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CISA Reprocessing Systems

Endoscope Reprocessing and Storage SystemERS

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The challenge of controlling cross-contamination in hospitals has been attracting increased at-tention. Health services are investing increasing sums to decrease the risk of possible cross-contamination, 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, decon-taminates, 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 CycleThe ERS has been designed to meet and exceed the usual levels of high disinfection (over log 12 kill rate) with the reprocess-ing 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.

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ERS/ESSAn innovative approach to the treatment, reprocessing, and aseptic storage of endoscopes and other medical equipment

ERS Endoscope Reprocessing System

Cleaning Bio Film removal

Rinse Using sterile water and sterile air

Processing Endoscope reprocessing with a log 12 reduction of bacteria

Final rinse Using sterile water and sterile air inside the channels

Continuous leak test At the start of the cycle and during all cycle phases, a continuous leak test is performed

Channel monitoring All internal channels are monitored continuously for channel obstruction

Alcohol purge This option that can be provided at the end of the cycle

Touch screen control and display Channel monitoring Function monitoring

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Biological and Chemical TestsCISA offers a complete set of quality control tests using biological and chemical indicators, designed specially for the CISA ERS.

Sterile Air & water

ERS Endoscope Sterile Storage System

Pre-Treatment and Treatment ChemicalsThe ERS System must use validated chemicals such as (but not limited to) Proteazone-ERS, manufactured to obtain proper clean-ing (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. 0,00045 - 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

ERS Endoscope Reprocessing System

Storage and DryingThe 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 proc-ess 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 lifeThe 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.

Chemical cost savingThere is a world wide guideline to reprocess scopes again if they have not been used within 3-4 hours of the original reproc-essing 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

Air exchange filter (0.2 micron) for Cassettes

Changes colour to brilliant green at the end of the cycle.

Indicates the Output temperature.

Indicates Cassette inserted.

Indicates the air Input pressure.

Indicates the Input temperature.

Total time since introduction of the Cassette into the ESS.

Air Input pressure into the Cassettes.

Selection button to access the maintenance screen.

LED to show the insertion of the Cassette correctly inside the ESS.

Cassette Lock/Unlock button.

Return to the previous screen.

Air Output temperature from the Cassettes.

Cassette 1

Cassette 2

Water Filter 1 (5 micron)

Water Filter 2 (0.5 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)

Water Filter 3 (0.1 micron)

Compressed air control valves (6-8 bar and 0.5 bar with absolute filters 0.2 micron air filters.

BOX

Media

Clamp

Strip

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ERS Endoscope Reprocessing and Storage System ERS Endoscope Reprocessing and Storage System

Management SystemThe 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.

Area Design - Pass ThroughPass through facilities can be incorporated into the design to separate the reprocessing area from the storage area with an airlock control.

MaintenanceThe 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 UsThe 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.

IndustrializationCISA’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 CertificationThe ERS System conforms to the requirements of the International and Europeans standard ISO EN 15883-4 and to CEI EN 61010-1, CEI EN 61010-2-040, CEI EN 60204-1 and to the standard UNI EN ISO 14937.The machines are CE marked according to the European Council Directive 93/42/EEC concerning medical devices.

The equipment conforms to ISO 14937 which covers the generic requirements for the characterization of a sterilizing agent and to HTM 2030 and its successors in the HTM01 series.

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 cross-contaminated. 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 endo-scope.A hermetic seal is guaranteed, and tamper-proof security tags pro-vide visual confirmation that the cassette has not been opened

since reprocessing. Each cassette can have its own microchip transponder which com-municates relevant data relating to the in-strument inside, the operator, the reproc-essing 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.

SafetyThe 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 va-pours 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 materi-als 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.

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ERS Connector Guide

Connection GuideThe 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:

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.

6

7 5 3 1

4 2

These are possible connections for this kind of endoscope:

these connection are enough to flush all the inner channels of this kind of endoscope. In the case of the endoscope de-scribed 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 indi-vidual 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 accesso-ries basket. The two CISA connectors used in this place are the 033735 and the 03373554. These connectors can be applied to any of the tubes 4, 5, 6 and 7 in the cassette.

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.

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 0337353 or 0337356, depending on the model of the endoscope.

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 connec-tors of the cassette) this creates turbulence and high pressure inside the internal link between A and E.

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 con-nectors can be used in case they are needed and i the skill of the users is establish a different configuration for safe flushing.

AuxiliaryElevator0337369

Leak Test03377341

Injection (1)0337355

Injection (2)0337354

Bypass (1)0337353

Sanization0337357

All types and brands of endoscope connection adaptors are available with CISA storecase

Suction0337335

Bypass (2)0337356

Biopsy ValveCap (B)

Connector Plug (C)

Cylinder Plug (A)

Air Port (D)

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).

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 plugB : Biopsy valveC : Connector plugD : AirE : Suction channel.

These are all channels which can be potentially used for flushing the endoscope.

ERS Connector Guide

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ERS Endoscope Reprocessing and Storage System

11

Additional connectors that are not shown on the diagram but are necessary.

LEAK TEST: This plug (0337341) 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 0337357 along with the leak test connection (0337341 + 0337357).

ELEVATOR CHANNEL: See picture below.

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 0337369.

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 shar-ing a connection with any other channels. In this case, the connector that could be used is 0337369.

PLEASE NOTE: If an endoscope has both an ELEVATOR and an AUXILIARY channel it will be necessary to have two of these connectors.

ERS Connector Guide

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

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

Elevator-Wire Channel

Elevator

InletInlet

All duodenoscopes (plus some therapeutic gastroscopes) have an elevator-wire channel inlet above the suction valve.

Auxiliary-Water Inlet

Auxiliary-Water Inlet Cap

Some endoscopes have an auxiliary-water inlet light guide connector.

Auxiliary-Water Inlet

Auxiliary-Water Channel Nozzle

Nozzle

Auxiliary-Water Channel

Auxiliary-Water Inlet

Some endoscopes have an auxiliary-water inlet above the suction valve.

* ERS 1 = 1 storecase ERS 2 = 2 storecases

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CISA GROUP of companies & o� ce

CISA America Inc.618 SW 3rd ST SUITE 180Cape Coral - Florida - Zip Code 33991Tel + 1 239 673 7041Fax + 1 239673 7045e-mail: america.sales@cisagroup.net

CISA Brasile Ltda.Rua Dona Francisca, 8300Distrito Industrial - Bloco I - Módulo 2CEP 89239 - 270 - Joinville - SC BrasilTel + 55 47 3801 9090 Fax + 55 47 3801 9099e-mail: cisa@cisabrasile.com.brwww.cisabrasile.com.br

CISA in GermanySchlumbohm Medizin-Labor-Technologie GmbHGrenzkehre 1 D-21079 HamburgTel + 49 40 769 150 0Fax + 49 40 769 160 26e-mail: info@schlumbohm-medizintechnik.de

CISA in FranceLaboratoire Aldor Dechosal SasZI B des Forges - BP 3108320 Vireux MolhainTel + 33 03 24 41 81 81Fax + 33 03 24 41 85 75e-mail: aldor.dechosal@wanadoo.fr

CISA Venezuela C.A.Calle Los Laboratorios Edi� cio Keydex, Piso 2 Los Ruices, Caracas Telf/Fax: +58 (0) 212 232 9653latinamerica.sales@cisagroup.it

CISA South America O� ceBogota, ColombiaTel +57 317 432 8726e-mail: cesar.cardenas@cisagroup.it

CISA Asia O� ce190 Middle Road # 19 - 05 Fortune CenterSingapore 188979Tel + 65 6826 1065Fax + 65 6826 3373e-mail: asia.sales@cisagroup.it

CISA S.p.A. Produzione e Direzione GeneraleVia Pontina Km 2800040 - Pomezia - Roma - ItaliaTel + 39 06 9114371Fax + 39 06 9107565e-mail: coordination.sales@cisagroup.itwww.cisagroup.it

CISA Middle East LTDP.O. Box 3692 Amman 11821 JordanTel: +962 655 16 592Fax: +962 655 11 596e-mail: middleeast.sales@cisagroup.it

CISA in U.K. and Ireland BES Decon131 South Liberty LaneAshton Vale, Bristol BS3 2SZ, UKTel +44 1179 666 761Fax +44 1179 539 478e-mail: info@besbiz.eu.com

CISA India O� ceNew Delhi - IndiaTel + 91 9811 1838 39Fax + 91 124 4370 397e-mail: india.sales@cisagroup.it

CI SA Russia O� ce Dmitrovskoe shosse, 100, stroenie 2, corp. 3, o� .31116127247 Moscow - Russiatel. +7 495 5458361 fax.+7 495 781 6112e-mail: cisarussia@cisagroup.it

CISA Africa O� ce 92, Rue 18 Janvier 1952Tunis 1049Tel/Fax +216 71 341 176e-mail: lamine.ra� k@cisagroup.it

CISA NusantaraMalyzia, Indonesia, BrunaiLOT 19, Ground Floor, Jalan Industri 2/1Rawang Integrated Industrial Park48000 Rawang Selangor, MalaysiaPhone +60 (3) 6093 7851Fax +60 (3) 6093 6872

CISA in LibyaAbdallah Alghareeb streetMisrata, LibyaPhone +218 51 2618401Fax +218 51 2621240

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