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DECLARATION OF CONFORMITY

Manufacturer:

FRANKE MEDICAL OY

Address:

Vartiokuja 1, 76850 Naarajärvi, FINLAND

Hereby declares that: Deko 190 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 13485:2016)

- EN ISO 15883-1

Washer-disinfectors, Part1: General requirements, definitions and tests

- EN ISO 15883-3

Washer-disinfectors, Part3: Requirements and tests for washer-disinfectors
employing thermal disinfection for human waste containers.

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

Eurofins Expert Services Oy

which

Notified Body is no. 0537 under the Council Directive 93/42/EEC.

(Signature)
Antero Asikainen, Managing Director

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Содержание DEKO 190GT

Страница 1: ...Rhima Australia Tel 03 8586 5444 www rhima com au WASHING EQUIPMENT OPERATORS MANUAL DEKO 190GT WASHER DISINFECTOR ...

Страница 2: ...2 ...

Страница 3: ...micals 11 5 4 Requirements on detergent in Deko washer disinfectors 12 5 5 Process variables 13 5 6 Required conditions 13 5 7 Controls 14 5 7 1 Operating systems manual door 14 5 7 2 Running a cycle 15 5 7 3 Malfunctions 20 5 8 Purging and disinfecting the WD 22 5 9 Methods of cleaning 22 5 10 Flushing of chemical dosing systems 22 6 TESTING 23 7 RECYCLING AND DISPOSAL INSTRUCTIONS 23 8 DECLARATI...

Страница 4: ...dition occurs repeatedly 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 ac...

Страница 5: ...ed items will be 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 a program You could burn yourself Do not hose the machine down to clean it Do not sit or lean on the open door This could cause the machine to tip and be damaged When disposing of an old machine make sure the door catch is removed This w...

Страница 6: ...le items textiles fabrics wood paper pulp products tissues and dissolving plastics must not be processed in the Deko 190 washer disinfector Items suitable for processing in a thermal disinfector All products accessories and other items to be cleaned and disinfected in the Deko 190 Washer Disinfector should have the following properties heat resistant to a temperature of up to 138 0 C corrosion res...

Страница 7: ...ical ratings See voltage ratings in chapter 6 5 Electrical connection 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 r 10 of the nominal voltage 7 ...

Страница 8: ...h with detergent 3 min 45 Circulation rinse hot water 15 s Disinfection 90 1 min Approximate total time with heating 11 min The following cycle is used for emptying only The items must be washed and disinfected before taken into use EMPTYING Phase 0 C Time ml Flush cold water 5 s Flush warm water 5 s Approximate total time 1 min The following cycle has longer washing time LONG Phase 0 C Time ml Fl...

Страница 9: ...3 min 45 Circulation rinse hot water 15 s Disinfection 90 1 min Approximate total time with heating 11 min The following cycle is used for emptying only The items must be washed and disinfected before taken into use EMPTYING Phase 0 C Time ml Flush cold water 5 s Flush warm water 5 s Approximate total time 1 min The following cycle has longer washing time LONG Phase 0 C Time ml Flush cold water 5 ...

Страница 10: ...5 1 3 Sequence diagrams Here is a typical curve of DEKO 190 process cycle with main sequences 10 ...

Страница 11: ...from chapter 10 0 Programming Maintenance manual 5 3 Process chemicals Deko 190 can be equipped with one adjustable dosage pump for detergent As an option the machine can be equipped with a descaling liquid pump Please note that the nature of the item to be processed can require additional actions such as dismantling for separate processing the pre cleaning of difficult surfaces inaccessible sites...

Страница 12: ...n process variables are used NOTE When using special chemicals pls find out from the chemical supplier the suitability for chamber material AISI 304 EN 1 4301 BS 304 S31 and chemical dosing system materials PVC and Silicone Chemical hoses are marked with the symbols Detergent 5 4 Requirements on detergent in Deko washer disinfectors 1 Use only liquid detergents 2 The detergent must not foam Even a...

Страница 13: ...lying the machine Water treatment equipment may include e g a softener de ioniser or reverse osmosis plant as necessary Note that many of the attributes of the water supplied to the machine can affect the efficacy and or efficiency of the process These include hardness pH microbial purity as well as various reactive anions and cations For testing the water quality please see EN ISO 15883 1 Chapter...

Страница 14: ...cters USER user mode ESC Backwards PROG programming cycles AC Delete all SERVICE service mode DEL Delete a character ENT ENTER KEY Switch between numbers and letters Note The door is interlocked without power 1 Main display and operation keys 2 Main switch 3 Door handle 4 Detergent container lockable door as option 2 3 1 4 14 ...

Страница 15: ...ard user s run mode page 1 Standard user s run mode page 2 to start NORMAL cycle to start INTENSIVE cycle to start EMPTYING cycle 4 5 6 to start cycles 4 5 or 6 to main menu HOME to next display back to previous display The next cycle number can be seen on the bottom of the display 3 By pressing HOME key other modes can be selected USER cycle running mode PROG cycle programming mode password requi...

Страница 16: ...are pushed over the spray tubes in the door stomach side turned upwards fig 1 2 3 and 4 Urine bottles can be washed together with bedpans bedpan buckets or wash pans Urine bottles can not be washed when an instrument basket is being used Wash pans 4 pcs are placed into the gaps of the grating turned down 3 Other objects as kidney bowls are washed on the grating they must be placed upside down on t...

Страница 17: ...ns 4 urine bottles 4 hand wash basins Various items on shelf Basket for small items 4 urine bottles 4 urine bottles 4 urine bottles Utensil basket Shoe rack Suction bottle rack Kidney bowl rack Rack for 4 extra urine bottles If bedpans do not fit properly to the rack please be in contact with the local distributor 17 ...

Страница 18: ...selected cycle may be cancelled by If the selected cycle does not include pressing key within 5 sec s disinfection phase e g emptying cycle a notice will appear on display this must be accepted by pressing key or cancelled by key NOTE The cycle will not start if the chamber temperature is too high Cool the chamber by opening the door During a cycle the display indicates Selected cycle number 6 Cyc...

Страница 19: ...he door open Beware of hot steam coming from the chamber after opening the door Beware of hot items and load carriers after opening the door It s recommended to allow load items to cool down sufficient time e g 1 min before unloading Note The door is interlocked without power If the machine is unused for a period of ten minutes it will go into standby mode By pressing key this will bring the machi...

Страница 20: ...he door for cooling the chamber Or press cancel to stop the cycle A new cycle will not start if the chamber temperature is over 60 0 C No disinfection Must be confirmed by the user if the cycle does not include disinfection phase Cycle OK No disinfection Must be confirmed by the user if the cycle does not include disinfection phase Open water valves Water valves shall be open when starting Power c...

Страница 21: ...ted and called for if a fault condition occurs In a Fault condition an ERROR code will be displayed identifying a possible cause of the fault See the list of malfunctions APPENDIX I Actions in Fault case are described in maintenance manual 9 3 Fault log After an incomplete operating cycle all items in washing chamber must be washed and disinfected again 21 ...

Страница 22: ...t all the sprayers rotate freely and the spray holes are open In case the fixed or rotating nozzles get blocked the cleaning effect will deteriorate Please take care of keeping the nozzles clear Weekly Use a toilet brush and clean the outlet sieve by brushing it a few times Clean the outer stainless steel panels with diluted washing agent and soft washcloth flush wipe and dry See also chapter 11 3...

Страница 23: ... in periodic routine tests carried out by the user 7 RECYCLING AND DISPOSAL INSTRUCTIONS Packing materials are recyclable and shall be disposed of in accordance with local regulations Electronic control cards and components shall be removed and delivered to respective collection places Machine framework and other metal parts can be recycled and delivered to metal collection places Please follow th...

Страница 24: ...rical equipment for measurement control and laboratory use EMC requirements EN ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes ISO 13485 2016 EN ISO 15883 1 Washer disinfectors Part1 General requirements definitions and tests EN ISO 15883 3 Washer disinfectors Part3 Requirements and tests for washer disinfectors employing thermal disinfection for human was...

Страница 25: ...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 26: ...26 ...

Страница 27: ...hamber bottom water trap check the function of siphon valve Air valve s are not open foam in steam generator 11 Low circulation water pressure Check circulation pump and it s running direction Foaming Check pressure sensor Air valves and siphon valve must be closed during recirculation wash Chamber outlet or drain sieve blocked Check function of tank valve part 2 40 only in open air gap models 12 ...

Страница 28: ...28 ...

Страница 29: ...s missing W105 Detergent calibration not done Calibrated value is missing W300 SD memory card not in place or write protected Files from SD memory card can t be read or write W301 SD memory card full Less than 1 kbyte space on SD memory card W302 Parameters not loaded from SD Fault when reading a file from SD memory card W303 Cycle recipes not loaded from SD Fault when reading a file from SD memor...

Страница 30: ...30 ...

Страница 31: ...APPENDIX 2 USER INSTRUCTIONS 31 ...

Страница 32: ...32 ...

Страница 33: ...date the level When you handle process chemicals wear protection gloves and follow the suppliers safety instructions CLEANING OF SPRAY WASHERS NOZZLES CHECK THAT SIDE WASHER ROTATES FREELY the washer can be removed by opening the screw on top without tool CHECK THAT BOTTOM WASHER ROTATES FREELY the washers can be removed by opening the screw on the top part of the washers without tool CHECK THE UR...

Страница 34: ...34 ...

Страница 35: ...a for centre of the pipe Drain flow rate 2ltr Sec S or P trap inside machine Max discharge temp 65 C 5 STEAM For steam heated model ONLY Steam flexible steel armoured inlet hose with R male thread L 1 2 m 6 CONDENSATE For steam heated model ONLY Flexible steel armoured inlet hose with R male thread L 1 2 m 7 SUCTION HOSE and place for detergent Wall anchors will be supplied must be installed by pu...

Страница 36: ...WM 022073 Rhima 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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