Durr Dental Hygosonic User manual

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2016/12SE
Hygosonic
Installation and Operating Instructions
9000-616-14/30
*9000-616-14/30*

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2016/12SE
Contents
Important Information
1. General . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Note on Conformity . . . . . . . . . . . . . 4
1.2 General Notes . . . . . . . . . . . . . . . . . 4
1.3 Appliance Disposal . . . . . . . . . . . . . 4
1.4 Notes on Medical Products . . . . . . . 4
1.5 Intended purpose . . . . . . . . . . . . . . . 4
1.6 Correct Usage . . . . . . . . . . . . . . . . . 5
1.7 Incorrect Usage . . . . . . . . . . . . . . . . 5
2. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 General Safety Notes . . . . . . . . . . . . 5
2.2 Electrical Safety Notes . . . . . . . . . . . 5
3. Warning and Symbols . . . . . . . . . . . . . 6
3.1 Model identification plate . . . . . . . . . 6
4. Delivery Contents . . . . . . . . . . . . . . . . 7
4.1 Special accessories . . . . . . . . . . . . . 7
4.2 Disposable materials . . . . . . . . . . . . 7
5. Technical Data . . . . . . . . . . . . . . . . . . . 7
6. Functional Description . . . . . . . . . . . . . 8
Installation
7. Set up . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.1 Room for set-up . . . . . . . . . . . . . . . . 9
7.2 Set-up alternatives . . . . . . . . . . . . . . 9
8. Electrical Connections . . . . . . . . . . . . 9
9. Circuit diagram . . . . . . . . . . . . . . . . . . . 9
Operation
10. Instructions for use . . . . . . . . . . . . . . 10
10.1 Performing routine checks of the
unit before initial commissioning . . 11
10.2 Preparation . . . . . . . . . . . . . . . . . . 12
10.3 Operation pad . . . . . . . . . . . . . . . . 13
10.4 Cleaning process . . . . . . . . . . . . . 14
10.5 Empty unit . . . . . . . . . . . . . . . . . . 14
10.6 Recommended disinfection and
cleaning agents . . . . . . . . . . . . . . . 15
11. Maintenance . . . . . . . . . . . . . . . . . . . . 15
11.1 Routine check of the unit . . . . . . . . 15
11.2 Ultrasound bath care . . . . . . . . . . . 15
11.3 Disinfection and cleaning . . . . . . . . 15

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Important Information
1. General
1.1 Note on Conformity
This product was tested for conformity to the
Guidelines 93/42/EWG of the European Union
and has been found to satisfy all criteria of these
guidelines.
1.2 General Notes
• These Installation and Operating Instructions
form an integral part of the unit. They must be
kept close to the unit at all times. Precise ob-
servance of these instructions is a precondi-
tion for use of the unit for the intended purpo-
se and for its correct operation.
New personnel must be made aware of the
contents, and they should be passed on to fu-
ture operating staff.
• Safety for the operator as well as trouble-free
operation of the unit are only ensured if use is
made of original equipment parts. Only acces-
sories which are expressly mentioned in the
Installation and Operating Instructions may be
connected or those recommended explicitly
by Dürr Dental. If other accessories are used
with this appliance, Dürr Dental cannot gua-
rantee safe operation or proper functioning.
No liability on the part of the manufacturer will
be accepted in the case that damage arises
through the use of non/approved accessories.
• Dürr Dental are only responsible for the equip-
ment with regard to safety, reliability and pro-
per functioning where assembly, resettings,
changes or modifications, extensions and re-
pairs have been carried out by Dürr Dental or
an agency authorized by Dürr Dental and if
the equipment is used in conformity with the
Installation and Operating Instructions.
• These Installation and Operating Instructions
conform to the relevant version of the equip-
ment and the underlying safety standards va-
lid at the time of going to press. All switches,
processes, trade marks, software programs
and appliances named in this document are
registered names.
• The translation of these Installation and
Operating Instructions has been carried out in
good faith. No liability can be accepted for mi-
stakes in the translation. The enclosed
German version of these Installation and
Operating Instructions is the reference versi-
on. If there is any doubt about the translation
please consult your dealer.
• Any reprinting of the technical documentation,
in whole or in part, is subject to prior approval
of Dürr Dental being given in writing.
• Retain the packaging for possible return of the
product to the manufacturers. Ensure that the
packaging is kept out of the reach of children.
Only the original packaging provides adequate
protection during transport of the unit.
Should return of the product to the manufac-
turers be necessary during the guarantee peri-
od, Dürr Dental accepts no responsibility for
damage occurring during transport where the
original packaging was not used!
1.3 Appliance Disposal
The EU Directive 2012/19/EU - WEEE (Waste
Electric and Electronic Equipment) and its
current version in national law states that dental
products are covered by this directive and,
within the European Union, must be disposed of
as special waste.
If you have any questions regarding the correct
disposal of this product please contact Dürr
Dental or your usual dental supplier who will be
happy to help.
1.4 Notes on Medical Products
• This product is a technical medical appliance
and, as such, may only be operated by
trained personnel, or persons who, as a result
of specialist knowledge, are familiar with this
type of appliance.
• Do not lay multi-socket power strips on the
floor. Where multi-socket power strips are
used then the requirements under
EN 60601-1-1 must be observed.
• Further units must not be operated via the
same multi-socket strip.
1.5 Intended purpose
The Hygosonic ultrasonic bath from Dürr Dental
is used for the intensive decontamination of
dental instruments and prostheses.

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1.6 Correct Usage
The Dürr Dental Hygosonic may only be used in
connection with a suitable insert container or
basket. Suitable non-fixing disinfectants desig-
ned for application in an ultrasonic bath (e.g.
Dürr Dental ID 213) or cleaning preparations
(e.g. Dürr Dental MD530) can add to or even
accelerate the cleaning performance. Comply
with the instructions of the cleaning and disin-
fectant agents and all applicable national regula-
tions for the reprocessing of medical devices.
1.7 Incorrect Usage
Any use of this appliance/these appliances abo-
ve and beyond that laid down in the Installation
and Operating Instructions is deemed to be in-
correct usage. The manufacturer cannot be held
liable for any damage resulting from incorrect
usage. The operator will be held liable and bears
all risks.
Medical devices not approved by their manufac-
turer for reprocessing in an ultrasonic bath may
not be reprocessed in the Dürr Dental
Hygosonic.
2. Safety
2.1 General Safety Notes
This appliance has been so designed and deve-
loped by Dürr Dental that under correct usage
that there can be no danger to operator or pati-
ent. In spite of this, we feel it is our duty to
mention the following safety measures in order
to prevent any possible danger.
• When using this appliance all local and rele-
vant regulations must be observed!
Converting or modifying the appliance in any
way is strictly prohibited. In such cases, any
and all guarantees immediately become inva-
lid. The operation of modified appliances can
be punishable by law. In the interests of trou-
ble-free operation the operator is responsible
for observing these regulations.
• Before every use the operator must check the
functional safety and the condition of the
appliance.
• The operator must be knowledgeable in the
operation of the appliance.
• The product is not designed to be used in
medical treatment areas where there exists
the danger of explosion. Areas where explosi-
ons could occur are those where flammable
anesthetic material, skin cleansers, oxygen
and skin disinfectants are present. This appli-
ance is not to be used in areas where the at-
mosphere could cause fire.
This appliance must not be used in
Operating Rooms.
2.2 Electrical Safety Notes
• This appliance may only be used when con-
nected to a correctly installed standard power
outlet socket.
• Before connecting the appliance to the power
supply check that the electrical current and
the frequency of the device as described on
the appliance are compatible with that of the
power supply.
• Check the appliance and the power supply
cables for possible damage before switching
on. Damaged cables, plugs and sockets must
be replaced before use.
• Never touch open supply outlets and patients
simultaneously.
• When working with the appliance all relevant
electrical safety procedures must be observed.

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3. Warning and Symbols
The Installation and Operating Instructions ma-
kes use of the following expressions and sym-
bols to refer to especially important instructions:
Information and/or mandatory re-
gulations or prohibitions for the
prevention of personal injury or
substantial property damage
Special information regarding the eco-
nomical use of the equipment and other
information
Warning: danger of high voltage!
Danger of fire or explosion!
Do not use with flammable cleaning
agents!
Danger of burns or scalding!
Danger: housing, bath and fluid can be-
come very hot.
Maintain max. fluid levels
Ultrasonic-operation with enhanced
performance
Optimum ultra sound distribution in the
fluid
Degassing of fluid
Ultrasonic-operation
On / Off
Temperature in °C
Time in minutes
Wear protective gloves
Wear protective glasses
3.1 Model identification plate
The model identification plate can be found to
the rear side of the appliance.
Order no. / Model no.
Serial no.
Observe Operating Instructions!
Manufacturer
Dispose of correctly as under
EU directive (2012/19/EU-WEE)
CE-Labeling without Notified Body
Number
1

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4. Delivery Contents
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
Hygosonic .........................................6035-50
- Installation and Operating Instructions
Hygosonic .........................................6035-51
- Installation and Operating Instructions
4.1 Special accessories
The following parts are not part of the Delivery
Contents (fig. 2)
Order separately as required!
Cover, plastic . . . . . . . . . . . . . . . .6035-000-01
Tray insert, stainless steel . . . . . . .6035-000-02
Submersible tray, stainless steel . .6035-000-03
Glass beaker for fluid (1 piece)
600 ml, mit Deckel u. Haltering . . .6035-110-00
Glass beakers for fluid (2 pieces)
600 ml, with lid, holding ring and
punched covering plate . . . . . . . . .6035-111-00
Instrument holding tongs . . . . . . . .6030-012-00
4.2 Disposable materials
Instrument disinfection
ID 212 .....................................CDI212C6150
ID 212 forte .............................C D I 212 F6150
ID 213 .....................................CDI213C6150
ID 220 Bath for drill heads . . . . . . CDI220C6150
MD 530 Cement remover/
denture cleaner . . . . . . . . . . . . . CCA530C6150
MD 535 Gypsum remover . . . . . CCA535C6150
5. Technical Data
Hygosonic
Voltage (V) ........................................ 220 - 240
Frequency (Hz) ...................................... 50 - 60
Ultrasonic-frequency (kHz) ............................37
Power consumption, est. (W) ......................280
Effective ultrasound output (W) ......................80
Maximum ultrasound performance (W) ........320
Heating (W) .................................................200
IP rating ...................................................IP23
Bath
Volume, useful (l) .........................................2.0
Volume, max. (l) ........................................2.75
Weight (kg) ........................................... ca. 3.3
Dimensions
Dimensions, external (mm) .......300 x 179 x 214
Bath, internal (mm) ...................240 x 137 x 100
Insert tray, internal (mm) .............. 198 x 106 x 50
Environmental conditions during operation
Temperature (°C) ..............................+10 to +40
Relative humidity (%) ............................ max. 70
Environmental conditions during storage
and transport
Temperature (°C) .............................. -10 to +60
Relative humidity (%) ............................ max. 95
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6. Functional Description
The Dürr Hygosonic uses ultrasound technology
in order to clean high quality instruments as
used in dental medical, surgical or dental tech-
nical surgeries and clinics or for cleaning den-
tures etc. quickly, thoroughly and gently. The
exact length of time for preparation in the
Hygosonic (1) will depend greatly on the particu-
lar materials, amounts and level of dirt. When
using disinfectants be sure to observe the reac-
tion times according to the manufacturer's
instructions.
An ultrasonic element is fitted under the floor of
the agitated bath, which converts electrical en-
ergy into a mechanical pulse. The fluid in the
Hygosonic is thus agitated at 37 kHz.
During this ultrasonic operation small vacuum
bubbles are produced and then dispersed. This
process allows dirt and impurities from the dee-
pest pores to be removed.
"Boost" function (2)
"Boost" extends the maximum performance of
the ultrasound source by ca. 25 %, meaning
that even the most stubborn of dried dirt parti-
cles will be thoroughly but gently removed.
"Sweep" function (3)
"Sweep" provides a homogenous ultrasound
wave distribution without any formation of ultra-
sound shadows behind or beneath instruments
which might be bundled together thus
enhancing the cleaning effect.
To achieve the optimum cleaning results, the
"Sweep" function should be switched on.
"Degas / Auto-Degas" function (4)
Fluids contain gaseous elements (e.g. oxygen).
This function removes any interfering gas bub-
bles from the fluid.
"Auto-Degas":
When fresh fluids have been added, press this
key for ca. 2 seconds - the "Auto-Degas" func-
tion is then automatically started for ca. 10 min.
"Degas":
this function can can be selected at any time,
whenever it is required: set time (7), then press
key (4).
The functions "Boost", "Sweep",
"Degas / Auto-Degas" can be chosen at
any time as required.
The functions can be changed at any
time but cannot be selected
simultaneously.
2
3
4
5
6
7
8
2"Boost" Ultrasonic-operation with
enhanced performance
3"Sweep" optimum ultrasound
distribution in the fluid
4"Degas / Auto-Degas"
Degassing of fluid
5Ultrasonic operation On /Off
6 On / Off
7
Cleaning time in minutes with LED-
Display of remaining cleaning time,
continuous operation;
after 12 hours continuous operation
(without any key being operated) the
appliance switches off automatically
8
Temperature range in
5 °C steps from 30-80 °C
LED-Display:
red - heating on
green-required temperature attained
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9. Circuit diagram
A1
B
C
D
K1
K5 K4
K7 K8
R1
R10
Z1
Installation
7. Set up
7.1 Room for set-up
• The Hygosonic can be set up in the technical
(preparation) rooms of any surgery.
• The room temperature in winter must not fall
below + 10 °C and must not exceed + 40 °C in
summer.
• Installation in purpose-built rooms, e.g. in the
boiler room, must be checked concerning buil-
ding regulations beforehand.
• Installation in so-called wet rooms is not
permitted.
7.2 Set-up alternatives
Place the Hygosonic on a horizontal, flat and dry
working surface at an appropriate height, pre-
ferably close to a correctly installed and earthed
power outlet socket.
8. Electrical Connections
• Before first operation check the supply voltage
with the voltage requirements of the model
identification plate.
• Power Supply, 220-240 V, using an earthed
shockproof power socket.
A1 Motor
K4 - Ultrasound
K5 - Mains and heating
K7 - Ventilation fan
K8 - Temperature sensor
B Base plate
C Casing
D Bath
K1 power supply
R1 Heating
R10 Temperature sensor
Z1 RFI-interference filter
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Operation
10. Instructions for use
• Only use this appliance with fluid and
correctly fitted cover!
• Do not fill the appliance excessively with
parts and ensure that all parts are cove-
red by the fluid.
• Do not exceed the maximum level of
fluids permitted in the bath!
• In order to protect the stainless steel ul-
trasound bath observe the following
points:
• The parts to be cleaned must not lie in
contact with the floor of the bath itself,
therefore always ensure that cleaning is
always carried out using the insert tray ,
submersible tray or the special beakers.
• Use the special beakers when using
agents containing strong acids (e.g.
MD 530, MD 535) or alkali (e.g. ID 220).
• Do not use any flammable fluids (e.g.
petrol, solvents).
• Do not use chemicals which contain or
produce chloride-ions (this includes
some disinfectants, household cleaning
agents, washing up liquids).
• Wear protective clothing, e.g. protective
gloves, protective glasses (goggles).
• Do not use the appliance for cleaning je-
welry, watches, glasses, etc.
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10.1 Performing routine checks of
the unit before initial
commissioning
A suitable procedure (e.g. foil test) must be used
within the scope of a validated reprocessing
programme.
The foil test must be subject to documented
checks at regular intervals in order to determine
deviations in the process.
Check the procedure-typical cavitation (distribu-
tion and intensity) before cleaning instruments in
the Hygosonic for the first time.
Dürr Dental recommends that you use the foil
test as it is simple to perform. Commercially-
available aluminium foil (10-25 µm) is inserted in
the ultrasonic bath. The aluminium foil is perfo-
rated via cavitation during operation.
The perforations in the foil are photographed or
scanned and compared with previous results.
The perforation and its distribution can be used
to determine the efficiency.
The inspection must always be perfor-
med under identical conditions. The in-
fluence factors to be determined are:
– The filling height of the ultrasonic bath
– Time and intensity of the ultrasonic
irradiation
– Temperature of the cleaning agent / disin-
fectant solution
– Nature and concentration of the cleaning
agent / disinfectant solution
– Degassing time
– Angle of the inserted aluminium foil
– Quality and thickness of the aluminium foil
• Perform the foil test at regular intervals.
The exact instructions for the foil test (routine
inspection of the Hygosonic) are available in
our download centre here:
www.duerrdental.com.

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10.2 Preparation
• Fill the ultrasound bath (9) up to the marking
with water.
10.1.1 Disinfection and Cleaning using
insert tray
Disinfection and cleaning of instruments is car-
ried out in the insert tray (10).
• If required add disinfectant and cleaning
agent, (e.g. ID 213) to the water. Observe
manufacturer's instructions concerning the
product carefully!
• Place the objects for disinfection and cleaning
using the instrument tongs into the insert tray.
The weight of the full insert tray must not ex-
ceed 1 kg, danger of filling too much!
• Place the insert tray into the Hygosonic.
• Place cover on unit.
• Proceed to sections 10.3 / 10.4
10.1.2 Disinfection and Cleaning using
beakers
Disinfection and cleaning using acidic or strong
alkali solutions should only be carried out in the
special glass beakers (12).
• Fill the solvents (e.g. MD 530) into the
beaker(s).
• Place the parts into the beaker (12).
• Place the punched steel cover (11) for the be-
akers into place.
• Place the glass beakers complete with lids into
the Hygosonic.
By increasing the temperature of the
bath (max. 50 °C) the cleaning effect
can be enhanced.
• Proceed to sections 10.3 / 10.4
10.1.3 Disinfection and Cleaning using
submersible tray
Disinfection and cleaning of small parts should
be carried out using the submersible tray (13)
together with the glass beakers.
• Fill the solvents (e.g. ID 220) into the beaker(s).
• Place the small parts using the instrument
tongs into the submersion tray.
• Place the tray into the beaker (12).
• Place the punched steel cover (11) for the
beakers into place.
• Place the glass beakers complete with
submersion tray into the Hygosonic.
• Proceed to sections 10.3 / 10.4
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2
3
4
5
6
7
8
The keys (2) to (5) allow the individual
functions to be switched on and off -
where the appliance has already been
switched on.
10.3 Operation pad
On / Off
all other functions can only be operated once the appliance has been switched on!
Start the ultrasound operation:
1. Set time on the rotating switch (7)
2. Press key (5)
Start the ultrasound operation independent of temperature:
1. Set time on the rotating switch (7)
2. Set temperature on the rotating switch (8)
3. Press key (5) (after the set temperature has been reached ultrasound operation will be-
gin automatically)
End ultrasonic ultrasound manually:
1. Set time on the rotating switch (70) to "0"
2. Press key (5)
Switch on heating
Set temperature on the rotating switch (8)
Switch off heating
Set temperature on the rotating switch (80) to "0"
Switch on Degas-function
1. Set time on the rotating switch (7)
2. Press key (5)
3. Press Degas key (4)
Switch off Degas-function
Press Degas key (4) (ultrasound continues normally)
Switch on Auto-Degas-function
Press Degas key (4) ca. 2 seconds (ultrasound continues for 10 minutes then switches off)
Switch on Sweep-function
1. Set time on the rotating switch (7)
2. Press key (5)
3. Press Sweep key (3)
Switch off Sweep-function
Press Sweep key (3) (ultrasound continues normally)
Switch on Boost-function
1. Set time on the rotating switch (7)
2. Press key (5)
3. Press Boost key (2)
Switch off Boost-function
Press Boost key (2) (ultrasound continues normally)

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2
3
4
5
6
7
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10.4 Cleaning process
Do not lay parts or containers in direct
contact with the bath floor!
Do not fill the appliance excessively with
parts and ensure that all parts are cove-
red by the fluid.
• Switch on the appliance.
• For freshly added fluids switch on the
"Auto-Degas" function to ensure degassing of
fluid: press key (4) for ca. 2 seconds; initiates
automatic start of "Auto-Degas" function
(ca. 10 min.)
• Recommended temperature settings:
• Room temperature for instrument disinfec-
tion and cleaning agent (e.g. ID 213)
• Max. 50 °C for cement removal / denture
cleaning (e.g. MD 530)
• Select times.
When using disinfectants be sure to observe
the reaction times according to the
manufacturer's instructions.
• Switch on ultrasound with key (5).
During operation never touch the
cleaning fluids or any ultrasound
parts!
• If necessary, switch on function "Boost" (2) or
"Sweep" (3).
• After the cleaning process has finished, place
the tray (10) and glass beakers (12) onto the
inner side of the cover (14) as shown. Allow
excess water to drip off.
• Rinse parts under running water as required.
• Visually check the parts to ensure complete
cleaning, if necessary repeat the process.
• Allow parts to dry.
10.5 Empty unit
• Remove plug (15) from mains.
• Remove the connector (16) at the rear of the
appliance.
• Holding the bath carefully, preferably by the
right rear corner, empty the bath, e.g. into a
washbasin or sink.
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10.6 Recommended disinfection
and cleaning agents
See fig. 15
Instrument disinfection
For general and surgical instruments, and also
for rotating instruments sensitive to alcohol and
alkali:
Dürr ID 212, ID 212 forte, ID 213 (aldehyde-free,
non-fixing, concentrated liquids)
Drill bits bath
To remove organic (tissue particles) or anorganic
(polishing paste) deposits on rotating
instruments.
Dürr ID 220 (aldehyde-free, non-fixing, ready-
for-use solutions)
Cement remover / denture cleaner
To remove substances which are soluble in acid,
e.g. cement or dental tartar from dentures:
Dürr MD 530 (ready-for-use solutions)
Gypum removal
Dürr MD 535 (ready-for-use solutions)
For order numbers, see 4.2 Disposable materials
For description, see enclosed leaflet, order
number: P007-080-01 (D), P007-080-02 (GB)
11. Maintenance
11.1 Routine check of the unit
• Perform the foil test at regular intervals.
The exact instructions for the foil test (routine
inspection of the Hygosonic) are available in
our download centre here:
www.duerrdental.com.
11.2 Ultrasound bath care
• In order to prolong the life of the ultrasound
bath, it is recommended to clean it on
changing cleaning agents.
• Do not use any foaming agent!
• Gentle removal of limescale which may
accumulate in the ultrasound bath can be
carried out using Dürr MD 555 Cleaner.
11.3 Disinfection and cleaning
Disinfect and clean the ultrasound bath and the
housing regularly according to the surgery
hygiene plan using an effective surface disin-
fectant cleaner (e.g. FD 322 / FD 333).
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DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Fon: [phone]
www.duerrdental.com
[email protected]