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DECLARATION OF CONFORMITY

Manufacturer:

FRANKE MEDICAL OY

Address:

Vartiokuja 1, 76850 Naarajärvi, FINLAND

Hereby declares that:

DEKO 25 complies with the following Directives:

- Medical Device Directive (93/42/EEC)

- The Restriction of Hazardous Substances Directive (RoHs 2011/65/EU)

And that the following harmonized standards have been applied:

- EN 61010-1

Safety requirements for electrical equipment for measurement,

control, and laboratory use

General requirements

- IEC 61010-2-040

Particular requirements for washer disinfectors used in medical,

pharmaceutical, veterinary and laboratory fields.

- EN 61326-1

Electrical equipment for measurement, control and laboratory use.
EMC requirements.

- EN ISO 13485

Medical devices. Quality management systems. Requirements for
regulatory purposes (ISO 13485:2003)

- ISO/FDIS 15883-1 Washer-disinfectors, Part1: General requirements, definitions and tests

- ISO/FDIS 15883-2 Washer-disinfectors, Part2: Requirements and tests for washer-disinfectors

employing thermal disinfection for surgical instruments, anaesthetic
equipment, hollowware, utensils, glassware etc.

This product complies with the essential requirements of the applicable
European laws and Directives with respect to safety, health, environment
and consumer protection. Design, manufacture and final inspection in
Franke Medical Oy are evaluated by

VTT

which Notified Body is no. 0537

under the Council Directive 93/42/EEC.

(Signature)
Antero Asikainen, Managing Director

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Содержание DEKO 25iX

Страница 1: ...Rhima Australia Tel 03 8586 5444 www rhima com au WASHING EQUIPMENT OPERATORS MANUAL DEKO 25iX WASHER DISINFECTOR ...

Страница 2: ...2 ...

Страница 3: ... 3 5 5 Requirements on detergent in Deko washer disinfectors 4 5 6 Controls 5 Operating systems 5 9DULRXV UDFNV IRU YDULRXV ORDGV 6 Starting a cycle 7 USER mode 8 3URFHVV UHFRUGLQJ 1 9LHZHU 3 0DOIXQFWLRQ DQG IDXOWV 4 5 7 Panel printer 6 5 8 Purge and disinfection 7 5 9 Methods of cleaning 7 5 10 OXVKLQJ RI FKHPLFDO GRVLQJ V VWHPV 8 5 11 Set the date and time in user s mode 8 6 TESTING 29 7 RECYCLI...

Страница 4: ...y please call for service In cases of emergency e g fire or flooding cut off the services to the machine using the safety controls provided externally to the unit The machine is completely isolated from the electricity supply only when it is unplugged or the circuit breaker is turned off This must be done before any repair work is carried out The machine is constructed in accordance with current s...

Страница 5: ...may have collected in incorrectly loaded items is very hot and should be emptied into the wash chamber Do not touch the inner surfaces of the wash chamber or the heating elements after the end of program You could burn yourself Do not spray water on the machine Do not sit or lean on the open door This can cause machine to tip and be damaged When disposing old machine make sure the door catch is re...

Страница 6: ... The efficacy of disinfection may be impaired if soil removal is incomplete before the start of the disinfection process Some medical devices may require pre treatment e g soaking brushing ultra sonic pre cleaning lumen irrigation or any combination of these techniques RESTRICTIONS IN USE A number of medical devices are excluded from processing in a washer disinfector altogether Always follow the ...

Страница 7: ...for processing in this machine Carbon steel may corrode in the process Please try the corrosion resistance of carbon steel instruments with initially one instrument or do not process carbon steel items at all Dental hand pieces drill bits grinders root canal instruments or other rotating instruments only have a limited suitability for the thermal disinfector Please ask the manufacturer s advice on...

Страница 8: ...al connections Maintenance manual Pollution degree Pollution degree 2 Installation category Installation category II Maximum relative humidity 80 for temperatures up to 31 0 C Operating temperature range 5 0 C to 40 0 C Maximum altitude Up to 2000 m Voltage fluctuation limits of the mains supply 10 of the nominal voltage Over voltage category Category II Note 61010 1 second edition 2001 02 specifi...

Страница 9: ...0 01 00 Approximate total time with heating 30 00 ANAESTHESIA PROGRAM WASH 7 min Phase 0 C mm ss ml Rinse warmwater 45 02 00 Wash with detergent 55 07 00 30 Rinse warm water 55 02 00 Disinfection A0 600 90 01 00 Approximate total time with heating 32 00 PLASTICS PROGRAM WITH DISINFECTION Phase 0 C mm ss ml Rinse warm water 45 01 00 Wash with detergent 55 03 00 30 Rinse warm water 55 01 00 Disinfec...

Страница 10: ...gent 55 10 00 30 Rinse warm water 55 2 00 Rinse pure water 45 2 00 Rinse pure water 45 2 00 Approximate total time with heating 35 00 SHORT LAB INCL DISINFECTION Phase 0 C mm ss ml Rinse warm water 45 2 00 Wash with detergent 55 7 00 30 Rinse warm water 55 2 00 Rinse warm water 55 2 00 Disinfection pure water 90 1 00 Approximate total time with heating 35 00 Remove unnecessary shelves and racks fr...

Страница 11: ... from chapter 10 0 Programming Maintenance manual Cold water in rinsing 2 min Chamber emptying Water in heating Washing 5 min Chamber emptying Hot water in heating Rinsing 2 min Chamber emptying Hot water in heating Disinfection 1 min Chamber emptying 11 ...

Страница 12: ...ote Do not use raw water rinsing or washing after disinfection phase Set time calculation starts when the required water level and set temperature have been reached Read more from chapter 10 0 Programming Maintenance manual 5 3 Process chemicals and variables DEKO 25 can be equipped with the maximum of 2 adjustable dosage pumps for process chemicals As standard the machine has one detergent pump o...

Страница 13: ...l on devices Note that the residual level which can be tolerated will depend upon the nature of the chemical and the intended use of the product being cleaned The specified performance may not be achieved if other process chemicals than those which have been tested during type testing or separately with certain process variables are used NOTE When using special chemicals find out from the chemical...

Страница 14: ...5 5 Requirements on detergent in Deko washer disinfectors 1 Use only liquid detergents 2 The detergent must be non foaming Even a small amount of foam will substantially decrease the cleaning effect In case there is plenty of foam in the system the machine is unable to clean the goods and automatic foam removal control will start 3 The liquid must be free of particles so that nozzles or detergent ...

Страница 15: ...acters USER user mode Change to alphabet number PROGRAMMING programming cycles SERVICE service mode Backward Forward ENTER Delete backward Note The door is interlocked without power 1 Door handle 2 Main display and operation keys 3 USB connector 4 Main switch 5 Serial printer 6 Ethernet connector 1 4 3 6 5 2 15 ...

Страница 16: ...rack Kidney bowl rack incl wash arm Injector rack for Injector rack for Microscope slide angle pcs and turbines angle pcs and turbines container Utensil basket with lid Petri dish rack Tray holder Bottle rack Mirror container Box for needles and bore bits 16 ...

Страница 17: ... 16 Starting a cycle 1 Open all water supply valves cold hot distilled water 2 Switch the machine ON Main menu is displayed once the system starts up 3 Press USER key to enter in user mode 17 ...

Страница 18: ...ey the steps and variables of the cycle can be checked NOTE The cycle variables i e temperatures times and chemical dosage volumes are pre set and cannot be adjusted prior to or during the cycle Possible changes to the pre set cycles may only be made by using a special code and into the cycle set up Validated factory set cycles however cannot be modified If the machine is unused for a period of te...

Страница 19: ...EL key within 5 sec s this will be warned on display During a cycle the display will indicate Name of cycle cycle phase chamber temperature pump pressure remaining cycle time ongoing cycle number and Trends key for temperature and pressure graph viewing The complete cycle is saved on SD memory card see 5 6 5 All events are printed option during the cycle See 5 7 Panel printer 19 ...

Страница 20: ... unload the chamber Beware of hot items and load carriers after opening the door It s recommended load items to cool down sufficient time e g 1 min before unloading Note The door is interlocked without power Press OK and return to the Cycle start view NOTE If the cycle did not include disinfection phase this will be warned on display 20 ...

Страница 21: ...er or saving on USB memory stick How to copy cycle files on USB memory stick Insert an empty USB memory stick to connector above the terminal In user s mode press Next key to find Copy cycle data to USB memory stick key by pressing it the copying starts automatically Wait until you see on the display that all files have been copied on the memory stick Now the stick can be removed and the cycles ca...

Страница 22: ...0 19 0 01 0 01 10 57 56 46 46 0 68 0 69 Detergent dosed 20 ml 10 57 58 46 46 1 13 1 15 11 01 34 56 56 1 12 1 13 Temperature attained T 56 C p 0 64 bar 11 01 36 56 56 1 08 1 10 11 06 36 57 57 1 13 1 15 Wash end T 57 C p 0 65 bar 11 06 38 56 57 1 16 1 18 Rinse start 11 07 33 56 56 0 01 0 01 11 19 29 56 56 0 66 0 65 Temperature attained T 56 C p 0 61 bar 11 19 31 56 56 1 16 1 17 11 21 30 56 56 1 13 1...

Страница 23: ... key and then double clicking the data file Zoom temperature Select a rectangular area from the display by pressing left button of the mouse and release the button By pressing right button the curve can be moved on the display Quit zooming Zoom pressure Same as above Print Charts By pressing PRINT CHARTS key first question is Do you use colorprinter Select No if you do not have a colorprinter 23 ...

Страница 24: ... closed correctly Chemical tank 1 empty Replace chemical tank 1 Chemical tank 2 empty Replace chemical tank 2 Rinse aid tank empty Replace rinse aid tank Periodic service is needed Inform the service to perform periodic service Power cut off during the cycle There has been a power failure during the last cycle THE CYCLE MUST BE RUN AGAIN Check parameters Call service Set parameters Call service ma...

Страница 25: ...e sensor has open circuit 25 Loading door lock not interlocked 5 Verifying temperature sensor has short circuit 26 Loading door stayed interlocked 6 Verifying temperature sensor has open circuit 27 Door is not closed 7 Water intake is blocked 8 There is water in the chamber 32 Loading door interlock opened during cycle 9 Water heating failed 33 Pressure transmitter has open circuit 10 Water circul...

Страница 26: ...he paper according to the picture above Cycle Report Owner PMK Hospital Machine 4 Cycle Name INSTRUMENT Cycle number 1452 Cycle start time 06 08 17 15 45 03 15 45 10 CW rinse start 15 46 34 CW rinse end 15 46 37 Wash start 15 47 26 Chem flow OK 15 47 30 Chem set 50 ml T 47 0 C 15 47 35 Temperature attained T 50 0 C p 0 73 bar 15 48 30 Wash end 15 48 33 HW rinse start 15 49 30 Temperature attained ...

Страница 27: ...soft washcloth Cleaning of the chamber Ask from the chemical supplier a special chemical with an acidic pH value for cleaning of washer disinfector s chamber surfaces stubborn lime dirt and rust stains and oxide films The dosing volume is generally informed as ml water volume or water volume E g if the recommended dosage is 1 it means with Deko 25 water volume 8 5 l 75 ml of chemical 7 5 l 1 100 0...

Страница 28: ...the container In user s mode press Next key to find Chemical dosing rinse key by pressing it the chemical dosing sytems in use can be flushed e g by pressing Chemical 1 key the pump starts and rotates for 30 sec If the dosing system is in order the number of pulses are about 4000 with water If needed repeat the flushing Put the suction tubes into the detergent container and turn on the pumps once ...

Страница 29: ...ic equipment hollowware utensils glassware etc They may be used in type tests work tests and in validation and re validation tests or in periodic routine tests carried out by the user 7 RECYCLING AND DISPOSAL INSTRUCTIONS Packing materials are recyclable Dispose in accordance with local regulations Electronic control cards and components shall be removed and delivered to respective collection plac...

Страница 30: ...for measurement control and laboratory use EMC requirements EN ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes ISO 13485 2003 ISO FDIS 15883 1 Washer disinfectors Part1 General requirements definitions and tests ISO FDIS 15883 2 Washer disinfectors Part2 Requirements and tests for washer disinfectors employing thermal disinfection for surgical instruments ...

Страница 31: ...ty period starts on the commissioning date The commissioning must be undertaken within 1 month of machine delivery or warranty will commence from the delivery date 3 A warranty claim is not valid for defects caused by tampering or repair work carried out by unauthorized persons This also applies to the fitting of additional accessories which were not designed for our machines 4 If a machine which ...

Страница 32: ...32 ...

Страница 33: ...perature above set limit Check contactors check hot water supply temperature 14 Water circulation pressure dropped too low Check foaming check pump function chamber sieve pressure sensor 16 Difference between temperature sensors is too high Calibrate sensors Values of both sensors can be looked in component testing mode 21 Water pump thermal relay has been tripped Reset thermal relay check the pum...

Страница 34: ...34 ...

Страница 35: ...11 APPENDIX II USER INSTRUCTIONS USER INSTRUCTIONS 35 ...

Страница 36: ...36 ...

Страница 37: ... 1 Replacing detergent containers 38 Cleaning spray arms nozzles 38 Checking free rotation of the wash arms 39 Checking functioning of wash arm water connectors 39 Cleaning outlet filter 39 37 ...

Страница 38: ...he container adjust the length 3 Replace the container of the suction pipe 5 For controlling the consumption of detergent it is recommended to mark with date the level Cleaning spray arms nozzles 1 Unscrew the locking screw and 2 Open the caps turn and pull at both remove the wash arm ends of the arm and clean thoroughly 38 ...

Страница 39: ...ction of water connector 1 Check that wash arms rotates freely 2 Check the operation of the water connector by pressing releasing it detach and clean if necessary Cleaning the outlet sieve 1 Remove the sieve by lifting 2 Flush and clean 39 ...

Страница 40: ...hima Australia Pty Ltd ABN 63 007 242 604 72 74 Woodlands Drive Braeside 3195 PO Box 605 Braeside Vic 3195 Tel 1300 347 944 or 03 8586 5444 Fax 03 8586 5454 www rhima com au Version 1 0 Quality ISO 9001 ...

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