Sirona DAC PROFESSIONAL, DAC PROFESSIONAL PLUS Operator's Manual
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General notes
ii
Dear customer
We should like to extend our thanks for the expression of trust in our company which you have displayed through the
purchase of this autoclave.
This autoclave was manufactured and checked in accordance with stringent quality criteria. Please read this operator
manual thoroughly before using the autoclave for the first time. The functionality and value retention of your autoclave
depends primarily on careful reprocessing of the instruments and the care taken with the device.
We wish you a great deal of success and enjoyment with DAC PROFESSIONAL / DAC PROFESSIONAL
+
.
Your DAC PROFESSIONAL/ DAC PROFESSIONAL+ team
General notes
Please read this instruction manual before using the device for the first time. The manual includes important safety
information. The functionality and value retention of your device depends on the care accorded to it.
Keep this instruction manual in a safe place near your device. It is a part of the product.
User Group
This manual is targeted at doctors, medical assistants and service.
Scope
This manual applies to the DAC PROFESSIONAL/ DAC PROFESSIONAL+ autoclaves.
About this manual
Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to lifethreatening injuries.
Indicates a situation, which if not avoided, could result in damage to the instruments,
the practice fittings or the device.
Inidcates important information.
Formatting rules
Symbol Explanation
Universal
Program
Words or groups of words that appear on the display of the autoclave are identified as
software quotes
Chapter 6 –
Logging
Reference to another text section within these instructions.
Figure 1/5 Reference to a detail in a figure—in the example given, the reference is to part no. 5
in Figure 1.
General notes
iii
Symbols on the device
Symbol Explanation
The symbol of a crossed-out wheeled bin is used for a device that must not be
disposed of in household waste. It must be sent for expert and proper disposal by the
seller of the device.
By labeling a device with this symbol, the manufacturer also declares that it has met
all legal requirements for the device regarding selling, accepting returns, and
environmentally friendly disposal of electrical and electronic equipment.
By labeling the device with this CE mark, the manufacturer declares that the medical
device meets the essential requirements of the Medical Device Directive. The fourdigit number indicates that an approved certification office monitors this compliance.
By labeling the device with this CE mark, the manufacturer declares that the medical
device meets the essential requirements of the Pressure Equipment Directive. The
four-digit number indicates that an approved certification office monitors this
compliance.
Scope of delivery
Standard scope of delivery
DAC PROFESSIONAL / DAC PROFESSIONAL+
Instruction sheet for downloading the technical documentation
Factory test results
Declaration of conformity with Medical Device Directive
Declaration of conformity with Pressure Equipment Directive
Rack for trays or cassettes
Tray lifter
1 hose to drain the internal water storage tank
1 TORX key to remove the carrying strap
1 lever for emergency locking of the door
1 key for the sterilization chamber filter
2 replacement fuses on the inner door of the autoclave
Optional
Trays
Standard tray cassettes and lifter
Additional racks
General notes
iv
Table of contents
Chapter 1 – Device description ....................... 7
Intended Use ................................................................7
Views of the device .......................................................8
Control panel ................................................................9
Racks for loading ..........................................................9
Chapter 2 – Installation ................................. 10
Electrical connections .................................................10
Feed water connection ...............................................10
Waste water connection .............................................10
Chapter 3 – First steps .................................. 11
Switch on the autoclave ..............................................11
Opening and closing the door .....................................11
Preparing the feed water ............................................11
Setting the date and time ............................................12
Chapter 4 – Sterilizing ................................... 13
Important information about routine operation ............13
Preparing the items to be sterilized ............................14
Loading the autoclave ................................................15
Program selection .......................................................18
Select automatic preheating .......................................19
Start program ..............................................................19
Select extended drying ...............................................20
Program running .........................................................20
Sterilization phase has ended .....................................20
Drying phase ..............................................................20
Program has ended ....................................................21
Manual termination of a program ................................21
Display daily batch counter .........................................23
Displaying the contents of the total batch counter ......23
Removing the sterilized items .....................................23
Storing sterilized items................................................24
Chapter 5 – Logging ..................................... 25
Documentation of batch results ..................................25
Immediate automatic output of logs ............................26
Delayed log output ......................................................27
Displaying the log memory .........................................28
Deleting logs in the internal log memory .....................29
Reading logs correctly ................................................29
Chapter 6 – Functional testing ...................... 31
Automatic functional testing ........................................31
Manual functional testing ............................................31
Batch-related tests ......................................................31
Vacuum test ............................................................... 31
Bowie & Dick test ....................................................... 32
Checking the water quality of the feed water ............. 33
Checking the preheat temperature of the chamber .... 33
Chapter 7 – Maintenance .............................. 34
Checks and cleaning .................................................. 34
Preventing spotting .................................................... 35
Changing the door seal .............................................. 35
Cleaning the filter in the chamber .............................. 36
Maintenance .............................................................. 36
Chapter 8 – Periods of disuse ....................... 37
Sterilization frequency ................................................ 37
Periods of disuse........................................................ 37
Shutdown ................................................................... 37
Starting up the autoclave again after changing location
................................................................................... 37
Chapter 9 – Function descriptions ................ 38
Sterilization procedure ............................................... 38
Type of feed water supply .......................................... 38
Internal process monitoring ........................................ 38
Programs ................................................................... 38
Chapter 10 – Malfunctions ............................ 42
Before calling customer service ................................. 42
Door emergency open in case of power failure .......... 48
Replacing the fuses.................................................... 49
Glossary ........................................................ 50
Technical Data .............................................. 52
Accessories ................................................... 53
Safety Instructions
5
Safety Instructions
When operating the autoclave, please observe the following safety instructions as well as those contained
in subsequent chapters.
Only use the device for the purpose stated in the instruction manual.
Do not use this autoclave to sterilize any liquids.
Power cables and power plug
Never damage or change power cables or power plugs.
Never operate the autoclave if the power cable or power plug are damaged.
Never pull on the power cable to remove the power plug from the socket. Always hold the power
plug itself.
Setting up, installing, starting up
Ensure the setting up, installation and initial start-up of the autoclave is only done by persons
authorized by Sirona.
The electrical connection and the connections to the feed and waste water must only be carried
out by a skilled technician.
In accordance with current VDE specifications, the autoclave is unsuitable for operation in areas
exposed to the danger of explosion.
The autoclave is conceived for use outside the patient environment. The device should be located
a minimum of 1.5 m radius away from the treatment area.
Observe all the information contained in the service handbook for the initial start-up.
DANGER!
Failure to comply with the set-up conditions can result in malfunctions or damage to the
autoclave and/or human injury.
Preparation and sterilization
Follow the instructions of the manufacturer of the textiles and instruments for preparing and
sterilizing the textiles and instruments.
Follow the relevant standards and directives for the preparation and sterilization of textiles and
instruments, e.g., from Robert Koch Institute and the German Association for Supply of Sterile
Goods (DGSV).
Only use wrapping materials and systems that are suitable for steam sterilization according to the
manufacturer.
Program terminated
Note that when opening the door after a program is terminated, depending on when the program
was interrupted, hot steam may escape from the sterilization chamber.
Depending on when the program was terminated, the load may not be sterile. Follow the clear
instructions on the display of the autoclave. If necessary, sterilize the affected load again after
rewrapping the items.
Removing the sterilized load
Never open the door with force.
Use a tray lifter to remove the trays. Never touch the sterilized items, the sterilization chamber or
the door with unprotected hands. These parts are hot.
Check the wrapping of the sterilized items for any damage when removing them from the
autoclave. If the wrapping is damaged, rewrap the item to be sterilized and sterilize it again.
Chapter 1 – Device description
6
Maintenance
Maintenance must only be carried out by authorized persons.
Carrying the autoclave
The autoclave must only be carried by two persons.
Use the supplied carrying belt to carry the autoclave.
Malfunctions
If error messages occur repeatedly during operation of the autoclave, shut down the autoclave
and inform your specialist supplier.
The autoclave may only be repaired by authorized persons.
Chapter 1 – Device description
7
Chapter 1 – Device description
Intended Use
The autoclave is designed for application in a medical context, e.g., hospitals and medical and dental
practices. According to DIN EN 13060, this autoclave is a class B sterilizer. As a universal autoclave it is
suitable for demanding sterilization tasks. You can, for example, sterilize narrow-bore instruments and
handpieces — wrapped or unwrapped — and large quantities of textiles.
DANGER!
When sterilizing liquids, boiling can be retarded which may lead to damage to the
autoclave and burns.
Do not sterilize liquids with this autoclave. It is not approved for the sterilization of liquids.
WARNING
Failure to comply with the safety information can lead to damage and/or safety hazards.
Only use the autoclave for the intended applications described in the accompanying technical
documents and only together with the devices and components recommended by Sirona.
As with the preceding instrument preparation, sterilization of instruments and textiles with this
autoclave may also only be carried out by competent personnel as defined in §2 of the
German Medical Device Operators Ordinance.
Only use instruments, wrapping, and textiles for sterilization that are suitable for steam
sterilization according to the manufacturer.
Chapter 1 – Device description
8
Views of the device
1. Control and display panel
2. Door, pivots open to the left
3. Sliding latch
4. Power switch
5. Front foot of the autoclave (adjustable)
6. Port for emptying the internal
water storage tank—waste water
7. Port for emptying the internal
water storage tank—feed water
8. Serial data and printer connection
(RS232)*
9. Reset key for overheat protection
10. Autoclave fuses—2× 16 A / gRL
*covered by white panel
Fig. 1: Views of the front of the device
11. Tank cap
12. Elongated hole for optional fitting with
the safety combination EN1717
13. Spring-loaded safety valve
14. Sterile filter
15. One-way drain (optional)
16. Emergency overflow hose
17. Cooler
18. Feed water inlet for
water preparation unit
19. Power cable
Fig. 2: Views of the back of the device
1. Rack to hold trays / cassettes
2. Chamber
3. Door lock pin
4. Door port
5. Door seal
Fig. 3: Internal view
Chapter 1 – Device description
9
Control panel
The control panel is made up of a two-line alphanumeric LED display and four membrane keys.
1. Chamber pressure (bar) and (steam) temperature (°C)
2. Time (h:min:s)
3. 2-line LC display
for program status indicators and parameter indicators
4. Function keys (-) and (+)
For selecting, setting, and displaying special functions:
printing, date / time, preheating, total number of sterilized batches, water conductivity, error message
acknowledgement, (+) key to unlock the door.
5. Program selection keys (P)
For selecting the sterilization and test programs and
for selecting/setting options
(submenus) for the special functions.
6. Start/stop key (S)
For starting and stopping programs, for drying, and to control special functions.
Default setting
The display switches to the initial operating state each time the autoclave is switched; the initial operating
state shows the current time and the chamber pressure in bar and the (steam) temperature in °C.
Racks for loading
Rack
The autoclave is always supplied with a rack for holding trays or
cassettes.
Rack (A) is standard and can hold either five trays or, when rotated by
90°, three standard tray cassettes.
Chapter 2 – Installation
10
Chapter 2 – Installation
NOTE
Please carefully follow the instructions for the installation given in the service manual. All
requirements for the building installation are listed in detail in the service manual.
Electrical connections
DANGER!
Improperly made electrical connections can lead to a short circuit, fire, water damage, and/or
electric shock.
Severe injuries may result.
The electrical connection and the connections to the feed and waste water must only be
carried out by a licensed electrician or plumber respectively.
Also note the information regarding the installation and initial start-up in the service manual.
Please comply with the following precautionary measures when handling power cables and power plugs.
Never splice or modify the power cable.
Never bend or twist the power cable.
Always hold the power plug itself to remove it from the power plug.
Do not place heavy objects on the power cable.
Ensure that the power cable is not compressed (e.g., between doors or windows).
Do not place the power cable in front a heat source.
Do not use any nails, staplers or similar objects to fix a cable.
Should the power cable or the power plug be damaged, shut the autoclave down. The power cable or
power plug may only be replaced by authorized persons.
Failure to comply with this precaution can lead to damage to the cable or to the plug and/or to fire or
an electric shock. Severe injuries may result.
Feed water connection
For steam sterilization, the use of distilled or demineralized water, referred to as feed water, is required.
The DIN EN 13060 intends that feed water in accordance with the recommended values in Annex C is
used. The feed water is supplied either via the internal water storage tank or via a separate water
treatment unit; see Chapter 3 – First steps. Detailed information about the connection to a water
treatment unit can be found in the service manual.
Waste water connection
The waste water can either be collected in the internal water storage tank on the waste water side (left)
and manually drained or automatically drained via the one-way drain. To connect the autoclave to the
waste water, a retrofit kit can be ordered for the tank drain.
Chapter 3 – First steps
11
Chapter 3 – First steps
Switch on the autoclave
The autoclave is switched on at the power switch (page 8, Fig. 1/4).
After switching the autoclave on at the power switch, the display shows the message: Unlock the door
with “+” key, if the door is closed, alternating with the initial operating state.
NOTE
Immediately after switching the autoclave on for the first time and before the initial start-up, all
accessory parts must be removed from the chamber.
Opening and closing the door
The door can only be opened when the message: Acknowledge with “+” / Unlock door with
“+” key appears on the display.
1. Press the (+) key. After an audible click, you can open the door.
2. To close the door, press it gently against the chamber flange while pushing the sliding latch down.
Preparing the feed water
Using the internal water storage tank
If the feed water is supplied via the internal water storage
tank, this must be manually filled from time to time. The
autoclave displays an appropriate message when this is
necessary.
The internal water storage tank holds a maximum of 5
liters. This quantity of feed water is sufficient for up to 7
sterilization cycles.
To fill the water storage tank with fresh feed water, remove
the lid and fill the tank (right chamber) up to the MAX mark
with fresh feed water:
Setting the feed water supply to the autoclave
To supply the feed water via the internal water storage tank, the function INTERNAL must be set. To
supply the feed water via a water preparation unit, the function EXTERNAL must be set.
1. Select the Function set-up menu by pressing the (+) and (-) keys at the same time. The display
shows the message Function: Last batch no.
2. Navigate to the message: Function: Feed water supply on the display using the (+) or (-)
keys.
3. Press the (P) key. The display shows the currently selected option.
4. Press the (P) key again to change to the desired setting (INTERNAL/EXTERNAL).
5. Press the (S) key to save the setting and exit the menu.
By pressing the (S) key again, you leave the menu completely and return to the initial operating state of
the display.
Chapter 3 – First steps
12
Using a water preparation unit
To use a water preparation unit, please follow the instructions in the service manual.
NOTICE
Please consult Sirona first if you would like to use a water preparation unit from another
manufacturer.
Failure to comply with these instructions can damage the autoclave and/or the items to be
sterilized.
Setting the date and time
For flawless batch documentation, the date and time of the autoclave must be set correctly. Please note
the switch to and from daylight savings in spring and fall as this is not done automatically. Set the date and
time as described below:
1. Select the Function set-up menu by pressing the (+) and (-) keys at the same time. The display
shows the message Function: Last batch no.
2. Navigate in the “Function” menu using the (+) or (-) keys until you reach the message:
3. Press the (P) key to confirm. The current hour is shown.
4. Using the (+) or (-) keys, select between the following setting options: hour, minute, second, day,
month, year.
5. To set the parameter “hour,” for example, press the (P) key to confirm.
The current value on the display flashes.
6. With the (+) and (-) keys, you can increase or decrease the value.
7. To save the value, confirm with the (P) key.
The value currently set on the display no longer flashes.
To adjust the other parameters, proceed as described above.
8. After the setting is complete, press the (S) key to leave the menu.
The display shows the message Function: Date/time.
9. After pressing the (S) key again, you leave the menu completely and the display shows the initial
operating state again.
Programm
Start-Stop
Function
Date/time
Chapter 4 – Sterilizing
13
Chapter 4 – Sterilizing
Important information about routine operation
Please follow the current recommendations from the Robert Koch Institute (RKI) and the directions in DIN
58946-7 regarding routine operation.
Manufacturer’s recommendation for routine operation of class B
autoclaves
(in accordance with the current recommendations from the Robert Koch Institute)
When does testing need to
be done?
How is testing done?
Once a working day Visual inspection of the door seal and the door closure for any
leaks.
Inspection of the operating media (electricity, feed water, water
connection where applicable).
Inspection of the documentation media (printer paper / computer /
network).
The steam penetration test with the Bowie - Dick test in the universal
program is recommended (test system in accordance with EN 867-5).
Once a week Vacuum test
Tip: In the mornings before starting work—the autoclave must be cold
and dry.
Batch-related tests For instruments in Critical B category:
the test set Helix test should be done together with every
sterilization cycle as a batch control.
For instruments in Critical A category:
a chemical indicator (class 5 as defined by ISO 11140) should be
included together with every sterilization cycle as a batch control.
For instruments in Critical A+B category:
The test set Helix test should be done together with every
sterilization cycle as a batch control.
This simplifies the workflow and increases the reliability. A daily steam
penetration test with the Bowie & Dick test (see above) can then be
omitted.
Another test system as defined by EN 867-5 can be used. Due to the
variety of test systems available, it is not possible for Sirona to provide
technical support for the use of another system.
WARNING
The results of the tests must be documented.
The used indicator test strips themselves do not have to be stored.
Chapter 4 – Sterilizing
14
Preparing the items to be sterilized
Follow the cleaning and care instructions of the manufacturer to prepare the items to be sterilized. This is a
prerequisite for both proper cleaning and disinfection and subsequent sterilization of the items to be
sterilized. The materials, cleaning agents, and preparation methods used are of critical importance.
NOTE
Sterilize textiles and instruments separately if possible in separate sterilizer containers or
sterilization wrap. This will achieve better drying results.
Preparing instruments
Pay attention to the following when preparing used and brand-new instruments:
It is essential that you follow the instructions of the instrument manufacturer when preparing and
sterilizing the instruments and comply with the relevant standards and directives, e.g., BGV A1, RKI,
and DGSV.
The instruments must be cleaned very thoroughly, e.g., with the help of a cleaning and disinfection
unit.
At the end of the disinfection and cleaning, rinse the instruments, preferably with demineralized or
distilled water, and then thoroughly dry the instruments with a clean, lint-free cloth.
Only use care products that are suitable for steam sterilization. Ask the manufacturer of the care
product.
DANGER!
As a result of incorrect preparation of instruments any residual soiling can become loose during
sterilization. Traces of disinfectant and cleaning agents lead to corrosion.
Unsuitable care agents, e.g., water-repellent care agents or oils that are impermeable to
steam, can lead to non-sterile instruments. This places your health and the health of your
patients at risk.
An increased need for maintenance and impaired function of the autoclave may result.
Therefore, it is essential that you follow the preparation instructions described in this manual.
When using ultrasonic units, cleaning equipment for handpieces and turbines, and cleaning and
disinfecting units, you must follow the preparation instructions of the instrument manufacturer.
Preparing textiles
When preparing textiles and when placing textiles in the sterilization containers, pay attention to the
following:
Follow the instructions of the textile manufacturer when preparing and sterilizing textiles and comply
with the relevant standards and directives, e.g., from RKI and DGSV.
Align the folds of the textiles parallel to one another.
Stack the textiles as vertically as possible and not too close to one another in the sterilization
container so that flow channels can form.
Keep the stacks vertical when you pack the textiles into the sterilization container.
If the textile packages do not stay together, wrap the textiles in sterilization paper.
Only sterilize dry textiles.
The textiles must not make direct contact with the floor and walls of the sterilization chamber because
otherwise they become saturated with condensate.
Chapter 4 – Sterilizing
15
DANGER!
The penetration of steam into the washing package can be hindered and/or you obtain poor
drying results. The textiles cannot be sterilized.
This could represent a risk to the health of the patient and the clinical team.
It is therefore essential that you follow the preparation instructions in this manual.
Loading the autoclave
Effective sterilization and good drying results can only be achieved when the autoclave is loaded correctly.
You must therefore pay attention to the following during loading:
Only place trays or cassettes with the corresponding rack into the chamber.
Use perforated trays such as the trays from MELAG. This is the only way to ensure the condensate
drains. If you use solid trays or open pans to hold the items to be sterilized, this may lead to poor
drying results.
Using tray inserts made of paper can also lead to worse drying results.
Wrapping
Only use wrapping materials and systems (sterile barrier systems) that comply with the DIN EN ISO
11607-1 standard.
The correct application of suitable wrapping is critical for the success of the sterilization.
You may use re-usable, rigid packaging such as standard tray cassettes or soft wrapping such as
transparent sterilization wrap, paper bags, sterilization paper, textiles or non-woven fabric.
Closed sterilization containers
When using closed sterilization containers to hold the items to be sterilized, pay attention to the following:
Use sterilization containers made of aluminum. Aluminum conducts and stores heat well and thus
accelerates drying.
Closed sterilization containers must have at least one side perforated—preferably on the bottom—or
have vents.
If possible, only stack sterilization containers of the same size on top of one another which allow
condensate to drain on the side facing the walls.
Chapter 4 – Sterilizing
16
WARNING
Using sterilization containers that are not suitable leads to insufficient stem penetration and the
sterilization may not be successful. The drainage of condensate may also be hindered.
Poor drying results are the consequence. This can ultimately lead to n o n-sterile
instruments and thus endanger the health of patients and the clinical team.
Closed sterilization containers must have at least one point—preferably on the bottom—with
perforations or vents.
WARNING
If the sterilization containers are stacked incorrectly, the dripping condensate cannot drain to the
floor of the chamber. It can saturate the items below.
Poor drying results are the consequence. Non-sterile instruments ma y resu lt an d these
can endanger the health of patients and the clinical team.
When stacking the containers ensure that the sterilization containers do not cover the
perforation.
Soft sterilization wrapping
Soft sterilization packages can be sterilized both in sterilization containers and on trays. Pay attention to
the following when using soft sterilization packages such as MELAfol:
Arrange the soft sterilization packages vertically and close together.
Do not lay several soft sterilization packages flat on top of one another on a tray or in a container.
If a sealed seam tears during sterilization, the packaging may have been too small. If this is not the
case, rewrap the instruments and sterilize them again.
If a sealed seam tears during sterilization, use a longer sealing time on the sealer or use a double
seam.
Multiple wrapping
Because the autoclave uses the fractionated pre-vacuum process, multiple wrapping can be used.
Chapter 4 – Sterilizing
17
Mixed loads
Pay attention to the following when sterilizing mixed loads:
Always place textiles on top.
Sterilization containers on the bottom.
Unpacked instruments on the bottom.
Transparent sterilization wrap and paper packages on top—the exception is when combining with
textiles, then on the bottom.
The heaviest items are on the bottom.
Stack transparent sterilization wrapping as upright as possible so that alternating paper side is against
paper side and film side against film side but if this is not possible then with the paper side facing
downwards.
Loading variations DAC PROFESSIONAL DAC PROFESSIONAL
+
Instruments Textiles Instruments Textiles
Maximum for each individual
part
2 kg 1.8 kg 2 kg 1.8 kg
Maximum total quantity 5 kg 1.8 kg 5 kg 1.8 kg
Loading variations
Rack A
Max. 5 trays, depth 420 mm
Max. 6 sterilization containers
15K
Max. 3 sterilization containers
15M
Max. 2 sterilization containers
15G
Max. 6 sterilization containers
17K
Max. 3 sterilization containers
17M
Max. 1 sterilization container
17G
Max. 3 swab drums 17R
Max. 1 sterilization container
23G
Max. 2 sterilization containers
23M
Max. 2 swab drums 23R
Max. 2 sterilization containers
28M
Max. 1 sterilization container
28G
Max. 3 standard tray cassettes
Max. 5 trays, depth 290 mm
Max 3. sterilization containers 15K
Max. 3 sterilization containers 17K
Max. 3 swab drums 17R
Max. 2 swab drums 23R
Max. 2 sterilization containers 28M
Max. 1 sterilization container 28G
Max. 3 standard tray cassettes
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