Eighteeth AirPex User Manual

Apex locator

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AirPex

Apex locator USER MANUAL

Changzhou Sifary Medical Technology Co.,Ltd.

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Summary of Contents for Eighteeth AirPex

Page 1 AirPex Apex locator USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
Page 2 P/N: IFU- 6135002 Version: 05 Issued: October.8, 2023 Size: 96mm X 119mm...
Page 3: Table Of Contents
Content 1. Scope of AirPex ..................4 Parts Identification ..............4 Components ................5 2. Symbols used ..................8 3. Before Use .................... 10 Scope of application ............... 10 Contra-indications ..............10 4. Installing the AirPex ................12 Connecting file clip, lip hook, extension cord and clip ..12 Use of touch probe ..............
Page 4: Scope Of Airpex
Scope of AirPex 1. Scope of AirPex Parts Identification ○ Charge Base ○ APEX Locator ○ Lip Hook ○ Touch Probe ○ File Clip ○ Extension Cord ○ Adapter ○ Tester ○ Clip Page 4 / 51...
Page 5: Components
Scope of AirPex Components APEX Locator(1pcs) Charge Base (1pcs) Clip(1pcs) Part No. 6151002 Part No. 6151001 Part No.6151008 Lip Hook (2pcs) Touch Probe (1pcs) File Clip (2pcs) Part No. 6072002 Part No. 6151011 Part No. 6151003 Extension Cord (2pcs) Tester (1pcs) Part No.6151004...
Page 6 Scope of AirPex For different regions, there are several different adapter options to be selected as follows. Standard Adapter Power plug Adapter (1pcs) Part No: 6016018 European standard Adapter (1pcs) American standard power plug (1pcs) Part No: 6516003 Part No: 6016011...
Page 7 Scope of AirPex Australian standard power plug (1pcs) Part No: 6016010 Argentina standard power plug (1pcs) Part No:6016014 Page 7 / 51...
Page 8: Symbols Used
Symbols used 2. Symbols used General warning sign Caution Serial number Catalogue number Batch code Medical device Authorized representative in the European Community Manufacturer Country of manufacture Class II equipment Washer-disinfector for thermal disinfection Type B applied part Keep dry CE marking Page 8 / 51...
Page 9 Symbols used Dispose of in accordance with the WEEE directive Direct current Consult instructions for use Manufacturer‘s Logo Sterilizable in a steam sterilizer (autoclave) at the 134 C temperature specified Temperature limit Humidity limitation Atmospheric pressure limitation Page 9 / 51...
Page 10: Before Use
Before Use Before Use Scope of application AirPex is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
Page 11 (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the AirPex, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 12: Installing The Airpex
Installing the AirPex 4.Installing the AirPex Connecting file clip, lip When using the touch probe, connect the lip hook, touch probe, hook, extension cord and clip extension cord to APEX Locator as Connect file clip, extension cord shown in below picture.
Page 13: Connecting Charge Base
Installing the AirPex Connecting charge Put the APEX locator in the groove in the middle of the charge base. base The power LED on charge base will Plug the USB of adapter into the light up. And the interface of APEX...
Page 14: Use Interface
Use Interface 5.Use Interface Turn Power On/Off Press to turn on. Long press more than 2 seconds, or no operation for 3 minutes to turn off. Volume control During standby state, shot press to cycle the volume through the minor to the maximum. Setting the reference point During standby state, press to set the...
Page 15: Operation
Operation 6.Operation Charge Display present remaining amount of the battery. Less than 15% remains, please charge.  If the power is less than 15%, the device must be recharged within 30 days, otherwise the battery will be damaged. Page 15 / 51...
Page 16 Operation Charging indication appears on the screen, and flashes slowly, when battery is fully charged or in a state near full charge, the flash will stop. It takes about 4-5 hours for full charge, depending on residual battery power and battery state. It can be recharged 300-500 times, depending operating...
Page 17: Function Checking Of Apex Locator
Operation Function checking of APEX locator  After turning on, insert the tester into the APEX locator.  Clamp the groove of tester with file clip or touch the groove of tester with touch probe.  The measuring bar flashes at the point when the displayed measured value is 02, 03 or ...
Page 18 Operation  Before each use, make the file clip touch the lip hook, or use the touch probe to touch the lip hook to confirm the device condition (short circuit).  Make sure that the tester is not installed on the APEX locator.
Page 19: Operation And Not Suitable Condition
Operation Operation and not suitable condition  Press the back cover of the file clip to make the hook of the file clip stick out. And hook the metal handle of the root canal file. Release the pressure and use the elasticity of the file clip to complete the connection between the file clip and the dental file.
Page 20 Operation  Hook the lip hook to the patient's lip. Make sure that the lip hook contacts with the lip fully. Then slowly insert the root canal file into the prepared root canal.  If the patient is fitted with a metal crown or other conductive device, the root canal file and the metal part of file clip should not be in contact with it, to avoid causing wrong...
Page 21 Operation foramen is about 2mm at this time. Meanwhile, the APEX locator makes a "didi" alarm sound at a long interval. Fig.1  When displayed as shown in figure 2, it means that the distance from the apical foramen is close, about 1.5 mm, and the time interval of "di~di~"...
Page 22 Operation which is the Minor/Physiological apical foramen prepared for root canal.  The value of the reference distance is only an estimated value, not a clinical basis. Fig.3  The measured value does not represent the distance. It simply indicates the file progression towards the apex.
Page 23 Operation Root canal with a large apical foramen The root canal cannot be accurately measured because of the lesion or incomplete development of the apical foramen. The results may show that the length measured is shorter than the actual one. Root canal blood overflow from the opening If blood spills from the root opening and contacts the gums, it will cause leakage of electricity, which...
Page 24 Operation Broken crown If the crown is broken, a segment of the gingival tissue enters the lumen, and the contact between the gingival tissue and the root file causes electrical leakage, which cannot be accurately measured. In this case, the appropriate material should be used to isolate the gingival tissue.
Page 25 Operation Crown or metal prosthesis that touches gingival tissue Accurate measurement cannot be obtained if the file touches a mental prosthesis that is touching gingival tissue. In this case, widen the opening at the top of the crown so that the file will not touch the mental prosthesis before taking a measurement.
Page 26 Operation Blocked canal The meter will not run if the canal is blocked. Opening the canal all the way to the apical construction to measure Extremely dry canal If the canal is extremely dry, the meter may not work until it is quite close to the apex.
Page 27 Operation The X-ray photo shows that the actual apex of the root canal is not the same as the anatomic end. In fact, the apical foramen is located at the coronal end. in this case, X-ray may indicate that the file needle has not reached the apical foramen, even if it has actually reached the apical foramen.
Page 28: Cleaning, Disinfection And Sterilization
Cleaning, Disinfection and Sterilization 7.Cleaning, Disinfection and Sterilization Foreword For hygiene and sanitary safety purpose, the file clip, lip hook, touch probe and extension cord must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well use the subsequent uses.
Page 29 Cleaning, Disinfection and Sterilization  For your own safety, please wear personal protective equipment (gloves, safety glasses, etc.).  Use only a disinfecting solution which is approved for its efficacy (VAH/DGHM-listing, CE marking, and FDA approval) and in accordance with the DFU of the disinfecting solution manufacturer. ...
Page 30 Cleaning, Disinfection and Sterilization Preparation at the Point of Use: Disconnect the components (Lip hook, file clip, touch probe and extension cord) from the main unit. Remove gross contaminations from the components with code water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°...
Page 31 Cleaning, Disinfection and Sterilization Pre-Cleaning: Do a manual pre-cleaning, until the components are visually clean. Submerge the components in a cleaning solution. Clean the surfaces with a soft bristol brush. Cleaning: Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety.
Page 32 Cleaning, Disinfection and Sterilization required for these devices. If a manual reprocessing method has to be used, please validate it prior to use.  Use only approved washer-disinfectors according to EN ISO 15883, maintain and calibrate it regularly.  Follow instructions and observe concentrations given by the manufacturer (see general recommendations).
Page 33 Cleaning, Disinfection and Sterilization Functional Testing, Maintenance: Visual inspection for cleanliness of the components and reassembling. Functional testing according to instructions of use. If necessary, perform reprocessing process again until the component is visibly clean. Before packaging and autoclaving, make sure that the device has been maintained acc.
Page 34 Cleaning, Disinfection and Sterilization EN 285.  Use a validated sterilization procedure according to EN ISO 17665.  Respect the maintenance procedure of the autoclave device given by the manufacturer.  Use only this recommended sterilization procedure.  Control the efficiency (packaging integrity, no humidity, color change of sterilization indicators, physicochemical integrators, digital records of cycles parameters).
Page 35 Cleaning, Disinfection and Sterilization Reprocessing validation study information: The above-mentioned reprocessing process (cleaning, disinfection, sterilization) has been successfully validated. Refer to test reports: Cleaning Disinfection Validation Report No. RDS2020D0063 001 Sterilization Validation Report No. RDS2020S0067 001 and RDS2020S0066 001  The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use.
Page 36 Cleaning, Disinfection and Sterilization Disinfection components APEX locator Charge Base Adapter Tester Clip Wipe all the surfaces with a cloth lightly moistened with Ethanol for Disinfection (Ethanol 70 to 80 vol%) at least 2min, repeat for 5 times.  Do not use anything except Ethanol for Disinfection (Ethanol 70 to 80 vol%).
Page 37: Troubleshooting
Troubleshooting 8.Troubleshooting When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor. Problem Cause Solution...
Page 38: Technical Data
Technical Data 9.Technical Data Manufacturer Changzhou Sifary Medical Technology Co.,Ltd Model AirPex Dimensions 13cm x 11cm x 8cm±1cm (package) Gross weight 0.35kg±10% Li-Polymer Battery: 3.7V, 110mAh, ±10% Power supply European standard Model: DJ-0500100-A5 Adapter Input: AC 100-240 V,50/60Hz,0.4Amax Output: DC 5V/1A...
Page 39 Technical Data Operation mode Continuous operation Use: in enclosed spaces Ambient temperature: 10° C ~ 40 ° C Operation conditions Relative humidity: 30%~75% Atmospheric pressure: 70kPa~106kPa Ambient temperature: -20 ° C ~ +55 ° C Transport and Relative humidity: 20% ~ 80 % storage conditions Atmospheric pressure: 70kPa~106kPa Page...
Page 40: Emc Tables
Guidance and manufacturer’s declaration – electromagnetic emissions The AirPex is intended for use in the electromagnetic environment specified below. The customer or the user of the AirPex should assure that it is used in such an environment. Electromagnetic environment -...
Page 41 Guidance and manufacturer’s declaration – electromagnetic immunity The AirPex is intended for use in the electromagnetic environment specified below. The customer or the user of the AirPex should assure that it is used in such an environment. Immunity test IEC 60601...
Page 42 EMC Tables Electrical fast ±2kV ±2kV Mains power quality transients/bursts 100kHz 100kHz should be that of a IEC 61000-4-4 repetition repetition typical commercial frequency frequency or hospital environment. Surge Line to line: Line to line: Mains power quality IEC 61000-4-5 ±0.5kV, ±0.5kV, ±1kV should be that of a...
Page 43 EMC Tables Voltage dips Mains power quality IEC 61000-4-11 should be that of a 0% UT; 0.5 0% UT; 0.5 typical commercial cycle cycle or hospital at 0° , 45° , 0° , 45° , environment. If the 90° , 135°...
Page 44: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
EMC Tables Guidance and manufacturer’s declaration – electromagnetic immunity The AirPex is intended for use in the electromagnetic environment specified below. The customer or the user of the AirPex should assure that it is used in such an environment. Electromagnetic...
Page 45 The AirPex has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2020. The customer and/or user should help keep a minimum distance between RF wireless communications equipments and the AirPex as recommended below.
Page 46 EMC Tables modulation 18Hz GMRS 430- ± 5 kHz deviation 1 kHz sine Pulse 704- Band modulation 217Hz 800/90, TETRA 800, Pulse 800- iDEN modulation 820, 18Hz CDMA 850, Band 5 1720 1800; 1845 CDMA 1900; Pulse 1700- 1900; modulation 1990 DECT;...
Page 47 5785 Guidance and manufacturer’s declaration – electromagnetic immunity The AirPex is intended for use in the electromagnetic environment specified below. The customer or the user of the AirPex should assure that it is used in such an environment. – Proximity...
Page 48 Unshielded 2 set cable  Use of AirPex adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, AirPex and the other equipment should be observed to verify that they are operating normally.
Page 49 EMC Tables safe with regard to electromagnetic disturbances throughout the expected service life. Page 49 / 51...
Page 50: Statement
Statement 11.Statement Service Life The service life of AirPex series products is 3 years. It is recommended that the equipment be checked and repaired at the dealer once a year. Maintenance MANUFACTURE will provide circuit diagrams, component part lists, descriptions,...
Page 51 Changzhou Sifary Medical Technology Co., Ltd. Add: No.99 Qingyang Road, Xuejia County, Xinbei District Changzhou city,213000 , Jiangsu, P.R. China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: info@sifary.com Web: www.sifary.com Caretechion GmbH Tel: +49 211 2398 900 Add: Niederrheinstr. 71, 40474 Dü sseldorf, Germany Email: info@caretechion.de All rights reserved.

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6151002