Rhima DEKO 25iX User manual

Rhima Australia
Tel: [phone]
www.rhima.com.au
WASHING EQUIPMENT
OPERATORS MANUAL
DEKO 25iX WASHER DISINFECTOR

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TABLE OF CONTENTS
1SAFETY INSTRUCTIONS AND WARNINGS............................................................................ 4
2INTENDED USE OF THE MACHINE........................................................................................ 6
3STORAGE CONDITIONS ......................................................................................................... 8
4OPERATING CONDITIONS...................................................................................................... 8
5OPERATING INSTRUCTIONS ................................................................................................. 9
5.1Washing and disinfection cycles 9
 Standard cycles / DEKO 25  9

Laboratory cycles / 25 CL 10

Process diagram ..1
5.2Values of the cycles2
5.3Process chemicals and variables2
5.4Required conditions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RECYCLING AND DISPOSAL INSTRUCTIONS......................................................................29
8DECLARATION OF CONFORMITY.........................................................................................30
9WARRANTY TERMS AND CONDITIONS................................................................................31
10APPENDIX I: FAULT LIST....................................................................................................33
11APPENDIX II: USER INSTRUCTIONS .................................................................................35
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1 SAFETY INSTRUCTIONS AND WARNINGS
When using an electrical appliance, basic precautions should always be followed including the
following:
OPERATOR TRAINING
The responsible body shall ensure that all personnel who operate or maintain our machine are
trained in its operation and in its safe use. Furthermore to organize regular training of all
personnel concerned with the operation and maintenance of the machine.
READ ALL INSTRUCTIONS BEFORE USING THE MACHINE
WARNINGS
The manufacturer cannot be held responsible for damage caused when the appliance is not used
according to the instructions, or for uses other than those for which it was intended.
This special commercial machine is suitable for the applications mentioned in the operating
instructions. Use only for purposes machine was designed. The manufacturer cannot be held
responsible for damage caused by improper use.
Do not allow children or unauthorised personnel access to the machine or its controls.
The process needs to be checked and documented by authorised persons regularly. See EN ISO
15883-1, -2, and IEC 61010-2-040.
The cycles must not be interrupted, as it would cause danger and affect the cleaning and
disinfection result. If interruption occurs, do not make an attempt to open door and start the
process again. In case the fault condition 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 accordance with current safety requirements. Any repairs shall
only be carried out by an authorised and a suitably qualified and competent engineer.
The electrical safety of this machine can only be guaranteed if connected to an electrical system
complying with all relevant regulations and checked by the regulating authority. The manufacturer
cannot be held responsible for damage caused by incorrect wiring.
Installation must be done by suitably qualified and competent contractor. Before connecting the
machine, the Installer shall check that the voltage and frequency of the electrical supply
correspond with the details on the data plate of the machine.
Only genuine Franke parts or accessories shall be used with the DEKO 25 Washer Disinfector.
The performance and safety of non-genuine parts or accessories cannot be guaranteed, and use
of such parts or items may void the machine warranty. If you have specific questions about
machine options or accessories, please call your supplier.
The water in this machine must not be used as drinking water.
Only use detergents recommended by Franke. Do not use solvents in your machine due danger
of explosion.
4

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Take care when handling liquids such as detergents, rinsing or neutralising agents. These may
contain acids or alkalis. Follow the instructions and safety procedures on the packaging carefully
and wear protective gloves and goggles. Read the Material Safety Data Sheets.
Empty all containers and glassware before placing in machine. Do not allow any acids or
solvents, especially hydrochloric acid and chlorides, into the wash chamber.
Be careful when sorting instruments with sharp pointed ends. Place the pointed end downwards
if possible.
Install special inserts in accordance with the instructions provided.
When using the machine be careful not to scald or burn yourself. Baskets and inserts must first
be allowed to cool down. Water 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 removed. This will prevent children to
be accidentally locked in.
Be careful when removing the panels and working inside the machine because of possible burrs
and sharp edges. Use safety gloves if possible.
The manufacturer cannot be held responsible for damage caused by failure to heed the warning
and safety instructions.
USED SAFETY SYMBOLS
Dangerous voltage
Be aware of the steam discharge.
The goods and racks are hot to handle.
When you handle process chemicals - wear protection
gloves and follow the suppliers’ safety instructions.
5

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2 INTENDED USE OF THE MACHINE
The DEKO 25 Washer Disinfector is suitable for automatic cleaning and thermal disinfection of
medical devices intended for re-use such as;
* Surgical instruments
* Instrument trays
* Instruments for minimum invasive surgery
* Rigid endoscopes
* Anaesthetic and respiratory equipment
* Hollowware
* Glassware and
* Transit containers
More information in standards:
- 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
When processed in the instrument washer-disinfector, the medical devices may be intended for
immediate use or packed and sterilised. In both cases the efficacy of the cleaning and
disinfection is of major importance. In the first case this is for the well being of the patient, in the
latter case it is for the safety of the staff who handles the instruments in the process of
inspecting, testing and packing the instruments.
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 Medical Device Manufacturer‘s instructions for reprocessing the particular item.
Re-usable medical devices including hazardous chemicals, gases, materials, parts, components
and/or constructions, which do not tolerate water treatment, spray washing and/or heat above
+55 Celsius degrees, disposable items, textiles & fabrics, wood, paper & pulp products, tissues
and dissolving plastics must not be processed in the DEKO 25 washer-disinfector. The DEKO 25
is not designed for the processing of thermo labile flexible endoscopes (covered in EN
ISO15883-1 and15883-4) or re-usable human waste containers (covered in EN ISO15883-1 and
15883-3), laundry or articles used for general catering purposes. DEKO 25 is not intended for the
sterilisation of the load as specified in other standards e.g. EN285.
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Instruments suitable for processing in a thermal disinfector
All instruments, accessories, and other items to be cleaned and disinfected in the DEKO 25
Washer 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. In this case a separate drying
cabinet is recommended.
Aluminium discolours. Aluminium only has a limited suitability 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 the
suitability for processing their items in this system.
Rhodium coated specula must be arranged so that their surfaces do not suffer any mechanical
damage. Not all specula with glass are suitable for machine treatment.
In case you have any questions regarding the suitability of instruments for being processed in the
DEKO 25 Washer Disinfector, please contact the instrument manufacturer for advice.
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3 STORAGE CONDITIONS
Ambient or room temperature 0
0
C-+50
0
C
Relative humidity, non-condensing 10-90 %
Max. storage time 1 year
Atmosphere Non-corrosive
4 OPERATING CONDITIONS
Electrical ratings
This machine is designed for
Voltage ratings: see 5.4 Electrical 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
Cto40
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 specifies over voltage categories only
for measuring equipment)
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5 OPERATING INSTRUCTIONS
5.1 Washing and disinfection cycles
 Standard cycles / DEKO 25
INSTRUMENT PROGRAM, WASH 5 min
Phase
0
C
mm:ss
ml
Rinse, cold water 01:00
Rinse, cold water 01:00
W
ash with detergent
55 05:00 30
Rinse, warm water 55 02:00
Disinfection A
0
= 600 90 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
W
ash with detergent
55 07
:00
30
Rinse, warm water 55 02:00
Disinfection A
0
= 600 90 01:00
Approximate total time with heating 32:00
PLASTICS PROGRAM WITH DISINFECTION
Phase
0
C
mm:ss
ml
R inse, warm water 45 01 :00
Wash with detergent 55 03:00 30
Rinse, warm water 55 01:00
Disinfection A
0
= 600 80 10:00
A
pproximate total time with heating
40
:00
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 Laboratory cycles / 25 CL
SHORT LAB
Phase
0
C
mm:ss
ml
Rinse, warm water 45 2:00
Wash with detergent 55 7:00 30
R
inse, warm water
55 2:
00
Rinse, warm water 55 2:00
Rinse, pure water 45 2:00
Approximate total time with heating 30:00
LONG LAB
P
hase
0
C
mm:ss
m
l
R
inse, warm water
45 2:
00
Wash with detergent 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 from the machine. Water valves in the wash chamber
are unnecessarily open decreasing water pressure.
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 Process diagram
Picture 1: Cycle diagram
Read more from chapter 10.0 Programming (Maintenance manual).
Cold water in + rinsin
g
2min
Chamber em
p
t
y
in
g
Water in + heatin
g
Washin
g
5min
Chamber em
p
t
y
in
g
Hot water in + heatin
g
Rinsin
g
2min
Chamber em
p
t
y
in
g
Hot water in + heatin
g
Disinfection 1 min
Chamber emptying
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5.2 Values of the cycles
Recommended phase values of the cycles.
Time, min,sec [ t ] Temperature,
0
C [ T ]
Chemical volume,ml [Q] Detergent container,nr Using of pure water Dosing temperature, ,
0
C[T]
CW-rinse (rinsing with cold water) 00,10-10 NA NA NA
Yes/No
NA
Wash
1-25
20-80 15-200 1/2
Yes/No
20-80
HW-rinse (rinsing with hot water) 1-25 20-80 NA NA
Yes/No
NA
Disinfection
1-60
75-95 0-10 NA
Yes/No
NA
Waiting time It’s possible to program a waiting time at the end of
the cycle 1-10 min
- Cold water rinse: Only time can be adjusted
-Wash:Time, temperature, chemical volume, chemical container number and chemical dosing point can be adjusted
-Hotwaterrinse:Time and temperature can be adjusted
(Note! Selected temperature must be above hot water supply temperature)
- Disinfection: Time, temperature and rinse aid volume can be adjusted
-Waitingtime:Waiting time after the cycle can be used for cooling down the instruments
-Purewatercanbeselectedinallwaterprocessphases
Note!
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 only.
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) by a
manual process etc. prior to the item being processed by the machine. Such pre-cleaning can be
necessary to reduce the initial bio burden and/or contamination. Please consult the manufacturer
of the medical device for processing instructions and note that the cleaning agents and
disinfectants used by manual processing must be carefully flushed away with water before the
items are loaded into the WD. Failure to do so, may cause excessive foaming and/or pressure
drop in the water recirculation system decreasing the cleaning efficacy and extending the cycle
time.
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Depending on the materials of the medical device being processed a variety of different cleaning
agents may be used. Generally, detergents shall be liquid, non-foaming, non-abrasive, free
rinsing and biodegradable and have the authorities' approvals for their intended use, as required.
For chromium steel surgical instruments alkaline detergents in the pH range 8 -- 14 are preferred.
Usually they may also be used for respiratory equipment. Acid based detergents should only be
used for stainless steel items. Medical devices made of aluminium need specific washing agents
designed especially for them. Please note that different chemicals may require different process
temperatures and times e.g. enzymatic cleaners a temperature between 30 - max 45 degrees
Celsius, whereas an alkaline one a temperature between 60 to 90 degrees. The instructions from
the manufacturer of the chemical e.g. regarding the concentration and temperature shall be
followed. Volume of water in the washing phase is 7.5 litres.
Please follow the instructions of the manufacturer of the chemical additive for safe handling, data
on the biocompatibility (e.g. the maximum permitted residual level 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 supplier the suitability
for chamber material AISI 304 (EN 1.4301, BS 304 S31) and chemical dosing system materials
PVC and Silicon.
Chemical hoses are marked with the symbols: Detergent Rinse aid
When you handle process chemicals - wear protection
gloves and follow the suppliers’ safety instructions.
5.4 Required conditions
See Technical specifications 6.0 and Installation instructions 7.0 (Maintenance manual).
Water quality
DEKO 25 is designed to operate with potable water (
WHO-Guidelines for drinking water quality 1996
refers
) supplied directly to it, or with potable water supplied to the water treatment equipment
supplying 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.
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Should purified water be required for the process, in addition to the direct supply of potable
water, the machine can be equipped with an additional solenoid valve, and in case of a non-
pressurised supply, also with an extra feed pump. In order to ensure freedom from microbial
contamination, rinse water used in a possible final rinse after disinfection shall be treated as
required. For testing the water quality please see EN ISO 15883-1 Chapter 6.4.
Quality of water used in the type tests
For reference, the quality of water used in the process, excluding any final rinse after disinfection,
the following values were determined during the microbiological type tests:
Conductivity: 16, 4 mS/m
PH: 8,1
Ox disables substances (Red ox potential): UH 482 mV
Total hardness (Salts of Ca
2+
,Mg
2+
, Sr
2+
expressed as mmol CaCO
3
): 0,59 mmol/l
Total dissolved solids (TDS) determined as evaporative residue: 96 mg/l
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 pump valves
will not block.
4. Normally detergents being used are highly alkaline. PH-value is
between 10 and 14.
A strongly alkaline liquid will corrode aluminium and its colouring.
Please use special washing agents for aluminium items.
The detergents are powerful and must be handled with care.
In case of accidental contact with the skin or clothing wash immediately
with clean water. For eyes, seek immediate medical attention.
5. Recommended dosage is normally 2-5 g/l.
The used concentration of detergent is related to
- The degree of water hardness
- The degree of uncleanness
- The water temperature
Usually washing temperature should be approx. +50...60
0
C,
With blood washing temperature is lower.
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5.6 Controls
 Operating systems
Touch screen display for user interface Alphanumeric keyboard to enter characters
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
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 9DULRXVUDFNVIRUYDULRXVORDGV
Top wash basket Peg 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

- 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

- 17 -
 USER-mode
START displays below illustrates the choice of max 6+6 different cycles.
Next display
Cycle start key (max 6+6)
Next cycle no to run
Previous display, main menu
Cycle checking
Start the cycle
Open the door, load the machine and close the door
Start the wanted cycle by pressing the start key. If needed, by pressing “Cycle checking” key,
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
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 interlock.
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Read the baskets and instruments (option) Enter the user ID if required.
The selected cycle may be cancelled by If the cycle does not include disinfection phase
pressing the CANCEL 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)
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- 19 -
End of cycle
The end of the cycle will be indicated with an audible buzzer and the text
“loading door can be opened.
Open the door and 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