Eighteeth Fast-Fill User Manual Download Page 6

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Błąd! Użyj karty Narzędzia główne, aby zastosować

标题

1 do tekstu, który ma się tutaj pojawić.

Błąd! Użyj karty Narzędzia główne, aby zas

tosować

标题

1 do tekstu, który ma się tutaj pojawić.

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2. Symbols used in the User Manual

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.

Serial number

Catalogue number

Manufacturer

Date of manufacture

LOT

Lot of manufacture

Class II equipment

Type B applied part

CE marking

Direct current

WEEE directive marking

Keep dry

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%

Humidity limitation

106kPa

70kPa

Atmospheric pressure limitation

Manufacturer’s LOGO

Consult instructions for use

Summary of Contents for Fast-Fill

Page 1: ...0197 Fast Fill USER MANUAL ...

Page 2: ......

Page 3: ...ta percha 11 4 2 Installation of Cartridge 11 4 3 Installation of adapter 12 4 4 Connecting charge base 12 5 Use Interface 13 6 Setting 15 6 1 Memory Parameter Setting 15 6 2 Advanced Setting 16 7 Operation 17 7 1 Charge 17 7 2 Heating and Using 18 7 3 Changing Gutta percha 19 8 Maintenance 21 8 1 Daily cleaning 21 8 2 Changing silver tube of cartridge 22 8 3 Cleaning Disinfection and Sterilizatio...

Page 4: ...ma się tutaj pojawić Błąd Użyj karty Narzędzia główne aby zas tosować 标题 1 do tekstu który ma się tutaj pojawić Page 4 37 1 Scope of Fast Fill 1 1 Parts Identification 1 2 3 4 6 5 1 Charge Base 2 Handpiece 3 Cartridge nut 2PCS 4 Silver tube 2PCS 5 Adapter 6 Bending Tool ...

Page 5: ...ll Handpiece 1pcs Part No 6351002 Charge Base 1pcs Part No 6351003 Adapter 1pcs Part No 6316001 6316005 Cartridge nut 2pcs Part No 6351207 Bending tool 1pcs Part No 6351010 Silver tube 1pcs Size 25Ga Color Black Part No 6351208 Disposable Silver tube 1pcs Size 23Ga Color Natural Part No 6351209 Disposable 1 3 Options sold separately Silver tube 1pcs Size 20Ga Color Black Part No 6351211 Disposable...

Page 6: ...er patient NOTE Additional information explanation of operation and performance Serial number Catalogue number Manufacturer Date of manufacture LOT Lot of manufacture Class II equipment Type B applied part CE marking Direct current WEEE directive marking Keep dry 134 C Can be autoclaved up to a maximum temperature of 134 Celsius Authorized Representative in the European Community 55 C 20 C Tempera...

Page 7: ...Narzędzia główne aby zastosować 标题 1 do tekstu który ma się tutaj pojawić Błąd Użyj karty Narzędzia główne aby zas tosować 标题 1 do tekstu który ma się tutaj pojawić Page 7 37 Washer disinfector for thermal disinfection ...

Page 8: ...ds 2 Do not expose the device to direct or indirect heat sources The device must be operated and stored in a safe environment 3 The device requires special precautions with regard to electromagnetic compatibility EMC and must be installed and operated in strict compliance with the EMC information In particular do not use the device in the vicinity of fluorescent lamps radio transmitters remote con...

Page 9: ...Błąd Użyj karty Narzędzia główne aby zastosować 标题 1 do tekstu który ma się tutaj pojawić Błąd Użyj karty Narzędzia główne aby zas tosować 标题 1 do tekstu który ma się tutaj pojawić Page 9 37 ...

Page 10: ...j karty Narzędzia główne aby zastosować 标题 1 do tekstu który ma się tutaj pojawić Błąd Użyj karty Narzędzia główne aby zas tosować 标题 1 do tekstu który ma się tutaj pojawić Page 10 37 4 Installing the Fast Fill ...

Page 11: ...dge Screw the cartridge along the thread of the handpiece to install The needle on cartridge cannot be turned or bended by hand Use bending tool to bend the needle Use bending tool with the hexagonal hole matched to rotate the needle Unscrew the cartridge from the handpiece to disassemble WARNING To remove the cartridge As shown in the picture touch the flow heater with finger rapidly make sure it...

Page 12: ...ter into the charge base and plug the other end into a power outlet The Power LED on charge base will light up in green NOTE Only the original adapter could be used Put the handpiece all the way into the charge base The charge state will show on the screen NOTE Put the handpiece into the charge base in the right direction otherwise the handpiece will not be charged If only need a base to put the d...

Page 13: ...ory Parameter Setting During standby state holding down press more than 2 seconds to enter memory parameter setting Parameter T1 to T3 can be set independently Press till target setting press to adjust then press to confirm Heating During standby state shot press and the indicator light flashes Stop heating During heating state shot press Pushing out Gutta percha When the heating is completed the ...

Page 14: ...a główne aby zastosować 标题 1 do tekstu który ma się tutaj pojawić Błąd Użyj karty Narzędzia główne aby zas tosować 标题 1 do tekstu który ma się tutaj pojawić Page 14 37 till target setting press to adjust then press to confirm ...

Page 15: ...ory holding down press in 2 seconds the Temperature of this memory can be changed Press till target temperature the temperature can be set from 100 to 200 Press to confirm and enter next interface The Push Speed of this memory can be changed Press till target speed the speed can be set Low Mid High Press to confirm and enter next interface The Change GP can be chosen Confirm the Gutta percha need ...

Page 16: ... adjust the auto power off time can be set to 5 10 and 15 minutes Press to confirm and enter next interface Beep Volume Vol 1 The Beep Volume can be changed Press to adjust The Beep Volume can be set to 0 1 and 2 Press to confirm and enter next interface RestoreSettings NO YES The RestoreSettings can be changed Press to adjust press to confirm and enter next interface NOTE If choose YES all the se...

Page 17: ... connect adapter to handpiece directly the charge state will show on the screen Charge with charge base is recommended See chapter 4 4 Connecting charge base NOTE Only the original adapter could be used Do not use the handpiece during the charging 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 Fully char...

Page 18: ...ing Shot press to heat the cartridge during standby state NOTE Push out insufficiently warmed Gutta percha about 10mm before each use The LED flashes in blue slowly during heating When up to target temperature the flash will stop and stay in blue WARNING If the handpiece is not operated for a long time after the heating completed press to stop heating Do not place the heated cartridge in the root ...

Page 19: ... light of direction flashes 2 the residual Gutta percha bar will change according Press to exit and return to standby interface NOTE If there is a little residual Gutta percha in handpiece or cartridge tighten the cartridge again to prevent leak Gutta percha after heating If there is too much residual Gutta percha in handpiece or cartridge please refer to daily cleaning process Please use good mob...

Page 20: ...n and position of push rod display on the screen The push rod needs returning to original position This operation needs about 50 seconds Finally when the push rod is back to original position Please insert GP will display on the screen Press any key to exit and return to standby interface NOTE During this state press can stop and return to standby interface After pushing the Gutta percha bar into ...

Page 21: ... remove the cartridge NOTE A small amount of Gutta percha residue have no effect of function Clean the residue inside the cartridge needle with medical forceps Clean the overflow Gutta percha on the top of the handpiece with medical forceps When the medical forceps cannot get into the cavity to clean Heat the handpiece to about 150 then unscrew the Cleaning Nut with the bending tool NOTE Heating t...

Page 22: ...install the Cleaning Nut to the handpiece after cleaning is completed 8 2 Changing silver tube of cartridge The silver tubes of cartridge are single use only and should only be used on one patient It can be replaced according to the following steps Cut the broken silver tube from the step where the arrow indicates with knife Push out the silver tube with the bottom plane of the bending tool Unscre...

Page 23: ...e 23 37 As shown push out the silver tube completely with the cleaning rod Insert the new silver tube as shown in the figure NOTE Remove the protective cover before installation There are two different specifications of the silver tube Part number 6351208 size silver tube 25Ga Part number 6351209 size silver tube 23Ga Need to order from distributor Screw the cap into the cleaning rod ...

Page 24: ...l For hygiene and sanitary safety purpose the components cartridge and bending tool must be cleaned disinfected and sterilized before each usage to prevent any contamination This concerns the first use as well as the subsequent uses Comply with your national guidelines standards and requirements for cleaning disinfection and sterilization 8 3 2 General recommendations The user is responsible for t...

Page 25: ...artridge nut Bending Tool Silver tubes WARNING Only the components above can be autoclaved Before first use and after each use sterilize the above components STEP NO INSTRUCTIONS 1 Initial treatment at point of use Immediately after using wipe gross contaminations from the components and cut out the silver tube refer to Chapter 8 2 Changing silver tube of cartridge and put them in container for tr...

Page 26: ...neral recommendations Sufficient rinsing step should be available in purified water max 10 germs ml and max 0 25 endotoxin units ml Avoid any contact between the cartridge nut and any instrument kit support or container Make sure the components are dry before moving to the 6 step 3 Cleaning Automated Carefully put the components Cartridge nut and Bending Tool into the washer disinfector and set th...

Page 27: ...ure according to 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 The sterilization procedure must comply with ISO 17665 Waiting for cooling bef...

Page 28: ...aj pojawić Page 28 37 actually performed using equipment materials and personnel in the processing facility achieves the desired result This requires verification and or validation and routine monitoring of the process Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences ...

Page 29: ...ill Handpiece Charge Base Adapter Handpiece Base 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 NOTE Do not use anything except Ethanol for Disinfection Ethanol 70 to 80 vol Do not use too much ethanol as it s going into machine and damage the components inside Do not spray any liquid directly on the handpiec...

Page 30: ...g adapter Use the original adapter 4 3 The adapter is not connected Check the connection 4 3 The plug of the adapter is not inserted into the outlet Check the connection There is no electricity in the outlet Check the connection No charge indicator flash on handpiece screen Put the handpiece into the charge base in the wrong direction Check the direction 4 4 Charge pin of charge base is unable to ...

Page 31: ... 8mm Length 14mm 16mm Applicable temperature 100 200 Weight 1 1kg 10 Power supply Lithium ion battery 3 7V 2600mAh 10 Charger power supply AC 100 240 V 10 Charger power output 6V 3A Frequency 50 60Hz 10 Temperature 100 200 Electrical safety class Class II Applied part B Operating conditions Use in enclosed spaces Ambient temperature 5 C 40 C Relative humidity 80 Operating altitude 3000m above sea ...

Page 32: ...sions CISPR 11 Class B The Fast Fill is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic im...

Page 33: ...90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles sine phase at 0 0 UT 250 300 cycle Mains power quality 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 uninterruptible power supply or a battery Rated Power frequency magnetic field IEC 61...

Page 34: ...mmunication equipment table in Recommended minimum separation distances Radiated RF EM fields IEC 61000 4 3 3V m Proximity fields from RF wireless communication equipment Complies IEC 61000 4 3 Recommended minimum separation distances Nowadays many RF wireless equipments have being used in various healthcare locations where medical equipment and or systems are used When they are used in close prox...

Page 35: ...0 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation 217Hz 0 2 0 3 9 5500 5785 WARNING 1 Use of accessories and cables other than those specified or provided by the manufacturer of Fast Fill could result in increased electromagnetic emissions or decreased electromagnetic immunity of Fast Fill and result in impr...

Page 36: ...ecycled Metal parts of the device are disposed as scrap metal Synthetic materials electrical 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 laws and regulation Rights All rights of modifying the product are reserved to the manufacturer without further n...

Page 37: ...hou 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 ivy sifary com Web www eighteeth com Llins Service Consulting GmbH Tel 49 175 4870819 Add Obere Seegasse 34 2 69124 Heidelberg Germany Email Llins Service gmail com Version 02 IFU 6335104 Issued 2019 11 11 All rights reserved...

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