EKOM ASPINA DO M User manual

ASPINA - DO M
User manual
EN
Benutzerhandbuch
DE
N
Manuel de l’utilisateur
FR
Návod na použitie
SK
Руководство пользователя
RU
Návod k použití
CS
Instrukcja obsługi
PL

THE DENTAL ASPIRATOR
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: [e-mail]
DATE OF LAST REVISION
DATUM DER LETZTEN ÜBERARBEITUNG
DATE DE MISE A JOUR
ДАТА ПОСЛЕДНЕГО ПЕРЕСМОТРА
DATA WYDANIA
DÁTUM POSLEDNEJ REVÍZIE
DATUM POSLEDNÍ REVIZE
10/2020
NP-DO M-37_10-2020
112000080-000

CONTENTS........................................ 5
INHALT ............................................ 22
SOMMAIRE...................................... 40
ОГЛАВЛЕНИЕ................................. 58
SPIS TREŚCI ................................... 76
OBSAH ............................................ 93
OBSAH ...........................................110

INSTALLATION –OPERATION –MAINTENANCE ASPINA - DO M
NP-DO M-37_10-2020 - 5 -
CONTENTS
IMPORTANT INFORMATION............................................................................................... 6
1. WARNINGS................................................................................................................6
1.1. CE Marking................................................................................................................ 6
1.2. General warnings....................................................................................................... 6
1.3. General safety warnings........................................................................................... 6
1.4. Safety warnings regarding the protection against electric current .............................. 6
1.5. Alert notices and symbols.......................................................................................... 7
2. PRODUCT INFORMATION ........................................................................................8
2.1. Intended Use............................................................................................................. 8
2.2. Contraindications and side-effects............................................................................. 8
2.3. Product Description ................................................................................................... 8
3. TECHNICAL DATA.....................................................................................................9
3.1. FAD efficiency correction for differences in elevation................................................. 9
3.2. Electromagnetic compatibility declaration .................................................................10
4. FUNCTION DESCRIPTION......................................................................................13
4.1. Function Description.................................................................................................13
4.2. Detailed Description of the Suction Part Function.....................................................13
ASSEMBLY.........................................................................................................................13
5. STORAGE AND TRANSPORT CONDITIONS..........................................................13
6. INSTALLATION AND INITIAL START-UP ................................................................14
6.1. Environmental Conditions.........................................................................................14
6.2. Electric Connection...................................................................................................14
6.3. Initial Start-ip.............................................................................................................14
USE......................................................................................................................................15
7. OPERATION.............................................................................................................15
7.1. Switching on the Dental Aspirator.............................................................................15
7.2. Use of antifoaming tablets ........................................................................................15
7.3. Filter use in the separation vessel.............................................................................15
8. MAINTENANCE INTERVALS - USER / TECHNICIAN..............................................16
9. MAINTENANCE, CLEANING AND DISINFECTION .................................................16
9.1. Inlet Sieve Cleaning..................................................................................................17
9.2. Lubricating seals and sliding closures.......................................................................17
9.3. Disinfection of Tubings and Separation Vessel.........................................................17
9.4. Cleaning and disinfection of the exterior surfaces of the product ..............................17
9.5. Replacement of the Output Pre-filter.........................................................................17
9.6. Replacement of Output Filter....................................................................................18
9.7. Cannulas handling and preparation operation...........................................................18
9.8. Replacing the filter in the separation vessel..............................................................19
10. PUTTING OUT OF OPERATION..............................................................................19
DISPOSAL...........................................................................................................................19
11. DISPOSAL OF APPLIANCE.....................................................................................19
TROUBLESHOOTING.........................................................................................................20
12. INFORMATION ON REPAIR SERVICE....................................................................20
13. SOLVING COMMON PROBLEMS............................................................................20
ANNEXES..........................................................................................................................126
14. WIRING DIAGRAMS...............................................................................................126
15. FUNCTION DIAGRAM............................................................................................128
16. ENCLOSURE NO. 1 ...............................................................................................129
17. INSTALLATION RECORD......................................................................................130

ASPINA-DO M INSTALLATION –OPERATION –MAINTENANCE
- 6 - NP-DO M-37_10-2020
IMPORTANT INFORMATION
1. WARNINGS
1.1. CE Marking
Products marked with CE mark of compliance meet requirements of European Union directives
(93/42/EEC).
1.2. General warnings
The installation, operation and maintenance manual is an integral part of the appliance. It is
necessary to always keep this document close to the appliance. Strict observance of this manual
is a prerequisite for the correct operation of the appliance.
The safety of operating personnel and failure-free operation of the appliance are ensured only
when using the original components of the appliance. It is possible to use accessories and spare
parts mentioned in the technical documentation or clearly permitted by the manufacturer.
When used with non authorized accessories or consumable material, the manufacturer cannot
assume responsibility for the safe operation and functionality of the device.
The Guarantee does not cover damages that originate due to the use of non authorized
accessories or consumable material other than those recommended by the manufacturer.
The manufacturer assumes responsibility regarding safety, reliability and function only if
-The installation, calibration, amendments, extensions and repairs are made by the
manufacturer or his representative or a service organization authorized by the manufacturer,
-The appliance is used in accordance with the installation, operation and maintenance
manual.
The installation, operation and maintenance manual, at the time of printing, corresponds to the
design of the appliance and its state according to the relevant safety and technical standards.
The manufacturer reserves all copyrights for the given wiring schemes, methods and names.
This user manual is the original instructions. Translation is performed in accordance with the best
available knowledge.
1.3. General safety warnings
The manufacturer developed and constructed the appliance so that damage would not occur when
the appliance is used for its intended purpose. The manufacturer considers it his obligation to
describe the following safety measures in order to avoid further damages.
When operating the appliance, it is necessary to observe laws and regional regulations valid in
the place of usage. In order to ensure safe course of works, the operator and user are responsible
for the observation of regulations.
The original packaging should be kept for the possible return of the unit. Only original packaging
guarantees an optimal protection of the appliance during transportation. If it would be necessary
to return the appliance during warranty period, the manufacturer is not responsible for damages
caused by incorrect packing.
It is necessary that the user ensures the appliance is safe to use prior to usage.
The user must familiarize himself with the correct operation of appliance.
If an undesirable event occurs in the operation of appliance, the user is obliged to immediately
inform his supplier to this event.
This product is not intended for use in areas with the risk of explosion.
1.4. Safety warnings regarding the protection against electric current
The appliance must only be connected toan appropriate power sourcethat has correct grounding.
Prior the connecting the compressor, verify whether the mains voltage and frequency specified
on the equipment are in accordance with the local supply.
Prior to putting into operation, check for possible damages on the appliance and the air
connectors. Damaged cables and sockets/plugs must be replaced immediately.

INSTALLATION –OPERATION –MAINTENANCE ASPINA - DO M
NP-DO M-37_10-2020 - 7 -
In the case of a dangerous situation or a technical failure, immediately disconnect the appliance
from mains supply.
During all repairs and maintenance:
-ensure that the mains plug is removed from the power socket
-pressure pipes must be air vented
-pressure must be released from pressure tank.
This appliance can only be installed only by a qualified expert.
1.5. Alert notices and symbols
For your information, the symbols below are used in the installation, operation and maintenance
manual, on packaging materials and on the product :
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
Handling mark on package –LIMITED STACKING
Mark on package –RECYCLABLE MATERIAL
Connection of protective ground wire
Fuse
Danger of biological hazard
Indicates a medical device that has not undergone sterilization

ASPINA-DO M INSTALLATION –OPERATION –MAINTENANCE
- 8 - NP-DO M-37_10-2020
Sterilizable in a steam sterilizer (autoclave) at specified temperature
Manufacturer
2. PRODUCT INFORMATION
2.1. Intended Use
The dental aspirator ASPINA DO M is a mobile equipment extending the possibilities of procedures
provided for by a physician and ensuring the increase of ergonomy at his work. It is suitable for the
dental units not equipped with the suction equipment and a separator. It is intended for the dental
practice needs for aspiration, separation and entrapping of the waste into the built-in separation
vessel. With regard to its mobility it enables a simple transport between the workplaces and can be
used above all where the connection to a sewerage system is impossible.
The dental aspirator is designed for the operation in dry, ventilated rooms, with the ambient
temperature ranging between +5°C up to +40°C, and relative humidity not exceeding the value of
70%.
The dental aspirator may not be exposed to rain. The equipment may not be operated in the
moist or wet environs. In addition, avoid the use near gases or combustible liquids.
Other use, or the use exceeding this scope, can not be regarded as the intended use. The
maufacturer is not responsible for the resulting damages. The risk will be born exclusively by the
operator / user.
2.2. Contraindications and side-effects
There are no contraindications or side-effects known.
2.3. Product Description
(Annex No.1)
The mobile dental aspirator ASPINA DO M is built-up on a movable bogie on which is situated a box,
lined by a noise damping material. Inside the box there is situated a fan cooled suction aggregate
(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 aggregate. In the upper –narrowed part of the aspirator - there is
situated a holder for suction tubings (2) equipped with cannulas (1), separation automatics and
therminal boxwith fuses. On the lateral part there is situateda main switch (5), over which are placed
the indicators for the network (3) and for the state of filling of the separation vessel (4).

INSTALLATION –OPERATION –MAINTENANCE ASPINA - DO M
NP-DO M-37_10-2020 - 9 -
3. TECHNICAL DATA
DO M
Rated voltage / frequency
V / Hz
230 / 50; 230 / 60*;
110 / 60*
Nominal current
A
2.6
maximum flowrate :
l/min
1100
maximum underpressure
kPa
12
Sound level
dB(A)
48
Mode of operation of the aspirator
permanent
S 1
Dimensions of the aspirator
mm
565x350x860
Dimensions of the aspirator with carton
(h x w x d)
mm
950x560x595
Weight of the apirator
kg
36
Weight of the aspirator with
Carton
kg
40
Model according to
STN EN 60 601-1 (IEC 60601-1)
equipment type B, class I
Classification pursuant to MDD 93/42/EEC,
2007/47/EC
IIa
(*) The rated voltage and frequency can be change by special order
Climatic conditions for the operation:
Temperature +5°C up to 40°C
Relative air humidity up to +70%
3.1. FAD efficiency correction for differences in elevation
FAD correction table
Elevation [mamsl]
0 - 1500
1501 - 2500
2501 - 3500
3501 - 4500
FAD [l/min]
FAD x 1
FAD x 0.8
FAD x 0.71
FAD x 0.60
FAD efficiency refers to conditions at an elevation of 0 mamsl:
Temperature: 20°C
Atmospheric pressure: 101325 Pa
Relative humidity: 0%

ASPINA-DO M INSTALLATION –OPERATION –MAINTENANCE
- 10 - NP-DO M-37_10-2020
3.2. 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.