Index. 1. Introduction. 2. Available models. 3. Sterilization Programs. 4. Mechanical features. 5. Electrical features

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2 Index 1. Introduction 2. vailable models 3. Sterilization Programs 4. Mechanical features 5. Electrical features 6. Laboratory Version with io Hazard Risk Special Specifications 7. Equipment markings 8. Network onnections 9. vailable accessoires 1. Warranty M15/2 E 6/4/1 Product escription entroclave Series 2/3

3 1. Introduction These equipments have a high quality standard, are fully tested in order to grant a high service level and a good performance. The steam sterilizers entroclave series has been designed to answer the most demanding requirements of steam sterilization of medical devices and in accordance with the European and ISO standards and regulations. The steam sterilizer entroclave is also manufactured in a version for Laboratory purposes. It is with pride and satisfaction we note that this equipment has deserved your approval and preference, therefore we will do everything on our hands to maintain the trust in our organization. The steam sterilizers entroclave series is particularly directed to provide sterilization service to the following market segments: Small/medium sized health centres Small/ Medium sized clinics Hospital Specific health care services with small/ medium sterilization volume Laboratories, for the sterilization of glassware, liquids, instruments, equipment and thermo sensitive materials Sterilization of io hazard material. The steam sterilizers entroclave series considers the current concerns in: Validation of sterilization processes, and quality management system certification. Water and energy savings Safety, reliability and ease of use M15/2 E 6/4/1 Product escription entroclave Series 3/3

4 2. vailable models The entroclave series is a free floor standing, front loading sterilizer, prepared for to sterilize hospital, Laboratory and io hazard instruments and materials. The equipment has a built in steam generator. The available models in the steam sterilizers entroclave series are listed here: RN SERIES MOEL HSP 1R (One door) HSP 2R (Two doors) Lab 1R (One door) J entroclave Lab 2R (Two doors) Lab io 1R (One door) Lab io 2R (Two doors) M15/2 E 6/4/1 Product escription entroclave Series 4/3

5 3. Sterilization Programs The steam sterilizers entroclave series has the following available working programs, accessible to the operator: Executable cycles and corresponding phases 3.1 Hospital standard version The steam sterilizer entroclave includes in Hospital standard version the programming of 9 working cycles that are intended to answer all foreseeable needs in steam sterilization process: YLE 1: Heating up cycle. ycle for the pre-heating of the sterilizer chamber Profile of cycle 1 - Sterilization at 121º H I J K E Point Pressure Point Pressure Point Pressure - 2 E - 2 H I J 15 - K M15/2 E 6/4/1 Product escription entroclave Series 5/3

6 YLE 2: owie & ick test cycle ycle to detect air pouches, vacuum pump malfunction and verification of steam penetration conditions Profile of cycle K L - Sterilization at 134º I J E H M N Point Pressure Point Pressure Point Pressure K L H 15 M I - N 11 E 15 J - 18 YLE 3: Vacuum test cycle Verification test to check for pressure leaks in mechanical circuits and in the sterilizers chamber. - Execution of the test Profile of cycle 3 Point Pressure M15/2 E 6/4/1 Product escription entroclave Series 6/3

7 YLE 4: ycle for wrapped Instruments ycle for glassware, utensils and wrapped surgical instruments. Profile of cycle N O - Sterilization at 134º H K L M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 12 2 O 341 J 2 P 9 2 E 12 2 K 1 Q 11 2 L YLE 5: ycle for wrapped Textiles Sterilization cycle for wrapped textiles. Profile of cycle N O - Sterilization at 134º H K L M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 18 2 O 341 J 2 P 2 E 18 2 K 1 Q 11 2 L M15/2 E 6/4/1 Product escription entroclave Series 7/3

8 YLE 6: ycle for ontainers ycle for instruments in containers, particularly heavy loads Profile of cycle E - Sterilization at 134º - Ventilation I H J K L Point Pressure Point Pressure Point Pressure 3 38 E I J K 7 - H L 7 YLE 7: ycle for Prions reutzfeldt-jakob isease Special cycle for instruments Profile of cycle N O - Sterilization at 134º H K L M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 12 2 O 341 J 2 P 9 2 E 12 2 K 1 Q 11 2 L M15/2 E 6/4/1 Product escription entroclave Series 8/3

9 YLE 8: ycle for wrapped temperature Sensitive Materials ycle for thermo-sensitive wrapped materials. Profile of cycle 8 - Sterilization at 121º K L N O H M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 12 2 O 249 J 2 P 9 2 E 12 2 K 1 Q 15 2 L YLE 9: Rapid cycle ycle for non-wrapped surgical instruments Profile of cycle Sterilization at 121º E H I Point Pressure Point Pressure Point Pressure - 2 E - 18 H I M15/2 E 6/4/1 Product escription entroclave Series 9/3

10 YLE 16: ycle for cleanness of the chamber (maintenance) ycle for the cleanness of the sterilization chamber. - Open the load door - lose the load door Note: s option it is possible to provide other sterilization cycles, in accordance with client specification. 3.2 Laboratory version YLE 1: Heating up cycle. ycle for the pre-heating of the sterilizer chamber Profile of cycle 1 - Sterilization at 121º H I J K E Point Pressure Point Pressure Point Pressure - 2 E - 2 H I J 15 - K M15/2 E 6/4/1 Product escription entroclave Series 1/3

11 YLE 2: owie & ick test cycle ycle to detect air pouches, vacuum pump malfunction and verification of steam penetration conditions Profile of cycle K L - Sterilization at 134º I J E H M N Point Pressure Point Pressure Point Pressure K L H 15 M I - N 11 E 15 J - 18 YLE 3: Vacuum test cycle Verification test to check for pressure leaks in mechanical circuits and in the sterilizer chamber. - Execution of the test Profile of cycle 3 Point Pressure M15/2 E 6/4/1 Product escription entroclave Series 11/3

12 YLE 4: ycle for wrapped Instruments ycle for glassware, utensils and wrapped surgical instruments. Profile of cycle N O - Sterilization at 134º H K L M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 12 2 O 341 J 2 P 9 2 E 12 2 K 1 Q 11 2 L YLE 8: ycle for wrapped temperature Sensitive Materials ycle for thermo-sensitive wrapped materials. Profile of cycle 8 - Sterilization at 121º K L N O H M E I J P Q Point Pressure Point Pressure Point Pressure M H N I 12 2 O 249 J 2 P 9 2 E 12 2 K 1 Q 15 2 L M15/2 E 6/4/1 Product escription entroclave Series 12/3

13 YLE 11(*): Laboratory cycle. Pre vacuum and fast exhaustion Profile of cycle 11 - Sterilization 121º E Point Pressure Point Pressure Point Pressure E YLE 12(*): Laboratory cycle. Pre steam and fast exhaustion Profile of cycle 12 - Sterilization 121º Point Pressure Point Pressure M15/2 E 6/4/1 Product escription entroclave Series 13/3

14 YLE 13(*): Laboratory cycle. Pre vacuum and slow exhaustion Profile of cycle 13 - Sterilization 121º E Point Pressure Point Pressure Point Pressure E YLE 14 (*): Laboratory cycle. Pre steam and slow exhaustion Profile of cycle 14 - Sterilization 121º Point Pressure Point Pressure (*) and Sterilization temperature can be selected by user, for cycles nº 11 to nº14. M15/2 E 6/4/1 Product escription entroclave Series 14/3

15 YLE 16: ycle for cleanness of the chamber (maintenance) ycle for the cleanness of the sterilization chamber at day start, when chamber is cold. - Open the load door - lose the load door Note: s option it is possible to provide other sterilization cycles, as client specification. The user that knows the password has permission to alter parameters (time and temperature of sterilization, designation and description of Laboratory cycles. The parameters by default are the ones mentioned above. 3.3 Laboratory version with io hazard risk YLE 1: Heating up cycle. ycle for the pre-heating of the sterilizer chamber Profile of cycle 1 - Sterilization at 121º H I J K E Point Pressure Point Pressure Point Pressure E H I J K 15 M15/2 E 6/4/1 Product escription entroclave Series 15/3

16 YLE 2: owie & ick test cycle ycle to detect air pouches, vacuum pump malfunction and verification of steam penetration conditions Profile of cycle K L - Sterilization at 134º I J E H M N Point Pressure Point Pressure Point Pressure K L H 15 M I - N 11 E 15 J - 18 YLE 3: Vacuum test cycle Verification test to check for pressure leaks in mechanical circuits and in the sterilizer chamber. - Execution of the test Profile of cycle 3 Point Pressure M15/2 E 6/4/1 Product escription entroclave Series 16/3

17 YLE 1: ycle for iologic risk level 3 ycle for materials of io hazard risk level 3 Profile of cycle E - Sterilization at 134º - Rapid Exhaust Point Pressure Point Pressure Point Pressure E YLE 1 (*)- LTERNTIVE: ycle for iologic risk level 3 ycle for materials of io hazard risk level 3 Profile of cycle E - Sterilization at 134º - Rapid Exhaust Point Pressure Point Pressure Point Pressure 12 E (*) and Sterilization temperature can be selected by operator M15/2 E 6/4/1 Product escription entroclave Series 17/3

18 YLE 11: ycle for iologic risk level 3 ycle for materials of io hazard risk level 3 Profile of cycle E - Sterilization at 134º - Rapid Exhaust Point Pressure Point Pressure Point Pressure E YLE 11 (*)- LTERNTIVE: ycle for iologic risk level 3 ycle for materials of io hazard risk level 3 Profile of cycle E - Sterilization at 134º - Rapid Exhaust Point Pressure Point Pressure Point Pressure E (*) and Sterilization temperature can be selected by operator M15/2 E 6/4/1 Product escription entroclave Series 18/3

19 YLE 16: ycle for cleanness of the chamber (maintenance) ycle for the cleanness of the sterilization chamber at day start, when chamber is cold. - Open the load door - lose the load door Note: s option it is possible to provide other sterilization cycles, as per client specification. M15/2 E 6/4/1 Product escription entroclave Series 19/3

20 4. Mechanical features 4.1 imensions The available models in the steam sterilizers entroclave series are listed here: RN SERIES MOEL HSP J entroclave L L IO STERILIZER IMENSIONS (height x width x depth.) ( cm ) 155x64x87 The chamber dimensions and capacities for each model of the sterilizer entroclave series are listed in the following chart: RN SERIES MOEL HSP J entroclave L L IO HMER HMER IMENSIONS PITY (diameter x depth.) ( litres ) ( cm ) 4x67 83 M15/2 E 6/4/1 Product escription entroclave Series 2/3

21 The usable chamber dimensions and capacities for each model of the sterilizer entroclave series are listed in the following chart: RN SERIES MOEL HSP J entroclave L L IO HMER HMER USLE USLE IMENSIONS PITY (diameter x depth) ( litres ) ( cm ) 37x Other mechanical features The sterilization body consists of a chamber and integral jacket that assures a high heating efficiency and uniform temperature distribution inside the chamber. The chamber is built in ISI 316 stainless steel and the jacket is built in ISI 34 stainless steel. The door is entirely built in stainless steel, thus the surface of contact with steam is in stainless steel ISI 316. The sterilization chamber, along with the rest of the components, is horizontally mounted in a structure entirely built in stainless steel ISI 34. To the sterilization chamber is adapted a loading system that allows condensation to the drainage and free flow of steam amongst the entire load. The sterilization chamber has an electrolytic polishing. The door(s) and its (their) support structure was designed in a way to assure its (their) perfect functioning and possess the necessary sturdiness to resist the pressure variations during normal operation. The groove that holds the chamber-sealing gasket is calibrated and planed. The door(s) sealing gasket(s) is (are) made of high temperature resistant silicone, and easy to replace, inspect and clean, not needing for such to dismantle any kind of door support or fixings. The frontal cover of the sterilizer is made of ISI 34 stainless steel. M15/2 E 6/4/1 Product escription entroclave Series 21/3

22 The door panel gives the equipment a modern and functional design. The sterilizer is equipped with a,1 µm (micron) bacteriological filter to equalize the chamber pressure to atmospheric at the end of drying phase, for admission of sterile air into the chamber. 5. Electrical features 5. 1 Safety and safety devices The sterilizer chamber and the jacket are each equipped with safety valve against overpressure with automatic differential discharge type and manual command opening for inspection and verification. The steam sterilizer entroclave is equipped with devices that allow the detection of: Electric power failure Temperature probe malfunction Pressure transducers malfunction Overpressure inside the jacket Overpressure inside the sterilization chamber Water lack Emergency pushbuttons Jacket/hamber pressure safety valve Steam generator pressure safety valve Steam generator water level control and safety devices Steam generator thermal protection safety device (Optional) Whenever one of these failures is detected the cycle is interrupted. In the over pressure cases, the steam flow is turned off. The steam generator incorporates a water level safety device that automatically prevents the starting and the function of the steam generator and switch off the heating element in case of water lack. dditionally and as an optional can be mounted, the thermal protection safety device that in case of a failure of the water level safety device switch off the heating elements. M15/2 E 6/4/1 Product escription entroclave Series 22/3

23 The steam inlets into the sterilization chamber are placed asymmetrically in its lateral side. Pressure and temperature are separated and individually controlled in the chamber and jacket within the pressure and temperature range. or the Hospital version, the parameters of the different cycles remain unchangeable. Sterilizer is equipped with emergency stop buttons, in the load and unload side, that turn off the power supply to the machine. The entroclave is equipped with a mechanical lock device that keeps the door from opening, while there is pressure inside the sterilizer chamber. In the progress of a cycle, the door locking mechanism prevents its opening if user tries to open the door. In any case the control system will open the chamber exhaust valve, putting the sterilizer chamber to atmospheric pressure and aborting the sterilization cycle if the user succeeds to overcome the locking mechanism. In the cooling and condenser tank, the water level safety device prevents the system against water lack and the water temperature thermostat; control the water temperature in the tank, for to grant an adequate water temperature for the liquid ring vacuum pump and the cooling system, on the benefit of water consumption saving. 5.2 INSTRUMENTTION N MONITORIN ETURES The pressure and temperature into the sterilization chamber and into the jacket can be permanently displayed at the touch screen of the operator-interface console (in hpa and º respectively). In the operator-interface console, can also be permanently displayed all the relevant information regarding the progress of the various cycle phases as well as all failures and anomalies. The process can be graphically displayed in real time, exhibiting temperature and pressure in function of cycle time. Through the touch screen keyboard of the operator-interface console it is possible to introduce cycle data, command selection and call any intended information to be displayed. The printer can output detailed reports on all cycle phases and the eventual failures with corresponding date and time. chart of the evolution, during the cycle, of pressure and temperature inside the sterilization chamber versus time can also be printed. M15/2 E 6/4/1 Product escription entroclave Series 23/3

24 The machine registers a count of the number of processed sterilizations. t the unload side the pressure into the chamber can be permanently displayed, as well as the pressure into the double body (jacket). The temperature probes are of the type PT1, class, one for control and another for registry of sterilization chamber temperature. s an option, it can be fitted a PT 1 product probe. Pressure transducers are used one in the sterilization chamber and another at the double body (jacket), have a scale of to 4 hpa (absolute). Normalized validation ports for external temperature and pressure sensors for validation and qualification purposes, as per EN 285 standard. Information available in the operator-interface console of the unload door side: losed doors ycle in progress ycle complete ailure occurrence (Error Message) oor open Pressure (in hpa) chamber/jacket hamber temperature Jacket temperature (Optional) M15/2 E 6/4/1 Product escription entroclave Series 24/3

25 5.3 Performance and control The steam sterilizer is equipped with a microprocessor that is programmed in a way to assure a repeatable process even with variable loads. The microprocessor controls in an adequate manner the pressure and temperature variations in a way that the programmed cycle is executed precisely from beginning to end. Energy savings are equally assured, as only the strictly necessary power to the process is used. The vacuum pump allows a through drying of the sterilized materials and utensils. The sterilizer is fitted with a liquid ring vacuum pump, that is designed to attain a final pressure of,33 bar (33 mbar) absolute pressure, or a relative pressure of,98 bar (98 mbar). The cooling and condenser tank system, incorporate three different systems: cooling and condenser system that cools down the temperature of the steam and liquid effluents coming from the exhaustion. cooling and condenser system that cools down the steam and gaseous effluents before the vacuum pump. water level safety device prevents the system against water lack and the water temperature thermostat; control the water temperature in the tank, for to grant an adequate water temperature for the liquid ring vacuum pump and the cooling system, on the benefit of water consumption saving. Temperature control is indicated with a resolution of,1 º. Pressure control is indicated with a resolution of 1 hpa. ailure and statistics are permanently registered in memory. Note: The sterilizer can process various fixed cycles and cycles with programmable parameters by the user, depending on version (Hospital, Laboratory or Laboratory with biohazard risk) or the client s specifications. or the cycles programmed by user, once the cycle is defined it is kept in the microprocessor s memory, remaining the active cycle until the next modification. The operator does not have to alter the active cycle unless it is desired. The temperature of the sterilization plateau is calculated by factor, allowing, in this way, to assure that, in the beginning of the sterilization time count, the temperature of the load is, in all, within the safety plateau both the temperature in the outskirts and on its inside (or Laboratory Programs). M15/2 E 6/4/1 Product escription entroclave Series 25/3

26 Pressure and temperature control of the sterilization chamber and of the double body (jacket) are separately achieved, as to assure that temperature and pressure values in the jacket are in the same range as the ones selected for the chamber s sterilization plateau. 5.4 Environmental conditions Ensure that the equipment-operating environment meets the following conditions: mbient temperatures ranging from 5 to 35 º Relative humidity lower than 8% 6. Laboratory version with io hazard risk Special specifications The sterilizer with special cycles for to process io hazard materials has a special design in order to prevent any contamination once the io hazard material is proper placed in the chamber of the steam sterilizer and the cycle is started. To grant this purpose the steam sterilizer incorporates two different systems, description as follows: System to prevent any contamination, from the gaseous effluents coming from the vacuum and exhaust. ny gas or steam coming from the chamber, after the cycle is started, is filtered on HEP filter,1 µm (micron) before exhaustion, so the contamination is prevented. The HEP filter is contained in a special stainless steel body with sealing by means of a clamp system. The filter at the end of each cycle is automatically sterilized, and a special design allows to do the sterilization of the filter in manually way. The gaseous effluents before discharging from the steam sterilizer are cooled down at the cooling and condenser system. M15/2 E 6/4/1 Product escription entroclave Series 26/3

27 System to prevent any contamination, from the liquid effluents that comes from the discharge and drain. ny liquid effluent coming from the chamber is collected in a small chamber, surrounded by a steam jacket assuring that the liquid effluent is automatically sterilized during the cycle before to be discharged at the end of each cycle through the drain system. special design allows to do the sterilization of the liquid effluent in manually way. The liquid effluents before discharging from the steam sterilizer are cooled down at the cooling and condenser system. 7. Equipment markings The horizontal steam sterilizers entroclave series has been designed and built to comply with the following directives: EUROPEN IRETIVE IRETIVE NUMER O THE NOTIIE NNEX OR MOULE ORNIZTION 93/42/EE II 12 27/47/E II 12 97/23/E 1155 The steam sterilizers entroclave series is compliant with the following technical standards: NP EN 285: Sterilization. Steam sterilizers. Large sterilizers. SME Sec. VIII e II SME oiler and pressure vessel code Section VIII and II. M15/2 E 6/4/1 Product escription entroclave Series 27/3

28 Electrical Safety: EN :25 Safety Requirements for electrical equipment for measurement, control and Laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials. EN 611-1:21 Safety requirements for electrical equipment for measurement, control and Laboratory use. eneral Requirements. Electromagnetic ompatibility EN :26 Electrical equipment for measurement, control and Laboratory use EM Requirements Part 1: eneral Requirements. EN 6-3-2:26 Electromagnetic compatibility (EM Part 3-2: Limits Limits for harmonic current emissions (Equipments input current 16 per phase). EN 6-3-3: :21+ 2:25. Electromagnetic compatibility (EM) Part 3: Limits Section 3: Limitation of Voltage fluctuations and flicker in low voltage supply systems for equipments with rated current t 16. The production of the steam sterilizer entroclave series is covered by the quality management system implemented in our company and complies with the following standards: NP EN ISO 91 Quality management systems Requirements ISO Quality System Medical evices Particular Requirements of ISO 91 This certificate has been given to the manufacturer by the ertification ody SS UKS. M15/2 E 6/4/1 Product escription entroclave Series 28/3

29 8. Network onnections Electrical connection Standard Version: Three-phase connection 4 V ~ 3 + N + PE, 5 Hz, with a 25 circuit breaker and a 3 m differential protection. Heating elements: 6 kw, (optionally: 9 kw). Other electrical power supply connections can be provided. Water connection 3/4 SP pipe with female valve at ground level, or at wall. Pressure: 3 to 6 bar rain connection 2 galvanized pipe or equivalent, resistant to a minimum temperature of 1 º with a 2 SP female thread at ground level, drain with siphon, totally independent on other discharges. M15/2 E 6/4/1 Product escription entroclave Series 29/3

30 9. vailable accessories The standard accessories available for the steam sterilizers entroclave series are as follows: exterior loading car rolling load platform load baskets water softener igital printer The company may provide, under request, any other types or variations in accessories, to be manufactured. 1. Warranty The steam sterilizers entroclave series have a warranty period of two years. M15/2 E 6/4/1 Product escription entroclave Series 3/3

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