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11 Statement

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Changzhou Sifary Medcial Technology Co., Ltd

Add: NO.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City,

213000 Jiangsu, China

Tel: +86-0519-85962691

Fax: +86-0519-85962691

Email: [email protected]

Web: www.eighteeth.com

Llins Service & Consulting GmbH

Tel: +49 175 4870819

Add: Obere Seegasse 34/2, 69124, Heidelberg, Germany

：

[email protected]

Version: S01

IFU-6335101

Issued: 2019.12.02

Содержание AirPex

Страница 1: ...AirPex Apex locator USER MANUAL Changzhou Sifary Medical Technology Co Ltd...

Страница 2: ......

Страница 3: ...ntended Use 8 3 2 Contraindications 8 4 Installing the AirPex 10 4 1 Connecting file clip lip hook and extension cord 10 4 2 Connecting charge base 11 5 Use Interface 12 6 Operation 13 6 1 Charge 13 6...

Страница 4: ...1 Scope of AirPex Page 4 41 1 Scope of AirPex 1 1 Parts Identification 1 2 3 4 6 5 7 8 9 1 Charge Base 2 APEX Locator 3 Lip Hook 4 Touch Probe 5 File Clip 6 Extension Cord 7 Adapter 8 Tester 9 Clip...

Страница 5: ...o 6151002 Charge Base 1pcs Part No 6151001 Adapter 1pcs Part No 6516001 Lip Hook 2pcs Part No 6072002 Touch Probe 1pcs Part No 6101001 File Clip 2pcs Part No 6151003 Extension Cord 2pcs Part No 615100...

Страница 6: ...eration may lead to hazards for the product or the user patient NOTE Additional information explanation of operation and performance Serial number Catalogue number Manufacturer Date of manufacture LOT...

Страница 7: ...134 C Can be autoclaved up to a maximum temperature of 134 Celsius Authorized Representative in the European Community 55 C 20 C Temperature limitation 80 20 Relative humidity 106kPa 70kPa Atmospheric...

Страница 8: ...ther electrical equipment and has been cautioned against the use of small electrical appliances such as electric shavers hair dryers etc Safety and effectiveness have not been established in pregnant...

Страница 9: ...s 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 perfo...

Страница 10: ...rd and lip hook to APEX locator as shown in the picture Also use both extension cords according to actual situation NOTE Please use the original file clip and lip hook that manufactured by Sifary Beca...

Страница 11: ...TE Only the original adapter could be used Put the APEX locator in the groove in the middle of the charge base The power LED on charge base will light up And the interface of APEX locator will light u...

Страница 12: ...cle the volume through the minor to the maximum Setting the reference point During standby state press to set the reference point between 0 1 Seven points can be selected circularly The cursor flashin...

Страница 13: ...Operation 6 1 Charge Display the present remaining amount of the battery Less than 15 remains please charge NOTE If the power if less than 15 the device must be recharged within 30 days otherwise the...

Страница 14: ...Fully charged will take about 4 5 hours depending on residual battery power and battery state It can be recharged 300 500 times depending on the operating conditions of the device WARNING Do not chan...

Страница 15: ...measuring bar on the screen flashes at point 02 03 or 04 Recommend to test the APEX locator with tester once a week NOTE If the measurements are not expected check that the tester is connected proper...

Страница 16: ...hook and extension cord according to chapter 5 1 Finally touch the lip hook with exposed metal position on file clip the measurement on the screen should be shown as 2 NOTE If the measurement shown i...

Страница 17: ...the file clip and the root canal file handle are basically perpendicular otherwise the chuck of the file clip will be easily damaged This equipment does not include the root canal file We need to buy...

Страница 18: ...void causing wrong measurement results APEX locator should be fixed in patient s collar with the clip NOTE To prevent measurement errors caused by conduction between the gums or adjacent root canals d...

Страница 19: ...ed by the APEX locator becomes shorter When displayed as shown in figure 3 it means that it reaches the tip of the tooth root The measured value is 00 which is the actual length of the root canal to b...

Страница 20: ...al entry WARNING During measuring enter slowly to prevent piercing the tip of the root The APEX locator is used to determine the working length of the root canal In clinical use it must be combined wi...

Страница 21: ...ning If blood spills from the root opening and contacts the gums it will cause leakage of electricity which cannot be accurately measured Wait for the bleeding to stop completely Clean the root canal...

Страница 22: ...ed to isolate the gingival tissue Branch Crack The crack tooth Leakage through branch of the root canal Broken teeth can cause electrical leakage and cannot be accurately measured Branch tubes can als...

Страница 23: ...e crown so that the file will not touch the mental prosthesis before taking a measurement Debris Pulp Cutting debris on tooth Pulp inside canal Remove all cutting debris on the tooth Remove all the pu...

Страница 24: ...quite close to the apex In this case try to moisten the canal with oxydol or saline Difference measuring result between Apex locator reading and Radiography Sometimes the reading of the apex locator...

Страница 25: ...hat 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...

Страница 26: ...eaned and sterilized before every use Pre cleaning Use a soft brush or moist cloth to remove visible contaminations then wipe all the surfaces with a cloth lightly moistened with Ethanol for disinfect...

Страница 27: ...ion 10 minutes Storage Keep the components in sterilization packaging in a dry and clean environment WARNING Comply with your national guidelines standards and requirements for cleaning disinfection a...

Страница 28: ...all the surfaces with a cloth lightly moistened with Ethanol for Disinfection Ethanol 70 to 80 vol at least 2min repeat for 5 times NOTE Do not use anything except Ethanol for Disinfection Ethanol 70...

Страница 29: ...distributor Problem Cause Solution The power is not turned on The battery is flat Charge the battery Press the power switch too short time Long press the power switch No charge indicator flash on hand...

Страница 30: ...gy Co Ltd Model AirPex Dimensions 13cm x 11cm x 8cm 1cm Outer box Weight 0 35kg 10 Power supply Lithium ion battery 3 7V 120mAh 10 Charger power supply AC 100 240 V 10 Charger power output 5V 1A Frequ...

Страница 31: ...ting conditions Use in enclosed spaces Ambient temperature 5 C 40 C Relative humidity 80 Operating altitude 3000m above sea level Atmospheric pressure 70kPa 106kPa Transport and storage conditions Amb...

Страница 32: ...emissions CISPR 11 Group 1 The AirPex uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment...

Страница 33: ...act 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8 kV 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least...

Страница 34: ...should be that of a typical commercial or hospital environment If the user of devices require continued operation during power mains interruptions it is recommended that devices be powered form an uni...

Страница 35: ...ducted dis turbances induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands be tween 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 3 V Portable and mobile RF...

Страница 36: ...or systems are used When they are used in close proximity to medical equipment and or systems the medical equipment and or systems basic safety and essential performance may be affected The AirPex has...

Страница 37: ...710 704 787 LTE Band 13 17 Pulse modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 90 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 19...

Страница 38: ...785 WARNING 1 Use of accessories and cables other than those specified or provided by the manufacturer of AirPex could result in increased electromagnetic emissions or decreased electromagnetic immuni...

Страница 39: ...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...

Страница 40: ...rical components and printed circuit boards are disposed as electrical scrap The lithium batteries are disposed as special refuse Please deal with them according to the local environmental protection...

Страница 41: ...rict Changzhou City 213000 Jiangsu China Tel 86 0519 85962691 Fax 86 0519 85962691 Email ivy sifary com Web www eighteeth com Llins Service Consulting GmbH Tel 49 175 4870819 Add Obere Seegasse 34 2 6...

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