medaxis Lucy Instructions For Use Manual

Microjet wound therapy
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Instruction for use US/EN
microjet wound therapy
microjet wound therapy
swiss medical technology

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Summary of Contents for medaxis Lucy

  • Page 1 Instruction for use US/EN microjet wound therapy microjet wound therapy swiss medical technology...
  • Page 3: Table Of Contents

    Connect the Lucy connecting tube with pump Attach the Lucy handpiece Placement of attached handpiece 11 Preparation for use/operating instructions for Lucy aspirator 120V Connecting the tube Connect Lucy microjet to mains Connect Lucy microjet to mains when using the aspirator...
  • Page 4 13 Wound treatment with DebriClip (aerosol insulation with mechanical wound cleansing) Debris and rising fluid removal with the Lucy microjet wound therapy system Mechanical treatment Adjustment of water jet intensity 14 Replace rinsing fluid 15 Error messages 16 General cleaning guidelines...
  • Page 5: Warnings And Safety Instructions

    Indicating useful information about the safe use of the device. The Lucy microjet wound therapy is approved exclusively for the use as described in these instructions for use. Medaxis can only guarantee the safe functioning of the system when is used in combination with the original Lucy microjet wound therapy accessories.
  • Page 6 Instructions for use. Subject to change. WARNING This manual must be read prior to the use of Lucy microjet wound therapy system. – – Please read and observe these warning and safety instructions before operation. These instructions for use must be –...
  • Page 7 The Lucy microjet wound therapy system has no user serviceable parts inside (open device with cover removed). – – For safety reasons, it is required that the Lucy microjet wound therapy device is repaired throughout its service life strictly and exclusively by Medaxis authorized service centers.
  • Page 8: Description

    2 Description Introduction Lucy is a microjet wound therapy system MWT with high precision micro water jet technology. It consists of Lucy microjet and the optional Lucy aspirator or Lucy trolley. The compact system produces a fine waterjet to clean acute and chronic wounds in a precise and tissue-preserving manner.
  • Page 9: Contraindications

    Compliance with the proper irrigation and wound therapy procedures and techniques remains the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based upon their own knowledge and experience. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 10: Overview Lucy Microjet

    Lucy contains items according to chapter 6 Lucy power cord, REF 2000.50XX Lucy foot on/off switch, REF 2000.5020 For country-specific power cord see chapter 17 For recurrent use, for multiple patients Bluetooth receiver medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 11 Pump / drive unit interface to microjet power unit / pump insert Lucy pump 2000.0200 single use, sterile Lucy pump, one day 2000.0201 one day use, multiple patients, sterile With protective cap medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 12 Lucy handpiece point jet REF 2000.0004 REF 2000.0003 Lucy connecting tube, REF 2000.0300 Sterile, details see chapter 8 ‚Replace rinsing fluid’ Vented spike Protective cover Clamp Connecting tube – Length 9.84" Connector to pump medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 13: Check Initial Delivery Lucy Microjet

    4 Check initial delivery Lucy microjet Check initial delivery Check the delivery package of Lucy microjet for completeness and general condition. Lucy microjet unit 1000.0000 with type label and transportation safety bolt Pole for rinsing fluid Knurled head screws for pole 8000.0001...
  • Page 14: Overview Lucy Aspirator 120V

    Connection to Lucy microjet Rail Compartment for accessories storage on/standby button Lucy aspirator unit Antistatic castors with brakes Back view Connection port for intermediate tube or filter Plug in for intermediate and power cord medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 15 Silicone tubing - Ø 7x12mm with 2 coupling pieces, 60cm Medela REF 077.0922 Coupling piece (to connect to competitor systems) Medela REF 077.1018 Disposable PVC Tubing, Ø 5.5x8.5mm, 180cm, non sterile Medela REF 077.0952 Plastic clampholder Medela REF 077.0521 medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 16: Check Initial Delivery Lucy Aspirator 120V

    6 Check initial delivery Lucy aspirator 120V Check initial delivery Lucy aspirator 120V Check the delivery package of Lucy aspirator 120V for completeness and general condition. Lucy aspirator base plate (with screws and washers) 8000.0006 1 Inlay for base plate...
  • Page 17: Optional Accessories

    Aeroguard Nebbia REF 2000.2003 Connection Lucy microjet/trolley Rail Storage for accessories Lucy trolley REF 1000.0500 (The installation of the Lucy trolley is the same as that of the Lucy aspirator) medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 18: Installation

    2. Unbag the device and foot switch from the cardboard box 1. Remove transportation safety bolt 3. Install pole for rinsing fluid, using the knurled head screw 2. Cover transportation safety hole with sticker medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 19: Installation Lucy Microjet To Aspirator

    9 Installation Lucy microjet to Lucy aspirator 9.1 Initial set up Lucy aspirator (same for trolley) Assemble Lucy base plate with the Lucy pole compartment unit: Place Lucy pole compartment approx. 4 inch above floor Lift Lucy base plate and align borings to bottom...
  • Page 20 Lift aspirator until screw heads Push aspirator towards pole until Tighten the four screws with are visible in the compartment screw heads are at limit stop allen key 4mm medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 21: Installing The Lucy Microjet With The Lucy Aspirator

    Get the allen key 6mm ready connection of the aspirator unit. and Lucy aspirator unit. for tightening. ↑ Lift and tighten the screw with Fully tighten the screw. the allen key 6mm. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 22: Preparation For Use/Operating Instructions For Lucy Microjet

    – – Open clamp and filter port (connection tube) – – Perform of wound treatment with micro jet (Lucy on/off with foot pedal / intensity level / distance – – and angle of micro jet to the wound) Remove handpiece –...
  • Page 23: Insert Lucy Pump

    CAUTION When the pump is not installed correctly, a leakage of the treatment fluid might occur. In this case do not use the device anymore and disconnect it from mains. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 24: Rinsing Fluid

    In chapter 23, you will find a list of rinsing fluids that are tested for compatibility with the Lucy microjet wound therapy system. NOTE: Approx. 1000ml rinsing fluid is used during 12 minutes of uninterrupted use on the highest intensity level.
  • Page 25: Attach The Connecting Tube

    Preparation for use of the Lucy microjet Attach the Lucy handpiece WARNING Use the handpiece solely in combination with Lucy pump and do not re-use (single use). 2. Attach the luer connection to the pump. Make sure the 1. Open sterile paunch. Recommen- connection is tightened securely.
  • Page 26: Preparation For Use/Operating Instructions For Lucy Aspirator 120V

    4. Connect disposable PVC tubing to the inlet port on the suction jar. 5. Connect the disposable bacteria filter with overflow protection to the vacuum inlet, marked with «inlet». medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 27 6. Connect the silicon tube with the 2 coupling pieces to the disposable bacteria filter with overflow protection. ↓ 7. Connect the other end of the silicon tube with the 2 coupling pieces to the suction jar vacuum inlet. Connected device medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 28: Connect Lucy Microjet To Mains

    Turn on Lucy microjet General Button Operation The Lucy microjet wound therapy system is a mains-powered devices. Before you plug in the device, please check that your local power supply is the same as the voltage given on the type label.
  • Page 29: Connect Lucy Microjet To Mains When Using The Aspirator

    Connect Lucy microjet to mains when using the Lucy aspirator - The Lucy aspirator is a mains-powered device. Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate.
  • Page 30: Wound Treatment With Lucy Microjet Wound Therapy System

    6. Start the treatment with either the pre-set intensity level for the chosen handpiece or set your desi- red intensity level manually. 7. Press the foot on/off switch and start the procedure with the Lucy microjet tangentially to the wound, nozzle distance at working distance to the wound as prescribed below. Guide the jet starting at the wound edge, and move the jet slightly back and forth.
  • Page 31: Optimal Working Parameters

    Working distance recommended Lucy power jet handpiece flat jet narrow REF 2000.0004 4-10cm Working distance recommended NOTE flat jet: The flat jet should be used like a spatula to the wound. (FIG) medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 32: Aerosol Containment During Wound Treatment (Optional Accessories)

    The Lucy DebriClip is an additional attachment for power jet hand- pieces and is used to reduce aerosols and to collect rinsing fluid with debris during mechanical wound cleansing if connected with suction unit or other suction pump.
  • Page 33: Wound Treatment With Debriclip (Aerosol Insulation With Mechanical Wound Cleansing)

    13 Wound treatment with Lucy DebriClip (aerosol insulation with mechanical wound cleansing) Basis: Lucy microjet wound therapy system ready for use 4. Optionen Remove Lucy DebriClip from packaging Open sterile package Snap the handpiece into the opening provided Remove the Lucy DebriClip from the...
  • Page 34: Debris And Rising Fluid Removal With The Lucy Microjet Wound Therapy System

    Not to be used with the point jet REF 2000.0003, since the point jet delivers a stronger and more intense water jet. If used in combination with Lucy DebriClip, the jet would be too close to the wound, much closer than the recommended minimum distance according to chapter «Optimal working parameter»...
  • Page 35: Adjustment Of Water Jet Intensity

    To increase the water jet’s intensity => press ‚+’ To decrease the water jet intensity => press ‚-’ CAUTION Switching off the device is possible at any time by pulling out the power plug. – – medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 36 Lucy microjet unit into standby mode and clamp the connecting tube. >3s 2. Take care of your patient according to your facility’s protocol. Steps after using Lucy pump, single use REF 2000.0200 3a. Remove all single patient use components in following order: Clost the clip.
  • Page 37 (Pull power cord) Steps after using Lucy pump, one day REF 2000.0201 Lucy pump, one day, can be used for multiple patients within one day. Therefore we recommend to keep all connections to the pump in place (rinsing fluid and connec- ting tube) until you either replace the pump or the rinsing fluid.
  • Page 38: Replace Rinsing Fluid

    3 seconds to set the power jet into standby mode. >3s 2. Prepare the new rinsing fluid bottle in order to keep the time to switching over as short as possible. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 39 4. Press to turn on power jet, and continue the treatment. If the foot on/off switch should not be connected anymore, follow the instructions ,connecting foot on/off switch’ in chapter 11. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 40: Error Messages

    Handpiece used multiple times or for too long Troubleshooting: Replace handpiece Handpiece missing or handpiece not recognized Troubleshooting: Replace handpiece. If the error can not be resolved, contact the Medaxis ser- vice department immediately. Nozzle blocked or motor overheated Troubleshooting: Change handpiece and pump if necessary. If the error can not be resolved, contact the Medaxis service department immediately.
  • Page 41: General Cleaning Guidelines

    Do not use cleaning agent/detergent based on phenol. – – Do not use steel brushes or steel wool for cleaning. – – Store medical products dry and dust free. – – medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 42: Disposables

    Exception – Lucy pump, one day The Lucy pump, one day, is intended to be used for multiple patients within one day. The sterile package for the pump contains a luer cap, which is intended to cover the luer connection for the handpiece between switching patients.
  • Page 43: Warranty, Maintenance And Checks

    Medaxis accessories with our appliances. In no event shall Medaxis AG be liable for claims which exceed the scope of warranty described inclu- ding liability for consequential damages, etc. The right to the replacement of faulty parts will not be recognized by Medaxis if any work has been carried out on microjet wound therapy system by un- authorized persons.
  • Page 44: Installation Or Replacement Of Battery On The Lucy Foot On/Off Switch

    Installation or replacement of battery on the Lucy foot on/off switch If the foot on/off switch needs a battery installation or replacement, turn on power jet by pressing the ON button, and follow the instructions below: 1a. Remove protective cover from foot on/off switch as shown (Phillips screw driver needed) 1b.
  • Page 45: Pairing Foot On/Off Switch With Lucy Microjet

    1b. Remove protective cover (phillips screw driver nee- ded). 2. Simultaneously press the on/standby and, „+“ buttons for > 1 second on Lucy power jet. 3. As soon as the symbol appears, press press the yellow button on the foot switch.
  • Page 46: Symbols On Lucy Microjet Display

    Symbols for the error messages are described in chapter 15 ,Error messages‘ Search for Bluetooth device for pairing Pressing the on/standby and ,+‘ buttons for > 1 s at Lucy microjet will show the ‚Search for Bluetooth device‘ sym- press bol for pairing a new or replacement of the foot on/off switch.
  • Page 47: Disposal

    Each time the device is switched on, a self-test is carried out which checks the internal functions of the power jet. Due to the device layout and construction design, Medaxis does not expect electrical safety to be affected at any time during the life of the product - provided that the microjet is e-paired throughout its service life strictly and exclusively by Medaxis authorized service centers and that it is used properly in accordance with the inten- ded use.
  • Page 48: Technical Specifications

    -20 until -40 kPa Operation below 2000 m (to sea level) Classification according to 60601-1 Medical equipment class I Continuous operation Protection class IP20 Applied part of aspirator device is DebriClip type B medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 49: Signs And Symbols

    / sterile to keep the device away weight of the system. packaging wrapped in a from sunlight. non-sterile protective pa- This symbol indicates ste- ckaging. rile barrier / sterile packa- ging. medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 50: Technical Documentation

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Lucy microjet wound therapy system, inclu- ding cables specified by the manufacturer. Otherwise, degradation of equipment performance could result.
  • Page 51 ISM band. RFID 13.56MHz, phase jitter modulation, max. Power: 200mW Service: Requirements for service personnel: The service personnel must be trained by Medaxis AG in order to service the Lucy microjet wound therapy system and its accessories. Medaxis AG will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information for Medaxis authorized service centers.
  • Page 52 The Lucy aspirator was tested according to IEC 60601-1-2:2014 + A1:2020 with the following limits: Emissions Test Compliance RF emissions Class A CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations / Complies flicker emissions IEC 61000-4-4 Immunity Test...
  • Page 53: Required And Optional Accessories

    Lucy handpiece flat jet narrow REF 2000.0004 Connecting tube Lucy connecting tube REF 2000.0300 Optional accessories AeroGuard Jellyfish REF 2000.2000 Lucy DebriClip REF 2000.4001 AeroGuard Nebbia REF 2000.2003 Lucy aspirator REF 1000.0801 medaxis Lucy microjet wound therapy MWT instruction for use...
  • Page 54 0.6m REF 8000.0010 Rinsing fluid The Lucy microjet wound therapy system was validated with the rinsing fluids listed below: NaCI 0.9% and ringer solution. There have been other rinsing fluids tested – please do not hesitate to contact us for further information.
  • Page 55 SAFETY INSTRUCTION Medaxis’ purpose of testing a variety of rinsing fluids is to make sure that these fluids work properly with microjet wound therapy system to not cause any harm to the system. In order to make sure the fluids you intend to use do not cause any harm to the patient, you must contact the manufacturer of the rinsing fluid.
  • Page 56 Medaxis AG, Bahnhofstrasse 9, 6340 Baar, Switzerland, info@medaxis.ch, www.medaxis.ch, T +41 62 823 88 00, F +41 62 823 88 01...

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