coxo DB-686 Nano 002 Curing Light User Manual

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

1. 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.

2. 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.

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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

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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