Summary of Contents for Leica Microsystems PROVEO 8x
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From Eye to Insight PROVEO 8x User Manual 10 735 160 version 02 Date of issue: 2025-01-21 0123...
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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.
3D Camera and Heads-Up Display 9.18 Hospital IT 9.19 User Management Controls 9.20 Support PROVEO 8x optics carrier including focus, tilt and XY with 2D4K IVC Phaco/VR PROVEO 8x optics carrier including focus, tilt and XY with 3D4K IVC Accessories Surgeon panel 11.1...
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Microscope features 15.2 Optical data 15.3 Microscope carrier 15.4 Camera 15.5 Floor stand 15.6 Ambient conditions 15.7 Standards fulfilled 15.8 Dimensional drawings Electromagnetic compatibility (EMC) Annex 17.1 Checklist before the operation PROVEO 8x / Ref. 10 735 160 / 02...
The availability varies from country to country and is subject to local regulatory requirements. Please contact your local representative In this user manual the surgical microscope PROVEO 8x is described. for availability. In addition to notes on the use of the instruments, this...
Indications for use • It is available on the floor stand. • The floor stand is for the positioning of the PROVEO 8x in the The PROVEO 8x surgical microscope is used for surgical procedures room.
Connect this equipment only to a supply mains with arrangement. protective earth. Directions for the operator of the Only use the PROVEO 8x surgical microscope if it is free of instrument defects. Inform your Leica representative or Leica Microsystems Follow the instructions described here.
Photochemical retinal damage is a possible complication of the necessity to use bright light to make eye structures visible during difficult ophthalmological processes. PROVEO 8x / Ref. 10 735 160 / 02...
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Always lock the parallelogram: CAUTION • when transporting the microscope Damage to the PROVEO 8x surgical microscope due to • when re-equipping uncontrolled movement! Hold the handle when releasing the brake. WARNING Risk of injury from parts falling down!
The surgical microscope can collide with surrounding components, the ceiling or lamps. Check the danger area before moving the swing arm. 3.11 MRI Safety Information The PROVEO 8x surgical microscope is Magnetic Resonance (MR) Unsafe. PROVEO 8x / Ref. 10 735 160 / 02...
Safety notes 3.12 Signs and labels 3.12.1 Floor stand PROVEO 8x / Ref. 10 735 160 / 02...
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à une prise équivalente, marquée "Hôpital seulement" ou "Qualité SIP/SOP warning Non-Protected Signal Inputs/Signal Outputs hôpital". label Entrées/sorties de signal non protégées 无保护信号输入/信号输出 PROVEO 8x / Ref. 10 735 160 / 02...
3 Stand monitor 4 Control unit with touch panel 5 Integrated video camera (IVC) 6 Footbrake 7 Base 8 Terminals (e.g. electrical, video, etc.) 9 Handrail 10 Monitor arm 11 Speaker PROVEO 8x / Ref. 10 735 160 / 02...
PROVEO 8x 2D 4K IVC • Optics carrier with integrated 2D 4K camera and integrated inverters 4.2.2 PROVEO 8x 3D 4K IVC • Optics carrier with integrated 3D 4K camera and integrated inverters PROVEO 8x / Ref. 10 735 160 / 02...
With a balanced surgical microscope PROVEO 8x you can move the The electromagnetic brakes can be released via handle or nurse optics carrier to any position without tilting or moving down.
Refer to the monitor's user manual on how to prevent such issue. The binoculars on the PROVEO 8x 3D 4K IVC can be removed to provide an unblocked full 3D heads-up surgical experience. For more instructions, refer to the heads-up ophthalmology instructions 10735165 distributed separately.
Balancing the parallelogram (see chapter 7.8.1 "Balancing the parallelogram", page 31). 1 Equipotential bonding socket For connecting the PROVEO 8x to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7).
LAN*: to connect to DICOM/Hospital network PHACO/VR: to connect to a phacoemulsification/vitreoretinal surgical device (Leica compatible) connect medical equipment only The following devices can only be connected to the PROVEO 8x surgical microscope if they are certified accordingly: Device Signal Voltage output...
OCT mode on/off* All Lights On/Off OCT mode on/off* Handles Handles Selected Brake OCT Overlay* OCT Overlay* Selected Brake All Brakes All Brakes All Brakes All Brakes * When OCT is available. PROVEO 8x / Ref. 10 735 160 / 02...
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OCT mode on/off* VR Mode On/Off OCT mode on/off* Handles Handles OCT Overlay* Selected Brake Selected Brake OCT Overlay* All Brakes All Brakes All Brakes All Brakes * When OCT is available. PROVEO 8x / Ref. 10 735 160 / 02...
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OCT mode on/off* Quick Tilt OCT mode on/off* Handles Handles Selected Brake OCT Overlay* OCT Overlay* Selected Brake All Brakes All Brakes All Brakes All Brakes * When OCT is available. PROVEO 8x / Ref. 10 735 160 / 02...
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OCT mode on/off* Red reflex On/Off OCT mode on/off* Handles Handles OCT Overlay* Selected Brake Selected Brake OCT Overlay* All Brakes All Brakes All Brakes All Brakes * When OCT is available. PROVEO 8x / Ref. 10 735 160 / 02...
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OCT Next Procedure OCT Z – OCT Z+ OCT Optimize Image OCT Auto Locate OCT Mode On/O OCT Live Mode/Stop OCT Down Handles Change View OCT Frame Forward OCT Frame Backward All Brakes PROVEO 8x / Ref. 10 735 160 / 02...
Always lock the footbrake when you are not moving the system. CAUTION Damage to the PROVEO 8x surgical microscope due to In case the PROVEO 8x is not in transport position, refer to uncontrolled movement! chapter 8.5 "Transport position", page 40. Hold the handle when releasing the brake.
• If necessary, wipe dust from the cover using a soft cloth. WARNING Risk of injury from parts falling down! Before the operation, make sure that the optical components and accessories are sufficiently secured and cannot move. PROVEO 8x / Ref. 10 735 160 / 02...
7.4.2 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. PROVEO 8x / Ref. 10 735 160 / 02...
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. PROVEO 8x / Ref. 10 735 160 / 02...
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Change the 0° assistant to another position The top (2) is lifted. The 0° assistant can be positioned on the left and on the right side. Unlock knob (1). Remove the dummy laser filter (3). PROVEO 8x / Ref. 10 735 160 / 02...
Remove the filter cover (1). Push in the filter slide, inclined slightly upwards, until it engages. When the desired position is reached, push the top down and lock the knob (1) again. PROVEO 8x / Ref. 10 735 160 / 02...
Microscope drifts downwards: Move the parallelogram up and down until the transport lock Turn balancing knob (2) clockwise. engages. Microscope drifts upwards: The parallelogram is now locked. Turn balancing rotary knob (2) counterclockwise. PROVEO 8x / Ref. 10 735 160 / 02...
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The handles can be individually assigned up to 4 functions for each user in the "User Settings" menu. The function "All Brakes" must be selected at least once. Selected brake can be configured by a qualified person only. PROVEO 8x / Ref. 10 735 160 / 02...
• The instrument must be positioned such that the range of movement is large enough for the expected tasks. Press the foot pedal at the front end (2) (lock closed) until the footbrake engages. PROVEO 8x / Ref. 10 735 160 / 02...
Attach steam-sterilizable covers on the handles, rotary knob for (1) and the external hard disk storage compartment opening (2) Red Reflex illumination diameter and rotary knob "Magnification". Attach steam-sterilizable covers to accessories as well (if present). PROVEO 8x / Ref. 10 735 160 / 02...
2–3 min for the microscope to boot-up completely and do not touch the microscope before it is ready. To avoid malfunctions, please always make sure the microscope is properly start up and shut down especially if OCT is connected. PROVEO 8x / Ref. 10 735 160 / 02...
Adjusting the tilt angle CAUTION Reset button for focus (line shows position of focus) Damage to the PROVEO 8x surgical microscope due to uncontrolled movement! Hold the handle when releasing the brake. PROVEO 8x / Ref. 10 735 160 / 02...
• Tilt angle range of movement is limited to +/– 10 degrees under VR mode. • Tilt movement is disabled with the electrical BIOM connected. • Attachment of Enfocus scan head does not limit the tilt angle range of movement. PROVEO 8x / Ref. 10 735 160 / 02...
Depending on the footswitch/handle assignment (see chapters 9.8 "Footswitch assignments", page 46 and 9.9 "Handle assignment", page 47), the brightness of the illumination can also be increased and decreased. Use the correspondingly assigned buttons on the footswitch/handle. PROVEO 8x / Ref. 10 735 160 / 02...
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49). • You can return the focus motor to the middle position by pressing the "Reset Focus" key on the touch panel of the control unit or on the surgeon panel. PROVEO 8x / Ref. 10 735 160 / 02...
Unplug and secure the power cable. Store the footswitch on the stand. NOTE Make sure that the video monitor does not collide with the parallelogram of the stand. Strap the monitor cover onto the stand monitor. PROVEO 8x / Ref. 10 735 160 / 02...
10" monitor can be switched over to the stand monitor. After adjusting the settings, tap the "Save" button (2) to save and persist the settings to the active surgeon profile. PROVEO 8x / Ref. 10 735 160 / 02...
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Patient Information Allows you to toggle between scene files and adjust the camera settings. By default, patient information is set to anonymous. Click on "Anonymous" to access and edit the patient details. PROVEO 8x / Ref. 10 735 160 / 02...
"Preset -". Tap on a surgeon profile to make that selection active. PROVEO 8x surgical microscope is ready to use. The system will ask you to confirm that you are changing profiles. PROVEO 8x / Ref. 10 735 160 / 02...
Changes to the profile can be done during the operation but will not be stored unless saved with the correct passcode. To overwrite and save settings to the selected surgeon profile, select "Save" in the bottom right corner of the screen. PROVEO 8x / Ref. 10 735 160 / 02...
Settings of default users preset by Leica cannot be overridden and saved. Save applies not only to changes on the current surgeon setting page but also to all adjusted surgeon profile settings. The "Surgeon Settings" screen is displayed: PROVEO 8x / Ref. 10 735 160 / 02...
• All Inverters On/Off • Main Inverters On/Off You can navigate the different categories through the tabs. • Camera Aperture+ Select the desired function. • Camera Aperture- Tap the "Confirm" button". PROVEO 8x / Ref. 10 735 160 / 02...
You can change the status of a function with the "Toggle" function (e.g. on/off or next). The "Pulse" function continuously changes a status (such as increasing the brightness). To remove an assignment, select the "Delete" button. PROVEO 8x / Ref. 10 735 160 / 02...
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• All Inverters On/Off • OCT Interface On/Off • Main Inverters On/Off • Camera Aperture+ • Camera Aperture- Others • All Brakes • Selected Brakes • Start/Stop Recording • Playback Start/Pause PROVEO 8x / Ref. 10 735 160 / 02...
It can be set to a desired value by directly clicking the bars. Focus Linked to Zoom When activated, the focus speed depends on the magnification: • low magnification – fast focus speed • high magnification – slow focus speed PROVEO 8x / Ref. 10 735 160 / 02...
If you move the PROVEO 8x back downwards across the operating • When Quick Focus and Quick Tilt are activated, they will field, the illumination switches on and the PROVEO 8x is ready to automatically reset to a deactivated state when switching to a operate immediately.
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To perform white balancing in anterior mode, use the light source (main and Red Reflex illumination) from PROVEO 8x. To perform white balancing in posterior mode, use only the light source which is used in the posterior segment surgical workflow.
"VR Mode On/Off" on footswitch/handles control again to deactivate VR mode. The microscope undoes all actions again. When an electrical BIOM is in use the VR mode is automatically activated/deactivated. PROVEO 8x / Ref. 10 735 160 / 02...
Press the "OCT" button on the "Quick Access" page, toolbar on stand monitor or "OCT Mode On/Off" on footswitch/handles control again to deactivate OCT mode. The microscope undoes all actions again. PROVEO 8x / Ref. 10 735 160 / 02...
When switching through the Combination Mode function, The VR Synchronized Focus+ / VR Synchronized Focus– only the actively set parameters for the individual user are synchronizes the focusing of both the PROVEO 8x optics carrier and activated. BIOM front lens, providing the following: Navigate between each step by tapping the step number at the •...
• Main Light and Red Reflex Light intensity will revert to values before Combination Mode is activated. • Magnification and Focus values will remain as per the last Combination Mode step settings. PROVEO 8x / Ref. 10 735 160 / 02...
"Include Overlay in Recording" is set as OFF. PROVEO 8x automatically starts video recording when the surgeon pulls the parallelogram down and stops video recording when the parallelogram is pushed up into the "auto-reset" position.
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Surgeon moves the parallelogram up to its end position, to the “auto-reset” position Recording stops End of surgery 27" Stand Monitor (Touchscreen) 10" Touch Panel Current case can either be ended by selecting "End Case" or automatically when the countdown timer has stopped PROVEO 8x / Ref. 10 735 160 / 02...
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Ensure the external storage drive has sufficient storage. If the external storage drive is running out of disk space, recording will stop automatically and there will be no prompting from the system. PROVEO 8x / Ref. 10 735 160 / 02...
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You have to clear disk space by deleting recorded media from the microscope to continue performing recording. This configuration can be set by hospital IT (see chapter 9.18 "Hospital IT", page 62). PROVEO 8x / Ref. 10 735 160 / 02...
GUI menus and define how the Date and Time should be displayed. * Selecting the 2D/3D display only affects the heads-up monitor. It will not affect the recording settings (see chapter 9.15.2 "Media Settings", page 56). PROVEO 8x / Ref. 10 735 160 / 02...
OCT functions are not found in the footswitch and handles assignment list (see chapters 9.8 "Footswitch assignments", page 46 and 9.9 "Handle assignment", page 47). PROVEO 8x / Ref. 10 735 160 / 02...
It is recommended to use a category 6 (Cat. 6 and above) 9.17.7 Licenses ethernet cable. Certain functions in the PROVEO 8x system are only activated if the When the system is connected to the Internet, you have the ability licenses are installed.
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Leica Microsystems’ personnel supporting remotely rather than being on site. Proveo 8x allows the user to configure multiple DICOM nodes that may be used simultaneously for obtaining modality work list for the microscope and for storage of acquired data.
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Danger to the patient due to changes in the user settings! Never change the configuration settings or edit the user Exporting audit log files list during an operation. You can export audit log files on this screen. PROVEO 8x / Ref. 10 735 160 / 02...
In the event the Clinical User password is forgotten, the Hospital IT User is able to reset the password. In the event the Hospital IT User password is forgotten, please contact your service representative for assistance. PROVEO 8x / Ref. 10 735 160 / 02...
8 characters with at least one capital letter, one lower-case letter, one number and one special character. Only the Hospital IT user can reset these passwords to the default password. The password reset is confirmed. PROVEO 8x / Ref. 10 735 160 / 02...
The "Support" screen appears. This page allows you to: • browse the issue list Exception: The default "IT" user cannot be disabled/enabled. • watch video tutorials (only available in English) • read the user manual PROVEO 8x / Ref. 10 735 160 / 02...
The surgeon can view Phaco VR information on the surgical cockpit This area is password-protected. at a glance. Simply connect the supported Phaco/VR machine to PROVEO 8x (see chapter 6.7 "Terminals", page 19, Phaco/VR LAN port). The information presented by the Phaco/VR machine is intended for reference purposes only and should not be used for diagnostic decisions.
The binocular tube 10-50°, ultra low III with 8.33x eyepieces is recommended for the main observer. A broad range of accessories enables the PROVEO 8x surgical microscope to be matched to the requirements of the user. Your 11.2 Third Party Devices and...
Care and maintenance 12 Care and maintenance 11.3 Accessories list for upgradable configurations To ensure that the PROVEO 8x surgical microscope operates safely and reliably over time, we recommend scheduling an annual Enfocus OCT system preventive maintenance (PM) visit to maintain equipment •...
Care and maintenance 12.1 Cleaning the touch panel Before cleaning the touch panel, switch off your PROVEO 8x and disconnect it from the power supply. Use a soft, lint-free cloth to clean the touch panel. Do not apply cleaning agent directly to the touch panel; rather, apply it to the cleaning cloth.
Preparation for cleaning Leica Microsystems (Schweiz) AG verified that the aforementioned Remove the product from the PROVEO 8x surgical microscope. instructions for the preparation of a product are suitable for its reuse. The processing person is responsible for reprocessing with...
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Steam autoclave PROVEO 8x 134 °C, t > 10 min. 10180591 Clip-on handle 10428328 Drive knob cover – 10448581 Cover, sterilizable for RUV800 – PROVEO 8x / Ref. 10 735 160 / 02...
Remove rechargeable batteries, other batteries and lamps from the old instrument to be disposed of. Make sure that the system is cleaned and disinfected completely and thoroughly and is free of hazardous substances and infectious agents. PROVEO 8x / Ref. 10 735 160 / 02...
Eyepieces are not mounted correctly. Screw the eyepieces all the way on. Diopters not set correctly. Perform dioptric correction exactly according to the instructions (see chapter 7.5.1 "Determining/adjusting diopter settings for users", page 28). PROVEO 8x / Ref. 10 735 160 / 02...
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Failure of inverter motor. Activate/deactivate by turning rotary knob "inverter" (see chapters 6.1 "PROVEO 8x optics carrier including focus, tilt and XY with 2D4K IVC", page 16 and 6.2 "PROVEO 8x optics carrier including focus, tilt and XY with 3D4K IVC", page 17).
Optics Carrier M850 Main LED current exceeds limit. • Optics controller board or LED defective. Contact Leica service. 904 ~ Camera Camera overheating, no live feed, binoculars Contact Leica service. required. PROVEO 8x / Ref. 10 735 160 / 02...
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Reboot the microscope. If the problem persists, contact Leica service. 7203* Software Unexpected exception while performing this Try the last action again. action. Reboot the microscope. If the problem persists, contact Leica service. PROVEO 8x / Ref. 10 735 160 / 02...
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The integrity of the application files has been Contact hospital IT and Leica service. compromised. Continuing to use the application may pose risks and lead to unforeseen consequences. Do you want to proceed despite the detected tampering? PROVEO 8x / Ref. 10 735 160 / 02...
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90F** Camera Fan 1 rotation stopped. If the problem persists, contact Leica service. B01** Camera IVC Iris motor initialization error Diaphragm PCBA or stepper motor has no power. Contact Leica service. PROVEO 8x / Ref. 10 735 160 / 02...
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~ Errors/Warnings as a toast notification * Errors/Warnings as a pop-up ** Errors/Warnings with a yellow triangle in the Main Menu that points to the issue list *** Errors/Warnings only in the issue list PROVEO 8x / Ref. 10 735 160 / 02...
Working diameter of coaxial illumination can be 12.5× 4.1×–24.5× 52.0–8.7 adjusted from 4 mm to 23 mm. Fine focus Available for assistant and 2D4K IVC The values above contain a tolerance of ±5 %. PROVEO 8x / Ref. 10 735 160 / 02...
Resolution 3840×2160 Max. monitor weight: 16 kg Materials Use of RoHS conform materials Surface coating The Proveo 8x microscope is coated with a white system paint which provides an antibacterial effect on surfaces Maximum height In park position: 1950 mm Range cantilever Max.
EN 10936-2, EN 62471, EN ISO 15223-1. • The Medical Division, within Leica Microsystems (Schweiz) AG, holds the management system certificate for the international standard ISO 13485 relating to quality management and quality assurance. PROVEO 8x / Ref. 10 735 160 / 02...
15.8 Dimensional drawings Statements given in parentheses are only for information and do not constitute an integral part of the specifications/ requirement. 15.8.1 Floor stand Side view dimensions (± 10%) 1557 ± 10% PROVEO 8x / Ref. 10 735 160 / 02...
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Specifications Front view dimensions (± 10%) 1557 ± 10% max 770 +0/-10% PROVEO 8x / Ref. 10 735 160 / 02...
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Specifications Top view dimensions PROVEO 8x / Ref. 10 735 160 / 02...
• The equipment is allowed a deviation at the immunity levels (0% of nominal voltage for 5s), provided the equipment remains safe, experiences no component failures and is restorable to the pre-test state with operator intervention. PROVEO 8x / Ref. 10 735 160 / 02...
(if used) for cleanliness. Remove dust and dirt. Installing the accessories Lock PROVEO 8x in place and install all accessories on the microscope so it is ready for use (see chapter 7.2 "Installing the monitor cover", page 26). Position the handles as desired.
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