取扱説明書 Instructions for Use
Contents
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7. IEC 60601 IEC 61000 4 2 6 kV 8 kV SH 6 kV 8 kV 30 IEC 61000 4 4 IEC 61000 4 5 1 kV 2 kV 2 kV kV 2 kV
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17. 150 kHz 80 MHz 3 V m 19 Read these Instructions carefully before use BlaeShot I Dental Light Curing Unit Instructions for Use Blqeshot I SHOFU INC Introduction Thank you for purchasing our SHOFU BlueShot II The instructions mentioned below provide necessary information on successful operation daily maintenance and safe use of this unit Please read the instructions carefully before use to attain maximum benefits and ensure durability of this unit Kindly keep this manual for your future reference No part of this manual may be copied or reproduced in any form by any means Some information in this manual may become inconsistent with the product due to product software updates The information in this manual is subject to change without prior notice All relevant issues have been considered in the preparation of this document However should you notice an omission or any questionable item in this document please feel free to notify SHOFU In case of missing pages or disorder please contact our local dealer for replace ment SHOFU will repair and replace main body and its system
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19. 5 5 OFF 6 11 6 5 KA 1 Ba 1 400mW cm a 5 10 0 5 10 20 MD a 1 000mW cm 10 20 30 hae 10 20 30 go 3 ee 5 0 650mW cm
20. 14 10 1 1 BaORR 12 DC3 7V L217 x W97 x H38mm 115g 10 40C 30 85 50 C 10 85 FZI O tha Ei 1400mW cm
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23. 15 1 000mW cm2 1000 20 5 10 15 20 4 7 1 000mW cms 0 1 0 05 ane oe 1000 a if it 20 30 CON 3 5 baer 650mW cmS a 20 30 CON 3 650 10 20 30 W 12 7 7 8 Mas OREHA 2K CSTD RODUN RRt Cite bl CT CIES 135C
24. 455 475nm BS2 02 DC5V D179 x W176 x H138mm 240g BS BP DC3 7V 2600mAh L108 x H34mm 65g BF a H Na HAD Hp Red Sa M wl ARG Hall p 8mm 4 95mm L90 x H60 x T3mm AC Aa AC100V 240V DC5V 16 13 e AC 14 1
25. MT CD 7 AS CARA RL EG 0FF ON ON OFF 1 E 2 LED 3 4 4 A 4 B 5 5 A 5 B 6 AC S BlueShot I BF I
26. To turn ON press the button when display is disappeared To turn OFF keep pressing the button when the Handpiece is ON To stop the light exposure press any button on the Handpiece 7 LCD Display Selected mode exposure time and remaining battery are displayed on the LCD Display in Graph Mode or Text Mode 2 Light Probe Effectively exposures the LED light 3 Anti glare Shield It is placed on the Light Probe to protect eyes from exposure light 4 Battery Pack 4 A Charging terminal area 4 B Connecting terminal area 5 Charger Base 5 A Light display to indicate the charging process with green and red lights 5 B Inlet 6 AC Adapter Symbols on Product 5 Trade Mark BlueShot I Product Logo Mark TYPE BF APPLIED PART CLASS II equipment Recycle Lithium ion battery 4 Installation and Connection Refer to 1 Safety Information about Installation and Connection 1 Connection between AC Adapter and Charger Base 1 Securely insert the connector of the AC Adaptor into the Inlet at the back of the Charger Base 2 The AC adaptor is compatible with a power outlet of 100 V to 240 V e Use only the original AC adaptor CD note supplied e When the power plug is connect ed both red and green lights flash instantly which is not a malfunction or an alarm sign 2 Inserting Battery Pack 1 Carefully insert the Battery Pack into the Handpiece as directed by the arrow Avoid forcing th
27. 605 0983 11 TEL075 5611112 Manufacturer SHOFU INC 11 Kamitakamatsu cho Fukuine Higashiyama ku Kyoto 605 0983 Japan SHOFU DENTAL CORPORATION 1225 Stone Drive San Marcos California 92078 4059 USA SHOFU DENTAL ASIA PACIFIC PTE LTD 10 Science Park Road 03 12 The Alpha Science Park II Singapore 117684
28. about 1 000 mW cm The exposure time can be 10 sec 20 sec and 30 sec Soft Start Mode In the 5 seconds output light intensity is increas ing from 0 mW cm to about 650 mW cm and then increases to about 1 000 mW cm during the next 15 seconds The exposure time can be 20 sec Pulse Mode The output light intensity starts at about 1 000 mW cm and holds for 0 1 seconds followed by a rest period of 0 05 seconds in repetition The exposure time can be 20 sec 30 sec and CON max 3 min Normal Mode Its output light intensity is about 650 mW cm The exposure time can be 20 sec 30 sec and CON max 3 min mW cm ei sec 20 mW cm2 A 1000 sec 10 30 mW cm2 1000 650 sec 5 20 mW cm2 0 1 sec 1000 gt sec mW cm2 A 650 sec 10 30 7 Durable Years Durable year are 7 years from the date of purchase under the unit is kept by 8 Maintenance 8 Maintenance Refer to 1 Safety Information about Maintenance Cleaning and Sterilization Avoid wetting the Handpiece and Charger Base to prevent electrical shock Ensure that the Charger Base and Battery Pack are always separated from the Handpiece prior to cleaning Clean the Handpiece and Charger Base gently with a clean soft lint free cloth Avoid us ing solvents containing oil or more than 50 of ethanol or acetone sharp or pointed tools to clean as they may damage or scratch the plastic Clean th
29. automatically be switched off In such a case press the button gently In case it still does not operate normally reset the equip ment and operate after charging Display screen does not If the battery is completely discharged or connected incor light rectly display will not appear Recharge the battery or reconnect the battery to reset the device Power off while in If the Start Button is pressed for more than 2 sec power operation will be switched off Press the Start Button again to restart the device Check the battery connection Not able to charge If the power cord is not correctly connected to the Charger Base or the Handpiece is not properly placed on the Char ger Base the battery can not be recharged Clean the Charger Base or the charging terminal When light intensity If the Light Probe has dirt or is damaged and the Battery is poor Pack is not charged enough intensity of light becomes poor Replace with new Light Probe or new Battery Pack 14 10 Storage and Transport Keep this packing materials until disposal to use for transport and storage Send back to your dealer if the unit need repair Only dental professionals must be in charge of storage and management of this unit Keep stable away from tilt vibration and impact during transportation as well Keep away from direct sunlight contamination and moisture 11 Disposal Do not dispose pollutant i
30. dip in Ur for 5 sec Mains power quality should be that of a typical commercial or hospital environ ment If the user of the EQUIPMENT or SYSTEM requires continued operation during power mains interruptions it is recommended that the EQUIPMENT or SYSTEM be powered from an uninter ruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical lo cation in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level 18 Guidance and manufacturer s declaration electromagnetic immunity This Model is intended for use in the electromagnetic environment specified below The customer or the user of this Model should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of this Model including cables than the recommended separation dis tance calculated from the equation ap plicable to the frequency of the transmit ter Recommended separation distance Conducted RF 3 Vrms d 1 2 4P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 2 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 4 2 3 vP 800 MHz to 2 5 GHz where Pis the maximum output power ratin
31. the following information to use this product safely warning Indicates a potentially hazardous situation which if not avoided could result in serious injury or death Indicates a potentially hazardous situation which if not avoided may result in minor moderate injury or damage of property Notes and Signs Other notes and signs used in this manual are shown below caution note e Indicates that potential malfunctions may occur if the description is ignored Installation and Connection warning Keep away from sources of ignition to avoid fire or explosion Protect the Handpiece Charger Base and Battery Pack from any liquid to avoid elec tric shock or functional error A Caution e Securely connect the dust free power plug to the outlet Use this unit in well venti lated areas Overheating may cause fire e Place the Charger Base on flat and stable surface not to get injured by the dropping unit warning Do not plug the power cord with wet hands This may result in an electric shock In case of fluid leak from battery or partial discoloration deformation or nasty smell of the Handpiece immediately discontinues use and send back to your dealer for repair In case of partial discoloration deformation or nasty smell of the Charger Base immediately disconnect the power plug and repair the base In case battery fluid contacts the eye immediately flush with copious a
32. MENT or SYSTEM is intended for use in the electromagnetic environment specified below The custom er or the user of the EQUIPMENT or SYSTEM should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Not Applicable Mains power quality should be that of a typical commercial or hospital environ ment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environ ment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 UT 30 dip in U7 for 25 cycles lt 5 UT gt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in CT for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95
33. e Battery Pack 3 Inserting Light Probe 1 Slowly insert the Light Probe into the Hand piece Push the Light Probe in till it firmly sets into position Charger Base AC Adapter Handpiece Battery Pack Handpiece Light Probe 4 Placing Anti glare Shield 1 Place the Anti glare Shield on the Light Probe 5 Charging Handpiece 1 Insert the Handpiece into the vertical slot at the front of the Charger Base The charger light at the front of the Charger Base will appear Handpiece Red light On Charging in progress Green light On Charging complete If the battery power level is extremely low red light may flicker while recharging which is not a malfunction It will take approximately 3 hours before the battery will be fully charged Depending on the volume of the re Note maining battery the sign of battery indicator varies Charger lamp ee Red light Charging in progress Green light Charging complete 5 Directions for Use Refer to 1 Safety Information about Operation 1 Activating Handpiece 1 Press the Start Button LCD Display indi cates standby mode and then the mode used last with a short audible tone 2 Select the curing mode and time by press ing the Turbo Mode Button Mode Button and Time Button Start Button Initial Screen Mode used last 2 Selection of the display mode Keep pressing Mode B
34. e Light Probe with a soft cloth and disinfect The Light Probe is autoclavable less than 135 C Remove restorative materials stuck to the Light Probe gently with a plastic spatula Avoid us ing sharp tools as they may scratch the surface of the Light Probe and affect the intensity of the light Avoid using alcohol and solvents to clean Anti glare Shield Maintenance and Replacement of the Battery Exposure to high room temperature may shorten the battery life The recommended room temperature ranges between 15 to 25 C Extremes of room temperature will affect the op eration of the LED light It is recommended for the rechargeable battery to be charged immediately before use to max imize the efficiency Remove the battery from the Handpiece if not being used for more than one week The rechargeable battery operating under normal conditions can be used for around 400 charging cycles This may vary depending on the using condition If the running time declines with a full charged battery replace the battery before use 9 Troubleshooting If your curing light unit is not operating normally discontinue use and send back to your dealer for inspection and repair If your unit corresponds following Troubles the unit may be normal Check your unit again along Cause and Measure before return the unit Trouble Cause and Measure Control button is not e If the control button is pressed with excess force the power operating normally will
35. g of the transmitter in watts W ac cording to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmit ters as determined by an electromag netic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mo bile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which this Model is used exceeds the applica ble RF compliance level above the Model should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating this Model 5 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 19 dada aa G
36. hin one year from the date of purchase repair will be free of charge However repair of consumables Light Probe Battery Pack and Anti glare Shield etc are not covered by the warranty For more information refer to the Warranty card enclosed 15 EMC Electromagnetic compatibility e This unit may be affected by portable and mobile type RF telecommunication Note equipment e This unit needs special notice about EMC Please obey EMC information below Guidance and manufacturer s declaration electromagnetic emissions This Model is intended for use in the electromagnetic environment specified below The customer or the user of this Model should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance This Model uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in near by electronic equipment RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 This Model is suitable for use in all establishments Harmonic emissions including domestic establishments and those di Class A rectly connected to the public low voltage power IEC 61000 3 2 supply network that supplies buildings used for do mestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 17 Guidance and manufacturers declaration electromagnetic immunity The EQUIP
37. in case of trouble within the warranty period However we do not assume any responsibility for subsequent damages arising from troubles during operation Introduectiom oe E RN Ny ii NO ji OhitenitS RR RR RR iil INGICATIONS isis eo tereeernvedereleedlen aR iv 1 Safety Information iene Na 1 SYDOST E eta E 1 Noles ang SNS ome ie 1 Installation ANd Connection 1 DealIOEESRRKRKRNNRRRKR KK KKKKNNS anana 2 MaintenanGe ester a a ae 3 List OF COMPONENTS sm Ns 4 3 Parts and Functions ee 5 oymbols on PIOGUCL ii ne adie i eis wine ie 6 4 Installation and Connection nn 7 5 Directions for Use nn 9 6 Selection of Curing Mode ee 12 7 Durable Years sm 13 8 Maintenance ee 13 Cleaning and Sterilization cece 13 Maintenance and Replacement of the Battery ee 13 9 Troubleshooting mm 14 10 Storage and Transport nnmnnn 15 T OS eee 15 12 SpecificationN ee ssania A 16 TS PC COS SOIICS RES 17 14 Warranty ee aaria raans aai AE a iors ES rr iSn AAE AESP Era Naen niaire aaRS Ea 17 15 EMC Electromagnetic compatibility pp 17 Indications For polymerization of light curing materials including the light cure catalyst initiated by the light with wavelength range 440 nm to 490 nm 1 Safety Information It is important to understand
38. lectric shock or fire Ncaution If LCD display malfunctions remove the battery from the Handpiece and reinsert it Users must be in charge of operation maintenance and check 2 List of Components Please check the contents described below when removing the contents from the original pack aging _ Biqcshotr Handpiece Charger Base AC Adapter Light Probe Anti glare Shield 8 mm Manual Instructions for Use Notes on use of medical electrical equipment for Japan e Warranty cards Japanese Package Insert e Label 3 Parts and Functions 7 Handpiece 1 A 1 B 1 C Turbo Mode Button For selection of Turbo Mode Each time the button is pressed the exposure time chang es to 5 sec 10 sec and 20 sec Time Button For selection of exposure time Each time the button is pressed the exposure time changes on each mode as follows Turbo Mode 5 sec 10 sec 20 sec High Mode 10 sec 20 sec 30 sec Soft Start Mode 20 sec Pulse Mode 20 sec 30 sec CON continuous Normal Mode 20 sec 30 sec CON continuous Maximum exposure time of CON is approximately 3 min To stop the light exposure press any button on the Handpiece Mode Button For selection of exposure mode High Mode Soft Start Mode Pulse Mode Normal Mode High Mode 7 Start Button Power ON OFF Button To start the light exposure press the button
39. mount of clean water and seek medical attention Wear the protest glasses or the Anti glare shield to avoid direct eye contact with LED light and also protect patient s eyes during exposure And avoid to see the re flected LED light directly As it may affect eyesight Do not use this product on patients with a history of cataract retinal damage or al lergic reaction to light Do not use this product on a person with a pacemaker as it may cause malfunction of the pacemaker Avoid exposing the light on intraoral soft tissue as it may affect the soft tissue A Caution Disconnect the power cord by grasping the power plug This may cause injuries or burns Avoid damage or use of unnecessary force on the power cord This may cause an electric shock or fire Do not exposure excessive time on same place as it may cause damage to gingiva and pulp Should battery fluid contact the skin or clothes immediately wash it off with copi ous amount of water to avoid skin damage Take the battery out of the Handpiece if it won t be used for more than 1 week Connect the power plug only when battery is being charged Insulation degradation may cause electric shock or fire Do not use this product for any purposes other than dental use Maintenance warning Use only the battery supplied to avoid fluid leak or explosion e Never disassemble or overhaul the product Unusual performance may cause inju ries e
40. ncluding the unit accessories packing materials etc Do not dispose the unit and accessories as general waste Follow each local law and regula tion 12 Specification RS Handpiece Operating voltage DC 3 7 V Dimensions L217 x W97 x H38 mm Weight 115g Usage environment Storage environment Temperature 10 C to 40 C Humidity 30 to 85 Temperature 0 C to 50 C Humidity 10 to 85 Protect against electric shock TYPE BF APPLIED PART Output light intensity 1400 mW cm Turbo Mode Wavelength range 455 nm to 475 nm Charger Base Model BS2 02 Operating voltage DC 5 V Dimensions D179 x W176 x H138 mm Weight 240g Battery Pack Model BS BP Type Lithium ion battery Nominal voltage DC 3 7 V Rating capacity 2600 mAh Dimensions Weight L108 x H34 mm 65g Light Probe Diameter p 8 mm Length 95 mm Anti glare Shield Material Acrylic Dimensions L90 x H60 x T3 mm AC Adaptor This specification 16 Power supply AC 100 V to 240 V Power output DC 5 V is subject to change without prior notice 13 Accessories Light Probe PN5112 Anti glare Shield PN5113 Battery Pack PN5114 AC Adapter PN5115 14 Warranty This product is shipped after strict inspection Should the product have any problem under nor mal usage wit
41. utton to select the dis play mode Graph or Text Mode Button 3 LCD Display Graph Mode and Text Mode are available lt Graph Mode gt lt Text Mode gt rs ui Wo TA OD a Abbreviation a Mode of curing Turbo Tur MODE MODE High High Soft Start Soft Pulse Pul Graph Mode Display Text Mode Display 1 3 i 1 j 4 Normal Norm 1 Abbreviation of curing mode 1 Abbreviation of curing mode 3 Remaining exposure time 2 Selected exposure time 4 Battery power level 3 Remaining exposure time 5 Output graph 4 Battery power level Initially the selected exposure time is displayed and subsequently the remaining ote exposure time is displayed during the curing process 10 4 Start of exposure 1 Press Start Button to start exposure with the selected mode 2 Press any button to stop the light exposure 5 Sleep Mode If unit is left unused for more than 5 minutes all functions are automatically turned off To turn off the device anytime keep pressing Start Button 6 Set up memory The unit records the setting used last 11 6 Selection of Curing Mode Curing mode can be selected by pressing the Mode Button or Turbo Mode Button Five curing programs are available 1 12 Turbo Mode The output light intensity is about 1 400 mW cm The exposure time can be 5 sec 10 sec and 20 sec High Mode The output light intensity is
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