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Content

Scope of Ultra X ..............................................................................................

Parts Identification ....................................................................................

Components and Accessories ..................................................................

Symbols Used .................................................................................................

Before Use .......................................................................................................

Scope of application ..................................................................................

Contraindications ......................................................................................

Setting up the Ultra X .....................................................................................

Installing the sleeve ..................................................................................

Installing the tip .........................................................................................

Tip Removal ..............................................................................................

Connecting the adapter.............................................................................

Use Interface ...................................................................................................

Panel key ..................................................................................................

Operation .........................................................................................................

......................................................................................................

Operation ..................................................................................................

Cleaning, Disinfection and Sterilization .......................................................

Foreword ...................................................................................................

General recommendations........................................................................

Autoclavable Components ........................................................................

Disinfection components ...........................................................................

Error Warning..................................................................................................

Troubleshooting .............................................................................................

Technical Data ..............................................................................................

EMC Tables ....................................................................................................

Statement ......................................................................................................

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Содержание 6251001

Страница 1: ...0197 Ultra X Ultrasonic Endo Activation Device USER MANUAL Changzhou Sifary Medical Technology Co Ltd...

Страница 2: ...007 2021 04 30 1 2 2021 06 10 2021 06 11 2021 06 21 3 2021 06 22 03 DCR 2020 009 20200629 04 DCR 2020 018 20200910 05 DCR 2020 023 20201202 06 DCR 2021 006 20210324 07 DCR 2021 011 3 2 10 Version 07...

Страница 3: ...cations Setting up the Ultra X Installing the sleeve Installing the tip Tip Removal Connecting the adapter Use Interface Panel key Operation Operation Cleaning Disinfection and Sterilization Foreword...

Страница 4: ...ettavaan tekstiin Virhe M rit Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Page 4 39 Scope of Ultra X Parts Identification 2 5 1 3 4 6 Accessories list 1 Tips 6pcs 2 Wrench 3...

Страница 5: ...ents and Accessories Ultra X handpiece 1pcs ORDER CODE 6251001 Tip SBG20 1pcs ORDER CODE 6251127 S20 6201032 B20 6251031 G20 6251021 Tip SBG25 1pcs ORDER CODE 6251129 S20 6201032 B25 6251033 G25 62510...

Страница 6: ...ols Used Warning If the instructions are not followed properly operation may lead to hazards for the product or the user patient NOTE Additional information explanation of operation and performance Se...

Страница 7: ...n tekstiin Page 7 39 Keep dry Consult instructions for use 134 C Sterilizable in a steam sterilizer autoclave at the temperature specified Authorized Representative in the European Community 55 C 20 C...

Страница 8: ...utcomes and reduces retreatment rate 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 Contrain...

Страница 9: ...ical Equipment in the hospital Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the...

Страница 10: ...Virhe M rit Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Virhe M rit Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Page 10 39...

Страница 11: ...carefully NOTE Only the original tip can be used The Activator tips are not sterile when deliver and must be When you set the tip on the device the tip can be set within a range of 10 therefore do no...

Страница 12: ...tekstiin Page 12 39 autoclaved before being used for the first time Clean and disinfect the Activator tips before every use Tighten the tip clockwise with provided wrench until the tip secure Warning...

Страница 13: ...he handpiece power connector and plug the other end into a power outlet The Power LED on the handpiece will flash yellow NOTE Only the original adapter can be used Do not use the device while charging...

Страница 14: ...Virhe M rit Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Virhe M rit Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Page 14 39 Use Interface...

Страница 15: ...de LED Power LED Turn Power On Press to turn on the device Output Power Adjustment Long press can switch to High Output Power Mode or Low Output Power Mode during working HIGH OUTPUT POWER MODE LOW OU...

Страница 16: ...Battery power is 15 50 Power LED light up in RED Battery power is 15 NOTE If the power is less than 15 the device must be recharged within 30 days otherwise the battery will be damaged Power LED flas...

Страница 17: ...ry is fully charged or in a state near full charge the flash will stop and light up in GREEN Fully charged will take about 4 hours depending on residual battery power and battery state It can be recha...

Страница 18: ...ain switch to turn power on Power LED and Mode LED will light up NOTE Once the device is started it will vibrate at the ultrasonic frequency Do not touch the tip at this time Do not let the device vib...

Страница 19: ...tput and enters the standby state The Ultra X will shut down after 1 minute of standby automatically The Ultra X will automatically shut down after 3 minutes of continuous operation In addition the ma...

Страница 20: ...ttavaan tekstiin Page 20 39 NOTE If there is any abnormal functioning stop using the device and report to the company This device is not suitable for all types of root canals Do not use this device on...

Страница 21: ...imitation of the numbers of reprocessing procedures is therefore determined by the function wear of the device From the processing side there is no maximum number of allowable reprocessing The device...

Страница 22: ...device Do not use bleach or chloride disinfectant materials Autoclavable Components Autoclavable Components Tip Wrench Insulating sleeve Warning Only the components above can be autoclaved Before firs...

Страница 23: ...r any other special types of water or commercial cleaning liquids Such liquids may result in metal corrosion and adhesion of the residual medical agents to the components Transportati on Safe storage...

Страница 24: ...ing potential and industrial safety Automated Cleaning Carefully put the components into the washer disinfector on a tray and set the parameters as follows then start the program 4 min pre washing wit...

Страница 25: ...ation of national requirements in regards to A0 value see EN ISO 15883 A disinfection cycle of 5 min disinfection at 93 C has been validated for the device to achieve an A0 value of 3000 After manual...

Страница 26: ...until instrument is visibly clean Before packaging and autoclaving make sure that the components have been maintained acc to manufacturer s instruction Packaging Pack the instruments in an appropriate...

Страница 27: ...uirements Minimum requirements 3 min at 134 C in EU 5 min at 134 C Maximum sterilization temperature 137 C Drying time at least 8min Flash sterilization is not allowed on lumen instruments Warning Use...

Страница 28: ...environment at modest temperatures refer to label and instructions for use Warning Sterility cannot be guaranteed if packaging is open damaged or wet Check the packaging before using it packaging int...

Страница 29: ...ed by the manufacturer of the medical device as being capable of preparing a medical device for use It remains the responsibility of the processor to ensure that the processing as actually performed u...

Страница 30: ...ge 30 39 Disinfection components Handpiece Handpiece Base Adapter Wipe all the surfaces with a cloth lightly moistened with Ethanol for Disinfection Ethanol 70 to 80vol at least 2min repeat for 5 time...

Страница 31: ...uat k ytt t h n kirjoitettavaan tekstiin Page 31 39 Error Warning The device stops working and beeping with Power LED flashes in red The power is very low Charge it immediately Power LED lights up in...

Страница 32: ...er action has been taken the product may have failed Contact your distributor Problem Cause Solution Ref chap The power is not turned on The battery is run down Charge the battery 6 1 The time to pres...

Страница 33: ...board is broken Contact your distributor The LEDs on handpiece do not light up The handpiece is broken Contact your distributor Tip does not vibrate Tip is not installed in place Check the installatio...

Страница 34: ...1 5cmx10cmx10cm 1cm package Weight 680g 10 Power supply Lithium ion battery 3 7V 1500mAh 10 Charger power supply AC100 240V 10 Charger power output 5V 1A Frequency 50 60Hz 10 Charger nominal power inp...

Страница 35: ...it Aloitus v lilehdess 1 jota haluat k ytt t h n kirjoitettavaan tekstiin Page 35 39 non condensing at 0 Operating altitude 3000m above sea level Transport and storage conditions Ambient temperature 2...

Страница 36: ...ustomer or the user of the Ultra X should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Ultra X uses RF...

Страница 37: ...r s declaration electromagnetic immunity The Ultra X is intended for use in the electromagnetic environment specified below The customer or the user of the Ultra X should assure that it is used in suc...

Страница 38: ...ne 0 5kV 1kV Line to earth 0 5kV 1kV 2kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruption s and voltage variations on power supply lin...

Страница 39: ...ncy magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT rated voltage s E g 25 30 cycles means 25 cycles at 50Hz or 30 cycle...

Страница 40: ...communic ation equipment table in Recomm ended minimum separation distances 3 V Portable and mobile RF communications equipment should be used no closer to any part of the Ultra X including cables th...

Страница 41: ...le and meet the related requirements of IEC 60601 1 2 2014 The customer and or user should help keep a minimum distance between RF wireless communications equipments and the Ultra X as recommended bel...

Страница 42: ...specified or provided by the manufacturer of Ultra X could result in increased electromagnetic emissions or decreased electromagnetic immunity of Ultra X and result in improper operation Cable informa...

Страница 43: ...omponents 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 laws an...

Страница 44: ...Page 44 39 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 ivy...

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