NSK Endo-Mate TC2 User manual

OPERATION MANUAL
Please read this Operation Manual carefully
before use, and file for future reference.
OM-E0390E 001
Cordless Handpiece
The EU directive 93/42/EEC was applied in the design and production of this medical device.
2013.02.20 02 B

OPERATION MANUAL
Cordless Handpiece
English

English
1
Classification of Devices
Classification by type of protection against electric shock:
— Class II devices
Classification by degree of protection against electric shock:
— Applied part type B
Classification by sterilization or disinfection method allowed by the manufacturer:
— Refer to Sterilization.
Classification by mode of operation:
— Continuously operating device
Thank you for purchasing the ENDO-MATE TC2.
Read this Operation Manual carefully before use for operation instructions and care and
maintenance guidelines. Keep this Operation Manual for future reference.
Application
This product is a cordless handpiece used primarily for root canal enlargement.
User
Only qualified personal is allowed to use the unit only in dentistry.
Prohibition
Do not use this motor handpiece for formation of an extremely bent root canal. Do not use this
for implants other than endodontic treatment or other dental treatment.
Guidance and manufacturer's declaration - electromagnetic emissions
The ENDO-MATE TC2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ENDO-MATE TC2 should assure that is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR11
RF emmissions
CISPR11
Harmonic emissions
IEC61000-3-2
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Group 1
class B
class A
Complies
The ENDO-MATE TC2 uses RF energy only for
its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The ENDO-MATE TC2 is suitable for use in
all establishments, including domestic
estabilishments and those directly connected
to the public low-voltage power supply
network that supplynetwork that spplies
buidings used for domestic purposes.

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Guidance and manufacturer's declaration - electromagnetic immunity
The ENDO-MATE TC2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ENDO-MATE TC2 should assure that it is used in such an environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Immunity test IEC60601 test level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
Electrical fast
transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8
±6kV contact
±8kV air
±2kV for power
supply lines
±1kV for
input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<5% Ut
(>95% dip in Ut)
for 0.5 cycle
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 secs
3 A/m
Compliance level
±6kV contact
±8kV air
±2kV for power
supply lines
±1kV line to line
±2kV lines to earth
<5% Ut
(>95% dip in Ut)
for 0.5 cycle
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
3 A/m
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
en
vironment.
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
ENDO-MATE TC2 requires
continued operation during power
mains interruptions, it is
recommended that the ENDO-MATE
TC2 be powered from an
uninterruptible power supply or a
battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Guidance and manufacturer's declaration - electromagnetic immunity
The ENDO-MATE TC2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ENDO-MATE TC2 should assure that it is used in such an environment.
NOTE 1 At 80MHz and 800MHz, 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) telephones
and land mobiles radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the ENDO-MATE TC2 is used exceeds the applicable RF compliance level
above, the ENDO-MATE TC2 should be observed to verity normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating
the ENDO-MATE TC2.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Immunity test
IEC60601 test level Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150 kHz to 80MHz
3V/m
80MHz to 2.5 GHz
Compliance level
3Vrms
3V/m
Portable and mobile FRO
communications equipment should be
used no closer to any part of the
ENDO-MATE TC2, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d= 1.2 P
d= 1.2 P80MHz to 800MHz
d= 2.3 P800MHz to 2.5GHz
Where Pis the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and dis the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

English
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150kHz to 80MHz
d=1.2 P
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CONTENTS
Cautions for handling and operation
1. FEATURES
2. SPECIFICATION
3. Name of each part
4. Parts and its function
5. Operations
6. Convenient Function
7. Cleaning
8. Sterilization
9. Motor Cap
10. Safety System
11. Changing Batteries
12. Error Code
13. Troubleshooting
14. Warranty
15. Disposing Product
Recommended separation distances between portable and mobile RF communications
equipment and the ENDO-MATE TC2
The ENDO-MATE TC2 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ENDO-MATE TC2 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ENDO-MATE TC2 as recommended below,
according to the maximum output power of the communications equipment.
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
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Rated maximum output
power of transmitter
W
0.01
800MHz to 2.5GHz
d=2.3 P
80MHz to 800MHz
d=1.2 P
0.12 0.230.12
0.1 0.38 0.730.38
1 1.2 2.31.2
10 3.8 7.33.8
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.
100 12 2312
Separation distance according to frequency of transmitter
m
Cautions for handling and operation
Read these safety cautions thoroughly before use and operate the product properly.
These indicators are to allow you to use the product safely and prevent danger and harm to
you and others. These are classified by degree of danger, damage and seriousness. All
indicators concern safety, therefore always follow them.
Degree of danger or damage and seriousness
Explains an instruction where death or serious injury may occur.
Explains an instruction where bodily injury or damage to device may
occur.
Explains an instruction where possibility for minor to medium bodily
injury or damage to device may exist.
Explains an instruction that should be observed for safety reasons.
Classification
DANGER
WARNING
CAUTION
NOTICE