Abstract:
System for washing and sterilizing endoscopes provided with multiple channels held by a sheath, comprising a machine connected by means of multiple connectors provided with safety valves to at least one case with hermetic closure into which the endoscope is positioned, in which each of the channels of the endoscope is connected by means of a connector, the inner space of the case is connected to at least one additional connector, in such a way as to inject the washing and sterilization liquids and/or the gases for emptying the channels or drying, into each of the channels of the endoscope and into the space of the case, in which the case is also provided with an outlet connector for system circulation, in which the case is detached after the working cycle of the machine and its inner space remains in sterile conditions.

Description:
SEQUENCE LISTING 
     Not applicable. 
     CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application corresponds to Italian Patent Application No. RM2003A000570, filed on Dec. 10, 2003, and International PCT Application No. PCT/IT2004/000685, filed on Dec. 10, 2004, both of which are incorporated herein in their entirety. 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
     Not applicable. 
     INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
     Not applicable. 
     BACKGROUND 
     The invention relates to a system for washing, sterilising and preserving endoscopes. 
     Endoscopy is one of the medical-surgical specialisations with the greatest requirement for washing and sterilisation safety since, to perform the activity, the instrument is used on the human body and on different patients several times a day. 
     BRIEF SUMMARY 
     There is a strongly felt need to have a system for washing, sterilising and drying endoscopes that is fully automatic, has a work process of a short duration, does not damage the instruments (e.g. with high operating temperatures) is economical in use, complies with regulations, uses non hazardous substances, and allows to preserve sterility over time. Currently, in endoscopy wards, endoscopes are washed and disinfected manually or by means of apparatuses that do not provide all desired results. Hand-washing is performed by operators using special mechanical tools and detergent soaps, which allow to remove deposits from the surface of the endoscope. Once it is washed, the endoscope is disinfected by immersion in a disinfecting chemical solution, then rinsed with demineralised water before being reused. 
     This process offers no guarantees at all, since disinfection is not total, and there is no certainty that both the outer surface and the inner tubes are in contact with the disinfection solution. Another problem is time: obtaining a satisfactory result requires over one hour, with the consequent reduction in the use of the instrument and hence of productivity. From this follows the need to have a high number of endoscopes available and, in view of the high purchase cost, to take into account considerable depreciation with respect to the fees paid by the national health care system for each endoscopic visit. Moreover, without a protective package, it is not possible to maintain the instrument washed and disinfected until its subsequent use. This is a very important limitation for safety and use of the instruments on the human body. 
     A more modern and effective method for washing and disinfecting endoscopes provides for the use of apparatuses that allow to perform the operations automatically, with results that are more certain and repeatable over time. 
     These apparatuses are studied and built to perform automatically, on one or more endoscopes, a complete washing and disinfecting treatment, assuring a satisfactory cleanliness result and a correct level of reduction of the microbe charge. Even when using such apparatuses, it is necessary to perform some preliminary operations manually in order roughly to eliminate residues from the surface of the instruments and reduce the level of the deposits to an acceptable and constant value. The limits of the apparatuses currently available on the market relate to the fact that they do not achieve sterilisation and hence the total elimination of living forms, and they do not allow to preserve the instruments under sterile conditions. 
     On the market, there are several manufacturers that produce such apparatuses at different levels of quality, automation and safety such as: Wassenburg, Medivators, Olympus, Belimed. There are also apparatuses that allow only to sterilise, and preserve the endoscopes, but are not capable of washing them. The authors of the invention have provided an automatic machine for washing, disinfecting and/or sterilising, testing the integrity of, and preserving surgical instruments such as flexible endoscopes. The machine is able to complete the entire cycle in about 30 minutes at low temperatures. Moreover, the machine performs the cycle in detachable cases, suitable for stowing in cabinets, which maintain the instruments in sterile environments until use. 
     The machine of the invention is particularly advantageous when using cold sterilising solutions, such as the one described in EP 1.059.292. However, it is readily apparent to those skilled in the art that any cold sterilising solution can be used. 
     Therefore, an object of the invention is to provide a system for washing and sterilising endoscopes provided with multiple channels held by a sheath, comprising a machine connected by means of multiple connectors fitted with safety valves to at least one case with hermetic closure into which the endoscope is placed, in which each of the channels of the endoscope is connected by means of a connector, the inner space of the case is connected to at least one additional connector, in such a way as to inject the washing and sterilisation liquids and/or the gases for emptying the channels or drying, into each of the channels of the endoscope and in the space of the case, in which the case is further provided with an outlet connector for the circulation of the system, in which the case is detached after the working cycle of the machine and its inner space remains in sterile conditions. 
     Preferably, the machine is provided with an additional connector able to inject sterile air into the region of the endoscope inside the sheath to verify its tightness. 
     Preferably, the machine is connected to more than one case and it is able to perform separate cycles for each case. 
     An additional object of the invention is to provide a machine for washing and sterilising surgical instruments with multiple compartments provided with means for the controlled injection under pressure of washing and sterilising liquids and of drying or tightness verifying gases, into each of the compartments of the instrument to be sterilised. 
     A further object of the invention is to provide a case with hermetic closure for housing an endoscope, to be connected to a washing and sterilising machine, provided with one connector for each channel of the endoscope, with a further connector for the region inside the sheath of the endoscope, and with at least two additional connectors for the space of the case. 
     Another object of the invention is to provide a method for washing and cold sterilising endoscopes provided with multiple channels held by a sheath, in a continuous and automatic cycle comprising the steps of:
         a) conducting a tightness test on the sheath of the endoscope by injecting sterile air into the region underlying it;   b) washing, introducing appropriate detergents at ambient temperature, into each channel of the endoscope, for appropriate time intervals;   c) rinsing, introducing water into each channel of the endoscope;   d) sterilising, introducing appropriate sterilising compounds at ambient temperature, into each channel of the endoscope, for appropriate time intervals;   e) rinsing, introducing sterile water into each channel of the endoscope;   f) drying, introducing sterile gases into each channel of the endoscope;       

    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
       The invention shall now be described in its preferred but not limiting embodiments with reference to the following figures: 
         FIG. 1  is a front external perspective view of an embodiment of the machine of the invention; 
         FIG. 1   a  is a front internal perspective view that highlights the containers of the chemical additives, the tanks and the dosing pumps; 
         FIG. 2  is a rear internal perspective view that highlights the filters and the water pumps, the air filter and the level tanks of the water; 
         FIG. 3  is the same rear internal perspective view of  FIG. 2  which highlights two series of pumps for injecting liquids into the sterilisation cases; 
         FIG. 4  is a front view; 
         FIG. 5  is a lateral view (technical compartment side); 
         FIG. 6  is a rear view; 
         FIG. 7  is a detail of the dosing assembly of  FIGS. 4 and 5 ; 
         FIG. 8  is a detail of the circuit for injecting liquids and air into the sterilisation cases by means of the connectors; 
         FIG. 9  is a rear view of the sterilisation case  12  which highlights the connectors; 
         FIG. 10  is a top view of the sterilisation case  12 ; 
         FIG. 11  shows the part of the hydraulic diagram of an embodiment of the machine according to the invention comprising the common circuit and the circuit dedicated to the sterilisation case  12 ; 
         FIG. 12  shows the part of the hydraulic diagram of an embodiment of the machine according to the invention comprising the circuit dedicated to the sterilisation case  12 . 
         FIG. 13  is a rear view of the sterilisation case  28  which highlights the connectors; 
         FIG. 14  is a side view of the sterilisation case  28 ; 
         FIG. 15  is a top view of the sterilisation case  28 ; 
         FIG. 16  shows the part of the hydraulic diagram of an embodiment of the machine according to the invention comprising the common circuit and the circuit dedicated to the sterilisation case  28 ; 
         FIG. 17  shows the part of the hydraulic diagram of an embodiment of the machine according to the invention comprising the circuit dedicated to the sterilisation case  28 . 
     
    
    
     DETAILED DESCRIPTION 
     Machine for Washing and Sterilising Endoscopes as Shown in  FIGS. 1-8 , and  11 - 12   
     The washing and sterilising machine  10  is provided with two compartments  11   a  and  11   b  easily accessible from the front part to allow the introduction of the cases  12  in a simple and safe manner, and to allow an easy coupling of the quick sanitary connections for connecting the channels. The compartments  11   a  and  11   b  are provided with guides to favour the sliding of the cases  12 . The machine  10  is provided with a lower compartment  15  with an access door  16  for housing the containers of the liquids for washing  17   a , for sterilising  17   b  and  17   c , and for alcoholising  17   d . The compartment  15  also houses the water filters FA 6 , FA 2  and FA 1  and the water pumps MP- 1 , MP- 2 , respectively for the circuits that serve the compartment  11   a  and  11   b.    
     The machine  10  is also provided with an upper compartment  18  provided with door  19 , which houses:
         the pumps from PP 1 - 1  to PP 6 - 1  for the compartment  11   a  and from PP 1 - 2  to PP 6 - 2  for the compartment  11   b;      the pressure sensors from TP 1 - 1  to TP 6 - 1 ; from TP 1 - 2  to TP 6 - 2 ;   the check valves for compressed air from NR 1 - 1  to NR 6 - 1 , and from NR 1 - 2  to NR 6 - 2 ;   a compressed air filter FA 3 ;   an intake air filter FA 4 ;   two case level tanks  20   a  and  20   b , respectively for the cases housed in the compartments  11   a  and  11   b.          

     Hydraulic system: it is constructed with pipelines and components (retaining valves, union fittings, etc.) of AISI 316 stainless steel. The pipelines are distinguished with conventional colours of the fluids and insulated with special silicone and Kevlar sheath to reduce thermal dispersion in the environment. All fluid inlets and the discharge are arranged in series and the connection is through flexible hoses. For each compartment  11   a  and  11   b  and hence for each case  12  a completely separate system is provided to allow treating two endoscopes at the same time. The diagram of the separate system for each case  12  is shown in  FIG. 12 . 
     The diagram shown in  FIG. 11  shows the set of the separate system for a case  12  and of the common parts of the hydraulic circuit which are shared between the separate circuits of the cases  12 . The used codes are described in the following table 1. 
     
       
         
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                 Code 
                 Description 
                 Notes 
               
               
                   
               
             
             
               
                   
                 PV1-1 
                 Sterile water 
                 Electr. + valve 
               
               
                   
                 PV2-1 
                 Alcohol 
                 ″ 
               
               
                   
                 PV3-1 
                 Channel Pumps H 2 O Inlet 
                 ″ 
               
               
                   
                 PV4-1 
                 Quick discharge 
                 ″ 
               
               
                   
                 PV5-1 
                 Discharge 
                 ″ 
               
               
                   
                 PV6-1 
                 Washing 
                 ″ 
               
               
                   
                 PV7-1 
                 Battery air intake 
                 ″ 
               
               
                   
                 PV8-1 
                 Pressure tightness test 
                 ″ 
               
               
                   
                 PV9-1 
                 Tightness Test Vent 
                 ″ 
               
               
                   
                 PV10-1 
                 Compressed air 
                 ″ 
               
               
                   
                 PV11-1 
                 Water recirculation 
                 ″ 
               
               
                   
                 PV12-1 
                 Water filter 
                 ″ 
               
               
                   
                   
                 sterilisation 
                   
               
               
                   
                 PV13-1 
                 Compressed air line 
                 ″ 
               
               
                   
                   
                 sterilisation 
                   
               
               
                   
                 MP-1 
                 Pump 
                 Water pump 
               
               
                   
                 PP1-1 
                 Peristaltic pump 1 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP2-1 
                 Peristaltic pump 2 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP3-1 
                 Peristaltic pump 3 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP4-1 
                 Peristaltic pump 4 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP5-1 
                 Peristaltic pump 5 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP6-1 
                 Peristaltic pump 6 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PD1-1 
                 Adazone dosing pump 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PD2-1 
                 Proteazone dosing pump 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 CA-1 
                 Engagement cylinder 
                 Cylinder 
               
               
                   
                 PP7 
                 Per. loading pump C1 
                 Per. Pump 
               
               
                   
                 PP8 
                 Per. Loading pump from C1 
                 ″ 
               
               
                   
                   
                 to C2 
                   
               
               
                   
                 PP9 
                 Per. Loading pump C2 
                 ″ 
               
               
                   
                 PP10 
                 Per. Loading pump C3 
                 ″ 
               
               
                   
                 MC 
                 Membrane compressor 
                 Air pump 
               
               
                   
                 TP1-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 1 
                 Transducer 
               
               
                   
                 TP2-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 2 
                 Transducer 
               
               
                   
                 TP3-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 3 
                 Transducer 
               
               
                   
                 TP4-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 4 
                 Transducer 
               
               
                   
                 TP5-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 5 
                 Transducer 
               
               
                   
                 TP6-1 
                 Peristaltic Pump Pressure 
                 0 −2 Bar 
               
               
                   
                   
                 Transducer 6 
                 Transducer 
               
               
                   
                 TP7-1 
                 Tightness test pressure 
                 Transducer 
               
               
                   
                   
                 transducer 
                   
               
               
                   
                 SL5-1 
                 Water level 
                 Level sensor 
               
               
                   
                 SL6-1 
                 Water level 
                 Level sensor 
               
               
                   
                 SP-1 
                 Pump manostat 
                 Manostat 
               
               
                   
                 SQ1-1 
                 Inserted drawer end stop 
                 End stop 
               
               
                   
                 SL1 
                 Additive 1 level (per 
                 Asp. nozzle + sens. 
               
               
                   
                   
                 acetic A.) 
                   
               
               
                   
                 SL2 
                 Additive 2 level 
                 ″ 
               
               
                   
                   
                 (Adazone) 
                   
               
               
                   
                 SL3 
                 Additive 3 level 
                 ″ 
               
               
                   
                   
                 (Proteazone) 
                   
               
               
                   
                 SL4 
                 Additive 4 level 
                 ″ 
               
               
                   
                   
                 (alcohol) 
                   
               
               
                   
                 LE1 
                 Electronic level probe 
                   
               
               
                   
                 LE2 
                 Electronic level probe 
                   
               
               
                   
                 LE3 
                 Electronic level probe 
                   
               
               
                   
                 LE4 
                 Electronic level probe 
                   
               
               
                   
                 LE5 
                 Electronic level probe 
                   
               
               
                   
                 LE6 
                 Electronic level probe 
                   
               
               
                   
                 FA1 
                 0.45 water pre-filter 
                   
               
               
                   
                 FA2 
                 0.2 water filter 
                   
               
               
                   
                 FA3 
                 0.2 compressed air filter 
                   
               
               
                   
                 FA4 
                 0.2 intake filter 
                   
               
               
                   
                 FA5 
                 Test compressed air 
                   
               
               
                   
                   
                 filter 
                   
               
               
                   
                 FA6 
                 1.00 water pre-filter 
                   
               
               
                   
                 NR1-1 to 
                 Channel compressed air 
                   
               
               
                   
                 NR6-1 
                 check valve 
                   
               
               
                   
                 NR9 
                 Water line check valve 
                   
               
               
                   
                 IR1-1 to 
                 Container quick coupling 
                   
               
               
                   
                 IR16-1 
                 fittings 
                   
               
               
                   
                 SR1-1 
                 Test compressed air tank 
                   
               
               
                   
                 FLV1-1 
                 Chamber flow regulator 
                   
               
               
                   
                 FLV2 
                 Discharge flow regulator 
                   
               
               
                   
                 SS1 
                 Compressed air safety 
                   
               
               
                   
                   
                 valve 
                   
               
               
                   
                 SS2 
                 Test compressed air 
                   
               
               
                   
                   
                 safety valve 
                   
               
               
                   
                 SS3-1 
                 Water loop safety valve 
                   
               
               
                   
                 RA2 
                 Compressed air reducer 
               
               
                   
               
             
          
         
       
     
     The points A, B, C, D, E, F, G and H shown in  FIGS. 11 and 12  are the connecting points between the two hydraulic diagrams. 
     The machine  10  is adapted to be connected and hence use cold water and compressed air. The water loop has a system NR 9  which prevents the water from flowing back and hence the risk of pollution in the line. The water, flowing into the machine  10 , is filtered by means of  10  the filters FA 6 , FA 1  and FA 2  arranged in series. A loop is provided for sterilising the filter FA 2  through the valve PV 12 . Also provided is a device for safely controlling the level of the water SL 5 - 1 , SL 6 - 1  for the case housed in the compartment  11   a , and SL 5 - 2 , SL 6 - 2  for the one housed in the compartment  11   b , to allow its automatic loading in sufficient quantities to assure its correct and total filling. For each inlet channels of the liquids of the case  12  are provided the pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1 , (compartment  11   a ) and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  (compartment  11   b ), appropriately dimensioned, complete with related devices TP 1 - 1 , TP 2 - 1 , TP 3 - 1 , TP 4 - 1 , TP 5 - 1 , TP 6 - 1  and TP 1 - 2 , TP 2 - 2 , TP 3 - 2 , TP 4 - 2 , TP 5 - 2 , TP 6 - 2  for safely controlling their functionality, which circulate the liquids in constant and continuous fashion to assure contact with the interior and exterior surface of the channels of the endoscope. 
     The liquids are discharged by means of the same pumps as the inlet channels of the liquids, in such a way as to assure their complete elimination. 
     Electrical System: 
     it is built inside the machine and in compliance with current applicable European and Italian regulations. All electrical components, with the exception of command and control components, which are conveniently located in the front, are mounted connected to a terminal board and enclosed in an electrical panel  13  with degree of protection IP55 which in turn is positioned inside the apparatus  10 , in a compartment  21  provided with door  22 . 
     The control panel  14  is installed on the front of the apparatus  10 , has an internal degree of protection IP54 and external degree of protection IP22 and provides all components for its command and control. 
     Drying Device: 
     a final drying step is provided with the removal of the residual water drops. A unit operating with sterile compressed air and complete with filter FA 3  allows to eliminate the residual drops present in the channels of the endoscope and inside the case  12 . A safety device SS 1  protects the instruments against overpressures. 
     Dosing Device: 
     The chemical additives which favour the washing and sterilising of the instruments are added to the water by means of four dosing pumps PD 1 - 1 , PD 2 - 1 , PD 1 - 2  and PD 2 - 2  which draw the liquid directly from the tanks C 2  and C 3 . 
     The very low delivery of the dosing pumps PD 1 - 1 , PD 2 - 1  and PD 1 - 2 , PD 2 - 2  and the control of the dosage by means of the measuring devices LE 1 , LE 2 , LE 3 , LE 4 , LE 5  and LE 6  of the tanks C 1 , C 2  and C 3 , allow to optimise the quantities of additives added to the water and to reduce their consumption. A level control SL 1 , SL 2 , SL 3  and SL 4  is provided for each container  17   a ,  17   b ,  17   c  and  17   d  of chemical additives and the presence of additive is indicated until the container is completely emptied. The additive is injected into the circuit gradually and it enters the case  12  already mixed to prevent it from coming in contact with the instrument yet concentrated. The additives which are added are: detergent, steriliser (adazone+peracetic acid) and alcohol. 
     Safety Device: 
     The machine  10  is provided with safety devices which make it extremely reliable, such as:
         device against the extraction of the case  12  during the execution of the cycle;   device for controlling the overpressure of compressed air SS 1  and SS 2  and of water SS 3 - 1  and SS 3 - 2 ;   device against the injection of water into the case  12  if the connection with the couplings did not take place;   magneto-thermal breakers to protect the motors;   fuse and electric protection on the auxiliaries of the electrical system;   short circuit and overheating protection (magneto-thermal breaker);   emergency mushroom head push-button for arresting all functions of the machine (returning to stand-by with the rotation of said push-button and restarting the cycle functionality with a new start command);   disengagement micro-switches on the electrical power panel;   emergency push-button positioned on the control panel for immediately arresting the operation;       

     Management System: 
     The machine  10  is fully controlled with programmable logic electronic systems which allow to manage the cycles, control the parameters and verify process safeties. The management system has the following characteristics:
         absolute simplicity and clarity in the information provided, both on monitor and on printer, without use of codes but with clear messages, thanks to the use of a “touch-screen” interactive system, thus requiring no personnel with machine language knowledge;   the programs required for washing are inserted in stable memories (EEPROM) in the machine at the time of delivery and therefore are indelible;   standard cycles are selectable from the “touch-screen”, selecting the cycles page on the menu; the cycles page shows the push-buttons of the executable cycles and, once the one for the selected cycle is pressed, starting authorisation is given, after confirming by pressing START; however new cycles can be programmed through the keyboard by setting their parameters;   the control system is provided with help pages which guide the operator, step by step, to use and learn the standard cycles and the new cycles. Access to the programming of new cycles requires knowledge of an “access key”.       

     Description of the Control Device: 
     The system comprises two devices, one (PLC) for controlling and the other one for verifying functionality and safety (W.D.). The two devices are installed aboard the machine inside the electrical panel  13 . A third operator interface device is installed on the control panel  14 . 
     The basic apparatus is constituted by a programmable electronic controller, comprising:
         power supply device, appropriately dimensioned for any subsequent expansions of the control boards;   PCU board with 7.2K of program memory and 6 K of data memory with 1.0 ms watchdog time;   memory card, complete with 8 KWORD EEPROM memory;   capability for remote connection with an external memory (RS232C serial output);   control boards, each for 16 digital outputs and 16 digital inputs, with connector connection, and for 4 analogue inputs 4-20 mA and 2 analogue outputs 4-20 mA;   data BACKUP battery, with a 10-year duration.       

     Apparatus Regulation System: 
     Managed by a programmable electronic controller, which in turn is verified for its integrity by an external device to have a confirmation on the correct performance of the cycle (W.D.). 
     The controller manages the recording of the data on the printer. 
     The process control system receives analogue signals from the measuring sensors and reports the value displayed on the “touch-screen” with real time updates. 
     The system is capable of self-diagnosis. 
     Programs can be freely set by the user through the “touch-screen” and, after a program is completely set, it can be executed automatically and remain available for repeated calls for execution. A 24 column alphanumeric printer records the documentation of the messages, of the parameters and of the regular performance of the cycles. 
     Safety and alarm systems of the programmable electronic controller are also provided at different levels, e.g.:
         indications which intervene during the execution of the cycle, before or after the cycle, but do not modify the execution of the cycle;   indications of alarm for non severe anomalies, with visual and acoustic signal, which recall the operator&#39;s attention, but without intervening in the execution of the cycle;   indications of alarm with visual and acoustic signal which intervene for sever anomalies and which modify the behaviour of the cycle even so far as to block it.
 
Case
       

     As shown in  FIGS. 9 to 10 , the case  12  is built to assure the effectiveness of the treatment of the instrument and its preservation in a sterile environment. For this reason it has the following requirements: it is made of plastic material; it is light, strong and non deformable; it can be drained perfectly; its inner surface is rounded and smooth; it is compatible with its intended use; it has a sanitary construction; it is resistant to the substances used for the treatment; it has an inner shape that is suitable to house all the endoscopes by the different manufacturers; it is hermetically sealed by means of closures  23 ; its inner space is right for the endoscope and its capacity in liters is minimal; it is easily transportable with a handle  24 ; it has a display where the data of the content can be shown; it has the capability of maintaining the content sterile; it has quick couplings for connection to the washing and sterilising machine,  25   a - f  for the channels of the endoscope,  25   g  for the tightness test, and  26   a  and  26   b  for injecting and discharging the liquid in the inner space of the case  12 . 
     Drying Cabinet 
     The drying cabinet has the function of drying the endoscope and preserving it in a sterile environment. Drying is achieved by safely heating the air that is injected into the channels of the endoscope inside the case by means of the connectors. 
     Work Cycle 
     The sequence of the various steps of the cycle is subordinated to the achievement of the specified conditions and of the set parameters. The steps are as follows: 
     Tightness Test: 
     Injection of compressed air into the sheath of the endoscope by means of the air pump MC and test of the pressure drop by means of pressure sensor TP 7 - 1  and TP 7 - 2 . The injected air is filtered by the filter FA 5 . 
     Washing: 
     Injection of the detergent into the dosage tank C 3  through the pump PP 10  with dosage control through the measuring devices LE 5  and LE 6 ; loading the sterile water with the related detergent into the case  12  by means of the pumps MP- 1 , PD 2 - 1  and MP- 2 , PD 2 - 2 ; forced washing with the circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  for a time interval that depends on the detergent in use; discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning of the channels with compressed air filtered by the filter FA 3 . 
     Rinsing: 
     Loading sterile air into the case  12  by means of the pumps MP- 1  and MP- 2 ; forced rinsing with circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; discharging through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by the filter FA 3 . 
     Sterilisation: 
     Preparation of the dosage of the peracetic acid and adazone (or of another sterilising compound) according to the following steps:
         injection of the peracetic acid into the dosage tank C 1  by means of the pump PP 7 , with dosage control by means of the measuring devices LE 1  and LE 2 ;   transferring the content of the dosage tank C 1  into the dosage tank C 2  by means of the pump PP 8 ;   injection of the adazone into the dosage tank C 2  by means of the pump PP 9 , with dosage control by means of the measuring devices LE 3  and LE 4 ;
 
loading sterile water with the related sterilising compound into the case  12  by means of the pumps MP- 1 , PD 1 - 1  and MP- 2 , PD 1 - 2 ; forced washing with the circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  for a time interval from 10 minutes to 40 minutes, variable according to the sterilising compound in use (sterilisation); discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by means of the filter FA 3 .
       

     Rinsing: 
     Loading sterile water into the case  12  by means of the pump MP- 1  and MP- 2 ; forced rinsing with circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by means of the filter FA 3 . 
     Alcoholisation: 
     Injection of alcohol into the channels through valve PV 2 - 1  and PV 2 - 2  by means of the pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; injection of compressed air filtered by means of the filter FA 3  into the channel and dilution of the alcohol; discharge of the residual solution. 
     Drying: 
     Drying takes place at the end of the cycle, preferably with injection of sterile air into the case and into the channels, but it can also be conducted subsequently in proper drying cabinet. 
     Description of the Apparatuses Machine for Washing and Sterilising Endoscopes as Shown in  FIGS. 1-8 , and  16 - 17   
     The washing and sterilising machine  10  is provided with two compartments  11   a  and  11   b  easily accessible from the front part to allow the introduction of the cases  28  in a simple and safe manner, and to allow an easy coupling of the quick sanitary connections for connecting the channels. The compartments  11   a  and  11   b  are provided with guides to favour the sliding of the cases  28 . The machine  10  is provided with a lower compartment  15  with an access door  16  for housing the containers of the liquids for washing  17   a , for sterilising  17   b  and  17   c , and for alcoholising  17   d . The compartment  15  also houses the water filters FA 6 , FA 2  and FA 1  and the water pumps MP- 1 , MP- 2 , respectively for the circuits that serve the compartment  11   a  and  11   b.    
     The machine  10  is also provided with an upper compartment  18  provided with door  19 , which houses: the pumps from PP 1 - 1  to PP 6 - 1  for the compartment  11   a  and from PP 1 - 2  to PP 6 - 2  for the compartment  11   b;  
         the pressure sensors from TP 1 - 1  to TP 6 - 1 ; from TP 1 - 2  to TP 6 - 2 ;   the check valves for compressed air from NR 1 - 1  to NR 6 - 1 , and from NR 1 - 2  to NR 6 - 2 ;   a compressed air filter FA 3 ;   an intake air filter FA 4 ;   two case level tanks  20   a  and  20   b , respectively for the cases housed in the compartments  11   a  and  11   b.          

     Hydraulic System: 
     It is constructed with pipelines and components (retaining valves, union fittings, etc.) of AISI 316 stainless steel. The pipelines are distinguished with conventional colours of the fluids and insulated with special silicone and Kevlar sheath to reduce thermal dispersion in the environment. All fluid inlets and the discharge are arranged in series and the connection is through flexible hoses. For each compartment  11   a  and  11   b  and hence for each case  28  a completely separate system is provided to allow treating two endoscopes at the same time. The diagram of the separate system for each case  28  is shown in  FIG. 17 . 
     The diagram shown in  FIG. 16  shows the set of the separate system for a case  28  and of the common parts of the hydraulic circuit which are shared between the separate circuits of the cases  28 . The used codes are described in the following table 2. 
     
       
         
               
               
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                   
                 Code 
                 Description 
                 Notes 
               
               
                   
               
             
             
               
                   
                 PV1-1 
                 Sterile water 
                 Electr. + valve 
               
               
                   
                 PV2-1 
                 Alcohol 
                 ″ 
               
               
                   
                 PV3-1 
                 Channel Pumps H 2 O Inlet 
                 ″ 
               
               
                   
                 PV4 
                 Sterilisation filter H 2 O 
                 ″ 
               
               
                   
                   
                 Inlet 
                   
               
               
                   
                 PV5-1 
                 Discharge 
                 ″ 
               
               
                   
                 PV6-1 
                 Washing 
                 ″ 
               
               
                   
                 PV8-1 
                 Pressure tightness test 
                 ″ 
               
               
                   
                 PV9-1 
                 Tightness Test Vent 
                 ″ 
               
               
                   
                 PV10-1 
                 Compressed air 
                 ″ 
               
               
                   
                 PV11-1 
                 Water recirculation 
                 ″ 
               
               
                   
                 PV12 
                 Sterilisation filter H 2 O 
                 ″ 
               
               
                   
                   
                 Outlet 
                   
               
               
                   
                 PV13-1 
                 Compressed air line 
                 ″ 
               
               
                   
                   
                 sterilisation 
                   
               
               
                   
                 PV14 
                 H 2 O Inlet 
                 ″ 
               
               
                   
                 MP-1 
                 Pump 
                 Water pump 
               
               
                   
                 PP1-1 
                 Peristaltic pump 1 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP2-1 
                 Peristaltic pump 2 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP3-1 
                 Peristaltic pump 3 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP4-1 
                 Peristaltic pump 4 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP5-1 
                 Peristaltic pump 5 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PP6-1 
                 Peristaltic pump 6 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PD1-1 
                 Adaz. dosing pump 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PD2-1 
                 Proteazone dosing pump 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 PD3-1 
                 Peracetic A. dosing pump 
                 Peristaltic 
               
               
                   
                   
                   
                 pump 
               
               
                   
                 CA-1 
                 Engagement cylinder 
                 Cylinder 
               
               
                   
                 PP7 
                 Per. loading pump C1 
                 Per. Pump 
               
               
                   
                 PP9 
                 Per. Loading pump C2 
                 ″ 
               
               
                   
                 PP10 
                 Per. Loading pump C3 
                 ″ 
               
               
                   
                 MC 
                 Membrane compressor 
                 Air pump 
               
               
                   
                 TP1-1 
                 Peristaltic Transducer 1 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP2-1 
                 Peristaltic Transducer 2 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP3-1 
                 Peristaltic Transducer 3 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP4-1 
                 Peristaltic Transducer 4 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP5-1 
                 Peristaltic Transducer 5 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP6-1 
                 Peristaltic Transducer 6 
                 0 −2 Bar 
               
               
                   
                   
                   
                 Transducer 
               
               
                   
                 TP7-1 
                 Tightness test pressure 
                 Transducer 
               
               
                   
                   
                 transducer 
                   
               
               
                   
                 TP8-1 
                 Pump pressure transducer 
                 Transducer 
               
               
                   
                 SL5-1 
                 Water level 
                 Level sensor 
               
               
                   
                 SL6-1 
                 Water level 
                 Level sensor 
               
               
                   
                 SQ1-1 
                 Inserted drawer end stop 
                 End stop 
               
               
                   
                 SL1 
                 Additive 1 level (per 
                 Asp. nozzle + sens. 
               
               
                   
                   
                 acetic A.) 
                   
               
               
                   
                 SL2 
                 Additive 2 level 
                 ″ 
               
               
                   
                   
                 (Adazone) 
                   
               
               
                   
                 SL3 
                 Additive 3 level 
                 ″ 
               
               
                   
                   
                 (Proteazone) 
                   
               
               
                   
                 SL4 
                 Additive 4 level 
                 ″ 
               
               
                   
                   
                 (alcohol) 
                   
               
               
                   
                 LE1 
                 Electronic level probe 
                   
               
               
                   
                 LE2 
                 Electronic level probe 
                   
               
               
                   
                 LE3 
                 Electronic level probe 
                   
               
               
                   
                 LE4 
                 Electronic level probe 
                   
               
               
                   
                 LE5 
                 Electronic level probe 
                   
               
               
                   
                 LE6 
                 Electronic level probe 
                   
               
               
                   
                 FA1 
                 0.45 water pre-filter 
                   
               
               
                   
                 FA2 
                 0.2 water filter 
                   
               
               
                   
                 FA3 
                 0.2 compressed air filter 
                   
               
               
                   
                 FA4 
                 0.2 intake filter 
                   
               
               
                   
                 FA5 
                 Test compressed air 
                   
               
               
                   
                   
                 filter 
                   
               
               
                   
                 FA6 
                 1.00 water pre-filter 
                   
               
               
                   
                 NR1-1 to 
                 Channel compressed air 
                   
               
               
                   
                 NR6-1 
                 check valve 
                   
               
               
                   
                 NR7-1 
                 Adazone check valve 
                   
               
               
                   
                 NR8-1 
                 Proteazone check valve 
                   
               
               
                   
                 NR9-1 
                 Perecetic A. check valve 
                   
               
               
                   
                 IR1-1 to 
                 Container quick coupling 
                   
               
               
                   
                 IR17-1 
                 fittings 
                   
               
               
                   
                 SR1-1 
                 Test compressed air tank 
                   
               
               
                   
                 FLV1-1 
                 Chamber flow regulator 
                   
               
               
                   
                 FLV2 
                 Discharge flow regulator 
                   
               
               
                   
                 SS1 
                 Compressed air safety 
                   
               
               
                   
                   
                 valve 
                   
               
               
                   
                 SS2 
                 Test compressed air 
                   
               
               
                   
                   
                 safety valve 
                   
               
               
                   
                 SS3-1 
                 Water loop safety valve 
                   
               
               
                   
                 RA2 
                 Compressed air reducer 
               
               
                   
               
             
          
         
       
     
     The points A, B, C, D, E, F, G, H and J shown in  FIGS. 16 and 17  are the connecting points between the two hydraulic diagrams. 
     The machine  10  is adapted to be connected and hence use cold water and compressed air. The water, flowing into the machine  10 , is filtered by means of the filters FA 6 , FA 1  and FA 2  arranged in series. A loop is provided for sterilising the filter FA 2  through the valve PV 4  and PV 12 . Also provided is a device for safely controlling the level of the water SL 5 - 1 , SL 6 - 1  for the case housed in the compartment  11   a , and SL 5 - 2 , SL 6 - 2  for the one housed in the compartment  11   b , to allow its automatic loading in sufficient quantities to assure its correct and total filling. For each inlet channels of the liquids of the case  28  are provided the pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1 , (compartment  11   a ) and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  (compartment  11   b ), appropriately dimensioned, complete with related devices TP 1 - 1 , TP 2 - 1 , TP 3 - 1 , TP 4 - 1 , TP 5 - 1 , TP 6 - 1  and TP 1 - 2 , TP 2 - 2 , TP 3 - 2 , TP 4 - 2 , TP 5 - 2 , TP 6 - 2  for safely controlling their functionality, which circulate the liquids in constant and continuous fashion to assure contact with the interior and exterior surface of the channels of the endoscope. 
     The liquids are discharged by means of the same pumps as the inlet channels of the liquids, in such a way as to assure their complete elimination. 
     Electrical System: 
     It is built inside the machine and in compliance with current applicable European and Italian regulations. All electrical components, with the exception of command and control components, which are conveniently located in the front, are mounted connected to a terminal board and enclosed in an electrical panel  13  with degree of protection IP55 which in turn is positioned inside the apparatus  10 , in a compartment  21  provided with door  22 . 
     The control panel  14  is installed on the front of the apparatus  10 , has an internal degree of protection IP54 and external degree of protection IP22 and provides all components for its command and control. 
     Drying Device: 
     A final drying step is provided with the removal of the residual water drops. A unit operating with sterile compressed air and complete with filter FA 3  allows to eliminate the residual drops present in the channels of the endoscope and inside the case  28 . A safety device SS 1  protects the instruments against overpressures. 
     Dosing Device: 
     The chemical additives which favour the washing and sterilising of the instruments are added to the water by means of six dosing pumps PD 1 - 1 , PD 2 - 1 , PD 3 - 1 , PD 1 - 2 , PD 2 - 2  and PD 3 - 2  which draw the liquid directly from the tanks C 1 , C 2  and C 3 . 
     The very low delivery of the dosing pumps PD 1 - 1 , PD 2 - 1 , PD 3 - 1  and PD 1 - 2 , PD 2 - 2 , PD 3 - 2  and the control of the dosage by means of the measuring devices LE 1 , LE 2 , LE 3 , LE 4 , LE 5  and LE 6  of the tanks C 1 , C 2  and C 3 , allow to optimise the quantities of additives added to the water and to reduce their consumption. A level control SL 1 , SL 2 , SL 3  and SL 4  is provided for each container  17   a ,  17   b ,  17   c  and  17   d  of chemical additives and the presence of additive is indicated until the container is completely emptied. The additive is injected into the circuit gradually and it enters the case  28  already mixed to prevent it from coming in contact with the instrument yet concentrated. The additives which are added are: detergent, steriliser (adazone+peracetic acid) and alcohol. 
     Safety Device: 
     The machine  10  is provided with safety devices which make it extremely reliable, such as:
         device against the extraction of the case  28  during the execution of the cycle;   device for controlling the overpressure of compressed air SS 1  and SS 2  and of water SS 3 - 1  and SS 3 - 2 ;   device against the injection of water into the case  28  if the connection with the couplings did not take place;   magneto-thermal breakers to protect the motors;   fuse and electric protection on the auxiliaries of the electrical system;   short circuit and overheating protection (magneto-thermal breaker);   emergency mushroom head push-button for arresting all functions of the machine (returning to stand-by with the rotation of said push-button and restarting the cycle functionality with a new start command);   disengagement micro-switches on the electrical power panel;   emergency push-button positioned on the control panel for immediately arresting the operation;       

     Management System: 
     The machine  10  is fully controlled with programmable logic electronic systems which allow to manage the cycles, control the parameters and verify process safeties. The management system has the following characteristics:
         absolute simplicity and clarity in the information provided, both on monitor and on printer, without use of codes but with clear messages, thanks to the use of a “touch-screen” interactive system, thus requiring no personnel with machine language knowledge;   the programs required for washing are inserted in stable memories (EEPROM) in the machine at the time of delivery and therefore are indelible;   standard cycles are selectable from the “touch-screen”, selecting the cycles page on the menu; the cycles page shows the push-buttons of the executable cycles and, once the one for the selected cycle is pressed, starting authorisation is given, after confirming by pressing START; however new cycles can be programmed through the keyboard by setting their parameters;   the control system is provided with help pages which guide the operator, step by step, to use and learn the standard cycles and the new cycles. Access to the programming of new cycles requires knowledge of an “access key”.       

     Description of the Control Device: 
     The system comprises two devices, one (PLC) for controlling and the other one for verifying functionality and safety (W.D.). The two devices are installed aboard the machine inside the electrical panel  13 . A third operator interface device is installed on the control panel  14 . 
     The basic apparatus is constituted by a programmable electronic controller, comprising:
         power supply device, appropriately dimensioned for any subsequent expansions of the control boards;   PCU board with 7.2K of program memory and 6 K of data memory with 1.0 ms watchdog time;   memory card, complete with 8 KWORD EEPROM memory;   capability for remote connection with an external memory (RS232C serial output);   control boards, each for 16 digital outputs and 16 digital inputs, with connector connection, and for 4 analogue inputs 4-20 mA and 2 analogue outputs 4-20 mA;   data BACKUP battery, with a 10-year duration.       

     Apparatus Regulation System: 
     Managed by a programmable electronic controller, which in turn is verified for its integrity by an external device to have a confirmation on the correct performance of the cycle (W.D.). 
     The controller manages the recording of the data on the printer. 
     The process control system receives analogue signals from the measuring sensors and reports the value displayed on the “touch-screen” with real time updates. The system is capable of self-diagnosis. 
     Programs can be freely set by the user through the “touch-screen” and, after a program is completely set, it can be executed automatically and remain available for repeated calls for execution. A 24 column alphanumeric printer records the documentation of the messages, of the parameters and of the regular performance of the cycles. 
     Safety and alarm systems of the programmable electronic controller are also provided at different levels, e.g.:
         indications which intervene during the execution of the cycle, before or after the cycle, but do not modify the execution of the cycle;   indications of alarm for non severe anomalies, with visual and acoustic signal, which recall the operator&#39;s attention, but without intervening in the execution of the cycle;   indications of alarm with visual and acoustic signal which intervene for sever anomalies and which modify the behaviour of the cycle even so far as to block it.
 
Case
       

     As shown in  FIGS. 13 to 15 , the case  28  is built to assure the effectiveness of the treatment of the instrument and its preservation in a sterile environment. For this reason it has the following requirements: it is made of plastic material; it is light, strong and non deformable; it can be drained perfectly; its inner surface is rounded and smooth; it is compatible with its intended use; it has a sanitary construction; it is resistant to the substances used for the treatment; it has an inner shape that is suitable to house all the endoscopes by the different manufacturers; it is hermetically sealed by means of closures  23 ; its inner space is right for the endoscope and its capacity in liters is minimal; it is easily transportable with a handle  24 ; it has a display where the data of the content can be shown; it has the capability of maintaining the content sterile; it has quick couplings for connection to the washing and sterilising machine,  25   a - f  for the channels of the endoscope,  25   g  for the tightness test,  26   a  and  26   b  for injecting and discharging the liquid in the inner space of the case  28  and  27  for water level control. 
     Drying Cabinet 
     The drying cabinet has the function of drying the endoscope and preserving it in a sterile environment. Drying is achieved by safely heating the air that is injected into the channels of the endoscope inside the case by means of the connectors. 
     Work Cycle 
     The sequence of the various steps of the cycle is subordinated to the achievement of the specified conditions and of the set parameters. The steps are as follows: 
     Tightness Test: 
     Injection of compressed air into the sheath of the endoscope by means of the air pump MC and test of the pressure drop by means of pressure sensor TP 7 - 1  and TP 7 - 2 . The injected air is filtered by the filter FA 5 . 
     Washing: 
     Injection of the detergent into the dosage tank C 3  through the pump PP 10  with dosage control through the measuring devices LE 5  and LE 6 ; loading the sterile water with the related detergent into the case  28  by means of the pumps MP- 1 , PD 2 - 1  and MP- 2 , PD 2 - 2 ; forced washing with the circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  for a time interval that depends on the detergent in use; discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning of the channels with compressed air filtered by the filter FA 3 . 
     Rinsing: 
     Loading sterile air into the case  28  by means of the pumps MP- 1  and MP- 2 ; forced rinsing with circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; discharging through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by the filter FA 3 . 
     Sterilisation: 
     Preparation of the dosage of the peracetic acid and adazone (or of another sterilising compound) according to the following steps:
         injection of the peracetic acid into the dosage tank C 1  by means of the pump PP 7 , with dosage control by means of the measuring devices LE 1  and LE 2 ;   injection of the adazone into the dosage tank C 2  by means of the pump PP 9 , with dosage control by means of the measuring devices LE 3  and LE 4 ;
 
loading sterile water with the related sterilising compound into the case  28  by means of the pumps MP- 1 , PD 1 - 1 , PD 3 - 1  and MP- 2 , PD 1 - 2 , PD 3 - 2 ; forced washing with the circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2  for a time interval from 10 minutes to 40 minutes, variable according to the sterilising compound in use (sterilisation); discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by means of the filter FA 3 .
       

     Rinsing: 
     Loading sterile water into the case  28  by means of the pump MP- 1  and MP- 2 ; forced rinsing with circulation pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; discharge of the solution through the discharge valve PV 5 - 1 , PV 5 - 2  and cleaning the channels with compressed air filtered by means of the filter FA 3 . 
     Alcoholisation: 
     Injection of alcohol into the channels through valve PV 2 - 1  and PV 2 - 2  by means of the pumps PP 1 - 1 , PP 2 - 1 , PP 3 - 1 , PP 4 - 1 , PP 5 - 1 , PP 6 - 1  and PP 1 - 2 , PP 2 - 2 , PP 3 - 2 , PP 4 - 2 , PP 5 - 2 , PP 6 - 2 ; injection of compressed air filtered by means of the filter FA 3  into the channel and dilution of the alcohol; discharge of the residual solution. 
     Drying: 
     Drying takes place at the end of the cycle, preferably with injection of sterile air into the case and into the channels, but it can also be conducted subsequently in proper drying cabinet.