EMS Swiss LithoCast Trilogy FT-231 Instructions For Use Manual
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EMS Swiss LithoCast Trilogy FT-231 Instructions For Use Manual

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INSTRUCTIONS FOR USE
FT-231
FT-232

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Summary of Contents for EMS Swiss LithoCast Trilogy FT-231

  • Page 1 INSTRUCTIONS FOR USE FT-231 FT-232...
  • Page 2 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 3 Please Read this First! Thank you for purchasing this new EMS product. It meets Intended User the highest quality and safety standards. The product must be used by qualified operating room We would be pleased to answer your questions and we personnel (with extensive training in urology) in hospitals, welcome your suggestions.

  • Page 4: Table Of Contents

    16. SYMBOLS 6.2. DISCONNECTING THE HANDPIECE 17. APPENDIX 6.3. RECORDING TREATMENT DATA 17.1. PROBE COMPATIBILITY TABLE 6.4. DISCONNECTING THE STONE CATCHER 17.2. FCC AND IC 6.5. ELIMINATING THE STONE CATCHER CONTENTS SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 5: Safety Precautions

    1. SAFETY PRECAUTIONS EMS and the distributor of this product accept no liability for direct or consequential injury or damage resulting from improper use, arising in particular through non-observance of the operating instructions, or improper preparation and maintenance. Instructions for use are explicitly given at installation by an EMS representative.

  • Page 6: Components

    Fluid management system - optional USB key 2.5 L Demineralized water Stone catcher support Cooling system filling kit Power cord Wired pedal Draining tube External video cord - optional Cleaning brush Cleaning rod Figure 1 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 7 STERILE ZONE DESIGNATION STERILE STATE Standard wrench To be sterilized before use Stone catcher - optional Provided sterile Multiuse torque wrench To be sterilized before use Probe Provided sterile Unclogging rod To be sterilized before use Aspiration plug To be sterilized before use Handpiece To be sterilized before use Figure 2...

  • Page 8: Installation

    Do not tilt the console more than 10 degrees when there is water in the cooling system. Figure 6 Figure 4 1. To remove the air vent plug, push the grey ring and pull the air vent simultaneously. Figure 7 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 9 2. Fill the filling bottle and close it. 5. Push the filling tube into the filling inlet connector until it engages. Figure 8 Figure 11 6. Invert the filling bottle and squeeze it to fill the tank. Only use demineralized water to fill the cooling system.

  • Page 10: Connecting The Console To The Equipotential Conductor

    1. Connect the video cord to the HDMI connector at the rear of the console and to a video monitor that supports “Picture-in-Picture.” 2. Follow the instructions provided for the video monitor to select the video input. Figure 17 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 11: Installing The Pedal

    3. Follow the instructions provided for the in-house aspiration system. Case 2: Use of a sterile, single-use Stone Catcher provided by EMS (optional) 1. Screw the sterile connector of the stone catcher into the handpiece. Figure 19 The pedal can be placed in a protective bag (not supplied).
  • Page 12 2. Place the stone catcher output tube into the pump. Figure 27 2. Connect the stone catcher output tube end with the conical connector (A) to an external vacuum source. Figure 25 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 13: Installing The Single-Use Fluid Management System Set (Optional) And Replacement Pouch

    4. When the open pouch is filled, open the closed clamp 3.7. INSTALLING THE SINGLE-USE FLUID (B) first. MANAGEMENT SYSTEM SET (OPTIONAL) AND 5. Close the open clamp (C) (adjacent to the filled pouch). REPLACEMENT POUCH 6. The filled pouch can be exchanged for a new empty For the peristaltic pump device only pouch, using the Luer-lock connection.

  • Page 14: Installing A Probe On The Handpiece

    3.9. INSTALLING A PROBE ON THE HANDPIECE 1. Select the appropriate probe. Risk of contamination: do not use after the expiration date on the package label. Refer to the Probe Compatibility Table section. Figure 37 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 15: Getting Started

    4. GETTING STARTED 3. The console automatically performs a series of 4.1. STARTING THE DEVICE diagnostic tests. 1. Use the mains power switch located on the rear panel 4. The console displays a green check mark for each to switch on the console. successfully completed diagnostic test.
  • Page 16 To confirm and return to the previous screen. Back Table 1 4.2.1. Choosing the Language 1. To access the language selection menu, press: From the READY screen From the STAND BY screen ð ð ð Table 2 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 17: Equipment Data

    2. Click the language you want to select. 2. Select Console to view the installed software version number, product serial number, and cumulated treatment statistics. Figure 43 3. To confirm the selected language, click OK. Figure 46 3. Select Handpiece to view the handpiece serial number and cumulated treatment statistics.

  • Page 18: Treatment

    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. Figure 52 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 19: Probe Insertion

    • For pinch valve device 5.2. PROBE INSERTION Do not touch the probe during activation. If a probe breaks distally, use sterile grasping forceps to remove probe pieces from the urinary tract. 1. Throughout the entire treatment, keep the probe tips under endoscopic vision.
  • Page 20 3. If required, adjust any settings manually as described 3. If required, adjust any settings manually as described in the table above. in the table above. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 21: Adapting Suction Flow Rate

    5.4. ADAPTING SUCTION FLOW RATE 5.5. STARTING TREATMENT 1. Go to the READY screen to start the treatment. An excessively high suction level can impair the endoscopic vision, collapse an organ, or damage 2. Press the pedal halfway (STEP 1) to activate the the mucosa.

  • Page 22: Post-Treatment Procedure

    Figure 58 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. Figure 60 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 23: Disconnecting The Handpiece

    Figure 63 Figure 61 1. Pull back the metallic part of the handpiece connector to disconnect the handpiece. Figure 64 If the mechanical disconnection of the handpiece is not possible when the console is switched off, Figure 62 refer to the Troubleshooting section. 2.

  • Page 24: Recording Treatment Data

    From the STAND BY screen: ð Table 4 2. Information on the previous treatment sessions will be displayed. Figure 66 3. Press NEXT PAGE to display more previous treatment data. Figure 67 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 25: Disconnecting The Stone Catcher

    6.4. DISCONNECTING THE STONE CATCHER 6.8. SWITCHING OFF THE CONSOLE 1. Disconnect the stone catcher from the handpiece Make sure that the lock icon is switched off and from the fluid management system or from your before turning off the console. vacuum system.

  • Page 26: Cleaning, Disinfecting, And Sterilizing

    (max. pressure 3 bar). process The instrument must never be heated >138°C. Cleaning EMS recommends using Neodisher® MediClean as the cleaning agent as it has been used for the validation study. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 27 Miele 7735CD washing Compliant with EN ISO 11607 or EN 868. machine, and the cleaning agent Neodisher® Mediclean. EMS recommends using Neodisher® Mediclean for their products. Step F. Sterilization Sterilization of instruments by applying a fractionated...

  • Page 28: Console, Pedal, And Cart

    2. Disconnect the power supply connector before cleaning. Figure 73 3. Remove the protective bag from the pedal, if appli- cable. 4. Plug the cap on the handpiece connector in the front panel Figure 74 SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 29: Product Maintenance

    For the spare parts described below, please refer to the order form or contact your EMS authorized service center. 8.1. COOLING LIQUID CIRCUIT MAINTENANCE The cooling liquid and the water filter must be replaced every year.

  • Page 30: Replacing Fuses

    8. Refill the cooling system. Refer to the Filling the An EMS service center may request this procedure. Cooling System section. 1. Plug the USB key provided by EMS at the rear of the console. 2. From the STANDBY screen, select PARAMETERS 8.2.

  • Page 31: Product Storage And Shipping

    9. PRODUCT STORAGE AND SHIPPING Do not tilt or invert the console without first having 5. Put the draining tube in a receptacle that is more than emptied the cooling liquid circuit. 600 ml in volume. Always empty the cooling liquid circuit before longterm storage (2 weeks or more) or shipping to avoid damage to the console.

  • Page 32: Shipping The Product

    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. Figure 85 9. Re-insert the air vent plug. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 33: Product Disposal

    Repair can be refused for products or accessories any product servicing or repairs. You must complete the received in a contaminated condition. appropriate EMS form in order to be issued a Return When sending your product directly to the EMS autho- Material Agreement (RMA) number.

  • Page 34: Troubleshooting

    1. Make sure that the stone catcher tube is correctly inserted in the peristaltic pump/pinch valve. Only contact an EMS service center if none of the following instructions works. 2. Make sure that the stone catcher roller clamp is not closed.
  • Page 35 E010 - Pedal not detected. Please verify that the connector of the pedal is connected to the console. Please contact your EMS authorized service center if the error persists. E016 - No suction system has been detected. Please restart device or contact your EMS authorized service center if the error persists.
  • Page 36 E012 - Probe not detected. Please check that the probe is correctly installed on the handpiece. Please contact your EMS authorized service center if the error persists. E013 - Unknown probe. Please verify that the probe is a valid one or undamaged. Please contact your EMS authorized service center if the error persists.

  • Page 37: Former Electromagnetic Compatibility

    13. FORMER ELECTROMAGNETIC COMPATIBILITY The SWISS LITHOCLAST® TRILOGY should not be used adjacent to or stacked with another SWISS LITHOCLAST® TRILOGY. If adjacent or stacked use is necessary, the SWISS LITHOCLAST® TRILOGY should be observed to verify normal operation in the configuration in which it will be used. Guidance and manufacturer’s declaration –...
  • Page 38 SWISS LITHOCLAST® TRILOGY. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. UT is the A/C mains voltage prior to application of the test level. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 39 Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Compliant cables and accessories 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.

  • Page 40: New Electromagnetic Compatibility

    30 A/m istic of a typical location in a field typical commercial or hospital IEC 61000-4-8 environment. Table 14 UT is the A/C mains voltage prior to application of the test level. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 41 Proximity fields from RF wireless communications equipment TEST FREQUENCY IEC 60601 MODULATION (MHZ) TEST LEVEL Pulse modulation 27 V/m 18 Hz ± 5 kHz deviation 28 V/m 1 kHz sine Pulse modulation 9 V/m 217 Hz Pulse modulation 28 V/m 18 Hz 1720 Pulse modulation...

  • Page 42: Technical Data

    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 humidity: max 85% Console and its accessories Temperature: +5°C to +38°C Relative humidity: max 85% SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...

  • Page 43: Symbols

    16. SYMBOLS Manufacturer logo Product name Origin of the product CE symbol refers to directive 93/42/EC, including EN 60601-1 and EN 60601-1-2 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 Manufacturer...
  • Page 44 Fuse Risk of electric shock Emptying Filling Foot pedal connection Do not allow fingers to come into contact with moving parts Flow direction Minimum tank level indicator Maximum tank level indicator SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 45 Degree of protection against water permeability USB connector HDMI connector Thermal disinfection 135°C Sterilizable at up to 135°C in the autoclave Do not re-sterilize STERILIZE Do not re-use Do not use if package is damaged Refer to instruction manual Content Sterilized using ethylene oxide STERILE Use by...

  • Page 46: Appendix

    (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.) is not more than that necessary for successful communication. SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL...
  • Page 47 Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
  • Page 48 Fax +33 1 34 58 03 90 e-mail: info@ems-medical.de e-mail: info@ems-france.fr ITALY SPAIN EMS Italia S.r.l EMS Electro Medical Systems España SL Manufacturer EMS Electro Medical Systems SA Via Faravelli 5 Bernardino Obregón 14 bis Ch. de la Vuarpillière 31...

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