Serial no:.............................................
Edition 5.01/ KOZN 374/2005
Żywiecka Fabryka Sprzętu Szpitalnego
FAMED S.A.
Page 2
Appendixes: 2, 3,
User manual – dental unit US-02.1 and US-02.3
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User manual – dental unit US-02.1 and US-02.3
This product complies with type category IIa in accordance with the European
Medical Device Directive (MDD) 93/42/EEC, June 14th 1993, Appendix 9.
The Manufacturer declares that this product conforms to the basic requirements
of the MPG, Appendix 7, and documents conformity by marking this product
Medical device was registered at Registration Office of Healing Products, Medical Products
and Bio fight Products in 18.09.2003 under no: PL/ DR 00 22 32
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User manual – dental unit US-02.1 and US-02.3
Dear Customer!
Please, read this user manual carefully because it contents the important
information and remarks of the manufacturer concerning proper product
installation, usage and conservation.
We congratulate you on good choice and wish satisfaction with
exploitation of our merchandise.
Żywiecka Fabryka Sprzętu Szpitalnego
FAMED S.A.
General notes
•The use, maintenance as well as servicing of this product performed in other
ways than those, which have been stated in this manual is forbidden and may
result in damages, which will encumber the user and which will not be a matter of
producer’s responsibility.
•When the operation and parameters of the product do not match the description in
item ‘Operation’ in this manual, the use of the product is not allowed and any
defects have to be reported to the producer or the supplier.
•Every repair of the product must be done by a factory or an authorized service (the
list of service companies enclosed in appendix 1) and recorded on the list of
repairs, which is supplied with the guarantee certificate. Disregarding this
requirement will cause the guarantee for the product to be invalid.
•Before starting any repairs the table must be disconnected from mains.
Notes concerned with safety
The sign shown below says: ‘Caution – pay special attention to the Operating Manual’.
A label showing this sign is placed on any parts or mechanisms, which may prove to
be harmful to the patient or the personnel if their operation does not comply with the
descriptions found in this Operating Manual.
•Do not connect the unit to mains in places where there is a danger of an explosion!
•Use of accessories, additional equipment, cables or spare parts other that those offered
and/ or advised by the producer may cause an increase of emission and/ or decrease of
bed resistance to all electromagnetic phenomena.
•Be careful when activating the pneumatic arm of the table of the unit. Moving elements
(moved by a pneumatic spring) may catch your fingers or hand. It is not allowed to put
hands or fingers on elements located close to moving elements of the structure..
Notes concerning: start-up, operation and maintenance
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User manual – dental unit US-02.1 and US-02.3
•While blockade is on a table position cannot be changed since it can lead to blockade
damage.
•Use distilled water only! Otherwise handpieces may get damaged and it results in lost of
guarantee.
•Tool’s terminals will not work until the distilled water cycle is OFF
•The terminals can not be used without tools.
•Electrical micro-motor must not be lubricated.
Notes concerning cleaning and disinfecting
•The product must not be disinfected in disinfection chambers!
•No bleaching agents (containing active chlorine or oxygen), caustic or corrosive chemicals
are allowed!
•No agents destroying the structure of plastic (organic solvents) can be applied to the
plastic elements!
•Before disinfecting disconnect from power socket.
Disregarding the above requirements concerning cleaning and disinfecting shall result in
losing the guarantee for the product!
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User manual – dental unit US-02.1 and US-02.3
Content
1 PROPER USE AND APPLICATION ................................................................................................... 8
5 CONTROL CRITERIA OF PRODUCT CORRECT FUNCTIONING .................................................. 27
6 SERVICE ........................................................................................................................................... 27
Dental unit US-02.1 and US-02.3 is destined for dental check-ups and procedures on adults, children
and disabled on wheelchairs.
1.2General requirements
The product is intended to be used indoors. Required climatic conditions: temperature from +10 to
+40ºC, acceptable change of surrounding temperature during 8 hours should not exceed 20°C,
relative humidity of the air should range from 30 to 80%, atmospheric pressure from 700 to 1060 hPa.
The product should be used, maintained and serviced according to the indications of this manual.
Using, maintaining and servicing the product in other way than indicated in this
manual is not permitted and may lead to damages for which the user is to blame
and for which the producer is not responsible.
Caution!
Installation of other accessories than those offered by the producer for the
product is allowed only on the basis of a written acceptance of the producer.
The Unit can not be used as hanger, stand, drill or vacuum.
1.3Duties of the user
User: any individual or corporate body who uses the product as its owner, lessee, pledge or who has
a different right to the product as well as an entity who uses the product on its own or on whose behalf
it is used.
The user must ensure that the product shall be used exclusively in conformity with its destination and
that it is used in appropriate conditions and in consistence with this manual. The user is also obliged to
take all necessary precautions in order to prevent all life and health haza rds concerning the user,
patients and any third party. Only authorised persons who underwent special training and are
acquainted with this manual may operate the product. The user must also ensure that all persons who
operate the product have read, understood and apply instructions contained in this manual.
1.4Technical data
-Power supply230V~ 50/60Hz
-Value of a fuse on voltage 230VT3, 15 A
-Power consumption (maximal)400 W
-Input air pressure0,45 MPa
-Filtration net on air filter on inlet5 µm
-Input water pressure0,25 MPa
Filtration net on water filter on inlet80 µm
-Water pressure in distilled water circulation0.2 MPa
Maximum light illumination 21500 lux (for light CELIA)
-Saliva ejector efficiency0,7 l/min by the water pressure 0.2MPa
-weight65 kg
Class of protection before electric paralysis I
Type of the part application B
-Protection degreeIPX2
-Usage period10 lat
-Maximal additional load of doctor’s table 3 kg
-Maximal additional load of cuspidor block1 kg
For the special cliente request it’s possiblr to produce the product with change parameters, not
lowering it’s safety.
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1.5Description of elements and functions
User manual – dental unit US-02.1 and US-02.3
FIG. 1
Pos. in
fig. 1
1Dental chair
2On / off switch
3Cuspidor block
4Cuspidor weight
5Cup filling point
6Saliva ejector
7Table’s pantograph arm
8Doctor’s table
9Steering panel
10Upper installed hoses
11Instruments
12Lamp’s pantograph arm
13Lamp
14On / off switch of lamp
Description
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User manual – dental unit US-02.1 and US-02.3
1.6Description of the product
The dental unit is installed on a dental chair. It can also operate independently (without the chair). A
change of the height of chair causes a change of position of the unit thanks to which it is not
necessary to adjust position of the unit after each change of height of the chair.
The unit may be provided with a doctor’s table fixed on the arm which allows to position the table
precisely. A set of tools (according to individual requirements of a client) and a panel which allows to
control unit and armchair functions are located on the table. The unit may be provided with an
assistant table. The unit may be provided with a shadowless lamp.
Because of universality and module structure and a wide offer of accessories the unit can be set in
various confgurations according to doctor’s specifications.
The producer reserves the right to introduce in the product structural modifications resulting
from technical progress which are not covered in this user manual.
The producer reserve that all parameters and accesories can be modyfied or change,
especially construction, technology and materials, not lowering accepted parameter
technically-user and safeties of products.
1.7Safety
The structure of the product assures its safe operation and use on condition that the rules
comprised in this manual are followed.
Caution: The sign shown below says: “Caution – pay special attention to the User Manual”.
A label showing this sign is placed on any parts or mechanisms, which may prove
to be harmful to the patient or the personnel if their maintenance will not comply
with the descriptions found in this Operating Manual.
When operating the product the user has to pay attention to the elements and
mechanisms marked as shown above.
1.8Critical parameters
Maximal input air pressure- 0,8 Mpa
Maximal input water pressure- 0,6 Mpa
1.9Electromagnetic compatibility
Medical device: dental unit US-02.1 and US-02.3 is an electric appliance. Electric appliances are a
source of electromagnetic radiation and themselves are under its influence. Therefore, use of an
medical devices requires some safety precautions connected with electromagnetic compatibility.
In tables: item 7Characteristics of electromagnetic environment – electromagnetic
environment in which medical device dental unit US-02.1 and US-02.3 should be used is
described. Recommendations and warnings which should be followed by the users were also
presented.
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Caution!
Pd2,1
=
Pd2,1
=
Pd3,2
=
User manual – dental unit US-02.1 and US-02.3
Use of different accessories, additional equipment, cables, spare parts than those
offered and/ or recommended by the producer may cause an increase of emission
and/ or decrease of bed’s resistance to all electromagnetic phenomena.
Recommended distances between portable radio-transmitters and product
Rated output
power of the
transmitter in watts
[W]
0.010.10.10.2
0.10.40.40.7
11.21.22.3
10447
100121223
For transmitters whose maximum output power is not detailed above, the separation distance
should be calculated on the basis of the formulas given above. P is the power in watts (W) as
declared by the producer of transmitter
ATTENTION
The above recommendations may be inadequate in some situations. Propagation of
electromagnetic waves can be absorbed or reflected from buildings, structures and people.
150 kHz to 80 MHz
distance in meters
150 kHz to 800 MHz
distance in meters
800 MHz to 2.5 GHz
distance in meters
2Transport and first use
2.1Transport
There is a possibility to transport the product by any covered transport means. While transporting, it is
necessary to immobilize the truck and protect it against moisture.
The transport conditions are as follows:
-temperature: from –10OC to 60OC (for the products including electronic parts),
from –20OC to 60OC (the other products),
-relative humidity: from 20% to 80%.
In case if unit is transported in temperature below zero degrees centigrade, all
tanks and conduits containing water should be emptied. Water left in unit
hydraulic systems during transport in freezing temperature may result in unit
damage.
Caution!
While product transporting, storage and unpacking, the temperature gradient should be less than 10OC
per hour. It is strongly recommended to unpack the product after reaching room temperature.
In case of products which comprise electronic systems when the difference between transport
temperature and room temperature in which the product is located is considerable, the product should
be left there for 12 hours. Only after that period it can be started.
Laminar storage is permissible in accordance with the packaging marking. In the absence of the
marking, storied storage is prohibited.
In case of the specific transport conditions (particularly: low temperature transport), it is necessary to
negotiate the way of transport and product packaging with the product manufacturer in order to ensure
safe transport.
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User manual – dental unit US-02.1 and US-02.3
2.2Unpacking and first use
2.2.1Unpacking
The set is delivered to the customer disassembled. It is packed in wooden or cartoon boxes.
Unpacking must be done inside a building as to protect the unit form damage. In order to make the
unit ready to work the following must be done:
•set the tray,
•remove strips,
•remove cartoon lid,
•remove cushioning material,
Package waste is recyclable and should be segregated before removed to a
disposal site. Returnable packaging should be returned to the producer of the
medical product.
Caution!
•carefully take the unit from wooden pallet and bring it into destined place
2.2.2Installation of cuspidor block on the chair .
Place the cuspidor on the chair arm. Protect it against turning using screws in the shank. Cuspidor’s
axis of rotation must be vertical.
A trained service worker must do the installation.
After each displacement of the chair level the cuspidor block.
Caution!
2.2.3Lamp installation
Remove cuspidor’s cover. Lead the power supply cable to the lamp holder and place the lamp in it.
Connect the power supply cable to electronic circuit according to proper markers.
A trained service worker must do the installation.
Caution!
2.2.4 Table installation.
Remove the table cover. Fix the table to arm with screws from the side of table metal plate and holder.
Lead wires through the hole in the table metal plate and connect them to the electronic circuits
according to proper markers. Connect water and sir pipes according to proper markers. Install the
table cover.
A trained service worker must do the installation.
Caution!
2.2.5Installing the unit
The floor where that unit is installed must be stiff (otherwise there can be a problem with levelling of
the unit).
All connections are placed inside of dental chair’s base. There are connections for power supply
water supply system, compressed air system and sewerage system.
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User manual – dental unit US-02.1 and US-02.3
In order to connect the unit to the media (water, air, power, sewerage system) the connections int the
floor should be made before installation (fig 2)
All connections::
water ((valve which ends with an external thread ½’’, pos. 1 on fig 2),
-sewerage system (Ø50, pos. 2 on fig 2) ,
-air ( pressure hose Ø
6mm/ Ø
wew
12mm, pos. 3 on fig 2),
zew
power supply 230V 50Hz (electric wire 3x1.5mm2,in double insulation, length 500 mm from the floor),
-suction pump (tube Ø32 elastic) - option,
-suction pump steering (electric wire 2x0,5mm2, lengthć 500 mm from the floor i) – option,
-possibility to disconnect voltage,
must be placed in marked area.
Connecting of sewerage system (Ø50) should be on floor’s level.
Location of connections is free (in the range of pointed area) because of elastic connections in the
chair.
Additionally, on the fig. 2 the free space around unit is shown. In this area the floor should be free of
obstacles in order to avoid collisions.
The valve closing inflow fo water to unit should be used in order to protect against water leakage.
Do not use drain trap on the connection to the sewerage system!.
A trained service worker must do the installation.
Caution!
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User manual – dental unit US-02.1 and US-02.3
Fig.2
Chart with location of the chair in dental surgery and a drawing of connections against the basis of the
chair
2.2.6Media
There are 2 basic kinds of media in dental unit : water and air. Air is being transported in blue hoses,
water in green ones.
The supply water must fulfil the requirements for drinking water according to § 2.1. of MOH
Directive from 04.09.00 no 82. Pos. 937. Required water hardness is 60÷170 mg/l CaCO3 .
Air must be clean – free of constant elements.
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User manual – dental unit US-02.1 and US-02.3
Air can be provided to the unit from the compressor or from a central compressed air unit. Provided air
can neither contain solids nor oil suspensions and because of that use of oil compressors is not
allowed.
In order to protect air system of the unit against water leakage the unit is provided with an air filter with
a condenser. Filtering effectiveness 5μm. The filter has a system of automatic ejection of condensed
water.
Solids with size below 2 mm, sewage, microbiological substances are discharged to sewers.
If the water doesn’t fulfil the above requirements, the user should supply outer
water filter.
Caution!
2.2.7Preparation for start-up
-check whether the equipment provided fits the documentation enclosed,
-read the Operating Manual carefully,
-start up the product as described in item: 2.3 Installation and first use,
If the air from compressor doesn’t fulfil the above requirements the filter of
constant elements is recommended.
If the product is not fully functional, i.e. the output parameters differ from the
description contained in this manual, the bed must not be used. This situation
should be reported to the producer or supplier (dealer). The use of an improperly
functioning product may result in damages, which will encumber the user and
Caution!
which will not be a matter of producer’s responsibility.
2.3Start-up
1. The unit with chair should be placed on stiff floor in required working place, which meets the
requirements descibed in this manual (item. 1.2 General requirements and 1.9 Electromagnetic compability).
2. If the chair is not stabile, the bottom plate of chair must be levelled using the adjustable foots.
3. Connect foot controller to the socket placed in chair’s base.
4. Fill the bottle with distilled water.
•Make sure that the bottle with distilled water is full.
•Make sure that valve which deliver the water to unit is open.
•switch on the main switch on armchair cover 5 minutes after switching on of the compressor: air
and water flow will open automatically and power will be connected to the unit.
•After 10 minutes water in the heater reaches the required temperature and dental unit gets ready
for exploaitation.
Before putting into use ensure that the set is plugged in and check if the voltage in
electrical installation is proper. Ensure also if the water and compressed air with
an appropriate pressure are conducted to the unit.
If the product is not fully functional, i.e. the output parameters differ from the
Caution!
description contained in this manual, the bed must not be used. This situation
should be reported to the producer or supplier (dealer). The use of an improperly
functioning product may result in damages, which will encumber the user and
which will not be a matter of producer’s responsibility.
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User manual – dental unit US-02.1 and US-02.3
3USAGE AND HANDLING
3.1Unit functioning
•Turning on the main switch in the chair base (or in the connecting box) causes automatic opening
of water and air supply. After 10 minutes water in a heater reaches adequate temperature and the
unit is ready for exploitation.
Always start the compressor first and the unit afterwards. .
CAUTION!
- Saliva ejector, suction terminals are placed on cuspidor block. In order to start the saliva ejector
work the switch should be placed in “red” position (red point) and terminal should be taken out from
the holder
•There are buttons (described in the paragraph 3.5 “Table”) on the control panel board allowing
flushing down the cuspidor and filling a cup with water. Short-duration pressing of the button will
result in function operating for a period of time programmed earlier. Holding a button for more than
3 seconds does programming of glass filling or flushing time. Then the time that has passed
starting from the moment of pressing and ending at the moment of releasing the button is
programmed and stored. Next short-duration pressing of the button will result in function operating
for a period of time programmed.
•A lamp has 2 stages of illumination. The control is done through switch located at the rear side of
lamp. Switching on the lamp is done by placing the switch in middle position.
•The control of polymerising lamp is done through button located in lamp’s arm. The sound signal
informs about half of working time.
•Spray function is switched on by switch on foot controller (option) or under doctor’s table.
Regulation of flow for each hose is possible thanks to knobs placed under the table (excluding the
syringe)
•When operation of the unit is finished it should be switched off with the main switch and the valve
on water connection to the unit should be closed.
Little water leaking through the pipe used for filling the cup with water is not the
sign of damage. It is caused by water dilatation while it is heated.
After finishing the work the spray for instruments should be turned off. Not
following this instruction can cause not big water leaking from hoses after turning
Caution!
off the power supply.
3.2Equipment functioning:
1. Syringe
Pressing the button “water” on the syringe casing will cause water flow from its terminal. Releasing the
button will stop the flow.
Pressing the button “air” will cause the flow of compressed air from its terminal. Releasing the button
will stop the flow.
Pressing both buttons “water” and “air” at the same time will result in spray flow form its terminal.
Releasing the button will stop the flow.
In case of six-way syringe the heating option can be turned on and then pressing proper buttons will
cause flow of appropriate mixture heated up to the temperature of about 36o C
2. Electrical micro-motor
Foot controller starts micro-motor after an arm with a terminal is taken out from the hanger. Micromotor revolution is changed through buttons “+” or “-“ located on the table panel board. Proper buttons
(as described earlier in clause table) change the sense of rotation and turn on light in the terminal.
Activation of any function is signalled through diode LED.
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User manual – dental unit US-02.1 and US-02.3
3. Contra-angle and pneumatic micro-motor
Foot controller activates these devices after arms with terminals are taken out form the hanger. Proper
buttons (as described earlier in clause table) turn on a spray and light at the terminal. Activation of any
function is signalled through diode LED
4. Piezoelectric scaler
Foot controller activates scaler after arm with a terminal is taken out of the hanger. Power of scaler is
changed through potentiometer in doctor’s table. Activation of any function is signalled through diode
LED.
5. Pneumatic scaler
Foot controller activates scaler after arm with a terminal is taken out of the hanger
The terminals cannot be used without tool.
Setting the correct parameters according to the instruction from the producer and
checking of the function working and instruments can be done by the worker of
service during the installation.
Caution!
3.3Equipment
Equipment adviced by manufacturer:
Hand pieces
Contra-angle turbines
BIEN AIRNSKFAROW&HSIRONAKAVO
Boralina
Bora L
Prestige L
BIEN AIRNSKFAROSIRONAKAVO
MC3 IR
MC3 LK
BIEN AIRNSKW&HSIRONAKAVO
CA 11 32
CA 11 L
CA 15 41
CA 10 141
BIEN AIRNSKW&HSIRONAKAVO
PM 11 32TI-65
PA-SU-M4
PTL-II-SU
Ti-Max A 600
Ti-Max A 600 L
Ti-Max A 700
Ti-Max A 700 L
Ti-Max E
Ti-Max EL
NSKW&H
EX-203-M4
IS-205-M4
PTL-CD
FPB-E
NPB-PTL
TI-25
TI-25 LJ
TI-95
TI-95 LJ
NRS-E
NRS-PTL
EX-VI
Delta P3
Delta LP3
Electric micromotors
Intramatic
Pneumatic micromotors
Contra-angles for micromotor
WA-56 A
WA-56 LT
WA-99 A
WA-99 LT
WA-86 A
WA-86 LT
Straight handpieces for micromotor
HA-43 ASeria T1 Line
Intralux
TE-95 RM
TA-98
TA-98 L
Motor SL
Motor EL 1
Seria T1 Line
Seria T1 Titan
Sironiti
Seria T1 Titan
Sironiti
T1
T2
T3
A-25
LT-25
Gentleforce
Supertorque
Intramatic
LUX
Gentlepower LUX
Intramatic LH/CH
Endoflash
Duratec
Multiflex
Gentlepower LUX
Intramatic LH/CH
Endoflash
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User manual – dental unit US-02.1 and US-02.3
Scalers
EMSMECTRONSIRONA
FS-133
FS-273
LUZZANISIE DENTAL
MinilightC-1600
FAROMECTRON
Polispot
Poliled
EMSNSK
HandyflowProchy Mate
Piezo p2KSiroson L
Siroson C8
Stronic L
Syringes
Curing lamp
Starlight
Compact + Starlight-P
Hand polieshing device
Duratec
Multiflex
Compressors
FIACEKOMFAMED
Ecu HP-1DK-50 Z
DK-50 10Z
DK-50 2V
Suction pumps
ECOMCATTANIDETAL CENTRA
DO-2.1Uni-Jet 75ARIA-1
Lighting lamps
CL TRENDFAROSIE DENTAL
CeliaEdiDuo Dental
The Producer reserves the right to introduce new equipment which will meet effective safety
standards.
BM-25
A-004
3.4Foot controller
The set has a foot controller, which controls working of micromotor, contra-angle, scaler and function
of chip blower chair and the unit (option). It is connected to a terminal placed on the chair base.
3.5Table
A table is fastened to a rotary hinge of pantograph arm mounted to the cuspidor block. There are
electronic control devices inside the table. The table position can be changed when blockade is
released. After adjustment a new position must be blocked.
While blockade is on a table position cannot be changed since it can lead to
blockade damage.
Caution!
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User manual – dental unit US-02.1 and US-02.3
There are four hoses with:
•Syringe.
•Contra-angle without light
•Electrical micro-motor with contra-angle witnout light,
•Piezoelectric scaler,
There is a possibility of adding following modules:
•curing lamp module
•negasoscope module
Unit can work with all instruments equipped in Midwest type connection. On the table there are
steering keyboards
It is not allowed to interchange location of the turbine and the pneumatic microengine as it can cause their damage.
CAUTION!
User can install a new turbine or a pneumatic micro-engine only when a tool
produced by the same producer and of the same type is used.
A new turbine or a new pneumatic micro-engine different from those installed
before can be installed only by an authorised service as it requires adjustment of
parameters of provided air.
Additional control panel (used when the unit is equipped in electrical micromotor)
Function of additional control panel:
•control of micromotor revolution,
•micromotor revolution direction change,
•handpiece light – turning on and off,
•monitoring of micromotor speed with linear light bar.
Fig.4.
1. rotation decrease button [-]
2. rotation increase button [+]
3. light button
4. rotation direction change button
5. additional function
6. light bar
Underneath the table, water control valves for each hose are located (except for chip blower syringe).
3.6Cuspidor block
Cuspidor is located under left armrest and can be turned round the column fixed to the chair arm.
From the patient side the porcelain, detachable bowl and glass container are located. The buttons on
the steering panels of the table and assistant table are used for operating the cuspidor block e.g. filling
the cup with water and cleaning the bowl.
Saliva ejector is placed in holder on the side of cuspidor block. Suction system caniules are placed on
rotary arm. Suction system and saliva ejector work automatically after taking out from holder.
In case of using the curing lamp, it is placed on the side of cuspidor block . In cuspidorb block there is
also module of internal circulation of distilled water.
3.7Lamp
Lamp rotary installed to the pantograph arm has two stages of illumination. The control is done
through switch located at the rear side of lamp. Switching on the lamp is done by placing the switch in
middle position.
3.8Internal distilled water cycle
The unit is equipped with distilled water cycle supplying tool’s terminals. It is placed inside cuspidor
block. ON/OFF switch for the water cycle is located under the cuspidor’s cover.
Switching the distilled water cycle on:
•make sure the bottle is filled with distilled water,
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User manual – dental unit US-02.1 and US-02.3
•switch the power supply on,
Refilling the distilled water bottle
•switch the power supply off
•turn on the bottle clockwise
•refill the bottle with distilled water
•turn off the bottle,
•switch the power supply on,
•Removing the air from the system.
Removing the air from the system.
•Switch on the water outflow from each tool until the constant, uninterrupted flow is obtained.
Use distilled water only! When not distilled water is used it can result in the lost of
guarantee for tools.
Caution!
3.9Scaler and Mectron polymerisation lamp
On customer’s demand unit may be equipped with general-purpose sleeve operating the scaler and
polymerisation lamp manufactured by Mectron. These instruments may be replaced if needed.
Instrument fixed to the sleeve is identified as scaler. If polymerisation lamp is connected to the sleeve,
cut off water supplied to the sleeve (scaler) and set maximum power.
3.10 Functional parameters
•table height adjustment range500 mm ±10 mm
•lamp height adjustment range520 mm ±10 mm
•rotation angle of cuspidor block>60°
•rotation angle of lamp arm300° ±10°
•rotation angle of table arm340° ±10°
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User manual – dental unit US-02.1 and US-02.3
Unit installation minimal free
space needed to table and lamp
non-collision work
Extreme arms positions
fig 5 Arms range
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User manual – dental unit US-02.1 and US-02.3
3.11 Collisions
In some extreme unit positions a mechanical collision may occur. Thus attention must be paid that the
unit and its elements are not damaged.
3.12 Operation when plugged to the power network
Built-in into a chair base power supplier enables supplying the set with a current of 230V, 50Hz form
the power network. Within the set only save voltage SELV.
The unit must be plugged according to the nameplate.
Caution!
The unit is entirely detached from the power supply when the plug is taken out from the socket.
Do not plug the unit in places where explosion hazard exists!
Caution!
4Additional modules
Dental unit US-02.1 and US-02.3 can be enriched with following modules:
Moduletype
1Start setWU-01.0
2Curing lamp FAROWU-02.0
3Aspirator system (additionally suction pump)WU-03.0
4Additional shelf for toolsWU-04.1
5Curing lamp tableWU-05.0
66 function chip blower syringe with lightWU-08.0
7X-ray viewer WU-11.0for US-02.1
8Light module – 1 hoseWU-18.0
In case of ordering additional equipment the above types should be used.
Assembly can be done only by authorised service worker.
4.1Starting set WU-01.0
Starting set is added to each unit equipped in sution system, it is a set of single used endings od
suction system.
4.2Curing lamp FARO WU-02.0
Curing lamp is assembled on special holder on the side of unit.
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User manual – dental unit US-02.1 and US-02.3
4.3Suction system WU-03.0 (additionally suction pump)
System of 4 sucking endings is mounted on special holder, raising of ending automatically switches on
it’s work of the suction pumps.
4.4Additional shelf for tools WU-04.1
Additional shelf for tools is mounted to the table
4.5Tray for curing lamp WU-05.0
It is a tray for curing lamp.
4.6Module of 6-way syringe with light WU-08.0
Module ensures proper working of 6-way syringe.
4.7Negatoscope WU-11.0
Negatoskope module is mounted on table.
4.8Light module 1-hose WU-18.0
Light module enables leading the light into the working end in one hose.
4.9Light module 2-hose WU-19.0
Light module enables leading the light into the working end in two hoses.
4.10 Ultrasonic scaler module WU-20.0
Ultrasonic scaler is installed on the table, enables the ultrasonic scaler connection.
4.11 Electric Micrimotor module WU-21.0
Electric micromotor module powers electric motor of the end, which can be replaced by pneumatic
micromotor.
The unit is equipped with a system that informs user that end-piece maintenance is required. The
system activates audio signal as soon as preset time has elapsed. Preset time ranges from 1 to 180
minutes. Setting change is possible through a terminal and may be done by a serviceman. Working
time is counted separately for each end-piece sleeve. The system counts total end-piece working time
and generates audio signal as soon as preset time has elapsed. In order to cancel audio signal,
simultaneously press the push-buttons [+] and [-] on the accessory panel. As soon as the audio signal
has been cancelled, time is counted from the beginning. Normally this system is inactive, however it
may be activated by a serviceman on customer’s demand.
This function is only informative and does not exempt the user from obligation to
observe maintenance instructions specified in service manuals for end-pieces and
in the maintenance guidelines provided in this manual.
Caution!
The unit is equipped with a system protecting against electric micro-motor overheating. According to
its service manual, micro-motor is a device prepared for intermittent running, and e.g. for Bien Air
micro-motor model MC3LK, its operation is as follows:
- continuous running 1,7A; ok. 0,8Ncm;
- intermittent running 3A for 60s; 5A for 10s;
cooling within 3 minutes with air, or 20 minutes without air supply.
When the above-listed parameters are exceeded, motor casing temperature excessively increases.
Motor control system controls current consumed by the unit during operation. Audio signal announces
exceeded parameters.
Further micro-motor operation is still possible for a moment. In case of continuing motor overheating,
it automatically deactivates. Further micro-motor operation is possible after having cooled it. Cooling
is continued even if an end-piece is put aside and its duration depends on overload degree and may
last even few minutes. Normally this system is active, however it may be deactivated by a serviceman
on customer’s demand.
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4.12 Water heater module WU-22.0
Water heater module enables warming up of water till 38°C ±5°C.
4.13 Additional hose module WU-23.0 and WS-23.1
Additional hose module assure extension of sleeves and is installed on the table.
4.14Arm with pneumatic block WU-38.1
The unit can be provided with an arm with doctor’s table with a pneumatic block. The arm is released
with a button situated at the handle of the table. Then the doctor’s table can be moved up and down.
When the button is released, the arm is blocked in chosen position.
Be careful when releasing the pneumatic arm. Moving elements of table arm
(moved by a pneumatic spring) may catch fingers or hands. It is not allowed to
support or put fingers or hands in places marked with the symbol
Caution!
5Control criteria of product correct functioning
The unit should be checked before first usage in each day.
Caution!
Way of checking the correct functioning:
After the first put in use in any day the correct tools and equipment functioning should be checked
according to the paragraphs “Unit functioning” and “Tools functioning”. If the unit passed positively all
tests and there were not any worrying sounds, water leaking, sounds of escaping air, vibration, the unit
may be safely used. Otherwise, see the point: “Damage and defects localisation and identifications”.
If the product is not fully functional, i.e. the output parameters differ from the
description contained in this manual, the bed must not be used. This situation
should be reported to the producer or supplier (dealer). The use of an improperly
functioning product may result in damages, which will encumber the user and
Caution!
which will not be a matter of producer’s responsibility.
6Service
6.1Storing
If the product will not be used for longer it should be stored in following climate conditions:
-temperature: 25o ± 10oC,
-relative humidity: 50% ± 25%.
6.2Washing, disinfecting and maintenance of the surface of the unit
For cleaning and disinfecting use cleaning solutions free from bleaching agents (active oxygen or
chlorine), recommended by Famed S.A. in Annex 2 to this manual ( allowed to turnover and use on
the territory of the country, where they are used).
After disinfecting wash the product with distilled water to remove stains.
After disinfecting dry thoroughly.
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User manual – dental unit US-02.1 and US-02.3
Drying should be carried out by use of hot air (temp. max. 60o) or by wiping with a dry, soft, sterile
clout.
The product must not be disinfected in disinfecting chambers.
Bleaching (containing active chlorine or oxygen), caustic and corrosive agents
must not be used.
No agents destroying the structure of plastic (organic solvents) can be applied to
Caution!
Operating Personnel should check the condition and cleanliness of filtration sieve in the spittoon mug
at least 2-3 times a day and clean them or replace when necessary.
Operating Personnel should rinse the saliva ejector pipe 2-3 times per shift.
the plastic elements.
Rinsing of saliva ejector pipe assures its proper operation.
Caution!
Disregarding the above requirements concerning cleaning and disinfecting shall result in
losing the guarantee for the product!
6.3Washing, disinfecting and maintenance of dental tools
Only agents recommended by FAMED Żywiec S.A. in appendix no. 2 to this manual (whose sale and
use is permitted in the country in which they are used) can be used for washing, disinfecting and
maintenance of dental tools, even if producer of tools allows to use other agents.
Washing, disinfecting and maintenance of dental tools should be done in accordance with tool
operating manuals provided by producers. Having in view well-being of the client FAMED Żywiec S.A.
developed the appendix ‘Washing, disinfecting and maintenance of dental tools: manual’ which
comprises descriptions of washing, disinfecting and maintenance of offered dental tools.
Using equipment elements incongruously with the user manual provided by the
producer will result in the loss of guarantee.
Caution!
FAMED Żywiec S.A. is not responsible for effects of use of agents for washing,
disinfecting and maintenance which are not on the list of recommended agents
included in appendix no. 2.
6.4Washing, disinfecting and maintenance of additional accessories
Additional accessories shall be washed, disinfected and maintained in accordance with the operating
manual provided by the producer. All maintenance activities which secure correct operation are
described in operating manuals of particular elements of accessories.
Caution!
Using compressor incongruously with the user manual provided by the producer
will result in the loss of guarantee.
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User manual – dental unit US-02.1 and US-02.3
6.5Bulb replacement in the illuminating lamp
Lamp EDI
Position the lamp with its lampshade up, and then turn lock screws to the left and remove the
lampshade.
Do not wipe the lampshade inside, in case if it is dusty, purge it with compressed
air.
Caution!
Remove bulb fitting as soon as the lampshade is taken off, in order to do that catch the fitting in its
lower part (as shown on the picture), softly press and take it out.
After taking out bulb fitting remove the bulb, holding it in its lower part. Replace removed worn bulb
with a new one (17 V, 95 W). Remember to hold the new bulb through a clean cloth.
Never touch the bulb with bare fingers, as grease left on its surface will lead to its
prompt wear.
Caution!
As soon as a new bulb is installed, fix bulb fitting and replace the lampshade. While installing the
lampshade, remember to position the lamp with its lampshade up. Fix the lampshade by turning lock
screws to the right.
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User manual – dental unit US-02.1 and US-02.3
Lamp CELIA
In order to remove the lampshade carefully turn it by 90°, paying attention to plastic catches. Remove
the lampshade after turning it.
Then unscrew bulb fitting. Remove worn bulb, holding it in its lower part. Hold the new bulb (12 V, 50
W) through a clean cloth and put it in place of the worn one.
Never touch the bulb with bare fingers, as grease left on its surface will lead to its
prompt wear.
Caution!
Then screw in bulb fitting, replace the lampshade and turn it by 90°, paying particular attention to
catches.
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6.6Conservation list – done only by a service worker:
User has to obey the frequency and range of conservation activities done only by authorised services.
User must pay for the inspections.
After 3 and 12 months from the selling date the inspection must be conducted. The user should
declare the inspection necessity.
The neccesity of providing the conservation should be demanded by user !
The following must be done:
•air and water filters in a chair base must be checked and changed as needed,
•air and water pressure for each tool in a chair base and table must be controlled and adjusted as
needed,
•clean saliva ejector hose and Venturi valve,
•check power, air and water leads, remove bands, if any
•operation of all the control and steering elements must be checked,
•make proper notes in guarantee card.
Damages caused by incrustation or another water pollution are not the object of
guarantee.
Caution!
For proper and safe functioning every 12 moths the technical inspection made by producer or
authorised service shop (on the user’s account) must be done. It should contain the conservation
activities conducted by the authorised service.
6.7Damages and defects localisation and identification
Damages and defects found in the product or product accessories should be reported immediately to a
person in charge of such issues. The bed which can not be safely operated (e.g. damaged electric or
mechanical elements ) must not be used till it is repaired.
6.8Repairs and maintenance activities.
Repairs are done by the producer or an authorised service. The user can not carry out any repairs on
his own unless he has undergone special training or has been authorised to do that. When the
producer has given his written permission for repair of the product by client’s technical staff, the
producer shall provide the client with necessary charts, lists of spare parts, descriptions and
information on repairs.
The producer allows only to use original spare parts. In order to provide safe and reliable operation of
the product one should use only spare parts provided by the producer. Worn out parts shall be
removed as provided in environmental protection regulations.
The product contains products which may be dangerous to the environment:
- oil (pneumatic spring),
Caution!
The rules of proceeding with used products which may be dangerous to the
environment are defined in regulations related to proceeding with waste.
Repairs and maintenance must be performed only by qualified personnel. If a product is operated
outside Poland, one should inform about a necessity of a repair a producer or the dealer from whom
the product was purchased.
Every repair of the product must be recorded on the list of repairs enclosed with the guarantee
certificate.
6.9List of the maintenance activities
In order to ensure safe and proper technical condition of the product during the whole life of
the product, the product should undergo periodical technical inspections to be carried out by
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the producer, an authorised service or authorised and trained technical staff of the customer
(at the expense of the user).
Only a positive result of product inspection can be the basis for its further operation.
The required surveys and their frequency are shown in the table below.
Survey’s subjectFrequency
•air and water filters in a chair base must be checked
and changed as needed,;
•air and water pressure for each tool in a chair base
and table must be controlled and adjusted as
needed,
•clean saliva ejector hose and Venturi valve,
•check power, air and water leads, remove bands, if
any
After 3 months and
after 12 months
after date of sale,
and then every 12
months
•operation of all the control and steering elements
must be checked,
•isolation of electric system must be controlled
Every 3 years
Every repair of the product must be recorded on the list of repairs enclosed with
the guarantee card.
Caution!
6.10 Damages and defects localisation and identification
DEFEC
Possible causeElimination
T
Unit does not react
Tool terminals do not
work
Lack of water in the
terminals
If the fault cannot be eliminated, put the product aside and call the repair department, local service
center or FAMED S.A’s service.
If the customer resign from further product exploitation, he is obliged to product liquidation according
to rules of environment protection, detailed information is situated in annex no. 3.
Lack of power supply
Lack of power supply
Switch the unit on
Switch the unit on
Lack of distilled waterSwitch the distilled water cycle on
Lack of distilled water,
Switched off the distilled water
knob
Switch the distilled water on,
Refill the bottle with distilled water,
Turn on the water regulation knob on the
terminal
7 Characteristics of electromagnetic environment
Medical device the dental unit US-02.1 and US-2.3 is to be used in electromagnetic environment specified below.
The customer or the user of medical device the dental unit US-02.1 and US-2.3 should assure that it is used in
such an environment.
with radio frequency only for its internal function. Therefore, its RF
emission are very low and are not likely to cause any interference in
nearby electronic equipment..
Medical device the dental unit US-02.1 and US-2.3 produces energy
emission RF
CISPR 11
Harmonic emission
IEC 61000-3-2
Voltage fluctuation,
flickering
Class B
Class A
Complies
Medical device the dental unit US-02.1 and US-2.3 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.
IEC 61000-3-3
Electromagnetic immunity
Medical device the dental unit US-02.1 and US-2.3 is to be used in electromagnetic environment specified below.
The customer or the user of medical device the dental unit US-02.1 and US-2.3 should assure that it is used in
such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Surge
IEC 61000-4-5
Series of quick
transitory stages
IEC 61000-4-4
Voltage dips, short
interruption and
voltage variations on
power supply input
lines
IEC 61000-4-11
NOTE UT is the a.c. mains voltage prior to application of the test level
and US-2.3 use the floor should be wooden,
concrete or covered with ceramic tiles. If the
± 8 kV air
floor is covered with a synthetic material,
the relative humidity should be at least 30%.
± 1 kV differential
mode
± 2 kV common
Mains power quality should be that of a
typical commercial or hospital environment
mode
± 2 kV for power
supply lines
± 1 kV for input/
Mains power quality should be that of a
typical commercial or hospital environment.
output lines
< 5% UT
(>95% dip UT)
for 0.5 cycle
40% U
T
(60% dip UT)
for 5 cycles
70% U
T
(30% dip UT)
for 25 cycles
Mains power quality should be that of a
typical commercial or hospital environment.
In normal use The dental unit US-01.2 is
battery operated.
Connect to mains network only for battery
charging.
< 5% UT
(>95% dip UT)
for 5 seconds
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Pd2,1
=
Pd2,1
=
Pd3,2
=
Electromagnetic immunity
Medical device the dental unit US-02.1 and US-2.3 is to be used in electromagnetic environment specified below. The
customer or the user of medical device the dental unit US-02.1 and US-2.3 should assure that it is used in such an
environment.
Immunity test
Transmitted
disturbances induced
by fields with radio
frequencies
IEC 61000-4-6
Portable and mobile RF communications
equipment should be not used not closer to
any part of the dental unit US-02.1 and US-
2.3 including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
trasmiter.
Recommended separating distance:
3 Vrms
Electromagnetic field
with radio frequency
IEC 61000-4-3
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radio, 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 medical device the
dental unit US-02.1
is used exceeds the applicable RF compliance level above medical device the dental unit US-02.1 and US-2.3
should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating medical device the dental unit US-02.1 and US-2.3.
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 800 MHz800 MHz to 2.5 GHz
where P is the maximal output power of the
transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey, a should be less than the compliance
in each frequency range.b
Interference may occur in the vicinity of
equipment marked with following symbol:
b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
NOTES
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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8Dental unit identification
When sending/ asking any questions concerning the table and when ordering spare parts, please give
the serial number of the table placed on the nameplate and the guarantee certificate.
The nameplate is located on the lower part of the backrest plate.
6.2Nameplate
Description of individual components of the nameplate
1 - Producer’s name, trademark (address),
2 - Symbol (name) of the product,
3 - Serial Number (country of manufacture),
4 –Product index
5 - Caution! – read the User Manual,
6 - CE Mark
7 – Power feed parameters
8 – Kind of work (after each 2 min of work, 18 min. of break)
9 – Description of the application part, class of protection from electric shock and additional markings,
IP-X2Protection degree
Application part type B
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6.3Labels
User manual – dental unit US-02.1 and US-02.3
OR
1See point 8.1Nameplate
Description of controls and
2
adjustments under the doctor’s
table.
Notice! The producer reserves the right to introduce in the product
modifications resulting from technical progress which are not covered in this
operating manual.
7Terminal conservation – guidelines
Attention! This guideline treat only as a help. Before beginning of tools exploitation the user
manuals attached to them should be read. Using the tools incongruously to them may result in
the loss of guarantee.
BIEN AIR
Turbine (Bora, Prestige, Black Pearl Eco):
Lubricate once a shift using the lubricator Lubrimed ®. The end of the lubricator put into the place of
turbine and rotate at ½ turn.
Clean once a week using the agent Spraynet ®.
Internal cleaning: lead the agent in the turbine propulsive air canal.
External cleaning: spray and remove dust with the cloth.
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Attention! Before each sterilisation turbine should be cleaned and lubricated.
Contra-angle (CA 1132, CA 1141)
Before lubrication take the head away from the contra-angle. Lubricate separately.
Shank – lubricate once a day, after work using the agent Lubrifluid ® leading in the spray end into the
place of micro-motor. Lubricate for 1 second.
Head – lubricate once a shift, twice a day, once for each 15-20 minutes of constant work putting the
head into the Lubrifluid spray applicator. Lubricate for 1 second.
Clean with the agent Spraynet ® once a week.
Attention! Before each sterilisation turbine should be cleaned and lubricated.
Straight handpiece (PM 1123, PM 1132)
Lubricate once a day, after work, using the agent Lubrifluid ®, leading in the spray end into the place
of micro-motor. Lubricate for 1 second.
Clean with the agent Spraynet ® once a week.
Attention! Before each sterilisation turbine should be cleaned and lubricated.
Electric micro-motor (MC2, MC3):
Do not lubricate!!!
PreparationBA 71
LubrimedLubrifluid
Spraynet
Contents 100 ml6 pcs.500 ml500 ml
Order no107.50.01107.37.01930.01.21930.01.23
*****
bearings
Electric motors BASCH*****
Contra-angles and
*****
straight handpieces
Sleeves With
*
cloth
Microsurgical cablesWith
**
cloth
Drop wires, lock
connectors
Electronic systemsWith
With
cloth
**
*
cloth
Electric micro-motors
MC2
Electric micro-motors
MC3
Brush purge with a compressed airWith
cloth
With
cloth
*
*
NSK
Turbine:
Lubricate once a shift, after work using the agent Panaspray ®. Lead the agent in the turbine
propulsive air canal. Lubricate for 1 second. In case of dirt lubricate as long as the agent will outflow
without the dirt. Lubrication = cleaning.
When the oil is used lead 2-3 drops in the turbine propulsive air canal, connect to the sleeve and start
it for 1 minute. When the lubrication is made in this way it is necessary to do it once a week.
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User manual – dental unit US-02.1 and US-02.3
Contra-angle:
Lubricate once a shift, after work using the agent Panaspray ®. Lead the agent in using the
appropriate end (provided with the contra-angle) into the place of micro-motor. Lubricate for 1 second.
Lubricate for 1 second. In case of dirt lubricate as long as the agent will outflow without the dirt.
Lubrication = cleaning.
FARO
Turbine:
Lubricate once a shift, after work using the agent Faro. Lead the agent in the turbine propulsive air
canal. If the turbine has a lock connector lead the agent using the appropriate end. Lubricate for 1
second. In case of dirt lubricate as long as the agent will outflow without the dirt. Lubrication =
cleaning.
Electric micro-motor:
Do not lubricate!!!
Clean every three months in the authorised service shop.
Others
Piezoelectric scaler:
Do not lubricate!!!
Syringe:
Do not lubricate!!!
End remarks
Using appropriate conservation agent is the guarantee of tool infallible work.
If the tool will not be used for longer it should be cleaned and stored in the dry, warm place.
The tool work must be immediately stopped when strange, unnatural sounds or too strong
vibrations are perceived.