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