precisionplus A08 User manual

Dental Apex Locator
USER MANUAL
A08 Rev. V3.0 © Precision Plus
A08
For your safety and the safety of your patients please read this user manual
carefully before use and file for future reference.
This manual is published by Precision Plus.
Precision Plus does not guarantee its contents and reserves the right to amend at
anytime without prior notice, amendments will be published in new editions of this
manual.
0197

1. Purpose- Intended Use ................................................................................. 1
2. Precautions for Handling and Operation ....................................................... 1
3. Contraindication ............................................................................................ 3
4. Package Contents ........................................................................................ 3
5. Component Names ....................................................................................... 5
6. Check before Treatment and Installation ...................................................... 7
7. Operation ..................................................................................................... 10
8. Audio Alarm Volume Control ....................................................................... 12
9. Maintenance ............................................................................................... 13
10. Charging Battery ....................................................................................... 15
11. Regular Maintenance Checks ................................................................... 15
12. Troubleshooting ........................................................................................ 16
13. Specifications ........................................................................................... 19
14. Classification of Equipment ...................................................................... 19
15. Operation Principle .................................................................................... 20
16. Declaration of Conformity ..........................................................................20
17. Transportation and Storage Environment ................................................. 21
18. Symbol ....................................................................................................... 21
19. Warranty .................................................................................................... 22
20. Disposal of Product ................................................................................... 22
21. EMC Information (Electromagnetic Compatibility Information) ................. 23
Contents

Intended use: determination of the apical foramen position and measurement of
the root canal length.
The product is only to be used in dental surgeries by qualified dental personnel.
1. Purpose- Intended Use
• All precautions should be read and understood before use.
• Equipment is only to be used for its specified intended use.
• Safety instructions are provided in order to prevent the risk of personal injury or
damage to the device and are classified as below in accordance with the level of
potential risk.
2. Precautions for Handling and Operation
1
WARNING: Indicates a hazard that may result in serious injury/device damage
if instructions are not correctly followed.
WARNING:
CAUTION: Indicates a hazard that may result in mild to moderate injury/device
damage if instructions are not correctly followed.
• Use this product in accordance with its intended use and proper method of use.
• This product is not waterproof. Avoid water or chemical solutions on the control
unit as it may cause electric shock due to a short circuit.
• The scale indication on the A08 screen does not represent a distinct length or
distance in mm or other linear units. It simply indicates the file’s progression
towards the apex.
• Do not expose to or dispose of the battery in a fire.
• Be sure to prevent the lip hook , file clip , file probe and their connector parts
from having contact with household power supply sources (such as electrical
outlets) as it may cause an electric shock.

2
CAUTION:
• The components in the product package are delivered in a non-sterile condition,
be sure to sterilize the file clip, file probe and lip hook by autoclave sterilization
prior to use and after each patient.
• Do not operate close to patients with cardiac pacemakers as there is a danger
that it may affect the pacemaker.
• Keep away from explosive substances and flammable materials.
• Do not keep using the product when the battery indicator “ ” is flashing.
Normal operation or indication may not be performed. Please recharge the battery.
• Should the product function abnormally during operation, cease operation
immediately.
• Do not use the product by connecting or integrating into other medical devices.
• Do not drop or allow impact on the product. This may result in personal injury or
damage to the unit.
• Avoid using chemical solutions on the lip hook, file probe or file clip during
procedures. Use of solutions may cause inflammation.
• When gripping the metallic part of a file or reamer with the file clip, grip the upper
part (near the handle). If the lower part (blade transition part and blade part) is
gripped, the root canal length cannot be correctly measured and the tip of the
file clip may be broken.
• Do not use or leave the product in a high-temperature environment such as under
strong direct sunlight, or next to equipment that produces heat as it may cause
overheating or fire due to a failure of the internal circuit.
• Do not attempt to disassemble the product nor tamper with the mechanism
except as recommend by Precision Plus in this User manual.
• This device is for indoor use only.
• Keep the control unit on a level surface.
• If the product is not used for a long period check it is functioning correctly before
using on a patient.

The A08 is not recommended for use:
a. In patients who have a pacemaker or other implanted electrical devices or have
been cautioned by their physicians against the use of small electric appliances
such as shavers, hair dryers etc.
b. In patents allergic to metals.
c. Children.
3. Contraindication
A08 is composed of a control unit, AC adapter, Plug adaptor, measuring wire,
lip hook, file clip, file probe and tester.
4. Package Contents
3
• Portable and mobile RF communications equipment can affect Medical Electrical
equipment. Do not use RF equipment near the product.
• During operation the Apex Locator may interfere with computers, LAN cables or
may cause noise in radio receivers nearby.
• Installation and use of this product requires special precautions regarding EMC
according to the EMC information.
• Use only original accessories with this device.
• The apical position is indicated on the screen with “00”. In order to avoid over
instrumentation, it is suggested to subtract 0.5mm from the reading when
determining the working length for shaping.
• Always dry the cavity entrance with a cotton pellet in order to obtain an accurate
measurement.
• Users are responsible for the operational control, maintenance and continual
inspection of this product.
• The battery can be replaced, please contact Precision Plus if a replacement
battery is required.

4
c). Battery
Accessories
Accessories list
a). File Clip b). Measuring wire
d). Lip Hook e). File Probe
ICR14500 3.6V 850mAh
f). Tester g). Plug adaptor h). AC adapter
No. Name
aFile clip
Quantity
4 PCS
Consumable?
YES
Can be sterilized?
YES
bMeasuring wire 1 PCS YES NO
cBattery 1 PCS YES NO
dLip hook 4 PCS YES YES
eFile probe 4 PCS YES YES
fTester 1 PCS NO NO
gPlug adaptor 1 PCS NO NO
hAC adapter 1 PCS NO NO

5. Component Names
5
Battery cover
Charging socket
Power key
LCD panel
Charging light Demonstration mode
Alarm key
Measuring
Wire Socket
LCD Panel
Power key
Alarm key
Measuring wire socket
Battery cover
Charging light
Demonstration mode
Charging socket Socket to which the AC adapter is inserted
Press the button to demonstrate the measurement process
The light will remain on when battery is charging
Secures battery in place.
Socket to which the measuring wire is inserted.
Displays the position of the file tip, remaining battery
level and alarm sound volume
When the Alarm key is pressed, the alarm audio volume
can be adjusted (rotation of OFF->Low->Medium->High).
When the Power key is pressed, the power turns on
sounding an alarm, then the LCD panel lights up, press the
Power key again, the power and the LCD panel turns off.
5-1 Control Unit

6
1
2
3
4
5
6
7
Bar graph
Battery indicator
Alarm indicator
Number display
Apex indicator
OVER Display
Measurement
indicator
Displays the approximate position of the end of the file
Indicates the files position in the root canal
* 4 is not a value to show the actual distance from the end of the root canal in the unit of mm.
It is to be used as indication for measurement.
Displays the remaining battery level. When the Battery indicator
flashes, immediately recharge the device with AC adapter
Turns on when the value representing the present position of the
file end reaches “00”
Turns on when the value representing the present position of the
file end reaches “-1”
Displays the present position from the end of the root canal in
numerical value. When the value displays “10” to “05”, an alarm
corresponding to each value sounds. When the value reaches
“04”to “00”, a short alarm sounds with “APEX”displayed on the
LCD panel. When the values reaches “-1” to “-3”, a shorter alarm
sounds with “OVER”displayed on the LCD panel
5-2 LCD Panel
Displays the alarm audio volume
(rotation of OFF ->Low ->Medium ->High )
4
3
2
1
657

The first time you use the device and any subsequent use, check the apex locator
with the tester as follows:
1) Press the Power Key to turn on the power. (The alarm sounds and the
LCD panel lights up)
2) Insert the plug of the tester into the Measuring wire socket (Fig.1). Check that the
number displayed on the LCD panel is within the range of “04 and 00” and that
the bar graph is yellow. If the numerical value is out of the range of “04 to 00”
and/or the bar graph is green or red, there may be a fault in the device.
Contact your Authorized Precision Plus Dealer.
7
6. Check before Treatment and Installation
6.1 Check with the Tester
Fig.1

(1) Connect the measuring wire: securely insert the plug of the measuring wire into
the Measuring wire socket on the unit.(Fig.2)
(2) Connect the file clip: connect the plug of the file clip to either plug of the
measuring wire. (Fig.3)
(3) Connect the lip hook: connect the lip hook to the other plug of the
measuring wire. (Fig.3)
(4) Make the lip hook touch the bent section
of the file clip (Fig.4), the screen will display
“OVER”,(as show in Fig.5 c), otherwise,
it means the file clip or the measuring wire is
damaged, and should be replaced.
8
6-2 Installation
Fig.2
Fig.3
Fig.4

(5) Display explanation
Display Screen explanation
• “10 to 05”, Green bar graph and/or low frequency sound: File has reached the
front region of the Apex;
• “04 to 00”, Yellow bar graph and/or middle frequency sound: File is very close
to the Apex;
• “-1 to -3”, Red bar graph and/or high frequency sound: File has exceeded the
Apex.
a) The file has reached the
front region of the apex
b) The file is very close
to the apex
c) The file has already
exceeded the Apex
9
Fig.5
(6) Demonstration mode
Demonstration mode tracks the movement of the file
1) Pull out the measuring wire and adapter.
2) Turn on Apex Locator
3) Press “ ”button for 2 seconds to enter demonstration mode
Demonstration mode will be exited by finishing demonstration or pressing
demonstration mode button.

• The use of apex locators alone, without a preoperative and postoperative radio
graph, is not a recommended practice as apex locators may not work properly
in all conditions. It is recommended to take an X-ray prior to the use of the
Apex Locator, to compare the information given by both means.
• The dentist should have a good understanding of the tooth and root canal in
question
• The root cavity should be sufficiently exposed and the root should be unblocked.
• The largest file that can correctly reach the apex should be selected.
• Avoid contact between the file, file clip and the gingiva or any metal crown and
bridge appliances. If the crown of the tooth is broken and there is a possibility of
the gingiva contacting either the file, file clip or a probe, an incorrect reading may
occur. An isolating barrier around the rim of the broken tooth must be created
before proceeding with the Apex location.
• Dry canals should be treated with an irrigation solution such as saline or
hydrogen peroxide. Access to the cavity should then be air dried or wiped dry
with a cotton pellet.
• If there is bleeding from the root canal or apical foramen, it must be stopped
before a correct measurement can be taken.
• Canals must be cleaned of all remnants after root canal treatment before
measurement can be taken.
• Accessories such as file clips, lip hooks and file probes should be clean and free
from any chemical disinfectant or medical solution residue.
• Mark the treated tooth and record the information on the patients medical records.
Be careful to make sure the tooth is marked in a practical and most resilient part
of the tooth.
• The root canal must be cleared of any pulp or necrotic tissue and there must be
no inflammation or infected material surrounding the apex.
10
7. Operation
7-1 Preparation

Touch probe
File clip
Endo file
11
7-2 Operating Procedure
Fig.6
• The following cases are not for use with the apex locator.
a) The measurement length of the canal may be shorter than its real length due
to root hypoplasia and thus a true reading is not possible
b) A crack in the root may allow electric leakage thus affecting accuracy of the
reading
• An X-ray shot at a difficult or unusual angle
may sometimes cause the illusion that the
file tip has not reached the apex. Results of
the Apex Locator and X-ray may possibly
not correlate when the apical foramen is
at an unusual or severe angle, which may
falsely indicate that the file tip has not
reached the root canal tip. (Fig. 6)
1) Grip the file inserted in the root canal with the
file clip. Grip the upper part (near the handle)
of the file’s metallic part. (Fig.7)
2) Hang the lip hook on a corner of the
patient’s mouth. (Fig.8) Fig.7
Fig.8Fig.9

12
8. Audio Alarm Volume Control
CAUTION: Never hold the measuring wire when removing the lip hook and
file clip from the measuring wire. Always hold the connector section.
NOTICE
The last setting is stored when the control unit is switched off.
3) Insert the file into the canal and push it slowly towards the Apex.
A continuous alarm will sound when the file is less than 2mm from the apex.
Gloves must be worn to avoid contact of the operators skin and metal shank of
the file.
4) The “APEX” will be indicated when the screen displays “00” but as previously
stated 0.5mm should be subtracted from the reading so as to not over
instrumentate.
5) When the file reaches this point, adjust the endo stop and remove the file.
By measuring the distance between the endo stop and the tip of the file, the
working length of the canal can be determined.
6) The file probe may also be used instead of the file clip to touch the file when
working on posterior to determine the working length of the canal. (Fig.9)
7) After use, press the Power key for approximately one second to turn off the
power (the alarm sounds and the LCD panel turns off). The device will shut
down automatically after 5 minutes if unit is not in operation.
8) Remove the file from the file clip.
9) Remove the lip hook and file clip from the measuring wire.
10) Remove the measuring wire from the control unit.
Alarm audio volume can be adjusted to “OFF ”, “Low ”, Medium ”,
and “High ”.
1) press the Alarm key.
2) The Alarm Indicator on the LCD panel and the sound volume will change.
3) Each time the key is pressed the sound volume changes.

13
9. Maintenance
9-1 Cleaning
CAUTION:
Non observance of the following precautions could lead to the deterioration or
failure of the accessories. Be sure to follow these precautions when cleaning the
accessories.
• When cleaning the product never use solvent such as benzine or thinner.
• Do not use a chlorinated cleaner.
• Do not clean the product with an ultrasonic cleaning apparatus.
• For your own safety, please wear personal protective equipment (gloves, glasses,
mask)
• After cleaning the measuring wire, make sure to dry the connector part of the
measurement wire.
Preparation prior to cleaning
1. Remove the file clip and lip hook from the measuring wire.
2. Remove the measuring wire from the control unit.
3. Check for damage on each cord or deformation on each connector.
Cleaning
1. Rinse accessories thoroughly with clean suitable water, then wipe clean with
alcohol-immersed cotton or cloth.
2. Repeat until accessories are visibly clean.
Note:
a. Clean and sterilize the accessories before each use to prevent any contamination.
This includes the first use as well as any subsequent use.
b. Accessories that should be cleaned include: measuring wire, file clip, lip hook,
file probe.
c. Do not use highly acidic water to immerse or clean .

14
9-2 Sterilization of the file clip, lip hook and file probe
CAUTION:
• The product must be cleaned before sterilization.
• Do not heat or cool the product too quickly. Rapid change in temperature could
cause damage to the product.
• Do not use Autoclaves exceeding 138ºC during sterilization.
• Precision Plus recommends sterilization according to EN13060, class B. Always
follow autoclave manufacturer’s instructions for use.
• Do not touch the product immediately after autoclaving as it will be very hot and
must remain in a sterile condition.
• Reprocessed products should be stored, protected from dust with minimum
exposure to germs in a dry, dark and cool place.
• Autoclave sterilization is the only agreed method to correctly sterilize this product.
The validity of other sterilization methods is not confirmed or guaranteed.
• Resistance to reprocessing: file clip: 200 cycles , other accessories have no cycle
limitation, but should be replaced when no longer in usable condition.
(reprocessing cycles include cleaning and sterilization).
Note: Sterilize file clip ,file probe and lip hook by autoclave sterilization, other parts
Apex Locator can not be sterilized.
Autoclave Procedure:
1) Insert into an autoclave pouch.
2) Seal the pouch.
3) Sterilize at 134ºC (273ºF) for 10 mins and a minimum drying cycle of 30 mins.
4) The product should remain in a sealed pouch until required for use.
10. Charging Battery
Do not use the Apex Locator whilst the indicator is flashing. Charge battery as below:
1) Connect the AC adapter to the Charging Socket of the device, then insert
AC adapter plug into supply power socket.
2) The Apex Locator will take approximately 2-3 hours to fully charge.

15
Points to check
ON/OFF operation Check that the power turns ON and OFF correctly
Process
11. Regular Maintenance Checks
CAUTION:
• Avoid shorting the battery.
• Do not disassemble or tamper with the battery.
• Use the AC adapter provided by Precision Plus (complies with IEC 60601-1) to
charge the device, never use a modified or damaged charger.
• Batteries will discharge over time if Apex Locator is not used. Always recharge if
the unit has not been used for extended periods.
• Only the NCM 14500 DC 3.6V/850mAh Rechargeable Li-ion Battery Cells which
have passed the IEC 62133 certification can be used.
3) If you need to replace battery please contact us or your dealer.
How to install the battery:
a. Open the battery housing
b. Insert battery connector into the square notch
c. Make sure it is firmly installed by gently pulling the battery
d. Reinstall the battery housing
Note: the square notch is an anti-mistake design, if the polarity is reversed,
the battery can not be installed.
Regular maintenance should be performed every 3 months as per the below chart.
If any abnormalities are found, immediately contact your authorized Precision Plus
dealer.
Attention:
a. Orange light indicates charging and will turn green once unit is fully charged.
b. Please do not use the device when it is charging.
c. We provide a plug adaptor for certain target markets, if the AC adapter can not
match the supply power socket, you can insert the plug of AC adapter into the
Plug adaptor, then insert the Plug adaptor into the supply power socket.

16
Alarm sound volume
Product operation
Remaining battery level
Press the Alarm key and check that the alarm audio
volume changes.(rotation of OFF->Low->Medium->High)
Connector part Check for debris or corrosion on the lip hook or connector
terminals of the cable
Check with the tester, that the cable and the control unit
operate properly, following the instruction in “6. Check
before Treatment and Installation”
Check that the Battery indicator does not flash. If the display
flashes, recharge the battery following the instruction in “10.
Charging battery”
12. Trouble Shooting
When a problem is detected, check the following again before requesting a repair.
Malfunction Cause Solution
The power
does not
turn on
Alarm sound
volume is low
Root canal
length
measurement
cannot be
performed
Battery is not inserted Insert battery
The alarm sound volume is
adjusted to “OFF”. Check the alarm sound volume.
The LCD panel
does not display The battery level is low
If the LCD panel does not display
after the battery is charged, failure of
the LCD panel is suspected
Battery is not correctly inserted Correctly insert the battery
The battery level is low Recharge the battery
The measuring wire or other
connectors are not properly
connected.
Securely insert the connector
Connect the lip hook and file clip and
make the lip hook touches the bent
section of file clip to check whether
the device has been connected
correctly.(refer to“6. Check before
Treatment and Installation”. )
* See trouble shooting chart if problems are discovered

17
The file clip is not clean or is damaged Replace or clean the file clip
The inside of the root canal is
extremely dry.
Moisten the root canal with a saline
solution
Large lateral canal Try continuing the procedure by
gently advancing the file
Bar graph is
not stable
Bar graph
does not
move
The lip hook is not firmly in contact
with the mucous membrane of the
patient’s oral cavity
Adjust the lip hook position so that it
correctly contacts the mucous
membrane in the oral cavity
Current leakage to the gingiva is
occurring due to a major collapse
of the crown
Form a matrix around the tooth to
prevent current leakage to the
gingiva
Bad electrical contact
Perform the cable connection test as
described in “6. Check before
Treatment and Installation”
The file is in contact with the gingiva
The file is in contact with a metal
prosthesis.
When the file contacts the gingiva the
entire bar graph will light be lit up. Check
if the file is in contact with gingiva
When the file contacts a metal
prosthesis, the measured current
flows to the gingiva or periodontal
tissues and the bar graph moves.
Check if the file has contacted a
metal prosthesis
Perforation of the canal or an
adjacent surface has caries
Remove the file , close the
perforation and repair the caries,
then repeat the apex detection
procedure, carefully inserting the file
in canal
The root canal is closed
Bar graph operates correctly when
the file reaches the apical
constriction. In this case, always
check in combination with X-ray
photography

18
If none of these are applicable or if the trouble is not fixed after the appropriate
action has been taken, a failure in this product is suspected. Contact your
Authorized Precision Plus Dealer.
Bar graph
does not
move
Display
indications are
incorrect, i.e.
unit displays
that “APEX” is
reached before
it has
The connection hook of file clip
is not properly connected to the file
Place the connection hook on the
metal part of the file below the
plastic handle
In the case of retreatment: residue
from old filling material may be
blocking the root canal
Remove old root filling material
residues prior to measuring
Root canal may be blocked by
remnants of medical products
(e.g. calcium hydroxide)
Rinse the root canal with NaCl
solution. Dry the access cavity
with a cotton pellet/air-blower
The selected file is too small for a
large root canal
Electronic malfunction Contact your distributor or
Precision Plus
Use the largest file possible for
the canal to produce the most
accurate result
Short circuit due to excess liquid
(irrigation solution, saliva or blood)
in the pulp chamber
Dry the access cavity with a
cotton pellet/air blower.
In case of excess bleeding,
wait until it has stopped
A direct contact of the file with the
gingiva proliferations or metal
restorations (crown, amalgam filling)
For isolation:
A) Do adequate preparation filling.
B) Use a rubber dam or isolate the
file by placing 2-3 silicone
stoppers on it