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OPERATOR'S MANUAL

TECHNICAL

STANDARDS

The device complies with Standards ISO 15883-1 and ISO 15883-2 on Washers/Disinfectors

and with Electric Safety Standards IEC 61010-1 and IEC 61010-2-040.

INTENDED USE

DEVICE FOR PROFESSIONAL USE ONLY NOT INTENDED FOR RETAIL SALE.

The product is intended only for the washing and/or thermal disinfection of re-usable surgical

instruments able to resist to a temperature of at least 80°C.

It is not intended for the washing and thermal disinfection of thermolabile medical devices.

It is not intended for the washing of instruments having deep cavities with reduced opening

(since cleaning and disinfection of the inner parts of cavities are not ensured).

It is not intended for the washing of rotary or electronic instruments, unless they are explicitly

indicated as suitable for ultrasonic washing and thermal disinfection by the manufacturer.

It is not intended for the washing of instruments made of not protected aluminium or with

decorative anodizing.

WARNING

THE DEVICE CAN BE USED BY SKILLED PERSONNEL ONLY. UNDER

NO CIRCUMSTANCES IT CAN BE USED OR HANDLED BY UNSKILLED

AND/OR UNAUTHORISED PERSONS.

WARNING

THE APPARATUS IS NOT A MOBILE OR PORTABLE DEVICE.

WARNING

THE TREATMENT IN THE INSTRUMENT WASHER CAN NEVER

REPLACE STERILIZATION. DISINFECTION IN THE INSTRUMENT

WASHER AIMS AT REDUCING THE RISK OF INFECTION OF

PERSONNEL

HANDLING

THE

INSTRUMENTS

DURING

RECONDITIONING PROCESS.

NOTE

INFORMATION CONTAINED IN THIS MANUAL IS SUBJECT TO CHANGE

WITHOUT NOTICE.

THE MANUFACTURER IS NOT RESPONSIBLE FOR DIRECT, INDIRECT

OR ACCIDENTAL DAMAGE RESULTING FROM OR RELATING TO THE

PROVISION OR USE OF THIS INFORMATION.

THIS DOCUMENT MAY NOT BE REPRODUCED, ADAPTED OR

TRANSLATED, IN PART OR IN FULL, WITHOUT THE PRIOR WRITTEN

PERMISSION OF THE MANUFACTURER.

PURPOSE OF THE

MANUAL

The purpose of this manual is to provide instructions for:

- becoming generally familiar with the product;

- its correct installation and configuration;

- its safe, efficient use;

- handling materials before and after washing and/or disinfection.

Its appendixes also provide:

- the product's general technical specifications;

- washing and/or disinfection programme specifications;

- maintenance operations;

- Troubleshooting.

Содержание Tethys H10

Страница 1: ...OPERATOR S MANUAL...

Страница 2: ...PRODUCT HANDLING 8 EMPTYING OF DETERGENT RESERVOIR AND WATER CIRCUIT 8 PRODUCT PRESENTATION 9 GENERAL CHARACTERISTICS 9 LCD ICONS 11 EXAMPLE OF WORKING CYCLE 11 SETTING UP THE DEVICE 12 FOREWORD 12 F...

Страница 3: ...MME 65 SCHEDULED MAINTENANCE MESSAGES 66 DESCRIPTION OF MAINTENANCE INTERVENTIONS 67 CLEAN THE GASKET 67 CLEAN EXTERNAL SURFACES 67 CLEAN WASHING CHAMBER 67 CLEAN CHAMBER FILTERS 68 HEPA FILTER REPLAC...

Страница 4: ...DESCRIBED IN THE MANUAL IN ORDER TO AVOID INJURING THE USER AND OR OTHERS HAZARD THIS SYMBOL INDICATES A POTENTIAL DANGER DUE TO HIGH TEMPERATURE THE MATERIALS THE DEVICE IS COMPOSED OF MUST BE DISPO...

Страница 5: ...E DEVICE CAN BE USED BY SKILLED PERSONNEL ONLY UNDER NO CIRCUMSTANCES IT CAN BE USED OR HANDLED BY UNSKILLED AND OR UNAUTHORISED PERSONS WARNING THE APPARATUS IS NOT A MOBILE OR PORTABLE DEVICE WARNIN...

Страница 6: ...void injury or property damage WARNING THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY DAMAGE THE DEVICE SEE TECHNICAL CHARACTERISTICS APPENDIX IN THIS REGARD Do not pour water or other fluids on...

Страница 7: ...MISSING PARTS OR ANY TYPE OF DAMAGE INFORM IMMEDIATELY AND IN DETAIL THE RESELLER AND THE CARRIER THAT MADE THE DELIVERY DESCRIPTION OF THE CONTENT In addition to the thermo disinfector the package co...

Страница 8: ...USE OF A DIFFERENT PACKAGE MIGHT DAMAGE THE PRODUCT DURING SHIPMENT EMPTYING OF DETERGENT RESERVOIR AND WATER CIRCUIT Before any transport following the first installation it is necessary to empty the...

Страница 9: ...ve hydraulic circuit and the electronic management integrated by high precision sensors ensure a high execution speed of the process and an excellent stability of thermodynamic parameters Moreover its...

Страница 10: ...Temperature probe input process validation 1 Stainless steel chamber 2 Stainless steel basket 3 Detergent reservoir 4 Salt reservoir 5 Chamber drainage filter 1 Air vapour outlet 2 Cooling fan 3 Hose...

Страница 11: ...OF USE WILL BE DESCRIBED IN THE RELATIVE PARAGRAPHS EXAMPLE OF WORKING CYCLE The disinfection programme of Tethys H10 series can be effectively described as a succession of phases each one with a ver...

Страница 12: ...ility and complete use of its features is a correct installation through the thorough compliance with these instructions NOTE TECHNICAL SERVICE DEPARTMENT SEE APPENDIX IS AVAILABLE FOR ANY DOUBT OR FU...

Страница 13: ...justable feet if necessary Check that the bearing surface is strong enough to support the weight of the device in operating conditions about 50 kg Leave adequate room for ventilation all around the th...

Страница 14: ...40V 50Hz 0 03 A 220V 60Hz 120V 60Hz WARNING THE MANUFACTURER IS NOT RESPONSIBLE FOR DAMAGES CAUSED BY THE INSTALLATION OF THE THERMO DISINFECTOR WITH UNSUITED ELECTRIC SYSTEMS AND OR NOT PROPERLY EART...

Страница 15: ...FILLING TAPS Filling taps must be positioned near the device in a position accessible to the user For the positioning of filling taps there are no special constraints of height except the length of t...

Страница 16: ...ER AND ABLE TO SUPPLY WATER WITH MAXIMUM HARDNESS OF 10 f MEASURE THE VALUE IN FRENCH DEGREES f OF MAINS WATER HARDNESS AND SET THE CORRESPONDING HARDNESS VALUE IN THE RELEVANT MENU THERMO DISINFECTOR...

Страница 17: ...rainage water is 95 C both drainage pipe ends must be fixed to the hose fitting and duly secured in place with the supplied clamp the end of the drainage pipe must be placed at a height that complies...

Страница 18: ...ART UP To open the thermo disinfector it is necessary to release the door applying moderate force and take it to the vertical position DOOR OPENING WARNING TO PREVENT THE RISK OF FINGER CRUSHING TAKE...

Страница 19: ...the proper handles as shown in the figure Once it is refitted inside the chamber make sure that both handles are correctly positioned in the proper seats on the chamber surface NOTE HANDLE WRONG POSIT...

Страница 20: ...slowly pour the salt up to the appearance of the salt at the plug level Check that the maximum reservoir filling level is not exceeded At the end of the operation screw the plug in its seat and wait...

Страница 21: ...LOTH OR ABSORBENT PAPER NOTE AT THE FIRST FILLING IT IS POSSIBLE THAT DETERGENT AUTONOMY IS LOWER THAN STANDARD BECAUSE THE SUPPLY CIRCUIT MUST BE COMPLETELY FILLED VALIDATED DETERGENTS We recommend u...

Страница 22: ...SE CIRCUMSTANCES WASHING AND THERMAL DISINFECTION EFFECTIVENESS CANNOT BE ENSURED AND A SPECIFIC VALIDATION TO THE USER IS THUS REQUIRED IN CASE OF DOUBT CONTACT THE TECHNICAL SERVICE DEPARTMENT SEE A...

Страница 23: ...IN MENU At the end of starting procedure the following main menu is displayed The device waits for the cycle selection WARNING THE FIRST TIME THE DEVICE IS USED AFTER THE INSTALLATION AND AFTER A PERI...

Страница 24: ...use Using the configuration programme the user can set a series of options available in user friendly menus NOTE A CORRECT CUSTOMIZATION OF THE DEVICE PROVIDES THE BEST PERFORMANCE AND THE MOST SATIS...

Страница 25: ...hermo disinfector to a pre defined number of users The first user defined on the device will be system administrator This user will thus be able to define and edit the rights of all the other users wo...

Страница 26: ...UNLOCKING PROCEDURE DESCRIBED IN APPENDIX ADMIN USER PIN RESET The ADMIN user can decide whether the device will ask for the generic user PIN at the cycle start PIN START and or at the end of the cyc...

Страница 27: ...By pressing button the ADMIN user can delete the highlighted user from the list Confirm the deletion by pressing OK or press button to go back By pressing button the ADMIN user can choose the cycles t...

Страница 28: ...irectly the new PIN he she can display the cycles he she is enabled to perform and consult his her data For the generic user not ADMIN the list of cycles is in read mode only OTHER CYCLES Press Other...

Страница 29: ...D1 Custom D2 Custom and W1 Custom In any case the first time thermo disinfector is used or after a period of inactivity exceeding 24 hours it is recommended to manually run a Resin Regeneration cycle...

Страница 30: ...Standard AS 2773 2 1999 Ultrasonic cleaners for health care facilities PART 2 SECTION 6 Point 6 2 method ii both for test execution and result Set the device as explained in the Standard and press the...

Страница 31: ...EN OPERATOR S MANUAL 31 Insert tester in the centre of basket and close cover NOTE BEFORE PRESSING YES MAKE SURE THAT TESTER HAS BEEN INSERTED IN THE CENTRE OF BASKET AND THAT COVER HAS BEEN CLOSED...

Страница 32: ...32 OPERATOR S MANUAL EN NOTE INSERT THE TESTER WITHIN 20 MINUTES At the end of the ULTRASOUND TEST the following screen appears and the device is ready to be used...

Страница 33: ...lly Use only limescale removers for water fittings based with Sulphamic Acid and or Citric Acid and or Phosphoric Acid WARNING AVOID USING TOILET PRODUCTS CONTAINING HYDROCHLORIC ACID OR NITRIC ACID O...

Страница 34: ...r hardness command NOTE TO KNOW THE HARDNESS VALUE OF YOUR MAINS WATER CHECK THE VALUE WRITTEN ON THE INVOICE OF YOUR WATER SUPPLY OPERATOR OR CONSULT THE TABLES AVAILABLE ON THE INTERNET The softenin...

Страница 35: ...TION PRE WASHING ULTRASONIC TEST DECALCIFICATION CAN BE INHIBITED IF THE TIME REQUIRED TO CARRY OUT A REGENERATION HAS ELAPSED IN THIS CASE THE DEVICE WILL SIGNAL THIS CONDITION BOTH UPON CYCLE START...

Страница 36: ...temperature water level conversion to inchH2O time format 12 or 24 hours and date Press to confirm the selection DISPLAY Use the cursors shown in the figure to set the desired screen brightness screen...

Страница 37: ...EN OPERATOR S MANUAL 37 SERVICE This menu is intended for the technical service department...

Страница 38: ...d basket or if their dimensions do not allow that fixed to the basket through a thin stainless steel wire WARNING AVOID DIRECT AND REPEATED CONTACT WITH DIRT MATERIALS ALWAYS USE THE UTMOST CARE USE A...

Страница 39: ...EN OPERATOR S MANUAL 39...

Страница 40: ...hase that eliminates traces of humidity from the load Thermal disinfection cycle is suitable for the treatment of the following materials Stainless steel surgical generic instruments Carbon steel surg...

Страница 41: ...perature NOTE A0 THERMAL DISINFECTION PARAMETER A0 PARAMETER INTRODUCED BY STANDARD EN 15883 ALLOWS TO ASSOCIATE A NUMERIC VALUE TO THE THERMAL DISINFECTION LEVEL REACHED A0 IS CALCULATED STARTING FRO...

Страница 42: ...ts or cavities with reduced opening and high depth are explicitly excluded from use The reflective surfaces of mouth mirrors can be damaged by ultrasounds WARNING THE LOAD TREATED WITH THIS PROGRAMME...

Страница 43: ...g the following washing or thermal disinfection cycle Rotary instruments instruments made of untreated aluminium or with decorative anodizing and instruments with ducts or cavities with reduced openin...

Страница 44: ...44 OPERATOR S MANUAL EN Start the cycle by pressing the button corresponding to PRE WASHING CYCLE The cycle counter appears in the upper left corner...

Страница 45: ...2 CUSTOM In thermal disinfection cycles set by the user the cycle can be customized by setting washing temperature A0 value washing duration and drying duration It is possible to set A0 to a value low...

Страница 46: ...er all these selections the estimated total time appears Use key to save settings and go back to the previous screen Press START key to start the cycle defined by the user NOTE THE A0 VALUE SET CORRES...

Страница 47: ...E TREATED AS A MINIMUM AT 80 C OR FOR MATERIALS NOT CONTAMINATED AND NOT INTENDED TO COME INTO CONTACT WITH PATIENTS AT THE END OF THIS PROGRAMME HANDLE THE LOAD WITH CARE USING THE SUITABLE PERSONAL...

Страница 48: ...48 OPERATOR S MANUAL EN WARNING AT THE END OF THE CYCLE IT IS ESSENTIAL TO VISUALLY INSPECT THE OBJECTS TO CHECK THEIR PROPER WASHING...

Страница 49: ...THE TYPE OF LOAD After selecting the desired cycle hold the following key pressed to set the drying time Set total drying minutes of the process The minimum value that can be set is the standard valu...

Страница 50: ...set the delay time Set delayed start time The minimum value that can be set is 30 minutes Cycle start time is displayed close to command Press Enter to confirm setting Cycle start time will be display...

Страница 51: ...e Pre washing phase CYCLE OUTCOME At the end of the cycle it is important to check the process outcome If message CYCLE COMPLETED is displayed this means that the cycle ended correctly without interru...

Страница 52: ...VISUALLY INSPECT THE OBJECTS TO CHECK THEIR PROPER WASHING MANUAL INTERRUPTION The cycle can be interrupted by the operator in any moment by holding down the key indicated in the figure for about thr...

Страница 53: ...mo disinfector settings are displayed DOWNL CYCLE DATA It is possible to copy data about the cycles carried out stored in the inner memory of the thermo disinfector on a USB stick To download the file...

Страница 54: ...st 10 Last 50 Last 100 or Custom Mode If you choose the Customized option set the cycle interval you want to download NOTE CYCLE REPORT FILES ARE IN PDF FORMAT NOTE WHEN A PRESET VALUE IS EXCEEDED THE...

Страница 55: ...ation data required to communicate correctly on the network Very often in small networks DHCP Server functionalities are integrated in the Internet network router For the proper configuration of the t...

Страница 56: ...en Home Type in the number present on the device followed by and by the TPC port number default 10080 in the web browser address toolbar of your PC i e 10 20 8 115 10080 The programme will display the...

Страница 57: ...all the numeric fields on the screen are disabled they get grey Take the first three numbers of the local network numbering in the example above the first three numbers are 192 168 0 NOTE AS AN ALTERN...

Страница 58: ...ector have to be configured in static mode as shown in the previous example taking care that the two devices have the first three fields with the same numbering e g PC 192 168 1 10 thermo disinfector...

Страница 59: ...EN OPERATOR S MANUAL 59 WIFI For WIFI configuration follow the instructions given above for Ethernet network configuration Select the option as shown below...

Страница 60: ...Ultrasonic pressure 79 dB 70 dB 90 dB Environmental operating conditions Ambient temperature between 5 C and 40 C Max relative humidity 80 non condensing up to 31 C Linear decreasing maximum limit up...

Страница 61: ...otection against the excessive absorption due to circuit faults or loads downstream fuses Action interruption of one or more circuits Thermal circuit breakers on mains voltage windings Protection agai...

Страница 62: ...6 25 20 PRE WASHING 25 5 7 DISINFECTION D1 CUSTOM 45 6 15 7 16 80 600 1 200 at 80 C 10 20 at 80 C 0 6 25 According to settings DISINFECTION D2 CUSTOM 90 600 6 000 at 90 C 1 9 at 90 C WASHING W1 CUSTOM...

Страница 63: ...ENTS HAVING DEEP CAVITIES WITH REDUCED OPENING SINCE CLEANING AND DISINFECTION OF THE INNER PARTS OF CAVITIES ARE NOT ENSURED IT IS NOT INTENDED FOR THE WASHING OF ROTARY OR ELECTRONIC INSTRUMENTS UNL...

Страница 64: ...DISINFECTION WASHING TIME means the period of time between the reaching of set washing temperature and drainage start WASHING WASHING TIME means the period of time between the reaching of set washing...

Страница 65: ...ribed below consists in easy manual operations and preventive interventions involving simple instruments WARNING IN THE EVENT OF REPLACEMENT OF COMPONENTS OR PARTS OF THE DEVICE REQUIRE AND OR USE ORI...

Страница 66: ...E OF THESE OPERATIONS Do not wash the thermo disinfector with direct jets of water neither under pressure nor sprinkled Seepage into electrical and electronic components could damage the functioning o...

Страница 67: ...ral detergent Dry the surfaces and remove any residues before using the device CLEAN WASHING CHAMBER Clean the washing chamber and internal surfaces in general with a clean cotton cloth soaked in wate...

Страница 68: ...residues do not drop inside the hole Rinse thoroughly the parts that compose filters 1 and 2 under running water and reposition them in their housings NOTE CORRECTLY PLACE FILTERS 1 AND 2 BACK IN THEI...

Страница 69: ...THE DEALER OR RESELLER THAT SUPPLIED THE PRODUCT CLEAN THE ROTARY NOZZLE Remove the rotary nozzle using the Allen wrench supplied Carefully clean the nozzle under running water and in case of limesca...

Страница 70: ...evidence that the device installed operates within the predefined limits when it is used according to its operational procedures Performance qualification PQ Process to obtain and document the evidenc...

Страница 71: ...th waste electrical and electronic equipment it is forbidden to dispose of this equipment in the municipal waste stream as unsorted municipal waste When purchasing a new equivalent piece of equipment...

Страница 72: ...on 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 w...

Страница 73: ...at the end of the programme Excessive load in the basket Check that the load does not exceed the maximum values allowed See the Summary Table in Appendix Technical Characteristics Load not correctly p...

Страница 74: ...pecialised technician Code format Axxx xxx identification number 000 999 H HAZARD Second level fault The problem can normally be solved by the Technical Service Centre Code format Hxxx xxx identificat...

Страница 75: ...ption Once alarm procedure is completed the indication of the following image is displayed Pressing the RESET button for 3 seconds the door is released and the device goes back to the initial menu Aft...

Страница 76: ...illing 3 A501 WATER LEVEL ABOVE MAX Water presence above the foreseen maximum level 3 A502 WATER FILLING SLOW Water filling time over the maximum limit 3 A503 WATER FILLING FAST Water filling time ove...

Страница 77: ...LAY DESCRIPTION EXIT A957 US UPDATE TRANSMISSION ERROR Ultrasound board update error 2 stand by A958 US VOLTAGE PROBLEM Incorrect US board power supply voltage 3 1 OK warning chamber emptying 2 OK war...

Страница 78: ...mber of cycles depending on set water hardness 2 E071 START CYCLE WITH REGENERATION Signal to start a cycle with resin regeneration Resin regeneration Disinf 90 C Washing D1 Custom D2 Custom and W1 Cu...

Страница 79: ...rature above the limit between Pt1 regulation probe and Pt2 control probe during thermal disinfection phase 3 H751 TEMPERATURE ABOVE MAX LIMIT Temperature PT1 over the limit permitted for thermal disi...

Страница 80: ...cessible during data storage phase 2 S018 IMPOSSIBLE TO OPEN CRC FILE CRC file inside SD card cannot be opened 2 S020 RUN BACKUP Cycle report to be downloaded recommended limit has been reached 2 S021...

Страница 81: ...board If the problem persists contact Technical Service Department A122 Failure to control board If the problem persists contact Technical Service Department A123 Failure to control board If the prob...

Страница 82: ...ap and contact Technical Service Department A601 Temperature sensor PT1 failed Contact Technical Service Department A602 Temperature sensor PT2 failed Contact Technical Service Department A603 Tempera...

Страница 83: ...he lid E552 Attempt to start a cycle with chamber drainage in progress after full chamber alarm Wait for the end of chamber drainage phase after full chamber alarm E070 Lack of salt in the suitable co...

Страница 84: ...epartment H750 Malfunction in temperature detection during thermal disinfection If the problem persists contact Technical Service Department H751 Too high temperature during thermal disinfection If th...

Страница 85: ...tment S018 Failure to control board If the problem persists contact Technical Service Department S020 Cycle report to be downloaded recommended limit has been reached Download cycle report through the...

Страница 86: ...TECHNICAL SERVICE DEPARTMENT OF THE DEALER OR RESELLER THAT SUPPLIED THE PRODUCT We will gladly provide any information you may need on the product as well as give you suggestions and advice on the wa...

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