Manual Bs Lipsm

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Power Assisted Liposuction System Model: BS-LIPSM Operation Manual > Portable PAL system > Mini design with powerful output > Rich optional accessoroes > Easy to operate > High mobility Product supplied with sincerity 2010 - 2020 READ THIS MANUAL TO BECOME FAMILIAR WITH ALL SAFETY REQUIREMENTS AND OPERATING PROCEDURES BEFORE ATTEMPTING TO OPERATE THE SYSTEM. COPYRIGHT © LUMSAIL INDUSTRIAL INC. All rights reserved Print date: March 31th, 2020 Change Log: Date Version _| Change Log Sep 2019 1.00 Draft version Oct 2019 1.10 _| Add foot pedal function related section Dec 2019 1.20 Revise packing related sections Feb 2020 2.00 Publish for 2" generation hardware BS-LIPSM Specifications are subject to change without notice. 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 2 TABLE OF CONTENT 1 Product Description... 4 41 Intended use and operation, 1.2 Technical data and parameters 4 14 Ambient conditions 5 15 Warranty service 5 2 Explanation Of Symbols. 3 Safety Information 5 3.1 Safety Indications 6 3.2 EMC Manufacturers Declaration of Conformity 7 A Check List. 7 5 Device Overview 8 5.1 Summary. 8 5.2 Front view. 8 5.3 Rear view 9 5.4 Vibration Handpiece view, 9 5.5 Canta VieW vosnsnes ss ns ns ve 1D 6 Start To Use . 10 6.1 Device setup 10 6.2 Connection tothe power supply. ray 6.3 Preparing Cannula & Handpiece u 7 Operation. a 7.1 Switching device on and of u 7.2 Operation of the foot pedals. 2 7.3 Handpiece. 2 8 Cleaning, disinfection and sterilization 12 8.1 Main unit and foot pedal 2 8.2 Cannulas and Cannula adapter. 2 9 Maintenance 9.1 Replacing the control unit fuse: 3B 10 Malfunction and troubleshooting... 11 Information on disposal... ‘Appendix. 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 3 1 Product Description 1.1 Intended use and operation INTENTION OF USAGE: aesthetic body contouring. ‘The BS-LIPSM model machine is a precisely electric power provider device, which can be used with BS-LIPS-APP applicatorthandpiece (in following section the two terms are both referring to the handheld power assisted handpiece for the machine. The machine provides the facility of combination with the corresponding accessories, to provide a safe, conservative treatment, as well as providing a crucial advantage in Liposuction treatment. With proper application, the tissue removal procedure is simple, safe and cost-effective and delivers. ‘optimal cosmetic results. ‘The BS-LIPSM model is composed by the main unit, handpiece, foot pedals, optional cannulas and other related accessories. The vibration speed of handpiece can be adjusted by the knobs on front panel, and operator can check the speed af them through the LED or LCD (optional) display window ‘on control panel. A single-way foot pedal is used lo control the handpiece vibration function, 1.2 Technical data and parameters Voltage 110V - 240 V~at 50 Hz or 60Hz Power consumption: 60VA. Fuses 3ATS AL 250 VAC. Protection class Class | Applied part ‘Type BF Dimensions, W x H x D: 128 x75 x 171 mm Weight 3kg including handpiece ‘Speed of vibrational handpiece Motor 10000RPM, 2800 strokes per minute Controller ‘way Foot pedal OR Auto-lock Foot pedal (optional) Equipment classification + CLASS 1 + Degree of electrical isolation: BF * Duty Cycle of Power assisted handpiece is designed to operate for up to 20 minutes of continuous use with intermittent operation over a period of 1-2 hours. Leave minutes for handpiece to.c0ol to room temperature, 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 4 1.4 Ambient conditions ‘Transportation and storage | Operation Relative humidity Max. 90% Max. 80% Temperature O°C to 60°C 10°C to 30°C ‘Atmospheric pressure 700 hPa to 1060 hPa £800 hPa to 1060 hPa 1.5 Warranty service Purchasing the BS-LIPSM system entitles you to a 1-year warranty. Consumable parts are not covered by the warranty. Improper use or repair, or failure to observe these instructions, relieve us from any obligations arising from warranty provisions or other claims. 2 Explanation Of Symbols Waring ‘Auto-clavable at 135°C Date of manufacturing Foot pedal to control handpiece Manufacturer ‘SN ‘Symbol indicating the serial number with the date of manufacture (yearimonth). Type BF applied part isthe filing tube with connected instruments © ‘Observe the instructions for use Handpiece socket. Commonly handpiece shall be connected before power on the machine, and cannot be unplugged before power off the machine. pe Electrical and electronic devices that hav reached the end of thir service ife comprise hazardous waste and may not be disposed of together wth household waste. Valid loal disposal regulations apely CE symbol ce ‘Symbol indicating the lot number. Not for reuse @ ‘Symbol indicating the order number. 3 Safety Information Human safety, including the safety of operators, as well as patients, is very important tous. Itis therefore essential to obey the rules of safety as following descriptions. 85-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 5 3.1 Safety Indications Throughout the manual, the following terms are used lo identily tips and precautions that will help ‘avoid accidental inury to patients or personnel, or prevent damage to the system. The words NOTE, WARNING, and CAUTION carry special meaning and should be carefully reviewed NOTE: Indicates special information to make maintenance easier or important instructions more clear. WARNING: Indicates that the safety of the patient and/ or hospital personnel could be involved. CAUTION: Indicates special service procedures or precautions that must be followed to avoid damaging the instrument and/ or system components. WARNING 1._Risk of fire. Replace fuse with T5AL250V Slow Blow. 2. Grounding reliability can only be achieved when the equipment is connected to equipment receptacle marked "Hospital Only’ or "Hospital Grade.” 3.__Disconnecting the supply cord will isolate the handpiece from the main unit simultaneously. ‘4__ Risk of fire. Use only verified cables to connect to the instrument. Explosion Hazard. Equipment and components are not suitable for use in the presence of flammable anesthetics or oxygen 6. Electric Shock. DO NOT remove back panels. “Type BF rating may only be maintained ifthe instrument is not used to bridge between the patient and ground. ‘8 Use care to ensure that there is no electromagnetic interference between this device and other devices in use. 8. Prioro use all system components (main uni, cables, handpiece, and tube sets) should be ingpected to detect any damage or malfunction, CAUTION 10. Ifused in USA, Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner. 11. Risk of overbalance due to siting or stepping on console. DO NOT sit on or step an console. 12, DO NOT twist or force the plug into the outlet. Doing so could bend the pins in the cable and damage the cable andlor the console. 13. DO NOT plug in handpiece when system is tumed on already. 14,_DO NOT unplug handpiece when system is tured on already. 1. DO NOT drop the handpiece to ground. 16. During operation if handpiece stuck (stop stroking), please withdraw cannula out and let it work again 17. Repairs may only be performed by authorized service technicians (contact LUMSAIL) 18. The device is not sterile on delivery. All serializable parts must be sterilized before use. 19. Improper use or repair of the device and failure to observe these instructions relieve us from any bigation arising from warranty provisions or other claims. NOTE 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 6 20. Tum off power supply by pressing power switch on back panel to O state. ‘The “OFF” positon is designated by O shape icon and the “ON" position is designated by | icon. 21._Do only use the handpiece provided together withthe device. 22. Check ifthe local power specification meets the requirement of the system before star fo use. 23. Prior to using the device, before startup, and before operalion, the user must always ensure that the device and accessories are in good working order and are clean, sterile and operational 3.2 EMC Manufacturer's Declaration of Conformity Please observe the information on electromagnetic compatibility provided with these operating instructions. 4 Check List Following items are delivered when you order the device. NOTE: Item marked with Optional is not delivered by default. Contact with sales preventives for details. Item No. | Description Quantity 5031 __| BS-LIPSSM main unit unit 4001 | Vibrating Handpiece ‘unit 4203 | Handpiece adapter (2015 cont) ‘unit 4204 | Handpiece adapter (2020 conf.) Optional accessory. ‘unit 4101 [ Cannula set (2015 cont., 5 pieces with different size), steriizable ‘set 5003 | Auto-lock foot pedal * Optional unit 5004 | Locker-plug * Can be replaced with 5003, ‘unit 5005 _| Traditional 1-Way foot pedal (2014 version) unit 5101 | Power cable * US style unit 5102 __ | Power cable “ European style unit 5105 | Backup fuse 2 units 7101 | Operating instruction manual for BS-LIPSM unit NOTE: items which are marked to be steriizable can be sterilized under proper method. Please refer to following sections for details. NOTE: forthe im of environmental protection, the hardcopy (paper version) booklet or operating instruction manval might not be provided in some markets, instead we shall provide link to download the lecitic-version or contact your local distributor for help. NOTE: * For power cable, it’s related to order issued by customer. 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 7 5 Device Overview 5.1 Summary @ 1 [Main Unit 2 | Cannula (already installed on the figure) Foot pedal 4 [Cannula adapter Hand NOTE: Foot pedal for handpiece controling is optional accessory. If not install, the Locker-plug shall be installed instead on same interface/socket (ITEM 5004). NOTE: Auto-ock foot pedal is optional accessory. Compare to traditional handpiece, it only needs to be ‘stepped on once, handpiece can work continuously, and then stop another stepping operation 5.2 Front view 1__ | Handpiece socket 2__| Vibration speed adjustment knob 3 | Vibration speed display 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 8 Find the socket marked wth oon: ©, tats the viraton handpice socks. Phy inthe handpiece plug before power on the machine. The display window will show the concurrent speed level. NOTE: Ifthe speed cisplay window turned off during operation, and the handpiece also stop vibrates, it ‘could be a kind of system auto-protection, which would happen when handpiece/cannula stuck. Release the cannula, thus reduce resistance to mavement of cannula, the handpiece will revert to work normally 5.3 Rear view Rear view of the BS-LIPS5/S machine: ® | Power Socket SN: 1 | Optional mode selection switch 2__| Serial number of the unit 3 | Foot pedal socket 4 | Power socket with fuse NOTE: Mode selection switch is optional feature, Without special requirement this switch isnot installed by default fit is installed, it has 0/1/2 levels to set. Contact us or local distributor for more, NOTE: Auto lock foot pedal is optional accessory, not included in standard configuration of the device, If without the auto lock foot pedal or normal foot pedal, please plug in the locker-plug on that socket, so that handpiece can work continuously after machine is powered on, 5.4 Vibration Handpiece view ® ‘Suction tube 2__| Handpiece Adapter 3__ | Rear end of handpiece 4 | Handpiece body (metal) 8S-LIPSM Operation Manual LUMSAILINDUSTRIALINC. V2020.2.2.00 ° NOTE: the vibration handpiece adapter is installed by default, NOTE: Rear end of handpiece is fragile, don't wrap at that position, and DO NOT drag the handpiece, ‘otherwise the cable there is easy to break, 5.5 Cannula view 1__ | Suction cannula Damm iL 350mm 2__| Suction cannula DSmm /L 300mm ‘Suction cannula Damm /L 300mm 4 | Suction cannula O3mm /L 360mm Suction cannula Damm /L 300mm NOTE: suction handpiece set includes 5 pieces popular cannulas, indifferent size and port type. Any ‘change of the configuration of the cannula set will happen without separate notify. Please contact with LUMSAIL Company for confirmation NOTE: customized cannulas are supported; please contact local distributor ar us directly. 6 Start To Use 6.1 Device setup Place the BS-LIPSM device on the even, non-slip desktop, and equip it wth all required accessories and instruments, Make sure you have good access to all controls. Do not allow the operating range of the device (including cable) and the connected instrument to be compromised by limiting factors, ‘The foot switch with pedal must be placed within stepping distance between the patient and the surgeon. it must be explicily ensured that no objects can fal on the pedal BS-LIPSM Operation Manual LUMSAIL INDUSTRIALINC. V2020.2.2.00 10 ‘The power plug at the rear of the device must be accessible at all times. ‘The ventilation slots at the rear panel of the BS-LIPSM device must be kept clear in order to prevent ‘temperature from becoming excessive. It shall be kept at least 10cm to the wall, so that air can flow smoothly to dispel heat transferred from inside of the device. 6.2 Connection to the power supply NOTE: Bofore switching on, make sure that the power supply unit of the device matches the local ‘specific service voltage. The power supply unit of the pump is not switchable to the local specific ‘service voltage. The device has to be ordered according to the country specific service voltage. In order to prevent the risk of an electric shock, the device may only be connected to a power network with a PE protective ground conductor ‘The power plug socket is located atthe rear of the device. Please use the power cable in accessory for the device, itis assumed to be working normally under AC230V voltage and working current over 3A, ‘There's separate grounding line interface on back panel. Connect it to local grounding line. 6.3 Preparing Cannula & Handpiece 1. Install the handpiece adapter. NOTE: the adapter s already installed, then just ignore the steps. 2. Connect the suction tube tothe handpiece adapter. 3. Connect the handpiece to main unit at the proper socket on side panel of the device, 4, Plug cannula into the adapter of handpiece. 7 Operation Prior to use, all sterlizable parts (e.g. Cannulas, handpiece and pipes) must be steriized. Connect all tube sets, and plug the power cable to wall socket, before ensuring the correct power spec meets the requirement of the device, 7.1 Switching device on and off Use the power switch “I/O, atthe rear of the device, to switch the device on and off. The backlight of the switch may turn on after device is powered on. ‘The device can be switched off at any time, irrespective of any procedure for device switch-of. BS-LIPSM Operation Manual LUMSAIL INDUSTRIALINC. V2020.2.2.00 u 7.2 Operation of the foot pedals ‘The foot pedal is used to control the suction or inflation. Keep stepping down the function will continuously work. When release the foot pedal, the corresponding function will stop automatically ‘The auto-lock foot pedal is used to control the operation ofthe vibration handpiece. I's designed to be locked by stepping dawn once, and release upon another stepping. So the doctor don't need to continuously stepping on the pedal during operation If don’t use the auto-lock foot pedal, then the locker-plug shall be plugged in the socket for this foot pedal. Itis optional accessory, not included by default, 7.3 Handpiece Handpiece vibration speed is controlled by tuning the speed controller knob on front panel, and the vibration speed levels displayed on the LED screen. The higher the value i, the faster the handpiece vibrates. NOTE: Long time working the handpiece will generate heat, if the temperature is high, please lt the handpiece cool down before resume, NOTE: Cable of handpiece is fragile, DO NOT DRAG during operation, otherwise the cable is easy to get broken, and the whole handpiece would lose function. Under that status the warranty of handpiece is void. 8 Cleaning, disinfection and sterilization “The folowing points in particular are important wih regard to caring for the materia: 8.1 Main unit and foot pedal Wie the outside using micro-biologically tested surface disinfectant or a 70% isopropyl solution. Don't lel liquid entering inside of the unit 8.2 Cannulas and Cannula adapter ‘The cannula adapter whichis installed on top of handpiece, shall be cleaned thoroughly and sterilized each time after using. Use autoclave to sterilize the cannulas, and keep dry before use. BS-LIPSM Operation Manual LUMSAIL INDUSTRIALINC. V2020.2.2.00 2 9 Maintenance 9.1 Replacing the control unit fuse: Users can replace faulty contral unit uses themselves, under help of authorized local electrical engineer. ‘These are located at the rear of the device in the fuse slot beside the power switch: “The following figure is taken on BS-LIPSS model, just for reference. Unplug the power plug. ‘Open the fuse slot using a screw driver. Replace defective fuses with the spare one. Slide the fuse holder back in and close the fuse slot Plug in the power plug again. NOTE: The socket contains dual fuses, just exchange the one which is broken, or both i the two fuses break down together. 10 Malfunction and troubleshooting Following with the common troubleshooting ist ofthe device, but for cases outside of the table, please contact local distributor or us directly for further information, Malfunction Cause Solution Device is not Improper input vollagelirequency __| Check power supply operational Fuse broken Exchange fuse Wall socket i faulty ‘Checkifx wall socket Foot pedal isnot connected ‘Connect foot pedal Foat pedal isnot pressed down Press down foot pedal Foat pedal failure Fix foot padal Vibration handpiece not | Switch on font panel notturned on | Turn on the switch working Foat pedal isnot connected ‘Connect foot pedal Foat pedal isnot pressed down Press down foot pedal again Foot pedal failure Fix foot pedal Locker‘plug isnot plugged iniffoot | Plugin the locker plug in proper pedals not avalable socket Handpiece not connected Connect handpiece No proper pawer to the handpiece | Check the speed LED on front panel BS-LIPSM Operation Manual LUMSAIL INDUSTRIALINC. V2020.2.2.00 3B Handpiece broken Exchange / fix handpiece 11 Information on disposal When disposing of the device, device parts and accessories, the regulations prescribed by law must be observed. Do not dispose of devices with household waste, please follow local rules, x Electric parts that have reached the end of their service life may not be disposed of with household waste, Handpiece and adapter of handpiece must be stelized before disposal, Contaminated single-use tubing sets are subject specific disposal requirements, Appendix Electromagnetic compatibility (EMC) Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the praduct and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows. WARNING Use of portable phones or other radio frequency (RF) emitting equipment near the product may cause unexpected or adverse operation WARNING The product shall not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the product shall be tested to verify normal operation in the configuration in which itis being used Compliant Cab and Accessories WARNING The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the product. The table below lists cables, transducers, and other applicable accessories for which the manufacturer claims EMC compliance. NOTE: Any supplied accessories that do not affect EMC compliance are not listed. ‘Guidance and manufacturer's declaration — electromagnetic emissions The Product ended Torus nthe electromagnet environment spected below. The cuslomor or Uve use ote Prom shoul Enis Foriiance | Efeciromagnetic environment guidance BS-LIPSM Operation Manual LUMSAIL INDUSTRIALINC. V2020.2.2.00 14 Harmonie emissions Not applicable 1c 6100033 Voltage futuationsfixer emisslons Not applicable onnoctd io the pubic lowevoltage paver supaly that supplies buigings used for domostle purposes, BF emissions Gaupt The Produet uses RF energy only Tor tanto net, cisPR tH Therefore ls RF emissions are very low'ana are nat ely cause any interference in nearby lactone equipment RF omissions Cae Tho Produel i sulabo for use h al cabiahrents, CISPR tt including domestic estabishments and nase direct work ‘Guidance and manufacturer's declaration ~ electromagnetic immunity “Tre Produet ended Tor se nthe electromagnet environment specie’ blow, The customer ore user of he POM (0160H2) magnet fla tec 6100048 thos a TESTO Complanas Taal —] Ehctomag a Tro eat Flere shold Bo Wood cone ‘ onic tf fous ar covered E80) seeky ai seek alr wan sytnatc mato, the lav reo sto00.2 amily shoud bea oat 90 Scat SER Tar pana ana] HER Tar Faw] Ms pow aT SOT a transom ines nes ofa commerl or hepa ke sro0044 1-40 forinpaoupt | a1 forinpuoupat Save TTR arent de [TR arora | Mats por Guay Sac a Catone! carmel or hosp IEC 61000-4-5 +1-2kV common mode | +/-2kV common mode | "vironment. ERE ET ‘as pow aay SOT Ta ven emavtage [eedonu:) — [eeekapnur) Shatincal cshmerel or hoop interruptions and voltage | 461 5 cycle for 0.5 cyte fewironment. tthe user of the : 7” Spestonesnng power mans ‘supply input ines 40% Ur 40% Ur interruptions, it is recommended (60% dp in) (60% apne) tha the brodet be powaed fm {orecyes ferscjles Shmterptle pov spol rec 6t0004-11 mater 70%; 70% U1 (0 %dpin us (20% ip nur) {eras orice for25 ee

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