CISA Reprocessing Systems

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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 Feel the innovation

ERS Endoscope Reprocessing System The challenge of controlling cross-contamination in hospitals has been attracting increased attention.

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

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.

3 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 7 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 7 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 Ers 3

ERS Endoscope Reprocessing System Pre-Treatment and Treatment Chemicals The ERS System uses Proteazone-ERS manufactured to obtain proper cleaning (including removal of bio film) and a cold

Bacteriologically-filtered water (or external RO water) guarantees the quality of the final rinse, while sterile compressed air dries the channels.

2,50-germicidal complex surfactant with linear structure (R=C10:C14) g. 60,50- coformulants and purified H2Oat ml.

4 ERS Endoscope Reprocessing System Pre-Treatment and Treatment Chemicals The ERS System uses 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. 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. BOX Clamp Media Strip 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 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) 4 Ers

ERS Endoscope Sterile Storage System 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

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

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

5 ERS Endoscope Sterile Storage System 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 72 hours without the need for reprocessing. Many studies carried out that even more than 72 hours for scope to be used without reprocessing are enough using unique CISA storecase ESS system. Chemical cost saving As the standard world wide instruct to reprocess the scope after 4 hours of reprocessing time even if not used if using regular drying cabinets and open endoscopes. With CISA storecase and ESS, the holding time will increase to 72 hours which will safe a lot of chemical cost and make the scope safe to use. CISA ESS is the cost effective solution with cutting unnecessary reprocessing and chemical waste. Changes color to brilliant green at the end of the cycle. Total time of introduction of the Store-case in the ESS. Lock/Unlock Store-Case button. Check LED of correct insertion of the Store-Case inside the ESS. Air temperature in output from the Store-Cases. Pressure of the air in input of the Store-Cases. Selection button to access the ordinary maintenance page. Visualize the Inserted Store-Cases. Visualize the pressure of the air in input. Back to the previous page. Visualize the temperature in Input. Visualize the temperature in Output. Ers 5

ERS Endoscope Reprocessing and Storage System Store Case The store-case is the biggest innovation in the ERS system.

The store-cases are made of specialised materials to prevent damage from chemicals, or leakage, with the help of silicon gaskets.

Its inner surface is smooth and rounded for optimal drainage. Furthermore, the store-case s inner shape and configuration makes it fully compatible with every make of endoscope.

Each store-case can have its own microchip transponder which communicates with the ERS and ESS relevant data relating to the instrument inside, the operator, the reprocessing cycle employed, etc.

6 ERS Endoscope Reprocessing and Storage System Store Case The store-case is the biggest innovation in the ERS system. It allows the handling, storage, and management of both rigid and flexible endoscopes without risk of their being crosscontaminated. The store-cases are made of specialised 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 store-case plastic is light, chemical resistant, transparent, and non-deformable. Its inner surface is smooth and rounded for optimal drainage. Furthermore, the store-case s inner shape and configuration makes it fully compatible with every make of endoscope. A hermetic seal is guaranteed, and tamper-proof security tags provide visual confirmation that the store-case has net been opened since reprocessing. Each store-case can have its own microchip transponder which communicates with the ERS and ESS relevant data relating to the instrument inside, the operator, the reprocessing cycle employed, etc... 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 store-case principle. The only manual operation, after the endoscope has been placed in the Cassette, is to introduce the Cassette in 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 preserving machines have been projected under every safety criterion, so they have the necessary protections for the patients, the operators, the instruments and the environment. The Endoscope Reprocessing and Storing System is a new generation equipment and satisfy every safety application. Thanks to this kind of reprocessing, the safety of the patients with No-diffusion of infections is guaranteed. The cycle is totally automatic and it doesn t need any operator action. The operator has just to introduce the endoscope in the Store case, than the Store case in the machine. The reprocessing is guaranteed by a cold sterile solution, absolutely no toxic and no obnoxious: the Adaspor ERS. The system doesn t need any particular attention and there is no risk for the medical staff about the chemical agents. The ERS System is compatible with high sensibility and high making criterion of endoscopes. There are many different safety devices to insure that every thing in the machine is constantly monitored. Even the environment protection has been studied a lot: the chemical agents needed are absolutely no dangerous and no polluting. 6 Ers

ERS Endoscope Reprocessing and Storage System Management System The ERS System is entirely checked by a PLC. The PLC has also an auto check-up device to make sure the cycle data bank.

The touch-screen monitor, programmed with different languages, it guides the operator to the correct use of the system.

Maintenance The ERS machine is freestanding with upon part for store case and lower part for chemical storage.

Preventive maintenance program and troubleshooting are easy with clear instructions follow up using the touch screen. Water and air filters are easily replaceable using limited efforts.

Energy Saving And Economy Using The ERS System has been projected with particular attention to energy consumption and for a low management cost.

7 ERS Endoscope Reprocessing and Storage System Management System The ERS System is entirely checked by a PLC. The PLC has also an auto check-up device to make sure the cycle data bank. This permits a very high quality control and the evaluation error has reduced. An integrated printer makes a cycle data report, easy to read. The touch-screen monitor, programmed with different languages, it guides the operator to the correct use of the system. The system can be also connected to the supervision network (Endo-Itineris) for the online check-up and the remote maintenance. Maintenance The ERS machine is freestanding with upon part for store case and lower part for chemical storage. Both ERS/ESS are designed to enable easy access for maintenance with door lock and clearly light and labeled parts. Preventive maintenance program and troubleshooting are easy with clear instructions follow up using the touch screen. Water and air filters are easily replaceable using limited efforts. Filters lifetime is controlled by executed cycle and monitor the change time touch screen. Energy Saving And Economy Using The ERS System has been projected with particular attention to energy consumption and for a low management cost. Technical solution had also agree to CISA to reduces the water consumption, necessary for the reprocessing cycle. Area Design - Pass Through Pass through facilities are possibly designed to separate reprocessing area from storage area with airlock control. Industrialization Cisa s prominent position on the market has allowed the company to develop sufficient sales volumes to ensure, for each model of the range, a production in series. The repetition of all assembly operations and the industrialization of the manufacturing process can therefore provide a very favourable quality/cost ratio. Quality And Safety Certificates The ERS System is conform to the requirements of the Europeans standards ISO EN and to the standards 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 is conform to the normative ISO to the generic requirements for the characterization of the sterilizing agent as well as in compliance with the HTM 2030 generic requirements. Ers 7

ERS Connecting Guide Connection Guide The range of CISA connectors are made in way to cover the whole range of endoscopes from the main worldwide manufacturer.

The STORE-CASE has 7 connection inside that can be applied for the flushing of the endoscope.

The channels are named from 1 to 7 starting from the right to the left while looking inside an open STORECASE: 6 4 2 7 5 3 1 CHANNEL 1: Preferentially reserved for flushing ELEVATOR channel of the

Example As the store-case is compatible with the connectors made from most of endoscope manufacturers, it is not necessary to consider the CISA connectors as the unique solution for a washing

8 ERS Connecting Guide Connection Guide The range of CISA connectors are made in way to cover the whole range of endoscopes from the main worldwide manufacturer. The ERS machine and, in the specific, the STORE-CASE of the ERS system has a modelled shape in order to accept any kind of flexible endoscope, even the one of new generation. The STORE-CASE has 7 connection inside that can be applied for the flushing of the endoscope. These connection are provided each of a silicon tube to which will be connected the actual endoscope flushing connector. The channels are named from 1 to 7 starting from the right to the left while looking inside an open STORECASE: CHANNEL 1: Preferentially reserved for flushing ELEVATOR channel of the endoscope. Otherwise dedicated to normal flushing. CHANNEL 2: Dedicated to leak test. CHANNEL 3-7: General flushing channel. Example As the store-case is compatible with the connectors made from most of endoscope manufacturers, it is not necessary to consider the CISA connectors as the unique solution for a washing configuration. As example, we will take now in consideration an Endoscope from a renowned manufacturer: A : Cylinder plug. B : Biopsy valve. C : Connector plug. D : Air pipe. E : Suction channel. 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). Cylinder Plug (A) Connector Plug (C) Air Pipe Port (D) These are all channels which can be potentially used for the inner flushing of the endoscope, we will take in consideration one of the many configuration of washing available with this configuration. 8 Ers

ERS Connecting Guide Here the connection available for this kind of endoscope: Leak Test 03377341 Auxiliary Elevator 0337369 Suction 0337335 Injection (1) 0337355 Bypass (1) 0337353 Bypass (2)

this kind of endoscope. In the case of the endoscope described in the figure above, is necessary to act in the following way: PLEASE NOTE: the following recommendation are for CISA connectors.

The metal plug (commonly called rail you can see it represented in the figure) from the manufacturer cannot be used to connect CISA connectors.

These connection must be applied to any of the tubes 3, 4, 5, 6 and 7 of the STORE-CASE. B: Biopsy Valve.

The plug is usually a flow-reducer silicone rubber cap and no tubes are necessary to be connected here from the STORE-CASE. C: Connector plug.

D: Air pipe. Usually left free as an outlet. E: Suction Channel. This channel is usually left as an outlet and does not need any connection.

9 ERS Connecting Guide Here the connection available for this kind of endoscope: Leak Test Auxiliary Elevator Suction Injection (1) Bypass (1) Bypass (2) Injection (2) Sanization All types and brands of endoscope connection adaptors are available with CISA storecase 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 above, is necessary to act in the following way: PLEASE NOTE: the following recommendation are for CISA connectors. It is obvious that is possible to use the plugs of the endoscope manufacturer simply adapting them to the silicone tube. A: Cylinder plug. The metal plug (commonly called rail you can see it represented in the figure) from the manufacturer cannot be used to connect CISA connectors. Remove the two push-buttons and insert them in the STORE-CASE for the washing, using the basket for accessories. The two CISA connector used in this place are the and the These connection must be applied to any of the tubes 3, 4, 5, 6 and 7 of the STORE-CASE. B: Biopsy Valve. The connection from CISA is present but we recommend to use the one from the manufacturer which is always present on the endoscope. The plug is usually a flow-reducer silicone rubber cap and no tubes are necessary to be connected here from the STORE-CASE. C: Connector plug. This is normal connection: it is usually left free as an outlet, otherwise it is possible to bypass the flow using the connection or , depending on the model of the endoscope. D: Air pipe. Usually left free as an outlet. E: Suction Channel. This channel is usually left as an outlet and does not need any connection. As is possible to see there is an internal connection between A and E: in case both channels are connected to a pressure source (the connection of the STORE-CASE) this is creating turbulence and high pressure inside the internal link between A and E. Both of them can be connected in case the endoscope has two Biopsy channels, which can afford the exhaust of the pressure coming from the flushing pumps. So actually, just connecting the two plugs in A, the endoscope is completely flushed internally. The other connections can be used in case of necessity and if the skill of the users is enough advanced in order to find different configuration of safe flushing. Ers 9

ERS Connecting Guide Looking at the connector that are not shown on the diagram but they are necessary for the work.

Pay attention in keeping this connection dry and to not create humidity or water to get inside of it.

ELEVATOR CHANNEL: See picture below. Inlet Inlet Elevator-Wire Channel Elevator All duodenoscopes (plus some therapeutic gastroscopes) have an elevator-wire channel inlet above the suction valve.

10 ERS Connecting Guide Looking at the connector that are not shown on the diagram but they are necessary for the work. LEAK TEST: this plug ( ) must be connected every time to the endoscope before the start of a cycle. Pay attention in keeping this connection dry and to not create humidity or water to get inside of it. For this reason during the LINE SANIZATION cycle using a normal STORE-CASE is necessary to place the plug along with the leak test connection ( ). ELEVATOR CHANNEL: See picture below. Inlet Inlet Elevator-Wire Channel Elevator 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 is good practice to reserve always the connection number 1 of the STORE-CASE for this application. The elevator channel has a particular mechanism able to move a driver on the head of the endoscope in an angle of 90 for diagnostic purposes: this is done by a metal tractor wire inside the channels itself. Therefore the space for the flushing is reduced if compared to the other general channels: an option in the ERS touchscreen is able to control the flushing pressure inside this channel in order to not occur in alarms of maximum pressure due to the efforts that the pump is doing to flush this semi-obstructed channel. The elevator channel can be connected to the STORE-CASE with the connector AUXILIARY: See pictures below. In this two cases, when an AUXILIARY channel is present, is necessary to flush it independently because usually is not sharing any connection with the other general channels. Also in this case, the connection that could be used is the 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. PLEASE NOTE: Obviously if an endoscope has both ELEVATOR and AUXILIARY channels is necessary to have two of these connection available. 10 Ers

ERS Endoscope Reprocessing and Storage System ERS1 - ERS2 STERILIZERS Dimensions mm ( W

Electrical power Watts 1000 Cold water supply DN 20 Water pressure Bar 1-3 Compressed

<53 * ERS 1 = 1 storecase ERS = 2 storecases ESS STORER Dimensions mm ( W Electrical

<53 STORE CASE Dimensions mm ( W x H x D ) 600 x 110 x 450 Weight Kg 4 Inside capacity

11 ERS Endoscope Reprocessing and Storage System 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 storecases 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 STORE CASE Dimensions mm ( W x H x D ) 600 x 110 x 450 Weight Kg 4 Inside capacity litres 14,5 Endoscope transport trolley Ers 11

12 ERS catalogue - GB - 04 CISA reserves the right of modifications without prior notice. The reproduction of this document is allowed if explicitly authorised by Cisa S.p.A. only.

CISA Reprocessing Systems

CISA Reprocessing Systems ERS Endoscope Reprocessing and Storage System Feel the innovation 0123 ERS/ESS An innovative approach to the treatment, reprocessing, and aseptic storage of endoscopes and other