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Leica PROVIDO User Manual

Leica PROVIDO User Manual

Surgical microscope
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From Eye to Insight
PROVIDO
User Manual
10732418 - Version 03

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Summary of Contents for Leica PROVIDO

  • Page 1 From Eye to Insight PROVIDO User Manual 10732418 - Version 03...
  • Page 2 The information provided by this manual is directly related to the operation of the equipment. Medical decision remains the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user manual highlighting the key areas of product use. Should additional information regarding the use of the product be required, please contact your local Leica representative.

  • Page 3: Table Of Contents

    14.8 List of weights of balanceable configurations Adjusting the eyepiece 14.9 Dimensional drawings Selecting the assistant Annex Positioning on the operating table 15.1 Checklist before the operation Attaching sterile controls and drape Function check PROVIDO Ref. 10732418 / Version 03...

  • Page 4: Introduction

    About this user manual The availability varies from country to country and is subject to local regulatory requirements. Please contact your local In this user manual the surgical microscopes PROVIDO is described. representative for availability. Product identification In addition to notes on the use of the instruments this user manual gives important safety information (see chapter "Safety notes").

  • Page 5: Safety Notes

    Allocate responsibilities for commissioning, operation and particular the safety notes. maintenance. Monitor compliance with this. Only use the PROVIDO surgical microscope if it is free of defects. Intended use Inform your Leica representative or Leica Microsystems (Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland, •...

  • Page 6: Directions For The Operator Of The Instrument

    Complete all preparations and adjustments to the stand WARNING before the operation. Danger of injury due to the PROVIDO moving down! Never change the accessories or attempt to rebalance Never rebalance or re-equip with the instrument over the microscope while it is above the field of operation.
  • Page 7 Adjust the field of view to match the operating field. Irrigate the wound frequently. CAUTION Cover the exposed parts of the pinna with a moist Damage to the PROVIDO surgical microscope due to surgical sponge. uncontrolled tilting. Hold the handle when releasing the brake.
  • Page 8 CAUTION Do not set the light intensity too high. Damage to the PROVIDO surgical microscope during transportation! CAUTION Never move the stand in the extended condition.
  • Page 9 Take care of monitor movement when rotating the tower. The monitor will move together with the tower and can collide with other medical equipment or personnel. CAUTION Risk of damage. Only move the surgical microscope when all brakes are released. PROVIDO Ref. 10732418 / Version 03...

  • Page 10: Signs And Labels

    Safety notes Signs and labels 11,12, 17,20, 21,22, Monitor arm (optional) - see chapter 10 Recording system (optional) - see chapter 10 PROVIDO Ref. 10732418 / Version 03...
  • Page 11 Do not look at operating lamp. Eye injury may result. NOTICE UV emitted from this product. Minimise exposure to eyes or skin. Use appropriate shielding. Grounding label (only USA and Canada) System weight label PROVIDO Ref. 10732418 / Version 03...
  • Page 12 (only brazil) INMETRO label (only brazil) Lamp Switch Label Lamp On/Off LAN (Local Area Network) Label (Optional) UDI Label Device Identifier (DI) GS1 Data Matrix Code Production Identifier (PI) Serial number Date of manufacturing PROVIDO Ref. 10732418 / Version 03...

  • Page 13: Design

    4 Microscope carrier 5 Handles 6 Leica M530 optics carrier 7 Tubes 8 Video monitor (optional) 9 Base 10 Handrail 11 Documentation system (optional) 12 Control unit 13 Camera control unit (optional) 14 Horizontal arm PROVIDO Ref. 10732418 / Version 03...

  • Page 14: Leica M530 Optics Carriers

    Optional accessessories to the optics carrier and their functions are described in the corresponding user manual. • Optics carrier with integrated C-mount video adapter for installing a camera • Assistant interface, switchable either to the left or to the right side PROVIDO Ref. 10732418 / Version 03...

  • Page 15: Functions

    A and B balancing range. Balancing system A list of balanceable configurations is provided in the With a balanced PROVIDO you can move the optics carrier in any technical data (see page 62). position without tilting or falling down.
  • Page 16 Functions The PROVIDO tilts left: Turn rotary knob C (1) clockwise until the PROVIDO is in balance with the brakes released. The PROVIDO tilts right: Turn rotary knob C (1) counter-clockwise until the PROVIDO is in balance with the brakes released.

  • Page 17: Brakes

    Brakes Pull the stop lever (4) and rotate it into a horizontal position. The transport lock is released. The PROVIDO has 6 electromagnetic brakes which stop the Press the ALL-FREE button. movements of the stand and surgical microscope: This frees the D brake.
  • Page 18 In the Carrier Free mode the handle button has to be pressed only once while in the Focus Lock mode the handle button has to be pressed and held. It is advisable to ensure that the PROVIDO is in balance stage before turning ON this function. PROVIDO Ref. 10732418 / Version 03...

  • Page 19: Illumination

    Functions Illumination BrightCare Plus display The main illumination of the PROVIDO is a xenon lamp and is located in the stand. Illumination is routed to the optics carrier via fibre optic light guide. The backup lamp can be either another xenon lamp or a LED lamp.

  • Page 20: Leica Speedspot

    Controls Controls Leica SpeedSpot PROVIDO is equipped with the Laser focussing aid Leica SpeedSpot. PROVIDO microscope with arm If Leica SpeedSpot is activated for the current user (see page 46), the focussing aid is released when the brakes are released or when system focussing.
  • Page 21 2 LED Focus lock active 3 Receiver Remote Control Camera 4 Rotary knob "Working distance" (emergency operation only) 1 CAN socket (Leica M530 with Top plate and IVA530 only) 5 Rotary knob "Manual override AutoIris" 2 Optical fiber connection 6 Rotary knob "Magnification" (emergency operation only) 7 Button "Reset AutoIris"...

  • Page 22: Control Unit

    Controls Control unit Leica M530 with ULT530 / Leica FL560 for M530 or with Leica FL800 ULT 11 10 9 8 8 Button "Focus lock" (counter-sunk) 9 LED Focus lock active 10 Receiver Remote Control Camera 11 Rotary knob "Working distance" (emergency operation only) 12 Rotary knob "Manual override AutoIris"...

  • Page 23: Terminals

    6 Power cord cable clip to connect CAN devices DIC in Not active The PROVIDO has a primary illumination source and an AD.F. Additional Function equivalent standby illumination source. PROVIDO Ref. 10732418 / Version 03...

  • Page 24: Handles

    Handles – Joystick (available with premium handles only) Y– No function No function Focus + Focus – X– X– Zoom + Zoom – Y– Y– No function No function Handles – Buttons Magni- Working Magni- fication distance fication Selected brakes PROVIDO Ref. 10732418 / Version 03...

  • Page 25: Preparation Before Surgery

    • tilting of the stand • feet in lightweight shoes could become trapped beneath the base For transportation, always move the PROVIDO into the transport position. Never move the stand in the extended condition. Never roll over cables lying on the floor.

  • Page 26: Locking/Unlocking The Provido

    Firmly hold the handles before triggering the "All Brakes" function. Pull the transport lock (1) and bring it into a horizontal position. Ensure that the PROVIDO is in the transport position. Bring swing arm into transport position. Release the ALL-FREE button.

  • Page 27: Installing Optical Accessories

    Grip and turn one handle to release the brakes. the microscope while it is above the field of operation. At the same time, pull the transport lock (1) and bring it into a Before changing accessories, always lock the PROVIDO. vertical position. Balance the PROVIDO after re-equipping it.

  • Page 28: Setting The Binocular Tube

    Slowly turn the eyepieces towards –5 individually for each eye until the test object appears in sharp focus. Select the highest magnification and check the sharpness. 7.5.2 Adjusting the pupillary distance Rotate the eyecups up or down until the desired distance is set. PROVIDO Ref. 10732418 / Version 03...

  • Page 29: Selecting The Assistant

    Risk of damage to the surgical microscope due to collision. Make sure that there is free space of about 1 m around the foot. The PROVIDO can be positioned easily on the operating table and offers a variety of possibilities for operations on the head or spinal column.
  • Page 30 Preparation before surgery The PROVIDO achieves this large range of positions through its very long and high arm system. Release the footbrakes (see page 23). Move the PROVIDO carefully over to the operating table by the handle and into the required position for the operation.

  • Page 31: Attaching Sterile Controls And Drape

    Attach steam-sterilizable covers to accessories as well (if present). 7.8.2 Sterile drape for stand • Only use the sterile Leica tested drapes specified in the Accessories section. • Drape only as far as the arm system (see picture below). CAUTION Risk of infection.

  • Page 32: Function Check

    Attaching the protective glass to the objective Place the sterilized protective glass on the optics carrier so that the markings on the PROVIDO (1) and on the protective glass (2) are aligned. Insert the protective glass upwards into the bayonet mount in direction (a).

  • Page 33: Operation

    If a defective lamp is detected, a warning message is WARNING displayed. Danger of fatal electrical shock. The PROVIDO may be connected to a grounded socket Check the fiber optics cable connection to the optics carrier. only. Switch on the illumination with the key (3) on the control unit.

  • Page 34: Positioning The Microscope

    Release the brakes button. On the touch panel monitor in the "Main" menu screen Also refer to the "Handles" chapter on page 22. CAUTION Damage to the PROVIDO due to uncontrolled tilting. Hold the handle when releasing the brake. 8.2.2 Fine positioning (optional) Position the microscope with the XY drive using the joystick on the handle or the joystick on the footswitch.
  • Page 35 Click the grey "BrightCare plus" button again. When shipped from the factory, the "BrightCare Plus" safety "BrightCare plus" is now activated and the button is again lit function is activated for all users green. PROVIDO Ref. 10732418 / Version 03...
  • Page 36 Never begin a surgery with only one functioning xenon lamp. The LED can only be exchanged by a Leica Service person. A dialog window informs you when the xenon lamp is losing luminosity and is no longer sufficient. We recommend that you keep a replacement lamp handy.
  • Page 37 • These values can be saved individually for each user (see page 41). WARNING Danger to the patient due to failure of the magnification motor. If the magnification motor fails, adjust the magnification manually. PROVIDO Ref. 10732418 / Version 03...
  • Page 38 Press the working distance adjustment bar directly. the microscope to laser distance and lock the microscope The working distance changes. in position. Do not adjust the rotary button for manual setting of the working distance while using the laser. PROVIDO Ref. 10732418 / Version 03...
  • Page 39 Operation 8.3.7 Adjusting the video fine focus (optional) CAUTION The Leica FL800 ULT and ULT530 offer fine focusing and parfocality Destruction of the working distance motor. reset of the video focus. Only adjust the working distance manually if the working distance motor is defective.

  • Page 40: Transportation

    Operation Transportation Ensure that the PROVIDO is in the transport position (see section 7.1). Release the foot brakes by depressing the foot lever (see WARNING page 23). Danger of injury due to: Move the PROVIDO using the handrail. • uncontrolled lateral movement of the parallelogram Lock the footbrakes by pressing the foot lever (see page 23).

  • Page 41: Control Unit With Touch Panel

    2 Status line 3 Display range 4 Dynamic button bar 5 Warning messages In operational mode, the status line displays the current user and specifies the current location in the menu at all times. PROVIDO Ref. 10732418 / Version 03...
  • Page 42 Presets 9.2.2 User list You can find a list of default users preset by Leica for the most The "User List" opens a two-page user list from which you can common types of operation under "Presets". select one of up to thirty users that can be saved.

  • Page 43: Menu - User Settings

    Allows to rename, to move or to delete users. cables during the preparation of the system prior to the surgery. Not well fitted parts and bad connections can lead to hazardous situations and system failures. PROVIDO Ref. 10732418 / Version 03...
  • Page 44 "(locked)" right after the user setting name on the GUI main page or by a lock icon in front of the user setting name in the Select User page. Select a user and click the "Change Password" button. Follow the instructions on the screen. PROVIDO Ref. 10732418 / Version 03...
  • Page 45 "All Brakes" are released. This function is deactivated in the factory default configuration. Clicking the "WD Reset" button activates/deactivates the "WD Reset" function and the color of the button changes to green (activated) / gray (deactivated). PROVIDO Ref. 10732418 / Version 03...
  • Page 46 In the left selection field, select the function group with the desired functions. You can scroll forwards or backwards in the list by clicking the arrowheads. Select the desired function. Click the caption of the desired key to assign the selected function to it. PROVIDO Ref. 10732418 / Version 03...
  • Page 47 The inner switch (2) to which "Selected Brakes" is pre-assigned can be freely assigned, as required. You can also assign one of the three defaults "X/Y", "FL800" or "FL560" completely to each handle. PROVIDO Ref. 10732418 / Version 03...
  • Page 48 5 % to 100 % SpeedSpot Delay Default setting: 50 % each, so the AutoFocus window is For switching off Leica SpeedSpot, a timeout can be configurated exactly in the middle from 0 to 10 seconds. AF Mode (optional) Default timeout is 5 seconds.
  • Page 49 Enter the desired username using the keyboard. CAUTION Risk of damage. Only move the surgical microscope when all brakes are released. Click the "Save" button to save the user at the desired location under the name you have entered. PROVIDO Ref. 10732418 / Version 03...

  • Page 50: Menu - Maintenance Menu

    Whenever you replace a bulb, reset the bulb's hour meter to 0 by double-clicking the "Reset" button. A dialog window informs you when the xenon lamp is losing luminosity and is no longer sufficient. PROVIDO Ref. 10732418 / Version 03...

  • Page 51: Menu - "How To

    30°–150° and eyepiece with 10 magnification. This area is password-protected. Before starting the service menu, end the recording procedure on the documentation system. Otherwise data could be lost. PROVIDO Ref. 10732418 / Version 03...

  • Page 52: Accessories And Options

    10 Accessories and options Footswitches • Leica Wireless Footswitch, 14 functions, type B A comprehensive range of accessories enables the PROVIDO to be • Leica Wireless Footswitch, 12 functions, type B matched to the requirements of the task in hand. Your Leica...

  • Page 53: Care And Maintenance

    • Protect the surgical microscope from damp, vapors, acids, alkalis, and corrosive substances. The PROVIDO generally requires no maintenance. To ensure that it Do not keep chemicals near the instrument. always operates safely and reliably, we recommend that you take •...

  • Page 54: Changing Bulbs

    Care and maintenance 11.4 Changing bulbs PROVIDO with LED as lamp 2 The LED can only be exchanged by a Leica Service person. Before replacing the lamp, disconnect the surgical microscope from the power supply. 11.4.1 System without documentation system Open access door (2) for lamp insert by unscrewing knob (1).

  • Page 55: Circuit Breaker Switch

    Cleaning: automatically Products • Equipment: cleaning/disinfecting device Reusable products supplied by Leica Microsystems (Schweiz) AG It is not recommended to clean products with optical components such as rotary knobs, objective protective glasses and capping in a cleaning/disinfecting device. In addition, optical components pieces.
  • Page 56 Address of local agent Leica Microsystems (Schweiz) AG verified that the aforementioned instructions for the preparation of a product are suitable for its reuse. The processing person is responsible for reprocessing with the equipment, materials and personnel and for achieving the desired results in the reprocessing installation.

  • Page 57: Disposal

    (possibly additional video cable). PROVIDO was balanced in a locked state. Release the locking mechanism (see page 23) and balance the PROVIDO (see page  13). The microscope and microscope carrier Balancing has not been completed.

  • Page 58: Malfunctions Documentation Accessories

    The stand of the PROVIDO moves. Footbrakes not applied. Fix footbrakes in place (see page 23). The range of movement of the PROVIDO is Cable laid too tightly. Re-lay the cable (see assembly instructions PROVIDO). limited (swing, tilt, rotate, XY movement).

  • Page 59: Error Messages On The Control Unit

    Luxmeter defective error Photodiode in the optics carrier may be defective Plug in the light guide properly or contact your or the light guide is not fully plugged in. Leica Representative if error persists. PROVIDO Ref. 10732418 / Version 03...

  • Page 60: Specifications

    Laser focussing aid for fast and exact positioning of the microscope Laser Class 2 Wave length 635 nm Optical power <1 mW Fine focus Available for back side assistant Magnification 1.4× multiplier IR sensor For remote control of the Leica HD C100 PROVIDO Ref. 10732418 / Version 03...
  • Page 61 ULT with the Leica FL800 function Light distribution 50 % for main surgeon assistants switchable: Leica FL560 for M530 Leica FL560 observation filter module either 15% for side assistant or 30% for back assistant 14.2.4 Leica M530 optics carrier Camera image size with respect to the field of view •...

  • Page 62: Provido Floor Stand

    10 V rms Load Max. 8.5 kg from microscope dovetail ring interface • Rated Power-frequency Magnetic Field IEC 61000- Weight Approx. 350 kg without load 4-8: 30 A/m • Voltage dips and interruptions IEC 61000-4-11: according to IEC 60601-1-2:2014 PROVIDO Ref. 10732418 / Version 03...

  • Page 63: Standards Fulfilled

    Specifications 14.6 Standards fulfilled 14.7 Limitations of use The PROVIDO may be used only in closed rooms and must be placed CE conformity • Medical Devices Directive 93/42/EEC including amendments. on a solid floor. • Classification: Class I, in compliance with Annex IX, Rule 1 and The PROVIDO is not suitable for crossing thresholds higher than Rule 12 of the Medical Devices Directive.

  • Page 64: List Of Weights Of Balanceable Configurations

    Specifications 14.8 List of weights of balanceable configurations 14.8.1 Leica M530 with top plate and 180° Dual Stereo Attachment The 180° Dual Stereo Attachment is mounted on the Leica M530 with Beamsplitter and 180° Dual Stereo Attach. 1 Optics carrier...
  • Page 65 Specifications Equipment of PROVIDO Serial No........Max. load on microscope optics carrier: 8.5 kg Equipment of Leica M530 with Top plate and 180° Dual Stereo Attachment Installation Art. No. Description Comment / Restrictions Weight Total Top plate 10448692 0.22 kg 10446565 Beamsplitter 70/30 %...
  • Page 66 Specifications Equipment of Leica M530 with Top plate and ULT530 Installation Art. No. Description Comment / Restrictions Weight Total Video adapter Only 1 piece, left or right 10448215 0,74 kg 0,40 kg MVA/RVA Camera Recommended: Leica HD C100 0,12 kg...
  • Page 67 Leica M530 with IVA530. Inclined Tube Tube 30°-150° Straight Tube Tube 0°-180° Magn. Multipl. Camera Inclined Tube Tube 30°-150° 1 or 2 side assistants, Stereo Attachment switchable - only one active Straight Tube 45° Tube PROVIDO Ref. 10732418 / Version 03...
  • Page 68 Specifications   Equipment of PROVIDO Serial No........Max. load on microscope optics carrier: 8.5 kg Equipment of Leica M530 with IVA530 Installation Art. No. Description Comment / Restrictions Weight Total 10448691 IVA530 0.82 kg Binocular tube for main surgeon Maybe the orientation of the tubes must be adapted to balance the system.
  • Page 69 Specifications 14.8.3 Leica M530 with ULT530 or Leica FL800 ULT and Leica FL560 1 Optics carrier 2 ULT530 or Leica FL800 ULT 3 ULT530 combined with Leica FL560 NOTE Destruction of the ULT530 optics. Do not use any video adapter in combination with the ULT530.
  • Page 70 Specifications Equipment of PROVIDO Serial No........Max. load on microscope optics carrier: 8.5 kg Equipment of Leica M530 with ULT530 or with FL800 ULT Installation Art. No. Description Comment / Restrictions Weight Total M Interface to ULT530 10449022 S ULT530 1.64 kg...
  • Page 71 Load from previous page Total Load M = Must, O = Option, S = Selection NOTE Destruction of the ULT530 optics. Do not use the Zoom Video Adapter in combination with the Leica M530 with ULT530. PROVIDO Ref. 10732418 / Version 03...

  • Page 72: Dimensional Drawings

    Specifications 14.9 Dimensional drawings 90° 90° +32° -25° ±270° 90° +180° -150° ±45° 360° +95° -30° 90° 165° 1801 max. 1487 Dimensions in mm PROVIDO Ref. 10732418 / Version 03...
  • Page 73 Specifications 700×700 Dimensions in mm PROVIDO Ref. 10732418 / Version 03...

  • Page 74: Annex

    (if used) for cleanliness. Remove dust and dirt. Installing the accessories Lock the PROVIDO in place and install all accessories on the microscope so it is ready for use (see page 24). Position the handles as desired. Connect the footswitch, if used.
  • Page 75 PROVIDO Ref. 10732418 / Version 03...
  • Page 76 10732418en/03• Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2020 • Printed – 11.2020 – Subject to modifications. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH. Leica Microsystems (Schweiz) AG · Max Schmidheiny Strasse 201 · CH-9435 Heerbrugg T +41 71 726 3333 ·...

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