EKOM ASPINA DO M User manual

ASPINA - DO M
User manual
Benutzerhandbuch
Manuel de l’utilisateur
Руководство пользователя
Instrukcja obsługi
Návod na použitie
Návod k použití

DENTAL SUCTION EQUIPMENT
DENTALE ABSAUGEINHEIT
L’ASPIRATEUR DENTAIRE
ДЕНТАЛЬНОЕ ОТСАСЫВАЮЩЕЕ УСТРОЙСТВО
ODSYSARKA DENTALNA
DENTÁLNA ODSÁVAČKA
DENTÁLNÍ ODSÁVAČKA
ASPINA - DO M
EKOM spol. s r. o.
Priemyselná 5031/18
SK-921 01 Piešťany
Slovak Republic
tel.: [phone]
fax: [phone]
www.ekom.sk
email: eko[email protected]k
DATE OF LAST REVISION
DATUM DER LETZTEN ÜBERARBEITUNG
DATE DE MISE A JOUR
ДАТА ПОСЛЕДНЕГО ПЕРЕСМОТРА
DATA WYDANIA
DÁTUM POSLEDNEJ REVÍZIE
DATUM POSLEDNÍ REVIZE
12/2021
NP-DO M-39_12-2021
112000080-000

CONTENTS.................................................................................................. 5
INHALT........................................................................................................ 31
TABLES DES MATIÈRES ...........................................................................57
ОГЛАВЛЕНИЕ ............................................................................................83
SPIS TREŚCI............................................................................................... 110
OBSAH ........................................................................................................136
OBSAH ........................................................................................................162

CONTENTS
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CONTENTS
IMPORTANT INFORMATION........................................................................................................6
CONFORMITY WITH THE REQUIREMENTS OF THE EUROPEAN UNION...................6
INTENDED USE ..............................................................................................................6
CONTRAINDICATIONS AND SIDE-EFFECTS................................................................6
SYMBOLS........................................................................................................................6
WARNINGS.....................................................................................................................7
STORAGE AND TRANSPORT ........................................................................................9
PRODUCT DESCRIPTION ..........................................................................................................10
PRODUCT FUNCTION..................................................................................................10
TECHNICAL DATA......................................................................................................................13
INSTALLATION...........................................................................................................................17
INSTALLATION CONDITIONS ......................................................................................17
PNEUMATIC CONNECTION.........................................................................................18
ELECTRICAL CONNECTION........................................................................................18
COMMISSIONING .........................................................................................................18
PNEUMATIC AND ELECTRICAL DIAGRAMS...............................................................19
OPERATION................................................................................................................................21
SWITCHING ON THE DENTAL ASPIRATOR................................................................21
PRODUCT MAINTENANCE ........................................................................................................23
MAINTENANCE, CLEANING AND DISINFECTION.......................................................23
LONG-TERM SHUTDOWN............................................................................................28
DISPOSAL OF DEVICE.................................................................................................28
TROUBLESHOOTING.................................................................................................................29
REPAIR SERVICE.........................................................................................................30
ANNEX .....................................................................................................................................188
23. INSTALLATION RECORD ...........................................................................................188

IMPORTANT INFORMATION
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IMPORTANT INFORMATION
CONFORMITY WITH THE REQUIREMENTS OF THE EUROPEAN UNION
This product conforms to the requirements of the Medical Device Directive (93/42/EEC), and is safe
for the intended use if all safety instructions are followed.
INTENDED USE
Dental suction equipment DO M is intended for suction, separation and retention of solid and liquid
particles generated during dental procedure.
Risk of injury or equipment damage.
The device must not be used to suction aggressive, flammable and explosive
mixtures.
Any other use of the product beyond its intended use is considered an incorrect use. The
manufacturer is not liable for any damages or injuries resulting from the incorrect use.
CONTRAINDICATIONS AND SIDE-EFFECTS
There are no contraindications or side-effects known.
SYMBOLS
The following symbols and marks are used in the User manual, on the device and its packaging:
General warnings
Warning
Danger, electric shock hazard.
Read the operating instructions
Refer to instruction manual
CE –marking
Attention! Hot surface.
Handling mark on package –FRAGILE
Handling mark on package –THIS SIDE UP
Handling mark on package –KEEP DRY
Handling mark on package –TEMPERATURE LIMITATIONS

IMPORTANT INFORMATION
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Handling mark on package –LIMITED STACKING
Mark on package –RECYCLABLE MATERIAL
Connection of protective ground wire
Fuse
Danger of biological hazard
Type B applied part
Indicates a medical device that has not undergone sterilization
Sterilizable in a steam sterilizer (autoclave) at specified temperature
Manufacturer
WARNINGS
The product is designed and manufactured to be safe for the user and the surrounding environment
when used in the defined manner. Keep the following warnings in mind.
5.1. General warnings
READ THE USER MANUAL CAREFULLY BEFORE USING THE DEVICE AND KEEP IT FOR
FUTURE USE!
The user manual supports the correct installation, operation and maintenance of the product.
Careful review of this manual will provide the information necessary for the correct operation of
the product for its intended use.
Original packaging should be retained for the return of the device. Only the original packaging
ensures protection of the device during transport. If it is necessary to return the product during
the warranty period, the manufacturer is not liable for damages caused by improper packaging.
This warranty does not cover damages originating from the use of accessories other than those
specified or recommended by the manufacturer.
The manufacturer only guarantees the safety, reliability and function of the device if:
-installation, new settings, changes, expansion, and repairs are performed by the
manufacturer or an organisation authorised by the manufacturer.
-the product is used pursuant to the user manual.
The user manual corresponds to the configuration of the product and its compliance with the
applicable safety and technical standards at the time of printing. The manufacturer reserves all
rights for the protection of its configuration, methods and names.
This user manual is the original instructions. Translation is performed in accordance with the best
available knowledge.

IMPORTANT INFORMATION
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5.2. General safety warnings
The manufacturer designed and manufactured the product to minimise all risks when used correctly
for the intended use. The manufacturer considers it its obligation to lay down the following general
safety precautions.
Use and operation of the product must comply with all laws and local regulations valid in the
place of use. The operator and user are responsible for following all the appropriate regulations
in the interests of performing work safely.
Only the use of original parts guarantees the safety of operating personnel and the flawless
operation of the product itself. Only the accessories and parts mentioned in the technical
documentation or expressly approved by the manufacturer should be used.
The operator must ensure that the device is functioning correctly and safely before every use.
The user must be familiar with the operation of the device.
Do not use the product in environments with a risk of explosion.
The user must inform the supplier immediately if any problem directly related to the operation of
the device occurs.
5.3. Safety warnings on protection from electric current
The device must only be connected to a properly installed, earthed socket.
Before the product is plugged in, ensure that the mains voltage and frequency stated on the
product are in compliance with thevalues of the mains.
Prior to putting the device into operation check for any damage to the connected pneumatic lines
and electrical wiring. Replace damaged pneumatic lines and electrical wirings immediately.
Immediately disconnect the product from the mains (remove power cord from the socket) in
hazardous situations or in the case of a technical malfunction.
During all repairs and maintenance, ensure that:
-the mains plug is removed from the power socket
-emptied separation vessel and equipment cleaned if possible
The product shall only be installed by a qualified technician.

IMPORTANT INFORMATION
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STORAGE AND TRANSPORT
The manufacturer provides sufficient protection of the appliance when it leaves the factory.
Therefore the product is protected against damage during storage and transport.
For the transport, always use an original product packing, if possible.
Transport the dental suction equipment in an upright position
Protect the suction equipment during transport against humidity, impurity or extreme
temperatures.
The suction equipment in an original packing can be stored in warm, dry and dustfree
rooms.
Keep packaging material if possible. If not, please dispose of the packaging material in
an environmentally friendly way. Cardboard can be recycled.
Risk of liquid spillage.
Mobile dental suction equipment may only be transported with emptied separation
vessel.
Always empty the separation vessel contents before any transport
Storing or shipping the equipment in any conditions other than those specified
below is prohibited.
6.1. Ambient conditions
Products may only be stored and transported in vehicles that are free of any traces of volatile
chemicals under the following climactic conditions:
Temperature
–25°C to +55°C
Relative humidity
max. 90% (non-condensing)

PRODUCT DESCRIPTION
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PRODUCT DESCRIPTION
Fig. 1: The mobile dental suction equipment ASPINA DO M is built-up on a movable base in a noise
damping cabinet. Inside the cabinet there is situated a fan cooled suction pump (9) with the electric
distribution and the waste entrapping separation vessel (11). In the lower part –under the box –
there is situated a silencer with an output filter (14) and a pre-filter (15) ensuring the air filtration
from the suction pump. In the upper –narrowed part of the suction equipment - there is situated a
holder for suction tubings (2) equipped with cannulas (1), separation automatics and therminal box
with fuses. Onthe lateral part there is situated a main switch (5), over which are placedthe indicators
for the network (3) and for the state of filling of the separation vessel (4).
PRODUCT FUNCTION
7.1. Function Description
Fig. 1: After switching-on the main switch (5) into the position „I“ the network indicator (3) goes on.
Taking the suction tubing (6) off the holder (2) will actuate the suction pump (9) and the vacuum
occurs at the suction mouthpiece (1). After repeated putting the suction tubing into the holder, the
suction pump turns off. When the separation vessel (11) is filled with waste products, the suction
pump turns off and the indicator for the separation vessel (4) filling goes on. Then it is necessary to
return the suction tubing back into the holder and to empty the separation vessel. During a longer
work, mainly with the desalivating mouthpiece, the box temperature may increase; the cooling fan
is then automatically actuated. The fan turns off automatically, when the box temperature drops.
7.2. Detailed Description of the Suction Part Function
Fig. 1: The vacuum air flows together with sucked waste products from the oral cavity through the
tubing system from the suction mouthpiece (1) at first through the inlet sieve (7), wherein the solid
impurities are entrapped. The vacuum air, together with the sucked waste products, free of solid
impurities greater than 2 mm, then flows into the separation vessel (11) wherein it is separated from
the vacuum air and entrapped into the separation vessel.
Suction air flows through the filter (18) and into the suction unit (9), from which it is pushed through
a noise muffler. Therein the output air passes through the output pre-filter (15) and the bacteriologic
output filter (14). After passing the filters, the airfree of impurities is blown off into afree space under
the dental suction equipment.

PRODUCT DESCRIPTION
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Fig. 1: Mobile dental suction equipment ASPINA DO M

PRODUCT DESCRIPTION
NP-DO M-39_12-2021 12 12/2021
Descriptions for fig. 1
1 Cannulas
2 Holder
3 Network indicator
4 Indicator for the separation vessel
5 Main switch
6 Suction tubing
7 Inlet sieve
8 Holder
9 Suction pump
10 Separator cover
11 Separation vessel
12 Bowl
13 Filter holder
14 Bacteriologic output filter
15 Output pre-filter
16 Fixing lugs
17 Antifoaming tables
18 Filter

TECHNICAL DATA
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TECHNICAL DATA
Products are designed to operate in dry, ventilated and indoor dust-free rooms with the following
climatic conditions:
Temperature
+5°C to +40°C
Relative humidity
max. 70%
DO M
Rated voltage / frequency
V / Hz
230 / 50; 230 / 60*;
110 / 60*
Rated current
A
2.6
Maximum flowrate :
l/min
1100
Maximum vacuum
kPa
12
Sound level
dB(A)
48
Mode of operation of the suction pump
permanent
S 1
Dimensions of the suction equipment
w x d x h
mm
354x575x845
Weight of the suction equipment
kg
36
Classification pursuant to STN EN 60 601-1 (IEC
60601-1)
class I
Applied parts type pursuant to STN EN 60 601-1 (IEC
60601-1)
B
Classification pursuant to MDD 93/42/EEC,
2007/47/EC
IIa
(*) - The rated voltage and frequency can be changed by special order

TECHNICAL DATA
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Electromagnetic compatibility declaration
Medical equipment needs special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided below.
Guidance and manufacturer's declaration - electromagnetic emissions
Pursuant to IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The equipment uses RF energy only for its
internal functions. Therefore, the RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
The equipment is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
The equipment is not
likely to cause any flicker,
as the current flow is
approx. constant after the
start up.

TECHNICAL DATA
12/2021 15 NP-DO M-39_12-2021
Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply
lines
±1 kV for
input/output lines
±2 kV
100 kHz repetition
frequency
Applied to mains
connection
Mains power quality should be
that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV L-N
±2 kV L-PE; N-PE
Applied to mains
connection
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short interruption,
and voltage
variations on
power
supply
input lines IEC
60601-4-11
UT=0%, 0,5 cycle
(at 0, 45, 90, 135,
180, 225, 270
and 315°)
UT=0%, 1 cycle
UT=70% 25/30
cycles (at 0°)
UT=0%, 250/300
cycles
UT=>95%, 0,5 cycle
(at 0, 45, 90, 135, 180,
225, 270 and 315°)
UT=>95%, 1 cycle
UT=70% (30% dipp
UT),
25(50Hz)/30(60Hz)
cycles (at 0°)
UT=>95%,
250(50Hz)/300(60Hz)
cycle
Mains power quality should be
that of a typical commercial or hospital
environment.
The device stops and restarts
automatically at each dip. In this case
does not occur unacceptable pressure
drop.
NOTE: UTis the A.C. mains voltage prior to application of the test level.

TECHNICAL DATA
NP-DO M-39_12-2021 16 12/2021
Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
3 Vrms
150 kHz to 80MHz
3 V/m
80 MHz to 2,7
GHz
9 to 28 V/m
15 specific
frequencies
(380 to 5800
MHz)
3 Vrms
3 V/m
9 to 28 V/m
15 specific
frequencies
(380 to 5800
MHz)
Portable and mobile RF communications
equipment should be used no closer to any
part of the equipment, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d=1,2√ P
d=1,2√ P, 80 MHz to 800 MHz
d=2,3√ P, 800 MHz to 2,7 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation dis-
tance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a, should be less than the
compliance level in each frequency range
b. Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the equipment is used exceeds the applicable RF compliance level above, the equipment should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the equipment.
bOver the frequency range 150 kHz to 80 kHz, field strengths should be less than 3 V/m.

INSTALLATION
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INSTALLATION
Risk of incorrect installation.
Only a qualified professional can install the equipment and place it into operation
for the first time. This professional is obliged to train operating staff as to the use
and maintenance of the device. Installation and training of all operators shall be
confirmed by the installer’s signature on the certificate of installation.
Risk of incorrect installation.
ANY MODIFICATION OF THIS EQUIPMENT IS FORBIDDEN!
Risk of damage to the device.
This equipment cannot be used nearby other instruments. If this equipment is
used nearby other instruments, the equipment must be observed in order to verify
normal operations in the configuration it will be used.
Instruments may be affected electro-magnetically!
You may notice a “new product” odour when you first place the product into
service (for a short period of time). This odour is temporary and does not impede
the normal use of the product. Ensure the space is properly ventilated after
installation.
INSTALLATION CONDITIONS
The equipment may only be installed and operated in dry, well ventilated and dust-free rooms.
The mobile dental suction equipment should be installed with regard to an easy access for the
operation and maintenance and good accessible rating plate.
The equipment should stand on a plane, sufficiently stable base (be aware of the suction
equipment weight, see Technical data).
The equipment may not be operated outdoors or in wet or damp environments.
Risk of explosion.
Do not use the equipment in the presence of explosive gases, dust or
combustible liquids.
To guarantee a trouble-free operation of the suction equipment, the room temperature should
never drop under +5˚C and exceed +40°C. The ideal ambient temperatures are between +10°C
up to +25°C.
Most of the electric energy used by the suction pump (9) is converted to heat and given off to the
ambient. During a longer lasting work, above all with the desalivating mouthpiece, the box
temperature increases over 40°C causing an automatic actuation of the cooling fan. After the
room is cooled down under approximately 32°C, the fan turns off again.

INSTALLATION
NP-DO M-39_12-2021 18 12/2021
PNEUMATIC CONNECTION
Risk of damage to pneumatic components.
Suction tubings must not be broken.
ELECTRICAL CONNECTION
The dental suction equipment model 230V is delivered with the safety plug.
Keep the socket easily accessible to ensure that in an emergency, the device can be safely
disconnected from the mains.
Risk of electric shock.
It is necessary to follow all local electro technical regulations. The mains voltage
and frequency must comply with the data stated on the device label.
Risk of fire and electric shock.
Power cord must not be broken.
COMMISSIONING
After unpacking, put the suction equipment on the floor, open the door and check whether the
separator’s cover (10) with sensing electrodes is attached to the separation vessel (11). In case of
need, fix the cover to the vessel and then follow the instructions in the Chapter No. 13. Close the
door and connect the suction equipment power cord to the socket. Change the main switch (5) over
into the position “I”, the indicating lamp for the network (3) goes on and the suction equipment is
ready for the operation.
Risk of use of incorrect cannulas.
Suction cannulas must comply with local legislative and technical requirements
for dental suction cannulas and their connection dimensions must be compatible
with suction cannulas connectors of 11mm and 16mm diameter.
Cannulas are not delivered in a sterile state!
Suction cannulas must undergo complete preparation cycles before first use and
after each patient or use following instructions in Chapter 14.8
Dental suction equipment is not equipped with a backup power supply!

INSTALLATION
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PNEUMATIC AND ELECTRICAL DIAGRAMS
12.1. Pneumatic diagram
Aspina DO M
Description to pneumatic diagram:
1 suction cannulas
2 vacuum valve
3 inlet sieve
4 separation vessel
5 suction pump
6 output pre-filter
7 output filter
8 noise muffler

INSTALLATION
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12.2. Electrical diagram
Aspina DO M
1/N/PE ~ 230V/50Hz, 230V/60Hz
ELEKTRIC OBJECT OF 1st. CAT.
Type B
Description to electrical diagrams
M
Suction pump 230 V/50 Hz
EV
Fan 230 V/50-60 Hz
HL1,2
Indicator glow lamps
PS
Control electronics
ST
Temperature switch
Q
Power-supply switch
A
Cover of bracket
B
Complete bracket
C
Complete cover
D
Cabinet cover
E
Main board
F
Doors of cabinet