Leica ARveo User Manual
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Leica ARveo User Manual

Leica ARveo User Manual

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ARveo
User Manual
10 747 384 - Version 04

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  • Page 1 ARveo User Manual 10 747 384 - Version 04...
  • 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

    Function check 15.3 Table 4 from EN 60601-1-2 Operation Annex Switching the microscope on 16.1 Checklist before the operation Positioning the microscope Adjusting the microscope Transport position Shutting down the surgical microscope ARveo / Ref. 10 747 384 / Version 04...

  • Page 4: Introduction

    Enter this data in your user manual and always refer to it when In this user manual the surgical microscope ARveo is described. you contact us or the service workshop regarding any questions you may have.

  • Page 5: Safety Notes

    • Only original Leica replacement parts may be used in servicing documentation and for human medical treatment. the product. • The ARveo surgical microscope may be used only in closed • After service work or technical modifications, the device must rooms and must be placed on a solid floor.

  • Page 6: Dangers Of Use

    • tilting of the stand, Risk of infection. • trapping of feet in lightweight shoes beneath the casing Always use the ARveo surgical with sterile controls and a sterile drape. of the base. For transportation, always move the ARveo surgical microscope into the transport position.
  • Page 7 Do not set the light intensity too high. CAUTION Danger to the patient due to changes in the user settings. Never change the configuration settings or edit the user list during an operation. ARveo / Ref. 10 747 384 / Version 04...

  • Page 8: Signs And Labels

    Safety notes Signs and labels 16/17 ARveo / Ref. 10 747 384 / Version 04...
  • Page 9 US Info Label ANVISA Registration Label UDI Label Type label Device Identifier (DI) GS1 Data Matrix Code Production Identifier (PI) Serial number Date of manufacturing Follow the user manual ARveo / Ref. 10 747 384 / Version 04...
  • Page 10 Safety notes Monitor weight label Warning sign for squeezing hands or fingers For installation only ARveo / Ref. 10 747 384 / Version 04...

  • Page 11: Design

    3 Video monitor (optional) 4 Control unit with touch panel 5 Suspension device for footswitch 6 Illumination unit 7 Base 8 Interface panel 9 Lock (for installation purpose only) 10 Leica M530 Optics carrier ARveo / Ref. 10 747 384 / Version 04...
  • Page 12 13 Footbrake 14 Handrail 15 Monitor arm 16 Camera control unit (optional) 17 Recording unit (optional) With its open architecture the ARveo provides space for holding the camera and recording units. ARveo / Ref. 10 747 384 / Version 04...

  • Page 13: Leica M530 Optics Carrier

    • Main surgeon and back assistant interface, 360° rotatable both • Back assistant interface with fine focus knob • For use with Image Injection Module CaptiView The Leica Accessories functions are described in the corresponding user manuals. ARveo / Ref. 10 747 384 / Version 04...

  • Page 14: Functions

    On the arm system the direction of movement C is balanced. Balancing system With a balanced surgical microscope ARveo you can move the optics carrier in any position without tilting or falling down. After balancing all movements during operation only need a minor force.

  • Page 15: Brakes

    Selected Brakes – XYZ Free The following movements can be performed with the surgical The ARveo may be moved only with released brakes. microscope when the brake combination "XYZ Free" is activated: Do not perform any movements when the brakes are locked.

  • Page 16: Illumination

    Luminous energy This feature provides an augmentation in resolution and depth of The optics of the ARveo surgical microscope have a variable working field for an ideal 3-D optical image. distance of between 225 and 600 mm. The system is designed in...

  • Page 17: Leica Speedspot

    Leica SpeedSpot Leica M530 is equipped with the Laser focussing aid Leica SpeedSpot. If Leica SpeedSpot is activated for the current user (see page 49), the focussing aid is released when the brakes are released or when focussing. Two convergent light beams meet exactly in the focussing point of the microscope.

  • Page 18: Controls

    8 Fine focus back assistant 12 Switch for manual balancing of the B carriage 9 Button "AutoIris reset" 13 B carriage 14 Microscope carrier The Leica Accessories controls are described in the corresponding user manuals. ARveo / Ref. 10 747 384 / Version 04...

  • Page 19: Control Unit

    (Schweiz) AG may be connected to the foot/handswitch 1 and 2 (3) 21 22 and (4) terminals. ** not used 21 S-Video *** Only systems verified by Leica Microsystems (Schweiz) AG may be 22 HDMI connected here. 23 BNC AD.F. 1 and 2 are digital relay outputs that can switch 24 Ethernet*** 24 V/2 A.
  • Page 20 Würth 74271622 (tested ferrite) 29 Ethernet*** Würth 74271112 (tested ferrite) Ferrites with the same frequency/impedance charateristic can also be *** Only systems verified by Leica Microsystems (Schweiz) AG may be used. connected here. ARveo / Ref. 10 747 384 / Version 04...

  • Page 21: Stand

    4 Master switch for ARveo surgical microscope 5 Power supply 6 Equipotential bonding socket For connecting the ARveo to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). 7 Fuse box flap...

  • Page 22: Handles

    For the joystick and the other keys presets are available according to your task. Presets for Cranial / Spinal / ENT Handles – Joystick X– X– Y– Y– Handles – Buttons 1 Magnification 2 Working distance 3 Selected brakes ARveo / Ref. 10 747 384 / Version 04...

  • Page 23: Footswitch

    • 16 functions • lengthwise • lengthwise 1 Release "XYZ Free" brakes Footswitch • 16 functions • crosswise • Footswitches can be assigned individually for each user in the configuration menu. ARveo / Ref. 10 747 384 / Version 04...

  • Page 24: Preparation Before Surgery

    Always push the ARveo surgical microscope; never pull CAUTION Surgical microscope can move without warning. Always lock the footbrake when you are not moving In case the ARveo is not in transport position, refer to the system. section 8.4. Depress the footbrake at the front end (FREE).

  • Page 25: Installing Optical Accessories

    The stored value can be read out with "Show Settings". 7.3.2 Adjusting the tilt Hold the binocular tubes with both hands. Tilt the binocular tube upwards or downwards until a comfortable position for viewing is reached. ARveo / Ref. 10 747 384 / Version 04...

  • Page 26: Adjusting The Eyepiece

    This procedure has to be performed only once for each user. The measured value can be stored for each user in the "User Settings" menu under "Tube Settings" (see page 44). ARveo / Ref. 10 747 384 / Version 04...

  • Page 27: Selecting The Assistant

    Switch on the microscope, see section 8.1. Make sure that all accessories needed are installed and that they are in the permitted weight range (see "Specifications" on page 63). Align the accessories in working position. ARveo / Ref. 10 747 384 / Version 04...
  • Page 28 The balancing procedure can be canceled at any time using "Interrupt Balancing". The first balancing step is completed when the acoustic signal no longer sounds and the autobalancing push-button is no longer flashing. ARveo / Ref. 10 747 384 / Version 04...
  • Page 29 Press the autobalancing push-button on the control unit again. During the balancing procedure, the push-button flashes yellow and an acoustic signal sounds (can be deactivated in the service menu). ARveo / Ref. 10 747 384 / Version 04...
  • Page 30 A axis forwards Optics carrier tilting forwards move A axis back Make sure no accessories collide with the microscope during manual balancing. Check the balancing. Press the "All Brakes" button on the handle. ARveo / Ref. 10 747 384 / Version 04...
  • Page 31 Microscope is too light ouch "if Scope is Rising" key To balance the D axis when using accessories with different weights, the number of D axis weight disks can be adapted accordingly (see below). ARveo / Ref. 10 747 384 / Version 04...
  • Page 32 7.6.4 Changing the weight disk on the D axis Unscrew the hexagonal nut (4). If the ARveo cannot balance the accessories in use, a weight disk must be added to or removed from the D axis. CAUTION Danger of injury due to falling weight disk or cover.

  • Page 33: Positioning On The Operating Table

    Never carry out the intraoperative AC/BC balancing above the patient. The ARveo can be positioned easily on the operating table and offers a variety of possibilities for operations on the head or spinal column.

  • Page 34: Attaching Sterile Controls And Drape

    Only use the sterile Leica tested drapes specified in the Accessories section. WARNING Risk of infection. Always use the ARveo surgical with sterile controls and a CAUTION sterile drape. Risk of infection. Leave sufficient space around the stand to ensure that the sterile drape does not come into contact with 7.8.1...

  • Page 35: Function Check

    Attaching the protective glass to the objective Place the sterilized protective glass on the optics carrier so that the markings on the Leica M530 (1) and on the protective glass (2) are aligned. Insert the protective glass upwards into the bayonet mount in direction (a).

  • Page 36: Operation

    Operation Switching the microscope on WARNING Danger of fatal electrical shock. The ARveo surgical microscope may be connected to a grounded socket only. Operate the system only with all equipment in its proper position (all covers fitted, doors closed). WARNING Danger of injury to the eyes due to possibly hazardous optical infrared and UV radiation.

  • Page 37: Positioning The Microscope

    Begin with the lower-intensity light source and slowly increase it until the operating physician has an optimally illuminated image. ARveo / Ref. 10 747 384 / Version 04...
  • Page 38 It is advisable to begin with a low light output and increase green. the light intensity until an optimum level of illumination is achieved. When shipped from the factory, the "BrightCare Plus" safety function is activated for all users. ARveo / Ref. 10 747 384 / Version 04...
  • Page 39 We recommend that you keep a replacement lamp handy. CAUTION Hot lamp insert can cause burns. Do not touch the hot lamp insert. Push up or down the lamp quick changer (4). ARveo / Ref. 10 747 384 / Version 04...
  • Page 40 Do not set the light intensity too high. Thanks to AutoIris, the field diameter is automatically adapted to the size of the field of view at the Leica M530 Optics carrier. To adjust the illumination field diameter manually, use rotary button (2).
  • Page 41 Set the desired magnification by turning the knob. Press the button on the bar for adjusting the working distance. – or – Press the working distance adjustment bar directly. The working distance changes. ARveo / Ref. 10 747 384 / Version 04...
  • Page 42 Do not adjust the rotary button for manual setting of the working distance while using the laser. NOTE Destruction of the working distance motor. Only adjust the working distance manually if the working distance motor is defective. ARveo / Ref. 10 747 384 / Version 04...

  • Page 43: Transport Position

    Transport position 8.3.7 Adjusting the video focus (optional) The Leica FL800 ULT and ULT530 and as well GLOW800 offer fine Press the "All Brakes" button and move the ARveo into the focusing and parfocality reset of the video focus. transport position.

  • Page 44: Control Unit With Touch Panel

    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. ARveo / Ref. 10 747 384 / Version 04...
  • Page 45 Presets The "User List" opens a two-page user list from which you can You can find a list of default users preset by Leica for the most select one of up to thirty users that can be saved. common types of operation under "Presets".

  • Page 46: Menu - User Settings

    "Edit User List" Allows to rename, to move or to delete users. ARveo / Ref. 10 747 384 / Version 04...
  • Page 47 If the re-entered password/PIN does not match the enter/re-enter process has to be repeated. If no password/PIN should be defined, you can exit the procedure by pressing "Skip" or before re-entering with "Cancel". ARveo / Ref. 10 747 384 / Version 04...
  • Page 48 The button for the preselected brake combination lights up the factory default configuration. green. Clicking the "WD Reset" button activates/deactivates the "WD Reset" function and the color of the button changes to green (activated) / gray (deactivated). ARveo / Ref. 10 747 384 / Version 04...
  • Page 49 You can also connect the optional 6-function footswitch to the Function" element - which can be found in all function groups - ARveo. The 6 available switches work similar to those of the and assign it to the key in question.
  • Page 50 The inner switch (2) to which "Selected Brakes" is pre-assigned can be freely assigned, as required. You can also assign one of the five defaults "X/Y", "FL400", "DIC", "GLOW800" or "FL560" completely to each handle. ARveo / Ref. 10 747 384 / Version 04...
  • Page 51 AF Mode SpeedSpot Delay Select from the following: Active, Not active For switching off Leica SpeedSpot a timeout can be configurated from 0 to 10 seconds. Break starts AF Default timeout is 3 seconds. When activated, releasing the breaks starts the AutoFocus function.

  • Page 52: Menu - Maintenance Menu

    (FL400 application only) or for white light (all other Click the "Save" button to save the user at the desired location applications). under the name you have entered. ARveo / Ref. 10 747 384 / Version 04...
  • Page 53 The comment "Tested" appears in If you do not make a selection, the magnification is the caption field of the key. calculated for the standard equipment: binocular tube 30°–150° and eyepiece with 10 magnification. ARveo / Ref. 10 747 384 / Version 04...

  • Page 54: Menu - "How To

    Press the button for the topic desired. Detailed information "How to ..." is displayed. The "Help" button in the static menu bar provides access to the "How To..." screens at all times. ARveo / Ref. 10 747 384 / Version 04...

  • Page 55: Accessories

    Devices and accessories A comprehensive range of accessories enables the ARveo surgical microscope to be matched to the requirements of the task in hand. Your Leica representative will be pleased to help you select the Mouth Switch appropriate accessories. 10.1 Devices and accessories...

  • Page 56: Devices And Accessories From Leica And 3Rd Party Manufacturers

    • Wireless Footswitch, 14 functions • Wireless Footswitch, 12 functions Cart • ITD for 31" and 55" Monitor See the corresponding instruction for use. Do not use third party products without premission of Leica. ARveo / Ref. 10 747 384 / Version 04...

  • Page 57: Care And Maintenance

    Care and maintenance 11 Care and maintenance 11.2 Cleaning the touch panel Before cleaning the touch panel, switch off your ARveo and 11.1 Maintenance instructions disconnect it from the power supply. Use a soft, lint-free cloth to clean the touch panel.

  • Page 58: Maintenance

    Press the "Close" button. The dialog window is closed. Replace the defective lamps. Before replacing the lamp, disconnect the surgical microscope from the power supply. Press the "CONFIRM" button. The dialog window is closed. ARveo / Ref. 10 747 384 / Version 04...

  • Page 59: Changing Fuses

    PRIM T6.3 AH 250V Main Xenon Power Supply F5, F6 PRIM T6.3 AH 250V Main Xenon Power Supply F7, F8 PRIM T6.3 AH 250V Video System T4 AH 250V Video System ARveo / Ref. 10 747 384 / Version 04...

  • Page 60: Notes On Reprocessing Of Resterilizable Products

    Rinse surface contamination off of the product (temp. < 40 °C). Use some rinsing agent depending upon degree of contamination. Alcohol may also be used to clean the optics if heavy contamination such as fingerprints, grease streaks etc. is present. ARveo / Ref. 10 747 384 / Version 04...

  • Page 61: Disposal

    Systems. Follow the instructions for use of your STERRAD® System User's Guide prior to sterilizing devices in STERRAD® Systems. 12 Disposal The respective applicable national laws must be observed for disposal of the products, with the involvement of corresponding disposal companies. The unit packaging is to be recycled. ARveo / Ref. 10 747 384 / Version 04...

  • Page 62: What To Do If

    (see page 39). No XY movements possible at one of the No XY movements configured for the Set the joystick to XY movement (see page 48). two handles. handles in the control unit. ARveo / Ref. 10 747 384 / Version 04...
  • Page 63 D axis cannot balance the installed page 30). accessories. ARveo was balanced in the transport Take the ARveo out of transport position and rebalance position. Iris does not follow magnification AutoIris in override mode Press the AutoIris reset button.

  • Page 64: Malfunctions Documentation Accessories

    The push button for Illumination on/off flashes. "Luxmeter is defective" Contact your Leica representative. "Microscope device controller not available" Contact your Leica representative. ARveo / Ref. 10 747 384 / Version 04...

  • Page 65: Specifications

    Laser Class 2 Wave length 635 nm Optical power <1 mW Fine focus Available for back assistant Magnification 1.4× (optional) multiplier IR sensor For remote control of the Leica HD C100 ARveo / Ref. 10 747 384 / Version 04...
  • Page 66 The values above contain a tolerance of ±5 % Binocular tubes Binocular tube Focal length Art. No Type A f162.66 10447701*, 10446575*, 10448088, 10446574, 10446587, 10446618 Type B f170.0 10446797, 10448159*, 10448217* * not recommended ARveo / Ref. 10 747 384 / Version 04...
  • Page 67 14.2.4 IGS Interface/ Open architecture for IGS systems Compatibility Please ask your Leica representative. 14.2.5 Lasers Interface/ Open architecture for laser systems Compatibility Please ask your Leica representative. ARveo / Ref. 10 747 384 / Version 04...

  • Page 68: Ambient Conditions

    12 VDC, 19 VDC and AC terminals Carrier for monitor 700 mm long and flexible arm with 4 axis for rotation and inclination to carry optional video monitor Materials All solid metal construction ARveo / Ref. 10 747 384 / Version 04...

  • Page 69: Standards Fulfilled

    ISO 13485 relating to quality management, quality assurance and environmental management. 14.5 Limitations of use The ARveo may be used only in closed rooms and must be placed on a solid floor. The ARveo is not suitable for crossing thresholds higher than 20 mm.

  • Page 70: List Of Weights Of Balanceable Configurations

    3 Leica ULT530 or GLOW800 or Leica FL800 ULT 4 Leica FL400/FL560 Stereo Attachment Optional: Side assistant Inclined Tube Tube 30°-150° Straight Tube Magni cation 45° Tube Multiplier Tube 30°-150° Tube 0°-180° Tube 0°-180° CaptiView Tube 30°-150° FL400/FL560 ARveo / Ref. 10 747 384 / Version 04...
  • Page 71 Leica HD C100 with external Power Supply (PIZOL) 10449017 Leica HD C100 without external Power Supply (PIZOL) M = Must, O = Option, S = Selection continued on next page Load ARveo / Ref. 10 747 384 / Version 04...
  • Page 72 M = Must, O = Option, S = Selection Load NOTE Destruction of the ULT530 optics. Do not use any video adapter in combination with the Leica M530 with ULT530 and CaptiView or GLOW800. ARveo / Ref. 10 747 384 / Version 04...

  • Page 73: Dimensional Drawings

    Specifications 14.7 Dimensional drawings ±270¡ ±50¡ ±50¡ ±40¡ +120¡ -30¡ ±360¡ Dimensions in mm ARveo / Ref. 10 747 384 / Version 04...
  • Page 74 Specifications 2685 1200 max. 1925 720 x 720 Dimensions in mm ARveo / Ref. 10 747 384 / Version 04...
  • Page 75 Specifications ARveo / Ref. 10 747 384 / Version 04...

  • Page 76: Manufacturer's Declaration Of Electromagnetic Compatibility (Emc)

    Guidance and manufacturer's declaration – electromagnetic emissions The ARveo surgical microscope is intended for operation in an environment as specified below. The customer or the user of the ARveo surgical microscope should make sure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 77 - interruptions on the HD Montior Non of the listed effects above have an impact on the essential performance or safety and effectiveness of the ARveo surgical microscope. Its no unacceptable risk for User, Patient or environment to be expected.
  • Page 78 If use is made of accessories or cables other than those specified in this user manual or approved by the manufacturer of the ARveo surgical microscope, this can lead to an increase in electromagnetic radiation or a reduction in EMC.

  • Page 79: Annex

    Safety check Check counterweights and accessories for secure seating. Positioning at the OP table Position the ARveo on the OP table as required and lock the foot brake (see page 31). Sterility Fit sterile components and sterile drape if used (see page 32).
  • Page 80 10 747 384 - 04en 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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