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Summary of Contents for NSK DXP clave
- Page 1 STEAM STERILIZER OPERATOR MANUAL DXPclave USE and MAINTENANCE Rev. 03 Date: February 2024 OM1018EN...
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Page 3: Table Of Contents
Sommario 1. General Information ............5 Purpose of the manual ............................5 Criteria for use of the manual and finding information ................... 5 Professional user profiles ..........................6 Conformity to European Directives ........................6 Warranty ................................7 2. Safety information ............8 General safety information ..........................8 Safety and protection features on the device .................... - Page 4 Sommario 4.8.5.b Export report at the end of cycle ........................32 4.8.5.c Format USB Stick..............................32 4.8.5.d Export report ..............................32 4.8.6 Maintenance menu ............................32 4.8.7 Technical menu..............................32 5. Using the sterilizer ............33 Turning the sterilizer on ...........................33 Opening / closing the door ..........................33 Disposizione vassoi e dimensioni ........................34 Daily tests to check the sterilizer’s performance ...................34 5.4.1...
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Page 5: General Information
General Information 1. General Information Purpose of the manual This operator manual was issued by NSK Dental Italy to provide the operator with the necessary information for: „ proper installation „ appropriate and safe use „ careful maintenance The manual is an integral part of the DXPclave steam sterilizer, hereafter referred to in this manual as the “sterilizer”... -
Page 6: Professional User Profiles
Note: Any serious accident occurring with the device must be reported to the Manufacturer and to the competent authority of the Member State where the accident occurred. Please report incidents, near misses and product malfunctions to the NSK Dental Italy customer care office at: servicesterilization@nsk-italy.it. -
Page 7: Warranty
„ In the event of faults and/or malfunction, follow the guidelines given in paragraph 6.3 “Notice list” and paragraph 6.4 “Alarms list”. If the problem persists, do not attempt to operate the device but contact the NSK Dental Italy technical support: NSK Dental Italy, Via dell’Agricoltura 21, 36016 Thiene (VI), email address: servicesterilization@nsk-italy.it... -
Page 8: Safety Information
Keep the plug in the socket until the sterilization is finished and do not use the socket for other devices at the same time. • Use only original NSK Dental Italy power cables, as other cables can cause electric shock, fires or damage to the device. •... -
Page 9: Safety And Protection Features On The Device
Safety information 2.2 Safety and protection features on the device The sterilizer has several devices, listed below, that ensure the total safety of operators. 2.2.1 Soft-close door with double safety An electromechanical device allows the door to be opened only under the following conditions: •... -
Page 10: Safety Signs On The Device
Safety information 2.3 Safety signs on the device The following warning and hazard signs are located on the sterilizer in the positions indicated. Caution! Hot surfaces. Caution! Drain water. Caution! Water loading area. Use only demineralized water. Tank capacity: 5 litres. Caution! Hot surfaces. -
Page 11: Residual Risks
Safety information 2.4 Residual risks The sterilization process works by means of pressurized steam at high temperature. When removing a load from the sterilization chamber, always use suitable tools and personal protective equipment for handling the hot racks and tools. When opening the sterilizer door, particularly during a cycle failure, a small quantity of steam or hot condensate may be released;... -
Page 12: Characteristics
Characteristics 3. Characteristics 3.1 Description of the sterilizer The DXPclave is a table-top steam sterilizer designed for the sterilization of dental and medical products and equipment, in accordance with the requirements of standard EN 13060. It consists of an airtight stainless steel sterilization chamber accessed through a front door; it is protected by an external shock-resistant moulded plastic body and equipped with protective devices that allow operators to use it in full safety. -
Page 13: Units That Make Up The Sterilizer
Characteristics Units that make up the sterilizer... - Page 14 Characteristics Position Description Door Clean demineralized water tank input Operator panel Front USB port Main switch Printer (optional) Handle Steel sterilizing chamber closure disc Sterilization chamber Safety valve connection Pressure sensor Temperature sensor Tray Holder Locking Electromagnet Drain Filter Water drain connection Water drain selector Bacteriological filter Condenser...
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Page 15: Components Supplied With The Sterilizer
Characteristics 3.5 Components supplied with the sterilizer Position Description Rubber hose Water filter extraction key Small tray (2 pieces) Large tray (3 pieces) USB-key with operator manuals and general catalog (it can also be used for cycle downloads) Tank water filter Chamber water filter Rear spacer (2 pieces) Rack insertion and extraction clamp... -
Page 16: Size And Weight Of Package
Characteristics 3.6 Size and weight of package Packaging size: 570 x 672 x 780 (L x A x P) Total weight of DXPclave 18 package: 67 kg Total weight of DXPclave 24 package: 69 kg Keep the original packaging intact. 3.7 Size and weight of sterilizer DXPclave 18 DXPclave 24... -
Page 17: Technical Specifications
Characteristics 3.8 Technical specifications DXPclave 18 DXPclave 24 Diameter 265mm 265mm Chamber dimensions Depth 382mm 475mm Chamber volume 18 lt 24 lt Solid load 5,0 kg 7,0 kg Maximum load (including trays) Porous load 1,5 kg 2,0 kg 6’30” from room temperature Heating time 1’30”... - Page 18 Characteristics Sound emission 60 dB(A) Operating cycle Continuous Pollution level 2 (IEC 61010-1) Transient overvoltage II (IEC 61010-1) LOW/HIGH WATER CONDUCIVITY (in reference to a Water conductivity control value of 15 microsiemens) Available volume on trays 10 l Maximum chamber temperature 137°C (-0+2°C) Safety valve intervention pressure [2] 2,55 bar...
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Page 19: Labels And Symbols
Characteristics 3.9 Labels and symbols 3.9.1 Labels present on the back of the sterilizer There are 2 labels which are fixed in the back of the sterilizer: the serial number label and the UDI label. These labels contain, in addition to the CE marking, important data for operation, already indicated in the technical data table, and the serial number. -
Page 20: Symbols Legend
The data given next to this symbol identifies the manufacturer. NOTE: this symbol must be accompanied by the name and address of the manufacturer. NSK Dental Italy S.r.l. Manufacturer’s name. Via dell’Agricoltura 21, 36016 Thiene (VI) IT Manufacturer’s address. Date of manufacture. - Page 21 Characteristics Identification number of the notified body. Notified body: TÜV SÜD Product Service GmbH, 0123 Zertifizierstelle, Ridlerstraße 65, 80339 München – Germany. EN13445 Ed.2019 Issue 4 Design code for the sterilization chamber. Fluid Group 2 Fluid classification according with the PED directive. Risk Category I Sterilization chamber risk category.
- Page 22 Characteristics Humidity limitation: Indicates the range of humidity to which the medical device can be safely exposed. Atmospheric pressure limitation: Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Fragile, handle with care: Indicates a medical device that can be broken or damaged if not handled carefully.
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Page 23: Installation
Installation 4. Installation Unpacking and transport The packaging of the sterilizer consists of a wooden pallet on which the sterilizer is placed, with adequate protective padding and a corrugated cardboard casing fixed to the pallet with metal staples. Place the package on a level surface free from clutter to facilitate easy opening and safe extraction of the sterilizer. There may be a small amount of water inside the chamber due to a residue inside the autoclave hydraulic circuit. -
Page 24: Positioning
Installation 4.2 Positioning Check that the power supply voltage to the device matches that one shown on the regulatory label on the rear panel, that the power outlet is designed to supply at least 16A and that it has an earth connection. If the installation makes the main power switch inaccessible, a specially dedicated accessible electrical disconnection switch should be provided. - Page 25 Installation In the case of built-in installation with a shelf above the device, a space of at least 5 cm should be left between the bottom of the shelf and the top of the device. Place the device on a mobile shelf with a sliding rail extraction system to allow filling of the deionized water tank, positioned on the top.
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Page 26: Initial Start-Up
Installation 4.3 Initial start-up The following operations must be carried out by qualified and properly trained personnel. Incorrect procedures and settings can jeopardize the quality of sterilization and cause hazards. BEEP „ Check that the power supply has the right voltage and plug the power cord into the outlet. -
Page 27: Home Menu
Installation Home menu The device has a HOME screen, where you can easily find the main menu of selectable programs and tests (CYLCES and TESTS), the selection of the most used cycles (B UNIVERSAL and VACUUM), the INFO menu (with a quick view of all general information of the device, such as serial number, firmware version and water conductivity) and the SETTINGS menu (to manage the parameters of configuration of the autoclaves, including date and time regulation, language selection, report download, connections with printers and ethernet). -
Page 28: Settings Menu
Installation 4.8 Settings menu The SETTINGS menu allows to manage the settings of the different autoclave options, connections with printers and ethernet. In this menu you can also manage the storage of reports on the device and all the advanced features relating to maintenance and technical assistance. 4.8.1 General settings The GENERAL settings menu allows to manage the settings of:... -
Page 29: Pressure And Temperature Unit Modification
Installation 4.8.1.b Pressure and temperature unit modification Pressing the UNITS button you access on the pressure measure unit menu. In this menu it is possible select the pressure and temperature measure unit to be displayed. Pressure unit modification: it is possible modify the pressure unit by clicking the PRESSURE UNIT button. -
Page 30: Operator Menu
Installation 4.8.2 Operator menu The OPERATOR menu allows to manage the operators and modify the operators name, password and the cycles they can use. 4.8.2.a Create a new operator Pressing the green button you access on the new operator menu. In this menu it is possible create a new operator to be selected on autoclave. -
Page 31: Printers Menu
Installation 4.8.3 Printers menu Pressing the PRINTER button you access on the printer magament menu (if available). In this menu you can manage the internal label, the external printer that generate labels, the printer that generate reports and any reprints. 4.8.3.a Activation / Deactivation internal printer Pressing the INTERNAL button you access on the menu for activating or deactivating the internal printer. -
Page 32: Export Report On Usb Insertion
Installation 4.8.5.a Export report on usb insertion Pressing the ON USB INSERTION button all reports are exported when a USB key is inserted. 4.8.5.b Export report at the end of cycle Pressing the AT END OF CYCLE button all report are automatically export after the termination of the cycle. -
Page 33: Using The Sterilizer
Using the sterilizer 5. Using the sterilizer 5.1 Turning the sterilizer on Turn the sterilizer on using the main switch on the right of the device. After initialization is complete (see paragraph 4.3 “Initial start-up”) the HOME screen will appear, showing the main menu setup with buttons. -
Page 34: Disposizione Vassoi E Dimensioni
Using the sterilizer Turn the handle and lift it upwards as far as it will go, then pull the door towards you. Note: The padlock remains ORANGE (door opening is possible) for 60 seconds after which it turns GREEN again, no longer allowing the door to be opened. -
Page 35: Vacuum Test
Using the sterilizer 5.4.1 Vacuum test Adhere to national and local guidelines regarding testing frequency. The purpose of the Vacuum test is to ensure that the sterilization chamber is perfectly sealed. The manufacturer recommends running the test at the start of the day, before beginning the daily sterilization cycles. The Vacuum test is activated with the machine unloaded, in standby mode and at an internal temperature below 35°C, which are the typical conditions of the state of the device at the start of a working day. -
Page 36: Treatment Of Materials And Instruments Before Sterilization
Using the sterilizer 5.5.2 Treatment of materials and instruments before sterilization Failure to clean and remove organic residues from the instruments to be sterilized can affect the sterilization process and cause damage to the instruments and/or the sterilizer. Clean and process the materials and instruments to be sterilized as indicated in the following points: 1. - Page 37 Using the sterilizer „ Arrange instruments of different metals, previously separated, on different trays; „ When sterilising instruments made of metal other than stainless steel, place a sheet of sterilization paper between the tray and the instrument to avoid direct contact between the two materials; „...
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Page 38: Program Selection
Using the sterilizer 5.7 Program selection Depending on the degree of sterilization to be obtained, the operator has various types of programs available, with a class B or class S sterilization cycle, described in the program table. To select the programs, press the corresponding button on the operator panel. PROGRAM TABLE Process Maximum... - Page 39 Formato / format Riproduzione vietata. Tutti i diritti sono riservati. Nessuna parte del presente documento può essere 1:50 riprodotta o diffusa con un mezzo qualsiasi, fotocopie, microfilm o altro, senza il consenso scritto di NSK Data / Date Nome / Name 0.000...
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Page 40: Sterlization Time Modification
Using the sterilizer 5.7.1 Sterlization time modification Pressing the highlighted button you access to the sterilization time modification menù. The minimum acceptable sterilization time is definied according to the cycle and the EN13060 standard (it will not be possible to have shorter sterilization times). - Page 41 Using the sterilizer CLASS B CYCLES Time Minimum Maximum Minimum Maximum (min) pressure (bar) pressure (bar) temperature (°C) temperature(°C) +0,5 bar +0,51 bar -0,81 bar -0,8 bar +0,5 bar +0,51 bar -0,81 bar -0,8 bar +0,5 bar +0,51 bar -0,81 bar -0,8 bar 4’...
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Page 42: Pre-Heating Phase (1)
Using the sterilizer CLASS S CYCLES Time Minimum Maximum Minimum Maximum (min) pressure (bar) pressure (bar) temperature (°C) temperature(°C) +0,5 bar +0,51 bar -0,81 bar -0,8 bar +0,5 bar +0,51 bar -0,81 bar -0,8 bar 3’30” +2,03 bar +2,3 bar 134°C 137°C 5.8.1 Pre-heating phase (1) -
Page 43: Sterilization Phase (3)
Using the sterilizer 5.8.3 Sterilization phase (3) During the sterilization phase, the temperature and pressure are kept stable for a predefined time in order to carry out the load sterilization process. The STOP during this phase leads to an interruption of the cycle according to EN 13060. 5.8.4 Drying phase (4) The drying phase begins at the end of the sterilization phase, the duration of which complies with the predefined parameters. -
Page 44: Interrupting The Programme
Using the sterilizer 5.9 Interrupting the programme If necessary, a running program can be aborted at any time by pressing the STOP button. In case of interruption of the cycle during the drying phase, the load is considered sterilized and it doesn’t foresee a restart of the cycle. -
Page 45: Checking The Water Quality
Using the sterilizer The water in the used water tank should be considered as biologically contaminated, therefore appropriate precautions should be taken if the tank is emptied. Used water must be disposed of in accordance with local or national regulations. The demineralized water tank can also be drained in the same way, if necessary, connecting the tube to the attachment quickly and positioning the selector on clean water. -
Page 46: Connections
The recommended printer model offered by NSK Dental Italy is coded Ref. 9900009, it’s a powerful compact desktop printer that can be connected to the USB port located in the back or front side of the device. In sequence: 1. -
Page 47: Cybersecurity
Using the sterilizer 5.12 Cybersecurity This sterilizer has been designed and manufactured by NSK Dental Italy with the aim of removing, as far as possible, the impairment of performance or the risks associated with possible negative interactions between the device and the IT environment in which it operates, even if the medical device does not patient data is managed or saved, but only cycle reports. -
Page 48: Alarms
Alarms 6. Alarms 6.1 Generality When the device is switched on and during each sterilization cycle, the characteristic parameters of the various phases of the cycle are constantly monitored, together with the proper functioning and acceptable condition of all the components. Any anomaly or fault is immediately indicated on the display through warning messages and alarm codes, together with an acoustic signal. -
Page 49: Notification List
Alarms Conductivity of clean water Replace or fill the clean water Check clean water quality higher than 15 µS/cm, therefore tank with demineralized water. too high. Chamber temperature too high, Turn off the device and leave the Wait for cooling Vacuum test not possible. -
Page 50: Alarms List
Alarms 6.4 Alarms list DISPLAY MESSAGE CAUSE SOLUTION Failure of the door closing Door closing fault system sensors during the cycle. Contact technical assistance. Sterilization not completed. Failure in the door closing Dry the load and use it Door closing fault system sensors during drying. -
Page 51: Maintenance
Maintenance 7. Maintenance Ordinary maintenance Maintenance of the device must be carried out by suitably trained personnel, who have read and understood all the procedures and information given in this instruction manual, particularly in chapter 2 “Safety information”. Always wear sterilized disposable latex gloves. To ensure maximum life and reliability of the device, it is recommended to perfect the cleaning and washing techniques of the instrumentation. -
Page 52: H2O Chamber Filter Clean And Replacement
Maintenance 7.1.2 H2O chamber filter clean and replacement To clean or replace the H20 filter in the chamber, it must be opened the hatch (unlocking it with the appropriate command on the screen) e unscrewing the filter at the bottom using the key supplied in the autoclave accessories kit. -
Page 53: Fuses Replacement
“Technician” who corresponds to qualified and authorized personnel who carry out the operations at the NSK Dental Italy company, if the sterilizer must be returned or collected for repairs to be carried out in the laboratory or in the factory, please remember to accompany the sterilizer with a photocopy of the sales invoice and in case of return of the appropriate RMA authorization which must always be requested in advance before sending the device to the customer office care of NSK Dental Italy. -
Page 54: Hot And Cold Spot Inside The Chamber
Maintenance VACUUM PUMP R604011 R604011 DRAINAGE SELECTOR ASSEMBLY R153009 R153009 CHAMBER ASSEMBLY R153002 R153001 TRAY HOLDER R716003 R716002 NARROW TRAY R716030 R716028 WIDE TRAY R716029 R716027 NETWORK FILTER R020185 R020185 SAFETY VALVE R220005 R220005 CHAMBER FILTER R105320 R105320 EU POWER CORD (SHUKO PLUG) R607003 R607003 UK POWER CORD (UK PLUG) -
Page 55: General Scheme
Maintenance General Scheme 7.8.1 Electric circuit... -
Page 56: Idraulic Circuit
Maintenance 7.8.2 Idraulic circuit Rev. 3 Rev. 2 Rev. 1 Scala / scale Peso (Kg) / Weight Formato / forma 1:20 0.000 Materiale / Material Materiale <non sp Trattamento / Treatment Descrizione / Descript Quote senza indicazione di tolleranza / Measures without tolerance indication Assieme ISO 2768 mK... -
Page 57: Disposal
Disposal 8. Disposal The disposal of this device, as an electrical and electronic device, must be carried out separately from household waste by delivering it to your local collection / recycling center. Packaging must be disposed of in accordance with local regulations applicable to the following materials: Outer box: carton;... - Page 59 www.dxp-sterilization.com...
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