Denjoy SMS-DY201 iFinder Apex Locator User Manual

: May 15, 2024
: Denjoy

Table of Contents

ASSEMBLY INSTRUCTION
PRODUCT DESCRIPTION
MAIN TECHNICAL INDEX
LCD SCREEN DISPLAY
For ACCURATE MARESUREMENT:
MANTENANCE & SERVICE
TOUBLESHOOTING GUIDE
ENVIRONMENTAL REQUIREMENTS
WARRANTY REGISTRATION FORM
References
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Denjoy SMS-DY201 iFinder Apex Locator User Manual

ASSEMBLY INSTRUCTION

REMARKS

The pictures here are for reference only. Real products shall prevail. The parameters and pictures in this manual are subject tochange without prior notice.

Please contact sales distributor directly from whom youhave purchased this device for user’s record and furtherafter-sale service.

PRODUCT DESCRIPTION

Thank you for purchasing our apex locator. For optimum safety and performance, read this manual carefully before use for operational struct ion, care and maintenance. Please keep this user’s manual for future reference.
Apex locator iFinder is our latest model with TFT touch-screen used for determining the position of apex of root canal with the up-to-date technology multi-frequency operation system.

Distinctive Features:

TF card to save data.
High-precision 4.3” TFT Touch-Screen with 800*480 Hd display
It is equipped with separate calibrator test instrument (calibrator)which can check the operation of control part and spare parts ofapex locator when apex locator doesn’t measure well.
Touch-screen key and traditional button control both available.

Other Features:

4.3” color screen with real-time graphic of root canals.
Foldable design to create more choices for view angle.
Up-to-date multi-frequency operating system.
Rechargeable, do not need prepare extra battery

SYMBOL DESCRIPTIONS

The following symbols may appear in this manual, on the label, or onit’s accessories. Some of the symbols represent standards and compliances associated with apex locator and its use.

Caution: Consult accompanying documents
Date of manufacture.
Manufacturer
Specifies serial number
Type BF applied part
Refer to instruction manual / booklet
Serializable up to the temperature specified at most
he device should not be used after the end of the shown or the day
DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
alarm indicator displayed on the LCD screen
Battery indicator displayed on the LCD screen

MAIN TECHNICAL INDEX

Classification: Internally powered equipment
AC Adapter Input voltage: 220V /50Hz Output voltage：5V 1A Battery：3.7V 2200mAh
Display mode: 4.3 “ TFT 800*480 color screen
Dimension: 13212031mm 5. Weight: about 500g6. Degree of protection against electric shock — Type BF applied part

COMPONENTS

Power on/off
SD slot
Probe wire socket
AC adapter socket
Mode Switch key
Up key
Down key
Save key

**Accessories：

**

A. Probe wire 1 pc
B. Autoclaved File holder 2 pcs
C. Stainless hook 4 pcs
D. Test instrument (Calibrator) 1pc
E. Charger 1pc

LCD SCREEN DISPLAY

Battery power indicator
Main interface
Self-calibration interface
Up key for length adjuster of apical constriction
Down key for length adjuster of apical constriction
Brightness control key
Sound adjuster
Save key
Length between top of file and the apex of root canal
Canal length indicator bar
Apical line adjustor

Save key

On the Main Interface, after insert the TF card, touch save key, ashen in Figure 1 , it means save successfully. Otherwise, If no TF card in serted or something wrong with TF card, as shown IN Figure 1, it means save unsuccessfully. Please note: no operation for 3 seconds, it will automatically return to Main Interface.

Brightness control key

On the Main Interface, user can adjust 4 level brightness of the screen by touching the brightness control key. After adjustment, touch the enter key, shown in Figure 2 , it means set successfully. Please note, cooperation for 10 seconds, it will automatically return to Main Interface.

Sound adjuster

On the Main Interface, touch sound adjuster, user can select required volume level, after adjustment, touch enter key, if as shown in Figure 3,it means set up successfully. Please note, no operation for 10 seconds, it will automatically return to Main Interface
Figure 3

4.4 Up/Down key for length adjuster of apical constriction On the Main Interface, user can touch up/down key for length adjuster of apical constriction to adjust the apical line.

Battery sign

The symbol lies on the top left corner of the screen.

Full charge
Battery is charging.
When it is flashed, please charge immediately.

SELF CALIBRATION INTERFACE

MARK 1. Calibration key for control part
MARK 2. Calibration key for accessories (probe wire, file holder, hooks)1)

1) Self-calibration steps:
Firstly, control part Secondly, accessories

2) The device needs self-calibration for following reasons:

The apex locating result is not accurate.
While the accessories are aging after a long time use.
While replacing new accessories (probe wire, file holder and hooks)

Calibration key for control part
On the self-calibration interface , insert the calibrator test instrument into matching socket, touch calibration key for control part (MARK 1),if as shown in Figure 4,

it means self-calibrating successfully showing“√” on the LCD. Otherwise, if as shown in Figure 5 , it means elf-calibrating unsuccessfully showing “X” on the LCD.

Calibration key for accessories (probe wire, file holder and hooks)On the self-calibration interface, insert the probe wire into matching socket, connect calibrator test instrument with file holder and electrode hook, touch Calibration key for accessories (MARK 2), if as shown in Figure 6 , it means self-calibrating successfully showing “√”onthe LCD.

If as shown in Figure 7, it means self-calibrating unsuccessfully “X”onthe LCD.

OPERATION

Touch-screen key and traditional button control are both available! When first used, insert the calibrator into the device to observe whether the screen display is 0.3 upper and lower two grids, otherwise the machine is defective ,and the plug of the cord should be inserted completely into the device.

The plug of the probe wire should be completely inserted into the socket on the right side of the midbody (control part).

Note: Do not pull out the probe wire by taking the wire instead of catching hold of the plug to avoid breaking down the probe wire.

Please connect file holder to probe wire and insert the stainless electrode hook into the socket.

Long pressing power on/off button,
Note: Long pressing power on/off button for 2 seconds to turn on/offthe device.

Clip the metal part of the endodontic file with the holder, then insert the file into the teeth.

using the cardiac pacemaker, or there is an electronic operation, please don’t put the machine around. The cardiac pacemaker sufferer, viz. the serious cardiac pulse abnormality sufferer, is for bidden to use this machine.

Please put in the battery before use. Make sure that the power of the battery is in sufficient supply to guarantee the correct measurement result. When change the battery, do not mix the old battery with the newton and mix the alkali battery with the manganic one.

. Please use the file with the resin handle rather than mental one. Even when using the file with the resin handle, please notice that the fingers should be avoided touching the mental part of file.

Please clip the upper portion of the file rather than the down portion with the holder, otherwise, the metal part of the holder and the resin part of the file would be damaged. The damaged holder will
affect the measure result.

When the file accidentally touches the inner part of the root-canal, the reading of scale will get a bit abnormality, then will gedrite automatically a few seconds later.

The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.

The enclosure of the main body of device is not designed togive any protection against ingress of water. Please keep the device away from any harmful ingress of water.

Please take off the battery in the event of longtime nonuse or long–distance transit.

For ACCURATE MARESUREMENT:

● Make sure that stainless hook entirely contact patient’s mouthmucosa.
Check all connections
Make sure that when the device is switched on, the device can complete self-checking procedure automatically and successfully.
When following situations appear, please use paper point part tomake root canal dry to increase accuracy of measurement.
It will cause bad electrical conduction between root canal andmetal or dental crown if overfull liquid. Other problems need to check:
Make sure that endodontic file was getting through the top hole ofthe root canal, the loose file will lead to measure incorrectly.
If the diameter of apical is more than 0.4mm, it will affect the accuracy.
Complicated root canal environment also will affect the accuracy.
Make sure that the battery is not too low, or it will lead to faulty measurements.
Avoiding endodontic file and probe contacting metal prosthesis, orit will form the earth current and lead to inaccurate indicating root tip.
If the root canal is too dry, please inject the NaOCI into the apical foramen.

MANTENANCE & SERVICE

MANTENANCE
The device is maintained free of charge and doesn’t require any routine maintenance within warranty period. The device cannot be repaired.
Do not modify and disassemble the device.
This device described below has been fully inspected and confronts to the current products specification.

This device is guaranteed for its designated use, against original
defects in materials and workmanship for a period of 12 months from date of purchase.

Products warranty or service will not be extended if (1) the products repaired, modified, misused, disassembled, or using the parts are not provided by the manufacturer, (2) The serial number of the product is defaced or missing.
The guarantee for accessories is 6 months. All accessories of the device are damaged or needed to be renewed, the user can purchase new accessories from the seller.

When the device has not been used for 6 months, please recharge for 5 minutes for restart the battery. If the device does not get into use for very long time, please recharge battery 5 minutes each 3 months.

CLEANING AND DISINFECTION

MAIN BODY CLEANING INSTRUCTION

When the surface of main body is polluted, please rub the surface with dry soft cloth ONLY. REMARKS: Any liquid lotion like ethanol, banana oil and light oil are nonallowed.

PROBE WIRE CLEANING INSTRUCTION

Please wipe the probe wire with the soft cloth stained with ethanol and reuse it after it is completely dry.

STAINLESS HOOK AND FILE HOLDER DISINFECTION INSTRUCTION
The front part of the file holder, which is easily get polluted with rubbished liquid medicine, should be disinfected by the ethanol.
Stainless electrode hook and file holder should be disinfected at temperature 135 ℃ for 10 minutes and disinfection by autoclave is preferred.

TOUBLESHOOTING GUIDE

After switch on, the LCD screen has no reaction.

a. Check that the power of the battery is in sufficient supply.
b. Check that hold the power on/off key for at least 2 seconds.
c. Check that the device can not be switched on when charging.

No alarm sound

a. Check the sound adjustor button of panel on top of unit.
b. The file has not reached the point less than 2.0 at which themachine will give an alarm.

NO changes or incorrect reading on the LCD screen

a. Do not clip the file with the holder firstly and switch on the devicesecondly.
b. Remember to hang the stainless electrode hook up at any side ofthe sufferer’s mouth.
c. Check probe wire connections both at unit and at AC outlet to besure they are properly seated.
d. The mental part of the file holder may be polluted or corroded.

The device can’t be charged normally.

a. The charger is not connected properly.
b. The charger is broken.
c. The battery is broken

ENVIRONMENTAL REQUIREMENTS

OPERATING CONDITIONS
Ambient temperature: 5℃ ~ 40℃
Relative humidity range : ≤80%
Atmospheric pressure: 80kPa~ 106kPa
Ambient temperature: -40℃ ~ 55℃
Relative humidity range : ≤95%
Atmospheric pressure: 50kPa~ 106kPa

Equipment is not suitable for storage in the presence of sunlight, rain, dust, corrosive gasoline and volatile without poor ventilation. Transportation is applicable to all common methods.

WARNING

The device is not repairable by user and contains no user serviceable parts.
No modification of this equipment is allowed.
The user must check that the equipment functions safely and see thatit is in proper working condition before being used.
The manufacturer does not require such preventive inspections byother persons.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

The [iFinder] is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the [iFinder] should assure that it is used in such an environment
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissionsCISPR 11 al| Group 1andent| The [iFinder] uses RF energy only afolr its. internal functions. Therefore, its RF emissions are very low and
| | are not likely to cause any interference in nearby electronicquipment.
---|---|---
RF emissionsCISPR 11| Class [B]| The [iFinder] is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning : This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment.It may be necessary to take mitigation measures, such as re-orienting or relocating the[iFinder] or shielding the location.
Harmonic emissionsIEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Complies

Table 2

Guidance and manufacturer’s declaration – electromagnetic emissions

The [iFinder] is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the [iFinder] 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| ±6 kVcontact±8 kV air| ±6 kV contact±8 kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity shouldbe at least 30 %
Electrical fast| ±2 kV for| ±2 kV for power supply lines

ntal.

| Mains power quality
transient/burst| power supply| should be that of a typical
IEC 61000-4-4| lines| commercial or hospital
| ±1 kV for| environment.
| input/output| The electrical fast
| lines| transient burst (EFT) is
| | generated by the
| | switching of inductive
| | loads. Separation
| | between the equipment
| | and other loads shall be
al| ande| considered before cinsotallamtion. Mains filter isrequired, if necessary.
SurgeIEC 61000-4-5| ±1 kV line(s) to line(s)±2 kV line(s)to earth| ±1 kV line(s) to line(s)| Mains power quality should be that of a typical commercial or hospital environment.
---|---|---|---
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11| <5% UT(>95% dip in UT)for 0.5 cycle
40% UT(60% dip in UT)for 5 cycle
70% UT(30% dip in UT)for 25 cycle| <5% UT(>95% dip in UT)for 0.5 cycle
40% UT(60% dip in UT)for 5 cycle
70% UT(30% dip in UT)for 25 cycle| Mains power quality should be that of a typical commercial or hospital environment. If the user of the [iFinder] requires continued operation during power mains interruptions, it is recommended the [iFinder] be powered from an uninterruptible power supply or a battery.
| <5% UT(>95% dip in UT)for 5s| <5% UT(>95% dip in UT)for 5s|
Power frequency al(50/60Hz)| 3 A/mande| 3 A/mntal.| Power frequency cmaognemtic fields should be at levels characteristic of

Table 3

Guidance and manufacturer’s declaration – electromagnetic emissions

Conducted

|

3Vrms

|

3V
ndent

| Portable and mobile RF communications equipment should be used no closer to any part of the [iFinder], including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
R e a co l m m. en c d ed om separation distance
RF| 150KHz
IEC 61000-4-6| toala 80MHz

Radiated RFIEC 61000-4-3

| 3 V/m80MHzto 2.5GHz| 3 V/m

ndent

|

d=135√P
d = [35]√P 80 MHz to 800 MHz E
7 d=VP 800 MHz to 2,5 GHz E1
where p is the maximum output power 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 RFtransmitters, as determined by an electromagnetic site survey,ashouldbe less than the compliance level ineach frequency range.bInterference may occur in the vicinityof equipment marked with thefollowing 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) 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 RFtransmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [iFinder] is used exceeds the applicable RF compliance level above, the [iFinder] should be observed toverify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [iFinder].b Over the frequency range 150 kHz to 80 MHz, field strengths should be lessthan 3 V/m.

Table 4

Recommended separation distances between portable and mobile Recommunication’s equipment and the [iFinder]

The [iFinder] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the[iFinder] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the [iFinder] as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter m
---|---
150 kHz to 80 MHz d=1.2| 80MHz to 800MHz d=1.2| 800MHz to 2.5GHz d=2.3
0,01| /| 0.12| 0.23
0,1| /| 0.38| 0.73
1| /| 1.2| 2.3
10| /| 3.8| 7.3
100| /| 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. 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.