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International Medical Service s.r.l.Via Laurentina, 169 - 00040 POMEZIA (RM) - ITALY

Tel +39 069145399 - Fax +39 069146099 www.imsonline.it - e-mail ims@imsonline.it

Distributed in ITALY - UK - USA :

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ENDOSCOPE REPROCESSING

AND STORING SYSTEM

E R S E N D O S C O P E R E P R O C E S S I N G A N D S T O R I N G S Y S T E M

0123

ENDOSCOPE REPROCESSING AND STORING SYSTEM

THE SYSTEM, ORIGINAL AND INNOVATIVE FOR THE TREATMENT, STERILIZATIONAND ASEPTIC PRESERVATION OF ENDOSCOPES AND MEDICAL DEVICES.

The crossed-contamination question in hospital field, becomes every day more important and binding. The HealtcareOrganization is investing a lot to reduce the risks of possible contaminations and to avoid development of hospitalinfections. The Endoscopy, nowadays very operative, is one of the procedures that needs safety both because of the daily numberof activities and the amount of expected re-utilization of the same device on the patient.To be able to guarantee the patients the utilization of endoscopical instruments adequately disinfected/sterilized is anirremissibly condition today. The technological search for the sterilization is in continuous evolution, this pertains the equipment and the chemicalagents. Having in mind this panoramic situation, the concept of a “modular system” ideally intended as an endoscopesreprocessing system in all its phases (including the storing in sterile condition until the next use) is very interesting:There was the needs of an innovative idea in order to make this process easy and repeatable.This idea, the focus of all the process, is revolutionaryand in the meantime very simple: a store-case, wherethe single endoscope inside will perform its pathtrough the sterilization process, the drying and thepreservation until next use.This is the idea that CISA, has released with aprogram of research and development that permittedthe realization of a system for detersion,decontamination, sterilization and asepticpreservation of flexibles and rigid endoscopes:

ERS, ”Endoscope Reprocessing and Storing System”

WORKING CYCLE

The ERS has been realized to reduce the time aboutthe detersion, decontamination and sterilization inonly 35 minutes.The distribution of the chemical solutions has beenstudied to guarantee the efficacy not only outside butalso inside all the inner channel that compose theendoscopes.A group of sensor guarantees for every channel theflow of the different liquids in the different phases.The asynchronous way to work of this machinepermits to sterilize two different store-casesindependently. The sterilization process works atenvironment temperature. The Store cases guaranteethe preservation and the aseptic transport of theinstruments.

TECHNICAL DATAS

STERILIZER

STORER

STORE CASE

Dimensions • mm ( W x H x D ) 1100 x 1700 x 750Weight • Kg 200Power supply • Volts 230 single phaseElectrical power • Watts 1000 Tapping • Model schuco 5 ampFrequency • Hz 50/60Cold water supply • DN 20 Water pressure • Bar 1 - 3 Compressed air • DN 8 Compressed air pressure • Bar 6 - 8 Drain • DN 32 Sound Level • dB. <53

Dimensions • mm ( W x H x D ) 1100 x 1700 x 750Weight • Kg 200Power supply • Volts 230 single phaseElectrical power • Watts 1000 Tapping • Modèle schuco 5 ampFrequency • Hz 50/60Compressed air • DN 8 Compressed air pressure • Bar 6 - 8 Sound Level • dB. <60

Dimensions • mm ( W x H x D ) 600 x 110 x 450Weight • Kg 4Composite material • Polycarbonate, Ultem 1000, MABS Inside capacity • litres 14,5

MAINTENANCE

ENERGY SAVING AND ECONOMY USING

The ERS System has been projected with a particularattention to energy consumption and for a low cost ofmanagement.Technical solution had also agree to CISA to reduces thewater consumption,necessary for the sterilization cycle.

INDUSTRIALIZATION

The main market position allowed to CISA the developingof every model so, a production in series.The assembling repetition and the industrialized product,insure a very good price/quality report.

QUALITY AND SAFETY CERTIFICATES

The ERS System is conform to the requirements of theEuropeans pre-standards pr EN 15883-1-4 and to thestandards EN 61010-1, EN 61010-2-045, EN60204-1 andto the standard ISO14937 for sterilizing agents.The machines are CE marked according to the Europeandirective CEE 93/42 for a medical devices.

The System has been studied to give to the operatora very easy access and maintenance.The components can be reached by the frontalaccess, that permitting the simple technicalassistance and the ordinary maintenance.For all the main components is expected aprogrammed and monitored maintenance by PLC.There is also an optional interface to make a remotemaintenance.

LEAK TEST Introduction of compressed air into the endoscope for the leak verification by active electronic sensorsfor all the cycle duration.

DECONTAMINATION Withdrawal of the pre-sterilizing chemical agent from the relative tank of dosage, loading of sterilewater in the store-case, detersion and decontamination with forced flow, draining of the solution andcleansing of inner channels with sterile compressed air.

STERILIZATION Dosage of the solutions to prepare of the sterilizing mixture, loading of sterile water, sterilization withforced flow, draining solution and cleansing the channels with sterile compressed air.The cycle is constantly monitored by electronic sensor.

RINSING Loading of sterile water in the Store-case, double rinsing with forced flow, draining of the residual andcleansing of the channels by sterile compressed air.

ALCOHOLIZATION Optional. Alcohol introduction in the channels by proportional pumps, sterile compressed airintroduction in the channels, and alcohol draining.

END CYCLE

The Machine executes all the cycle’s phases only when the safety conditions are satisfied.

TIPIC CYCLE:

The ERS System uses Proteazone solution manufactured to obtain a proper decontamination (removal of biofilm) and acold sterilizing solution, Adaspor single shot.The water bacteriologic-filtered guarantees the final rinse, while the sterile compressed air dries in the channels.

PRE-STERILIZING AND STERILIZING SOLUTIONS

Cold sterilizing solutionAdazone(5,7-diphenyl-1,3

diazoadamantan-6-one) g 0,00045 - peracetic acid g 0,085 -

coformulants purified H2O at ml. 100

ADASPOR ®ERSDecontaminating concentrate

Adazone L g. 2,50 -germicidalcomplex surfactant with linear

structure (R=C10:C14) g 60,50-coformulants and purified H2O at ml 100

PROTEAZONE ®

ADAZONE ®

The Store case is a real innovation in the ERS System.It allows without compromises the handling, preservation and management ofendoscopes, flexible or rigid, with any contamination of infection risks.The Store cases is made of a special material, no leak is guaranteed by a specialsilicon gaskets, the connection channels are sealed from external environmentthanks to auto-seal clutches, and they ensure always an endoscope ready touse.The material is plastic, light, resistant and transparent; is non-deformable, itsinner surface is also a smooth and rounded surface and therefore its perfectly drainable andcompatible with the adopted chemical solutions.Furthermore its inner shape and configuration make it perfectly compatible with every model of

endoscope. Obviously is guaranteed the hermetic tight and finally there is the presence of an innermicrochip were are contained all the information regarding the relevant data relatives to instrumentsinside, the operator, of the cicle etc. The electronic system makes sure the total traceability.

STORE CASE

EASY TO USE

The ERS System has been studied to have the easiest using,thanks to the operativity of the Store cases. The only manualoperation is to introduce the case into the machine, all theothers operation are automatic, even the channelconnection/disconnection. By the touch-screen, the operator isbrought to the machine use and he can check the cycle inprogress for both cases.

STORING AND DRYING

The ERS System is composed by two machines, the first designed todecontaminate and sterilize, while the second to the asepticpreservation of the endoscopes in the Store-cases.The model ESS (Storer) for the endoscopes preservation and thehumidity erasing, has a very important function, because it is easy andfast to use and has no long times to wait for.The Storer has been designed for the storage of 6 Store-cases: allconstantly monitored, blown by warm sterile air in all the inner channelsand on the external surface (sleeving) of the endoscope to remove anytrace of residual humidity and to greatly enlarge the time of theinstrument preservation after the treatment.

SAFETY

The sterilizing and preserving machines have been projected underevery safety criterion, so they have the necessary protections forthe patients , the operators, the instruments and the environment.The Endoscope Reprocessing and Storing System is a newgeneration equipment and satisfy every safety application.Thanks to the sterilization process, it guarantees the safety to thepatients with No-diffusion of infections.

The cycle is totally automatic and it doesn’t need any operatoraction. The operator has just to introduce the endoscope in theStore case, than the Store case in the machine.The sterilization process is guarantied by a cold steril solution,absolutely no toxic and no obnoxious : the “Adaspor ERS”. Thesystem doesn’t need any particular attention and there is no risk forthe medical staff about the chemical agents.The ERS System is compatible with high sensibility and highmaking criterion of endoscopes.There are many different safety devices to insure that every thing inthe machine is constantly monitored.Even the environment protection has been studied a lot: thechemical agents needed are absolutely no dangerous and nopolluting.

The ERS System is entirely checked by a PLC. The PLC has also an auto check-updevice to make sure the cycle data bank. This permits a very high quality control andthe evaluation error has reduced. An integrated printer makes a cycle data report,easy to reed.The touch-screen monitor, programmed with different languages, it guides theoperator to the correct use of the system. The system can be also connected to thesupervision network (Endo-Itineris) for the on-line check-up and the remotemaintenance.

MANAGEMENT SYSTEM