6.10 Footswitch and handles equipment. Medical decision remains the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user Preparation before surgery manual highlighting the key areas of product use. Should additional information...
In this user manual the surgical microscope PROVEO 8 is described. for availability. The present user manual applies to the PROVEO 8 with the following stand variants: F42 and CT42. In addition to notes on the use of the instruments this...
It can be applied for observation and documentation and for human and veterinary medical Only use the PROVEO 8 surgical microscope if it is free of treatment. defects. • The major field of use is Ophtalmology.
Retina Protection Function Activated In addition, the Retina Protection function can be activated during the surgery to reduce the main light intensity below 10% and RedReflex below 20%. PROVEO 8 / Ref. 10 733 910 / Version 02...
Always lock the parallelogram: illumination! • when transporting the microscope If the integrated slit illumination motor fails, the slit • when re-equipping illumination can be manually activated/deactivated using the rotary knob (2). PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 8
Danger of damage! microscope is over the patient. Before lifting the optics carrier make sure that the area above the parallelogram is clear to avoid collisions with OR lamps, ceiling etc. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 9
The surgical microscope can collide with surrounding components, the ceiling or lamps. Check the danger area before moving the swing arm. Carefully move the ceiling mount upwards, and observe ceiling and lamps. PROVEO 8 / Ref. 10 733 910 / Version 02...
Safety notes Signs and labels 3.5.1 F42 floor stand PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 11
à une prise équivalente, marquée "Hôpital seulement" ou "Qualité hôpital". 15 UDI Label MET label Device Identifier (DI) GS1 Data Matrix Code Production Identifier (PI) Serial number Date of manufacturing PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 12
Safety notes 3.5.2 CT42 telescope mount 10 9 PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 13
équivalente, marquée MODULE Swing Arm "Hôpital seulement" ou "Qualité hôpital". 15 UDI Label MET label Device Identifier (DI) GS1 Data Matrix Code Production Identifier (PI) Serial number Date of manufacturing PROVEO 8 / Ref. 10 733 910 / Version 02...
8 Terminals (e.g. electrical, video, etc.) 9 Handrail 10 Monitor arm (optional) 11 Speaker With its open architecture the PROVEO 8 provides space for holding the camera and video control units. PROVEO 8 / Ref. 10 733 910 / Version 02...
8 Rack Compartment Set (optional) 2 Holder for footswitch 3 Video control units and recording systems (optional) 4 Control unit with touch panel 5 Wireless foot switch 6 Wall plate PROVEO 8 / Ref. 10 733 910 / Version 02...
• Optics carrier with C-mount interface, without integrated inverters • Optics carrier with integrated camera and integrated inverters 4.3.2 PROVEO 8 with IVC module without inverter • Optics carrier with integrated camera, without integrated inverters PROVEO 8 / Ref. 10 733 910 / Version 02...
With a balanced surgical microscope PROVEO 8 you can move the The electromagnetic brakes can be released via handle or nurse optics carrier to any position without tilting or moving down.
Page 18
4 Rotation of microscope carrier Don't move the system without released brakes. 1 Rotation of horizontal arm 2 Rotation of parallelogram 3 Up/Down movement of parallelogram 4 Rotation of microscope carrier PROVEO 8 / Ref. 10 733 910 / Version 02...
Functions Illumination The illumination of the surgical microscope PROVEO 8 consists of two LED modules and are located in the optics carrier. There are two lamps, main lamp and Red Reflex lamp. Fusion Optics This feature provides an augmentation in resolution and depth of field for an ideal 3-D optical image.
16 Objective 7 Handle 17 Mounting threads for accessories 8 Rotary knob for Red Reflex illumination diameter 18 Socket for BIOM 9 PROVEO 8 optics carrier 10 Fine focus for assistant PROVEO 8 / Ref. 10 733 910 / Version 02...
4 Main switch for PROVEO 8 surgical microscope 5 Power LED Indicator 1 Transport lock (block parallelogram) 6 Remote control holder 2 Balancing knob 7 Nurse switch holder Balancing the parallelogram see chapter 7.7.1. PROVEO 8 / Ref. 10 733 910 / Version 02...
Don't plug/unplug external devices at the "Line In" input during surgery. Make sure that the volume level on audio device is set to the minimum before connecting to the "Line In" input. PROVEO 8 / Ref. 10 733 910 / Version 02...
3 Equipotential bonding socket For connecting the PROVEO 8 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). PROVEO 8 / Ref. 10 733 910 / Version 02...
1 Nurse switch holder (can be pasted in individual location) Focus− Focus+ 2 Nurse switch port Magnification− Magnification+ All Lights On/Off Handles Selected Brake: Selected Brake: All Brakes All Brakes PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 26
OCT Live Mode/Stop All Lights On/Off VR Mode On/Off OCT Down Handles Handles Selected Brake: Selected Brake: Change View OCT Frame Forward All Brakes All Brakes OCT Frame Backward All Brakes PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 27
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 8 / Ref. 10 733 910 / Version 02...
Always lock the footbrake when you are not moving the system. CAUTION Damage to the PROVEO 8 surgical microscope due to In case the PROVEO 8 is not in transport position, refer to uncontrolled tilting! section 8.6. Hold the handle when releasing the brake.
Make sure that the optical accessories are clean and free of dust and dirt. Loosen clamping screw (1). Insert the accessories into the dovetail ring. Tighten the clamping screw (1). PROVEO 8 / Ref. 10 733 910 / Version 02...
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. PROVEO 8 / Ref. 10 733 910 / Version 02...
Without looking into the eyepieces, turn both eye lenses to +5 diopters. 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 8 / Ref. 10 733 910 / Version 02...
Change the 0° assistant position (3). Tighten the allen screw (2). When the desired position is reached, push the top down and lock the knob (1) again. Connect preinstalled camera cable to camera (1). PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 33
The GG420 UV protection filter is built-in. In addition, the "GG475 UV protection filter" and the "Protection Filter 5×" are available. Remove the filter cover. Push in the filter slide, inclined slightly upwards, until it engages. PROVEO 8 / Ref. 10 733 910 / Version 02...
There is a risk of damage to the surgical microscope from If necessary, rebalance the parallelogram. uncontrolled tilting! Firmly hold the handles before triggering the "All Brakes" function. Pull the transport lock (1) and bring it into a horizontal position. PROVEO 8 / Ref. 10 733 910 / Version 02...
Turn forwards and hold: All brakes are released 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. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 36
S Surgeon N Nurse WARNING Danger to the patient due to downward movement of the CT42 telescope mount! Do not use the up/down movement when the microscope is over the patient. PROVEO 8 / Ref. 10 733 910 / Version 02...
Swing the microscope away. Remove the sterile components. Lock the swing arm. Switch off the power switch on the swing arm. Press the "Up" key on the remote control and raise the stand. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 38
• Always use the drape with a protective glass. • Do not drape further than to position (1). F42 floor stand 7.10 Function check Refer to the checklist before operation (see chapter 17.1). PROVEO 8 / Ref. 10 733 910 / Version 02...
Operation Operation CT42 telescope mount The fixed installation of the PROVEO 8 Control Unit has to be Switching the microscope on carried out by a licensed electrican. Switch on the microscope using the power switch (1) on the rack WARNING controller (2).
Value of Red Reflex illumination Hold the handle when releasing the brake. Value of magnification Keys with touch function: Adjusting the tilt angle Reset button for focus (line shows position of focus) PROVEO 8 / Ref. 10 733 910 / Version 02...
The microscope can be tilted 15° forwards and 105° backwards. handle. Pressing the "Reset" button on the control unit returns the microscope to home position (0°). PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 42
• You can adjust the magnification motor speed in the function, the light intensity will go back to previous intensity. "Speed" menu. • These values can be saved individually for each user (see chapter 9.3.3). PROVEO 8 / Ref. 10 733 910 / Version 02...
"Speed" menu (see chapter 9.3.3). • You can return the focus motor to the middle position by pressing the "Reset Focus" key on the touch panel or on the surgeon panel. PROVEO 8 / Ref. 10 733 910 / Version 02...
If the Enfocus OCT scanhead is mounted below the optics carrier, rotate the optics carrier by 90 degree to avoid colliding the scanhead with the microscope front panel. PROVEO 8 / Ref. 10 733 910 / Version 02...
2 Status line 3 Display range 4 Dynamic button bar In operational mode, the status line displays the current user and specifies the current location in the menu at all times. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 46
9.2.1 Presets You can find a list of default users preset by Leica for the most common types of operation under "Presets". Click the "1-15" or "16-30" button to switch between screens.
Never change the configuration settings or edit the user settings of the desired preset and to load or list during an operation. modify the user's settings. "Edit User List" Allows to rename, to move or to delete users. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 48
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”. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 49
Password" button and enter a new password. The protection of a user setting by a password/PIN is indicated by “(locked)” right after the user setting name on the GUI main page or PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 50
You can scroll forwards or backwards in the list by clicking the You can also set the desired value by directly clicking the bars. arrowheads. Select the desired function. Click the caption of the desired key to assign the selected PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 51
• Reset Magnification • OCT Auto Brighten • Reset Focus • OCT Focus+ • Reset Tilt • OCT Focus- • Reset XY • OCT Z+ • Reset All • OCT Z- PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 52
• VR Lens Focus + • VR Lens Focus – • Tilt + • Tilt – • Slitwidth + • Slitwidth – • Slitlamp left • Slitlamp right • Main Inverters In/Out PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 54
Running Combination Mode Activate the key of your footswitch to which the Combination Mode function is assigned by clicking it. You run through a continuous loop of the stored steps. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 55
Electronic Inverter active = active When an electrical BIOM is in use the VR mode is Footswitch assignment VR automatically activated/deactivated. You can store a special footswitch assignment for VR (vitreoretinal) mode here. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 56
Ending OCT VR mode Press the button with the "OCT Mode on/off" assignment again. The microscope undoes all actions again. For detail explanation of individual OCT function, please refer to Enfocus user manual. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 57
DI C800, see separate user manual. The VR Synchronized Focus+ / VR Synchronized Focus– synchronizes the focusing of both the Proveo 8 optics carrier and BIOM front lens, providing the following: This menu tab appears only when a DI C800 is connected.
Page 58
• The current user settings are reloaded. • The illumination is switched off. Enter the desired username using the keyboard. If the user move the PROVEO 8 back downwards across the operating field, the illumination switches on and the PROVEO 8 is ready to operate immediately.
Light and Red Reflex Light. Select Surgeon Tube In this field you can enter the binocular tube currently being used by the surgeon. Scroll forwards or backwards in the list by clicking the arrowheads. PROVEO 8 / Ref. 10 733 910 / Version 02...
This screen displays, in short form, user instructions for operating This area is password-protected. your surgical microscope. Before starting the service menu, end the recording procedure on the documentation system. Otherwise data could be lost. PROVEO 8 / Ref. 10 733 910 / Version 02...
11 Accessories Picture Devices and accessories DI C800 A broad range of accessories enables the PROVEO 8 surgical microscope to be matched to the requirements of the user. Your Leica representative will be pleased to help you select the appropriate accessories.
• 24" Monitor (non touch function) • 27" Monitor (with touch function) Footswitch • Wireless Footswitch, 14 functions • Wireless Footswitch, 12 functions Leica is not responsible for the use of non-approved third party products. PROVEO 8 / Ref. 10 733 910 / Version 02...
It is recommended to conclude a service contract with Leica Service. 12.2 Cleaning the touch panel Before cleaning the touch panel, switch off your PROVEO 8 and Press the "CONFIRM" button. disconnect it from the power supply. The dialog window is closed.
Limitation of reprocessing Frequent reprocessing has little effects on these products. The end of the product life cycle is usually determined by wear and tear and damage through use. PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 65
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 66
1) This medical device falls within the validated sertility claims of the STERRAD®100S / STERRAD® 100NX™ / STERRAD®50 / STERRAD®200 Systems.Please follow the instructions for use of your STERRAD® System Umser's Guide prior to sterilizing devices in STERRAD® Systems. PROVEO 8 / Ref. 10 733 910 / Version 02...
The Leica CT42 is protected by a Wait approximately 30–45 minutes until the telescope down. temperature switch that switches off in motor has cooled off. case of overheating. Bad plug-in connection. Check the clamping terminal. PROVEO 8 / Ref. 10 733 910 / Version 02...
• No DIC800 installed (Device list not correctly configured) • RS232 connection loose. FE07h HDR not found • Cable damaged. • Controller defective. • No IVR850 installed (Device list not correctly configured). PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 69
• No SDI module installed (Device list not correctly configured). • RS232 connection loose. FE09h Camera control unit not found • Cable damaged. • Controller defective. • No CCU module installed (Device list not correctly configured). PROVEO 8 / Ref. 10 733 910 / Version 02...
52.0 – 8.7 Fine focus Available for assistant and integrated camera or C-mount interface The values above contain a tolerance of ±5 %. IR sensor For remote control of the HDR recorder PROVEO 8 / Ref. 10 733 910 / Version 02...
Four electromagnetic brakes, operated by turning developments the handles, one stop lever for vertical movement Control elements 14/12 function wireless footswitch and rotary Load Swing arm: Max. 8.0 kg from microscope/dovetail handles ring interface PROVEO 8 / Ref. 10 733 910 / Version 02...
660 mm x 330 mm x 480 mm 15.7 Limitations of use (only F42) Weight max. 52 kg (including documentation accessory) The PROVEO 8 may be used only in closed rooms and must be placed on a solid floor. Wall attachment Brick wall...
Page 73
Move the surgical microscope across the threshold in transport position, pushing it by the handgrip. Without auxiliary equipment, the PROVEO 8 can be moved across thresholds up to a max. height of 5 mm. PROVEO 8 / Ref. 10 733 910 / Version 02...
Specifications 15.8 Dimensional drawings 15.8.1 F42 floor stand max. 1571 max. 1231 PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 75
Specifications PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 76
Specifications 15.8.2 CT42 telescope mount 380x380 Ø400-Ø530 ±190° 350° ±150° 1490 * variable, depending on OR height **up/down movement of Parallelogram, w/o Tilt-Focus PROVEO 8 / Ref. 10 733 910 / Version 02...
Guidance and manufacturer's declaration – electromagnetic emissions The PROVEO 8 surgical microscope is intended for operation in an environment as specified below. The customer or the user of the PROVEO 8 surgical microscope should make sure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
Page 78
• interruptions on the HD Montior Non of the listed effects above have an impact on the essential performance or safety and effectiveness of the PROVEO 8 surgical microscope. Its no unacceptable risk for user, patient or environment to be expected.
Page 79
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PROVEO 8 surgical microscope is used exceeds the applicable RF compliance level above, the PROVEO 8 should be observed to verify normal operation.
Page 80
PROVEO 8 surgical microscope, this can lead to an increase in electromagnetic radiation or a reduction in EMC. The PROVEO 8 surgical microscope must not be used directly adjacent other instruments. If it is necessary to operate it in the vicinity of other instruments, the devices should be monitored to ensure that they function properly in this arrangement.
Page 81
Fit sterile components and sterile drape if used (see chapter 7.9.2). Repeat balancing. Positioning at the OP table Position the PROVEO 8 on the OP table as required and lock the footbrake (see chapter 7.1) (only F42). PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 82
PROVEO 8 / Ref. 10 733 910 / Version 02...
Page 83
PROVEO 8 / Ref. 10 733 910 / Version 02...
Need help?
Do you have a question about the PROVEO 8 and is the answer not in the manual?
Questions and answers