper f ilt er select ion. 3. For met al ret ent ion plat es. Remove ret ent ion plat e by pushing inw ard on t he t w o but t ons on t he side of t he cent er sect ion of t he ret ent ion plat e. a. For single use f ilt ers. Place one sheet of t he appropriat e Aesculap® single use f ilt er over each perf orat ed sect ion on t he inside of t he cont ainer lid and if used, t he perf orat ed bot t om. b. For reusable f ilt ers. Leave f ilt er in place during inspect ion. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 15 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Reusable f ilt er may remain in place inside lid during inspect ion. Check f ilt er int egrit y f or damage. The ret ent ion plat e may be inst alled during mechanical washing. Image 5: Aluminum Lid with Metal Retention Plate and Reusable Filter c. Conf irm t he f ilt er lays f lat , and secure each f ilt er w it h t he ret ent ion plat e. List en t o audible t o conf irm f ilt er is locked in place. Conf irm t he f ilt er is laying f lat , and secure each f ilt er wit h t he ret ent ion plat e. f ilt er is locked in place. Image 6: Aluminum Lid with Metal Retention Plate and Single Use Filer Assembly 4. For PrimeLineTM and PrimeLine Pro ret ent ion plat es. (From Aesculap® DOC1006) Remove f ilt er ret ent ion plat e by t urning count er clockwise. Ret ent ion plat e should be f ree of cracks and damage. Image 7: PrimeLineTM Lid Inspection Process Reusable f ilt er may remain inside lid during inspect ion. Check f ilt er int egrit y f or rips/t ears. Check t hat f ilt er is w it hin use- by dat e. Ret ent ion plat e may be inst alled during mechanical washing. a. Remove ret ent ion plat e by t urning count er clockw ise. Leaving f ilt er in place. b. Inspect reusable f ilt er f or holes, t ears and rips. Conf irm filt er is w it hin use- by dat e (<2,200 cycles). Replace as needed w it h Aesculap® part number JP050. Arrow s on f ilt er and f ilt er housing w ill align when f ilt er is properly inst alled, see phot o. c. Replace ret ent ion plat e by t urning clockw ise. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 16 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Notes: The orient at ion of t he paper f ilt er w it h indicat or can be placed in eit her orient at ion, indicat or dot f acing in or out of t he ret ent ion plat e. Facilit y should det ermine orient at ion based on it s est ablished policy and procedures. Single use paper f ilt ers are not compat ible w it h Low Temperat ure st erilizers. Aesculap® only used one f ilt er under each ret ent ion plat e during our validat ion t est ing. If mult iple f ilt ers are placed under ret ent ion plat e accident ally w e recommend t hat t he set be reject ed and be reprocessed. Cont ainer lid must ONLY be used w it h Aesculap® brand ret ent ion plat e(s). Aesculap®ret ent ion plat es may be ident if ied by t he Aesculap® name, t he t w o release but t ons on t he cent er sect ion and/or t he part number. 6.2 Assembly of Surgical Instrumentation Inst rument s and all component s of t he Syst em must be complet ely dry prior t o st erilizat ion processing t o allow f or adequat e st erilant penet rat ion. Sort and assemble t horoughly cleaned and dried inst rument s int o t he inst rument basket (s), according t o est ablished hospit al procedures Inst ruct ions f or Use. 6.3 Loading of Basket, Lifting Platform and Tray The Aesculap® Syst em may be used w it h a variet y of basket s, t rays and plat f orms. Inst rument s set (s) should meet t he f ollow ing requirement s: 1. Fit in t he cont ainer w it h t he proper clearance bet w een t he t op of t he set (s) and t he lid; 2. Able t o be asept ically removed in t he OR; 3. w hichever is low er; and 4. Inst rument (s) and cont ainer IFUs paramet ers (t ime/t emperat ure and dry t ime) can be reconciled. Please ref er t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers t o det ermine maximum w eight of Syst em f or st erilizat ion modalit y select ed. 1. Place assembled inst rument basket (s), lif t ing plat f orm or support racks int o t he prepared cont ainer bot t om. 2. Place assembled lid ont o t he cont ainer bot t om, aligning handles on bot t om w it h lat ches on lid. 3. Simult aneously close bot h locking lat ches on t he cont ainer lid. Notes: All inst rument s should be arranged per t he inst rumen Hospit als should refer t o AAM I and accept ed indust ry guidelines, and (IFU) regarding w eight s and w eight limit s. Hospit als should reconcile t he Aesculap® St eril Trays and basket s may be st acked inside t he Syst em if clearance requirement s (below) are met and t he set f ollow s proper acet ic present at ion guidelines. o Full-Size, Three-Quarter Size, Half-Size Wide-Body, Extra-Long Container Leave one inch of free space bet ween t he inst rument s and t he rim of t he cont ainer f or ef f ect ive processing. Basket handles may closure. o Extra-Long Mini-Size Container Inst rument s and basket s can be loaded t o t he rim of t he cont ainer as long as t hey o Mini-Size and Quarter-Size Container Leave one quart er of an inch of free space bet ween t he inst rument s and t he rim of t he cont ainer f or ef f ect ive processing. Basket handles may encroach int o t his clearance space as long as SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 17 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Basket s w it h or w it hout f eet maybe used w it h Syst em. Using basket s w it h f eet may help reduce t he possibilit y of scrat ching of basket on t he cont ainer bot t om. The black PEEK feet on t he Aesculap® JF basket s assist in aligning t he JF basket s when st acking t hem in a cont ainer or during t he reprocessing process. These f eet may w ear and/or break overt ime depending on t he processing (number of t imes, chemicals, w at er qualit y), applicat ion (t ype of set ) and use (handling of t he product ). Inspect basket and feet prior t o use. Replace if desired, using Aesculap® part number JF112210. The Syst em PreVac St eam validat ion st udies w ere perf ormed w it h a silicone mat and non- lint ing "Non- lint ing absorbent mat erial may be placed in t he t ray t o mat erial be non- lint ing because lint can carry microorganisms int o t he surgical sit e as w ell as cause f oreign- body 6.4 Internal Process Indicators Per AAM I ST79, int ernal process indicat ors are used t o indicat e t hat t he cont ainer has been exposed t o t he st erilizat ion process. If more t han one basket /t ray is used inside t he cont ainer syst em, an indicat or should be placed on each basket /t ray. The int ernal biological and/or chemical indicat ors may be placed in t he cent er of each t ray, unless t he user feels a more challenging posit ion exist s elsew here. In t hat case, place t he chemical indicat or w here t he user has det ermined t he most challenging locat ion. Use of int ernal indicat ors should be in accordan procedures. Process indicat ors are designed t o indicat e t hat t he device w as exposed t o t he st erilizat ion process w hile, int egrat ing indicat ors are designed t o react t o all crit ical variables, w it h t he st at ed values having been generat ed t o be equivalent t o, or exceed, t he perf ormance requirement s given in t he ISO 11138 series f or BIs. See AAM I ST79 f or f ull descript ion and use of each t ype of chemical indicat or. Notes: See Sect ion 12.0 Cust omer Verif icat ion f or inf ormat ion on chemical and biologic indicat or placement and on how t o perf orm a verif icat ion. Aesculap® does not validat e cont ainers w it h paper count sheet s cont aining ink. Users t o process count sheet s 6.5 External Process Indicators and Tamper Evident Seals Per AAM I ST79, ext ernal process indicat ors are used t o indicat e t hat t he cont ainer has been exposed t o t he st erilizat ion process and t o dist inguish bet w een processed and unprocessed cont ainers. Use of ext ernal indicat ors Please ref er t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers t o det ermine appropriat e cont ainer bot t om, lid, f ilt er, lock and indicat or card f or st erilizat ion cycle being used. 1. If desired, select t he appropriat e Aesculap® Indicat or Card and insert int o t he holding bracket on t he out side of t he cont ainer. A t ab at one end of t he indicat or card w ill f acilit at e insert ion and removal. 2. Insert t he appropriat e t amper evident lock int o t he locking channel on each end. 3. Secure and close t he t amper evident lock. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 18 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Tamper Evident Locks PreVac Steam PreVac IUSS Gravity EtO Low Temp Blue / US900 No Indicat or X X X X X Green / US905 X Change1 Yellow t o Orange Orange / US906 X X X Change1 Blue t o Brow n Pink / US9102 X2 Change1 M agent a t o Blue Yellow / US399 X Change1 Blue t o Brow n 1. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post sterilization indicator color may vary and not be evenly shaded. 2. Locks must be st ored in a cont rolled room t emperat ure, aw ay f rom alkaline chemicals, acids and sources of light . Figure 5: Tamper Evident Locks Insert t he lock int o t he channel, close and conf irm it is secure. Repeat on t he ot her side of cont ainer. Installation Instructions for All Tamper Evident Locks Close t he lat ch t o secure t he lid t o cont ainer bot t om. Insert t he t amper evident lock t hrough t he channel. Indicat or should be f acing up (away f rom cont ainer.) To close, insert end int o t he base unt il it clicks and locks in place. Gent ly pull on t he lock t o conf irm it is f ully f ast ened and secure. Repeat on t he ot her side of cont ainer. Indicator & Communication Cards PreVac Steam PreVac IUSS Gravity EtO Low Temp MD334, MD335 w/ Indicator X Change1 Blue MD346, MD876, US754 w/ Indicator X X X X Change1,2 Brow n in St eam Change1,2 Orange in Et O US963 w/o Indicator X X X X X MD399, MD345 w/ Indicator X Change1 Brow n 1. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post sterilization indicator color may vary and not be evenly shaded. 2. Filt er cont ains a dual indicat or dot , which changes t o brown in st eam, and t o orange in Et O. Figure 6: Indicator and Communication Cards SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 19 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Notes: The Aesculap® t amper evident locks w it h indicat or and/or process indicat or card may be used as ext ernal process indicat ors. See t he out side product packaging label f or care and handling inf ormat ion. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post st erilizat ion indicat or color may vary and not be evenly shaded. There is no indust ry st andard f or t he color shift of pre- and post - st erilizat ion indicat ors t o dist inguish if a set has been exposed t o st erilizat ion. Refer t o f ilt er, lock and indicat or card chart s f or proper Aesculap® indicat or color changes. Tamper Evident Locks US900, US905, US906 and US399 St ore in a cool, dry place. Temperat ures bet ween 15° C/60° F and 30° C/86° F should be maint ained. Signif icant changes in st orage condit ions f or prolonged periods can have an adverse ef fect on t he product . (M inor variat ions over short periods of t ime w ill have lit t le or no ef fect on product .) Ext reme st orage condit ions such as exposure t o direct sunlight and/or st orage on t op of or near heat source should be avoided. DO NOT USE if t he indicat or dot color has changed before being processed. Tamper Evident Lock US910 Low Temperat ure ext ernal Chemical Indicat ors (CIs) are part icularly sensit ive and must be st ored in a cont rolled room t emperat ure, aw ay f rom alkaline chemicals, acids and sources of light prior t o use. DO NOT USE beyond t he expirat ion dat e provided on t he out side product packaging. Change of color prior t o use in t he st erilizer could indicat e t hat t hese CIs w ere exposed t o t oo much light or high t emperat ures during st orage. Af t er being processed, low t emperat ure t amper evident lock should be st ored at a cont rolled room t emperat ure aw ay f rom alkaline chemicals, acids and sources of light . Indicat ors may t urn w hit e post - st erilizat ion if not st ored out of direct light ing. Indicator & Communication Cards MD334, MD335 St ore in original packaging unt il needed. St ore unused indicat ors in cont rolled room t emperat ure, aw ay from any alkaline chemicals, acids and sources of light . DO NOT USE beyond t he expirat ion dat e provided on t he out side product packaging. Indicat or & Communicat ion Cards M D346, M D876, US754, M D399 St ore in dry cool place. The Aesculap® M D347 ext ernal indicat or card is designed f or t he Aesculap® current Syst em has a slight ly dif ferent card holder size t han t he generat ion 3 cont ainer. The f unct ionalit y and perf ormance of t he M D347 is t he same as our current M D346 ext ernal indicat or card. 6.6 Container Storage and Transportation The Aesculap® rigid Syst em is st ackable. Af t er st erilizat ion, cont ainers should be st ored in a manner t hat reduces t he pot ent ial for cont aminat ion, see AAM I ST79 and ASHRAE guidelines f or f urt her det ails. DO NOT st ack more t han t hree, 25 lbs each, cont ainers high. Follow shelf manuf act urer w eight and height limit recommendat ions w hen st acking t he cont ainers during st erile st orage. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 20 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) The Syst em has show n t o maint ain t he st erilit y of it s cont ent s f ollow ing successf ul event relat ed st erilit y maint enance validat ion t est ing, see chart . Product Family Bottom Series Lid Series JK JN Solid, Perf orat ed, Anodized Anodized JK PrimeLineTM PrimeLine Pro JK PrimeLine PrimeLine Pro PreVac Steam 360 360 Days Days 360 360 360 Days Days Days 360 Days PreVac IUSS * * * Gravity 360 Days EtO 360 Days 360 Days Low Temp STERRAD® Low Temp STERIS® Low Temp STERIZONE® * Each f acilit y should def ine how t o handle immediat e use inst rument set s in t heir set t ing. S JM Perf orat ed, Non- Anodized JM 360 Days 360 Days 360 Days 360 Days 360 Days 180 Days S2 JS Perf orat ed, Anodized JS 360 Days 360 Days 360 Days 360 Days 360 Days 180 Days St ore processed Syst ems in a dry, clean and prot ect ed place. The loss of st erilit y is normally event - relat ed and not t ime- relat ed. Loss of st erilit y is not so much connect ed t o t he st orage periods as t o out side inf luences and t he ef f ect s of st orage, t ransport at ion, and handling. Theref ore, blanket st at ement s cannot be made regarding appropriat e st orage periods, see EN ISO 11607- 1, ANSI/AAM I ST79 and DIN 58953- 8. Facilit ies should est ablish processes and procedures relat ed t o st orage and shelf life. The st orage period of t he Syst em has been invest igat ed in various long- t erm st udies. The preservat ion of st erilit y w as demonst rat ed over t his ent ire period. The st orage condit ions used in t he t est s met t he requirement s of ANSI/AAM I ST79 and ASHRAE. Follow AAM I ST79 guidelines f or t ransport at ion of set s bet w een buildings and of f - sit e. 7.0 SterilContainerTM System Sterilizer Cycle Parameters -- Steam and EtO This sect ion provides det ailed chart s t hat ident if y t he Syst em conf igurat ions, locks, indicat or cards and filt er(s), which should be used t oget her for Steam and EtO modalities. Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions shown. These conf igurat ions are support ed by t he numerous FDA 510(k) clearances held by Aesculap®. Conf iguring t he Syst em in a manner not show n in t he t ables const it ut es an of f label use of t he product . Each cont ainer bot t om must ONLY be used w it h t he specific lid designed f or t hat series of cont ainer, and it should not be combined w it h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. In t he event t he inst rument IFU does not mat ch t he Syst em IFU, t he inst rument IFU should t ake precedence. See AAM I ST79 f or inf ormat ion on how t o reconcile mult iple IFUs. See Sect ion 2.0 Syst em f or an explanat ion of t he Syst em. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 21 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Notes: Cont ainer size abbreviat ions on modalit y chart s. Detailed Size Description Full- Size Three- Quart er Half XL- Long Wide Body XL- M ini Quart er M ini Abbreviation Size Description 1:1 3:4 1:2 XLL Wide XLM Qt r M ini 7.1 Steam and EtO Sterilization Modality Cycle Parameters Primary Name Which Includes May Also Be Referred to As St eam St erilizat ion1 Et hylene Oxide Dynamic Air Removal PreVacuum St eam Dynamic Air Removal Immediat e Use Gravit y Et hylene Oxide PreVacuum St eam, PreVac St eam1,2 PreVacuum Immediat e Use, PreVac IUSS1,2 Gravit y1 Et O1 1. These t erms will be used t hroughout t he remainder of t he Inst ruct ions f or Use (IFU). 2. Aesculap® validat ions f or PreVac St eam may be applied t o St eam Flush Pressure Pulse (SFPP) wit h like cycles. Accessories Compatible with Steam and EtO PreVac Steam PreVac IUSS Gravity Steam EtO St ainless St eel basket s, basket lids, Yes Yes Yes Yes and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, Yes Yes Yes Yes bracket s, holders, and clamps) Silicone mat s Yes Yes Yes Yes Notes: The numbers in parent heses af t er each descript ion below correlat es w it h t he numbers in t he St erilizat ion M odalit y columns on t he t ables t hat follow . M ax Tot al Weight = Syst em (bot t om and lid) + Basket s (including mat s) + Inst rument s + Cont ainer Accessories. For st eam cycles, running a longer exposure t ime and/or drying t ime t han t hose st at ed w ill not harm t he Syst em. See inst rument IFU regarding t he ef fect on inst rument s. For st eam cycles, if diff erent t imes or t emperat ures are used, t hey must be equivalent or great er t han t he minimum paramet ers not ed. Posit ion cont ainers on t he aut oclave cart below w rapped set s. For Immediat e Use St eam St erilizat ion (IUSS), Aesculap®recommends t hat each f acilit y est ablish it s ow n guidelines and policies f or processing, holding/t ransport ing and using IUSS set s based on accept ed indust ry st andards, and OR and pat ient needs. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 22 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) For PreVac St eam, st acking should not exceed 18 inches in height f or ef f ect ive air removal and adequat e st eam penet rat ion. Bot h solid and perf orat ed bot t oms can be st acked during st erilizat ion and in st orage. See Sect ion 14.0 Indicat ions f or Use f or addit ional inf ormat ion on t he Syst em and accessories. 7.1.1 PreVac Steam Sterilization Cycle Parameters (1) M inimum dry t imes requirement s. Act ual dry t ime may be longer in pract ice depending on st erilizat ion load densit y, quant it y of inst rument s, inst rument mat erial, cont ainer size, lid used and wat er/st eam qualit y. Exposure Time: 270° F f or 4 minut es Dry Time Aluminum lid w it h met al ret ent ion plat e(s): 15 minut es minimum Dry Time PrimeLineTM & PrimeLine Pro lids: 30 minut es minimum 7.1.2 PreVac IUSS Sterilization Cycle Parameters (2) Only Aesculap® JK Series solid bot t om cont ainers can be used f or PreVac IUSS. Do not st ack cont ainers in t he IUSS cycle. M inimum dry t imes requirement s Porous Instruments Exposure Time: 270° F f or 4 minut es Dry Time: 0 minut es Non-Porous Instruments Exposure Time: 270° F f or 3 minut es Dry Time: 0 minut es 7.1.3 Gravity Steam Sterilization Cycle Parameters (3) Do not st ack cont ainers in t he gravit y cycle. Exposure Time: 250° f or 30- 60 minut es, depending on load size Dry Time: 15 minut es minimum 7.1.4 EtO Cycle Parameters (4) Temp: 125°F - 130° F PreVac (minimum): 25" Hg Humidit y: 40- 60% RH Gas Pressure (minimum): 600 mg/L EO Gas M ixt ures may vary i.e. 10/90% by weight or 100% Exposure Time (minimum): 60 M inut es Post Vac (minimum): 20" Hg Aerat ion (minimum): 8 Hours 7.1.5 PreVac Steam Sterilization Cycle Parameters (5) This cycle is only f or t he JK744 and JN744 cont ainer. Aesculap because t hey have t he low est vent t o volume rat io. Exposure Time: 270° F at 4 minut es Dry Time (minimum): 30 minut es minimum SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 23 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 7.1.6 Steam and EtO SterilContainerTM JK Series Validated and FDA 510(k) Cleared Sterilization Modalities JK Series Bottom 1:1 JK440 JK441 JK442 JK444 JK446 3:4 JK740 JK741 JK742 JK744 1:2 JK340 JK341 JK342 JK344 JK346 Wide JK817 JK821 XLL JK443 Mini JK187 JK188 Lid 1:1 JK485 JK486 JK487 JK488 JK489 3:4 JK785 JK786 JK787 JK788 JK789 1:2 JK385 JK386 JK387 JK388 JK389 Wide JE601 XLL JK490 Mini JK170 JK171 JK172 JK173 JK174 Processing Supplies PreVac St eam (1) PreVac IUSS (2) Gravit y (3) Filter US751, US994 M D344, JK090 US751, US994 N/A M D344, JK090 Indicator Card M D345, M D346 M D399 N/A Lock US900, US906 US900, US399 N/A Filter Indicator Card US999, M D355, JK091 US999, M D355, N/A JK091 M D876 N/A N/A Et O (4) US751, US994, M D344 M D345, M D346 US900, US905 US999, M D355 M D876 Lock US900, US906 US900, US399 N/A US900, US905 Max Total WeightA 25 Pounds 25 Pounds A. M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 24 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 7.1.7 Steam and EtO SterilContainerTM JK Series with PrimeLineTM Pro / PrimeLine Lid Validated and FDA 510(k) Cleared Sterilization Modalities JK Series Bottom Lid Processing PreVac St eam PreVac IUSS Gravit y Et O Supplies (1) (2) (3) (4) 1:1 1:1 JK440 JK441 JK442 JK444 3:4 JP101 JP102 JP103 JP104 JP105 3:4 Filter, LidB JP050 Filter, Bottom N/A JP050 N/A N/A N/A N/A N/A JK740 JP111 JK741 JP112 JK742 JP113 Indicator JK744 JP114 JP115 Card M D345, M D346 M D399 N/A N/A 1:2 1:2 JK340 JK341 JK342 JK344 JP121 JP122 JP123 JP124 JP125 Lock US900, US906 US900, US399 N/A N/A 1:1 JK440 JK441 JK442 JK444 3:4 JK740 JK741 JK742 JK744 1:2 JK340 JK341 JK342 JK344 A. B. 1:1 JP001 JP002 JP003 Filter, LidB JP050 JP050 N/A N/A JP004 JP005 JP006 JP007 3:4 JP011 Filter, Bottom N/A N/A N/A N/A JP012 JP013 JP014 JP015 JP016 Indicator JP017 Card M D345, M D346 M D399 N/A N/A 1:2 JP021 JP022 JP023 JP024 JP025 JP026 JP027 Lock US900, US906 US900, US399 N/A N/A M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. JP050 reusable f ilt er is int egrat ed int o t he PrimeLineTM and PrimeLine Pro lids Max Total WeightA 25 Pounds 25 Pounds SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 25 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 7.1.8 Steam and EtO SterilContainerTM JN Series Validated and FDA 510(k) Cleared Sterilization Modalities JN Series Bottom 1:1 JN440 JN441 JN442 JN444 JN446 3:4 JN740 JN741 JN742 JN744 1:2 JN340 JN341 JN342 JN344 JN346 XLL JN443 JN445 Wide JN817 JN821 Qtr JN086 JN088 JN089 JN090 Mini JN187 JN188 XLM JN021 Aluminum Lid 1:1 JK485 JK486 JK487 JK488 JK489 3:4 JK785 JK786 JK787 JK788 JK789 1:2 JK385 JK386 JK387 JK388 JK389 XLL JK490 Wide JE601 Qtr JN091 M D151 S76115 Mini JK170 JK171 JK172 JK173 JK174 M D149 S76113 XLM JK020 M D153 Processing Supplies Filter Indicator Card Lock Filter Indicator Card Lock PreVac St eam (1) PreVac IUSS (2) US751, US994 N/A M D344, JK090 M D345, M D346 N/A US900, US906 N/A US999, M D355, JK091 N/A N/A N/A US900, US906 N/A Gravit y (3) US751, US994 M D345, M D346 US900, US906 US999 N/A US900, US906 Et O (4) US751, US994, M D344 M D345, M D346 US900, US905 US999, M D355 N/A US900, US905 A. M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. Max Total WeightA 25 Pounds 25 Pounds SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 26 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 7.1.9 Steam and EtO SterilContainerTM JN Series, PrimeLineTM Pro / PrimeLine Lid JN Series Bottom 1:1 JN440 JN441 JN442 JN444 JN446 3:4 JN740 JN741 JN742 JN744 1:2 JN340 JN341 JN342 JN344 Lid 1:1 JP101 JP102 JP103 JP104 JP105 3:4 JP111 JP112 JP113 JP114 JP115 1:2 JP121 JP122 JP123 JP124 JP125 Processing Supplies Validated and FDA 510(k) Cleared Sterilization Modalities PreVac St eam PreVac IUSS Gravit y Et O (1) (2) (3) (4) Filter, LidB JP050 N/A N/A N/A Filter, Bottom US751, US994 N/A M D344, JK090 Indicator Card M D345, M D346 N/A N/A N/A N/A N/A Lock US900, US906 N/A N/A N/A 1:1 JN440 JN441 JN442 JN444 JN446 3:4 JN740 JN741 JN742 JN744 1:2 JN340 JN341 JN342 JN344 1:1 JP001 JP002 JP003 JP004 JP005 JP006 JP007 3:4 JP011 JP012 JP013 JP014 JP015 JP016 JP017 1:2 JP021 JP022 JP023 JP024 JP025 JP026 JP027 Filter, LidB JP050 N/A Filter, Bottom US751, US994 N/A M D344, JK090 Indicator Card M D345, M D346 N/A Lock US900, US906 N/A N/A N/A N/A N/A N/A N/A N/A N/A A. M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. B. JP050 reusable f ilt er is int egrat ed int o t he PrimeLineTM and PrimeLine Pro lids Max Total WeightA 25 Pounds 25 Pounds SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 27 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 7.1.10 Steam and EtO SterilContainerTM JM Series Validated and FDA 510(k) Cleared Sterilization Modalities JM Series Bottom 1:1 JM 440 JM 441 JM 442 JM 444 3:4 JM 740 JM 741 JM 742 1:2 JM 340 JM 341 JM 342 Aluminum Lid 1:1 JM 489 3:4 JM 789 1:2 JM 389 Processing Supplies Filter Indicator Card Lock PreVac St eam (1) US751, US994 M D344, JK090 PreVac IUSS (2) N/A M D345, M D346 N/A US900, US906 N/A Gravit y (3) US751, US994 M D345, M D346 US900, US906 Et O (4) US751, US994, M D344 M D345, M D346 US900, US905 Mini JM 188 XLM JM 021 Mini JM 174 M D152 XLM JM 020 M D150 S76114 Filter Indicator Card Lock US999, M D355, N/A JK091 N/A N/A US900, US906 N/A US999 N/A US900, US906 US999, M D355 N/A US900, US905 A. M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. Max Total WeightA 25 Pounds 25 Pounds 7.1.11 Steam and EtO SterilContainerTM JS Series Validated and FDA 510(k) Cleared Sterilization Modalities JS Series Bottom 1:1 JS440 JS441 JS442 JS444 3:4 JS740 JS741 JS742 1:2 JS340 JS341 JS342 Aluminum Lid 1:1 JS489 Processing Supplies Filter 3:4 JS789 1:2 JS389 Indicator Card Lock PreVac St eam (1) US751, US994 M D344, JK090 PreVac IUSS (2) N/A M D345, M D346 N/A US900, US906 N/A Gravit y (3) US751, US994 M D345, M D346 US900, US906 Et O Max Total (4) WeightA US751, US994, M D344 M D345, M D346 25 Pounds US900, US905 A. M ax w eight based on indust ry guidelines. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 28 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.0 SterilContainerTM System Sterilizer Cycle Parameters -- ASP STERRAD® This sect ion provides det ailed chart s t hat ident if y t he S and S2 conf igurat ions, locks, indicat or cards and filt er(s) t hat should be used t oget her for t he Low Temperature modality when used with ASP STERRAD® sterilizers. Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions shown. These conf igurat ions are support ed by t he numerous FDA 510(k) clearances held by Aesculap®. Conf iguring t he S and S2 in a manner not show n in t he t ables const it ut es an of f label use of t he product . Each cont ainer bot t om must ONLY be used w it h t he specif ic lid designed f or t hat series of cont ainer, and it should not be combined w it h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. In t he event t he inst rument IFU does not mat ch t he St e AAM I ST79 f or inf ormat ion on how t o reconcile mult iple IFUs. S IFU, t he inst rument IFU should t ake precedence. See See Sect ion 2.0 Syst em f or an explanat ion of t he Syst em. Notes: The S is made of non- anodized aluminum w hich undergoes a nat ural oxidat ion process. This oxidat ion process produces a very t hin layer on t he surf ace w hich may appear brow n or black. This oxidat ion process w ill cont inue unt il t he ent ire raw surf ace is oxidized. This brow n or black discolorat ion is part of t he nat ural processes. St acking is NOT permit t ed in Low Temperat ure st erilizers per t he manuf act urer of t he st erilizer. Single use paper f ilt ers are NOT compat ible w it h Low Temperat ure st erilizers. Nylon coat ed met al holding clamps are NOT compat ible w it h Low Temperat ure st erilizers. ment s should be assembled t o allow f or unif orm exposure t o st erilizat ion agent s. Conf irm basket , inst rument s and basket accessories are complet ely dry bef ore assembling inst rument set . See Sect ion 14.0 Indicat ions f or Use f or addit ional inf ormat ion on t he Syst em and accessories. Cont ainer size abbreviat ions on modalit y chart s. Detailed Size Description Full- Size Three- Quart er Half XL- Long Wide Body XL- M ini Quart er M ini Abbreviation Size Description 1:1 3:4 1:2 XLL Wide XLM Qt r M ini SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 29 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1 STERRAD® Sterilization Modality Cycle Parameters Primary Name Which Includes May Also Be Referred to As Hydrogen Peroxide Gas Plasma Low Temperat ure1, H2O2, STERRAD®2 1. These t erms will be used t hroughout t he remainder of t he Inst ruct ions f or Use (IFU). 2. The JM Series and JS Series have received FDA clearance f or t he f ollow ing STERRAD® cycles. Ref er t o each sect ion ident if ied in t he chart f or proper cont ainer conf igurat ion and processing supplies. STERRAD® NX1 NX1 100NX1 100S 200 Standard Advanced Standard JM Series 8.1.1 8.1.3 8.1.4 8.1.6 8.1.8 JS Series 8.1.2 N/A 8.1.5 8.1.7 8.1.9 1. Includes NX AllClear® and 100NX AllClear® st erilizers. See STERRAD® IFU f or f ull det ails. 100NX1 Flex 8.1.10 8.1.11 100NX1 Express 8.1.12 N/A 100NX1 Duo 8.1.14 8.1.13 St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s NX Standard Yes Accessories Compatible with STERRAD® NX 100NX 100NX 100NX Advanced Standard Flex Express Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No No Yes 100NX Duo Yes Yes Yes SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 30 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.1 STERRAD® 100S Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 STERRAD® 100S Max Total Efficacy WeightA 3:4 JM 740 JM 789 Indicator 13.90 JM 741 Card M D334 St andard Cycle Pounds JM 742 1:2 JM 340 JM 389 JM 341 JM 342 Lock US900, US910 Filter M ini JM 188 JM 174 M D152 Indicator Card Lock M D355 M D335 US900, US910 St andard Cycle See Not es Filter M D355 JM 020 Indicator XLM JM 021 M D150 Card S76114 Lock M D335 US900, US910 St andard Cycle See Not es A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. Notes: The w eight of t he inst rument load should not exceed 14 Pounds Pounds each w hen using t w o smaller cont ainers f or ef f ect ive st erilizat ion and drying. It is import ant not t o exceed t he unif orm exposure t o st erilizat ion agent s. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 31 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.2 STERRAD® 100S Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies 1:1 JS440 JS489 Filter JS441 M D344 JS442 JS444 Indicator Card M D334 STERRAD® 100S Efficacy Max Total WeightA 3:4 JS740 JS789 JS741 JS742 Lock 1:2 JS340 JS389 JS341 JS342 US900, US910 St andard Cycle 13.90 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 8.1.3 STERRAD® 200 Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies 1:1 JM 440 JM 489 Filter JM 441 JM 442 JM 444 M D344 Indicator M D334 3:4 JM 740 JM 789 Card JM 741 JM 742 1:2 JM 340 JM 389 Lock JM 341 JM 342 US900, US910 M ini JM 188 JM 174 Filter M D152 M D355 Indicator M D335 XLM JM 021 JM 020 M D150 Card S76114 Lock US900, US910 STERRAD® 200 Efficacy Max Total WeightA 21.46 Pounds St andard Cycle 14.42 Pounds 14.42 Pounds St andard Cycle 7.64 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 32 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.4 STERRAD® NX Standard Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERRAD® NX Efficacy 1:1 JM 440 JM 489 Filter JM 441 JM 442 JM 444 M D344 Indicator M D334 3:4 JM 740 JM 789 Card JM 741 St andard Cycle JM 742 1:2 JM 340 JM 389 Lock JM 341 JM 342 US900, US910 Max Total WeightA 10.70 Pounds M ini JM 188 JM 174 Filter M D152 Indicator XLM JM 021 JM 020 M D150 Card S76114 Lock M D355 M D335 US900, US910 St andard Cycle 7.64 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 8.1.5 STERRAD® NX Standard Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERRAD® NX Efficacy 1:1 JS440 JS489 Filter JS441 JS442 JS444 M D344 Indicator M D334 3:4 JS740 JS789 Card JS741 St andard Cycle JS742 1:2 JS340 JS389 Lock JS341 JS342 US900, US910 Max Total WeightA 10.70 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 33 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.6 STERRAD® NX Advanced Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERRAD® NX Efficacy 1:1 JM 440 JM 489 Filter JM 441 JM 442 JM 444 M D344 Indicator M D334 3:4 JM 740 JM 789 Card JM 741 Advanced Cycle JM 742 1:2 JM 340 JM 389 Lock JM 341 JM 342 US900, US910 Max Total WeightA 10.70 Pounds M ini JM 188 JM 174 Filter M D152 Indicator XLM JM 021 JM 020 M D150 Card S76114 Lock M D355 M D335 US900, US910 Advanced Cycle 7.64 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 8.1.7 STERRAD® NX Advanced Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERRAD® NX Efficacy 1:1 JS440 JS489 Filter JS441 JS442 JS444 M D344 Indicator M D334 3:4 JS740 JS789 Card JS741 Advanced Cycle JS742 1:2 JS340 JS389 Lock JS341 JS342 US900, US910 Max Total WeightA 10.70 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may al so be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 34 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.8 STERRAD® 100NX Standard Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERRAD® 100NX Efficacy 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 Max Total WeightA 21.46 Pounds 3:4 JM 740 JM 789 Indicator 13.85 JM 741 Card M D334 St andard Cycle Pounds JM 742 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 13.85 Pounds M ini JM 188 JM 174 M D152 Filter XLM JM 021 JM 020 Indicator M D150 Card S76114 Lock M D355 M D335 US900, US910 St andard Cycle 7.64 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 8.1.9 STERRAD® 100NX Standard Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERRAD® 100NX Efficacy 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 Max Total WeightA 21.46 Pounds 3:4 JS740 JS789 Indicator 13.85 JS741 Card M D334 St andard Cycle Pounds JS742 1:2 JS340 JS389 JS341 JS342 Lock US900, US910 13.85 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 35 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.10 STERRAD® 100NX FLEX Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERRAD® 100NX Max Total Efficacy WeightA 1:1 JM 440 JM 489 J JM 441 JM 442 Filter JM 444 M D344 3:4 JM 740 JM 789 Indicator JM 741 Card M D334 Flex Cycle JM 742 See Not es 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 8.1.11 STERRAD® 100NX FLEX Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERRAD® 100NX Max Total Efficacy WeightA 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 3:4 JS740 JS789 Indicator JS741 Card M D334 Flex Cycle JS742 JS389 1:2 JS340 JS341 JS342 Lock US900, US910 See Not es A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. Notes: M ax Tot al Weight o Full- size: 10.95 Pounds one cont ainer, 21.6 Pounds t ot al chamber load o Three- quart er size: 10.35 Pounds one cont ainer, 21.6 Pounds t ot al chamber w eight o Half - size: 10.35 Pounds one cont ainer, 21.6 Pounds t ot al chamber weight SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 36 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 8.1.12 STERRAD® 100NX Express Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERRAD® 100NX Max Total Efficacy WeightA 1:1 JM 440 JM 489 JM 441 Filter M D344 JM 442 JM 444 Indicator 1:2 JM 340 JM 389 Card M D334 Express Cycle 25 Pounds JM 341 JM 342 Lock US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. Notes: During validat ion, chamber load consist ed of one cont ainer placed on bot t om shelf w it h an ot herw ise empt y chamber. The cont ainer should be placed f lat on t he shelf and should not t ouch t he w alls of t he chamber. The cont ainer should not be st acked in t he chamber. 8.1.13 STERRAD® 100NX DUO Cycle -- SterilContainerTM S2 JS Series Cust omers t hat w ish t o use t he JS Series in t he STERRAD® 100NX Duo cycle must use: only t he JS Series cont ainers list ed in t able 2 of t he K193582 cleared Indicat ions f or Use below ; icies and procedures; t he Aesculap® M D344 round polypropylene f ilt er(s); t he Aesculap® US900 blue locks w it hout indicat or; a STERRAD® 100NX Duo cycle FDA 510(k) cleared ext ernal indicat or; and Notes: Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. As part of t he FDA submission, Aesculap® has perf ormed validat ion t est ing and event relat ed st erilit y maint enance t est ing on t he Syst em. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked, see sect ion 6.6 Cont ainer St orage and Transport at ion. Aesculap® US910 lock may NOT be used w it h STERRAD®100NX Duo. Consult w it h t he manuf act urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w it h t he inst rument IFU. FDA 510(k) clearance Indications for Use: The Aesculap® St erilCont ainer S2 Syst em is a reusable rigid st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in t he STERRAD® 100NX DUO st erilizat ion modalit y. The Aesculap® S2 Syst em includes accessories such as silicone mat s and organizers, st ainless st eel basket s, t rays, holders, st erilizat ion indicat or cards and t amper proof locks. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 37 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) The at t ached t able ident if ies t he validat ed load conf igurat ions f or each of t he modalit ies. SterilContainerTM S2 System Validated Load Configurations Sterilization Cycle Container Size Validated Load Configuration STERRAD®100NX DUO (bot t om shelf only) Full Three- Quart er Half Flexible scope (> 1mm ID x < 850mm L) SterilContainerTM S2 System Load Weights Sterilization Method Container Size STERRAD®100NX DUO Full Size Full Size Full Size Full Size Three- Quart er Size - 4 Three- Quart er Size - 5 Three- Quart er Size Half Size Half Size - 5 ½ Half Size - Container Bottom Part # JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 Container Lid Part # JS489 JS789 JS389 Total Loaded Container (lb) 10.97 10.04 11.7 Sterilization Cycle Compatible Accessories Accessories Compatible with STERRAD®DUO St ainless St eel basket s, basket lids, and dividers Yes Inst rument Organizat ion Syst em (Silicone and St ainless St eel rack bracket s, holders, and clamps) Yes Silicone mat s No Tamper Evident locks and indicat or cards Yes 8.1.14 STERRAD® 100NX DUO Cycle -- SterilContainerTM S JM Series Cust omers t hat w ish t o use t he JM Series in t he STERRAD® 100NX Duo cycle must use: only t he JM Series cont ainers list ed in t able 2 of t he K182032 cleared Indicat ions f or Use below ; an int ernal biological t he Aesculap® M D344 round polypropylene f ilt er(s); t he Aesculap® US900 blue locks w it hout indicat or; a STERRAD® 100NX Duo cycle FDA 510(k) cleared ext ernal indicat or; and f ollow st erili Notes: Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked, see sect ion 6.6 Cont ainer St orage and Transport at ion. Aesculap® US910 lock may NOT be used w it h STERRAD®100NX Duo. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 38 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) FDA 510(k) clearance Indications for Use: The S Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h f lexible endoscopes and accessories, cables, and camera heads. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERRAD® 100NX Duo cycle. The S Syst em includes accessories such as silicone mat s, basket s, t rays, racks, f ilt ers, indicat or cards, locks, and inst rument holders. Validat ion t est ing f or event relat ed st erilit y maint enance has been conduct ed f or up t o 365 days. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 39 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.0 SterilContainerTM System Sterilizer Cycle Parameters -- STERIS® V-PRO® This sect ion provides det ailed chart s t hat ident if y t he St erilC S and S2 conf igurat ions, locks, indicat or cards and filt er(s) t hat should be used t oget her for t he Low Temperature modality when used with STERIS® V- PRO® sterilizers. Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions shown. These conf igurat ions are support ed by t he numerous FDA 510(k) clearances held by Aesculap®. Conf iguring t he S and S2 in a manner not show n in t he t ables const it ut es an of f label use of t he product . Each cont ainer bot t om must ONLY be used w it h t he specif ic lid designed f or t hat series of cont ainer, and it should not be combined w it h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. In t he event t he inst rument IFU does not mat ch t he St erilCont ain AAM I ST79 f or inf ormat ion on how t o reconcile mult iple IFUs. S IFU, t he inst rument IFU should t ake precedence. See See Sect ion 2.0 Syst em f or an explanat ion of t he Syst em. Notes: The S is made of non- anodized aluminum w hich undergoes a nat ural oxidat ion process. This oxidat ion process produces a very t hin layer on t he surf ace w hich may appear brow n or black. This oxidat ion process w ill cont inue unt il t he ent ire raw surf ace is oxidized. This brow n or black discolorat ion is part of t he nat ural processes. St acking is NOT permit t ed in Low Temperat ure st erilizers per t he manuf act urer of t he st erilizer. Single use paper f ilt ers are NOT compat ible w it h Low Temperat ure st erilizers. Nylon coat ed met al holding clamps are NOT compat ible w it h Low Temperat ure st erilizers. Conf irm basket , inst rument s and basket accessories are complet ely dry bef ore assembling inst rument set . It is should be assembled t o allow f or unif orm exposure t o st erilizat ion agent s. See Sect ion 14.0 Indicat ions f or Use f or addit ional inf ormat ion on t he Cont ainer size abbreviat ions on modalit y chart s. Syst em and accessories. Detailed Size Description Full- Size Three- Quart er Half XL- Long Wide Body XL- M ini Quart er M ini Abbreviation Size Description 1:1 3:4 1:2 XLL Wide XLM Qt r M ini SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 40 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1 STERIS® Sterilization Modality Cycle Parameters Primary Name Which Includes May Also Be Referred to As Hydrogen Peroxide Vapor Hydrogen Peroxide Low Temperat ure1, H2O2, STERIS®2, V- PRO®2 1. These t erms will be used t hroughout t he remainder of t he Inst ruct ions f or Use (IFU). 2. The JM Series and JS Series have received FDA clearance f or t he f ollow ing STERIS® cycles. Ref er t o each sect ion ident if ied in t he chart f or proper cont ainer conf igurat ion and processing supplies. STERIS® V-PRO® 60 maX1 Lumen Non-Lumen Flexible Flexible Lumen Non-Lumen JM Series 9.1.1 9.1.3 9.1.5 9.1.7 N/A N/A JS Series 9.1.2 9.1.4 9.1.6 9.1.8 9.1.9 9.1.10 1. The STERIS® maX2 and S2 st erilizers includes t he Lumen, Flexible and Non- Lumen V- PRO® cycles. See STERIS® IFU f or f ull det ails. St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s Lumen Yes Accessories Compatible with STERIS® V-PRO® 60 maX Non-Lumen Flexible Flexible Lumen Yes Yes Yes Yes Non-Lumen Yes Yes Yes Yes Yes Yes Yes No No No No No No SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 41 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1.1 STERIS® V-PRO® 60 Lumen Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERIS® V-PRO® 60 EfficacyB 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 Max Total WeightA 11.10 Pounds 3:4 JM 740 JM 741 JM 789 Indicator Card M D334 Lumen Cycle 9.60 Pounds JM 742 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 9.60 Pounds M ini JM 188 JM 174 M D152 Filter XLM JM 021 JM 020 Indicator M D150 Card S76114 Lock M D355 M D335 US900, US910 Lumen Cycle 7.64 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 9.1.2 STERIS® V-PRO® 60 Lumen Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERIS® V-PRO® 60 EfficacyB 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 3:4 JS740 JS789 Indicator JS741 Card M D334 Lumen Cycle JS742 1:2 JS340 JS389 JS341 Lock JS342 US900, US910 Max Total WeightA 11.10 Pounds 9.60 Pounds 9.60 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. B. The V- PRO® cycle validat ion w it h t he subject device w as conduct ed w it h t he V- PRO® maX. VPRO® 60 cycles w ere not direct ly ut ilized in validat ion t est ing. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 42 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1.3 STERIS® V-PRO® 60 Non-Lumen Cycle -- SterilContainerTM S JM Series STERIS® V-PRO® 60 Size Bottom Lid Processing Supplies Efficacy 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 Max Total WeightA 3:4 JM 740 JM 741 JM 789 Indicator Card M D334 Non- Lumen Cycle 12.00 Pounds JM 742 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 M ini JM 188 JM 174 M D152 Filter XLM JM 021 JM 020 Indicator M D150 Card S76114 Lock M D355 M D335 US900, US910 7.64 Non- Lumen Cycle Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 9.1.4 STERIS® V-PRO® 60 Non-Lumen Cycle -- SterilContainerTM S2 JS Series STERIS® V-PRO® 60 Size Bottom Lid Processing Supplies Efficacy 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 Max Total WeightA 3:4 JS740 JS789 Indicator 12.00 JS741 Card M D334 Non- Lumen Cycle Pounds JS742 1:2 JS340 JS389 JS341 JS342 Lock US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. B. The V- PRO® cycle validat ion w it h t he subject device w as conduct ed w it h t he V- PRO® maX. VPRO® 60 cycles w ere not direct ly ut ilized in validat ion t est ing. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 43 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1.5 STERIS® V-PRO® 60 Flexible Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERIS® V-PRO® 60 Efficacy 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 Max Total WeightA 3:4 JM 740 JM 789 Indicator JM 741 Card M D334 Flexible Cycle See Not es JM 742 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 9.1.6 STERIS® V-PRO® 60 Flexible Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERIS® V-PRO® 60 Efficacy 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 Max Total WeightA 3:4 JS740 JS789 Indicator JS741 Card M D334 Flexible Cycle See Not es JS742 1:2 JS340 JS389 JS341 JS342 Lock US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. B. The V- PRO® cycle validat ion w it h t he subject device w as conduct ed w it h t he V- PRO® maX. VPRO® 60 cycles w ere not direct ly ut ilized in validat ion t est ing. Notes: M ax Tot al Weight o Load limit def ined by load conf igurat ion and not load weight . o 1 f lexible scope (single or dual lumens > 1mm ID and < 990 mm L) w it h light cord (if not int egral t o endoscope) and mat wit hout any addit ional load. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 44 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1.7 Amsco® STERIS® V-PRO® maX Flexible Cycle -- SterilContainerTM S JM Series Size Bottom Lid Processing Supplies STERIS® V-PRO® maX Efficacy Max Total WeightA 1:1 JM 440 JM 489 JM 441 JM 442 Filter JM 444 M D344 3:4 JM 740 JM 741 JM 789 Indicator Card M D334 Flexible Cycle 10.00 Pounds JM 742 1:2 JM 340 JM 389 JM 341 Lock JM 342 US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 9.1.8 Amsco® STERIS® V-PRO® maX Flexible Cycle -- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERIS® V-PRO® maX Efficacy Max Total WeightA 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 3:4 JS740 JS741 JS789 Indicator Card M D334 Flexible Cycle 10.00 Pounds JS742 1:2 JS340 JS389 JS341 Lock JS342 US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 45 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 9.1.9 Amsco® STERIS® V-PRO® maX Lumen Cycle-- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERIS® V-PRO® Max Efficacy Max Total WeightA 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 11.10 Pounds 3:4 JS740 JS789 Indicator JS741 Card M D334 Lumen Cycle JS742 9.60 Pounds 1:2 JS340 JS389 JS341 Lock JS342 US900, US910 9.60 Pounds A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. 9.1.10 Amsco® STERIS® V-PRO® maX Non-Lumen Cycle-- SterilContainerTM S2 JS Series Size Bottom Lid Processing Supplies STERIS® V-PRO® maX Efficacy Max Total WeightA 1:1 JS440 JS489 JS441 JS442 Filter JS444 M D344 3:4 JS740 JS741 JS789 Indicator Card M D334 Non- Lumen Cycle 18.6 Pounds JS742 1:2 JS340 JS389 JS341 Lock JS342 US900, US910 A. M ax w eight used during validat ion t est ing. Weight limit may also be impact ed by cont ainer size. Follow st erilizer manuf act urer IFU w eight limit s if less. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 46 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 10.0 SterilContainerTM System Sterilizer Cycle Parameters -- STERIZONE® This sect ion provides det ailed chart s t hat ident if y t he S conf igurat ions, locks, indicat or cards and f ilt er(s) t hat should be used t oget her for t he Low Temperature modality when used with STERIZONE® sterilizers. Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions shown. These conf igurat ions are support ed by t he numerous FDA 510(k) clearances held by Aesculap®. Conf iguring t he S and S2 in a manner not show n in t he t ables const it ut es an of f label use of t he product . Each cont ainer bot t om must ONLY be used w it h t he specific lid designed f or t hat series of cont ainer, and it should not be combined w it h ot her Aesculap® or non- Aesculap® series of bot t oms or lids. In t he event t he inst rument IFU does not mat ch t he AAM I ST79 f or inf ormat ion on how t o reconcile mult iple IFUs. IFU, t he inst rument IFU should t ake precedence. See See Sect ion 2.0 Syst em f or an explanat ion of t he Syst em. Notes: The S is made of non- anodized aluminum w hich undergoes a nat ural oxidat ion process. This oxidat ion process produces a very t hin layer on t he surf ace w hich may appear brow n or black. This oxidat ion process w ill cont inue unt il t he ent ire raw surf ace is oxidized. This brow n or black discolorat ion is part of t he nat ural processes. St acking is NOT permit t ed in Low Temperat ure st erilizers per t he manuf act urer of t he st erilizer. Single use paper f ilt ers are NOT compat ible w it h Low Temperat ure st erilizers. Nylon coat ed met al holding clamps are NOT compat ible w it h Low Temperat ure st erilizers. Conf irm basket , inst rument s and basket accessories are complet ely dry bef ore assembling inst rument set . should be assembled t o allow f or unif orm exposure t o st erilizat ion agent s. See Sect ion 14.0 Indicat ions f or Use f or addit ional inf ormat ion on t he Cont ainer size abbreviat ions on modalit y chart s. Syst em and accessories. Detailed Size Description Full- Size Three- Quart er Half XL- Long Wide Body XL- M ini Quart er M ini Abbreviation Size Description 1:1 3:4 1:2 XLL Wide XLM Qt r M ini SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 47 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 10.1 STERIZONE® Sterilization Modality Cycle Parameters Primary Name Which Includes May Also Be Referred to As Hydrogen Peroxide Ozone Low Temperat ure1 TS032, STERIZONE®2, VP42 and Ozone 1. These t erms will be used t hroughout t he remainder of t he Inst ruct ions f or Use (IFU). 2. ame. 10.1.1 STERIZONE® VP4 Cycle -- SterilContainerTM S2 JS Series Cust omers t hat w ish t o use t he JS Series in t he STERIZONE® VP4 cycle must use: only t he JS Series cont ainers list ed in t able 2 of t he K193582 cleared Indicat ions f or Use below ; an int ernal biologi t he Aesculap® M D344 round polypropylene f ilt er(s); t he Aesculap® US900 blue locks w it hout indicat or; and Notes: Hospit al procedures and AORN guidelines f or asept ic present at ion should alw ays be follow ed. Employees should be St acking is NOT permit t ed in Low Temperat ure st erilizers per t he manuf act urer of t he st erilizer. Single use paper f ilt ers are NOT compat ible w it h Low Temperat ure st erilizers. Nylon coat ed met al holding clamps are NOT compat ible w it h Low Temperat ure st erilizers. Aesculap® US910 lock may NOT be used w it h VP4. Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. As part of t he FDA submission, Aesculap® has perf ormed validat ion t est ing and event relat ed st erilit y maint enance t est ing on t he St erilCont Syst em. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked. Consult w it h t he manuf act urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w it h t he inst rument IFU. FDA 510(k) clearance Indications for Use: The Aesculap® St erilCont ainer S2 Syst em is a reusable rigid st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in t he STERIZONE® VP4st erilizat ion modalit ies: The Aesculap® S2 Syst em includes accessories such as silicone mat s and organizers, st ainless st eel basket s, t rays, holders, st erilizat ion indicat or cards and t amper proof locks. The at t ached t able ident if ies t he validat ed load conf igurat ions. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 48 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) SterilContainerTM S2 System Validated Load Configurations Sterilization Cycle Container Size Validated Load Configuration STERIZONE® VP4 Validat ed Loads 1 & 2 (Based on STERIZONE® Load # 7) Full Three- Quart er Half Non Lumened Inst rument s STERIZONE® VP4 Validat ed Load 3 (Based on STERIZONE® Load # 8) STERIZONE® Validat ed Load 4 (Based on STERIZONE® Load # 4) JS440 (base) + JS489 (lid) JS440 (base) + JS489 (lid) (1) Single Channel Flexible Scope (> 1mm ID x < 850mm L) OR (1) Dual Channel Flexible Scope (> 1mm ID x < 850 mm L and > 1 mm ID x < 989mm L) (1) Semi- rigid dual channel scope (> 0.7mm ID x < 500mm L and > 1.1mm ID x < 500mm L) AND one of t he follow ing: (4) St ainless st eel lumens (> 5.5mm ID x < 166mm L; > 7mm ID x < 105mm L; > 7.0mm ID x < 227mm L; > 7.8mm ID x < 198mm L) OR (2) St ainless st eel lumens (> 4mm ID x < 370mm L; > 2mm ID x < 152mm L) OR (3) St ainless st eel lumens (> 2.2mm ID x < 173mm L; > 4.7mm ID x < 270mmL ; > 4mm ID x < 445mm L) SterilContainerTM S2 System Load Weights Sterilization Method Container Size STERIZONE® Validat ed Loads 1 & 2 (Based on STERIZONE® Load # 7) Full Size Full Size Full Size Full Size Three- Quart er Size - 4 Three- Quart er Size - 5 Three- Quart er Size Half Size Half Size - 5 ½ Half Size Half Size - 5 ½ Half Size - Container Bottom Part # JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS341 JS342 Container Lid Part # JS489 JS789 JS389 Total Loaded Container (lb) 25 25 25 STERIZONE® Validat ed Load 3 (Based on STERIZONE® Load # 8) Full Size - JS440 JS489 See load configurat ion in t able 1 above SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 49 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) STERIZONE® Validat ed Load 4 (Based on STERIZONE® Load # 4) Full Size - JS440 JS489 See load configurat ion in t able 1 above Sterilization Cycle Compatible Accessories Accessories St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s Tamper Evident locks and indicat or cards VP4 Yes Yes Yes Yes 10.1.2 STERIZONE® VP4 Cycle -- SterilContainerTM S JM Series Cust omers t hat w ish t o use t he JM Series in t he STERIZONE® VP4 cycle must use: only t he JM Series cont ainers list ed in t able 2 of t he K162815 cleared Indicat ions f or Use below ; t he Aesculap® M D344 round polypropylene f ilt er(s); t he Aesculap® US900 blue locks w it hout indicat or; and foll Notes: Hospit al procedures and AORN guidelines f or asept ic present at ion should alw ays be follow ed. Employees should be The art icipat ing in t he Operat ion Room. S is made of non- anodized aluminum w hich undergoes a nat ural oxidat ion process. This oxidat ion process produces very t hin layer on t he surf ace w hich may appear brown or black. This oxidat ion process w ill cont inue unt il t he ent ire raw surf ace is oxidized. This brow n or black discolorat ion is part of t he nat ural processes. St acking is NOT permit t ed in Low Temperat ure st erilizers per t he manuf act urer of t he st erilizer. Single use paper f ilt ers are NOT compat ible w it h Low Temperat ure st erilizers. Nylon coat ed met al holding clamps are NOT compat ible w it h Low Temperat ure st erilizers. Aesculap® US910 lock may NOT be used w it h VP4. FDA 510(k) clearance Indications for Use: The S Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h st ainless st eel and Tef lon lumens, hinged, and knurled inst rument s. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERIZONE® VP4 Low Temperat ure St erilizat ion Syst em. The S Syst em includes accessories such as silicone mat s, basket s, t rays, racks, eyepiece holders and sleeve holders. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 50 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table 1: Validat ed VP4 Cycle Load Conf igurat ions Load Conf igurat ion 1 (31.2 lb) Flexible endoscopes load accommodat ing t hree single channel f lexible endoscopes, one per cont ainer: Load Conf igurat ion 2 (29.4 lb) Load Conf igurat ion 3 (10.2 lb): Int ernal channel diamet er of 1 mm and lengt h of 850 mm. Semi- rigid and rigid channel devices load accommodat ing t hree double channel semi- rigid endoscopes and one lengt h of medical grade st ainless st eel t ubing. Lengt h of t ubing: o Int ernal channel diamet er of 1.0 mm and lengt h of 500 mm. Double channel semi- rigid endoscope o Int ernal channel diamet ers of 0.7 mm and 1.1 mm, and lengt h of 500 mm Worst - case volume t o surface perf orat ion area rat io using a perf orat ed cont ainer including t w o st acked basket s. Each basket w as covered w it h a f ul l lengt h silicone mat . At least one inoculat ed medical device w as added per level of t he cont ainer. Load Conf igurat ion 4 (25 lb) Worst - case volume t o surface perf orat ion area rat io using a perf orat ed cont ainer w it h maximum w eight of inst rument , f or a t ot al mass of 25 lb. At least t hree inoculat ed medical devices w ere added in t he cont ainer. Load Conf igurat ion 5 (75 lb) Heavy w eight load composed of t hree perf orat ed cont ainers, w it h a t ot al mass of 25 lb per cont ainer. The heavy validat ion load w as prepared based on t he Aesculap® S cont ainer let halit y st udies (PRO- 169) and adapt ed t o include a maximum w eight in a single load. Table 2: VP4 St erilizer Cycle Compat ible S Cont ainer Syst ems Lid Bottom Description JM 489 JM 789 JM 389 JM 440 JM 441 JM 442 JM 444 JM 740 JM 741 JM 742 JM 340 JM 341 JM 342 Full Size 187mm ( Total Loaded Container Weight (if container does not contain a flexible endoscope or bronchoscope)* 25 lbs f or one cont ainer in t he chamber *Loads cont aining a f lexible endoscope or bronchoscope should f ollow Table 1 recommendat ion. Table 3: VP4 St erilizer Cycle Compat ible Accessories Accessories St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s St ainless St eel racks, t rays, holders, clamps, bracket s, and plat f orms VP4 Yes Yes Yes Yes SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 51 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 11.0 Aseptic Presentation Hospit al procedures and AORN guidelines should always be f ollow ed when using and present ing t he Syst em. The f ollow ing are a set of suggest ed st eps f or an asept ic present at ion of a processed st erile cont ainer. 1. Non- scrubbed person posit ions cont ainer on a separat e dry f lat surface at or slight ly above t he level of t he st erile f ield. 2. Non- scrubbed person inspect s physical int egrit y of t he closed cont ainer syst em t o assure seals are in place. 3. Non- scrubbed person inspect s t he ext erior chemical indicat or(s). a. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post st erilizat ion indicat or color may vary and not be evenly shaded. b. Tamper Evident Lock US910 Low Temperat ure ext ernal Chemical Indicat ors (CIs) are part icularly sensit ive and must be st ored in a cont rolled room t emperat ure, aw ay f rom alkaline chemicals, acids and sources of light prior t o use. DO NOT USE beyond t he expirat ion dat e provided on t he out side product packaging. Change of color prior t o use in t he st erilizer could indicat e t hat t hese CIs w ere exposed t o t oo much light or high t emperat ures during st orage. Aft er being processed, low t emperat ure t amper evident lock should be st ored at a cont rolled room t emperat ure away f rom alkaline chemicals, acids and sources of light . Indicat ors may t urn w hit e post st erilizat ion if not st ored out of direct light ing. 4. Non- scrubbed person breaks locks by simult aneously moving t he lat ches int o t he open posit ion. Bef ore removing t he lid, discard all broken pieces of t he locks. 5. Non- scrubbed person opens t he lat ches t he rest of t he way and removes t he lid in one single st ep, making sure t hat t he cont ainer edge/bot t om is not cont aminat ed. 6. Non- scrubbed person and/or scrubbed person assures chemical dot indicat or on f ilt er(s) changed, if using f ilt ers w it h indicat ors. 7. Non- scrubbed person checks t he int egrit y of t he f ilt er(s) w it h t he naked eye by removing t he f ilt er ret ent ion plat e and examining. Reusable f ilt er may remain in place inside lid during inspect ion. Replace f ilt er ret ent ion plat es af t er examining f ilt er. 8. Scrubbed person removes t he st erile cont ent s inside by grasping bot h handles using appropriat e asept ic t echnique, lif t ing basket and cont ent s out . 9. Non- scrubbed person checks t he f ilt er(s) on t he bot t om if a perf orat ed bot t om cont ainer is used. Replace f ilt er ret ent ion plat es aft er examining f ilt er. 10. Scrubbed person may move t he st erile cont ent s int o t he st erile f ield once inspect ion has been complet ed successf ully. Notes: Hospit al procedures and AORN guidelines f or asept ic present at ion should alw ays be follow ed. Employees should be s procedures bef ore perf orming asept ic present at ion or part icipat ing in t he Operat ion Room. Bef ore t he inst rument s are placed on t he st erile f ield, t he inside surf ace of t he cont ainer should be inspect ed f or debris, cont aminat ion, or damage per AAM I ST79. Visit ww w .yout ube.com/Aesculapusa Syst em sect ion f or inf ormat ional videos on Syst em proper st erile reprocessing preparat ion. Using inspect ion and t est met hods ot her t han t hose out lined in t his IFU are not recommended and have not been validat ed by Aesculap®. Basket s w it h or w it hout f eet maybe used w it h Syst em. Using basket s w it h f eet may help reduce t he possibilit y of scrat ching of basket on t he cont ainer bot t om. The black PEEK feet on t he Aesculap® JF basket s assist in aligning t he JF basket s when st acking t hem in a cont ainer or during t he reprocessing process. These f eet may w ear and/or break overt ime depending on t he processing (number of t imes, chemicals, w at er qualit y), applicat ion (t ype of set ) and use (handling of t he product ). Inspect basket and feet prior t o use. Replace if desired, using Aesculap® part number JF112210. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 52 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Ret ent ion plat es should be replaced w hen t hey show w ear, age and/or are damaged. The ret ent ion plat e on t he met al lids should not spin f reely when properly inst alled and in proper w orking condit ion. Not e t hat t he ret ent ion plat e may move a lit t le if signif icant amount of pressure is applied w hile t rying t o t w ist or t urn (especially w hen f ilt er is inst alled). Inspect reusable f ilt er f or holes, t ears and rips. Conf irm f ilt er is w it hin use- by dat e (< 2,200 cycles). Arrow s on f ilt er and f ilt er housing w ill align w hen f ilt er is properly inst alled, see phot o. If t he PrimeLineTM or PrimeLine Pro int ernal or ext ernal cover f alls of f aft er st erilizat ion and bef ore t he set is used, t he set can maint ain st erilit y if no ot her event relat ed incidence has occurred since it is a sealed f ilt er syst em. The broken dust cover should be replaced and/or t he lid should be serviced by Aesculap®. See Sect ion 3.0 Syst em Service f or f ull det ails regarding service. Through t he st erilizat ion process t he f ilt er may become wavy f rom moist ure but should remain held in place by t he ret ent ion plat e and cover t he f ilt er openings. Reusable f ilt ers and t he int egrat ed reusable f ilt er, PrimeLineTM, should also be checked prior t o use. See Sect ion 6.0. Hospit al procedures and AORN guidelines f or asept ic present at ion should alw ays be follow ed. Employees should be For Reference Only, See Sect ion 6.0 Preparat ion and Assembly of Syst em f or more inf ormat ion. Filter Type PreVac Steam PreVac IUSS Gravity EtO Paper Filter w/ Indicator1 X1 X1 X1 X1 US751 Paper Filter w/o Indicator X X X X US994, US999 Polypropylene Filter w/o Indicator X X X M D344, M D355 Metal Retention Plate PTFE Reusable Filter X X JK090, JK091 PrimeLineTM & PrimeLine Pro PTFE Reusable Filter X X JP050 1. Filt er cont ains a dual indicat or dot , which changes f rom blue t o brow n in st eam, and t o orange in Et O. Low Temp X SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 53 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Tamper Evident Locks PreVac Steam PreVac IUSS Gravity EtO Low Temp Blue / US900 No Indicat or X X X X X Green / US905 X Change1 Yellow t o Orange Orange / US906 Change1 Blue t o Brow n X X X Pink / US9102 X2 Change1 M agent a t o Blue Yellow / US399 X Change1 Blue t o Brow n 1. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post sterilization indicator color may vary and not be evenly shaded. 2. Locks must be st ored in a cont rolled room t emperat ure, aw ay f rom alkaline chemicals, acids and sources of light . Notes: The expirat ion dat e on t he product labels, f ilt ers and indicat or cards are a pre- st erilizat ion dat e. This means t hat t he product should be processed (gone t hrough t he st erilizat ion process) by t his t ime t o achieve maximum result s. If processed af t er t his dat e t he product may st ill w ork. The indicat or w ill remain t he post st erilizat ion color f or up t o t hree years, w hen st ored properly. This is known as t he post - st erilizat ion dat e. Af t er t his t ime, t he color of t he indicat or may shif t or f ade over t ime. Proper st erilizat ion care, handling and st orage inst ruct ions can be f ound on t he labels of each product . For Reference Only, See Sect ion 6.0 Preparat ion and Assembly of Syst em f or more inf ormat ion. Indicator & Communication Cards PreVac Steam PreVac IUSS Gravity EtO Low Temp MD334, MD335 w/ Indicator X Change1 Blue MD346, MD876, US754 w/ Indicator X X Change1,2 Brow n in St eam Change1,2 Orange in Et O X X US963 w/o Indicator X X X X X MD399, MD345 w/ Indicator X Change1 Brow n 1. Af t er st erilizat ion, t he ext ernal indicat or should change f rom t he original indicat or color t o indicat e exposure t o st erilant . The post sterilization indicator color may vary and not be evenly shaded. 2. Filt er cont ains a dual indicat or dot , which changes t o brown in st eam, and t o orange in Et O. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 54 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 11.1 SterilContainerTM System Reference Guidelines All inf ormat ion and st eps out lined in t his IFU should be follow ed. Aesculap® DOC1006 and DOC1007 may be used as a ref erence guide in Prep and Pack, and t he OR respect ively once personnel t raining and compet ency is achieved. Cont act Aesculap® cust omer service t o order. Guidelines During Prep and Pack (Aesculap® DOC1006) Guidelines During Asept ic Present at ion (Aesculap® DOC1007) Figure 7: Easy Reference Handout 11.2 SterilContainerTM System Transportation to Decontamination Aesculap® suggest s f ollow ing AAM I ST79 guidelines f or t he handling and t ransport at ion of cont aminat ed inst rument s and cont ainers in conjunct ion w it h f acilit y policies and procedures. If t he cont ainer and/or lid are soiled, t hey must be f ully cleaned. For cont ainers and/or lids t hat are not soiled and have been removed f rom t he operat ing room bef ore t he pat ient ent ered, t he f acilit y should det ermine best cleaning pract ice based on it s est ablished policy and procedures. Aesculap® of fers bio bins t hat are specif ically designed for t ransport of soiled inst rument s. Aesculap® bio bins should be decont aminat ed f ollow ing t he same processes and pract ices as st erile cont ainers. See Aesculap® cont ainer cat alog f or more inf ormat ion on bio bins. Cont act Aesculap® cust omer service t o order. 12.0 Sterile Container Validation Summary Aesculap® t ainer syst ems, has been at t he f orefront of st erile packaging t echnology f or more t han 120 years. Aesculap® w as t he f irst vendor t o int roduce rigid st erile cont ainer syst ems t o t he Unit ed St at es at t he 1980 AORN Congress. Rigid st erile cont ainers, which are part of a medical st erilizat ion packaging syst em, are classif ied in t he Unit ed St at es as FDA Class II devices and t heref ore require rigorous validat ion t est ing t o st rict FDA guidance in order t o be cleared f or market ing and sale by t he FDA. Since t he int roduct ion of t he Syst em for St eam st erilizat ion in 1980, Aesculap® has expanded st erilizat ion modalit ies and product of f erings t o meet t he changing needs of healt hcare. Over t he last 35 years, Aesculap® has perf ormed t he required validat ion t est s and received FDA clearance f or st erile cont ainer product s t hat include PreVac, PreVac IUSS, Gravit y St eam, Et O, and Low Temperat ure st erilizat ion modalit ies. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 55 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 12.1 Validation Testing To achieve FDA clearance, t he cont ainer syst em must undergo validat ion t est s, w hich can be grouped int o t hree cat egories: 1. Reprocessing Validat ion and Verif icat ion 2. St erilizat ion Ef f icacy 3. St erilit y M aint enance Crit ical t o t he ef fect ive operat ion of t he St erile Processing Depart ment (SPD) in an acut e care surgical facilit y is t he need t o ef f icient ly decont aminat e, clean, st erilize, st ore and deliver st erile cont ainers and inst rument s t o t he Operat ing Room (OR). 12.1.1 Reprocessing Validation and Verification The Aesculap® Syst em of rigid cont ainers are designed t o be reused, as long as t hey meet t he inspect ion crit eria out lined in Sect ion 5.0 Inspect ion Prior t o Use of t he Aesculap® Inst ruct ions f or Use (IFU). If t hese crit eria cannot be achieved, t he product should be serviced t o bring it back w it hin st andards or replaced if st andards cannot be achieved. See Sect ion 3.0 Syst em Service f or f ull det ails regarding service. As part of obt aining FDA clearance on t he Syst em, Aesculap® perf ormed cleaning validat ion t est s. 12.1.2 Sterilization Efficacy The Syst em includes many dif f erent sizes and designs and can be used t o st erilize a w ide variet y of surgical inst rument s and t ools w hile maint aining package int egrit y. As part of obt aining FDA clearance on t he Syst em, Aesculap® perf ormed ef f icacy validat ion t est s relat ed t o t he st erilizat ion of cont ainer cont ent s, such as surgical inst rument s, scopes, pow er t ools et c. As per t he FDA Guidance, Aesculap® loads and conf igurat ions t o validat e t he cont ainer syst em. The Syst em w as validat ed using t he overkill met hod. The st erilit y assurance level (SAL) of 10-6 was achieved by placing spores of Geobacillus st earot hermophilus in t he most challenging locat ions inside t he cont ainer syst em and t hen st erile processing at one- half t he expect ed f ull cycle st erilizat ion exposure. 12.1.3 Sterility Maintenance To accommodat e surgical schedules, packaged st erile inst rument set s may need t o maint ain int egrit y f or st orage periods of days, w eeks or even mont hs. Inst rument set s t hat maint ain t he st erile barrier t hroughout st orage periods ensure conf idence t hat t he surgeon w ill have t he necessary t ools w hen needed t o provide opt imal care of t he surgical pat ient . As part of obt aining FDA clearance on t he Syst em, Aesculap® perf ormed st erilit y maint enance validat ion t est s t o ensure post st erilizat ion t ransport , st orage and delivery of st erile inst rument s t o t he Operat ing Room (OR). Event Related Storage Study Syst em t est unit s t hat w ere reprocessed f or more t han 100 cycles w ere st erilized and t hen st ored in a simulat ed SPD environment at an ISO cert if ied laborat ory f or a period of t ime. The cont ainer syst em w as handled on a rout ine basis t o simulat e a SPD st orage environment . At t he end of t he t est period, t he cont ainer syst em was asept ically opened and evaluat ed f or st erilit y. The Aesculap® Syst em successf ully complet ed t he validat ion t est . SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 56 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Aerosol Challenge Test Syst em t est unit s t hat w ere reprocessed f or more t han 100 cycles w ere st erilized and t hen placed in an aerosol chamber¹. At t he end of t he t est period, t he cont ainer syst em was asept ically opened and evaluat ed for st erilit y. The Aesculap® Syst em successf ully complet ed t he validat ion t est , Zero Colony Forming Unit s (CFU) were det ect ed. Notes: In order t o minimize pot ent ial cont aminat ion of st erilized surgical inst rument s in t he clinical set t ing, healt h care inst it ut ions should alw ays est ablish and f ollow int ernal writ t en policies and procedures f or inst rument st erilizat ion, t ransport , st orage and maint enance of st erile packaging, f ollow ing t he guidelines of AAM I ST79 and AORN st andards. Syst em should be used, cleaned, inspect ed, serviced and maint ained as specif ied in t he Aesculap® Inst ruct ions For Use (IFU). The Aesculap® Syst em should only be serviced by an Aesculap® service cent er. 12.2 Aesculap® SterilContainerTM System and FDA Clearances Excerpt s f rom t he FDA websit e, ww w .f da.gov, are included here t o provide a brief overview of t he 510(k) process. Sect ion 510(k) of t he Food, Drug and Cosmet ic Act requires device manufact urers who must regist er, t o not if y FDA of t heir int ent t o market a medical device at least 90 days in advance. This is known as Premarket Not if icat ion also called PM N or 510(k). A 510(k) is a premarket submission made t o FDA t o demonst rat e t hat t he device t o be market ed is at least as saf e and ef fect ive, subst ant ially equivalent , t o a legally market ed device. Unt il t he submit t er receives an order declaring a device SE (subst ant ially equivalent ), t he submit t er may not proceed t o market t he device. Once t he device is det ermined t o be SE, it can t hen be market ed in t he U.S. The t able below ident if ies t he st erilizat ion syst ems/modalit ies f or which t he Aesculap® received FDA 501(k) Clearance. Container System Description Syst em f or St eam St erilizat ion, Gravit y, St eam Pre Vacuum and Et hylene Oxide (ETO) Syst em f or St eam Pre Vacuum IUSS (Flash) S Syst em f or Advanced St erilizat ion Product s, STERRAD® Syst ems S Syst em f or STERIS® Amsco® V- PRO® 1 and V- PRO® 1 Plus Low Temperat ure St erilizat ion Syst em Aesculap® Reusable St erile Cont ainer Filt er f or St eam Pre Vacuum and St eam Pre Vacuum IUSS (Flash) Aesculap® wit h PrimeLineTM Lid f or St eam Pre Vacuum and St eam Pre Vacuum IUSS (Flash) Aesculap® f or PreVac St eam, Immediat e Use St eam, and Et O St erilizat ion S Syst em f or STERRAD 100NX Express Cycle S Syst em f or V- PRO® 60 St erilizat ion Syst em St erilCont S Syst em f or V- PRO® maX Flex Cycle Wit h PrimeLine Pro Lid S2 Syst em S Syst em f or STERRAD 100NX Duo Cycle S Syst em f or STERIZONE® VP4 Cycle Syst ems have FDA 510 (k) Clearance K792558 K053389 K040865,K093493 K093649 K041623 K073168 K112671 K142970 K143729 K151242 K172850 K182414 K182032 K162815 K193582 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 57 of 83 References: Aesculap® SterilContainerTM System Instructions for Use (IFU) 1. ANSI/AAM I ST- 77:2013 Cont ainment devices f or reusable medical device st erilizat ion 2. ANSI/AAM I ST- 79:2010 Comprehensive guide t o st eam st erilizat ion and st erilit y assurance in healt h care f acilit ies. 13.0 Customer Verification There is a dif f erence bet ween validat ion and verif icat ion. Aesculap® has perf ormed t est ing t o validate t hat it s Syst em can achieve and maint ain st erilit y in St eam, Et O and Low Temperat ure st erilizat ion modalit ies. Aesculap® validat ion paramet ers are t he basis f or t he recommended paramet ers included in t his IFU. Facilit ies verify t he perf ormance of Aesculap® Inst ruct ions f or Use can be achieved in t heir applicat ion. This inf ormat ion is int ended t o provide a guide f or users on how t o perf orm product t est ing in regards t o t he Syst em and does not supersede policies and procedures of t he healt hcare facilit y. Product Test ing can be broken int o t hree sub- cat egories: 1. Pre- Purchase Evaluat ion 2. Product Test ing 3. Periodic Product Qualit y Assurance Test ing Aesculap® recommends t he SPD M anager or Technician perf orming t he t asks t o ref erence AAM I ST79, Annex on t he - Purchase Evaluat ion Prot ocol f or R management and inf ect ion cont rol depart ment s w it hin t he facilit y regarding act ual t est prot ocols. The purpose of perf orming a pre- purchase evaluat ion of a rigid cont ainer syst em is t o evaluat e st erilizat ion ef f icacy of t he mast er product inst rument set under w orst case st erilizat ion paramet ers prior t o purchasing t he product . Per AAM I ST79: The concept of product f amilies is used t o group product s similar in const ruct ion, mat erials, size, and packaging. The most dif f icult - t o- st erilize device in each group is designat ed t he mast er product and is used as t he PCD f or t hat f amily w hen product t est ing is perf ormed. The st erilizat ion process used f or t he mast er product can t hen be applied t o all members of it s product f amily. The concept of product f amilies enables t he healt h care f acilit y t o ensure a high level of st erilit y assurance w it hout t est ing all product s being st erilized. Product t est ing should be perf ormed more t han once in each st erilizer t hat may be used during rout ine use f or t he mast er product inst rument set . SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 58 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) A biological indicat or (BI) and int ernal chemical indicat or (CI) should be placed in each int ernal t ray/basket in each corner and cent er. Pict ure below show s a single t ray w it h a BI and CI in each corner and in t he cent er. Placement of Chemical and Biological Indicators for Product Testing The st erilizat ion load should be conf igured as w orst case. Dry t ime should be evaluat ed f or t he mast er product inst rument set t o det ermine t he appropriat e drying t ime. Aesculap® recommends aft er t he st erilizat ion load has been removed f rom t he st erilizat ion chamber, allow t he load t o cool f or safe handling. Open t he cont ainer syst em and visually inspect int erior of t he cont ainer f or moist ure. If moist ure is present , reevaluat e dry t ime paramet ers and repeat t est . Per AAM I ST79: Every st erilizat ion load should be physically monit ored. Every packaged it em should be labeled ext ernally w it h a process indicat or SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 59 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Follow ing t able summarizes Aesculap® suggest ions on meet ing t he above guidelines: AAMI ST79 Guideline Aesculap® Product Placement Ext ernal Package Process Indicat or Int ernal Chemical Indicat or (CI) Tamperproof lock w it h Indicat or Ext ernally on Lock or Indicat or Process Card w it h Indicat or card Of f ered by 3rd part ies such as SPSM edical and 3M Place at least one CI per inst rument t ray in cent er, unless ot her locat ion in t ray is considered more challenging based on device and/or ot her cont ent s. (ref erence AAM I ST79 Int ernal Chemical Indicat ors) Pict ure below show s ext ernal Chemical Indicat ors f or t he Aesculap® . Example of External Chemical Indicators SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 60 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Pict ure below show s placement of an int ernal Chemical Indicat or in t he cent er of t he t ray f or rout ine load release. Example placement of Chemical Indicator for Routine Load Release 3. Periodic Product Quality Assurance Testing AAM I ST79 Sect ion 10.9 recommends periodic product t est ing as part of t he heal assurance program. Aesculap® recommends performing periodic t est ing of syst ems using t he same t est met hodology as t he Pre- Purchase Evaluat ion procedure out lined above. The int erval of periodic t est ing should be det ermined achievable and meet s t he overall qualit y assurance goals of t he organizat ion. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 61 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) AAMI ST79 Reference Ref erences in t his document st at ed as per AAM I ST79 are specif ically ref erring t o ANSI/AAM I ST79:2010 & A1& A2& A3 (Consolidat ed Text ), Comprehensive guide t o st eam st erilizat ion and st erilit y assurance in healt h care facilit ies. AAM I is t he primary source of consensus and t imely informat ion on medical inst rument at ion and t echnology, please refer t o w w w .aami.org for more informat ion. Pert inent def init ions f rom AAM I ST79 are list ed below . Biological indicators (BIs): o Test syst ems cont aining viable microorganisms providing a def ined resist ance t o a specif ied st erilizat ion process. Chemical indicators (CIs): o Devices used t o monit or t he presence or at t ainment of one or more of t he paramet ers required f or a sat isfact ory st erilizat ion process, or are used in specif ic t est s of st erilizat ion equipment . Master product: o (St erilizat ion) product designat ed as represent at ive of all members of a product family. o This product has t he most dif f icult - t o- st erilize at t ribut es of any member of t he family. Product family: o (St erilizat ion) group or subgroup of product t hat is charact erized by similar at t ribut es, such as mass, mat erial, const ruct ion, set weight , shapes, lumens, and packaging syst em, and t hat present s a similar challenge t o t he st erilizat ion process. Notes: Cont act inst rument manuf act urer f or t heir Inst ruct ions f or Use (IFU). Users, not Aesculap®, are responsible f or t he f inal det erminat ion of verif ying t he inst rument set t o t he st erile package select ion. Please ref er t o Sect ions 7.0 (St eam and Et O), 8.0 (STERRAD®), 9.0 (STERIS®) Cycle Paramet ers t o det ermine appropriat e cont ainer bot t om, lid, f ilt er, lock and indicat or card f or st erilizat ion cycle being used. 14.0 Indications for Use The f ollow ing are FDA 510(k) cleared Indicat ions f or Use f or t he Syst em. The FDA st erile packaging 510(k) submission requirement s have evolved over t he years so t he same inf ormat ion may not be show n f or each sect ion. See Sect ion 6.6 Cont ainer St orage and Transport at ion for det ails relat ed t o st orage, st acking and shelf life. 14.1 SterilContainerTM and SterilContainerTM S -- Steam and EtO Sterilization The Aesculap® Syst em is a reusable st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y f or 360 days. The Syst em includes accessories such as mat s, basket s, t rays, holders, organizers, f ilt ers, indicat or cards and t amper proof locks. The cont ainer syst em consist s of a t hree- quart er size, 8" t all perf orat ed (JN744) or solid (JK744) aluminum bot t om and a t hree- quart er size aluminum or PrimeLineTM Lid*. The lids are available in dif f erent colors t o aide in set recognit ion. There are t hree t ypes of f ilt er mat erials. A single use paper f ilt er (US751, US994), a single use polypropylene f ilt er (M D344), and a reusable PTFE f ilt er (JK090). The reusable PTFE is validat ed f or 2,200 uses. There are a variet y of accessories f or use w it h t he cont ainer syst em. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 62 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.2 SterilContainerTM -- PreVac IUSS Sterilization The Aesculap® is a reusable st erilizat ion cont ainer syst em (consist ing of a solid bot t om, a perf orat ed lid w / f ilt er ret ent ion plat es, and disposable paper f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer has been validat ed w it h st ainless st eel lumens, hinged, and knurled inst rument s (st ainless st eel lumens of great er t han 3 mm inner diamet er or less t han 400 mm in lengt h*). This cont ainer syst em is compat ible f or use in PreVac IUSS. The as basket s, t rays, and racks. Syst em f or includes accessories such 14.3 SterilContainerTM -- JK / JN744 PreVac Steam, IUSS and EtO Sterilization The Aesculap® Syst em is a reusable st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y f or 360 days. The Syst em includes accessories such as mat s, basket s, t rays, holders, organizers, f ilt ers, indicat or cards and t amper proof locks. The cont ainer syst em consist s of a t hreea t hree- quart er size aluminum or PrimeLineTM lid. The lids are available in dif f erent colors t o aide in set recognit ion. There are t hree t ypes of f ilt er mat erials f or aluminum lids: single use paper f ilt ers (US751, US994), single use polypropylene f ilt er (M D344), and a reusable PTFE f ilt er (JK090). The reusable PTFE is validat ed f or 2,200 uses. There are a variet y of accessories for use w it h t he cont ainer syst em. Validated Sterilization Cycle Parameters Pounds or less in t he healt hcare set t ing. Validat ion t est ing f or event relat ed st erilit y maint enance has been conduct ed f or up t o 360 days. Sterilization Cycle Parameters PreVac IUSS f or Nonporous Inst rument s PreVac IUSS f or Porous Inst rument s PreVac St eam Et O Max No. of Lumens/Lumen Configuration* 1 lumen w it h 3mm I.D. x 400mm L and a second lumen 3.8mm I.D. x 370mm L 1 lumen w it h 3mm I.D. x 400mm L and a second lumen 3.8mm I.D. x 370mm L 1 lumen w it h 3mm I.D. x 400mm L and a second lumen 3.8mm I.D. x 370mm L Accessories PreVac PreVac Steam IUSS EtO St ainless St eel basket s, basket lids and dividers Yes Yes Yes Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and Yes Yes Yes clamps) Silicone mat s Yes Yes Yes St ainless St eel racks, t rays, holders, clamps, racket s and plat f orms Yes Yes Yes SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 63 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.4 SterilContainerTM with PrimeLineTM Lid The Aesculap® Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of solid and perf orat ed bot t oms, a perf orat ed lid w / f ilt er ret ent ion plat es, and reusable polyt et raf luoroet hylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in PreVac St eam and PreVac IUSS st erilizat ion. The Syst em includes accessories such as silicon mat s, basket s, t rays, and racks. 14.5 SterilContainerTM with PrimeLineTM Pro Lid The Aesculap® Syst em is a reusable st erilizat ion cont ainer syst em consist ing of a solid & perf orat ed bot t oms, a perf orat ed lid w / f ilt er ret ent ion plat es, and reusable polyt et raf luoroet hylene (PTFE) f ilt er(s) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in pre- vacuum st eam and IUSS (Immediat e Use St eam St erilizat ion) st erilizat ion modalit ies. The Syst em includes accessories such as silicone mat s, basket s, t rays, and racks. Steam and IUSS Compatible SterilContainerTM with PrimeLineTM Pro Lid A combined maximum load validated for all container configurations is 25lbs Sterilization Cycle Parameters PrimeLineTM Pro Solid Base to be used Immediate Use Non-porous Container Lid with JP050 Lid Size ½ size Lid with Lid JK340 (4- 1/4 in height ) 270ºF Temp, 3 min. Exposure (298 x281 x36) JK341 (5- 1/2 in height ) No st acking recommended Art . No. JP121 JP125 JK342 (6 in height ) Immediate Use porous 270ºF Temp, 4 min. Exposure No st acking recommended ¾ size Lid (465 x 281 x 36) Art . No. JP111 JP115 JK344 (8 in height ) JK346 (10- 1/2 in height ) JK740 (4- 1/4 in height ) JK741 (5- 1/2 in height ) JK742 (6 in height ) JK744 (8 in height ) PreVacuum Dry Time Study 270ºFTemp, 4min.Exposure, 30 min. Dry Time St acking should not exceed 16height Full size Lid (588 x 281 x 36) Art . No. JP101 JP105 JK440 (4- 1/4 in height ) JK441 (5- 1./2 in height ) JK442 (6 in height ) JK444 (8 in height ) JK446 (10- 1/2 in height ) ½ size Lid JN340 (41/2 in height ) Prevacuum Dry Time Study (298 x281 x36) Art . No. JP121 JP125 JN341 (51/2 in height ) JN342 (6 in height ) 270ºFTemp, 4min.Exposure, 30 min. JN344 (8 in height ) Dry Time JN346 (101/2 in height ) St acking should not exceed 16- ¾ size Lid JN740 (4- 1/4 in height ) height (465 x 281 x 36) JN741 (5- 1/2 in height ) Art . No. JP111 JP115 JN742 (6 in height ) JN744 (8 in height ) Full size Lid JN440 (4- 1/4 in height ) (588 x 281 x 36) JN441 (5- 1/2 in height ) Art . No. JP101 JP105 JN442 (6 in height ) JN444 (8 in height ) JN446 (10- 1/2 in height ) Max No. of Lumens Lumen Configuration Immediate Use NonPorous No lumens, a hinged device, and a knurled (irregular surf ace) device. Immediate Use Porous 1 SS lumen w it h 3mm I.D. x 400mm L and a hinged device. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 64 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table 2: Steam and IUSS Cycle Compatible Accessories Accessories Steam and IUSS Stainless Steel baskets, Yes basket lids, and dividers Instrument Organization System (Silicone and Stainless Steel racks, Yes brackets, holders, and clamps) Silicone mats Yes Stainless Steel racks, trays, holders, clamps, brackets, and platforms Yes 14.6 SterilContainerTM with Aluminum Lid and Metal Retention Plate -- Reusable Filter The Aesculap® reusable f ilt er (JK090) is a PTFE (Polyt et raf luoroet hylene) f ilt er t hat allow s f or t horough penet rat ion and evacuat ion of t he st erilant (st eam), w hile maint aining an ef f ect ive barrier against microbial cont aminat ion f or a maximum of 2,200 uses. This f ilt er is f or use w it h t he Aesculap® in PreVac St eam st erilizat ion cycle f or 4 minut es at 270° F and in PreVac IUSS*. 14.7 SterilContainerTM -- JS Series The Aesculap® St erilCont ainer S2 Syst em is a reusable rigid st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in t he f ollow ing st erilizat ion modalit ies: Dynamic- air removal st eam (PreVac) (Exposure: 270°F f or 4 minut es w it h 15 minut e dry t ime) Gravit y St eam (Exposure: 250°F f or 30- 60 minut es w it h 15 minut e dry t ime) STERRAD® 100S, STERRAD®NX St andard, STERRAD®NX Advanced, STERRAD®100NX St andard, STERRAD® 100NX Flex Cycles STERIS® V- PRO® 60 Lumen, V- PRO® 60 Non- Lumen, V- PRO® 60 Flex, V- PRO® maX Lumen, V- PRO® maX Non- Lumen, and V- PRO® maX Flex Cycles. The Aesculap® S2 Syst em includes accessories such as silicone mat s and organizers, st ainless st eel basket s, t rays, holders, st erilizat ion indicat or cards and t amper proof locks. The at t ached t able ident if ies t he validat ed load conf igurat ions f or each of t he modalit ies Table 1. SterilContainerTM S2 Validated Load Configurations Sterilization Cycle Dynamic Air Removal St eam (PreVac) Gravit y St eam STERRAD® 100S STERRAD® NX St andard STERRAD® NX Advanced Container Size Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Validated Load Configuration 1 lumen w it h > 3mm ID x <400mm L and a second lumen > 3.8mm ID x < 370mm L Non lumen st ainless st eel inst rument s 5 St ainless st eel lumens > 3.0mm ID and < 400mm L 5 St ainless st eel lumens > 2mm ID and< 400mm L 1 Flexible lumens (> 1mm ID and < 850mm L) SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 65 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Sterilization Cycle STERRAD® 100NX St andard STERRAD® 100NX Flex STERIS® V- PRO® 60 Lumen STERIS® V- PRO® 60 Non- Lumen STERIS® V- PRO® 60 Flex Container Size Half Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er Half STERIS® V- PRO® maX Lumen STERIS® V- PRO® maX Non- Lumen Full Three- Quart er Half Full Three- Quart er Half Full Three- Quart er STERIS® V- PRO® maX Flex Half Validated Load Configuration 5 St ainless st eel lumens 0.7mm ID and 500mm L 1 Flexible Lumen 1mm ID and < 850mm L St ainless st eel lumens 1 lumen > 0.77mm ID and <410mm L 1 lumen > 1.2mm ID and < 275mm L 1 lumen > 1.8mm ID and <310mm L 1 lumen > 2.8mm ID and <317mm L Non- lumen st ainless st eel inst rument s 1 f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and mat w it hout any addit ional load. The f lexible endoscope may be a single or dual lumens t hat are > 1mm ID and <990 mm L St ainless st eel lumens 1 lumen > 0.77mm ID and <527mm L 1 lumen > 1.2mm ID and < 275mm L 1 lumen > 1.8mm ID and < 310mm L 1 lumen > 2.8mm ID and < 317mm L 1 lumen > 3.0mm ID and < 400mm L Non- lumen st ainless st eel inst rument s 2 f lexible endoscopes w it h a light cord (if not int egral t o endoscope) and mat w it h no addit ional load. The scopes can have: a single lumen t hat is 1 mm ID and 1050 mm L or t w o lumens w it h one 1 mm ID and 990 mm L and t he ot her 1 mm ID and 850 mm L OR 1 f lexible endoscope w it h a light cord (if not int egral t o endoscope) and mat and addit ional non- lumened inst rument s. The scope can have: a single lumen t hat is 1 mm ID and 1050 mm L or t w o lumens w it h one 1 mm ID and 990 mm L and t he ot her 1 mm ID and 850 mm L SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 66 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table 2. SterilContainerTM S2 System Configurations PreVac Steam and Gravity Steam Sterilization Method Container Size Container Container Total Loaded Bottom Part # Lid Part # Container Weight* Full Size - JS440 Full Size Full Size - JS441 JS442 JS489 25 Pounds Dynamic- air removal st eam (PreVac) & Gravit y St eam Full Size Three- Quart er Size Three- Quart er Size - JS444 JS740 JS741 JS789 25 Pounds Three- Quart er Size - JS742 Half Size Half Size - 5 ½ JS340 JS341 JS389 25 Pounds Half Size - JS342 *M aximum load weight is 25 Pounds or t he maximum indicat ed w eight f or t he st erilizer, w hichever is less. Table 3. Sterilization Cycle Compatible Accessories - PreVac Steam and Gravity Steam Compatible with Accessories PreVac Steam Gravity Steam St ainless St eel basket s, basket lids, and dividers Yes Yes Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Yes Yes Silicone mat s Yes Yes Table 4. SterilContainerTM S2 System Configurations STERRAD® Sterilization Systems Sterilization Method Container Size Full Size - Full Size - Full Size - Full Size - Three- Quart er Size - 4 ¼ STERRAD® 100 S Three- Quart er Size - Three- Quart er Size - Half Size - 4 ¼ Half Size - 5 ½ Half Size - Full Size - Full Size - Full Size - STERRAD® NX Full Size - St andard Three- Quart er Size - 4¼ Three- Quart er Size - Three- Quart er Size - Half Size - 4 ¼ Container Bottom Part # JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 Container Lid Part # JS489 JS789 JS389 JS489 JS789 JS389 Total Loaded Container Weight 13.95 Pounds 13.90 Pounds 13.90 Pounds 10.70 Pounds 10.70 Pounds 10.70 Pounds SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 67 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Sterilization Method Container Size Half Size - 5 ½ Half Size - Full Size - Full Size - STERRAD® NX Advanced Full Size Full Size Three- Quart er Size - 4 ¼ Three- Quart er Size Three- Quart er Size - Half Size - 4 ¼ Half Size - 5 ½ Half Size - Full Size - Full Size - Full Size - 6 Full Size - Three- Quart er Size - 4 ¼ STERRAD® 100NX St andard Three- Quart er Size - Three- Quart er Size - Half Size - 4 ¼ Half Size - 5 ½ Half Size - Full Size - Full Size - Full Size - Full Size - STERRAD® 100NX Three- Quart er Size - 4 ¼ Flex Three- Quart er Size - Three- Quart er Size - Half Size - 4 ¼ Half Size - 5 ½ Half Size - Container Bottom Part # JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS440 JS441 JS442 JS444 Container Lid Part # JS489 JS789 JS389 JS489 Total Loaded Container Weight 10.70 Pounds 10.70 Pounds 10.70 Pounds 21.45 Pounds JS740 JS741 JS789 13.85 Pounds JS742 JS340 JS341 JS389 13.85 Pounds JS342 JS440 JS441 JS442 JS489 10.95 Pounds JS444 JS740 JS741 JS789 10.35 Pounds JS742 JS340 JS341 JS389 10.35 Pounds JS342 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 68 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table 5. Sterilization Cycle Compatible Accessories STERRAD® Sterilization Systems Compatible with STERRAD® Accessories St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s 100S Yes Yes Yes NX Standard Yes NX Advanced Yes 100NX Standard Yes Yes Yes Yes No Yes No 100NX Flex Yes Yes No Table 6. SterilContainerTM S2 System Configurations STERIS® Sterilization Systems Sterilization Method Container Size Container Bottom Part # Container Lid Part # Total Loaded Container Weight Full Size - JS440 Full Size Full Size - JS441 JS442 JS489 11.1 Pounds Full Size - JS444 STERIS® V- PRO® 60 Three- Quart er Size - 4 ¼ Lumen Three- Quart er Size - JS740 JS741 JS789 9.6 Pounds Three- Quart er Size - JS742 Half Size - 4 ¼ JS340 Half Size - 5 ½ JS341 JS389 9.6 Pounds Half Size - JS342 Full Size - JS440 Full Size Full Size - JS441 JS442 JS489 12.0 Pounds Full Size - JS444 STERIS® V- PRO® 60 Three- Quart er Size - 4 ¼ Non- Lumen Three- Quart er Size - JS740 JS741 JS789 12.0 Pounds Three- Quart er Size - JS742 Half Size - 4 ¼ JS340 Half Size - 5 ½ JS341 JS389 12.0 Pounds Half Size - JS342 Full Size - JS440 JS489 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 69 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Sterilization Method Container Size Full Size Full Size Full Size - Three- Quart er Size - 4 ¼ STERIS® V- PRO 60 Flex Three- Quart er Size Three- Quart er Size - Half Size - 4 ¼ STERIS® V- PRO® maX Lumen STERIS® V- PRO® maX Non- Lumen Half Size - 5 ½ Half Size Full Size Full Size Full Size Full Size Three- Quart er Size - 4 ¼ Three- Quart er Size Three- Quart er Size Half Size - 4 ¼ Half Size - 5 ½ Half Size Full Size Full Size Full Size Full Size Three- Quart er Size - 4 ¼ Three- Quart er Size Three- Quart er Size Half Size - 4 ¼ Half Size - 5 ½ Half Size - Container Bottom Part # JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 Container Lid Part # JS789 JS389 Total Loaded Container Weight 1 f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and mat w it hout any addit ional load. The f lexible endoscope may be a single or dual lumens t hat are 1 f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and mat w it hout any addit ional load. The f lexible endoscope may be a single or dual lumens t hat are > 1mm ID and < 990 mm L 1 f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and mat w it hout any addit ional load. The f lexible endoscope may be a single or dual lumens t hat are > 1mm ID and < 990 mm L JS489 11.1 Pounds JS789 9.6 Pounds JS389 9.6 Pounds JS489 18.6 Pounds JS789 18.6 Pounds JS389 18.6 Pounds SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 70 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Sterilization Method STERIS® V- PRO® maX Flex Container Size Full Size Full Size Full Size Full Size Three- Quart er Size - 4 ¼ Three- Quart er Size Three- Quart er Size Half Size - 4 ¼ Half Size - 5 ½ Half Size - Container Bottom Part # JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 Container Lid Part # JS489 JS789 JS389 Total Loaded Container Weight 10.3 Pounds 10.0 Pounds 10.0 Pounds Table 7. Sterilization Cycle Compatible Accessories STERIS® Sterilization Systems Compatible with STERIS® V-PRO® 60 60 60 maX maX Accessories Lumen Non-Lumen Flex Lumen Non-Lumen St ainless St eel basket s, basket lids, and dividers Yes Yes Yes Yes Yes Inst rument Organizat ion Syst em (Silicone and Yes Yes St ainless St eel racks, bracket s, Yes Yes Yes holders, and clamps) Silicone mat s No No No No No maX Flex Yes Yes No 14.8 SterilContainerTM S -- STERRAD® 100S The Aesculap® is a reusable st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERRAD®100S. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 71 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.9 SterilContainerTM S -- STERRAD® 200 System, NXTM System, and 100NX System The Aesculap® S is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and disposable polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer has been validat ed w it h st ainless st eel lumens, hinged, and knurled inst rument s. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERRAD® 200, STERRAD®NX (St andard cycle and Advanced cycle), and STERRAD®100NX (St andard cycle and Flex cycle). The St erilCont ai S includes accessories such as silicone mat s, basket s, t rays, racks, eyepiece holders and sleeve holders. The S is recommended f or surf ace and lumens: STERRAD® 200, st ainless st eel lumens 3mm I.D. x 400mm L STERRAD®NX st andard cycle, st ainless st eel lumens 2mm I.D. x 400mm L STERRAD®NX advanced cycle, st ainless st eel lumens 1mm I.D. x 500mm L STERRAD®100NX st andard cycle, st ainless st eel lumens 0.7mm I.D. x 500mm L STERRAD®100NX f lex cycle, porous lumens (f lexible endoscope) 1mm I.D. x 850mm L Validat ion t est ing f or event relat ed st erilit y maint enance has been conduct ed f or up t o 360 days. For STERRAD® 200 Syst em, STERRAD®NX Syst em (St andard and Advanced cycle), and STERRAD®100NX Syst em (St andard) f ull, t hree- quart er, half and quart er size cont ainers have been validat ed w it h 5 st ainless st eel lumens per cont ainer syst em. The ext ra- long mini and mini cont ainer have been validat ed w it h 2 st ainless st eel lumens per cont ainer syst em. For STERRADR® 100NX Syst em Flex cycle f ull, t hree- quart er, half and quart er size cont ainers have been validat ed w it h 1 PTFE/PE lumen per cont ainer syst em. 14.10 SterilContainerTM S -- STERRAD® 100NX EXPRESS Cycle The S is a reusable st erilizat ion cont ainer syst em (consist ing of perforat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single- use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h hinged, and knurled inst rument s. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h STERRAD® 100NX EXPRESS Cycle. The S includes accessories such as silicone mat s, basket s, t rays, racks, eyepiece holders and sleeve holders. Test ing has been complet ed on t he 360 days f ollow ing successful st erilizat ion. S Full size cont ainer t o maint ain t he st erilit y of it s cont ent s f or Test ing has been complet ed on t he days f ollow ing successf ul st erilizat ion. S ½ size cont ainer t o maint ain t he st erilit y of it s cont ent s f or 360 SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 72 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) The validat ed chamber load f or t he S Full and Half sizes in t he STERRAD® 100NX EXPRESS Cycle consist ed of one S placed on t he bot t om shelf in an ot herw ise empt y chamber. Container Configuration JM 440, JM 441, JM 442 bot t om w it h JM 489 lid JM 340, JM 341, JM 342 bot t om w it h JM 389 lid Intended Load Reusable met al and non- met al medical devices w it hout lumens including endoscopes w it hout lumens OR t he da Vinci Scope Plat f orm (M D425) and t w o Si or S series da Vinci Scopes Reusable met al and non- met al medical devices w it hout lumens including endoscopes w it hout lumens Accessories St ainless St eel basket s, basket lids and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s St ainless St eel racks, t rays, holders, clamps, racket s and plat f orms STERRAD® 100NX Express Cycle Yes Yes Yes Yes 14.11 SterilContainerTM S -- STERRAD® 100NX DUO Cycle The S Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h f lexible endoscopes and accessories, cables, and camera heads. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERRAD® 100NX Duo cycle. The St erilCon S Syst em includes accessories such as silicone mat s, basket s, t rays, racks, f ilt ers, indicat or cards, locks, and inst rument holders. Validat ion t est ing f or event relat ed st erilit y maint enance has been conduct ed f or up t o 365 days. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 73 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.12 STERIS® V-PRO® 60 -- SterilContainerTM S with Aluminum Lid The S is a reusable st erilizat ion cont ainer syst em (consist ing of perforat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h st ainless st eel and Tef lon lumens, hinged, and knurled inst rument s. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he V- PRO® - Lumen and Flexible Cycles. The S includes accessories such as silicone mat s, basket s, t rays, racks, eyepiece holders and sleeve holders. The S w as demonst rat ed t o maint ain t he st erilit y of it s cont ent s f or 360 days f ollow ing successf ul st erilizat ion. Lumen Cycle Validated Container Load Lumened and non- lumened devices w it h dif f usion- rest rict ed spaces such as t he hinged port ion of f orceps and scissors M edical devices, including single, dual and t riple channeled rigid and semi rigid endoscopes, w it h t he f ollow ing conf igurat ions: o Single or dual lumen devices w it h st ainless lumen(s) t hat is (are) 0.77 mm int ernal diamet er (ID) and 410 mm lengt h o Triple lumen devices w it h st ainless st eel lumens t hat are 1.2 mm ID and 275 mm lengt h 1.8 mm ID and 310 mm lengt h 2.8 mm ID and 317 mm lengt h Each cont ainer held six (6) lumens f or a t ot al of 12 t ot al lumens per load. For f ull, t hree- quart er and half size cont ainers, t he validat ion chamber load consist ed of one cont ainer cont aining a basket and basket lid, mat , accessories, 12 lumens, and met al and non- met al medical devices. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 74 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) For ext ra- long mini and mini, t he validat ion chamber load consist ed of t w o cont ainers cont aining a basket and basket lid, mat , accessories, and met al and non- met al medical devices f or a t ot al chamber load w eight of 15.30 lbs. Non-Lumen Cycle Validated Container Load Non- lumened devices including devices w it h st ainless st eel or t it anium dif f usion rest rict ed spaces such as t he hinged port ion of f orceps and scissors. For f ull, t hree- quart er and half size cont ainers, t he validat ion chamber load consist ed of one cont ainer w it h a basket and basket lid, mat , accessories, and met al and non- met al medical devices. For ext ra- long mini and mini, t he validat ion chamber load consist ed of t w o cont ainers w it h a basket and basket lid, mat , accessories, and met al and non- met al medical devices f or a t ot al chamber load w eight of 15.30 lbs. Flexible Cycle Validated Container Load One f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o t he endoscope) and mat w it hout any addit ional load. The f lexible endoscopes may cont ain: single or dual lumen devices w it h lumens t hat are 1 mm ID and 990 mm lengt hs. The validat ion chamber load consist ed of one cont ainer w it h a basket and lid, mat , accessories, t hree (3) 1 x 1000mm lumens, one f lexible endoscope, and one light cable. Accessories St ainless St eel basket s, basket lids and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s St ainless St eel racks, t rays, holders, clamps, racket s and plat forms V-PRO® 60 Yes Yes Yes Yes SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 75 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) 14.13 STERIS® V-PRO® maX Flexible Cycle -- SterilContainerTM S with Aluminum Lid The S Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he V- PRO® maX Low Temperat ure St erilizat ion Syst em Flexible Cycle. Validated V-PRO® maX Sterilizer Flexible Cycle Load Configurations Load Configuration 1 Two S Syst em cont ainers each w it h a basket , mat , accessories and a f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and no addit ional load. The f lexible endoscopes may cont ain eit her: A single lumen w it h an inside diamet er of 1 mm or larger and a lengt h of 1050 mm or short er Or t w o lumens: one lumen w it h an inside diamet er of 1mm or larger and lengt h of 990mm or short er; t he second lumen w it h an inside diamet er of 1mm or larger and lengt h of 850mm or short er Load Configuration 2 Two and accessories1. S Syst em cont ainers, each w it h a basket , mat The f irst S Syst em cont ainer holds a f lexible surgical endoscope or bronchoscope w it h a light cord (if not int egral t o endoscope) and no addit ional load. The f lexible endoscopes may cont ain eit her: A single lumen w it h an inside diamet er of 1 mm or larger and a lengt h of 1050 mm or short er Or t w o lumens: one lumen w it h an inside diamet er of 1mm or larger and lengt h of 990mm or short er; t he second lumen w it h an inside diamet er of 1mm or larger and lengt h of 850mm or short er The second S Syst em cont ainer holds reusable met al and non- met al non- lumened inst rument s including inst rument s w it h dif f usion- rest rict ed areas such as t he hinged port ion of f orceps or scissors. The t ot al load w eight validat ed was 24 lbs. 1. The validat ion st udies w ere conduct ed wit h a f lexible endoscope in a S Syst em cont ainer wit h basket , silicone mat , accessories and light cord (if not int egral t o endoscope). Also included in t he load w as an addit ional St erilCont ain S Syst em cont ainer wit h inst rument s f or a t ot al load weight of 24.0 lbs. V-PRO® maX Sterilizer Flexible Cycle Compatible SterilContainerTM S Container Systems Tot al Loaded Cont ainer Weight (if cont ainer does not cont ain a f lexible endoscope or bronchoscope) 24 lbs f or one cont ainer in t he chamber OR 24 lbs split bet w een t w o cont ainers in t he chamber. Loads cont aining a f lexible endoscope or bronchoscope should f ollow Load Conf igurat ions recommendat ions. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 76 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Accessories St ainless St eel basket s, basket lids and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s St ainless St eel racks, t rays, holders, clamps, racket s and plat forms V-PRO® maX Flexible Cycle Yes Yes Yes Yes 14.14 STERIS® V-PRO® 1 and V-PRO® 1 Plus-- SterilContainerTM S with Aluminum Lid The Aesculap® S is a reusable st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he V- PRO® 1 and V- PRO® 1 Plus Syst ems. The S includes accessories such as silicon mat s, basket s, t rays, and racks Processing STERIS® V-PRO® Low Temperature Sterilization Systems Lumen and Non-Lumen Cycles Suggested Sterilizer Cycle Parameters for SterilContainerTM S products: The f ollow ing validat ed paramet ers are based on t he validat ion of t he non- anodized Aesculap® S in t he Amsco® V- PRO® St erilizat ion Syst ems. The V- PRO® 1 Syst em has one pre- programmed and unalt erable st erilizat ion cycle, Non- Lumen. The S Syst em is validat ed and FDA cleared in t he V- PRO® 1 Syst em. The V- PRO® 1 Plus Syst em has t w o pre- programmed and unalt erable st erilizat ion cycles: Non- Lumen and Lumen cycles. The St eri S Syst em is validat ed and FDA cleared in t he V- PRO® 1 Plus Syst em. The V- PRO® maX Syst em has t hree pre- programmed and unalt erable st erilizat ion cycles: Non- Lumen, Lumen, and Flex cycles. The S Syst em is validat ed and FDA cleared in t he V- PRO® maX Non- Lumen and Lumen cycles. V- PRO® 1; V- PRO® 1 Plus and V- PRO® maX Lumen Cycles o Condit ion: 3 minut es o St erilizat ion: 8 minut es per inject ion, 4 inject ions, (32 minut es t ot al) o Aerat ion: 6 minut es V- PRO® 1 Plus and V- PRO® maX Non- Lumen Cycles o St erilizat ion: 3 minut es per inject ion, 4 inject ions, (12 minut es t ot al) o Aerat ion: 6 minut es Consult w it h t he manufact urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w syst em has been validat ed w it h 5 st ainless st eel lumens per cont ainer. Do not exceed a maximum of 20 lumens per load. Only load lumens t hat f all w it hin t he f ollow ing limit at ions: > 1mm int ernal diamet er and < 125 mm in lengt h > 2mm int ernal diamet er and < 250 mm in lengt h > 3mm int ernal diamet er and < 400 mm in lengt h SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 77 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Notes: Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. As part of t he FDA submission, Aesculap® has perf ormed event relat ed validat ion t est ing on t he Syst em. To det ermine if t he maint ained st erilit y during t he event relat ed validat ion t est ing, t he cont ainer w as opened t o check st erilit y of t he cont ent s. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked. Consult w it h t he manuf act urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w it h t he inst rument . 14.15 STERIZONE® VP4-- SterilContainerTM S with Aluminum Lid The S Syst em is a reusable st erilizat ion cont ainer syst em (consist ing of perf orat ed bot t oms and perf orat ed lids w it h f ilt er ret ent ion plat es, and single use polypropylene f ilt ers) int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. This cont ainer syst em has been validat ed w it h st ainless st eel and Tef lon lumens, hinged, and knurled inst rument s. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use w it h t he STERIZONE® VP4 Low Temperat ure St erilizat ion Syst em. The S S Syst em includes accessories such as silicone mat s, basket s, t rays, racks, eyepiece holders and sleeve holders. Table 1: Validat ed VP4 Cycle Load Conf igurat ions Load Conf igurat ion 1 (31.2 lb) Flexible endoscopes load accommodat ing t hree single channel f lexible endoscopes, one per cont ainer: Load Conf igurat ion 2 (29.4 lb) Load Conf igurat ion 3 (10.2 lb): Int ernal channel diamet er of 1 mm and lengt h of 850 mm. Semi- rigid and rigid channel devices load accommodat ing t hree double channel semi- rigid endoscopes and one lengt h of medical grade st ainless st eel t ubing. Lengt h of t ubing: o Int ernal channel diamet er of 1.0 mm and lengt h of 500 mm. Double channel semi- rigid endoscope o Int ernal channel diamet ers of 0.7 mm and 1.1 mm, and lengt h of 500 mm Worst - case volume t o surface perf orat ion area rat io using a perf orat ed cont ainer including t w o st acked basket s. Each basket w as covered w it h a f ull lengt h silicone mat . At least one inoculat ed medical device w as added per level of t he cont ainer. Load Conf igurat ion 4 (25 lb) Worst - case volume t o surface perf orat ion area rat io using a perf orat ed cont ainer w it h maximum w eight of inst rument , f or a t ot al mass of 25 lb. At least t hree inoculat ed medical devices w ere added in t he cont ainer. Load Conf igurat ion 5 (75 lb) Heavy w eight load composed of t hree perf orat ed cont ainers, w it h a t ot al mass of 25 lb per cont ainer. The heavy validat ion load w as prepared based on t he Aesculap® S cont ainer let halit y st udies (PRO- 169) and adapt ed t o include a maximum w eight in a single load. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 78 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Table 2: VP4 St erilizer Cycle Compat ible Lid Bottom Description JM 489 JM 789 JM 389 JM 440 F JM 441 JM 442 JM 444 JM 740 JM 741 JM 742 JM 340 JM 341 JM 342 S Cont ainer Syst ems Total Loaded Container Weight (if container does not contain a flexible endoscope or bronchoscope)* 25 lbs f or one cont ainer in t he chamber *Loads cont aining a f lexible endoscope or bronchoscope should f ollow Table 1 recommendat ion. Table 3: VP4 St erilizer Cycle Compat ible Accessories Accessories St ainless St eel basket s, basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, bracket s, holders, and clamps) Silicone mat s St ainless St eel racks, t rays, holders, clamps, bracket s, and plat f orms VP4 Yes Yes Yes Yes Notes: Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. As part of t he FDA submission, Aesculap® has perf ormed event relat ed validat ion t est ing on t he Syst em. To det ermine if t he maint ained st erilit y during t he event relat ed validat ion t est ing, t he cont ainer w as opened t o check st erilit y of t he cont ent s. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked. Consult w it h t he manuf act urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w it h t he inst rument . 14.16 SterilContainerTM -- JS Series EtO, STERRAD®100NX DUO & STERIZONE® VP4 The Aesculap® St erilCont ainer S2 Syst em is a reusable rigid st erilizat ion cont ainer syst em int ended t o be used t o enclose anot her medical device t hat is t o be st erilized by a healt hcare provider. It is int ended t o allow st erilizat ion of t he enclosed device and also maint ain st erilit y of t he enclosed device unt il used. This cont ainer syst em is compat ible f or use in t he f ollow ing st erilizat ion modalit ies: Et hylene Oxide STERRAD®100NX DUO cycle STERIZONE® VP4 The Aesculap® S2 Syst em includes accessories such as silicone mat s and organizers, st ainless st eel basket s, t rays, holders, st erilizat ion indicat or cards and t amper proof locks. SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 79 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) The at t ached t able ident if ies t he validat ed load conf igurat ions f or each of t he modalit ies. SterilContainerTM S2 System Validated Load Configurations Sterilization Cycle Container Size Validated Load Configuration Et O (130°F, 60 minut e exposure, > 50% RH 725mg/L gas pressure) STERRAD®100NX DUO (bot t om shelf only) STERIZONE® VP4 Validat ed Loads 1 & 2 (Based on STERIZONE® Load # 7) Full Three- Quart er Half (1) lumen (> 3mm ID x < 400mm L) AND (1) lumen ( > 3.8mm ID x < 370 mm L) Full Three- Quart er Half Full Three- Quart er Half Flexible scope (> 1mm ID x < 850mm L) Non Lumened Inst rument s STERIZONE® VP4 Validat ed Load 3 (Based on STERIZONE® Load # 8) STERIZONE® Validat ed Load 4 (Based on STERIZONE® Load # 4) JS440 (base) + JS489 (lid) JS440 (base) + JS489 (lid) (1) Single Channel Flexible Scope (> 1mm ID x < 850mm L) OR (1) Dual Channel Flexible Scope (> 1mm ID x < 850 mm L and > 1 mm ID x < 989mm L) (1) Semi- rigid dual channel scope (> 0.7mm ID x < 500mm L and > 1.1mm ID x < 500mm L) AND one of t he follow ing: (4) St ainless st eel lumens (> 5.5mm ID x < 166mm L; > 7mm ID x < 105mm L; > 7.0mm ID x < 227mm L; > 7.8mm ID x < 198mm L) OR (2) St ainless st eel lumens (> 4mm ID x < 370mm L; > 2mm ID x < 152mm L) OR (3) St ainless st eel lumens (> 2.2mm ID x < 173mm L; > 4.7mm ID x < 270mmL ; > 4mm ID x < 445mm L) SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 80 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) SterilContainerTM S2 System Load Weights Sterilization Method Container Size Et O STERRAD®100NX DUO STERIZONE® Validat ed Loads 1 & 2 (Based on STERIZONE® Load # 7) Full Size Full Size Full Size Full Size Three- Quart er Size - 4 Three- Quart er Size - 5 Three- Quart er Size Three- Quart er Size Half Size Half Size - 5 ½ Half Size Full Size Full Size Full Size Full Size Three- Quart er Size - 4 Three- Quart er Size - 5 Three- Quart er Size Half Size Half Size - 5 ½ Half Size Full Size Full Size Full Size Full Size Three- Quart er Size - 4 Three- Quart er Size - 5 Three- Quart er Size Half Size Half Size - 5 ½ Half Size Half Size - 5 ½ Half Size - Container Bottom Part # JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS744* JS340 JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS440 JS441 JS442 JS444 JS740 JS741 JS742 JS340 JS341 JS342 JS341 JS342 Container Lid Part # JS489 JS789 JS389 JS489 JS789 JS389 JS489 JS789 JS389 Total Loaded Container (lb) 25 25 25 10.97 10.04 11.7 25 25 25 STERIZONE® Validat ed Load 3 (Based on STERIZONE® Load # 8) Full Size - JS440 JS489 See load configurat ion in t able 1 above SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 81 of 83 Aesculap® SterilContainerTM System Instructions for Use (IFU) Sterilization Method Container Size Container Bottom Part # Container Lid Part # Total Loaded Container (lb) STERIZONE® Validat ed Load 4 (Based on STERIZONE® Load # 4) Full Size - JS440 JS489 See load configurat ion in t able 1 above *JS744 is f or use in Et hylene Oxide only. Sterilization Cycle Compatible Accessories Accessories Compatible with Ethylene Oxide St ainless St eel basket s, Yes basket lids, and dividers Inst rument Organizat ion Syst em (Silicone and St ainless St eel racks, Yes bracket s, holders, and clamps) Silicone mat s Yes Tamper Evident locks and indicat or cards Yes Compatible with STERRAD®DUO Yes Yes No Yes Compatible with STERIZONE® VP4 Yes Yes Yes Yes Notes: Aesculap® has perf ormed validat ion t est ing t hat support t he conf igurat ions show n in t his sect ion. As part of t he FDA submission, Aesculap® has perf ormed event relat ed validat ion t est ing on t he Syst em. To det ermine if t he maint ained st erilit y during t he event relat ed validat ion t est ing, t he cont ainer w as opened t o check st erilit y of t he cont ent s. Facilit ies should f ollow indust ry guidelines and est ablish w rit t en policies and procedures on how shelf lif e is det ermined and t racked. Consult w it h t he manuf act urer of t he st erilizer f or specif ic recommendat ions. Complex devices such as lumened inst rument s should be st erilized in accordance w it h t he inst rument . SOP-AIC-5001592 Rev. 06 As of June 2020 Intended for US Only Page 82 of 83 M anuf act ured by: Aesculap® AG Am Aesculap®- Plat z 78532 Tut t lingen Germany Dist ribut ed in t he U.S.A by: Aesculap®, Inc. 3773 Corporat e Parkway Cent er Valley, PA 18034 800- 258- 1946 w w w .Aescul ap®usa.com Product and Service Cont act Inf ormat ion: Aesculap®, Inc. At t n: Aesculap® Technical Services 615 Lambert Point e Drive Hazelwood, M O 63043 Aesculap® Service Hot line: Phone: 800- 214- 3392 Fax: 314- 895- 4420 Ref erence t o AAM I (Associat ion f or t he Advancement of M edical Inst rument at ion) and AORN (Associat ion of periOperat ive Regist ered Nurses) recommended pract ices are based on t he guidelines t hat w ere available at t he t ime of t his publicat ion. Since t hese st andards are regularly updat ed, it is recommended t o review t he most current document and st andards f rom t hese organizat ions. STERRAD and AllClear are registered t rademarks of Advanced St erilizat ion Product s (ASP), a Division of Fort ive Corporat ion. STERIS, AM SCO and V- PRO are regist ered t rademarks owned by STERIS Corporat ion. STERIZONE and VP4 are a regist ered t rademarks of TS03, Inc., part of St ryker SOP- AIC- 5001592 Rev. 06, June 2020 The most current version of Aesculap® Inst ruct ions f or Use int ended f or US Only Inst ruct ions f or Use are published on w ww.Aesculap®usaif us.com/
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