CISA Reprocessing Systems

Transcription

1 CISA Reprocessing Systems ERS Endoscope Reprocessing and Storage System Feel the innovation 0123

2 ERS/ESS An innovative approach to the treatment, reprocessing, and aseptic storage of endoscopes and other medical equipment ERS Endoscope Reprocessing System The challenge of controlling cross-contamination in hospitals has been attracting increased attention. Health services are investing increasing sums to decrease the risk of possible crosscontamination, and thereby decrease the risk of contracting a Hospital Acquired Infection. Endoscopy is an area that has received particular attention, partly because of the number of uses of an endoscope in a day, and partly because the cost of an endoscope means that a long life is expected of it. To protect the patient, there is a demand for fast and effective disinfection between uses. Engineers have been looking at ways and means for continued improvements both in the design of washer disinfectors and in the chemical washing and disinfecting agents. Bearing in mind these requirements, a modular system for the various stages of endoscope reprocessing, including storage, which also makes the process easier, safer, and reproducible, would help to meet these needs. CISA has carried out a programme of research and development ending in the production of a system that washes, decontaminates, even exceeds high level disinfection, and provides aseptic storage of flexible and rigid endoscopes, named ERS/ ESS: The Endoscope Reprocessing and Storage System. The element at the centre of the whole process is revolutionary, and at the same time very simple: a cassette in which a contained endoscope is enclosed through the disinfection process, drying, and storage, and until required for the next use without any further exposure to the outside world and its risks of cross-contamination. Operating Cycle The ERS has been designed to meet and exceed the usual levels of high disinfection (over log 12 kill rate) with the reprocessing of endoscopes within less than 45 minutes. The distribution of the chemicals in the cassettes has been designed to guarantee their efficacy both inside and outside the separate channels that make up an endoscope. A group of sensors monitors the required flow of each liquid through each channel during each phase of the cycle. The ERS has been designed so that the reprocessing of two separate cassattes can be carried out independently. The processing is all carried out at room temperature. The cassatte provides aseptic storage and transportation of the processed endoscopes. The ERS will only operate each phase of the cycle (see page 6) when each phase s - check criteria have been met. Innovative system for Endoscope reprocessing: Cleaning, Bio Film Removal, Treatment exceeding high level disinfection involves the following steps. Cleaning Rinse Processing Final rinse Continuous leak test Channel monitoring Alcohol purge Bio Film removal Using sterile water and sterile air Endoscope reprocessing with a log 12 reduction of bacteria Using sterile water and sterile air inside the channels At the start of the cycle and during all cycle phases, a continuous leak test is performed All internal channels are monitored continuously for channel obstruction This option that can be provided at the end of the cycle Touch screen control and display Channel monitoring Function monitoring Feel the innovation Ers 3

3 ERS Endoscope Reprocessing System ERS Endoscope Sterile Storage System Pre-Treatment and Treatment Chemicals The ERS System must use validated chemicals such as (but not limited to) Proteazone-ERS, manufactured to obtain proper cleaning (including removal of bio film) and a cold sterilizing solution, Adaspor-ERS single shot for reaching greater than the high level of disinfection. Bacteriologically-filtered water (or external RO water) guarantees the quality of the final rinse, while sterile compressed air dries the channels, as well as any other chemicals that are pre-approved by CISA Research & Development. Cold sterilizing solution Adazone (5,7-diphenyl-1,3 diazoadamantan-6-one) g. 0, peracetic acid g. 0,085 - coformulants purified H2O at ml. 100 Decontaminating concentrate Adazone L g. 2,50-germicidal complex surfactant with linear structure (R=C10:C14) g. 60,50- coformulants and purified H2Oat ml. 100 Biological and Chemical Tests CISA offers a complete set of quality control tests using biological and chemical indicators, designed specially for the CISA ERS. Storage and Drying The ERS System is made up of two machines, the first, the ERS, designed to decontaminate, and the second, the ESS, designed for the aseptic storage of the endoscopes in their cassettes. The ESS storage unit for storing endoscopes and drying them is easy to use, and is fast and effective. The ESS will take up to six cassettes at a time: each one is monitored individually and constantly as warm sterile air is blown through each internal channel and across the external surface of the scope, to remove any trace of water. This process allows storage of endoscopes that are ready for use for at least 72 hours after reprocessing and storage without the need to reprocess again within this period which increases endoscope shelf life and thereby reduces unnecessary costs. Increased shelf life The ESS unit offers sterile storage shelf life of 72 hours without the need for reprocessing. Many studies have been carried out that show that storage can be extended to even more than 72 hours without the need for reprocessing using the unique CISA cassette and ESS combined system. BOX Clamp Strip Media Chemical cost saving There is a world wide guideline to reprocess scopes again if they have not been used within 3-4 hours of the original reprocessing time, if using unvalidated drying cabinets and open endoscope trays. With the CISA cassette and ESS, the holding time can be increased to 72 hours or more, which saves a lot of chemical costs and still leaves the scope safe to use. The CISA ESS is a cost effective solution for cutting out unnecessary reprocessing time and chemical waste. ERS - Biological Test Sterile Air & water Air exchange filter (0.2 micron) for Cassettes Compressed air control valves (6-8 bar and 0.5 bar with absolute filters 0.2 micron air filters. Cassette 1 Cassette 2 Changes colour to brilliant green at the end of the cycle. Total time since introduction of the Cassette into the ESS. Cassette Lock/Unlock button. LED to show the insertion of the Cassette correctly inside the ESS. Air Output temperature from the Cassettes. Air Input pressure into the Cassettes. Selection button to access the maintenance screen. Water Filter 1 (5 micron) Water Filter 2 (0.5 micron) Water Filter 3 (0.1 micron) Chemical container 1 (isopropyl alcohol or secondary disinfectant) Chemical container 2 (Proteazone-ERS) Chemical container 3 (5% peracetic acid) Chemical container 4 (Adazone-ERS buffer) Indicates Cassette inserted. Indicates the air Input pressure. Return to the previous screen. Indicates the Input temperature. Indicates the Output temperature. 4 Ers Ers 5

4 ERS Endoscope Reprocessing and Storage System ERS Endoscope Reprocessing and Storage System Cassette The cassette is the biggest innovation in the ERS system. It allows the handling, storage, and management of both rigid and flexible endoscopes without their risk of being crosscontaminated. The cassettes are made of special materials to prevent damage from chemicals, or leakage, with the help of silicon gaskets. The channel connectors are sealed from the external environment by auto-seal attachments. The cassette plastic is light, chemical resistant, transparent, and non-deformable. Its inner surface is smooth and rounded for optimal drainage. Furthermore, the cassette s inner shape and configuration makes it fully compatible with all makes of endoscope. A hermetic seal is guaranteed, and tamper-proof security tags provide visual confirmation that the cassette has not been opened since reprocessing. Each cassette can have its own microchip transponder which communicates relevant data relating to the instrument inside, the operator, the reprocessing cycle employed, etc. between the ERS and ESS, providing for full tracking and traceability. Easy To Use The ERS system has been designed for maximum ease of use, thanks in great part to the flexibility of the cassette principle. The only manual operation, after the endoscope has been placed in the Cassette, is to introduce the Cassette into the ERS or ESS. All of the other operations are automatic, including channel connection and disconnection. The operator controls the reprocessing procedure through a touch screen, where the progress of the cycle and all security checks can be monitored. Safety The processing and storage units have been designed to meet every safety criterion, to give the necessary protection to patients, operators, instruments, and the environment. The Endoscope Reprocessing and Storing System is a new generation of equipment, and meets every safety application. Thanks to this kind of reprocessing, the safety of patients without cross-infection is guaranteed. The cycle is totally automatic and requires no operator interaction. The operator has just to introduce the endoscope into the Cassette, then the Cassette into the machine. Reprocessing is guaranteed by cold chemical sterilisation, with no toxic or harmful vapours through the use of Adaspor ERS. The system does not need any particular interaction and there is no risk to the medical staff from the chemical agents. The ERS System is compatible with the high level of sophistication and specialist materials involved in the construction of endoscopes. There are many different safety measures to ensure that everything in the machine is being monitored constantly. Even protection of the environment has been covered: the chemical agents used are without danger and are non polluting. Management System The ERS System is managed by a PLC. The PLC has also an auto check device to verify the cycle data bank. This provides very high quality control and thus error is reduced. An integrated printer gives easy to read cycle data reports. The touch-screen monitor, programmed in different languages, guides the operator through the correct use of the system. The system can be also connected to the (Endo- Itineris) track and trace storage software and also can be connected to online check-up and remote maintenance. Maintenance The ERS machine is freestanding with the upper part for cassettes and the lower part for chemical storage. Both the ERS and the ESS have been designed to enable easy access for maintenance with a lockable door and clearly visible and labelled parts. The preventive maintenance program and troubleshooting are easy with clear instructions and follow up using the touch screen. Water and air filters are easily replaceable using limited effort. Filter changes are controlled by the number of executed cycles and by the touch Screen monitor. Energy Saving and Economy of Us The ERS System has been designed with particular attention to energy consumption and low management costs. The design solution minimises the water consumption needed for the reprocessing cycle. Area Design - Pass Through Pass through facilities can be incorporated into the design to separate the reprocessing area from the storage area with an airlock control. Industrialization CISA s prominent position in the marketplace has allowed the company to develop sufficient demand to ensure for very model in its range, volume production. This repetition of assembly operations and the streamlining of the manufacturing process therefore provides a favourable quality/cost ratio. Quality and Safety Certification The ERS System conforms to the requirements of the International and Europeans standard ISO EN and to CEI EN , CEI EN , CEI EN and to the standard UNI EN ISO The machines are CE marked according to the European Council Directive 93/42/EEC concerning medical devices. The equipment conforms to ISO which covers the generic requirements for the characterization of a sterilizing agent and to HTM 2030 and its successors in the HTM01 series. 6 Ers Ers 7

5 ERS Connector Guide ERS Connector Guide Connection Guide The range of CISA connectors have been designed to cover the whole range of endoscopes from the main international manufacturers. The Cassette of the ERS system has been shaped to accept all designs of flexible endoscope, even the latest desugns. The Cassette has six connections inside that can be applied for the flushing of individual endoscope channels, as well as a leak test connection. The channels are numbered from 1 to 7 from right to left while looking inside an open cassette: These are possible connections for this kind of endoscope: Leak Test Auxiliary Elevator Suction Injection (1) Bypass (1) Bypass (2) CHANNEL 1: Preferentially reserved for flushing the ELEVATOR or AUXILIARY channel of the endoscope. Otherwise dedicated to normal flushing. CHANNEL 2: Dedicated to leak test. CHANNEL 3: Preferentially reserved for flushing the ELEVATOR or AUXILIARY channel of the endoscope. Otherwise dedicated to normal flushing. CHANNEL 4-7: General flushing channels. Injection (2) Sanization All types and brands of endoscope connection adaptors are available with CISA storecase Example As the cassette is compatible with the connectors made from most endoscope manufacturers, it is not necessary to use CISA connectors as the unique solution for connecting the endoscope channels. As an example, let us take as an example an endoscope from a well-known manufacturer: A : Cylinder plug B : Biopsy valve C : Connector plug D : Air E : Suction channel. these connection are enough to flush all the inner channels of this kind of endoscope. In the case of the endoscope described in the figure opposite, one needs to connect in the following way: PLEASE NOTE: the following recommendation are for CISA connectors. It is possible to use the the connectors from individual endoscope manufacturers simply adapting them to attach to the cassette tubeinge. A: Cylinder plug. The metal plug (commonly called a rail as shown in the figure) from the manufacturer cannot be used to connect CISA connectors. Remove the two push-buttons and insert them in the cassette for washing, using the accessories basket. The two CISA connectors used in this place are the and the These connectors can be applied to any of the tubes 4, 5, 6 and 7 in the cassette. Biopsy Valve Cap (B) The Channel Plug (connections A & B) and Injection Tube (connections C, D & E) flush the standard air, water and suction channels only. They do not flush any special channels (e.g. auxiliary-water, elevator-wire). B: Biopsy Valve. A connector from CISA is available, but we recommend using the one from the manufacturer which is always provided with the endoscope. The plug is usually a flow-reducer silicone rubber cap and no tubes need necessarily be connected here to the cassette. Cylinder Plug (A) C: Connector plug. This is a normal connector: it is usually left free as an outlet, otherwise it is possible to bypass the flow using the connector or , depending on the model of the endoscope. Connector Plug (C) Air Port (D) D: Air. Usually left free as an outlet. E: Suction Channel. This channel is usually left free as an outlet and does not need any connector. As one can see there is an internal connection between A and E: in the case that both channels are connected to a pressure source (the connectors of the cassette) this creates turbulence and high pressure inside the internal link between A and E. These are all channels which can be potentially used for flushing the endoscope. Both of these can be connected where the endoscope has two Biopsy channels, which can relieve the pressure coming from the flushing pumps. So by just connecting the two plugs in A, the endoscope is flushed completely internally. The other connectors can be used in case they are needed and i the skill of the users is establish a different configuration for safe flushing. 8 Ers Ers 9

6 ERS Connector Guide ERS Endoscope Reprocessing and Storage System Additional connectors that are not shown on the diagram but are necessary. LEAK TEST: This plug ( ) must be connected every time to the endoscope before the start of a cycle. Take care to in keep this connector dry and not to allow humidity or water to get inside it. For this reason, if one is carrying out a LINE SANITIZATION cycle using a normal Cassette, it is necessary to cap the connector with cap no along with the leak test connection ( ). ELEVATOR CHANNEL: See picture below. Inlet Inlet Elevator-Wire Channel ERS1 - ERS2 STERILIZERS Dimensions mm ( W x H x D ) 1100 x 1700 x 750 Weight kg 200 Power supply Volts 230 single phase, 50/60 Hz Electrical power Watts 1000 Cold water supply DN 20 Water pressure Bar 1-3 Compressed air Nl 15 Compressed air pressure Bar 6-8 Drain DN 32 Sound Level db. <53 * ERS 1 = 1 storecase ERS 2 = 2 storecases All duodenoscopes (plus some therapeutic gastroscopes) have an elevator-wire channel inlet above the suction valve. The elevator channel is present in some endoscopes. When present it is good practice to reserve the connector number 1 or 2 of the Cassette for this application. The elevator channel has a particular mechanism that is able to move a driver on the head of the endoscope at an angle of 90 for diagnostic purposes: this is done by a metal tractor wire inside the channel itself. Therefore the space for flushing is reduced as compared with to the other channels: one of the ERS touchscreens is needed to set the flushing pressure inside this channel in order to not to set off a maximum pressure alarm due to the efforts that the pump is attemtimg to flush this semi-obstructed channel. The elevator channel can be connected to the Cassette with connector AUXILIARY: See pictures below. In these two cases, when an AUXILIARY channel is present, it is necessary to flush it separately because it is not usually sharing a connection with any other channels. In this case, the connector that could be used is Elevator ESS STORER Dimensions mm ( W x H x D ) 1100 x 1700 x 750 Weight kg 200 Power supply Volts 230 single phase, 50/60 Hz Electrical power Watts 1000 Compressed air pressure Bar 6-8 Sound Level db. <53 CASSETTE Dimensions mm ( W x H x D ) 600 x 110 x 450 Weight kg 4 Internal capacity litres 14,5 Auxiliary- Water Inlet Auxiliary-Water Inlet Cap Auxiliary-Water Channel Nozzle Auxiliary- Water Inlet Auxiliary-Water Channel Nozzle Some endoscopes have an auxiliary-water inlet light guide connector. Auxiliary- Water Inlet Some endoscopes have an auxiliary-water inlet above the suction valve. ENDOSCOPE TRANSPORT TROLLEY PLEASE NOTE: If an endoscope has both an ELEVATOR and an AUXILIARY channel it will be necessary to have two of these connectors. 10 Ers Ers 11

7 Feel the innovation CISA GROUP of companies & office CISA S.p.A. Produzione e Direzione Generale Via Pontina Km Pomezia - Roma - Italia Tel Fax coordination.sales@cisagroup.it CISA Middle East LTD P.O. Box 3692 Amman Jordan Tel: Fax: middleeast.sales@cisagroup.it CISA in Libya Abdallah Alghareeb street Misrata, Libya Phone Fax CISA Nusantara Malyzia, Indonesia, Brunai LOT 19, Ground Floor, Jalan Industri 2/1 Rawang Integrated Industrial Park Rawang Selangor, Malaysia Phone +60 (3) Fax +60 (3) CISA Africa Office 92, Rue 18 Janvier 1952 Tunis 1049 Tel/Fax lamine.rafik@cisagroup.it CISA India Office New Delhi - India Tel Fax india.sales@cisagroup.it CI SA Russia Office Dmitrovskoe shosse, 100, stroenie 2, corp. 3, off Moscow - Russia tel fax cisarussia@cisagroup.it CISA Asia Office 190 Middle Road # Fortune Center Singapore Tel Fax asia.sales@cisagroup.it CISA Brasile Ltda. Rua Dona Francisca, 8300 Distrito Industrial - Bloco I - Módulo 2 CEP Joinville - SC Brasil Tel Fax cisa@cisabrasile.com.br CISA America Inc. 618 SW 3rd ST SUITE 180 Cape Coral - Florida - Zip Code Tel Fax america.sales@cisagroup.net CISA Venezuela C.A. Calle Los Laboratorios Edificio Keydex, Piso 2 Los Ruices, Caracas Telf/Fax: +58 (0) latinamerica.sales@cisagroup.it CISA South America Office Bogota, Colombia Tel cesar.cardenas@cisagroup.it CISA in U.K. and Ireland BES Decon 131 South Liberty Lane Ashton Vale, Bristol BS3 2SZ, UK Tel Fax info@besbiz.eu.com CISA in Germany Schlumbohm Medizin-Labor-Technologie GmbH Grenzkehre 1 D Hamburg Tel Fax info@schlumbohm-medizintechnik.de CISA in France Laboratoire Aldor Dechosal Sas ZI B des Forges - BP Vireux Molhain Tel Fax aldor.dechosal@wanadoo.fr ERS Worldwide catalogue agents - GB - 04 & CISA distributors reserves the right of modifications without prior notice. The reproduction of this document is allowed if explicitly authorised by Cisa S.p.A. only.