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Dentsply Sirona Propex IQ, Инструкция по применению

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Appendix A: Electromagnetic Emissions and Immunity

66/74

BENPPIQDFUWEB / Rev.04 / 08-2018

Power 
frequency

 

(50 / 60 Hz) 
magnetic field 
IEC 61000-4-8

3 A/m

30 A/m

Power frequency magnetic 
fields should be at levels 
characteristic of a location 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 to 

any part of the 

Propex IQ

®

 

Apex Locator, including 
cables, than the 
recommended separation 
distance calculated from the 
equation applicable to the 
frequency of the transmitter.

Recommended separation 
distance

150 kHz to 80 MHz

d

1.2

P

×

=

Содержание Propex IQ

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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