Dentsply Maillefer PROPEX II Manuale utente

APEX LOCATOR

User Manual

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CONTENTS

English ....................................................................................... 5

Français ...................................................................................... 25

Deutsch ...................................................................................... 47

Español ...................................................................................... 69

Italiano ........................................................................................ 91

Electronic instructions for use

For additional languages, visit our website: www.dentsplymaillefer.com

Technical modifications on our products are not subject to notification. Photos of our

devices are not contractual.

Des modifications techniques peuvent être apportées à nos produits sans préavis.

Les photos de nos dispositifs sont non contractuelles.

Technische Änderungen an unseren Produkten können ohne Vorankündigung

erfolgen. Fotos unserer Produkte sind unverbindlich.

Las modificaciones técnicas de nuestros productos no son objeto de notificación.

Las fotos de nuestros dispositivos no son contractuales.

Modifiche tecniche dei prodotti non soggette a notifica. Le foto dei dispositivi sono

solo indicativel.

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User Manual

Table of contents

Introduction 6

1. Indications for use 6

2. Contraindications 7

3. Warnings 7

4. Precautions 8

5. Adverse Reactions 9

6. Step-by-Step Instructions 10

A. Contents 10

B. Recharging the Battery 10

C. Replacement of the Rechargeable Battery 11

D. Getting Started 12

E. Search for the Apex 13

F. Sound Adjustment 15

G. Demo Mode 15

H. Automatic Shutdown 16

I. Maintenance of your ProPex

®

II 16

J. Warranty 17

K. Technical Specifications 17

L. Standard Symbols 18

7. Disinfection, cleaning and sterilization 19

8. Troubleshooting 22

9. Disposal of the Product 24

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FOR DENTAL USE ONLY

DIRECTIONS FOR USE

Introduction

Congratulations on the purchase of ProPex

®

II.

ProPex

®

II is a device aimed at detecting the minor apical foramen based on

analysis of electrical properties of different tissues inside the root canal system. For

optimal safety and performance, read this user manual carefully before use. Make

sure you have understood and followed the clinical precautions - as well as the

general warnings, precautions and contraindications - before proceeding to

determining a working length.

Keep this user manual for future reference.

1. Indications for use

ProPex

®

II is an electronic device used to indicate the location of the apex and the

working length. This product must only be used in hospital environments, clinics or

dental offices, by qualified practitioners.

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2. Contraindications

The ProPex

®

II is not recommended for use:

 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,

 in patients allergic to metals,

 in children.

3. Warnings

 The scale indication on the ProPex

®

II screen does not represent a distinct

length or distance in mm or other linear units. It simply indicates the file

progression towards the apex.

 The following patient's related factors may prevent accurate readings:

- Blocked root canals,

- Teeth with large apices,

- Root fracture or perforation,

- Metal crowns or bridges, if they come into contact with the file or the lip clip.

 Inaccurate or incorrect readings due to the environment are likely to occur in the

following cases:

- Presence of portable or movable radio frequency transmitters in the

surroundings.

- Film viewers or other Illumination devices which use an inverter may cause

abnormal operation of the apex locator. Such devices should be turned off

during use of the ProPex

®

II.

 Electromagnetic interference could cause improper operation of the device. In

such cases the device behavior may become abnormal or random. Usage of

any devices emitting electromagnetic radiation, such as cellular phones, remote

controls, transceivers, etc., should be prohibited in the vicinity of ProPex

®

II.

 General safety warnings:

- In order to prevent infectious agent transfer it is highly recommended to use

a rubber dam system during the endodontic procedure.

- Make sure that the lip clip, hook or fork does not come into contact with an

electric power source such as an electrical socket. This could result in a

severe electrical shock.

- Do not use ProPex

®

II in the presence of flammable substances.

 Only use the original battery pack from your supplier.

 Only use the original charger.

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4. Precautions

Important notice

The use of apex locators alone without a preoperative and postoperative radiograph

is not a recommended practice, since apex locators may not be able to work

properly in all conditions.

It is mandatory to confirm radiographically the working length established using the

apex locator.

It is important to follow the precautions below and pay close attention to any

condition or situation that may influence the electrical conductivity during the

procedure.

 Inaccurate or incorrect readings are likely to occur in the following cases, all

procedure related:

- Partially blocked canal.

- Size of the measuring file differing significantly from the canal diameter.

Ideally, the selected file should be the thickest one capable of reaching the

apex.

- Presence of liquids and/or tissue debris in the access cavity. Prior to the use

of the device, the access cavity must be dried with a cotton pellet in order to

prevent leaking current.

- Contact of the file or the lip clip with metallic dental structures. Be particularly

careful with patients fitted with metal crowns or bridges.

- Contact of the file with another instrument.

- Very dry canal, for instance in the presence of restoration. In this case the

canal must be moistened with an irrigation solution, or with Glyde

TM

file prep.

- Contact between the file and the gums (this may cause a false reading

indicating that the apex has been reached).

- Use of an ultrasonic scaler with the counter electrode attached to the patient

(electrical noise from the scaler could interfere with the apex localization).

- Use of the apex locator in conjunction with an electric scalpel.

- Use of a damaged lip clip, hook or fork.

 For apex localization, concentrations of NaOCl higher than 5 % may result in

reduced accuracy.

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 As a safety precaution in order to avoid over-instrumentation, it is recommended

to proceed as follows: place the file onto an endodontic ruler at the point where

the ProPex

®

II indicates ‘APEX’. Subtract a minimum of 0.5 mm from the

measured file length.

 Please also respect the following precautions:

- For your own safety, be aware of wearing personal protective equipment

(gloves, glasses, mask).

- If the bar graph makes sudden large movements in the coronal part of the

canal, slowly continue advancing the file toward the apex until the signal

returns to normal.

- This ProPex

®

II unit 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. Using replacement parts or accessories not

supplied by the original manufacturer or vender could adversely affect the

EMC performance of the ProPex

®

II.

- The device must be used with the manufacturer's original accessories only.

- Unplug the device before replacing the battery.

- Never use batteries that are leaky, deformed, discolored or otherwise

abnormal.

- In case of battery leakage, carefully dry the battery terminals and remove all of

the leaked liquid. Then replace the battery with a new one.

- Dispose of old batteries according to local codes and regulations.

- Accessories including lip clips, hooks or forks should be clean and without

residue of chemical disinfectants or other medicinal solutions such as sodium

hypochlorite or formalin.

- Do not expose ProPex

®

II to any liquid.

- ProPex

®

II must be stored in normal temperature (< 60°C) and humidity

conditions.

5. Adverse Reactions

If the apex locator provides incorrect reading and there is no radiographic data (see

"Important notice" in the “Precautions” section in chapter 4), the following adverse

reactions may occur:

 Incomplete root canal treatment,

 Apex perforation.

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6. Step-by-Step Instructions

A. Content

Check the content of the equipment before use:

- one ProPex

®

II apex locator

- one charger

- one measurement cable

- two lip clips

- two connection hooks

- two connection forks

- one user manual

B. Recharging the Battery

The ProPex

®

II is delivered with a rechargeable battery.

On ProPex

®

II a screen indicator shows the level of the battery charge. When this

is flashing, the battery requires recharging. However, it is still functional for several

treatments before the battery shuts down.

Procedure for recharging the battery:

1. Disconnect the measurement cable

2. Connect the charger cable to the ProPex

®

II

3. Connect the charger to the mains

Charging screen will appear during battery charging. When the battery image on the

screen stops blinking and turns green, the charging is complete.

Low Mid Full

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Duration of charging: About 12 hours (24 hours after long periods without use).

Note: ProPex

®

II cannot be used while charging.

C. Replacement of the Rechargeable Battery

The battery compartment is located at the bottom of ProPex

®

II and its cover is

secured by a screw.

1. Release the screw and remove the battery compartment cover

2. Remove the battery and disconnect the battery cable from the connector

3. Insert the new battery cable into the connector

4. Insert the battery into the battery compartment

5. Close the battery compartment and secure it with the screw

Warning: Use only original battery pack from your supplier !

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D. Getting Started

1. Disconnect the charger from the device if connected.

2. Connect the measurement cable and switch the device On – after a short

logo presentation, the main screen is displayed and the cursor on the tooth

image will start blinking.

(While turning the device On without the measurement cable – the main

screen will be displayed without cursor on the tooth image).

3. Attach the lip clip to the patient.

4. Insert the file into the canal – (to ensure precise measurements the file size

should be adjusted to the canal diameter).

5. Connect the hook to the file.

The cursor on the tooth will stop blinking (accompanied by a double beep signal).

A blinking cursor and no sound signal indicates a faulty connection. Check your

connections, clean your hook connection, moisten the canal, if necessary, and start

again.

No other adjustments are necessary before starting measurement.

Note: Connection test feature is included in ProPex

®

II

in order to check the cables:

● Connect metal part of the connection hook

to the lip clip

● “Connection test” icon should appear

in the bottom left corner of the display,

indicating proper connection

● If no icon appears, the connection hook or

the measurement cable should be replaced

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E. Searching for the Apex

1) Coronal and Medial Zone

Slowly introduce the file into the canal.

The cursor on the tooth icon indicates the progression of the file inside the canal.

Further progression of the file in the canal is shown both by the cursor on the tooth

icon and by numerical value on the graphical scale. ProPex

®

II emits audible

information of file progression via a series of progressive rate beeps. If the bar

graph makes sudden large movements in the upper part of the canal, continue

slightly towards the apex so the signal returns to normal.

Warning: The scale indication on the ProPex

®

II screen does not represent a

distinct length or distance in mm or other linear units. It simply indicates

the file progression towards the apex.

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2) Apical Zone

The apical zone is divided into 10 segments graduated from 0.9 to 0.0 (apex) as

visual information of file progression.

When the apex is reached, the cursor shows “APEX” and a solid tone is emitted.

Beginning of Apical

Zone

Middle of Apical Zone

A

pical position

Note: As a safety precaution in order to avoid over-instrumentation, it is

recommended to proceed as follows: place the fill onto an endodontic ruler

at the point where the ProPex

®

II indicates ‘APEX’. Subtract a minimum of

0.5 mm from the measured file length.

3) Over-instrumentation

A red segment and a warning signal indicate that the file has passed the Apex. The

cursor on the tooth icon shows “OVER”.

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F. Sound Adjustment

ProPex

®

II is equipped with a sonic indicator which enables monitoring of the

progression of the file within the canal.

This function, in conjunction with the display of progression, enables working "blind"

while still monitoring the progression of the file.

The volume can be adjusted to one of four levels: mute, low, normal and high, by

successive presses on the volume key.

G. Demo Mode

The built-in Demo mode is available to become acquainted with the device and to

demonstrate its operation.

1. Disconnect the measuring cable or the charger from the device if

connected and turn Off the device.

2. To start Demo Mode, press and hold the (On/Off) button for about 2

second until the second beep sounds and “Demo” indication appears in the

bottom left corner of the display.

3. During Demo cycle device operating sequence is shown on the screen.

Press button to pause the simulation; press button again to resume.

4. When Demo cycle is completed, it is repeated automatically until

interrupted by the operator.

5. To exit Demo mode press button and hold it for about 2 sec. until a

beep sounds.

Note: If measurement cable is connected to ProPex

®

II during Demo cycle, the

device switches automatically to normal operation mode.

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H. Automatic Shutdown

ProPex

®

II automatically shuts down after 5 minutes without use. It is advisable,

however, to manually switch off equipment after measurement by simply pressing

the key (On/Off).

I. Maintenance of your ProPex

®

II

 The device does not contain user serviceable parts. The service and repair

should be provided by factory trained service personnel only.

 After each use, all the objects that were in contact with infectious agents should

be cleaned using towels impregnated with a disinfecting and detergent solution

(a bactericidal, fungicidal and aldehyde free solution). Use of chemical agents

may cause damage to the equipment. We recommend to use only a disinfecting

solution which is approved for its efficacy (VAH/DGHM-listing, CE marking, FDA

approval).

 Other recommendations:

- Do not expose ProPex

®

II to any liquid. In particular, avoid spilling with

chemical solutions used for treatment. These chemicals could cause damage,

deform or discolor the device. Be especially careful to avoid spilling formalin

cresol (FC) and sodium hypochlorite as they are quite aggressive. Wipe up

any chemical spills immediately (some chemicals may leave discoloration and

spots even if they are immediately wiped up).

- Handle the device carefully; do not drop, bump or expose the unit to any kind

of impact or shock. Rough handling could cause significant damage.

- Do not drop anything on or bang the measuring cable plug after it has been

inserted into the connector.

- ProPex

®

II must be stored in normal temperature (< 60°C) and humidity

conditions.

 Reprocessing procedure:

- The lip clip, the hook and the fork must be sterilized between treatments by

autoclaving at 134°C.

- The measuring cable cannot be autoclaved.

See the section "Disinfection, cleaning and sterilization procedure for the ProPex

®

II

accessories" for the detailed procedure.

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J. Warranty

ProPex

®

II is warranted for 24 months from the date of purchase. The accessories

(cables, battery etc.) are warranted for 6 months from the date of purchase.

The warranty is valid for normal usage conditions. Any modification or accidental

damage will render the warranty void.

K. Technical Specifications

ProPex

®

II complies to IEC60601-1 safety standard and the requirement of CE

Marking of Conformity.

ProPex

®

II electronic apex locator belongs to the following category of medical

devices:

- Internally powered equipment (2.4V NiMH rechargeable battery)

- Type BF applied parts

- Not suitable for use in the presence of flammable anesthetic mixtures with air,

oxygen or nitrous oxide

- Continuous operation

- Ingress of liquids – not protected

- Environmental conditions during transportation: temperature: –20ºC to +60ºC

- (0 to 140ºF); relative humidity: 10% to 90%, non-condensing

Technical specifications

Dimensions: 130 x 80 x 63 mm

Weight: 360 gr.

Type of screen: Color Graphic TFT

Screen dimensions: 3.5 “

Supply: 2.4V NiMH rechargeable battery

External charger: Input: 120 V / 50-60 Hz or 230V / 50-60 Hz

Output: 6V DC

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L. Standard symbols

On the device label appear standard symbols as follows:

Class II equipment

Type BF Applied part

Follow instructions for use

Direct current

Recycling : PLEASE DO NOT THROW AWAY! This product and all

its components must absolutely be recycled through your supplier

.

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7. Disinfection, cleaning and sterilization procedure

for the ProPex

®

II accessories

Foreword

The lip clip, the hook and the fork must be cleaned, disinfected and sterilized before

each use to prevent any contamination. This concerns the first use as well as the

subsequent uses.

General recommendations

 The user is responsible for the sterility of the product for the first cycle and

each further usage as well as for the usage of damaged or dirty instruments.

 For your own safety, please wear personal protective equipment (gloves,

glasses, mask).

 Use only disinfecting solution which is approved for their efficacy (VAH/DGHM-

listing, CE marking, FDA approval)

Procedure for lip clip, hook and fork

Operation Operating mode Warning

1. Pre-

Disinfection or

Decontaminati

on

- Soak immediately just

after usage all

instruments in a

disinfectant solution

combined with proteolytic

enzyme if possible.

- Follow instructions and observe

concentrations and immersion

time given by the manufacturer

(an excessive concentration may

cause corrosion or others defects

on instruments).

- The disinfectant solution should

be aldehyde free (to avoid blood

impurities fixation).

- Do not use disinfectant solution

containing Phenol or any products

which are not compatible with the

instruments (See general

recommendation).

- For visible impurities that are

observed on instruments, a pre-

cleaning is recommended by

brushing them manually with soft

material.

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Operation Operating mode Warning

2. Rinsing - Rinse manually and

abundantly the

accessories with current

water

3. Manual

Cleaning

- clean manually the

accessories with an

adequate brush,

preliminary soaked in a

clean pre-disinfectant

solution

- the hook mechanism has to be

activated during the cleaning

process (press several times the

push button)

- no visible impurities should be

observed on the accessories

4. Rinsing See point # 2

5. Disinfection - Immerse the

accessories in a

disinfectant solution

(bactericidal, virucidal,

fungicidal, tuberculocidal

and aldehyde free)

according to the

manufacturer

recommendations

- Follow instructions and observe

concentrations and time given by

the manufacturer

6. Final rinsing - See point # 2

- After rinsing, the

accessories have to be

dried.

7. Inspection - Inspect devices and sort

out those with defects.

- Dirty instruments must be

cleaned and disinfected again.

8. Packaging - Pack the devices in

“Sterilization pouches”.

- Check the validity period of the

pouch given by the manufacturer

to determine the shelf life.

- Use packaging which are

resistant up to a temperature of

141°C (286°F) and in accordance

with EN ISO 11607.

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