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Dentsply Sirona Propex IQ, Directions For Use Manual

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Dentsply Sirona Propex IQ Directions For Use Manual Download Page 48

Technical Characteristics

48/74

BENPPIQDFUWEB / Rev.04 / 08-2018

8

TECHNICAL CHARACTERISTICS

Specification

Description

Manufacturer

Maillefer Instruments Holding Sàrl

 

Chemin du Verger 3

 

CH-1338 Ballaigues

 

Switzerland

Telephone  +41 21 843 92 92
Fax 

+41 21 843 92 93

[email protected]
dentsplysirona.com

Model

Propex IQ

®

 Apex Locator

Dimensions

Length: 75 mm
Width: 46 mm
Height: 20 mm

Cable length

•

Charger cable: 2 m

•

Propex IQ

®

 and 

X-Smart IQ

®

 

Measurement cables: 1.3 m

•

Propex IQ

®

 File clip FCA: 0.15 m

Weight

80 g (0.18 lbs)

Material

User control panel:
Polyester PVS-F

Housing:
ABS plastic

Cables:
TPE, silicone, TPV

Propex IQ

®

 File Clip:

Glass filled nylon

Propex IQ

®

 Lip Clip:

Stainless steel
Screws:
Stainless steel

Summary of Contents for Propex IQ

Page 1: ...EN Propex IQ Apex Locator Directions for Use...

Page 2: ...2 74 BENPPIQDFUWEB Rev 04 08 2018 PAGE INTENTIONALLY LEFT BLANK...

Page 3: ...IQ Apex Locator 21 6 5 1 General overview 21 6 6 Description of the LED Colors 22 6 7 Description of the Sounds 24 6 8 Plugging in the Propex IQ Measurement Cable 25 6 8 1 Plugging in the Propex IQ M...

Page 4: ...nd by Mode 40 6 12 Battery Care 41 6 12 1 Battery Replacement 42 7 Cleaning Disinfection and Sterilization 43 7 1 General 43 7 2 Cleaning Procedure 44 7 3 Disinfection 46 7 4 Sterilization of the File...

Page 5: ...be accessed at dentsplysirona com and is also available from Endo IQ App We strongly recommend that you periodically check this website for updates of this DFU The DFU is available in other languages...

Page 6: ...2 CONTRAINDICATIONS Read the following contraindications before use Do not use Propex IQ Apex Locator on patients wearing active implantable devices such as a heart pacemaker or defibrillator The use...

Page 7: ...an environment Place Propex IQ Apex Locator on a flat and stable surface if used without the clamp or firmly attached to the lab coat when used with the clamp Propex IQ Apex Locator must not be placed...

Page 8: ...Make sure the cables are not obstructed or have limited mobility Refer also to section 8 Technical Characteristics for general Environmental Conditions specifications Use of Propex IQ Apex Locator adj...

Page 9: ...y signals emitted by Propex IQ Apex Locator can be received If any irregularities with Propex IQ Apex Locator should occur during treatment switch it off consult Section 10 Troubleshooting or Contact...

Page 10: ...le This could result in severe electrical shock if they come into contact with an electrical source Follow instructions given in section 7 Cleaning Disinfection and Sterilization Battery Always use th...

Page 11: ...gnals Combined mode Propex IQ Apex Locator can be used in combined mode with X Smart IQ Handpiece Only use X Smart IQ Handpiece for working in combined mode Using Propex IQ Apex Locator with another H...

Page 12: ...sply Sirona Endodontics Customer Service for assistance Propex IQ Apex Locator does not contain user serviceable parts except batteries The service and repair should be provided by factory trained ser...

Page 13: ...esult in increased emissions or decreased immunity of the Propex IQ Apex Locator Use of Propex IQ Apex Locator adjacent to or stacked with other equipment should be avoided because it could result in...

Page 14: ...ake a second radiograph with an endodontic file in place at the selected working length 5 ADVERSE REACTIONS The use of Propex IQ Apex Locator is not recommended with patients allergic to metals see Se...

Page 15: ...roduct or the user patient Additional information explanation on operation and performance Suggestion or advice Specification Description iPad iPad Mini 2 iPad Mini 3 iPad Mini 4 iPad 6th gen iPad Pro...

Page 16: ...e components shown below and that all components are in good condition List of components with Dentsply Sirona Stock Keeping Unit Propex IQ Apex Locator B00PPIQ000000 supplied with rechargeable batter...

Page 17: ...ne sleeves are supplied separately Propex IQ Lip Clip x 5 B00PPIQ5ACLCL Propex IQ File Clip x 2 B00PPIQ2ACFCL Propex IQ Clamp B00PPIQCLAMP0 AC Adapter Plugs EU UK US ANZ and universal adapter B00PPIQ1...

Page 18: ...r country which can be installed on the back of the device with a screw included in the package The clamp can be installed with a standard flat slot drive screwdriver not included in the package Remov...

Page 19: ...and slide it downwards until it locks with a click Uncombined mode Combined mode Working only with Propex IQ Apex Locator Working with Propex IQ Apex Locator plugged to X Smart IQ Handpiece for shapi...

Page 20: ...dpiece sleeve shown on the illustration For cable connection see 6 8 1 Plugging in the Propex IQ Measurement Cable in uncombined mode For cable connection see 6 8 2 Plugging in the X Smart IQ Measurem...

Page 21: ...with your distributor for more information about the clamp if not included in the kit The illustration above might slightly differ from the actual product Connector for Propex IQ Measurement Cable X...

Page 22: ...is on Stand by LED flashing every 2 5 seconds with a color corresponding to battery status Battery status Device is charging LED flashing every second Device is sufficiently charged Enough autonomy f...

Page 23: ...ile progress information File progress information The color blue green flashing green red flashing varies according to the progression of the file in the root canal See 6 10 3 Working length determin...

Page 24: ...Handpiece Three longer beeps if the combination is lost See 6 10 5 Combined mode Device test Double beep when Propex IQ Apex Locator device test is successful Alternating beeps when Propex IQ Apex Lo...

Page 25: ...ment Cable in uncombined mode N Action A Insert Propex IQ Apex Locator inside its proprietary single use protective sleeve B Plug in the Propex IQ Measurement Cable 2 to Propex IQ Apex Locator 1 C Con...

Page 26: ...en the contra angle and the patient s mouth which might cause wrong readings on Propex IQ Apex Locator B Insert Propex IQ Apex Locator inside its proprietary single use protective sleeve C Plug in the...

Page 27: ...ent Cable 2 or 5 to Propex IQ Apex Locator 1 C Connect the Propex IQ Lip Clip 3 and the Propex IQ File Clip 4 or X Smart IQ Handpiece 6 to the Propex IQ or X Smart IQ Measurement Cable 2 or 5 Ensure t...

Page 28: ...g period of time or for troubleshooting reasons as per Section 10 Troubleshooting The Endo IQ App will guide you through the different steps of the device test See Endo IQ App User Manual 6 Step by St...

Page 29: ...sly C You can now unplug the Propex IQ External Tester from Propex IQ Apex Locator N Action Central LED will light up red and alternating beeps will be emitted simultaneously D Unplug the Propex IQ Ex...

Page 30: ...terminology is defined as follows N Description 1 Coronal and medial regions 2 Region coronal to the reference point for working length determination 3 Reference point for working length determinatio...

Page 31: ...ropex IQ Apex Locator on a patient the access cavity must be dried with a cotton pellet to prevent an electric short circuit through another canal However the canal being treated must be humid to allo...

Page 32: ...orking length determination This is the relevant position to determine the working length LED Solid green Sound Solid tone In combined mode the Apical Reverse function can be activated Refer to Endo I...

Page 33: ...touching the device with contaminated gloves to prevent contamination near the connector or underneath the clamp Apical foramen Major apical foramen or diameter passed over instrumentation Alarm condi...

Page 34: ...e 6 9 1 Closed loop test G Put the lip clip 3 on the patient s lip on the opposite site of the tooth to be treated H Insert the endodontic file 5 into the root canal and attach the file clip 4 to the...

Page 35: ...BENPPIQDFUWEB Rev 04 08 2018 35 74 Step by Step Instructions 1 2 3 3 4 5 6 Please note that the mandatory rubber dam is not shown in the schematic image below for clarity s sake...

Page 36: ...or in a single use Propex IQ Disposable Barrier Sleeve with the long end of the barrier sleeve at the top If the optional Propex IQ Clamp is used pull a second Propex IQ Disposable Barrier Sleeve over...

Page 37: ...Instructions 2 1 3 3 4 6 7 5 Please note that the mandatory rubber dam is not shown in the schematic image below for clarity s sake The Handpiece sleeve supplied in your country may look different fro...

Page 38: ...e rinsing solution blood or saliva creating wrong conductive path and incorrect length determination Dry the access cavity with a cotton pellet air blower Wait until any bleeding has stopped Gingival...

Page 39: ...is reached Retreatment blockage by old canal filling material residue impeding the conductive path and preventing normal device functioning Take a radiograph to re check and try to completely remove...

Page 40: ...ption Wake up action Device active ON OFF Standby LED emits a color corresponding to the battery status None Propex IQ Apex Locator ready to be used Stand by mode ON OFF Standby LED flashes and emits...

Page 41: ...It is recommended that you charge the device at the end of each day Charge the battery overnight after using Propex IQ Apex Locator The battery is fully charged after up to 6 hours of charging Always...

Page 42: ...located at the rear of Propex IQ Apex Locator and its cover is secured by two 6 lobe screws screw type KN6041 screwdriver type Torx T5 It is recommended to read section 3 Warnings Battery before readi...

Page 43: ...reprocessing these plugs You must consult the special Propex IQ Cleaning Disinfection and Sterilization Guide before proceeding with cleaning disinfection and sterilization Part Reprocessing steps Pr...

Page 44: ...gle use wipe or soft cloth soaked in cleaning fluid containing Alcohol Quaternary Ammonium active ingredients e g CaviWipes or CaviCide C For the Propex IQ Apex Locator clean the grooves and device sc...

Page 45: ...cleaning bath for the prescribed contact time e g CIDEZYME ENZOL Enzymatic Detergent Solutions Johnson Johnson Medical 0 8 for 1 minute make sure that the devices are fully immersed if necessary use a...

Page 46: ...Once the devices have been cleaned and inspected place them into the disinfection bath for the prescribed contact time Cidex OPA Johnson Johnson Medical 100 for 20 minutes the devices must be fully im...

Page 47: ...only Please note Do not exceed a sterilization temperature of 135 C 275 F and a sterilization duration of 18min Always observe the operating instructions of the manufacturer for your sterilizer especi...

Page 48: ...843 92 93 endo dentsplysirona com dentsplysirona com Model Propex IQ Apex Locator Dimensions Length 75 mm Width 46 mm Height 20 mm Cable length Charger cable 2 m Propex IQ and X Smart IQ Measurement c...

Page 49: ...60 Hz Nominal power output 5 5 VA Electrical safety class Class II Applied part BF Propex IQ File Clip and Propex IQ Lip Clip Protection against water ingress IP 20 Safety level in the presence of fl...

Page 50: ...ent iPad iPad Mini 2 iPad Mini 3 iPad Mini 4 iPad 6th gen iPad Pro 10 5 iPad Pro 12 9 2nd gen Endo IQ App Operating System iOS Refer to Endo IQ App User Manual EMC Tables See Appendix A Electromagneti...

Page 51: ...overable Charge Propex IQ Apex Locator see 6 12 Battery Care It the problem persists return the instrument to your service center Sound triple beep Device warning recoverable Connect to Endo IQ App fo...

Page 52: ...Q App User Manual 6 Step by Step Instructions Sound triple beep General firmware failure Connect to Endo IQ App for further information instructions See Endo IQ App User Manual 6 Step by Step Instruct...

Page 53: ...ce in combined mode Refer to Endo IQ App User Manual for any troubleshooting related to Bluetooth connection To perform a factory reset Dentsply Sirona requires that you reprocess the product before s...

Page 54: ...d the power socket is under tension switched ON if applicable Ensure that the original adapter is being used The battery is wrongly inserted The original battery has been replaced with a non original...

Page 55: ...ned mode ensure that the original X Smart IQ Contra angle is being used If in combined mode ensure that the endodontic file has been correctly inserted into the X Smart IQ Contra angle Clean the lip c...

Page 56: ...ld gutta percha intra canal medicament Endodontic file too narrow for large root canal Large lateral canal Deep caries provide a conductive path outside the canal Perforation Select a larger endodonti...

Page 57: ...ssfully stopped Direct contact between endodontic file and gingiva gingival proliferation i e in cases with fractured metal crowns Direct contact between endodontic file and metal restoration work cro...

Page 58: ...t start Possible causes Solutions Propex IQ External tester is not working properly Electronic malfunction Perform a factory reset Contact Dentsply Sirona Endodontics Customer Service X Smart IQ Handp...

Page 59: ...irmware of X Smart IQ Handpiece not up to date Ensure that X Smart IQ Handpiece firmware is the latest version available updated for Propex IQ Apex Locator feature Apical Reverse setting on the Endo I...

Page 60: ...ond the realm of repair such as claims for damages will not be covered This warranty does not include any compensation for direct or indirect personal injuries or material damage of any kind The custo...

Page 61: ...bly and disposal your device must not be contaminated and must have been completely reprocessed Refer to Section 7 Cleaning Disinfection and Sterilization 13 IDENTIFICATION OF SYMBOLS 13 1 Normative S...

Page 62: ...erature specified Opened packages are not replaced Temperature limit Humidity limitation Keep dry Fragile handle with care Accessory Use by date Do not steam sterilize Do not re use Caution Bluetooth...

Page 63: ...cial safety precautions and must be installed and placed in operation in accordance with the below EMC information Compliant Cables and Accessories Information about charger The charger must be used w...

Page 64: ...ions Propex IQ Apex Locator is intended for use in the electromagnetic environment specified below The customer or the user of Propex IQ Apex Locator should ensure that it is used in such an environme...

Page 65: ...ly lines Not applicable no input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to Line s mode 2 kV line s to earth 1 k...

Page 66: ...in a typical commercial or hospital environment Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer t...

Page 67: ...situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular c...

Page 68: ...Hz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 0 12 0 23 0 For transmitters rated at a maximum output power not listed abo...

Page 69: ...anufacturer s declaration electromagnetic emissions Propex IQ Apex Locator is intended for use in the electromagnetic environment specified below The customer or the user of Propex IQ Apex Locator sho...

Page 70: ...of their operation shall be tested at the frequency of reception Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS This test assesses the BASIC SAFETY...

Page 71: ...on frequency Pass Surges a b j o Line to line IEC 61000 4 5 0 5 kV 1 kV Pass Surges a b j k o Line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Pass Conducted disturbancesinduced by RF fields c d o IEC 61...

Page 72: ...cable only to ME EQUIPMENT and ME SYSTEMS connected to single phase a c mains h E g 10 12 means 10 periods at 50 Hz or 12 periods at 60 Hz i ME EQUIPMENT and ME SYSTEMS with RATED input current greate...

Page 73: ...ower input might cause an overcurrent protection device to open This can occur due to magnetic flux saturation of the transformer core after the voltage dip If this occurs the ME EQUIPMENT or ME SYSTE...

Page 74: ...BENPPIQDFUWEB Rev 04 08 2018 dentsplysirona com Maillefer Instruments Holding S rl Chemin du Verger 3 CH 1338 Ballaigues Switzerland endo dentsplysirona com dentsplysirona com 0086...

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