Poldent Endostar User manual

INSTRUCTIONS FOR USE
Apex Locator
Thank you for purchasing the Endostar Navigator.
For optimum safety and performance, read this manual thoroughly before using the unit and pay close attention to
warnings and notes. Keep this manual in a readily accessible place for quick and easy reference.
Poldent Co. Ltd.

1Instructions for Use 2019-03-20
Table of Contents
Accident Prevention 3
Precautions 5
Indications for Use 5
Parts Identification and Accompanying Items 6
Usage 7
1. Before Using the Endostar Navigator 7
Installing the Batteries 7
Connecting the Probe Cord 8
Checking the Function 8
2. Using the Endostar Navigator 10
Operation Panel Display and Switches 10
Settings 11
Meter Display 13
Operating Procedures 14
Root Canal Not Suitable for Electronic Measurement 16
Endostar Navigator Meter Reading and Radiography 18
3. After Using the Endostar Navigator 19
4. Replacing Batteries 20
Maintenance 22
Autoclavable Components 22
Other Components: Wiping with Ethanol (70 vol% to 80 vol%) 27
Replacement Parts, Transport and Storage 28
Replacement Parts 28
Transport and Storage Environments 28

2Instructions for Use 2019-03-20
Inspection and Warranty 29
Maintenance and Inspection Items 29
Warranty 30
Troubleshooting 31
Technical Specifications 33
Specifications 33
Symbols 34
Electromagnetic Disturbances (EMD) 35
Electromagnetic Disturbances (EMD) 35
Essential Performance 38
Cable List 38
Trademarks (™) and Registered Trademarks (®):
The names of companies, products, services, etc. used in this manual are either trademarks or registered trade-
marks owned by each company.

3Instructions for Use 2019-03-20
The warning symbols ( ) and caution symbols ( ) that appear next to the main text on the right hand
side of the page refer to and are explained by the Warnings and Cautions at the bottom of the page.
Accident Prevention
Make sure to obtain clear instructions concerning the various ways to use the device described in this accompa-
nying manual.
Most operation and maintenance problems result from insufficient attention to basic safety precautions and not
being able to foresee potential accidents.
Problems and accidents are best avoided by anticipating potential dangers and operating the device in ac-
cordance with the manufacturer’s recommendations. First, thoroughly read all precautions and instructions
pertaining to safety and accident prevention. Then operate the device with the utmost caution to prevent either
damaging the device itself or causing bodily injury.
The following symbols and expressions indicate the degree of danger and harm that could result from ignoring
the corresponding instructions:
This alerts the user of important points concerning operation or the risk of equipment damage.
The user (e.g., healthcare facility, clinic, hospital etc.) is responsible for the management, maintenance and use
of medical device.
This equipment must only be used by dentists and other legally licensed professionals.
Do not use this equipment for anything other than its specified dental purpose.
This alerts the user of the possibility of extremely serious injury or complete destruction of the
device, as well as other property damage including the possibility of fire.
This alerts the user of the possibility of minor or moderate injury or damage to the device.
Customers
Preventing Accidents

4Instructions for Use 2019-03-20
■Poldent Co. Ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from:
1. Repairs made by personnel not authorized by Poldent Co. Ltd.
2. Any changes, modifications, or alterations of its products
3. The use of products made by other manufacturers, except for those procured by Poldent Co. Ltd.
4. Maintenance or repairs using parts or components other than those specified by Poldent Co. Ltd. or other
than in their original condition
5. Operating the device in a manner other than described in the operating procedures in this manual or in a
manner inconsistent with the safety precautions and warnings in this manual.
6. Workplace, environmental, or installation conditions that do not conform to those stated in this manual,
such as an improper electrical power supply.
7. Fires, earthquakes, floods, lightning, natural disasters, or forces majeure.
■The useful life of the Endostar Navigator is 6 years from the date of installation provided it is regularly and
properly inspected and maintained.
If an accident occurs, the Endostar Navigator must not be used until repairs have been completed by a qualified
and trained technician authorized by the manufacturer.
Intended Operator Profile
a) Qualification : Legally qualified person such as dentists for endodontic device operation (it may
differs among countries).
b) Education and Knowledge: It is assumed that the understands the risks of root canal measuring and treat-
ment. It is also assumed the user is thoroughly familiar with root canal measuring
and treatment including the prevention of cross contamination.
c) Language Understanding : English (Intended for professional use as described above)
d) Experience : Experienced person with operating endodontic device.
No special training is required except in cases where this is required by legal regu-
lations of the relevant country or region.
Disclaimers
In Case of Accident
User Qualifications
Patient Population
Age Child to Elderly
Weight N/A
Nationality N/A
Sex N/A
Health It is not intended for use on patients wearing pacemakers or ICDs.
Condition Conscious and mentally alert person. (Person who can stay still during treatment.)
• The Endostar Navigator is not recommended for use in children under 12 years of age.

5Instructions for Use 2019-03-20
• Accurate canal measurement is not always possible depending on the shape and condition of the tooth as well as a
decline in the equipment’s performance.
• Do not use damaged file holders; an accurate measurement cannot be made with a damaged file holder.
• When a continuous tone is heard while the Power Switch is on and without any operation, some electrical part may
be malfunctioning. Do not use the device and send it to Poldent Co. Ltd. for repairing.
• A rubber dam should be used when performing endodontic treatment.
• Some care must be taken concerning electromagnetic compatibility (EMC) when using the device. Refer to the user’s
manual and other attached documents for EMC information regarding installation and operation.
• Both portable and movable radio frequency transmitters may have some effect on the device.
• Using replacement parts or accessories not supplied by Poldent Co. Ltd. could adversely affect the EMC performance
of the device.
• As far as possible, do not use the Endostar Navigator near or simultaneously with other devices. If this cannot be
avoided, observe carefully and make sure both the Endostar Navigator and the other device operate normally.
• No modification of the device is allowed.
* Poldent Co. Ltd. is not responsible for any accidents or other types of trouble that are caused by not following
the precautions noted below.
• Do not use the device in conjunction with an electric scalpel or on patients who have a pacemaker.
• Blocked canals cannot be accurately measured.
• Except for ways described in this manual, the device must not be connected to or used in combination with any other
apparatus or system. It must not be used as an integral component of any other apparatus or system. Poldent Co.
Ltd. will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from
ignoring this prohibition.
• Illumination devices such as fluorescent lights and film viewers which use an inverter can cause the Endostar Naviga-
tor to operate erratically. Do not use the Endostar Navigator near devices such as these.
• Electromagnetic wave interference could cause the Endostar Navigator to operate in an abnormal, random and pos-
sibly dangerous manner. Cellular phone, transceivers, remote controls and all other devices which transmit electro-
magnetic waves located inside the building should be turned off.
• Do not perform maintenance while using the device for treatment.
Precautions
Indications for Use
: This indicates when not to use the equipment.
The Endostar Navigator is a dental device, Apex Locator.
It can be used to detect the apex of root canal.

6Instructions for Use 2019-03-20
Parts Identification and Accompanying Items
Contrary Electrode
File Holder
Set Switch
Power Switch
Data Output Port
(to transmit display data)
Probe Cord
Strap Hole
LCD Screen
Accompanying Items (Parts of Device and Consumables)
⹅Standard Parts
Parts Identification
Probe Cord
(Qty: 1)
File Holder
(Qty: 3)
Contrary Electrode
(Qty: 5)
Tester
(Qty: 1)
Alkaline Dry Cells
(Qty: 3)
Long File Holder
(Qty: 1)
(LR03 [AAA size] batteries)
⹅Optional Parts

7Instructions for Use 2019-03-20
• The device is shipped without the batteries installed. Remove the cover and install three LR03 (AAA size) batteries.
• Do not reverse the plus and minus poles.
• Never allow the spring contact to push against the edge of the battery. This could damage the outer cover causing a short
or a leakage of battery liquid.
• After installation, give the cover a light tug to confirm it is securely attached.
1. Before Using the Endostar Navigator
1. Slide the cover in the direction by the arrow in the illustration
and remove it from the device.
Before using the device, be sure that all autoclavable components have been sterilized.
p. 22 “Autoclavable Components”
2. Insert three LR03 (AAA size) batteries included in the package.
(1) Insert the batteries by first pressing center of the minus end
against its spring contact.
(2) Slide the plus end down into place and make sure the
contacts are not bent or damaged.
3. Slide the cover all the way down until it is securely closed.
Installing the Batteries
Usage
Wrong

8Instructions for Use 2019-03-20
• Handle the device carefully; do not drop, bump or expose the device to other kinds of impacts or shocks. Rough handling
could cause damage.
• Make sure the probe cord plug is securely plugged into the jack. A poor connection can prevent measurement.
• Do not drop anything on or bang the probe cord plug after it has been inserted into the jack.
• Make sure to match colors of the file holder and contrary electrode to the probe cord.
Measurements cannot be made if these connections are reversed.
• The device may turn off if its side is bumped.
1. Insert the probe cord completely into the jack on the left side of
the device.
1. Press the Power Switch to turn the device on. The display will
appear in the LCD screen.
* The device turns itself off if it is not used for 10 minutes.
2. Check that the probe cord is properly plugged into the jack.
3. Check that the file holder and contrary electrode are properly
connected to the probe cord.
4. Touch the metal part of the file holder with the contrary elec-
trode. Check that all the meter indicator bars on the display
light up.
2. Insert the file holder’s gray male plug into the gray female con-
nector on the probe cord. Insert the contrary electrode into the
white female connector on the probe cord.
Probe Cord
Connector (white)
Probe Cord
Connector (gray)
File Holder Contact
Power Switch
Contrary Electrode
Contrary Electrode
File Holder Plug
Connecting the Probe Cord
Checking the Function

9Instructions for Use 2019-03-20
• Check operation before each patient. If the indicators in the display do not all appear normally, the device may not be
able to make an accurate measurement. In this case, stop using the device and have it repaired.
Checking the Function
⹅Checking the Function with the Tester
Check device performance with the tester once a week.
1. Press the Power Switch to turn the device on.
2. Insert the tester into the probe cord jack.
Check that the meter indicates within ±3 bars away from (above
or below) 1.
* The meter may jump when the tester is inserted. If it does, wait
for about 1 second until the meter stabilizes and then check the
reading.
* If the reading is 4 or more bars away from 1, the device will not
make an accurate measurement. In this case, contact Poldent Co.
Ltd.
Must be
within this
range
Tester

10
OFF
Instructions for Use 2019-03-20
• Never connect the device to any product not approved by Poldent Co. Ltd.
• Never use the device if the battery power indicator is flashing on and off. The device may not function properly if the bat-
tery power is low.
• The meter readings 1, 2, and 3 do not correspond to any actual distance and should only be used as estimates.
2. Using the Endostar Navigator
Operating Environments
Temperature: +10°C to +35°C (+50°F to +95°F)
Humidity: 30% to 80% (without condensation)
Atmospheric Pressure: 70 kPa to 106 kPa
* If the device has not been used for some time, make sure it works properly before using it again.
Operation Panel Display and Switches
Sound VolumeCanal Length Indicator Bars
Meter
Power Switch Set Switch
Battery Power Indicator
Flash Bar
Memory Bar
Information Display
OFF, Soft, or Loud
This bar graph indicates remaining
battery power. Replace the batteries
when this indicator begins flashing.
* When battery power falls too
much, alarm will sound and the
device will automatically turn itself
off.
* The device will automatically turn
itself off after 10 minutes of non-
use.
Use this line as an estimate for root
canal measurement.
Use this as an estimate of some
intermediate point inside the canal.
• Standby (file outside the canal): Memory number for the flash bar.
• During Measurement (file inside the canal): Number of bars left before the flash bar is reached.
• When Flash Bar position is being set: Position of the flash bar.

11 Instructions for Use 2019-03-20
Settings
1. Select Memorized Flash Bar
Method
Press the Set Switch. Each press of the Set Switch will change the
memory selected in the sequence 01 to 02 to 03 and then back
to 01 again. The flash bar set for each memory will appear when
that memory is selected. The memory selected when the device is
turned off is the one that will be selected when is it turned back on
again.
2. Set the Flash Bar
The flash bar can be set anywhere from 2 to the APEX (0).
Use it as an estimate of the canal’s working length.
Method
When the file is not inserted, hold down the Power Switch and
then press the Set Switch at the same time. Each press of the Set
Switch will move the flash bar one bar towards the APEX. The posi-
tion will be automatically memorized.
• The flash bar cannot be set beyond the APEX.
Flashes

12Instructions for Use 2019-03-20
Settings
3. Memory Bar
The memory bar can be set anywhere up to the APEX.
The memory bar can be set during treatment to mark a point
of interest inside the canal such as the beginning of a curve, a
certain distance from the apex, or the point to change file size
for enlargement.
Method
Insert the file up to the desired point and then press the Set Switch.
This will cause another bar to flash on and off at a slightly slower
speed that the main flash bar. This will not change the point where
the alarm is activated.
4. Beeper Volume
The volume of the beep can be set to “Loud” or “Soft”, or it can
be turned off.
Method
Hold down the Set Switch and turn the device on. This
will change the setting of the beep from “Loud” to “OFF”.
Repeat the procedure to change it from “OFF” to “Soft”.
The setting will be memorized and stay the same the
next time you turn the device on.
• The memory bar should only be used as an estimate. You may need to change it during enlargement and cleaning. If
there seems to be some problem, stop using the device immediately.
• Check the settings displayed after selecting memories.
• The memory bar cannot be set beyond the APEX.
• The memory bar can be set at a different point for each of the 3 memories.
• The memory bar will stay wherever you set it until the device is turned off, but it will not be memorized.
• The volume of the beep that sounds when the device is turned on cannot be adjusted.
Memory Bar
starts flashing
File position
OFF Soft Loud

13 Instructions for Use 2019-03-20
Meter Display
The position of the file tip is shown by the canal length indica-
tor bar on the display. The flash bar flashes on and off once file is
inserted into the root canal.
The meter’s 0.5 reading indicates that the tip of the file is in or
very near the apical constriction.
* The numerals on the meter gauge do not represent millimeters.
If the file tip reaches the apical foramen, a single, sustained beep
will sound, and the word “APEX” and the little triangle next to the
flash bar will start to flash on and off.
• In some cases such as a blocked canal, a measurement cannot be made. pp. 16 and 17 “Root Canal Not Suit-
able for Electronic Measurement”
• Always check the measurement with an X-ray. In some cases, an accurate measurement cannot be made because of the
canal shape, unusual cases, or poor performance of the device. p. 18 “Endostar Navigator Meter Reading and
Radiography”
• Stop using the device immediately if you sense something odd or abnormal while taking a measurement.
• Do not let the file touch the gums. This will cause the meter to jump to the APEX.
• If the canal is extremely dry, the meter may not move until it is quite close to the apex. If the meter does not move, try
moistening the canal with oxydol or saline.
• Occasionally the canal length indicator bar will make a sudden and large movement as soon as the file is inserted into the
root canal, but it will return to normal as the file is advanced down towards the apex.
Flashes
Flashes
Flashes

14Instructions for Use 2019-03-20
• Do not use an ultrasonic scaler with the contrary electrode attached to the patient. Electrical noise from the scaler could
interfere with canal measurements.
• Make sure that the contrary electrode, file holder, etc. do not come into contact with an electric power source such as an
electrical socket. This could result in a severe electrical shock.
• The contrary electrode could cause an adverse reaction if the patient has an allergy to metals. Ask the patient about this
before using the contrary electrode.
• Take care that medicinal solutions such as formalin cresol (FC) or sodium hypochlorite do not get on the contrary elec-
trode or the file holder. These could cause an adverse reaction such as inflammation.
• Always clip the file holder to the upper part of the file shaft, near the handle. The metal and plastic part of the file holder
can be damaged if they are attached to the file’s cutting part or the transition to the cutting part.
Operating Procedures
1. Turn the device on.
2. Hook the contrary electrode in the corner of the patient’s
mouth.
3. Clip the file holder to the metal shaft of the file.
(1) Press in direction of arrow with the thumb.
(2) Clip the file.
(3) Release thumb.
Contrary Electrode
File Holder
File or Reamer
Metal part of
file holder
Handle
Cutting part and
transition to cut-
ting part
Do not clip onto
this part!
Press

15 Instructions for Use 2019-03-20
Operating Procedures
12
• Use files and reamers with plastic handles only. If the file has a metal handle, electrical leakage will occur when the
handle is touched by fingers and it will prevent an accurate root canal measurement. Even if the file handle is made of
plastic, make sure not to touch the metal part of the file with finger.
• Do not use damaged file holders. An accurate measurement cannot be made using a damaged file holder.
• Clip the file as shown in illustration #1 to the left. If the file is in the position shown in illustration #2, it may not make a
correct measurement and the file holder could be damaged.
• Make sure to take an X-ray to check the results.
• Make sure the long file holder does not prick or pierce the patient’s oral mucosa .
4. Press the Set Switch to select memory 01, 02, or 03.
5. Insert the file up to the flash bar (this point can also be recog-
nized by the change in the beeping). Position the rubber stop-
per on the tooth surface as a reference point to determine the
root canal’s working length. Use the 0.5 reading on the meter
to estimate the canal’s length.
6. Determine the working length.
If the file tip is at the 0.5 meter reading, subtract from 0.5 to 1.0
mm to determine the working length.
* The working length will differ somewhat depending on each
individual tooth. This discrepancy must be judged by the dentist
as he works on the tooth.
When using the long file holder instead of the file holder
Flash Bar
Set Switch
File Holder
Rubber Stopper
Long File Holder (Option)
0.5 Reading
WrongRight

16Instructions for Use 2019-03-20
Clean
Build-up
Fracture
Branch
Gutta-Percha
Root Canal Not Suitable for Electronic Measurement
Accurate measurement cannot be obtained with the root canal conditions shown below.
There may be cases other than these where an accurate measurement cannot be made.
Root canal with a large apical foramen
Root canal that has an exceptionally large apical foramen due to a
lesion or incomplete development cannot be accurately measured;
the results will show shorter measurement than the actual length.
Root canal with blood, saliva or a chemical solution overflow-
ing from the opening
If blood, saliva, or a chemical solution overflows from the opening
of the root canal and contacts the gums, this will result in electrical
leakage and an accurate measurement cannot be obtained. Wait
for bleeding to stop completely. Clean the inside and opening of
the canal thoroughly to get rid of all blood, saliva and chemical
solutions and then make a measurement.
Broken crown
If the crown is broken and a section of the gingival tissue intrudes
into the cavity surrounding the canal opening, contact between
the gingival tissue and the file will result in electrical leakage and
an accurate measurement cannot be obtained. In this case, build
up the tooth with a suitable material to insulate the gingival tissue.
Fractured tooth
Leakage through a branch canal
Fractured tooth will cause electrical leakage and an accurate mea-
surement cannot be obtained.
A branch canal will also cause electrical leakage.
Re-treatment of a root filled with gutta-percha
The gutta-percha must be completely removed to eliminate its
insulating effect. After removing the gutta-percha, pass a small file
all the way through the apical foramen and then put a little saline
in the canal, but do not let it overflow the canal opening.

17 Instructions for Use 2019-03-20
Root Canal not suitable for Electronic Measurement
Crown or metal prosthesis touching gingival tissue
Accurate measurement cannot be obtained if the file touches a
metal prosthesis that is touching gingival tissue. In this case, widen
the opening at the top of the crown so that the file will not touch
the metal prosthesis before taking a measurement.
Cutting debris on tooth
Pulp inside canal
Thoroughly remove all cutting debris on the tooth.
Thoroughly remove all the pulp inside the canal; otherwise an ac-
curate measurement cannot be made.
Caries touching the gums
In this case, electrical leakage through the caries infected area to
the gums will make it impossible to obtain an accurate measure-
ment.
Blocked canal
The meter will not move if the canal is blocked.
Open the canal all the way to the apical constriction to measure it.
Extremely dry canal
If the canal is extremely dry, the meter may not move until it is
quite close to the apex. In this case, try moistening the canal with
oxydol or saline.
Crown
Debris
Pulp
Caries touches
gums
Blocked
Too Dry

18Instructions for Use 2019-03-20
X-ray Tube
X-ray Film Apical foremen is located up towards the crown.
* Depending on the angle of penetration of the X-ray beam, the apex may not appear correctly,
and the position of the apical foramen may appear to be located differently than it actually is.
Endostar Navigator Meter Reading and Radiography
Sometimes the device meter reading and the X-ray image will not correspond. This does not mean that the
device is not working properly or that the X-ray exposure is a failure.
* Occasionally, the actual apical foramen does not correspond exactly. The actual apical foramen may be lo-
cated up towards the crown. In these cases, the X-ray image will seem to indicate that the file has not reached
the apex.

19 Instructions for Use 2019-03-20
3. After Using the Endostar Navigator
1. Turn the device off.
* The device will automatically turn off after 10 minutes of non-
use.
2. Disconnect the probe cord and other cords or cables.
• Do not pull directly on the cords when connecting or disconnecting the probe and file holder. Always grip the connectors
to connect and disconnect cords.
• Do not wrap the probe cord around the main unit.
Cord
Always grip the connectors to con-
nect and disconnect cords.
Wrong