VRN ProPex User manual

ProPex
Apex locator user manual
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Contents
1.Symbols ......................................................................................................... 2
2.Technical Data.............................................................................................. 3
3.Parts Identification..................................................................................... 4
4.Intended use ................................................................................................ 4
5.Contraindications ....................................................................................... 5
6.Installation .................................................................................................... 6
7.Using............................................................................................................... 9
8.Maintenance and sterilization..............................................................18
9.Troubleshooting........................................................................................20
10.EMC table .................................................................................................21
11.Warranty ..................................................................................................26
12.Service life ................................................................................................26
13.Declaration...............................................................................................26
14.Environmental protection ..................................................................26
15.Right...........................................................................................................27
16.Warranty Card.........................................................................................28
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If the instructions are not followed properly,
operation may lead to hazards for the product or
the user/patient.
Additional information, explanation of operation
and performance.
Do not dispose of with normal household waste.
(WEEE)
Serial number
Catalogue number
manufacture
Date of manufacture
Direct current
Type BF applied part
Safety class II device
Store in a dry place
Can be autoclaved up to a maximum temperature
of 135° Celsius
Temperature limitation
Relative humidity
Transport and storage pressure conditions: 70 kPa -
106 kPa
1. Symbols
Warring
NOTE
-20℃
55℃
80%
20%
106kPa
70kPa
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2. Technical Data
Model ProPex
Package Size 205 mm x 185 mm x 50mm
Package weight Approx. 550g, ±10%
Power supply ICR14500, 3.7V 800mAh ±10%
Charger power
supply AC100-240V，50/60Hz
Charger nominal
power input 5VA
Degree of Protection IPX 0
Electrical safety class Class II
Applied part BF
Operating
conditions
Use: in enclosed spaces
Ambient temperature: 5° C ~ 40 ° C
Relative humidity: <80%
Operating altitude < 2000m above sea level
Atmospheric pressure: 70kPa ~ 106kPa
Transport and
storage
conditions
Ambient temperature: -20 ° C ~ +55 ° C
Relative humidity: 20% ~ 80 %
Atmospheric pressure: 70kPa ~ 106kPa
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3. Parts Identification
Components and Accessories
Main unit 1 (pcs) Measuring Wire 1 (pcs)
Adapter 1 (pcs) Tester 1 (pcs)
Probe 2 (pcs) File clip 2 (pcs)
Lip hook 2 (pcs) User manual 1 (pcs)
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2
3
4
5
6
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4. Intended use
ProPex is an electronic apparatus for determining the apex location
during an endodontic treatment.
The device must be only used by or under instruction of quali-
fied medical personnel. The personnel who use the device must be
trained. FOR DENTAL USE ONLY !
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5. Contraindications
This equipment is contraindicated in cases where patient/user carry
medical implants such as pace makers or cochlear implants etc.
Do not use the device for implants or other non-endodontic dental
procedures.
Safety and effectiveness have not been established in pregnant
women and children.
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Read the following warnings before use:
1. The device must not be placed in humid surroundings or any-
where where it can come into contact with any type of liquids.
2. The device is intended for endodontic treatment and may only
be used by trained and qualified professionals such as dentists in the
hospital.
3. Do not expose the device to direct or indirect heat sources. The
device must be operated and stored in a safe environment.
4. The device requires special precautions with regard to electro-
magnetic compatibility (EMC) and must be installed and operated in
strict compliance with the EMC information. In particular, do not use
the device in the vicinity of fluorescent lamps, radio transmitters, re-
mote controls, portable or mobile RF communication devices, and do
not charge, operate or store at high temperatures. Comply with the
specified operating and storage conditions.
5. Gloves and a rubber dam are compulsory during treatment.
6.If irregularities should occur in the device during treatment, switch
it off. Contact the agency.
7.Do not open or repair the device by yourself，otherwise, void the
warranty.
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6. Installation
6.1 Charging
1
Turn the device on by pressing the button.
connect the USB cable to the unit power connector,
and plug the other end into a power outlet.
While charging, the battery symbols on the screen is displayed in
sequence as bellow:
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When the charging is completed, the battery symbols displays as :
IF the power is too low, the battery indicator will flash in:
Fully charged will take about 4 hours, depending on residual battery
power and battery state.
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1. Charge the device for more than 4 hours before using the product
for the first time.
2. Only the original adapter and battery can be used.
3. Disposal of waste batteries in accordance with local regulations.
4. Do not use the device while charging.
5.Do not change the battery, only trained technician or distributor
can change the battery, the electronic parts will be damaged if use a
wrong battery or install with a wrong way.
6. Need to charge immediately, if the battery is low.
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Plug the measuring wire into the socket of the device .make sure
connect properly.
1
2
3
Power button
Volume key
Reference key
Turn power on:
Short press the power button on the top of the machine, the ma-
chine will boot and enter the standby interface.
Turn power off:
Short press the power button .
6.2 Install accessories and power on-off
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Insert the lip hook and file clip into the other end of the measuring
wire.
NOTE
After the measuring wire is installed, gently pull the measuring
wire, lip hook and file clip to ensure that they are firmly connected.
Only the original accessories can be used.
7. Using
7.1 Volume setting
2
Touch the volume button( )in the
panel to select different volume set-
tings, and the modified volume settings
will be saved automatically.
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Volume indicator
beeper off Medium volume
Low volume High volume
7.3 Connection test
Touch ( ) on the device，can set the reference point，between
0~1 mm, and the number “00”-“06”.
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7.2 Setting the reference point
Check the measuring wire, file clip, lip hook and the APEX
LOCATOR are connecting properly.
Make file clip hook with lip hook (short circuit).
The reference point will be saved
automatically.
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Observing the device display, the "APEX" sign will flash, the number
will display “--”,the root canal length strip will be all lighted,and a
rapid bee sound will be generated at the same time,
That means the device is working well.
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1. Testing the device before using every time.
2. If the testing fails, stop using the device and contact your distrib-
utor.
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After installing the measuring wire, plug the tester into the two
sockets of the measuring wire and observe the number displayed on
the screen . If it is 02, 03 or 04.
7.4 Accuracy the device
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1. It is recommended to perform a test on the device every one or
two weeks to ensure that the device is working well.
2. If the testing fails, stop using the device and contact your distrib-
utor.
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7.5 Making a measurement
Clip the file clip to the metal shaft the file. Press in direction of arrow
and clip file,then release to finish installation
Connect the lip hook to the patient’s lower lip and the file clip to
the file that is inserted into the treated root canal. The progression of
the file into the canal in reference to the apex will be indicated on the
display.
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Make sure that the connection between the root canal ,lip hook
and the file clip is reliable, otherwise cannot make a measurement.
The following conditions are not suitable for root canal measure-
ment：
（1）Apical foramen of the root canal has be expanded；
（2）The root canal which is bleeding or blood overflow apical fora-
men .
（3）The crown of the root canal is damage；
（4）The tooth root has cracks；
（5）The root canal filled with gutta-percha；
Only the original accessories can be use.
Observing the strips and numbers indicated on the display while
moving the file into the root canal slowly.
The numbers indicates the remaining number of strips before reach-
ing the major apical foramen.
Strips become yellow into the apical zone. The minor and major api-
cal foramens are separated by 7 strips form 00 to 06, “00” will dis-
play when the major apical foramen is reached and the beep will
sound continuously.
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Apporx. 0.5–2.0 mm
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Apex
Approx. 0.5mm
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The“00”display means major apical foramen (not the minor api-
cal foramen), in clinic the measure length need minus 0.5 to 1mm as
the root canal length.
The device's screen do not show the actual length of the root canal
,the number reducing only means a trend that file move to apical .
In order to prevent the liquid from contacting the gum or the ad-
jacent root canal to interfere with each other and cause the measure-
ment error, the mouth should be dry before measurement.
The accessories which contact with patient (file folder, lip hook)
can be reused ,and should be sterilized by high temperature before
using every time.
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When the file tip over the apex, strips become red ,number becomes
“--”and the label “APEX” blinks with a rapid beep.
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The measurement should be stopped and restarted when the file tip
over the apex.
7.6 Connect with the Endo Smart II endomotor
The ProPex can be used with our company's endomotor Endo
Smart II. After the connection, it can activate more functions of the
endomotor. For details, refer to the instruction manual of the Endo
Smart II.
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8. Maintenance and sterilization
8.1 Cleaning and disinfection
Step Operation Parts Processing
1 cleaning All
Remove debris under running
water
(except electronic parts), and
then wipe off all components.
2 Disinfection
Main unit ,
Measuring
wire,
Adapter
Wipe the components with a
piece of gauze impregnated
with Ethanol (Ethanol 70 to 80%
vol.). Make sure the components
are dry before next step If use
of washer-disinfectors, use only
approved devices according to
EN ISO15883 and refer to their
manufacturer’s instructions for
use.
3 Packing
Lip hook
File clip
Probe
Pack components in sterilization
pouches Use pouches which resist
to a temperature up to 141 ° C
and comply with EN ISO11607.
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