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8 DECLARATION OF CONFORMITY

Manufacturer:

FRANKE MEDICAL OY

Address:

Vartiokuja 1, 76850 Naarajärvi, FINLAND

Hereby declares that: Deko 190 LC 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 ward 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)

- 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

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 190iX

Страница 1: ...DEKO 190iX WASHER DISINFECTOR Rhima Australia Tel 1300 347 944 www rhima com au WASHING EQUIPMENT OPERATORS MANUAL ...

Страница 2: ...2 ...

Страница 3: ...2 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 Operating systems non touch door 15 5 7 3 Running a cycle 16 5 7 4 Cycle recording 22 5 7 5 Viewer 24 5 7 6 Malfunctions 25 5 8 Panel printer 27 5 9 Purging and disinfecting the WD 28 5 10 Methods of cleaning 28 5 11 Flushing of chemical dosing systems 29 5 12 Set the date and time in...

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: ...nto 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 will prevent children at play from being accidenta...

Страница 6: ...o be cleaned and disinfected in the Deko 190 iX Ward Disinfector should have the following properties heat resistant to a temperature of up to 138 0 C corrosion resistance in the presence of heat and alkalinity The high heat retention capacity of stainless steel allows for fast drying Plastics and rubber have a lower heat retention capacity thus needing a longer drying time after processing Alumin...

Страница 7: ...ical ratings See voltage ratings in chapter 5 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: ...with detergent 3 min 45 Circulation rinse hot water 15 s Disinfection 90 1 min Approximate total time with heatings 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 can be loaded on the display LONG Phase 0 C Time m...

Страница 9: ... 3 min 45 Circulation rinse hot water 15 s Disinfection 90 1 min Approximate total time with heatings 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 ...

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

Страница 11: ...cle Read more from chapter 9 0 Programming Maintenance manual 5 3 Process chemicals Deko 190 iX 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 in...

Страница 12: ...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 small amount of foam will substantially decr...

Страница 13: ...plying 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 Chapte...

Страница 14: ...r mode Change to alphabet number PROGRAMMING programming cycles SERVICE service mode Backward Forward ENTER Note Delete backward The door is interlocked without power 1 USB memory stick connector 2 Main display and operation keys 3 Main switch 4 Door handle 5 Panel printer option 6 Detergent container lockable door as option 2 3 4 1 6 5 14 ...

Страница 15: ...USER user mode Change to alphabet number PROGRAMMIN programming cycles SERVICE service mode Backward Forward ENTER Delete backward 1 USB memory stick connector 2 Main display and operation keys 3 Door opening sensor photocell 4 Main switch 5 Panel printer option 6 Detergent container lockable door as option 5 1 2 3 6 4 15 ...

Страница 16: ...tandard user s run mode Adapted user s mode one start key only back to previous display main menu to next display to start NORMAL cycle to start INTENSIVE cycle to start EMPTYING cycle The next cycle number can be seen on the bottom of the display 3 By pressing Prev key back to previous display other modes can be selected USER cycle running mode PROGRAMMING cycle programming mode password required...

Страница 17: ...re 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 th...

Страница 18: ...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 18 ...

Страница 19: ...iables 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 If the machine is unused for a period of ten minutes it will go into standby mode By pressing the CONTINUE key this will bring the machine out of standby and open the door ...

Страница 20: ...se e g emptying cycle a notice will appear on display this must be accepted by pressing OK key or canceled by CANCEL 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 will indicate Name of cycle cycle phase chamber temperature pump pressure remaining cycle time ongoing cycle number and Trends key for temperature...

Страница 21: ...w 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 CONTINUE key this will bring the machine out of standby and open the door interlock manual door Cycle Report Owner PMK Hospital Machine 4 Serial number HK01 Cycle Name BEDPAN Cycle number 1452 C...

Страница 22: ...on USB memory stick Delivered with the manual 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 ...

Страница 23: ... 08 04 51 40 39 0 00 Circulation wash start 08 04 53 40 39 0 00 08 05 41 48 48 0 98 Chem set 45ml T 48C p 0 99bar 08 05 45 48 48 0 99 08 05 48 48 48 0 97 08 05 50 48 48 0 97 Chem flow OK 08 05 54 49 48 0 97 08 05 56 49 48 0 96 08 07 32 49 49 0 92 08 07 36 49 49 0 94 Circulation wash end T 49C p 0 99bar 08 07 39 49 49 0 01 08 07 42 49 49 0 00 08 07 44 49 49 0 01 Hot water rinse start 08 07 50 49 49...

Страница 24: ...g 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 24 ...

Страница 25: ...isinfection Must be confirmed by the user if the cycle does not include disinfection phase Cycle No 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 cut during the cycle There has been a power cut and the ongoing cycle must be restarted Periodic service is needed Will appear if this fe...

Страница 26: ...n an ERROR code will be displayed identifying a possible cause of the fault By pressing Info the possible cause and recommended actions for repair will be displayed See also APPENDIX I List of malfunctions e g Fault 27 needs the actions as follows Actions in Fault case are described in maintenance manual 8 3 Fault log After an incomplete operating cycle all items in washing chamber must be washed ...

Страница 27: ... paper according to the picture above Cycle Report Owner PMK Hospital Machine 4 Serial number HK01 Cycle Name BEDPAN Cycle number 1452 Cycle start time 06 08 17 15 45 03 15 45 10 Cold water flush start 15 46 00 Cold water flush end 15 46 03 Warm water flush start 15 46 34 Warm water flush end 15 46 37 Circulation wash start 15 47 26 Chem flow OK 15 47 30 Chem set 30 ml T 47 0 C 15 48 30 Circulatio...

Страница 28: ...ast phase of the process Service engineers shall pay attention to the state of the machine before dismantling any parts of the chamber or pipework Unless informed otherwise it shall always be assumed that there may be harmful microorganisms present by a Fault condition or water system breakdown 5 10 Methods of cleaning Daily Check that all the sprayers rotate freely and the spray holes are open In...

Страница 29: ...ll a container with hot tap water and put the detergent suction tubes into 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 Repeat the flushing 3 times Put the suction tubes into the deterg nt container and turn on the pumps once again to refill the system with the current detergent 5 12 Set the date and t...

Страница 30: ... 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 31: ...1326 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 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 f...

Страница 32: ...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 33: ...and siphonage 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 Temperature difference between sensors T1 and T2 is over 2 C Calibrate the temperature sensors T1 and T2 13 Water tank is not empty Check pump is running Check function of water level switch Drain blocked 14 Door is not interlocked...

Страница 34: ...34 ...

Страница 35: ...APPENDIX 2 USER INSTRUCTIONS 35 ...

Страница 36: ...36 ...

Страница 37: ...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 38: ...38 ...

Страница 39: ...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 40: ...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 4 Quality ISO 9001 ...

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