spirit of excellence Hygiene Manual Reprocessing of RICHARD WOLF Heat--Sensitive Instruments

spirit of excellence Manual Reprocessing of RICHARD WOLF Heat--Sensitive Instruments

GA -J 050 /en/ Index: 05--09--5.0 / ÄM: PDB 09--3623

Important general instructions for use Reprocessing should be carried out by adequately trained and qualified staff using suitable procedures, in accordance with the state of the art and taking the manufacturer s instructions into account. Reprocessing must be traceable and reproducible. A classification and risk assessment must be carried out. The individual stages and responsibilities must be defined and documented in writing. Requirements for reprocessing! Basic requirements are defined in ' the Medical Product Law (MPG) ' the Medical Product Operator Directive (MedBetreibV) ' the Agreements on Quality Assurance (QA) ' the European Standards (DIN EN) ' the appropriate Recommendations on Hospital issued by the Robert- Koch- Institute and ' the current rules and regulations issued by the Employers Liability Insurance Associations. Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. This product should only be used with the combinations and with the accessories and spare parts listed in this instruction manual. Only use other combinations, accessories and replacement parts if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user and third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. CAUTION - USA only: Federal law restricts this device to sale by or on the order of a physician. Safety instructions and levels of danger Symbol Level of danger WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product. Failure to observe can result in damage to the product or surroundings.. NOTE! Tips for optimum use and other useful information. GA--J 050 0

Contents 1 General Information... 1 1.1 Manuals / Instructions for use... 1 1.2 Questions on reprocessing / service... 1 1.3 General guidelines... 2 1.4 Brand new products... 2 1.5 After use... 2 1.6 Disposable items... 3 1.7 Characteristic features of steam sterilizability... 3 1.8 Manual reprocessing or machine reprocessing... 4 1.9 Overview of reprocessing... 5 2 Product variants... 6 2.1 Illustration... 7 2.1.1 Legend and identification... 7 3 Water quality... 8 3.1 Ion exchanger for full demineralization... 8 4 Preparation of instruments at the point of use or at the reprocessing station.. 9 4.1 Transport... 10 4.1.1 Dry preparation at the point of use... 10 4.1.2 Wet preparation... 10 4.1.3 Storage systems... 10 4.2 Preparatory measures for machine and manual reprocessing... 10 5 Machine reprocessing... 11 5.1 Auxiliary resources required... 11 5.2 Manual pre--cleaning... 12 5.2.1 Working channel (1) / suction channel (6) / laser fiber channel (12)... 12 5.2.2 Biopsy valve (4) / suction valve (7)... 13 5.2.3 Stopcocks (3.2)... 14 5.3 Heat--Sensitive Instruments... 15 5.3.1 Chemo--thermal procedure... 15 5.3.2 Chemical procedure... 15 5.4 Connect flexible endoscope to automatic washer disinfector... 15 5.4.1 Rinsing set II... 16 5.4.2 Rinsing sets III and IV... 16 5.4.3 Rinsing set V... 17 5.4.4 Fastening adapter (x) to receptacle for adjustment unit (12.1) [only for 2--channel continuous irrgation laser URS]... 18 5.5 Connection for automatic leakage tester... 18 5.6 After machine reprocessing... 19 5.7 Storage systems... 19 6 Manual reprocessing... 20 6.1 Manual cleaning and disinfection... 20 6.2 Required resources... 20 6.3 Manual leakage test... 21 I GA--J 050

Contents 6.4 Manual cleaning... 22 6.4.1 Biopsy valve (4) / suction valve (7)... 22 6.4.2 Stopcocks (3.2)... 23 6.4.3 Working channel (1) / suction channel (6) / laser fiber channel (12)... 23 6.5 Manual disinfection... 25 6.5.1 After disinfection... 25 6.6 Storage systems... 25 7 Checking and maintenance... 26 7.1 Visual check... 26 7.2 Function check... 26 8 Sterilization... 28 8.1 Required equipment... 28 8.2 Preparation for sterilization (gas / plasma procedure)... 29 8.3 Gas sterilization... 30 8.3.1 Gas sterilization using ethylene oxide gas (EO)... 30 8.3.2 Gas sterilization with formaldehyde gas (FA)... 31 8.4 Further sterilization procedures... 31 8.4.1 Low temperature plasma procedure (LTP) / agent: hydrogen peroxide (STERRAD 100S or 50)... 31 8.4.2 STERIS procedure... 32 8.5 Sterilization of reprocessing systems and cleaning accessories... 32 8.5.1 RIWO System Tray... 32 8.5.2 Cleaning brushes... 32 9 Storage... 33 9.1 After disinfection... 33 9.2 After sterilization... 33 10 Repairs, products returned... 33 11 Reprocessing of accessories... 34 12 Information on cleaning and care products... 37 12.1 Instrument cleaner 100.00... 37 12.1.1 Product description... 37 12.1.2 Notes and instructions for use... 37 12.1.3 Product specifications... 37 13 Certified chemicals for reprocessing... 38 13.1 Approved chemicals for rigid telescopes, flexible endoscopes / videoscopes (fiberscopes) and instruments... 38 13.2 Approved surface cleansers and disinfectants for devices and universal device carts and auxiliary carts... 43 14 Fault description / notes... 44 15 Literature... 46 GA--J 050 II

General Information 1 General Information 1.1 Manuals / Instructions for use For safe use and correct reprocessing of RICHARD WOLF products and accessories, RICHARD WOLF provides the following manuals / instructions: Z GA -J020 Manual Reprocessing of RICHARD WOLF Heat--Stable Instruments Z GA -J050 Manual Reprocessing of RICHARD WOLF Heat--Sensitive Instruments Z KA -J050 Quick guide Reprocessing of RICHARD WOLF Flexible Endoscopes Z Product -specific Instructions for Use They describe the specific use of the product with all the specifications required. Z Latest version of the Manual / Instructions for Use Ongoing new and further development of RICHARD WOLF products as well as technological progress require updating of the instruction manual at regular intervals. Please check the number of the latest version by checking the last numbers of the index on the front page. Example: GA -J020 / en / Index: xx -xx -15.0 /... You may call up the latest version from our website and download it, or request from us. http://www.richard -wolf.com kundenservice@richard-wolf.com 1.2 Questions on reprocessing / service If you have any further questions on RICHARD WOLF products, please feel free to contact us at the following address: RICHARD WOLF kundenservice@richard-wolf.com Service Department Hotline +49 (0)7043 35-389 Service Fax: Service Mail: +49 (0)7043 351209 kundenservice@richard- wolf.com To allow your service order to be processed swiftly, please use the form in section 14 entitled Fault description / Notes. 1 GA--J 050

General Information. NOTE! In addition to these manuals / instructions for use, we recommend reading the following brochure published by the AKI Working Group (Arbeitskreis Instrumenten -Aufbereitung)(Working group on instrument reprocessing). Proper Maintenance of Instruments 1.3 General guidelines The brochure is available from RICHARD WOLF or can be downloaded free of charge from the www.a- k- i.org website. WARNING! kundenservice@richard-wolf.com Creutzfeldt- Jakob Disease! If the patient is suspected of having the Creutzfeldt- Jakob disease (CJD) or a variant of the Creutzfeldt- Jakob disease (vcjd) or the latter has been diagnosed, adequate measures must be taken to prevent possible transmission to other patients, users and third parties. For this purpose, apply the country- specific regulations and laws. Rental instruments must not be used in pathology or veterinary medicine! During the entire reprocessing procedure follow the relevant guidelines on staff protection. 1.4 Brand new products Z Do not immerse the instruments in physiological saline and do not rinse instruments with physiological saline to prevent contact corrosion on the metal surfaces. Z Avoid frequent changes in the reprocessing methods or the cleaning agents and disinfectants to prevent damage to the product as a result of interaction between the various methods and substances. Z After use, reprocess the products without any major delay to guarantee efficient and gentle reprocessing. 1.5 After use. NOTE! Before reprocessing remove all protection foils and shipping locks from the products and accessories. Reprocess the products and accessories before the first use and after each further use. For the approved methods and processes, please refer to the descriptions in the following sections. Immediately after use the products must be handled as specified in section 4 entitled Preparation of instruments at the point of use and/or in reprocessing. GA--J 050 2

General Information 1.6 Disposable items Use disposable items ' Only once. ' Discard immediately after use. WARNING! Do not re- use disposable items! Products marked disposable, i.e. for single use only, have been designed for only one use on or in a single patient. If disposable items are reprocessed to be used again, product quality may deteriorate, which will endanger the patient, user and others. In this case, the manufacturer can no longer guarantee the product s safety and performance. 1.7 Characteristic features of steam sterilizability The product number of RICHARD WOLF products helps to identify steam sterilizability: Z Steam sterilizable ' Characteristic feature: the numbers begin with 8 example: 8654.422 Z Not steam sterilizable ' Characteristic feature: the numbers begin with 4 example: 4840.501 Details on reprocessing and sterilizability in the instructions for use should be read and implemented where type numbers do not begin with 8. 3 GA--J 050

General Information 1.8 Manual reprocessing or machine reprocessing The products and accessories can be reprocessed manually or machine reprocessed in a washer/disinfector. For validation reasons, machine reprocessing is preferred. The following overview is a schematic of the sequence of reprocessing steps for heat--sensitive instruments -- in the following descriptions called Flexible Endoscopes. The sections mentioned refer to the corresponding methods and procedures. Preparation Section 4 Instruments at the point of use Section 4 Section 4.1 Disposal - Transport Section 4.1 Section 6 Manual reprocessing Machine reprocessing Section 5 product-specific instructions for use Dissassembly product-specific instructions for use Manual Machine Section 6.3 leak tightness test cleaning / disinfection Section 5.4 Section 6.4 Manual cleaning Cleaning possibly manual precleaning Section 5.2 Rinsing Section 6.5 Manual disinfection Machine leak tightness test Section 5.5 Disinfection Rinsing Cleaning Disinfection Drying Drying Section 7 product-specific instructions for use Inspection - Assembly - Maintenance - Care Section 5.6 / 7 product-specific instructions for use Section 8 Sterilization Section 8 Section 9 Storage Section 9 GA--J 050 4

General Information 1.9 Overview of reprocessing PROCEDURES Preparation at the point of use Decontami - nation Maintenance, Checks Sterilization Condition PRODUCTS Flexible endoscope e Flexible Forceps Accessories 04) Flexible coagulation button electrode Stone extractor Stone grasper Cytology brush Rubber bulb 103.00 Double bulb 127.00 Suction / Biopsy connector / adjustment unit Valves Seals Adapter Adjustment unit Leak - tightness tester Tube section, Twist--lock mechanism Wipe outside, Rinse out inside D d d D d d d d d d d d Wet preparation at the point of use D D D D Y d D Y D D D D Dry preparation at the point of use D D D D Y D D Y D D D D Preparation Leakage test D d d d d d d d d d D d Cleaning Manual D D D D d D D d D D D D Machine D D D D d D D d D D D D Ultrasound 04) d D D D d d D d D D d D Alkaline d D D D d d D d D D D D Contains citric acid d D D D d d D d D D D D Neutral / enzymatic D D D D d D D d D D D D Contains peracetic acid D D 03) D D d d D d D D D D Rinsing 01) D D D D d D D d D D D D Chemical at max. 60_C D D D D d D D d D D D D Dis-- ) infection 02) Thermal at max. 93_C d D D D d D D d D D D D Drying T max in C 60 93 93 93 d 100 93 d 93 93 93 93 Steam 04) After decontamination H H H H d D H d H H D D Fractional prevacuum method at 134_C / 273_F d D D D d d D D D D D D Formaldehyde (FA) D D 03) D D d d D D D D D D Ethylene oxide (EO) D D 03) D D d D 03) D D D D D D Low-- temperature STERIS D D 03) D D d d D D D D D D STERRAD 100S or 50 (Plasma) D D 03) D D d d D D D D D D Cleaning brushes 01) Fully demineralized water is recommended for the last rinsing Legend: D Permissible 02) Certified chemicals for reprocessing ' See section 13 d Not permissible 03) Material compatibility certified Y Disposable item discard 04) Detailed reprocessing instructions ' See GA -J020 Heat -Stable Instruments H See product--specific instructions 5 GA--J 050

Product variants 2 Product variants VIDEOSCOPES Urology / ENT FIBERSCOPES Urology / Gynecology FIBERSCOPES ENT Flexible Video -Urethro -Cystoscope / PDD Video -Urethro -Cystoscope with working channel and suction valve Flexible Fiber -Uretero -Renoscope with working channel Flexible Bronchoscope / DAFE Bronchoscope with working channel and suction valve Flexible Video -Urethro -Cystoscope with working channel Flexible 2 -Channel Continuous Irrigation Laser URS with working channel and laser fiber channel Flexible Nasopharyngo -Laryngoscope with working channel Flexible Video -Bronchoscope / DAFE Video -Bronchoscope with working channel and suction valve Flexible Urethro -Cystoscope / Hysteroscope with working channel Flexible Nasopharyngo -Laryngoscope Flexible LED Video Urethrocystoscope with working channel and suction valve Fig. 1 Flexible Fiber -Uretero -Renoscope with working channel Flexible Naso -Laryngoscope for HRES -ENDOCAM GA--J 050 6

Product variants 2.1 Illustration 1/6 3.2.1 3.2.2 3.2 3.2.3 The reprocessing is described by the example of flexible video urethrocystoscopes with working channel and suction valve. Depending on how the product variant is equipped, the description shall apply by analogy. 3.2.4 3.1 3 2 1 4 4.3 4.2 4.1 6 7.1 5 7.2 7.3 7 7.4 8 1 8 12 8 9 8 11.1 11 10 Fig. 2 2.1.1 Legend and identification Item Designation Item Designation 1 Working channel 6 Suction channel 2 Luer connector 7 Suction valve 3 Attachment 7.1 Valve tappet 3.1 Irrigation, drain and insertion stopcock 7.2 Valve insert 3.2 Stopcock assembly in case of adapter/post with disassemblable stopcocks 7.3 Tube connector 3.2.1 Stopcock plug 7.4 Sealing membrane, blue (disposable product, for single use only) 3.2.2 Stopcock housing 8 Connector for leakage test and pressure equalization 3.2.3 Luer fitting 9 Cold -light connector 3.2.4 Passage identification on stopcock housing, stopcock plug 10 Camera cable 4 Biopsy valve 11 Camera plug 4.1 Valve housing 11.1 Protection cap for camera plug 4.2 Sealing valve, transparent (disposable product, for single use only) 8 only for 2 -channel continuous irrigation laser URS 4.3 Sealing cap 12 Laser fiber channel 5 Valve holder 12.1 receptacle for adjustment unit (not shown) 7 GA--J 050

Reprocessing water 3 Water quality The water quality used for product reprocessing has a great influence on the preservation of value. Differing drinking water qualities (types and concentrations of the ingredients) depending on the water hardness and temperature, can cause difficult--to--dissolve hardness deposits, corrosion and discoloration on the products. The concentration of the water ingredients varies depending on the source and type of drinking water treatment. When water evaporates these ingredients remain in the form of a salt crust. Amongst these ingredients chlorides are particularly critical. Excessive chloride concentrations cause pitting corrosion on stainless steel! To avoid this, when machine -cleaning products we recommend using fully demineralized water of a defined water quality in accordance with DIN EN 285, Appendix B for the final rinsing. Extract from table B1: Contamination in the feed water Evaporation residues Silicon oxide, SiO 2 Iron Lead Traces of heavy metal with the exception of iron, cadmium, lead Chloride (Cl -- ) Phosphates (P 2 O 5 ) Conductivity (at 20 C)* ph value (degree of acidity) Color Hardness Σ (alkaline earth ions) Feed water 10 mg/l 1 mg/l 0.2 mg/l 0.005 mg/l 0.1 mg/l 2 mg/l 0.5 mg/l 15 S/cm 5to7 colorless clear without residues 0.02 mmol/l 3.1 Ion exchanger for full demineralization When using ion exchangers for full demineralization please note that exceeding the regeneration cycle can cause silicic acid (silica) to break through, which will cause deposits. Timely regeneration of the exchanger can avoid this, please follow the manufacturer s instructions. Source: Proper Maintenance of Instruments http://www.a -k -i.org. NOTE! Fully demineralized water with the following microbiological drinking water quality should be used kundenservice@richard-wolf.com for final rinsing: ' The total bacteria count must not exceed the value of 100 CFU *) / ml during an incubation period of 48 4 hours at 36 1 C. ' Escherichia coli must not be present in 100 ml. ' Pseudomonas aeruginosa must not be present in 100 ml. *) Colony -forming units GA--J 050 8

Preparation of instruments 4 Preparation of instruments at the point of use or at the reprocessing station. NOTE! Drying of contaminant residues such as blood, tissue particles, drugs, makes reprocessing difficult and increases the danger of corrosion. We therefore recommend carrying out the measures listed below on the instrument table in parallel with the operation or immediately after use: Fig. 3 Z Flexible endoscope ' Wipe outside - with a lint -free cloth soaked with cleaning agent / disinfectant. ' Rinse inside - with a cleaning / disinfectant solution. To prevent the plastic outer coating from wrinkling or folding over apply minimal pressure when wiping the distal end of the hose. In the case of wrinkling or folding over immediately fold back and smooth out the plastic outer coating carefully. Fig. 3 Z Lay down the instruments with due care to avoid damage. Carry out a leak tightness test immediately after each use and before each use. ' See section 6.3 manual leak tightness test (leakage test) Z Disassemble the flexible endoscope, if required. ' See product--specific instructions for use 4.2 Fig. 4 7.4 Fig. 4 Z Discard disposable items immediately. ' Sealing valve (4.2) ' Sealing membrane (7.4) Fig. 5 Z Open the supply and insertion stopcock (3.1). Fig. 5 3.1 9 GA--J 050

Preparation of instruments 4.1 Transport The parts can be transported to the reprocessing rooms either under wet or in dry conditions, depending on the reprocessing method used. 4.1.1 Dry preparation at the point of use In the case of machine reprocessing in a washer disinfector, dry preparation at the point of use should be the method of choice, because residues of the wet preparation solution (disinfectant) may jeopardize the cleaning result in the machine. Z Carry out preparatory measures at the point of use: section 4 4.1.2 Wet preparation In the case of manual reprocessing, wet preparation at the point of use is recommended in order to avoid contaminant residues drying on the instruments and prevent germs from being carried over. For wet preparation at the point of use, use a combined cleaning and disinfectant solution with certified disinfection efficacy. For this purpose, use the same products as for subsequent cleaning and disinfection. 4.1.3 Storage systems For safe and trouble--free transport to reprocessing, cleaning and disinfection we recommend using the specially designed storage systems. For further information please see: ' Section 11 Accessories for reprocessing ' RICHARD WOLF catalog sheets -- reprocessing 4.2 Preparatory measures for machine and manual reprocessing The contaminated camera plug (11) must be manually reprocessed before the protective cap is attached (11.1). Z Thoroughly clean the camera plug (11) with a solution of cleaning agent and disinfectant. Z Then rinse with sterile water. Z Adequately dry the outside with a lint--free disposable cloth and dry the contactsinsidewithacottonswab. ' Residual moisture in the contacts can impair signal transmission (e.g. interruptions, poor contacts). 11.1 11 Fig. 6 Only reprocess the camera plug (11) from flexible endoscopes (videoscopes) with the protective cap (11.1) in place! If liquid enters the camera plug (e.g. because you forgot to put the cap on) carefully rinse the plug out with clear water and dry carefully (with compressed air if necessary). Fig. 6 Z Screw the protective cap (11.1) onto the camera plug (11). GA--J 050 10

Machine reprocessing 5 Machine reprocessing We recommend not using cleaning and disinfectant solutions in powder form because undissolved particles may clog narrow channels of the instruments. When using powder -based solutions, make sure that all the powder has dissolved. Only use disinfectants whose efficacy and material compatability with flexible endoscopes and endoscopic accessories has been certified. ' See section 13 Certified chemicals for reprocessing. Concentration and exposure time for the cleaning and disinfection agent should be taken from the instructions provided by the chemical manufacturer. Do not use any care products for the last rinsing, as these can cause deposits on the products and damage to the plastic materials. Only use washer disinfectors which are equipped with a reprocessing program for flexible endoscopes. Cleaning agents and disinfectants must be compatible with each other and compatible with the procedures and flexible endoscope as well as the endoscopic accessories. According to DIN EN ISO 15883 machine reprocessing processes must be validated. Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF products.. NOTE! To avoid perforations of the plastic outer sleeve, never grasp a flexible endoscope with instrument forceps. Remove the flexible endoscope from the disinfectant solution only by hand. 5.1 Auxiliary resources required Z Lint--free disposable cloth and cotton swab Z Cleaning brushes ' See section 6.4 Z Storage systems ' RIWO BOX Z Washer disinfector ' Notes / follow the instruction manual provided by the washer disinfector manufacturer ' Observe the notes in section 1.9 Overview on reprocessing. 11 GA--J 050

Machine reprocessing 5.2 Manual pre -cleaning Fig. 7 Z Apply a cleaning disinfectant solution to the instrument connectors covered by the connecting hoses before placing them into the washer disinfector. Fig. 7 Manually preclean the following parts before machine reprocessing, depending on the product design. 5.2.1 Working channel (1) / suction channel (6) / laser fiber channel (12) Fig. 8 / Fig. 9 Z In order to remove any clogging or residues, carefully clean all channels using suitable cleaning brushes (see table in section 6.4). Adhere to the following sequence: 1. the suction channel (6) via the valve holder (5) 2. the working channel (1) via the luer connector (2) Only for 2 -channel continuous irrgation laser URS 3. clean the laser fiber channel (12) via the receptacle for adjustment unit (12.1) Cleaning the suction channel (6)! Introduce the short cleaning brush into the valve holder (5) as far as it will go, do not insert forcibly. Pull the cleaning brush back and forth in the suction channel. Cleaning the working channel (1) / laser fiber channel (12)! Introduce the long cleaning brush only from proximal to distal, do not introduce forcibly into the working channel (1) / laser fiber channel (12). Do not push the cleaning brush back and forth in the working channel as this can cause damage. Guide the cleaning brush only in one direction through the working channel (1) / / laser fiber channel (12) and pull back only after the brush head has fully emerged at the distal end. 5 2 1 6 Fig. 8 GA--J 050 12

Machine reprocessing Fig. 9 (Only for 2 -channel continuous irrigation laser URS) 12.1 12 1 Fig. 9 Z Rinse the flexible endoscope inside and out with a cleaning solution to remove any loose particles. Z Reprocess the cleaning brushes. ' See section 1.9. overview on reprocessing Fig. 10 Z Clean with cleaning brush 86.90 : ' Valve holder (5) ' Luer connector (2) 2 5 Fig. 10 5.2.2 Biopsy valve (4) / suction valve (7) Fig. 11 Z Cleaning with a short cleaning brush: ' Valve housing (4.1), sealing cap (4.3) ' Valve tappet (7.1), valve insert (7.2), tube connector (7.3) 7.1 7.2 7.3 Fig. 11 4.3 4.1 13 GA--J 050

Machine reprocessing 5.2.3 Stopcocks (3.2) 3.2.1 Fig. 12 Z Remove the stopcock plug (3.2.1). ' See product--specific instruction manual 3.2.2 Z Cleaning with a short cleaning brush: ' Stopcock plug (3.2.1) ' Stopcock housing (3.2.2) Fig. 12. NOTE! For machine reprocessing of biopsy valve (4), suction valve (7) and stopcock plug (3.2.1) use a small -parts basket. Fig. 13 Z Remove the cold light adapter and place in the small parts basket or utensils basket. Fig. 13 GA--J 050 14

Machine reprocessing 5.3 Heat -Sensitive Instruments For machine reprocessing of heat--sensitive instruments we recommend using a chemo -thermal or a chemical procedure. Thedisinfectionstepinthechemo -thermal procedure is carried out by adding disinfectant. Disinfection is supported by temperatures up to 60_C. In the chemical procedure, the disinfection step is carried out by adding a disinfectant. The procedure is not supported by increased temperature. 5.3.1 Chemo -thermal procedure Adhere to the following process parameters: ' Irrigation pressure: max. 0.5 bar ' Temperature: max. 60_C 5.3.2 Chemical procedure Adhere to the following process parameters: ' Irrigation pressure: max. 0.5 bar 5.4 Connect flexible endoscope to automatic washer disinfector Not necessary for pressure chamber devices. For machine reprocessing of the various flexible endoscopes use suitable rinsing set. Illustration Product no. Designation 163.907 163.908 163.909 163.910 886.00-163914 Rinsing set II for flexible ' Bronchoscope ' DAFE Bronchoscope Rinsing set III for flexible ' Video Urethrocystoscope ' PDD Video Urethrocystoscope ' LED Video Urethrocystoscope ' Video Bronchoscope ' DAFE Video Bronchoscope ' LED Video Bronchoscope Rinsing set IV for flexible ' Video Urethrocystoscope adapt length if necessary Rinsing set V with double luer lock tube connector for flexible ' Fiber Ureterorenoscope ' Adapter Luer lock tube connector for flexible ' Urethrocystoscope / Hysteroscope ' Nasopharyngo--Laryngoscope Cleaning adapter for Olympus automatic washer disinfector (device end) available directly from Miele (item number 69744701) Adapter for cleaning the laser fiber channel in the flexible ' 2--channel continuous irrigation laser URS Z After having connected the rinsing set to the flexible endoscope and to the automatic washer disinfector, check the connections for firm seating. 15 GA--J 050

Machine reprocessing 5.4.1 Rinsing set II Fig. 14 Z Connect rinsing set II to the luer connector (2) and the valve holder (5) as well as to the automatic washer disinfector. ' Lock at the valve using the twist--lock mechanism. Connection in AWD device Fig. 14 5.4.2 Rinsing sets III and IV Fig. 15 Z Push sleeve to unlocked position. Fig. 15 Fig. 16 Rinsing set III Z Connect rinsing set III to luer connector (2) and valve holder (5) as well as to AWD device. ' Lock the sleeve in place by pushing forward. ' Lock to valve holder (5) using the twist--lock mechanism. Connection in AWD device Fig. 16 GA--J 050 16

Machine reprocessing Fig. 17 Rinsing set IV Z Connect rinsing set IV to luer connector (2) as well as to the AWD device. ' Lock the sleeve by pushing forward. Connection in AWD device Fig. 17 5.4.3 Rinsing set V Fig. 18 Z Connect the rinsing set V to luer connectors (2) as well as to AWD device Connection in AWD device Fig. 18 Connection in AWD device Fig. 19 Z Connect the rinsing set V to luer connectors (3.2.3) as well as to AWD device. 3.2.3 Fig. 19 17 GA--J 050

Machine reprocessing 5.4.4 Fastening adapter (x) to receptacle for adjustment unit (12.1) [only for 2 -channel continuous irrgation laser URS] 12.1 Fig. 20 Z Introduce adapter (x) in receptacle for adjustment unit (12.1). ' pin (a) engages in groove (b). Z Lock adapter (x) with twist--lock mechanism. Z Connectel the irrigation tube to the Luer connector (y) and the automatic washer / disinfector. (x) (y) (b) (a) Fig. 20 5.5 Connection for automatic leakage tester. NOTE! When carrying out the automatic leakage test please observe the following: ' Use adapter (15092.102) in conjunction with AWD devices with integrated leakage test or ask the AWD device manufacturer for the corresponding adapter. ' The adapter (163.905) is specially designed for AWD devices made by Olympus ' Make sure you follow the AWD device manufacturer s instructions. 15 092.102 Fig. 21 Z Connect adapter (15092.102) to the tube of the leakage tester to the corresponding AWD device under dry conditions and screw onto the connector for leakage test and pressure equalization (8). from the AWD device Fig. 21 8 Fig. 22 a 163.905 8 Z Connect adapter (163.905) to the connector (a) of the leakage tester on the Olympus AWD device under dry conditions and screw onto the connector for leakage test and pressure equalization (8).. NOTE! If the machine does not allow an integrated leakage test, carry out a manual leakage test before reprocessing (see section 6.3). from the Olympus AWD device Fig. 22 GA--J 050 18

Machine reprocessing Z Check the connections for firm seating. Z After machine reprocessing, remove adapter (163.905) from the connector for leakage test and pressure equalization (8). 5.6 After machine reprocessing Z Check for cleanliness: ' Any parts that have not been cleaned completely must be cleaned again manually. ' Replace defective parts. Z Further checks to be performed: ' See section 7 ' See product--specific instruction manual 5.7 Storage systems Z Remove the silicone peg mats from the RIWO System Trays. Z RIWO System Trays and separate silicone peg mats can be reprocessed using the thermal procedure up to 93 C. 19 GA--J 050

Manual reprocessing 6 Manual reprocessing 6.1 Manual cleaning and disinfection 6.2 Required resources Do not clean flexible endoscopes in ultrasonic baths! Use only disinfectants whose efficacy and material compatibility with endoscopes and endoscopic accessories has been checked and approved. ' See section 13 Approved chemicals for reprocessing. Concentration and exposure time for the cleaning and disinfection agent should be taken from the instructions provided by the chemical manufacturer. Do not use care products as these products leave behind deposits on the instruments and may damage the plastic material. The cleaning and disinfecting agents must be compatible. Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF products. Do not use metal brushes for cleaning. When using a cleaning gun make sure that the rinsing pressure is not higher than 0.5 bars. Use a pressure reducing valve if necessary. Z Leakage tester Z Cleaning gun Z Cleaning brushes Z Lint--free disposable cloth and cotton swab Z RIWO BOX or similar Z Cleaning solution Z Disinfectant solution Z Conventional syringe Z Tap water and sterile water GA--J 050 20

Manual reprocessing 6.3 Manual leakage test Z Connect the tube connector [with twist--lock mechanism (a)] to the pressure gage. Fig. 23 Z Connect the leakage tester (163.903) to the connector for leakage test and pressure equalization (8). ' Place connector (a) onto the connector for leakage test and pressure equalization (8) as far as it will go and lock the twist--lock mechanism. Z Close the knurled screw (b). Z Pump air into the flexible endoscope using the rubber bulb until the needle is in the green range (100 -- 200 mmhg). ' An initial pressure drop is due to the expansion of the elastic tubes. ' The flexible endoscope leaks if the pressure drops within 30 seconds. In this case please return the flexible endoscope to RICHARD WOLF for repair. If the pressure reading is constant the flexible endoscope is leak--tight. Z Opening the knurled screw (b) serves to equalize the pressure. After having opened the knurled screw wait at least 20 seconds until you remove the leakage tester to guarantee complete pressure equalization. 163.903 b Fig. 23 8 a In the case of leakage (i.e. proven perforation) do not continue to reprocess the flexible endoscope to prevent extension of the damage. Carefully wipe the outside of the flexible endoscope with a disposable cloth soaked with cleaning and disinfectant solution. Clean the channels with compressed air. ' Follow the staff protection measures. Remove the included foil from the foil bag and place the flexible endoscope into the transport case for shipment as described in accompanying note SF -015. Z Immediately after the leakage test, remove the tube [with twist--lock mechanism (a)] from the pressure gage. Z Spray the pressure gage and rubber bulb with surface disinfectant and wipe with a lint--free disposable cloth. Z Reprocessing tube and twist--lock mechanism. ' See section 1.9 Overview of reprocessing. 21 GA--J 050

Manual reprocessing 6.4 Manual cleaning Fig. 24 Z Remove the cold--light connector and place in the small parts basket or utensils basket. Fig. 24 Selecting the cleaning brushes for the cleaning of Illustration Product no. 7264.691 7321.911 7326911 7268.691 Designation Cleaning brush dia. 3 mm for instruments with working channels of diam. 2 mm and more brush length 8 mm, overall length 1000 mm Cleaning brush dia. 2.5 mm for instruments with working channels smaller than diam. 2 mm brush length 10 mm, overall length 1000 mm Cleaning brush dia. 2.2 mm for instruments with working channels smaller than diam. 1.2 mm brush length 15 mm, overall length 1200 mm Cleaning brush dia. 5 mm brush length 10 mm, working length 175 mm, overall length 285 mm working channel laser fiber channel suction channel suction valve biopsy valve D d d d d D d d d d D D d d d d d D D D 86.90 Cleaning brush brush length overall length 42 mm, 147 mm Legend: D = allowed d = not allowed 6.4.1 Biopsy valve (4) / suction valve (7) 7.1 7.2 7.3 Fig. 25 Z Immerse the following parts in a cleaning solution and clean outside with a lint-- free disposable cloth or cotton swab. ' Valve housing (4.1), sealing cap (4.3) ' Valve tappet (7.1), valve insert (7.2), tube connector (7.3) ' Follow the disinfectant manufacturer s instructions. Z Then clean with a short cleaning brush or in an ultrasonic cleaning bath. Z Rinse all parts with tap water and check for cleanliness. Z Dry with a lint--free disposable cloth or cotton swab, clean openings and hollow spaces with compressed air. Fig. 25 4.3 4.1 GA--J 050 22

Manual reprocessing 6.4.2 Stopcocks (3.2) 3.2.1 Fig. 26 Z Remove the stopcock plug (3.2.1). ' See product--specific instruction manual 3.2.2 Z Cleaning with a short cleaning brush: ' Stopcock plug (3.2.1) ' Stopcock housing (3.2.2) Fig. 26 6.4.3 Working channel (1) / suction channel (6) / laser fiber channel (12) Fig. 27 / Fig. 28 Z To remove any clogging or residues, carefully clean all channels with suitable cleaning brushes (see table in section 6.4). Adhere to the following sequence: 1. Suction channel (6) via valve holder (5) 2. Working channel (1) via luer connector (2) Only for 2 -channel continuous irrgation laser URS 3. clean the laser fiber channel (12) via the receptacle for adjustment unit (12.1) Cleaning the suction channel (6)! Insert a short cleaning brush into the valve holder (5) as far as it will go without applying any force. Pull the cleaning brush back and forth in the suction channel. Cleaning the working channel (1)/ laser fiber channel (12)! Insert the long cleaning brush into the working channel (1) / laser fiber channel (12) only from the proximal end to the distal end without applying any force. Do not pull the cleaning brush back and forth in the working channel (1)/ laser fiber channel (12) as this can result in damage. Guide the cleaning brush through the working channel (1)/ laser fiber channel (12) only in one direction and pull back only after the brush head has been fully exposed at the distal end. 5 2 1 6 Fig. 27 23 GA--J 050

Manual reprocessing Fig. 28 (only for 2 -channel continuous irrgation laser URS) 12.1 12 1 Fig. 28 Z Rinse the flexible endoscope inside and out with a cleaning solution to remove any loosened/dissolved particles. Z Reprocess the cleaning brushes. ' See section 1.9 Overview on reprocessing Fig. 29 Z Clean the glass surfaces as well as the light exit areas with a cotton swab (wooden stick, not metal or plastic). CAUTION! Spraying of contaminants! To prevent the spraying of contaminants in the vicinity, always rinse out the channels while the instrument is immersed in the cleaning solution. Follow the relevant guidelines and directives on personnel protection. Z Immerse the flexible endoscope in a RIWO BOX filled with water (in accordance with section 3 water quality ), then rinse out all channels to fully remove the cleaning solution. 1 6 Fig. 29 Z Then dry all channels (1) (6) until the air coming out is dry. ' with pressure--reduced, filtered compressed air or ' with special air pumps or ' with a syringe Z Dry outside with a lint--free disposable cloth or cotton swab. GA--J 050 24

Manual reprocessing 6.5 Manual disinfection Fig. 30 Z For manual disinfection we recommend our RIWO BOX. This system features the following advantages: ' Thanks to integrated support points, liquid can drip of the basket ensuring that the liquid flows back into the container. Fig. 30 Z Immerse the flexible endoscope in a disinfectant solution. Follow the disinfectant manufacturer s instructions with regard to ' Disinfection efficacy ' Concentration ' Immersion time and ' Use life Z To avoid mechanical damage, immerse the flexible endoscope and accessories separately in disinfectant solution. Z Open the supply and drain stopcocks (3.1). Z Fill all channels with a syringe containing disinfectant solution. Z Cover the RIWO BOX during disinfection. 6.5.1 After disinfection Z Rinse the following with sterile water: ' Rinse out all channels with a disposable syringe until the liquid running out is clear. ' Biopsy valve (4) and suction valve (7). If disinfection is not followed by sterilization, sterile water must be used for rinsing the inside and outside. Z Dry all channels until the air coming out is dry: ' with pressure--reduced filtered compressed air or ' with special air pumps or ' with a syringe Z Dry the outside with a lint--free disposable cloth or a cotton swab.. NOTE! In order to improve drying, the working channel (1) and the suction channel (6) and the laser fiber channel (12) can be rinsed out with sterile 70% alcohol (ethanol, isopropanol) before drying. If flexible endoscopes are not dried properly, micro -organisms can multiply in the residual moisture, e.g. in the channel system of the endoscope during storage, representing an infection source for patients examined subsequently. Complete drying should therefore be the aim. 6.6 Storage systems Z The RIWO System Trays and RIWO BOXES can be cleaned with cleaning solutions -- e.g. enzymatic cleaning agent. Z After cleaning, rinse all parts under the tap and carefully dry with a lint--free disposable cloth. 25 GA--J 050

Checking and maintenance 7 Checking and maintenance 7.1 Visual check 7.2 Function check CAUTION! Be careful if products are damaged or incomplete! Possible injury of patient, user or third persons. Run through the checks before and after each use. Do not use products which are damaged or incomplete or have loose parts. Return damaged products together with loose parts for repair. Do not attempt to do any repairs yourself. Z Check the flexible endoscope in particular its distal area and the accessories for: ' Damage ' Sharp edges ' Loose or missing parts ' Rough surfaces Z Any lettering, labeling or identification necessary for the safe intended use must be legible. ' Any missing illegible lettering, labeling or identification leading to incorrect use or reprocessing must be restored. Z Check for perfect condition and replace if necessary: ' Sealing valve (4.2) ' Sealing membrane (7.4) Z Check for free passage (patency): ' Working channel (1) ' Suction channel (6) ' Supply and drain stopcocks (3.1) ' Laser fiber channel (12) [only for 2 -channel continuous irrgation laser URS] Z Check opening and closing of supply / drain stopcocks (3.1). Z Check the connections for firm seating. Fig. 31 Z Check image quality and light output in conjunction with the system components. ' See product--specific manual Z Check glass surfaces for possible deposits. ' Deposits on glass surfaces can cause a spotted or blurred field of view and may considerably impair light transmission. ' Clean glass surfaces with a cotton swab soaked with alcohol (wooden swab carrier, not metal or plastic), clean hard--to--remove deposits with instrument cleaner (see sections 11 / 12). Fig. 31 GA--J 050 26

Checking and maintenance Fig. 32 Z Check light output without the system components. Z Direct the distal end of the flexible endoscope towards a light source. ' At the cold light connector, broken fibers appear as black dots. The light output is no longer sufficient if approximately 30% of the fibers are broken. Fig. 32 Only use instrument cleaner (100.00) to remove hard -to -remove deposits from glass and metal surfaces. If you cannot remove the deposits send in the flexible endoscope for repair. Regular cleaning with alcohol after reprocessing avoids deposits. 27 GA--J 050

Sterilization 8 Sterilization 8.1 Required equipment CAUTION! High thermal load! To avoid damage to the flexible endoscopes as a result of the high thermal load, flexible endoscopes must not be steam or hot- air sterilized. The instructions listed in section 1.9 Overview on reprocessing have been approved by RICHARD WOLF as suitable for the preparation of a medical product whichistobereused. It is the responsibility of the reprocessor to make sure that the reprocessing actually carried out comprising the equipment, materials and personnel achieves the required results in the reprocessing unit. This requires validations and routine monitoring of procedures. Any deviation from the instructions provided should be carefully evaluated by the reprocessor for efficacy and possible unfavorable results. Z Connector for leakage test and pressure equalization (8) Z Lint--free disposable cloth and cotton swab Z E.g. RIWO System Tray Z Specific packaging / wrapping GA--J 050 28

Sterilization 8.2 Preparation for sterilization (gas / plasma procedure) Z The instruments must be sufficiently dry for sterilization. Z Open the irrigation, drain and insertion stopcock (3.1) (see fig. 5 on page 10) Z Do not expose flexible endoscopes to sudden temperature changes. ' Allow the container with the flexible endoscopes to cool down slowly to hand warm in the sterilizer. Z Follow the instructions / manual of the sterilizer manufacturer. Z Depending on the product version, disconnect the biopsy valve (4) and the suction valve (7) from the flexible endoscope and sterilize in disassembled condition. Fig. 33 For gas sterilization or plasma sterilization (STERRAD ) install the pressure equali - zation valve (A) on the connector for leakage test and pressure equalization (8). Z Attach pressure equalization valve (A) to the connector for leakage test and pressure equalization (8). ' Push the pressure equalization valve (A) onto the connector for leakage test and pressure equalization (8) as far as it will go and lock the twist--lock mechanism. A Fig. 33 8 Only attach the pressure equalization valve (A) during gas sterilization. With the pressure equalization valve (A) attached during cleaning or during immersion in disinfectant, liquid would enter into the flexible endoscope and destroy internal components. Unscrew the pressure equalization valve (A) after removing the sterilization packaging.. NOTE! Optionally the following parts can also be steam -sterilized at 134 C (273 F) using the fractional pre -vacuum method: ' Suction valve (7) / sealing membrane (7.4) ' Biopsy valve (4) / sealing valve (4.2) ' Adjustment unit of 2 -channel continuous irrgation laser URS 29 GA--J 050

Sterilization 8.3 Gas sterilization Use the gas sterilization procedure only for sterile items which due to their heat sensitivity cannot be sterilized using the steam sterilization process. 8.3.1 Gas sterilization using ethylene oxide gas (EO) Under ambient conditions ethylene oxide is a gas. It is both toxic and flammable, and in conjunction with air forms an explosive mixture over a wide range of concentrations. In animal experiments under ambient conditions comparable to conditions of possible exposure of persons at the workplace ethylene oxide has proven to be carcinogenic. Most materials (mainly rubber and plastic materials) absorb ethylene oxide during exposure. Desorption is a slow process; a certain residual amount of gas therefore remains in sterile items. In accordance with ISO 10993 part 7, the ethylene oxide dose administered to a patient via devices for a single or multiple use or which have contact with the patient for no more than 24 hours must not exceed 20 mg. Desorption depends on a multitude of factors, such as: ' Type of sterilization procedure (EO concentration -- gas exposure time), ' Inert gases, ' Material properties of the sterile items, ' Permeability of the packaging / wrapping, ' Type of storage of the sterile items, ' Temperature and frequency of air change during storage. In desorption chambers operated at 30 C --60 C in most cases an aeration time of several hours is sufficient. At room temperature desorption usually takes several days. Sterilizability of RICHARD WOLF heat--sensitive instruments using ethylene oxide gas has been proven under the following conditions: ' Sterilization temperature: 40_C 3_C ' Pre--vacuum: >110 mbar 10 mbar ' Relative humidity: 60% 10% (before gas exposure) ' Contact time: 180 minutes ' EO concentration: 1000 mg EO/l 50 mg/l ' EO chamber pressure: 750 mbar 30 mbar absolute ' N 2 buffer: 150 mbar 10 mbar ' Number N 2 purging cycles: 2 ' Number of purging cycles: 4 According to manufacturer s specifications, EO devices operating in accordance with a validated procedure in accordance with EN 1422, annex F, guarantee safe sterilization and desorption. ' Follow the device manufacturer s instructions. Heat--sensitive RICHARD WOLF endoscopes which have been sterilized applying the conditions referred to above can be used again on the patient providing the desorption conditions listed below have been observed and 6 hours of aeration time has been allowed in accordance with ISO standards 10 993 part 7: ' Temperature: 32 -- 35 _C ' Air circulation: 10 times per hour ' Air exchange: once per hour ' Desorption time: 6 hours GA--J 050 30

Sterilization 8.3.2 Gas sterilization with formaldehyde gas (FA) Gas sterilization with formaldehyde is an alternative to sterilization using ethylene oxide gas. Compared to the ethylene oxide procedure, the FA procedure offers a number of advantages. The formaldehyde water vapor mixture is neither flammable nor explosive. On completion of the sterilization cycle, this mixture is removed from the products to the extent that the products can always be reused without further aeration time. Sterilizability using formaldehyde gas has been certified under the following conditions: ' Sterilization temperature: 60_C + 3_C ' Fractional pre--vacuum: 15--fold pressure change between 50 and 200 mbars ' Exposure time: 60 minutes ' Formaldehyde concentration: 2% ' Chamber volume: 100 liters ' Fractional steam cleaning: 20 times 8.4 Further sterilization procedures RICHARD WOLF has checked and validated the reprocessing procedures described below only with regard to their material compatibility. With limitations - see notes - these procedures have been approved for use with flexible endoscopes and endoscopically controlled accessories. ' The sterilizer manufacturers carried out efficacy tests (microbiological examinations). Exception: ' RICHARD WOLF flexible endoscopes have been validated using STERRAD 100 S to check efficacy. 8.4.1 Low temperature plasma procedure (LTP) / agent: hydrogen peroxide (STERRAD 100S or 50). NOTE! Severe discolorations may occur in the case of various materials such as black anodized aluminum or plastic materials. However, this does not represent any functional impairment. Fig. 34 Do not plug the booster onto the distal end of the flexible endoscope. Concentrated hydrogen peroxide acting directly on the instrument will damage the bonding areas. Booster Fig. 34 31 GA--J 050

Sterilization 8.4.2 STERIS procedure The STERIS procedure applies peracetic acid as an agent in conjunction with corrosion inhibitors. If used as intended, corrosion can be excluded. Under no circumstances attach the pressure equalization valve (A) during the STERIS procedure! If the pressure equalization valve (A) were attached during sterilization using the STERIS procedure, liquid would penetrate into the flexible endoscope and destroy internal components. Only attach the pressure equalization valve (A) during gas sterilization!. NOTE! Connect instrument channels to the system so that all lumens are fully accessible by the reprocessing medium. Follow the sterilizer manufacturer s instructions. 8.5 Sterilization of reprocessing systems and cleaning accessories 8.5.1 RIWO System Tray Z RIWO System Trays do not need separate sterilization. Sterilization takes place together with the flexible endoscope stored in the tray. 8.5.2 Cleaning brushes Z Cleaning brushes and cleaning wires can be steam sterilized at 134 C (273 F) using a fractional pre--vacuum procedure. GA--J 050 32