CEFLA MOCOM Supreme-17 Manual
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CEFLA MOCOM Supreme-17 Manual

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97055023
Rev. 00
2019-03
EN
https://stomshop.pro/

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Summary of Contents for CEFLA MOCOM Supreme-17

  • Page 1 97055023 Rev. 00 2019-03 https://stomshop.pro/...

  • Page 2: Table Of Contents

    INDEX FOREWORD ........................................5 1.1. SYMBOLS USED ......................................5 1.2. SYMBOLS ON THE DEVICE ..................................5 1.3. RELEVANT EUROPEAN DIRECTIVES ..............................5 1.4. CLASSIFICATION .......................................5 1.5. INTENDED USE ......................................6 1.5.1. IMPORTANT NOTES ..................................6 1.6. GENERAL WARNINGS....................................6 1.7. RESIDUAL RISKS.......................................7 1.8. INFORMATION ON MITIGATION OF RESIDUAL RISKS ...........................7 PACKAGE CONTENT .....................................
  • Page 3 10. INSTRUCTIONS ......................................48 11. SERVICE ........................................48 12. PREPARATION OF THE MATERIAL ................................49 12.1. TREATING THE MATERIAL BEFORE STERILIZATION ........................... 49 12.2. ARRANGING THE LOAD ..................................50 12.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT ........................52 13. STERILIZATION CYCLES ..................................... 53 13.1.
  • Page 4 23. SYSTEM RESET......................................92 24. ALARM CODES......................................93 24.1. ERRORS (CATEGORY E) ..................................93 24.2. ALARMS (CATEGORY A) ..................................95 24.3. HAZARDS (CATEGORY H) ..................................97 24.4. SYSTEM ERRORS (CATEGORY S) ................................. 98 24.5. TROUBLESHOOTING ....................................99 24.5.1. ERRORS (CATEGORY E) ................................99 24.5.2.

  • Page 5: Foreword

    FOREWORD The instructions inform the user on how to properly operate the device. It is extremely important to read this manual carefully and thoroughly before using the device. This publication must not be reproduced, copied or transferred in any manner (electronically, mechanically, via photocopies, translations or other means) without the prior written consent of the manufacturer.

  • Page 6: Intended Use

    1.5. INTENDED USE The product described in this manual is only intended for sterilization of reusable surgical instruments and materials. DEVICE INTENDED FOR PROFESSIONAL USE The use of the device is strictly reserved to qualified personnel. It must never be used or handled by untrained and/or unauthorised persons.

  • Page 7: Residual Risks

    1.7. RESIDUAL RISKS FOR THE USER • Contamination due to improper handling of the load; • Burn by contact with hot surfaces or fluids. FOR THE PATIENT • Contamination due to unsterilised material caused by wrong cleaning treatment before sterilization; •...

  • Page 8: Package Content

    PACKAGE CONTENT Check the integrity of the product package upon receipt. 2.1. DIMENSIONS AND WEIGHT Once the package is opened, check that: • The supply matches the specifications of the order (see the delivery note); • There is no visible damage to the product. Dimensions and weight A Height 600 mm...

  • Page 9: Description Of The Content

    2.2. DESCRIPTION OF THE CONTENT In addition to the sterilizer, the package contains: Instrument trays: Allen wrench (for door manual unlocking); - 5 pcs for 17 and 22 - 6 pcs for 28; Tray holder support; Plastic tube for direct water drainage, with fastening clamp; Operator’s documentation and safety valve’s EC Declaration of Rear spacers;...

  • Page 10: Product Handling

    2.3. PRODUCT HANDLING The packed product must be handled using, where possible, suitable mechanical means (lift truck, pallet truck, etc.) and following the indications on the package. In case of manual handling, the product must be lifted by two persons using the suitable available means. Once the sterilizer has been removed from the package, it must be lifted by two persons using the suitable available means and handled, if possible, using a truck or similar means.

  • Page 11: General Description - Product Presentation

    GENERAL DESCRIPTION - PRODUCT PRESENTATION 3.1. GENERAL CHARACTERISTICS The device is an electronic water steam sterilizer, entirely operated by a micro-processor, with a large, printed stainless steel sterilization chamber. It is characterized by an advanced fractionated vacuum system for the complete removal of air, even from hollow, porous materials, and an effective final vacuum drying phase capable of eliminating all traces of humidity from any load.

  • Page 12: Technical Specifications

    SUMMARY TABLE WATER STEAM STERILIZER Device Class (according to Directive 93/42/EEC and subsequent amendments) CEFLA s.c. Manufacturer Headquarters Via Selice Provinciale 23/A – 40026 Imola (BO) IT 220 V - 240 V~ 50 Hz Input voltage 220 V - 230 V~ 60 Hz...
  • Page 13 WATER STEAM STERILIZER Device Stick capacity lower than or equal to 2GB: FAT formatting with 16K/sector USB connection Keys capacity higher than 2GB: FAT32 formatting with 16K/sector Printer connection Serial RS232 (printer cable max length 2.5 m) Printer insulation class: Class I or Class II Compliant with Standard EN 60950.

  • Page 14: Safety Devices

    3.3. SAFETY DEVICES The sterilizer is equipped with the following safety devices for which we provide a brief description of their function: • Mains fuses (see data in summary table) Protection of the whole device against possible failures of heating elements. Action: power supply interruption.

  • Page 15: Water Supply Characteristics

    3.4. WATER SUPPLY CHARACTERISTICS The sterilizer is equipped with a demineralisation filter fitted inside the filling tank, which allows supplying the device with standard water from the mains. The quality of the water treated by the integrated filter is checked automatically through a conductivity sensor. If the demineralisation filter is not present, ONLY use demineralised/distilled water having the following characteristics to supply the sterilizer.

  • Page 16: Front

    3.5. FRONT LCD touch screen control panel Door Power switch Dust filter USB port NFC reader Sterilization chamber Bacteriological filter Door locking system Steam diffuser Water drainage filter Water top-up quick connector Water drainage quick connector Waste water drainage quick connector Door https://stomshop.pro/...

  • Page 17: Rear

    3.6. REAR Fastening slots for rear spacers Heat exchanger Connection for direct water drainage Connection for distilled water automatic filling (only for PURE 100 / 500 and automatic filling accessory kit / AUX EV Kit) Data plate SERIAL NUMBER LABEL (See image *) Ethernet cable connection (max length 29 m) Serial cable connection...

  • Page 18: Display Icons

    3.7. DISPLAY ICONS The screens in the following pictures may vary in shapes and colours, but their contents are the same as shown on the sterilizer display. A Door opening B Settings C Sterilizer information D Performed cycle list Sterilization cycles Test cycles G Custom cycle (customisable) Other particular symbols relating to the various conditions of use will be described in the relative paragraphs.

  • Page 19: Example Of Working Cycle

    3.8. EXAMPLE OF WORKING CYCLE The sterilisation program can be effectively described as a succession of phases, each one with a very precise objective. For example, the universal program (cycle B, 134°C - 4’): after loading the material in the chamber, closing the door, selecting the program and starting the cycle (after locking the door opening mechanism), the following sequence will be suggested (see the graph below): Preheating the generator and sterilization chamber;...

  • Page 20: Setting Up The Device

    SETTING UP THE DEVICE The safety of every system which integrates the device is responsibility of the system assembler. The first and essential step for a proper operation of the sterilizer, its durability over time and complete use of its features is a correct and careful commissioning.

  • Page 21: Compartment Dimensions For Built-In Installation

    4.2. COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATION When installing the sterilizer inside a cabinet, you must provide adequate space all around the device to provide effective ventilation as well as an opening in the back (180 sq.cm) that, in addition to allowing the passage of the power cord, will also provide an adequate air flow and the consequent optimum cooling of the heat exchanger.

  • Page 22: Electrical Connections

    4.5. ELECTRICAL CONNECTIONS The sterilizer must be connected to a socket of the electric system having adequate capacity for the absorption of the device and properly earthed, in accordance with laws and/or regulations in force. The socket must be properly protected through magneto-thermal and differential circuit breakers having the following characteristics: •...

  • Page 23: First Start-Up

    FIRST START-UP The time required to start the sterilizer is approximately 30 seconds. 5.1. STARTING Once the sterilizer has correctly been installed, turn it on with the main switch on the right-hand side of the machine. Do not turn on the sterilizer if USB key is inserted. When the device is first turned on, the display shows the selection of LANGUAGE, DATE and TIME settings.

  • Page 24: Main Menu

    5.2. MAIN MENU At the end of starting procedure the main menu is displayed on the side. 5.3. UPPER DOOR OPENING Remove the upper panel by lifting it and sliding it forward. https://stomshop.pro/...

  • Page 25: Discharge Water Recovery And Demineralization System

    5.4. DISCHARGE WATER RECOVERY AND DEMINERALIZATION SYSTEM The demineralisation and discharge water recovery system is an innovative instrument designed to treat mains water and recover the condensate drained from the sterilizer. Filters are made of bacteriostatic material to prevent the proliferation of bacteria on their surfaces. The system consists of two filters housed, respectively, inside the filling tank and inside the discharge tank: FILLING TANK DEMINERALISATION FILTER DISCHARGE TANK RECIRCULATION FILTER...

  • Page 26: Installing The Recirculation Filter Inside The Tank

    5.4.1. INSTALLING THE RECIRCULATION FILTER INSIDE THE TANK Take the recirculation filter from the package, then proceed as follows: Turn the sterilizer off; Move the filter locking lever (1) backward; Fit the recirculation filter (2) onto the hole located in the upper part of the discharge tank;...

  • Page 27: Installing The Demineralization Filter Inside The Tank

    5.4.2. INSTALLING THE DEMINERALIZATION FILTER INSIDE THE TANK This device has been designed to demineralise drinkable water from the water mains to make it usable for the supply of the steam sterilizer. The INTEGRATED DEMINERALISATION FILTER is an ion-exchange water treatment system integrated in the autoclave's filling tank. It is a cutting-edge device with an attractive design which combines high performance, user-friendliness and a small size compared to similar water treatment systems.

  • Page 28: Technical Specifications

    5.4.4. TECHNICAL SPECIFICATIONS Operating temperature +15°C ÷ +35°C Storage temperature +5°C ÷ +30°C Cartridge weight 1.2 kg Internal Inlet water Mains drinkable water Conductivity < 15μS/cm Outlet water quality Demineralised water production approx. 170 litres Demineralisation filter performance H2O conductivity at filter outlet Litres of treated water 5.5.

  • Page 29: Filling Distilled Water

    5.6. FILLING DISTILLED WATER The sterilizer is equipped with a demineralisation filter fitted inside the filling tank, which allows supplying the device with standard water from the mains. The quality of the water treated by the integrated filter is checked automatically through a conductivity sensor. If the demineralisation filter is not present, ONLY use demineralised/distilled water having the following characteristics to supply the sterilizer.

  • Page 30: Configuration

    CONFIGURATION The sterilizers offer a wide range of customisable options. The user can thus configure the device according to his/her own needs, adapting the performance based on, for example, the type of activity carried out, the type of material to be sterilised and the frequency of use. Using the configuration program, the user can set a series of options available in user-friendly menus.

  • Page 31: Date And Time

    6.1.2. DATE AND TIME Select DATE AND TIME option. Select the field to edit. Set DATE and TIME and confirm by pressing the CONFIRM icon. https://stomshop.pro/...

  • Page 32: Unit Of Measurement

    6.1.3. UNIT OF MEASUREMENT Select UNIT OF MEASUREMENT to set the reading of temperature and pressure values. Confirm by pressing the CONFIRM icon 6.1.4. SCREEN AND AUDIO Select SCREEN AND AUDIO to set the parameters of screensaver, audio volume and brightness of screen and LED bars. Use the Screensaver control to set the activation time.
  • Page 33 Use the Personalise control to select one of the screensavers provided or to load an image from an USB memory support to be connected to the front USB port. Use the AUDIO control to set the volume of notifications. Use the BRIGHTNESS control to set the brightness intensity of the screen. https://stomshop.pro/...

  • Page 34: Preheating

    The LED Brightness control affects the internal LED bar, activated when the door is opened. When the LED brightness value is set to 00, both bars remain off. 6.1.5. PREHEATING Select PREHEATING to activate the PREHEATING of the sterilization chamber. Select ACTIVE to activate the PREHEATING, OFF to disable it.

  • Page 35: Water Filling

    6.1.6. WATER FILLING Select WATER FILLING to choose the type of water filling. Available options include: When the automatic filling system is connected, the sterilizer asks to Identify the type of device actually connected by pressing the corresponding key. If connecting the filling system when the sterilizer is off, access the menu via the configuration program and manually select the correct option. This menu can also be used to temporarily deactivate the automatic filling system (filters exhausted, fault, etc.) and go to manual tank filling, keeping the automatic filling system connected.

  • Page 36: Printers

    6.1.7. PRINTERS Select PRINTERS to choose which support to use for printing. Select PRINTER ENABLED to view the list of printers that can be controlled from the device, which are connected via RS232 port or Wi-Fi. Select AUTOMATIC PRINTING to access the print mode selection menu, activated when the door is opened at the end of the cycle.

  • Page 37: Print Labels

    6.1.7.1. PRINT LABELS If Labels option is selected, the dedicated menu is displayed when the door opens at the end of the cycle to allow setting: • Number of labels; • Package validity interval, in days. The date that will be printed is indicated below. https://stomshop.pro/...

  • Page 38: Cycle List

    CYCLE LIST From the Home page it is possible to access the CYCLE LIST menu in order to display, manage and download the cycle reports stored in the internal memory of the device. Access CYCLE LIST to view the list of all the cycles performed by the device and the final outcome of each one of them.
  • Page 39 The control activates the download of reports, based on the filters enabled. Reports are downloaded in PDF format. The control activates the printing of cycle reports, according to the mode selected. https://stomshop.pro/...

  • Page 40: Connectivity

    CONNECTIVITY Select CONNECTIVITY to set WIFI, ETHERNET or NFC connection. 8.1. WIFI Select Wi-Fi to connect the sterilizer to a local Wi-Fi network. DHCP can be set as automatic or manual. In automatic mode the network configuration parameters are assigned automatically, in manual mode the network configuration parameters must be set manually.

  • Page 41: Manual Dhcp

    8.2. MANUAL DHCP Set IP, Mask, Gate and DNS fields and confirm. 8.3. ETHERNET CONNECTIVITY In this case too, it is possible to set DHCP as automatic or manual. If automatic mode is selected, the network configuration parameters are assigned automatically, whereas in manual mode they must be manually set.

  • Page 42: User Management

    USER MANAGEMENT Select USER MANAGEMENT to set the users. Upon the first use, create the ADMIN user following the indications in the figure below. The first user entered is given administrator rights. When the user enters an incorrect PIN for 3 times, it is necessary to perform the unlocking procedure described IN THE APPENDIX - USER PIN RESET.

  • Page 43: Create New

    9.1. CREATE NEW This function allows adding new users by entering a name and an identification PIN for each one of them. It is possible to enter up to 30 users in the list. 9.2. CHANGE This function, reserved to ADMIN, allows associating one or more sterilization cycles with each user, choosing them among the six available ones.

  • Page 44: Change Pin

    9.3. CHANGE PIN This function allows each single user to change the identification PIN originally entered. https://stomshop.pro/...

  • Page 45: Associate Nfc

    9.4. ASSOCIATE NFC This function, reserved to ADMIN, allows associating an NFC card with each user. To perform user/NFC card pairing, first activate the NFC magnetic card reader from SETTINGS. 9.5. USER PIN REQUEST This function, reserved to ADMIN, allows activating the user identification request: •...

  • Page 46: User Deletion

    9.6. USER DELETION This function, reserved to ADMIN, allows eliminating the user entered in the list. The user deletion is not reversible. The name of the deleted user will still be shown in any cycle reports associated with the removed account. Select ADMIN user to view the summary data on the user.

  • Page 47: Users List

    9.7. USERS LIST Select the desired user and identify yourself with your personal PIN. You will access the screen containing data of the selected user. Once entered, a NON ADMIN user can see only a summary of his/her data, or change his/her PIN (see entering PIN - the following is requested in sequence: current PIN, new PIN, new PIN confirmation).

  • Page 48: Instructions

    10. INSTRUCTIONS Select INSTRUCTIONS to access the instructions and video tutorials for the user. Press on the video of your interest to show the selected tutorial on the sterilizer display. 11. SERVICE This menu is intended for the technical service department. It can be used only by an authorised technician.

  • Page 49: Preparation Of The Material

    12. PREPARATION OF THE MATERIAL Always use personal protective equipment. First of all, it should be recalled that, when handling and managing contaminated material, it is a good idea to take the following precautions: • Wear rubber gloves of suitable thickness and the specific protective mask on your face; •...

  • Page 50: Arranging The Load

    12.2. ARRANGING THE LOAD Always use personal protective equipment. To get the best effectiveness of the sterilization process and preserve the material over time, increasing its useful life, follow the instructions below. General notes for the positioning on trays: • Arrange instruments made of different metals (stainless steel, hardened steel, aluminium, etc.) on different trays or anyway on trays well separated from one another.
  • Page 51 Notes for packed material: • Individually pack the instruments or, in case several instruments are placed inside the same bag, make sure they are made of the same metal; • Seal the case with a thermosealer or adhesive tape for autoclaves; •...

  • Page 52: Positioning And Use Of Tray Holder Support

    12.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT Tray holder support can be used in "tray" version (5/6 compartments based on the sterilizer model). Or, if tray holder support is extracted and turned by 90°, it can be used to house special "boxes"...

  • Page 53: Sterilization Cycles

    13. STERILIZATION CYCLES A sterilization cycle consists of a determined number of phases. The number and duration of the phases can differ for the different cycles, based on the type of air extraction, sterilization process and drying methods: • B 134 Universal •...

  • Page 54: Delayed Start

    When the cycle is in progress, the following screen is displayed: Press INFO to display the information on the cycle parameters and the graph. 13.1. DELAYED START The control allows accessing the start delay setting, expressed in hours. The delayed start date and time are indicated at the centre. The cycle start screen and the set delay value will be displayed when confirming Delayed start can be activated/disabled without changing the setting.

  • Page 55: Extra Drying

    13.2. EXTRA DRYING The control allows accessing the additional drying time setting, expressed in minutes. The total drying time is indicated at the centre. The cycle start screen and the set extra drying time value will be displayed when confirming. Extra drying can be enabled/disabled without changing the setting.

  • Page 56: Door Opening At Cycle End

    13.5. DOOR OPENING AT CYCLE END To open the sterilizer door, press the icon indicated in the figure: User identification is required in this phase, if enabled. If enabled, the label printing management screen will be displayed once the door has been opened. https://stomshop.pro/...

  • Page 57: User-Defined Cycle

    13.6. USER-DEFINED CYCLE To set parameters press CUSTOM Select the type of pre-vacuum, the process temperature, the exposure time and extra drying if necessary. Once selections have been made, save the settings with CONFIRM key. Press INFO to display the information on the cycle parameters. Press START to start the user-defined cycle.

  • Page 58: Material Storage

    14. MATERIAL STORAGE The sterilized material must be adequately treated and stored to maintain its sterility over time, until its use. Inadequate storage can cause rapid recontamination. This leads to problems regardless of what you do since you will either be using recontaminated material (most of the time unconsciously), placing the user and patient at risk, or you will have to run the sterilization cycle again, with an inevitable waste of time and resources.

  • Page 59: Test Programs

    15. TEST PROGRAMS To protect the safety of users and patients, a fundamental process like sterilizing medical devices should be periodically checked. The device offers the possibility of easily and automatically executing two distinct test cycles: • VACUUM TEST; • HELIX / Bowie&Dick TEST; •...

  • Page 60: Helix / Bowie Dick Test

    15.2. HELIX / BOWIE DICK TEST HELIX/Bowie&Dick TEST is a cycle at 134°C characterised by a sterilization phase having a special duration time (3.5 minutes); the cycle includes fractionated vacuum phases similar to those used in the sterilization cycles. Using an appropriate device, you can assess correct steam penetration into hollow loads (Helix Test). The cycle is also suitable to measure steam penetration into porous loads (Bowie &...

  • Page 61: Test Reminder

    15.4. TEST REMINDER This function allows displaying, based on the chosen interval, a message recalling the performance of the relevant test. Set whether and when Test reminders are to be activated (Vacuum - Helix/Bowie&Dick Test- Vacuum + Helix/Bowie&Dick Test) based on the available options.

  • Page 62: H2O Test

    15.5. H2O TEST Select this option to test the water quality. The water conductivity is automatically measured at each sterilization or test cycle start. https://stomshop.pro/...

  • Page 63: Door Opening

    15.6. DOOR OPENING Press the indicated icon to open the sterilizer door when cycle ends. The door opens and remains ajar. Then the door can be opened manually. 15.7. MANUAL INTERRUPTION The cycle can be manually interrupted by the operator at any time, by keeping the icon shown in the figure pressed for about three seconds.

  • Page 64: Used Water Drain

    16. USED WATER DRAIN This operation is required only if a sterilizer without used water recirculation filter is used. When the water maximum level is reached, a specific message is displayed. Open the door and continue as follows: Detaching the tube Prepare a basin with a capacity of at least 4 litres in proximity to the sterilizer;...

  • Page 65: Data Management

    18. DATA MANAGEMENT To access DATA MANAGEMENT section press the relevant icon. See also the chapter CYCLE LIST. 18.1. CYCLE DOWNLOAD Before carrying out the following operations insert the USB key. It is possible to copy data about the cycles carried out, stored in the inner memory of the sterilizer, on a USB key.

  • Page 66: Appendix - Programs

    19. APPENDIX – PROGRAMS Water steam sterilization is suitable for almost all the materials and instruments, provided that they can bear without damage a minimum temperature of 121°C (if this is not the case, other low-temperature sterilization systems must be used). The following material can normally be sterilized with water steam: •...

  • Page 67: Summary Table Of 17 220 V - 240 V Cycles

    19.1. SUMMARY TABLE OF 17 220 V - 240 V CYCLES NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped porous 1.00 0.30 0.30 materials Porous materials in 0.75 0.25 0.25 single pack Porous materials in 0.60 0.20 0.20 double pack 134°C...
  • Page 68 NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped hollow 6.00 1.20 0.50 134°C instruments HOLLOW 4(*) 0.65 Unwrapped solid UNWRAPPED 6.00 1.20 0.50 instruments Solid and hollow It is advisable to use instruments "B" in 3.00 1.00 0.25 the 3-tray 134°C SOLID...

  • Page 69: Summary Table Of 17 120 V Cycles

    19.2. SUMMARY TABLE OF 17 120 V CYCLES NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped porous 1.00 0.30 0.30 materials Porous materials in 0.75 0.25 0.25 single pack For wrapped Porous materials in 0.60 0.20 0.20 materials and double pack 135°C...
  • Page 70 NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped solid 4÷30 instruments (other load Variable parameters XXX°C USER 135- 2.2- n.a. 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the (see note) 20÷30 depending on the user settings made settings) HELIX/BD...

  • Page 71: Summary Table Of 22 220 V - 240 V Cycles

    19.3. SUMMARY TABLE OF 22 220 V - 240 V CYCLES NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped porous 1.20 0.40 0.30 materials Porous materials in 1.00 0.30 0.25 single pack Porous materials in 0.75 0.25 0.20 double pack 134°C...
  • Page 72 NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped hollow 7.50 1.50 0.50 134°C instruments HOLLOW 4(*) Unwrapped solid UNWRAPPED 7.50 1.50 0.50 instruments Solid and hollow It is advisable to instruments "B" in single 4.00 1.00 0.25 use the 3-tray 134°C SOLID pack...

  • Page 73: Summary Table Of 22 120 V Cycles

    19.4. SUMMARY TABLE OF 22 120 V CYCLES NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped porous 1.20 0.40 0.30 materials Porous materials in 1.00 0.30 0.25 single pack For wrapped Porous materials in 0.75 0.25 0.20 materials and double pack 135°C...
  • Page 74 NOMINAL VALUES BASIC CYCLE PARAMETERS STERILIZABLE MATERIALS NOTES CYCLE DESCRIPTION Unwrapped solid 4÷30 instruments (other load Variable parameters XXX°C USER 135- 2.2- n.a. 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the (see note) 20÷30 depending on the user settings made settings) HELIX/BD...

  • Page 75: Summary Table Of 28 220 V - 240 V Cycles

    19.5. SUMMARY TABLE OF 28 220 V - 240 V CYCLES BASIC CYCLE NOMINAL VALUES STERILIZABLE MATERIALS NOTES PARAMETERS CYCLE DESCRIPTION Unwrapped porous 1.50 0.50 0.50 materials Porous materials in single 1.25 0.35 0.35 pack Porous materials in 0.90 0.30 0.30 double pack 134°C...
  • Page 76 BASIC CYCLE NOMINAL VALUES STERILIZABLE MATERIALS NOTES PARAMETERS CYCLE DESCRIPTION Unwrapped hollow 9.00 1.50 0.50 134°C instruments HOLLOW 4(*) Unwrapped solid UNWRAPPED 9.00 1.50 0.50 instruments Solid and hollow It is advisable to instruments "B" in single 5.00 1.00 0.25 use the 3-tray pack configuration...

  • Page 77: Summary Table Of 28 120 V Cycles

    19.6. SUMMARY TABLE OF 28 120 V CYCLES BASIC CYCLE NOMINAL VALUES STERILIZABLE MATERIALS NOTES PARAMETERS CYCLE DESCRIPTION Unwrapped porous 1.50 0.50 0.50 materials Porous materials in single 1.25 0.35 0.35 pack For wrapped Porous materials in materials and 0.90 0.30 0.30 double pack...
  • Page 78 BASIC CYCLE NOMINAL VALUES STERILIZABLE MATERIALS NOTES PARAMETERS CYCLE DESCRIPTION HELIX/BD Test device only (without TEST another load) VACUUM -0.8 Empty chamber TEST VACUUM + HELIX/BD TEST (executable in sequence) (*) To set a sterilization time of 5.5 minutes, contact the Technical Service. Single Pre-Vacuum = 1 pre-vacuum;...
  • Page 79 PRESSURE, TIME AND TEMPERATURE In compliance with EN 13060: 2014 for operating cycles 134°C cycles Max pressure EN 13060:2014 Time (minutes) Min temperature Max temperature Min pressure (bar) (bar) -0.81 -0.79 +0.97 +1.03 -0.81 -0.79 +0.97 +1.03 -0.81 -0.79 4 / 5.5 +134 +138 +2.04...

  • Page 80: Sterilization Program Diagram

    19.7. STERILIZATION PROGRAM DIAGRAM PROGRAM A PRESSURE (BAR) 134°C UNIVERSAL B PROCESS 134°C – 4’ 00’’ C TIME (MIN) D FRACTIONATED VACUUM PROGRAM VACUUM DRYING 134°C PRION 134°C – 18’ 00’’ PROGRAM A PRESSURE (BAR) 121°C UNIVERSAL B PROCESS 121°C – 20’ 00’’ C TIME (MIN) FRACTIONATED PRE-VACUUM G LONG DRYING...
  • Page 81 PROGRAM A PRESSURE (BAR) 134°C HOLLOW UNWRAPPED B PROCESS 134°C – 4’00’’ C TIME (MIN) FRACTIONATED PRE-VACUUM H SHORT DRYING PROGRAM A PRESSURE (BAR) 134°C SOLID WRAPPED B PROCESS 134°C – 4’00’’ C TIME (MIN) SINGLE PRE-VACUUM G LONG DRYING https://stomshop.pro/...

  • Page 82: Diagrams Of The Test Programmes

    19.8. DIAGRAMS OF THE TEST PROGRAMMES PROGRAM A PRESSURE (BAR) HELIX B&D TEST B PROCESS 134°C – 3’0’’ C TIME (MIN) FRACTIONATED PRE-VACUUM H SHORT DRYING PROGRAM A PRESSURE (BAR) VACUUM TEST C TIME (MIN) -0.80 bar INTERMEDIATE CONDITION TO CONTINUE THE TEST M FINAL CONDITION TO PASS THE TEST N VACUUM PHASE O STANDBY...

  • Page 83: Appendix - Maintenance

    20. APPENDIX - MAINTENANCE In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the device’s entire life. Always use personal protective equipment. For better quality of maintenance, supplement routine checks with regular periodic check-ups that can be performed by Technical Service Department (see Appendix).

  • Page 84: Scheduled Maintenance Messages

    20.2. SCHEDULED MAINTENANCE MESSAGES The sterilizer periodically displays warning messages relevant to "routine" maintenance operations that must be carried out in order to ensure the proper operation of the device. Press OK to confirm that the required maintenance operation has been completed. Press “REMIND”...

  • Page 85: Description Of Maintenance Interventions

    20.3. DESCRIPTION OF MAINTENANCE INTERVENTIONS Let’s now look at the various operations to be carried out. 20.3.1. CLEAN GASKET AND PORTHOLE To eliminate any traces of limestone, clean the gasket of the chamber and the door porthole with a clean cotton cloth soaked in a soft solution of water and vinegar (or a similar product, checking the contents on the label before using).

  • Page 86: Door Lock Lubrication

    20.3.5. DOOR LOCK LUBRICATION Using a clean cloth, remove any residues from the bushing and the screw. Lubricate the inside of the bushing on the sterilizer door with a film of the silicon-based grease provided (as shown in the figure). Wear single-use gloves before application.

  • Page 87: Demineralization System Cartridge Replacement

    20.3.9. DEMINERALIZATION SYSTEM CARTRIDGE REPLACEMENT The sterilizer is equipped with an integrated demineralisation system that performs an automatic check of the water conductivity value, including a set of signals. If conductivity exceeds 20 μS/cm, the message E008 - “FILTER NEARLY EXHAUSTED” is displayed. It is possible to carry on using the device without any further action required.

  • Page 88: Periodic Sterilizer Validation

    20.4. PERIODIC STERILIZER VALIDATION As happens with all devices, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components along their lifespan, in a period of time dependent on its frequency of use. To guarantee the safety of the process over time, it is periodically (possibly annually) necessary to verify, the thermodynamic process parameters (pressure and temperature), to check if they continue to remain within allowed limits or not.

  • Page 89: Appendix - General Problems

    21. APPENDIX - GENERAL PROBLEMS If while using the device a problem or an alarm occurs, this DOES NOT mean that the device is out of order. It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a blackout), or incorrect use. In any case, it is important to first identify the cause of the failure and then take suitable corrective actions, either autonomously or with the intervention of the Technical Service Department (see Appendix).
  • Page 90 PROBLEM POSSIBLE CAUSE SUGGESTED SOLUTION Check the quality of instruments, making sure that the Quality of the instruments not adequate. material they are made of is suitable to tolerate the steam sterilization. Empty the tank and fill it with high-quality distilled water.

  • Page 91: Appendix - Alarms

    22. APPENDIX – ALARMS If the problem persists, contact the technical service (see APPENDIX) communicating the sterilizer model and serial number. These data are indicated on the registration plate on the rear side of the device and on the declaration of conformity and can be viewed also by means of the “sterilizer information”...

  • Page 92: System Reset

    23. SYSTEM RESET The system can be reset in two alternative ways, depending on the type of alarm occurred (see the List of alarm codes below in this appendix): Pressing the OK button; Following the instructions displayed and holding down the RESET button for about 3 seconds. Press the RESET button for approx.

  • Page 93: Alarm Codes

    24. ALARM CODES The list of alarm codes, the relevant messages displayed and RESET modes, are indicated in the following table: 24.1. ERRORS (CATEGORY E) The alarm codes in the list can refer to functions that are not present on the models concerned in this Manual CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY...
  • Page 94 CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE WI-FI CONFIG. ERROR E061 The autoclave cannot connect to Wi-Fi network CHECK SETTINGS TEST FAILED Vacuum test failed E900 SECOND STEP (during TEST PHASE) CONTACT TECH.SERVICE TEST FAILED Vacuum test failed E901 FIRST STEP (during STAND-BY PHASE)

  • Page 95: Alarms (Category A)

    24.2. ALARMS (CATEGORY A) CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE FILL.WATER LEVEL A032 Problem with the level sensor of the filling tank SENSOR PROBLEM CONTACT TECH.SERVICE DISCH.WATER LEVEL A033 Problem with the level sensor of the discharge tank SENSOR PROBLEM CONTACT TECH.SERVICE FILLING TANK FILTER...
  • Page 96 CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE SOLENOID VALVE 1 ERROR A131 Solenoid valve 1 failed CONTACT TECH.SERVICE SOLENOID VALVE 2 ERROR A132 Solenoid valve 2 failed CONTACT TECH.SERVICE SOLENOID VALVE 3 ERROR A133 Solenoid valve 3 failed CONTACT TECH.SERVICE SOLENOID VALVE 4 ERROR A134...

  • Page 97: Hazards (Category H)

    24.3. HAZARDS (CATEGORY H) CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE PRESSURE H150 MPX pressure sensor broken/not connected SENSOR OPEN CIRCUIT CONTACT TECH.SERVICE PRESSURE H160 MPX pressure sensor short-circuited SENSOR SHORT-CIRCUIT CONTACT TECH.SERVICE INCORRECT P/T RATIO H400 Pconv/T ratio not balanced (Pconv>T) (STERILIZATION phase) CHECK LOAD INCORRECT T/P RATIO H401...

  • Page 98: System Errors (Category S)

    24.4. SYSTEM ERRORS (CATEGORY S) CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE FLASH MEMORY S001 Flash memory 1 on process board failed NOT ACCESSIBLE CONTACT TECH.SERVICE FLASH MEMORY S002 Flash memory 2 on process board failed NOT ACCESSIBLE CONTACT TECH.SERVICE FLASH MEMORY S003...

  • Page 99: Troubleshooting

    24.5. TROUBLESHOOTING According to the type of alarm occurred, please find below the indications to detect the possible causes and restore the proper operation: 24.5.1. ERRORS (CATEGORY E) The alarm codes in the list can refer to functions that are not present on the models concerned in this Manual. CODE POSSIBLE CAUSE SUGGESTED SOLUTION...
  • Page 100 CODE POSSIBLE CAUSE SUGGESTED SOLUTION The discharge tank contains water of very poor RESET according to the instructions. Empty both tanks IMMEDIATELY, E011 quality. replace filter elements and fill the filling tank. The cycle limit after which integrated filters must be RESET according to the instructions.
  • Page 101 CODE POSSIBLE CAUSE SUGGESTED SOLUTION Contact Technical Service Problem in the hydraulic circuit. (see Appendix). RESET according to the instructions. Excessive humidity in the sterilization chamber. Thoroughly dry the inside of the chamber and restart the program. RESET according to the instructions. E902 Air seepage through the gasket.

  • Page 102: Alarms (Category A)

    24.5.2. ALARMS (CATEGORY A) CODE POSSIBLE CAUSE SUGGESTED SOLUTION Connector of water level sensors in the filling tank not connected. A032 Contact Technical Service (see Appendix). Failure of water level sensor(s) in the filling tank. Connector of water level sensors in the discharge tank not A033 connected.
  • Page 103 CODE POSSIBLE CAUSE SUGGESTED SOLUTION RESET according to the instructions. Thoroughly dry the inside of the sterilization chamber and restart the Water or condensate in the sterilization chamber. cycle. Do not insert material impregnated with water or in general with liquids into the chamber.
  • Page 104 CODE POSSIBLE CAUSE SUGGESTED SOLUTION RESET according to the instructions. Steam seepage through the gasket. Thoroughly clean the gasket with a clean cotton cloth moistened with water and restart the program. RESET according to the instructions. Excessive load. Check that the load does not exceed the maximum values permitted. A258 (See the Summary Table in Appendix Technical Characteristics).

  • Page 105: Hazards (Category H)

    24.5.3. HAZARDS (CATEGORY H) CODE POSSIBLE CAUSE SUGGESTED SOLUTION Pressure sensor failure H150 (MPX). Pressure sensor (MPX) not properly connected to the connector. H160 Pressure sensor short-circuit (MPX). H400 Problem in the hydraulic circuit. H401 Problem in the hydraulic circuit. Steam generator malfunction.

  • Page 106: System Errors (Category S)

    24.5.4. SYSTEM ERRORS (CATEGORY S) CODE POSSIBLE CAUSE SUGGESTED SOLUTION Error of Flash memory 1 on process board S001 Contact Technical Service (see Appendix). Flash memory 1 on process board failed Error of Flash memory 2 on process board S002 Contact Technical Service (see Appendix).
  • Page 107 CODE POSSIBLE CAUSE SUGGESTED SOLUTION Malfunction of control board or Contact Technical Service S041 control software (see Appendix). S042 Malfunction of control board or software Contact Technical Service (see Appendix). S099 Try restarting the program a second time. Malfunction of control board or Try replacing the USB key.

  • Page 108: User Pin Reset

    25. USER PIN RESET If the user enters the pin incorrectly for 3 times, it is necessary to enter the following unlock pin for four consecutive times when you will be prompted to enter pin again: 9999 26. APPENDIX - ACCESSORIES Only use spare parts and accessories that meet the manufacturer’s specifications.
  • Page 109 EXTERNAL PRINTER BARCODE READER NETWORK PRINTER DATA STER SOFTWARE MY TRACE SOFTWARE https://stomshop.pro/...

  • Page 110: Local Printer Connection

    27. LOCAL PRINTER CONNECTION Connect the printer to the RS232 serial port located on the rear of the autoclave (see figure). Load the desired type of paper and turn on the printer. Set the type of paper loaded (see the paragraph PRINT MANAGEMENT). Refer to the printer manual for printer starting and paper loading.

  • Page 111: Appendix - Spare Parts And Accessories

    28. APPENDIX - SPARE PARTS AND ACCESSORIES Only use spare parts and accessories that meet the manufacturer’s specifications. Description Code bacteriological filter 97290160 door gasket (17/22 l) 97400145 door gasket (28 l only) 97467176 demineralised water tank/chamber filter 97290210 discharge tank demineralisation filter and recirculation filter. 97290264 https://stomshop.pro/...

  • Page 112: Appendix - Technical Service

    We will gladly provide any information you may need on the product as well as give you suggestions and advice on the water steam sterilization procedures. In this regard, please refer to the following address: Cefla S.c. Plant Via Bicocca, 14/C 40026 - Imola (BO) IT Tel.
  • Page 113 https://stomshop.pro/...

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