coxo DB-686 Nano 002 Curing Light User Manual
- June 6, 2024
- coxo
Table of Contents
coxo DB-686 Nano 002 Curing Light
WARNING:
If indicators are not lit within preset range, stop using the equipment
immediately and repair it.
Replacing File Electrode
In the multi-function mode, the root canal indicator bar flashes or the indicator bar does not light up when the file touches the opposite electrode, and the problem cannot be solved after cleaning the rotor axle and the built- in electrode. The built-in electrode is worn out and the following steps must be followed replace with new electrode.
-
Loosen the screw and remove the built-in electrode;
-
Clean the rotor axle with Ethanol (Ethanol 70 to 80 % );
-
Use blow air to remove remaining moisture;
-
Hold down the push-button, insert the guide bar and turn
CAUTION- Always use the guide bar and ensure that other parts will fix in place.
- If the guide bar cannot be properly fixed in place, the internal contact could be bent, and then the instrument might not be able to make accurate measurements or it might malfunction.
- Do not run the motor with the guide bar inserted.
-
Slide the built-in electrode onto the guide bar and line up the screw whole;
-
Slowly turn the screw and make sure the built-in electrode goes into the head properly;
-
Tighten the screw securely and then hold down the push button and pull out the guide bar.
WARNING:
Make sure screws are firm enough; otherwise it will cause claw and parts of
the holder to loosen, causing rotation failure or inaccurate
measurement.
Calibration and Factory Reset
-
Calibration
Calibration is required to ensure the motor parameters are accurate.-
Press to enter setup state and then press to prepare the calibration;
Torque Calibration
Before calibration,connect
Motor,Contra-angle and File. -
Follow the prompt step by step
-
During calibration, the icon mean:
CAUTION: Calibration is required after disinfection, sterilization, replacement of a new contra-angle or priro to use.
-
-
Factory Reset
-
Press to enter setup state and then press to prepare to factory reset;
Factory defaults
All parameters set by user will be removed. -
Follow the prompt step by step
-
During calibration, the icon mean:
-
NOTE:
After factory setting, all parameters set by the user will be removed.
Lubrication
- Remove the contra-angle from handpiece;
- Mount the tip nozzle into the spray can port and align the nozzle to the contra-angle;Spray lubricating oil into contra-angle until clean liquid flows out.
CAUTION:
- When the head overflows with clean liquid, the entire cleaning and maintenance steps should be repeated.
- It is recommended to inject lubricating oil before sterilization.
Cleaning, Disinfection and Sterilization
Device:
| Contra-angle, File clip, Lip hook and Motor Handpiece. The procedure for cleaning, disinfection and sterilization applies only to the accessories Contra angle, File clip,
Lip hook.
---|---
ADVICE:
| Reprocessing procedures have only limited implications to a surgical instrumert. The limitation of the numbers of reprocessing procedures is therefore determined by the function/ wear of the device. There is no limit of maximum allowable reprocessing cycles. The device should no longer be reused in case of signs of material degradation.
In case of damage the device should be reprocessed before sending back to the
manufacturer for repair.
Reprocessing Instructions
Preparation at the Point of Use:
| Disconnect the Contra angle from handpiece, the File clip from the test wire and the Lip hook. Remove gross soiling of the instrument with cold water (<40’C) immediately after use. Don’t use a fixating detergent or hot water (>40’C) as this can cause the fixation of residuals which may influence the result of the reprocessing process.
Store the instruments in a humid surrounding.
Transportation:
| Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.
Preparation for Decontamination:
| The devices must be reprocessed in a disassembled state.
Only Contra-angle, File clip and Lip hook can be cleaned and disinfected with automated methods and sterilized with steam sterilization process.
Do not sterilize the Motor Handpiece and AC adapter.
The Motor Handpiece and AC adapter cannot be cleaned and disinfected in a washer/disinfector. For these parts, only a general wipe decontaminalon is possible!
Decontamination of other parts than Contra- angle, File
clip ,Lip hook :
| After operation, take out the Motor Handpiece and AC adapter on thework bench Soak a soft cloth completely with distilled water or deionized water, Decontamination and wipe all the surfaces of these components, until the surface of the parts the components is visually clean
For decontamination, soak a dry soft cloth with 75% alcohol or other contra- angle, File clip, disinfects which are approved for its efficacy by VAH/DGHM- LISTING-Lip hook and CE marking, FDA and Health Canada Approval lighting device:
Wipe all surfaces of Motor Handpiece, AC adapter and other components with the
wet soft cloth for about 3 minutes. Please follow the instructions of manufacturer of disinfectant swipe the surface of the component with a dry soft lint-free cloth
Pre-Cleaning:
| Following instruction are only relevant for Contra-angle, File clip and Lip hook! Not use automated cleaning, disinfection and sterilisation for other parts than Contra-angle, File clip and Lip hook in this system!
Do a manual pre-cleaning, until the instruments are visually clean. Submerge the instruments in a cleaning solution and flush the lumens with a water jet pistol with cold tap water for at least 10 seconds.
Clean the surface with a soft bristol brush.
Cleaning:
| Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety.
Automated Cleaning:
Use a washer-disinfector meeting the requirements of the ISO 15883 series.
Put the instrument into the machine on a tray. Connect the instrument with the WD by using suitable adapter and start the program:
• 4 min pre-washing with cold water (<40’C)
• 5 min washing with a mild alkaline cleaner at 55’C
• 3 minneutralising with warm water (>40’C)
• 5 min intermediate rinsing with warm water (>40’C)
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Disinfection:
| ****
Automated Disinfection:
Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to AO-Value (see EN 15883).
A disinfection cycle of 5 min disinfection at 93’C hasbeen validated for the device to achieve an AO value of 3000.
Drying:
| Automated Drying:
Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel.
Functional Testing, Maintenance:
| ****
Visual inspection for cleanliness of the instruments and reassembling. Functional testing according to instructions of use.
If necessary, perform reprocessing process again until instrument is visibly clean.
Packaging:
| Pack the instruments in an appropriate packaging material for sterilization. The packaging material and system refer to EN ISO 11607.
Sterilization:
| Sterilization of instruments by applying a fractionated pr&vacuum steam sterilization process (according to EN 285 / EN 13060 I EN ISO 17665) under consideration of the respective country requirements.
Minimal requirements: 3 min at 134 ‘C In EU, 5 min at 134 ‘C is required.
Maximal sterilization temperature: 137’C
Storage:
| Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.
Reprocessing validation study information
| ****
The above-mentioned reprocessing process (cleaning, disinfection sterilization) has been successfully validated.
Additional Instructions: None
It is the duty of the user to ensure that the reprocessing processes including
resources, materials and personnel are capable to reach the required results.
State of the art and often national law requiring these processes and included
resources to be validated and maintained properly.
Troubleshooting
Malfunction | Cause | Remedy |
---|
Cannot turn on the power
|
The battery is low
|
Please charge in time
Battery failure
|
Replace the battery
Cannot charge the battery
| The adapter is not reliably connected| Check that the adapter connection is
reliable
Battery failure| Replacement battery
Apex locator imprecise/ not sensitive
| Test wire connection unreliable| Reconnect the test wire or you can contact
the file clip to lip hook directly to check the connection status
The test wire has an
open circuit or a short circuit
| Replace test wire
The root canal is in poor condition| Refer to 7
Cannot start the motor/ motor does not work
| Low voltage protection| Please charge in time
Contra-angle stuck| Clean or replace the contra-angle
Handpiece failure| Replace handpiece
Control unit failure| Contact the dealer
Motor stops automatically
| Torque reverse is not set| Turn on the Torque reverse
The load is too large to exceed the maximum
output of the instrument
|
Manually release the load
Handpiece LED is not light
| LED light is not turned on| Turn on the LED light on the settings page
LED light is damaged| Contact the dealer
Symbols
Guarantee
Product and technical services are in charge of our company, the technical
department will provide technical support for you when there are technical
problems. can be affected by portable and mobile RF
The control unit is guaranteed for 24 months from the date of purchase.
- The accessories (adaptor, contra-angle, file clip and so on) are guaranteed for 6 months.
- The guarantee is valid for normal usage conditions. Any modification or accidental damage will render the guarantee void.
Guidance and manufacturer’s declaration–EMC:
This instrument needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this instrument can be affected by portable and mobile RF communications instrument.
CAUTION:
Do not use mobile phone or other instruments that emit electromagnetic fields,
near the instrument. This may result in incorrect operation of the instrument.
This instrument has been thoroughly tested and inspected to assure proper
performance and operation!
This instrument should not be used adjacent to or stacked with other
instrument and that if adjacent or stacked use is necessary, this instrument
should be observed to verify normal operation in the configuration in which it
will be used.
Guidance and manufacture’s declaration – electromagnetic emission
The instrument is intended for use in the electromagnetic environment
specified below. The customer or the user of the instrument should assure that
it is used in such an environment.
Emission test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The instrument use 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 instrument.
RF emission CISPR 11| Class B| The instrument is suitable for use in all
establishments, including domestic establishments directly connected to the
public low-voltage power supply network with specific requirement.
Harmonic emissions
IEC 61000-3-2
| Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
| Complies
Guidance and manufacture’s declaration – electromagnetic immunity
The instrument is intended for use in the electromagnetic environment
specified below. The customer or the user of instrument should assure that it
is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic
environment – guidance
Electrostatic discharge (ESD)IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV,±8kV,±15 kV
air
| ±8 kV contact
±2 kV, ±4
kV,±8kV, ±15 kV
air
| Floors should be wood, concrete or ceramic tile. If floor are covered with
synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/bu rst IEC
61000-4-4
| ±2kV for power supply lines
±1 kV for
Input/output lines
| ±2kV for power supply lines
±1 kV for Input/output lines
| Mains power quality should be that of atypical commercial or hospital
environment.
Surge IEC 61000-4-5| ±0.5 kV, ±1 kV
line to line
±0.5 kV, ±1 kV,
±2 kV
line to ground
| ±0.5 kV, ±1 kV
line to line
| Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short interruptions and voltage variationson power supply input
lines IEC 61000-4-11| <5% UT
(>95% dip in UT.) for 0.5 cycle
<5% UT
(>95% dip in UT) for 1 cycle
70% UT
(30% dip in UT) for 25/30 cycles
<5%UT
(>95 % dip in UT)
for 5/6 sec
| <5% UT
(>95% dip in UT.) for 0.5 cycle <5 % UT (>95% dip in UT) for 1 cycle 70% UT (30% dip
in UT) for 25/30 cycles <5% UT (>95 % dip in UT) for 5/6 sec
| Mains power quality should be that of a typical commercial or hospital
environment. If the user of the instrument requires continued operation during
power mains interruptions, it is recommended that the instrument be powered
from a unit eruptible power supply or a battery.
Power frequency(5 0/60
Hz)magneti
cfield IEC 61000-4-8
| 3Nm| 3Nm| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital
environment.
NOTE:UT is the a.C mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity
The instrument is intended for use in the electromagnetic environment
specified below. The customer or the user of instrument should assure that it
is used in such an environment.
Immunity| IEC 60601 test Compliance level| Electromagnetic environment
– guidance
test| level|
Conducted| | 3Vrms 3Vrms
150 kHz to 80 150 kHz to 80 MHz
MHz 6Vrms in ISM 6Vrms in ISM and amateur
and amateur radio bands 3 V/m,
radio bands 3 10V/m
V/m, 10V/m 80 MHzto2.7
80 MHzto2.7 GHz GHz
385MHz-5785M 385MHz-
Hz Test 5785MHz Test specifications for specifications for ENCLOSUREP ENCLOSUREPOR ORT IMMUNITY T IMMUNITY to RF
to RF wireless wireless communication communication instrument(Refer instrument(Refer to to table 9of IEC table 9 of
60601-1-2:2014) IEC60601-1-2:201
| Portable and mobile RF communications
RF| instrument should be used no closer to
IEC61000-4| any part of the instrument, including
-6| cables, than the recommended separation
| distance calculated from the equation
| applicable to the frequency of the
| transmitter.
| Recommended separation distance
| d=[3,5/V1]XP1/2
Radiated| d=1.2xP112 80 MHz to 800 MHz
RF| d=1.2xP112 800 MHz to 2, 7 GHz
IEC| Where the maximum is output power
61000-4-3| rating of the transmitter in watts (W)
| according to the transmitter manufacturer
| and d is 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.b
| Interference may occur in the vicinity of
| instrument marked with the following
symbol: ¢’fl)
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2These guidelines may not apply in all situations. Electromagnetic
affected by absorption and reflection from structures, objects and people.
|
propagation is
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile 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 instrument is used exceeds the applicable RF compliance level above, the instrument should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the instrument.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than3 V/m.
Recommended separation distances between portable and mobile RF communications instrument and the instrument.
The instrument is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
instrument can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications instrument
(transmitters) and the instrument as recommended below, according to the
maximum output power of the communications instrument.
Rated maximum output power of transmitter (W)| Separation distance according
to frequency of transmitter
150 kHz to 80 MHz d=1.2xP112| 80 MHzto800
MHZ d=1.2xP112
| 80 MHz to 800 MHz d=2.3xP112
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
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 P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2: 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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