Please read this manual thoroughly before
using the equipment to ensure safe and
correct usage.
Page 2
Check the matters below
Before you read this user manual
before reading this user manual
Used in cautionary matters for safety
SymbolNameFunction
Caution
Warning
Mandatory actionYou must observe the following instructions.
ProhibitionYou should not do the following.
Disassembling
Prohibited
You may damage the equipment if you do not observe the following
instructions.
You may lose your life or sustain serious injury if you do not observe the
following instructions.
This is a sign of prohibition of disassembly.
SymbolFunction
The instruction is a supplementary description or a reference regarding the movement
of equipment motion.
Refer to the relevant page
Before Use!
2460
Setting necessary before operating the product function.
Refer to instruction manual / booklet
Manufacturer
Date of manufacture
European Authorized Representative
Serial Number
Type B Applied Part
CE Marking of Conformity
Waste Electrical and Electronic Equipment symbol
Warning: Dangerous Voltage
Warning: Biological hazard
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Medical Equipment,
(E482378)
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH [STANDARD]
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA C22.2 NO. 60601-1:14 (2014)
IEC 80601-2-60 (2012)
IEC 60601-1-6 (2010) + AMD 1 (2013)
Intended use
Intended for use on humans in the area of dentistry and may only be used by trained dental
professionals.
Frequently used functions
Supports the patient’s body during treatment and allows selection of the treatment position.
Provides convenience in using instruments (Hand-piece, Scaler, Suction, etc) during treatment.
This User Manual
This user manual is for the K3 Mount/K3 Cart model of Osstem Implant Co., Ltd. (hereinafter referred to
as Osstem) and issued on 2017. 08. 10
The pictures on this user manual are drawn for descriptions, which may be partially different from the
actual items.
Refer to “Caution and Notice signs” and “Matters to check before reporting on failure” at the back of
the user manual to recheck the failure of the product before requesting service.
Be sure to read “Matters requiring attention for safety” before using the product to ensure correct
product use.
The user shall assume responsibility for injury or product damage occurring due to failure to follow
this user manual.
The exterior design and the product size may be changed without prior notice to improve the product’s
performance.
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Matters requiring attention for safety
Related to installation
This Product should be installed by Osstem or an expert designated by Osstem, based on the installation
manual.
You should not do the following.
• Do NOT use this product in conditions other than the indicated power supply voltage [V~],
frequency [㎐] and acceptable current [A] (or power consumption) specifications.
- Have an exclusive power circuit ready for each machine; never share or divide the power with
that of another machine.
- Overheating and short-circuit may occur, which may cause accident or failure.
• Do NOT install the product in a place of high humidity or moisture, or where water splashes may
occur.
- Overheat and short-circuit may occur, which may cause accident or failure.
• Do NOT install the product in a place where chemicals are stored or where gas is generated.
- Electric shock or short circuit may occur, which may cause accident or failure.
• Do NOT put the product in a place where its power code, ground wire and wire for Foot Controller
may be damaged, such as places like door or passage.
- Electric shock or short circuit may occur, which may cause accident or failure.
• Do NOT use environmentally regulated substances.
• Do NOT use unpurified water for the chair.
You may lose your life or sustain serious injury if you do not observe the following instructions.
• Do NOT install the equipment in an unstable place with incline, vibration, or shock.
- Inappropriate installation may cause malfunction or failure.
• Do NOT use in a place negatively influenced by air pressure, temperature, humidity, ventilation,
sunlight, dust, and air containing salt.
- Inappropriate installation may cause malfunction or failure.
• Be sure to perform earthing for safety. Do NOT earth to gas pipes, plastic water pipes, or the
telephone line.
- This may cause electric shock, fire, failure, or explosion.
- Be sure to use ground plug socket.
- Be sure to perform earthing separately if the internal wiring of the ground terminal is not
connected, even if the plug socket has a ground terminal.
• Installation, modification, adjustment, exchange, maintenance, and repair of the product shall be
performed by an engineer who has been trained by Osstem or the employee of the official
distributors certified by Osstem.
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Matters requiring attention for safety
Matters requiring attention regarding power supply
You may lose your life or sustain serious injury if you do not observe the following instructions.
• Wipe off foreign substances (dust, water) on the power plug terminal and contact part with dry
cloth regularly.
• Do NOT pull the power code (wire) from the power plug.
• Never bend, pull excessively, twist, or tie the power code. Never hang it on a metal part, put a
heavy object on it, insert it in between, or push it in behind the product.
• Connect the power plug to the tip of the plug socket firmly, do NOT use a damaged power plug,
or power code or loose plug socket.
• WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
You may damage the equipment if you do not observe the following instructions.
• Disconnect the power plug if you will not use it for a long time, or in case of thunder and
lightning.
- Failure to do so may cause electric shock or fire.
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The K3 is suitable for use in all establishments other than
establishments
Matters requiring attention for safety
Matters requiring attention regarding the EMC
The equipment requires special prevention measures related to EMC, and should be installed and
operated in an environment that complies with the following EMC guide.
• Mobile RF communication device may disrupt the equipment.
• Using a cable other than one provided by Osstem may negatively affect EMC
performance.
• Do not use the equipment in the proximity of or mounted on another electronic device.
K3 is designed to be used in an electromagnetic emission environment designated in the table
below.
* Guidance and manufacturer’s declaration - Electromagnetic emission
• The K3is intended for use in the electromagnet environment specified below.
• The customer or the user of the K3 should assure that it is used in such an environment.
Emission
RF emission - CISPR11Group 1
RF emission - CISPR11Class A
Harmonic emission
IEC 61000-3-2
Voltage fluctuation / Flicker
emission IEC 61000-3-3
Compliance
Class A
Complies
Electromagnetic Environment - Guide
The K3uses RF energy only for its internal function. There
fore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
domestic, and may be caused in domestic
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes, provided the following warning is
needed:
Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/ system
may cause radio interference or may disrupt the
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operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or
relocating the K3 or shielding the location.
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* Guidance and manufacturer’s declaration – Electromagnetic wave immunity
Immunity
Electrostatic
discharge(EDS)
IEC 61000-4-2
Electric transient /
Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601
Test level
± 6 kV Contact
± 8 kV Air
± 2 kV
(for power supply line)
± 1 kV
(for input/output line)
± 1 kV (line-line)
± 2 kV (line-earth)
<5 %
U
T
for 0,5 cycle
40 %
U
T
for 5, 6 cycles
70 %
U
T
for 25, 30 cycles
<5 %
U
for 5 s
T
Compliance
level
± 6 kV
± 8 kV
± 2 kV
± 1 kV
1 kV
± 2 kV
<5 %
U
T
for 0,5 cycle
40 %
U
T
for 5, 6 cycles
70 %
U
T
for 25, 30 cycles
<5 %
U
for 5 s
T
Electromagnetic Environment
- Guide
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %..
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the K3 requires continued
operation during power mains
interruptions, it is recommended
that the K3 be powered from an
uninterruptible power supply or a
battery
Power frequency
(50/60Hz)
3 A/m3 A/m
magnetic field
IEC 61000-4-8
Note: UTis the AC main power voltage prior to application of the test level.
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Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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Immunity
Conductive RF
IEC 61000-4-6
IEC 60601
Test level
3 Vrms
150 kHz to
80 MHz
Compliance
level
3 Vrms
Electromagnetic Environment
- Guide
Portable and mobile RF communications
equipment should be used no closer to any part
of theK3 including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800MHz
800 MHz to 2,5GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the trans
mitter manufacturer and d is the recommended
separation distance in meters (m)
Field strengths from fixed RF transmitters, as
Radioactive RF
IEC 61000-4-3
3 V/m
80 MHz to
2,5 GHz
3 V/m
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
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephon
es and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF tr
ansmitters, an electromagnetic site survey should be considered. If the measured field strength in t
he location in which the K3 is used exceeds the applicable RF compliance level above, the K3 shoul
d be observed to verify normal operation. If abnormal performance is observed, additional measure
s may be necessary, such as re- orienting or relocating the K3.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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* Recommended separation distance between portable and mobile RF communication
equipment and the K3
• The K3is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the K3can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the K3as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to the transmitter frequency [M]
Maximum rated
output
150 kHz - 80 MHz
80 MHz - 800 MHz800 MHz - 2,5 GHz
of transmitter [W]
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the tra
nsmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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
0.120.12
0.380.38
1.21.2
3.83.8
121223
0.23
0.73
2.3
7.3
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Matters requiring attention for safety
Matters requiring attention regarding the operation of the equipment
You should not do the following.
• Do NOT put an object or your finger or foot in the part or range of operation of the body such as
under the Seat or Backrest joint.
- If caught while in operation, you may get injured or the equipment may get damaged or fail.
• Never apply excessive load to the Table Arm, Lamp Arm, put something heavy, or lean or sit on
the Seat and tips of the Backrest and Headrest or Table, Assistant Tray, and Mouse Tray.
- The reversion and damage of the equipment may cause injury or failure.
• This Product is only to be used in the field of dentistry. It is forbidden to use this product for
anything other than the field of dentistry.
You may damage the equipment if you do not observe the following instructions.
• While operating the equipment, observe the following and check if it is safe.
- Inappropriate operation may cause malfunction or failure.
• Do NOT install the equipment in an unsafe place with Incline, vibration, and shock.
- The equipment should not be operated by a person other than a qualified personnel in charge
- Do NOT take motion or position that may put the patient at risk.
- Do NOT put your finger, part of your body, or baggage in or around the moving part of the
main body.
- Do NOT allow more than two persons on the Seat.
(e.g. holding a child while undergoing treatment).
- Do NOT allow any person who is not involved in the treatment near the equipment.(infant, etc.)
- Do NOT do any risky act other than those mentioned above.
• If there is risk such as collision while operating the Seat of the main body, perform emergency
stop urgently as follows.
- Press one of the keys to operate the chair on the Doctor’s Side Table Control panel.
- Press one of the keys to operate the chair on the Assistant Side Table Control panel.
• WARNING: Do not modify this equipment without authorization of the manufacturer.
• The responsibility for use and maintenance lies with the user(hospital or clinic, etc.) and only
dentists and dental hygienists are recommended to use the product.
• Refilling or injecting distilled water over the scale marking the limit of the distilled water bottle
can cause damage to the product or the risk of electric shock and fire.
• Check the tube connection state of all instruments before using the device.
• Expel water from the device pipe for about 2 ~ 3 minutes every day before starting treatment.
• Supply spittoon with water a few times.
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Matters requiring attention for safety
Matters requiring attention regarding the operation of the equipment
You must observe the following instructions.
• The waste generated from the product should be discarded or recycled to prevent environmental
pollution. Please comply with the pertinent country’s or local regulations for the details on waste.
• Please use the Clean Head System Hand-piece for infection prevention.
• The user must wear personal protective equipment to prevent the infection during dental
procedures.(e.g. gowns, lab coats, gloves, masks, and protective eyewear or face shields)
• Recommended that the K3 use in the combination with anti suction equipment and amalgam
separator device.
• Osstem does not provide the Hand-piece and the Scaler. And recommend that user contact us
before using the purchased Hand-piece and Scaler. Also, risk/side effects associated with the
purchased Hand-piece and Scaler is not responsible.
• The 3-Way syringe Nozzle provided by Osstem is not sterilized.
Before using for the first time, Do sterile to the according below.
- Sterilization type : Gravity
- Exposure time : 132˚C, 7min
- Dry time : 15min
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Matters requiring attention for safety
On matters requiring attention regarding the operation of the equipment
You may damage the equipment if you do not observe the following instructions.
• The patient and operator may be injured or harmed by the operation of the examining table.
- Both patient and operator should take caution while the examining table is operating.
- Avoid acts like getting on and jump down the examining table.
- Do NOT place your finger, part of your body or baggage on the moving part of the main body
or around it.
- No more than one patient should be on the Seat.
• Adding excessive load to the moving Arm may cause risk or injury on the patient or user.
- Do not add excessive load to the Table Arm.
- Do not add load heavier than 50N (5kgf) on the Doctor’s Side Table.
• Connecting inappropriate medical system equipment to the medical device may cause electric
shock.
- To connect an IT device to the medical device, follow the regulations of EN 60601-1.
• Do NOT attach sticker or adhesive tape to the Instrument Tube.
- The instrument Tube may be torn.
- Discharge water in the pipe of the medical device for about two minutes before treatment each
day.
- Cleanse the water and air pipes or discharge water or air before and after using the equipment
during weekends or holidays when you will not use it.
- Sterilize thoroughly.
- Supply water to the spittoon a few times.
• Occurrence of bedsores
- Pay attention to the occurrence of bedsores in case of long treatment.
• To change all instrument tips or bars, be sure to do so when they are stopped.
- Replacement during operation may cause unexpected accident and risk.
- Using an uncertified product may cause unexpected accident and risk.
- When putting each instrument into the holder, do so slowly and surely.
• Do NOT apply heavy shock or load to the Water Supply Device. Likewise, never operate or
disassemble it by force.
• This product meets the application requirements(EN60601-1-2) of the electromagnetic field.
- Try not to use cell phones in hospital or dental offices.
- Turn off electric equipment such as computer storage media or portable hearing aids during
treatment.
- When high frequency electronic equipment is used, make sure to turn off the main power of
the dental unit chairs. Otherwise unexpected accidents or failures of the product may occur
due to malfunction.
You may lose your life or sustain serious injury if you do not observe the following instructions.
• When reaching your hand toward the Table or Instrument, your hand or sleeve may get caught in
the instrument housed on the holder, which may lead to injury or infection.
• Take special caution of instrument installed in the holder when reaching your hand toward the
Table or Instrument.
• To disassemble it for sterilization, or repair, be sure to turn the Main Power OFF; disassemble
only after the equipment has sufficiently cooled down.
13-3. Cleaning the Unit………………………………………………………………………………………………..….....
13-4. Cleaning the 3-Way Syringe………………………………………………………………………………..……
13-5. Saliva Ejector...…………………………………………………………………………………………………..……….
13-6. Water System Cleaning and Maintenance .………………………………………………………..……
14. Cleaning and Maintenance - Option……….……………………………….…….…...
14-1. Cleaning the Spittoon Valve..……………………………………………………………………………..…….
14-2. Water System Cleaning and Maintenance .………………………………………………………..……
15. How to store and maintain after use..……………………………………….……….
17-1. Product Specifications.…………………………………………………………………………………………..….
17-2. Chair of Human Body Mass Distribution ………………………………………………..….…………..
17-3. Information on the packaging: Storage and transportation…….……………….…..………..
- Make sure the power cord is plugged into an outlet properly.
(AC 100-120/220-240V)
Chair won’t work.
H.P. won’t work.
Low H.P. won’t work.
- Make sure the main switch is turned on.
- Check for any fuse abnormality.
(Disconnection in fuse can be checked visually)
- Make sure the foot controller is not pressed. (Safety switch operation)
- Ensure the proper inflow of air pressure.
(40psi or 2.5 - 3㎏/㎠)
- Check the gauges in the table’s lower part.
- Oil injection should be thoroughly checked. (Once a day as a rule)
- Make sure that each HP is put in place. (Not working at the same time)
- Ensure the proper inflow of air pressure.
(40psi or 2.5 - 3㎏/㎠)
- Check if the rotation control switch on the body is placed on F or R.
(Does not operate if switch is placed on the center)
- Make sure that the wet/dry switch is turned on.
Water won’t run from H.P.
Scaler won’t work.
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- Make sure that the supply control valve on the lower part of the doctor’s tabl
e is open.
- Make sure the tubing is not clogged. (Check after removing the H.P. body.)
- Remove the tubing of the supply control valve and blow with a syringe.
- Water supply is OK but no vibration.
Is the tip loosened?
(If the tip is loose, power is not supplied.)
Check the power control volume.
- It vibrates, but water won’t run.
Check if the WET/DRY switch is turned on.
Check the supply control valve at the lower part of the Doctor’s Table.
Is the tubing clogged? (Check by removing the Scaler body.)
(Remove the tubing of the supply control valve and blow with a syringe.)
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17. Product Specifications
17-1. Product Specifications
17-1-1. Electrical system
ItemDetails
Input Voltage AC 100-120 / 220-240V
Frequency50/60Hz
Power Consumption1.2kVA
Customer-provided fuse protectionAutomat C 16 or screw-plug fuse 10A
Class I
Classification
IPX0(Dental Chair and Unit)
17-1-2. Water supply
ItemDetails
Water qualityTap water
Water pressure limits2.0 to 6.0 bar
Water rated flow rating3l/min
Water hardness1.5 to 2.14 mmol/l ≤ 8.4 to 12º dH
pH6.5 to 8.0
Particle filterFilterability : 90㎛
B type
IPX1(Foot Controller)
Reference
• If the water is very hard (above 12 dH), a water softening device must be fitted in the ion-
exchange process.
• Insufficient water hardness (below 8.4 dH) can promote the formation of algae.
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Caution
• Danger of infection if the national guidelines are not observed.
• Contamination of the treatment water or the drinking water network.
- Observe and adhere to the national guidelines concerning the quality of water for human
consumption (potable water) – if available.
- Observe and adhere to the national guidelines concerning the prevent of reflux (flow of water
from the treatment unit to the public water network) – if relevant.
17-1-3. Air supply
ItemDetails
Air rated Max. pressure7.5 bar
Water rated flow rating50Nl/min
Particle filterFilterability : 5㎛
Solids filter for suction systemFilterability : 2mm
pH6.5 to 8.0
Particle filter5㎛
Caution
• Danger of infection due to non-adherence to the national guidelines concerning the quality of
dental air.
- Observe and adhere to national guidelines concerning the quality of dental air – if available.
* Suction
Suction vacuum at device intake
Suction air quantity at spray
mist cannula
with wet suction
with dry suction
minimal V~250 Nl/minX> 85 mbar
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17-1-4. Environment
ItemDetails
Atmospheric pressure
Relative Humidity
Ambient Temperature
17-1-5. Weight
ItemDetails
Weight318 kg
Lift MethodHydraulic electromotor
Operation : 700 ~ 1060 hPa
Storage/Ship : 500 ~ 1060 hPa
Operation : 30 ~ 75 %RH
Storage : 10 ~ 90 %RH
Ship : 30 ~ 85 %RH
Operation : 10 ~ 35 ℃
Storage : -10 ~ 35 ℃
Ship : 38 ~ 60 ℃
Chair Height
Chair Length1,800 mm
Mass of Patient135 kg
Back Rest
Head Rest
Chair Duty CycleON: 60s, OFF:600s
Applicable Standards
IEC 60601-1-6 (2010) + AMD 1 (2013)
Max.: 735±10mm
Min.: 365±10mm
Max.: 63±5°
Min.: 1±5°
Max.: 45°
Min.: -10°
EN 60601-1, EN 60601-1-2
IEC 60601-1,
IEC 80601-2-60 (2012)
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17-2. Chair of Human Body Mass Distribution
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17-3. Information on the packaging : Storage and transportation
The symbols printed on the outside are for transportation and storage, and have the following
meaning
SymbolFunction
Keep
Use no hook
Fragile
This Side up
Humidity
Temperature range
Air pressure
Reference
• Please keep the packaging in case you need to return the product for servicing or repair.
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18. Product Indications
This is a product used for dental examination and treatment; the following are the product
indications:
• Marking may vary by country.
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19. Warranty
19-1. Scope
• Osstem warrants all goods listed below against defects in material or workmanship under normal
intended use when purchased from Osstem or an authorized Osstem dealer. Osstem’s sole obligation
under the warranty is to provide parts for the repair, or replacement of any defective component with
one that is equivalent to the original in performance.
• This warranty is in lieu of all other warranties or obligations express or implied. Osstem expressly
disclaims all implied warranties of merchantability or fitness for a particular purpose. In no event will
Osstem be liable for indirect, special, incidental, exemplary, or consequential damages of any kind.
• The repair or replacement of components is contingent upon Osstem’s styles and color options available
at the time of the warranty claim. If a warranty claim is filed after a product or color has been
discontinued, Osstem reserves the right to honor the warranty in one of the following ways:
I.Replace the affected component with a new component in the same style and/or color.
II.Replace the affected component, and other product components in the operatory with a product
style and/or color similar to the originally purchased style and/or color.
• The buyer shall have no other remedy. The warranties set forth herein provide specific legal rights.
Additional rights may exist, based on the jurisdiction of purchase and use of the product to the extent
that those rights apply to this agreement.
• Warranty exclusions are identified in section 19-3.
• Written notice of product failure must be given to Osstem within the warranty period.
19-2. Period
• The period of warranty is 2 years from the date of delivery for all products and parts hitherto mentioned
• Components replaced under warranty or purchased retain the balance of the original product warranty
or are warranted for 1 year after delivery (whichever is greater).
19-3. Exclusions
The warranty does not cover:
I.Damage resulting from improper maintenance, maintenance, or alterations.
II.Damage resulting from unwarranted movement of equipment installation site, accident, or freight
damage.
III.Damage resulting from use of parts and consumables other than those provided by Osstem.
IV.Damage resulting from natural disasters such as, but not limited to, fire, salt damage, flood,
earthquake, lightning and mains voltage failure.
V.Normal service items such as (but not limited to): light shields, light bulbs, filters, O-rings,
handpiece tubing, and water cartridges.
VI.Natural wear and tear
VII. All other products, not manufactured by Osstem, including OEM, follow the original manufacturer’s
warranty, and are not covered by Osstem’s warranty. Examples include, but not limited to:
sterilizers, maintenance equipment, cameras, curing lights, ultrasonics, control modules, electric
motors, attachments, handpieces, and turbines.
※ Failure to follow Osstem’s Instructions for Use will void the warranty
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20. Contact Information
Manufacturer : OSSTEM IMPLANT Co., Ltd.
Address :1stfloor, B-dong, 135, Gasan digital 2-ro, Geumcheon-gu, 08504, Seoul, Korea