mk-dent EM1190K User manual

Instrucon manual
EM1190K
0123
Intended use
The electric motor is intended for the electric drive of dental straight and contra-angled handpieces
used in the preparation of cavity and / or crowns.
Important Details
The MK-dent Electric Motor (EM1190K)
- is only intended for dental treatment of patients.
- is according to relevant national regulations as a medical device.
These provisions indicate, that
- applicable accident prevention regulations and health and safety regulations must be observed.
- only a competent user is allowed to use the product according to this instruction.
- only faultless work equipment is to be used.
- any contamination from the product must be avoided.
- patients, users and third parties are to be protected from danger.
Risks from electromagnetic Fields
When treating patients with cardiac pacemakers or comparable implanted systems it must be expected that electromagnetic
 eldswillinuencethefunctioningoftheimplantedsystems.Beforebeginningofthetreatment,theusermustbequestionthe
 patientaccordingly.
Technical Facts
MK-dent Electric Motor EM1190K
Motor Voltage: min. 1,6 - 2,5 V DC, max. 26 V DC Air Cooling: 2,4 - 4,6 bar (34.8 - 66.7 psi)
RPM: min. 450min-1, max. 40.000 min-1 Cooling Capacity: 31 ± 5 NL/min.
Torque: max. 2,8 Ncm Air Out Motor Coupling: 7,6 ± 1,5 NL/min.
Operating Mode: Intermittend Duty 2 min on, 5 min o󰀨 Air Pressure of Spray Cooling: 1,0 - 2,4 bar (14.5 - 34.8 psi)
Operating Voltage
of LED: 3,0 - 3,5 V DC (recommended: 3,2 V DC) Spray Pressure: 0,9 - 2,0 bar (13.0 - 29.0 psi)
Meaning of Symbols
REF SN
0123
Item No. Serial No. Caution! CE-Sign
Guidance and manufacturer´s declaration - electromagnetic emission
Theelectricmicromotorsareintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserof
 theelectricmicromotorsshouldassure,thatitisusedinsuchanenvironment.
Emission Test Compliance Elecromagnetic Environment - Guidance
RF emissions CISPR 11 Group 1 The dental electrical micromotors use RF energy only for its inter-
nal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B The dental electrical micromotors are suitable for use in all
establishments other than domestic and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/
icker emissions IEC 61000-3-3
Complies
- 1 -

Guidance and manufacturer´s declaration - Electromagnetic Immunity
Theelectricmicromotorsareintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserof
 theelectricmicromotorsshouldassure,thatitisusedinsuchanenvironment.
Immunity Test IEC 60601 Test Level Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
± 6kV Contact
± 8kV Air
Floors should be wood, concrete or ceramic
tile. If oor is covered with synthetic material,
the relative humidity should be at least 30%.
Radiated RF immunity test IEC
61000-4-3
Level 3V/m 80%AM
80MHz - 2,5GHz
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/ output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV in differential mode
± 2 kV in common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Conducted RF immunity test
IEC 61000-4-6
Level 3V 80%AM
150kHz - 80MHz
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
< 5% UT (> 95% dip in UT) for 0,5 cycles Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the electric micro motor requires continued
operationduring power mains interruptions, it
is recommended, that the electrical micromo-
tors be powered from an uninterruptible power
supply or battery.
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
< 5% UT (> 95% dip in UT) for 5 sec.
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
3A/m The power frequency magnetic eld should be
measured in the intended installation location
to assure that is su󰀩ciently low.
UT istheA/Cmainspowervoltagepriortheapplicationofthetestlevel.
Storage & Transportation
At temperature below 20°C (68°F),malfunctionsmayoccurwhenstartingtheproduct.
 Bringstronglycooledinstrumentstoatemperatureof20°C (68°F) up to 25°C (77°F)beforeusing.
Protect from moisture!
Temperaturemax./min.: - 30° C (-58° F) up to 40° C (176° F) Air Pressure: 710hPa (10.2 psi) up to 1065 hPa (15.5 psi)
Air Moisture: non-condensing
Starting Up
DisinfecttheElectricMotorbeforerstuseandaftereachuse.Usedry,notcontaminated,cleanedcompressedaironly.
Contaminated or humid air will cause premature wear!
Connection to the Treatment Unit
Use MK-dent Premium Service Oil to lubricate the o-rings on the tubing.
Plug the connection 1 into the motor bearing assembly. Pay attention to the right
position of contacts. Fasten the tubing 2 by turning in dirction of arrow.
Spray Regulation
Turn the regulating sleeve 1 right or left to regulate the spray water.
In the center position (button is in line with the dot on the adjustment ring),
you have reached the highest spray water pressure.
- 2 -
1 2
1
2

Connecting with Instruments
Instrumentsmaynotbeconnectedordisconnectedduringrunningrotation.Thismaycausedamagesonmotorandinstrument.
 Onlyuseoperationallysafeinstruments.Doneverrunthemotorwithoutair-cooling!Thismaycauseoverheating!
Attach the instrument to the motor, until it clicks in place. Turn in direction of arrow until
xing projection clicks in place.
To remove, pull instrument in axial direction from the motor.
The disconnection of instruments from the motor during operation may cause danger to patient and operator!
 Beforeeachstartofoperation,makesurethatinstrumentandmotorareconnectedproperly.
Replacement of the LED
Push button 1 and pull o󰀨 sleeve 2
from socket and take it out.
Cleaning and Care
Clean the motor externally with a Pull o󰀨 the sleeve and clean with
moistened cloth, then clean with water rst, then with a solution
a solution containing 60 - 70% alcohol. containing 60 - 70% alcohol.
Swipe o󰀨 with a cotton cloth. Swipe o󰀨 with a cotton cloth.
Ultrasonic cleaning may cause malfunctions! The motor may only be cleaned manually!
 Aftereachtreatmentsprayairandwaterforatleast20seconds.
Disinfection
Spray disinfecting solution on a cloth and swipe o󰀨 the motor. See manufacturers´ manual for contact time.
Only use DGHM/VAH listed chemical disinfectants for spray and wipe disinfection.
Themotormaynotbedisinfectedindisinfectionbaths!Thismaycausemalfunctions.Onlydesinfectmanually!
Sterilization
 TheElectricmotorEM1190Kcannotbesterilizedinanautoclavedevice.
Storage
Cleaned instruments should be stored protected from dust in a dry, dark and cool room. Store low-germ.
- 3 -
Press the porter 4 to the body 5 and push the
LED 3 with screw driver in direction of arrow
out of the socket. Take it out.
Place the new LED in the socket. Pay attention
to the right position of contacts. Push the LED
into the socket and reattach sleeve. Turn LED
180º, in case it doesn´t light.

Warranty
MK-dent provides the end user a warranty for proper function, immaculate material and workmanship for the period of 12 months after purchasing.
Relevant for this is the invoice date.
In case of justied complaints MK-dent carries out a free repair or a possible free replacement. This will be decided by MK-dent.
Other claims of any kind, in particular damage compensation are excluded. In the event of default, gross negligence or intent, this shall only apply
unless there are compelling legal regulations.
MK-dent is not liable for defects and their consequences that have arisen whose arising may be due to natural wear, improper handling, improper
cleaning, or maintenance, non-compliance with operating or manual instructions,
calcination or corrosion, contaminated air and water supply or chemical or electrical inuences that are unusual or not permitted according to
MK-dent’s instruction for use or to other manufacturer‘s instructions.
The warranty does usually not cover lamps, light conductors made of glass bers, glassware, rubber parts and the color fastness of plastic parts.
All liability is excluded if defects or their consequences arise because of interventions or modications on the product by the end user or by a third
party not authorized by MK-dent.
Warranty claims will only be accepted if the product is submitted with a proof of purchase in the form of an invoice or a copy of the delivery note.
Dealer, purchase date, model and serial number must be clearly visible.
MANUFACTURER
MK-dent GmbH
Marie-Curie-Str. 2
D-22941 Bargteheide
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.mk-dent.com Valid from: 09.06.2020 TF-TPL-15-EN-Reg.12-IFU_MK_EM_01_EN_RevD