Feel the innovation 0123

CISA Reprocessing Systems

Endoscope Reprocessing and Storage SystemERS

Feel the innovation

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

Ers 3

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 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.

ERS Endoscope Reprocessing System

Cleaning Bio Film removal

Rinse Using sterile water and sterile air

Processing Endoscope reprocessing with a log 7 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

Ers4

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

Sterile Air & water

Pre-Treatment and Treatment ChemicalsThe ERS System uses Proteazone-ERS manufactured to obtain proper cleaning (including removal of bio fi lm) and a cold sterilizing solution, Adaspor-ERS single shot for reaching greater than the high level of disinfection. Bacteriologically-fi ltered water (or external RO water) guarantees the quality of the fi nal rinse, while sterile compressed air dries the channels.

Cold sterilizing solution

Adazone (5,7-diphenyl-1,3

diazoadamantan-6-one)

g. 0,00045 - peracetic acid

g. 0,085 - coformulants

purifi ed 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

purifi ed H2Oat ml. 100

ERS Endoscope Reprocessing System

ERS - Biological Test

Air exchange fi lter (0.2 micron) for 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 buff er)

Water Filter 3 (0.1 micron)

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

BOX

Media

Clamp

Strip

Ers 5

ERS Endoscope Sterile Storage System

Storage and DryingThe ERS System is made up of two machines, the fi rst, 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 eff ective.The ESS will take up to six cassettes at a time: each one is monitored individu-ally 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 lifeThe ESS unit off ers sterile storage shelf life 72 hours without the need for re-processing. 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 savingAs 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 eff ective solution with cutting unnecessary reprocessing and chemical waste.

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

Visualize the temperature in Output.

Visualize the Inserted Store-Cases.

Visualize the pressure of the air in input.

Visualize the temperature in Input.

Total time of introduction of the Store-case in the ESS.

Pressure of the air in input of the Store-Cases.

Selection button to access the ordinary maintenance page.

Check LED of correct insertion of the Store-Case inside the ESS.

Lock/Unlock Store-Case button.

Back to the previous page.

Air temperature in output from the Store-Cases.

Ers6

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 cross-contaminated. 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 round-

ed 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 pro-vide 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 rele-vant data relating to the instrument inside, the operator, the reprocessing cycle em-ployed, 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.

SafetyThe 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 sat-isfy 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 ob-noxious: 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 endo-scopes. 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.

Ers 7

ERS Endoscope Reprocessing and Storage System

Management SystemThe 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 diff erent 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 on-line check-up and the remote maintenance.

Area Design - Pass ThroughPass through facilities are possibly designed to separate reprocessing area from storage area with airlock control.

MaintenanceThe 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 fi lters are easily replaceable using limited eff orts. Filters lifetime is controlled by executed cycle and monitor the change time touch screen.

Energy Saving And Economy UsingThe 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.

IndustrializationCisa’s prominent position on the market has allowed the company to develop suffi cient 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 Certifi catesThe ERS System is conform to the requirements of the Europeans standards ISO EN 15883-4 and to the standards 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 is conform to the normative ISO 14937 to the generic requirements for the characterization of the sterilizing agent as well as in compliance with the HTM 2030 generic requirements.

Ers8

ERS Connecting Guide

Connection GuideThe range of CISA connectors are made in way to cover the whole range of endoscopes from the main worldwide manufac-turer. The ERS machine and, in the specifi c, the STORE-CASE of the ERS system has a modelled shape in order to accept any kind of fl exible endoscope, even the one of new generation.The STORE-CASE has 7 connection inside that can be applied for the fl ushing of the endoscope. These connection are provided each of a silicon tube to which will be connected the actual endoscope fl ushing 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 fl ushing ELEVATOR channel of the endoscope. Otherwise dedicated to normal fl ushing.CHANNEL 2: Dedicated to leak test.CHANNEL 3-7: General fl ushing channel.

6

7 5 3 1

4 2

Biopsy ValveCap (B)

Connector Plug (C)

Cylinder Plug (A)

Air PipePort (D)

The Channel Plug (connections A & B) and Injection Tube (connections C, D & E) fl ush the standard air, water and suction channels only. They do not fl ush any special channels (e.g, auxiliary-water, elevator-wire).

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 confi guration.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.

These are all channels which can be potentially used for the inner fl ushing of the endoscope, we will take in consideration one of the many confi guration of washing available with this confi guration.

Ers 9

ERS Connecting Guide

Here the connection available 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 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 manufac-turer 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 0337355 and the 0337354. 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 0337356 or 0337353, 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 pres-sure 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.

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

Ers10

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

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

ELEVATOR CHANNEL: See picture below.

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 fl ushing is reduced if compared to the other general channels: an option in the ERS touchscreen is able to control the fl ushing pressure inside this channel in order to not occur in alarms of maximum pressure due to the eff orts that the pump is doing to fl ush this “semi-obstructed” channel.The elevator channel can be connected to the STORE-CASE with the connector 0337369.

AUXILIARY: See pictures below.In this two cases, when an AUXILIARY channel is present, is necessary to fl ush 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 0337369.

PLEASE NOTE: Obviously if an endoscope has both ELEVATOR and AUXILIARY channels is necessary to have two of these connection available.

ERS Connecting Guide

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

ERS Endoscope Reprocessing and Storage System

11

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

STORE CASE

Dimensions mm ( W x H x D ) 600 x 110 x 450

Weight Kg 4

Inside capacity litres 14,5

Ers 11

Endoscope transport trolley

* ERS 1 = 1 storecase ERS = 2 storecases

ERS

cata

logu

e - G

B - 0

4 C

ISA

rese

rves

the

right

of m

odifi

catio

ns w

ithou

t prio

r not

ice.

The

repr

oduc

tion

of th

is d

ocum

ent i

s al

low

ed if

exp

licitl

y au

thor

ised

by

Cisa

S.p

.A. o

nly.