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INSTRUCTIONS FOR USE

Caution! Federal (USA) law restricts this device

to sale by or on the order of a physician

Содержание Swiss LithoCast Trilogy FT-235

Страница 1: ...INSTRUCTIONS FOR USE Caution Federal USA law restricts this device to sale by or on the order of a physician ...

Страница 2: ...2 ...

Страница 3: ...ints Intended Use The product is intended for the fragmentation and removal of urinary tract calculi in the kidney ureter and bladder Operating mode The product can deliver ultrasound and ballistic energies through a single probe simultaneously or separately to fragment stones The product can extract stone fragments through the probe while delivering energy or without delivering energy The product...

Страница 4: ...OCEDURE 23 6 1 COMPLETING TREATMENT 23 6 2 DISCONNECTING THE HANDPIECE 24 6 3 RECORDING TREATMENT DATA 25 6 4 DISCONNECTING THE STONE CATCHER 26 6 5 ELIMINATING THE STONE CATCHER CONTENTS 26 6 6 CONSERVING THE STONE CATCHER CONTENTS 26 6 7 DISPOSING OF SINGLE USE COMPONENTS 26 6 8 SWITCHING OFF THE CONSOLE 26 7 CLEANING DISINFECTING AND STERILIZING 27 7 1 MULTIUSE COMPONENTS 27 7 2 CONSOLE PEDAL A...

Страница 5: ... aspiration connector and re usable wrenches are sterilized before proceeding with installation To avoid the risk of electric shock this product must only be connected to a mains power supply with protective earth No modification shall be made on this product The mains power switch of the product must be accessible at any time For sterilization the handpiece must have the lumen positionned vertica...

Страница 6: ...E REF DESIGNATION QTY 1 Console with peristaltic pump or 1 2 Cart optional 1 3 Fluid management system optional 1 4 USB key 1 5 2 5 L Demineralized water 1 6 Stone catcher support 1 7 Cooling system filling kit 1 8 Power cord 1 9 Wired pedal 1 10 Draining tube 1 11 External video cord optional 1 12 Cleaning brush 1 13 Cleaning rod 1 Figure 1 ...

Страница 7: ...d before use 19 Handpiece 1 To be sterilized before use Figure 2 1 2 4 3 5 6 8 7 11 9 10 13 12 REF DESIGNATION TO BE USED 1 Mains power switch YES 2 Power supply connector YES 3 Bus bar YES 4 Pedal cord connector YES 5 USB connector YES 6 USB connector YES 7 HDMI connector YES REF DESIGNATION TO BE USED 8 RJ45 connector NO 9 Outlet connector YES 10 Air plug connector YES 11 Sub D NO 12 Level indic...

Страница 8: ...onal designed for the console 2 Remove the protective film from the console 3 Install the stone catcher support Figure 4 3 2 FILLING THE COOLING SYSTEM To avoid interruptions during treatment make sure that the cooling liquid is above the minimum level before use If needed fill the cooling system as described below Figure 5 Do not tilt the console more than 10 degrees when there is water in the co...

Страница 9: ... metal locking part is in the down position Figure 10 5 Push the filling tube into the filling inlet connector until it engages Figure 11 6 Invert the filling bottle and squeeze it to fill the tank In case of over filling please refer to Emptying the Cooling Liquid Circuit section Figure 12 Make sure that the level of water in the tank is between the min and max indicators Figure 13 ...

Страница 10: ... a connection between the unit and the potential equalization bus bar of the electrical installation when necessary Figure 16 The equipotential cable is not supplied with the console 3 4 CONNECTING THE VIDEO CORD OPTIONAL Only connect products compliant with IEC 60950 or equivalent The console must be OFF before connecting the video cord 1 Connect the video cord to the HDMI connector at the rear o...

Страница 11: ...crew the securing nut Figure 19 The pedal can be placed in a protective bag not supplied 3 Make sure that the pedal is in an accessible location before starting treatment 3 6 INSTALLING THE STONE CATCHER Case 1 Use of a sterile single use Stone Catcher optional 1 Screw the sterile connector of the stone catcher into the handpiece Figure 20 2 Tighten the Stone Catcher lid Figure 21 3 Insert the sto...

Страница 12: ...nagement system or to your fluid disposal system A Figure 25 8 Make sure that the output tube is not twisted or under tension when placed in the peristaltic pump device head Case 2 Use of an in house aspiration system 1 Screw the aspiration plug to the handpiece Figure 26 2 Connect the in house aspiration system on the aspiration plug 3 Follow the instructions provided for the in house aspiration ...

Страница 13: ... Clamp C stays open A B C Figure 29 4 When the open pouch is filled open the closed clamp B first 5 Close the open clamp C adjacent to the filled pouch 6 The filled pouch can be exchanged for a new empty pouch using the Luer lock connection Figure 30 3 8 CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE Make sure that the handpiece connector is dry be fore connecting it to the console 1 To remove...

Страница 14: ...n orange handpiece activation icon remains illuminated Do not exceed the maximum number of usage cycles for the handpiece as specified in the Technical Data section 3 9 INSTALLING A PROBE ON THE HANDPIECE 1 Select the appropriate probe Refer to the Probe Compatibility Table section 2 Use the wrench to firmly tighten the appropriate probe on the handpiece Multiuse Torque wrench Figure 34 3 10 CONNE...

Страница 15: ...ears Figure 38 3 The console automatically performs a series of diagnostic tests 4 The console displays a green check mark for each successfully completed diagnostic test Incaseoferrormessages refertothetroubleshoo ting information provided on the screen or to the Troubleshooting section 5 The console is ready for use when all diagnostic tests have been successfully completed The touch screen can ...

Страница 16: ...the display language Refer to the Setting the Language section Brightness Use the and buttons to adjust the display brightness Volume Use the and buttons to adjust the volume Back To confirm and return to the previous screen Table 1 4 2 1 Choosing the Language 1 To access the language selection menu press From the READY screen ð ð From the STAND BY screen ð Table 2 ...

Страница 17: ...onsult its equipment data Figure 43 2 Select Console to view the installed software version number product serial number and cumulated treatment statistics Figure 44 3 Select Handpiece to view the handpiece serial number and cumulated treatment statistics Figure 45 4 Select Probe to view the probe reference number batch number probe dimensions and cumulated treatment statistics Figure 46 ...

Страница 18: ...ing section 1 From the STAND BY screen press the START button to access the READY screen 2 Insert the probe into a sterile receptacle of physio logical fluid 3 Use the 2 mode foot pedal 4 Press the pedal halfway STEP 1 to activate suction and make sure that suction is working properly fluid moving through the suction tube 1 Figure 47 5 Press the pedal completely STEP 2 to activate both suction and...

Страница 19: ... to configure the console parameters for each probe type 2 If a new probe is connected the system automati cally set the recommended treatment parameters of this probe Figure 50 3 All probe and handpiece usage information are automatically recorded in the console number of uses time of use etc 4 According to the type of treatment two pre settings are available Hard Stones Treatment Soft Stones Tre...

Страница 20: ...n integrated peristaltic pump device Treatment Efficiency Indicator To provide instant visual feedback about the efficiency of the treatment Green the treatment is working optimally Orange the treatment is working suboptimally Menu To return to the STAND BY screen from the READY screen Table 3 5 3 2 Hard Stones Treatment Settings 1 To use the hard stones pre settings press the HARD STONES TREATMEN...

Страница 21: ...EADY screen to start the treatment 2 Press the pedal halfway STEP 1 to activate the suction 3 Press the pedal completely STEP 2 to activate both suction and the energies 4 Release STEP 2 to deactivate energies 5 Release STEP 1 to deactivate suction Refer to the Functional Tests section for pedal use After 1 minute of inactivity the system automatically executes a purge and stops cooling the circui...

Страница 22: ...before starting this procedure 3 Tilt the stone catcher Figure 54 4 Press the pedal halfway STEP 1 for a few seconds to empty the suction circuit and reduce the level of water in the stone catcher 1 Figure 55 To accelerate the emptying procedure the stone catcher can be disconnected from the handpiece 5 The suction tubes must be cleared 6 Loosen the probe from the handpiece using one of the follow...

Страница 23: ...e is still on during this procedure Make sure that the lock icon is off Figure 59 1 Pull back the metallic part of the handpiece connector to disconnect the handpiece Figure 60 If the mechanical disconnection of the handpiece is not possible when the console is switched off refer to the Troubleshooting section 2 Plug the cap on the handpiece connector in the front panel Figure 61 ...

Страница 24: ...iew the statistics for the last 5 treatment sessions From the READY screen ð From the STAND BY screen Table 4 2 Information on the previous treatment sessions will be displayed Figure 62 3 Press NEXT PAGE to display more previous treatment data Figure 63 ...

Страница 25: ... section 6 6 CONSERVING THE STONE CATCHER CONTENTS If the stone fragments are to be kept for analysis close the receptacle with the yellow transport closing cap supplied with the stone catcher Figure 65 6 7 DISPOSING OF SINGLE USE COMPONENTS Dispose of single use components probe Stone Catcher and fluid management system in accordance with hospital protocol 6 8 SWITCHING OFF THE CONSOLE Make sure ...

Страница 26: ...h to remove gross contamination Rinse the product under running tap water for 20 seconds Immerse the product in 0 5 cleaning solution for 10 minutes Make sure that all surfaces are moistened EMS recommends using Neodisher MediClean at 30 C Rinse the product with a water jet pistol for 20 seconds while paying special attention to each gap slit or hidden surface Rinse the product under cold tap wate...

Страница 27: ... after disinfection Drying Drying of outside of instrument through drying cycle of the Washer Disinfector If needed additional manual drying can be performed using a lint free towel and filtered compressed air max pressure 3 bar The instrument must never be heated 138 C Step D Functional Testing Maintenance If stains are still visible on the product after cleaning disinfection the entire cleaning ...

Страница 28: ... cable 4 Plug the cap on the handpiece connector in the front panel Figure 70 5 Use a cleaning wipe with proven efficacy e g enzol 2 to clean the surfaces The housing of the console is not waterproof 6 To disinfect use 70 isopropyl alcohol or other EPA recognized surface disinfectant Be sure to carefully follow the instructions provided by the disin fection solution manufacturer ...

Страница 29: ...Regular maintenance is required for product to function properly 1 Empty the cooling liquid circuit Refer to the Product Storage and Shipping section for instructions on emptying the cooling liquid circuit 2 Place the console flat on its side Figure 71 3 Use the Torx tool size 20 to remove the water filter cover A 4 Push the colored ring with your left hand and simulta neously pull the plug to rem...

Страница 30: ...fuses with the fuse type specified on the identification plate at the rear of the console 4 Re insert the fuse drawer 5 If the fuses fail again please contact your local Boston Scientific sales representatives 8 3 DOWNLOADING LOGFILE Your local Boston Scientific sales representatives may request this procedure 1 Plug the USB key provided by EMS at the rear of the console 2 From the STANDBY screen ...

Страница 31: ...lug all cables at the rear of the console 2 Place the console on a flat stable surface 3 To remove the air vent plug push the grey ring with your left hand and simultaneously pull the plug Figure 76 4 Make sure that the metal locking device is in the down position Figure 77 5 Put the draining tube in a receptacle that is more than 600 ml in volume Figure 78 6 Connect the draining tube supplied wit...

Страница 32: ...plug 9 2 SHIPPING THE PRODUCT Before shipping the product follow the instructions provided in the Cleaning Disinfecting and Steril izing section To avoid damage pack the product and all acces sories in the original packaging Make sure to insert the air vent plug prior to packing and shipping the product ...

Страница 33: ...sentative for any product servicing or repairs Boston Scientific and EMS declines responsibility for the safety of the product and declares the warranty null and void if service or repair is carried out by an unauthorized third party or if non genuine spare parts are used It is mandatory to return your product in its original packaging By following these packaging guidelines your product shall be ...

Страница 34: ...ump 2 Make sure that the stone catcher roller clamp is not closed 3 Check that no clogging occurs in the handpiece or probe 4 Make sure that there are no leaks in the suction circuit 5 Replace the liquid collection pouch if it is full 6 Make sure that the stone catcher cover is fully tightened up to the stop 7 Make sure that the stone catcher is correctly tightened on the handpiece 8 Increase the ...

Страница 35: ...nformations might be incorrect Please contact your service center E009 Console internal communication error Please restart device Please contact your service center if the error persists E010 Pedal not detected Please verify that the connector of the pedal is connected to the console Please contact your service center if the error persists E016 No suction system has been detected Please restart de...

Страница 36: ... The handpiece temperature is rising and could be harmful Please let the system cool down Verify cooling tank water level and handpiece cord sealing Please check that after handpiece disconnection that the handpiece cooling circuit is dry Please contact your service center if the error persists E004 The handpiece temperature is high Treatment is still possible but verify cooling tank level E005 Ha...

Страница 37: ...uidance and manufacturer s declaration electromagnetic emissions The SWISS LITHOCLAST TRILOGY is intended for use in the electromagnetic environment specified below The customer or the user of the SWISS LITHOCLAST TRILOGY should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The SWISS LITHOCLAST TRILOGY use...

Страница 38: ...uality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 ...

Страница 39: ...broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered Immunity Test IEC 60601 Test Level Compliance level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 3 V rms 150 kHz to 80 MHz 6 V rms in ISM and amateur radio bands 3 V rms 150 kHz to 80 MHz 6 V rms in I...

Страница 40: ...f the measured field strength in the location in which the SWISS LITHOCLAST TRILOGY is used exceeds the applicable RF compliance level above the SWISS LITHOCLAST TRILOGY should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SWISS LITHOCLAST TRILOGY Table 9 Recommended separation distances between...

Страница 41: ...sories The use of accessories and cables other than those specified or sold by EMS as replacement parts may result in increased emissions or decreased immunity of this product Cables and accessories Maximum length Complies with Handpiece cord Pedal HDMI Sector cord 2 9 m 2 9 m 2 9 m 2 9 m CISPR 11 Class A Group 1 RF electromagnetic disturbance IEC 61000 4 2 Electrostatic discharge ESD IEC 61000 4 ...

Страница 42: ...ensions Ø5 X 20 mm CONSOLE Weight 13 5 kg Dimensions height 135 mm width 360 mm depth 420 mm OPERATING CONDITIONS Temperature 10 C to 30 C Relative humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa Max altitude 3000 m TRANSPORT AND STORAGE CONDITIONS Probes Stone catcher Fluid Management system Temperature 29 C to 38 C Relative humidity 10 to 90 Handpiece Temperature 29 C to 38 C Relative...

Страница 43: ...rking CSA marking with C identification for products in conformance with Canadian standards and US for products in conformance with US standards Batch Number DEKRA INMETRO identification for products in conformance with Brazilian electrical standards GOST R marking for products in conformance with Russian standards Lock icon Applied part type BF ...

Страница 44: ...uropean Union and other European countries with separate collection systems Equipotential plug Serial number Refer to the instruction manual Device requiring protective earth Input Fuse Risk of electric shock Emptying Filling Foot pedal connection Do not allow fingers to come into contact with moving parts Flow direction ...

Страница 45: ...r permeability USB connector HDMI connector Thermal disinfection 135 C Sterilizable at up to 135 C in the autoclave 2 STERILIZE Do not re sterilize Do not re use Do not use if package is damaged Refer to instruction manual Content STERILE EO Sterilized using ethylene oxide Use by Danger Table 11 ...

Страница 46: ...including interference that may cause undesired operation Any changes or modifications not expressly approved by Electro Medical Systems for compliance could void the user s authority to operate this equipment This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protectio...

Страница 47: ... may cause undesired operation of the device Under Industry Canada regulations the radio transmitter s in this device may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potential radio inter ference to other users the antenna type and its gain should be so chosen that the equivalent isotropically radiated power e i r p i...

Страница 48: ...v_A 01 ed 2017 09 Distributed by Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752 Customer Service 1 888 272 1001 Manufactured by EMS Electro Medical Systems SA Ch de la Vuarpillière 31 CH 1260 Nyon SWITZERLAND ...

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