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Technical Data

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11.Technical Data

Manufacturer

Changzhou Sifary Medical Technology
Co., Ltd

Model

E-xtreme

Dimensions

17.5cm x 10.9cm x 8.4cm±1cm (Outer
box)

Weight

0.6kg±15%

Contra angle

Compatible with rotary and
reciprocating instruments, equipped
with 2.35mm nickel titanium root canal
file conforming to ISO 1797:2017, Type
1, Files length 11-31mm.

Power supply

Lithium ion battery: 3.7V, 800mAh, ±10%

Charger power supply

AC 100-240 V, ±10%

Charger power output

Frequency

50/60Hz，±1Hz

Charger nominal power
input

0.4A Max

Torque range

0.5 – 4.0N·cm

Speed range

120-650 rpm

Type of protection
against electrical shock

Class Ⅱ and internally powered
equipment

Applied part

Operation mode

Intermittent operation, working for 60
minutes / stopping for 5 minutes

Ingress Protection

IPX0

Operation conditions

Use: in enclosed spaces
Ambient temperature: 5°C ~ 40 °C
Relative humidity: <80%
Operating altitude < 3000m above sea
level

Содержание E-xtreme

Страница 1: ...Endo Motor USER MANUAL Changzhou Sifary Medical Technology Co Ltd E xtreme...

Страница 2: ...Version S02 IFU 6035009 S02 Issued Dec 10 2020 Size 160mm X 92mm...

Страница 3: ...1Intended Use 9 3 2Contraindications 9 4 Installing the E xtreme 11 4 1Installation of the contra angle 11 4 2Install the file 11 4 3Charging 12 4 4Install the Insulation Sleeve 13 5 Use Interface 14...

Страница 4: ...Motor Operation 30 8 Cleaning Disinfection and Sterilization 32 8 1Foreword 32 8 2General recommendations 32 8 3Autoclavable Components 33 8 4Disinfection Components 38 9 Error warnings 39 10 Troubles...

Страница 5: ...reme Page 5 52 1 Scope of E xtreme 1 1 Parts Identification 1 Contra Angle 2 Motor Handpiece 3 Handpiece Base 4 Insulating Sleeve optional 5 Spray Nozzle 6 Adapter Note This product does not contain r...

Страница 6: ...me Page 6 52 1 2 Components and Accessories Motor Handpiece 1pcs Handpiece Base 1pcs Contra Angle 1pcs Adapter 1pcs Spray Nozzle 1pcs USER MANUAL 1pcs Certificate 1pcs Warranty card 1pcs 1 3 Options I...

Страница 7: ...tion of operation and performance Serial number Catalogue number Manufacturer Date of manufacture LOT Batch number Safety class II device Type B applied part CE marking Direct current Dispose of in ac...

Страница 8: ...used in the User Manual Page 8 52 106kPa 70kPa Atmospheric pressure limitation Manufacturer s LOGO Consult instructions for use Be careful Refer to relevant documents Washer disinfector for thermal di...

Страница 9: ...o direct or indirect heat sources The device must be operated and stored in a safe environment 3 Do not use the equipment in the presence of free oxygen anesthetic gas or combustible materials The equ...

Страница 10: ...t during charging 10 If liquid flows out of the handpiece it can be judged as battery leakage Please stop using immediately and contact the local dealer for treatment 11 Do not dismount the contra ang...

Страница 11: ...is connected properly otherwise might cause unexpected motor reverse even hurt the patients 2 After connecting the contra angle and handpiece pull it gently to make sure the connection is good 4 2 In...

Страница 12: ...le press the button tightly to release the internal bayonet If the bayonet is not fully released the bearing will be damaged 5 Make sure the motor is stopped when inserting and removing files 4 3 Char...

Страница 13: ...13 52 4 4 Install the Insulation Sleeve Install assemble according to the left figure Remove pull out the cover in the opposite direction NOTE The insulating sleeve is ma inly used for secondary isol...

Страница 14: ...or wait 5 seconds to con firm Parameter Adjustment Press S till target parameters are displayed at standby mode press or to adjust then press or wait 5 seconds to confirm Preset Program Selection Long...

Страница 15: ...interface 1 Residual battery power 2 Speed 3 Unit of speed Revolutions Per Minute 4 Memory mode number 5 Torque 6 Unit of torque Newton Centimeter 7 Operation mode 500rp m Working mode interface 1 The...

Страница 16: ...rocation Be applied to reciprocating file path file and rotary file protection by setting some special angle Memory mode Such as M0 M9 Operation mode Such as Fwd Rev set in M1 M9 Reciprocation M0 TRQ...

Страница 17: ...own speed operation mode and torque These para meters can be set separately Adjust parameters according to chapter 6 2 M 0 180 30 M0 is a separate mode of recip rocating mode Including forwa rd angle...

Страница 18: ...h and then press or wait for 5 se conds to confirm the operation mode M 1 s T RQ SPEED 400 M 1 R D TORQUE 3 0 M 1 MEM DIR Fwd s s Rv F w s M 1 3 0 N cm 400 rpm M 1 3 0 N cm 400 RPM M 1 3 0 N cm 400 rp...

Страница 19: ...ss S at standby mode till sp eed is displayed press or to set then press or wait for 5 seconds to confirm T he left figure means after pr essing S again will enter torq ue TRQ setting M 1 R D TORQUE 3...

Страница 20: ...memory mode MEM NOTE When Rev operation mode is se lected a continuous alarm sound will appear after the device is started to remind the operator that the motor is in reverse rotation M 0 30 150 s s...

Страница 21: ...jump to the next page Then press to con firm Fw d 2 0N cm 300RPM One Flare One Shape One Curve If you select one of the preset program ms such as one curve the corr esponding operation mode speed and...

Страница 22: ...M 2 5N cm When the preset mode is selected the memory number will be changed to the preset name operation mode speed and torque will also be automatically set NOTE All memory modes from M1 to M9 can b...

Страница 23: ...to confirm and shut down The left figure means press S again will enter a uto set confirm time S T L R SET TIME 5 Sec Press S again at auto power off time set will enter SET TIME auto set confirm tim...

Страница 24: ...piece and the root canal file is not installed on the contra angle If the contra angle is not insta lled or non original contra angle is installed the torque after calibration may be incorrect which m...

Страница 25: ...6 Setting Page 25 52 parameters If necessary please reco rd the parameters before restoring th e factory settings...

Страница 26: ...e REC Fwd Fwd Fwd Fwd Fwd Rev Rev Fwd Fwd Speed rpm N A 350 300 400 400 300 350 500 500 650 Torque N cm N A 2 5 3 0 2 0 1 5 1 5 2 5 2 0 2 5 2 0 Fwd angle 30 N A N A N A N A N A N A N A N A N A Rev ang...

Страница 27: ...tion mode when the speed value is set differently See the table below for details Fwd Rev REC 0 5 0 8 1 0 1 5 1 8 2 0 2 2 2 5 3 0 3 2 3 5 4 0 There are 5 fixed values of reciprocating Angle in M0 reci...

Страница 28: ...me please charge the product at least once a month Low Power Please Charge If the battery power is lower than 15 the speed and to rque may be lower than the set value As shown in the left fig ure the...

Страница 29: ...lly charge the battery If the rema ining charge of the battery is different or the state of the ba ttery is different such as agi ng the charging time will be different According to the use state of t...

Страница 30: ...he correct operation parameters and methods 3 Even if the normal parameters are set due to the metal fatigue of the root canal file the instrument will be separated Therefore when using the root canal...

Страница 31: ...2 The root canal file is easy to fracture at high speed Please follow the rotation speed recommended by the manufacturer Please check the set speed before use 3 When using this equipment use the root...

Страница 32: ...terial degradation In case of damage the device should be reprocessed before sending back to the manufacturer for repair 8 2 General recommendations The user is responsible for the sterility of the pr...

Страница 33: ...ns from the components with code water 40 C immediately after use Don t use a fixating detergent or hot water 40 C as this can cause the fixation of residuals which may influence the result of the rep...

Страница 34: ...jet pistol with cold tap water for at least 10 seconds Clean the surfaces with a soft bristol brush Cleaning Regarding cleaning disinfection rinsing and drying it is to distinguish between manual and...

Страница 35: ...see general recommendations 3 Avoid any contact between the contra angle and any instrument kit support or container Disinfection Automated Thermal Disinfection in washer disinfector under considerat...

Страница 36: ...the contra angle must be lubricated 2 Attaching the spray nozzle to oil can and contra angle press the oil can button more than 3 seconds till all the black oil flow out from the head of the contra a...

Страница 37: ...ange of sterilization indicators physicochemical integrators digital records of cycles parameters 6 The sterilization procedure must comply with EN ISO 17665 7 Wait for cooling before touching Storage...

Страница 38: ...should be properly evaluated for effectiveness and potential adverse consequences 8 4 Disinfection Components Disinfection components Motor Handpiece Handpiece Base Adapter Wipe all the surfaces with...

Страница 39: ...rt Motor This warning will appear on the display screen if the load exceeds the capacity of the standby machine during reversal Please press the main switch key to restart the standby machine Low Powe...

Страница 40: ...not appear on the handpie ce screen Wrong power adapter is used Please use the origin nal power adapter The power adapter is not plugged into the socket Please check the con nection The socket is not...

Страница 41: ...of the torque setting is reached Check whether the torque limit is too small Rev inversion mode is set Check settings Motor does not reverse Excessive torque reversal value is set Check settings Frequ...

Страница 42: ...ower supply Lithium ion battery 3 7V 800mAh 10 Charger power supply AC 100 240 V 10 Charger power output 5V 1A Frequency 50 60Hz 1Hz Charger nominal power input 0 4A Max Torque range 0 5 4 0N cm Speed...

Страница 43: ...11 Technical Data Page 43 52 Transport and storage conditions Ambient temperature 20 C 55 C Relative humidity 20 80 Atmospheric pressure 70kPa 106kPa...

Страница 44: ...terference in nearby electronic equipment RF emissions CISPR 11 Class B The E xtreme is suitable for use in all establishments incl uding domestic establishen ts and those directly connect ed to the p...

Страница 45: ...e relative humidity should be at least 30 Electrical fast transients b ursts IEC 61000 4 4 2kV 100kHz repetition frequency 2kV 100kHz repetition frequency Mains power quality should be that of a typic...

Страница 46: ...should be that of a typical commercial or hospital environment If the user of devices require continued operation during power mains interruptions it is recommend ded that devic es be powered form an...

Страница 47: ...Hz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz See the RF wireless communicate on equipment table in Recommend ed minimum separation distance...

Страница 48: ...ity test level in the below table 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...

Страница 49: ...WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modu lation 217Hz 2 0 3 28 5240 5100 580 0 WLAN 802 11 a n Pulse modu lation 217Hz 0 2 0 3 9 5500 5785 WARNING 1 Use of accessories and cables other than t...

Страница 50: ...or not Remark Adapter Cable 1 2 No 2 Use of E xtreme adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary E xtreme and...

Страница 51: ...lectrical 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 protect...

Страница 52: ...Road Xuejia County Xinbei District Changzhou City 213000 Jiangsu P R China Tel 86 0519 85962691 Fax 86 0519 85962691 Email ivy sifary com Web www sifary com Caretechion GmbH Tel 49 211 3003 6618 Add...

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