MEDICAL DIVISION

PROVEO 8
User Manual
10 733 910 – Version 03


Thank you for purchasing a Leica surgical microscope system.

In developing our systems, we have placed great emphasis on simple, self-
explanatory operation. Nevertheless, we suggest studying this user manual in
detail in order to utilize all the benefits of your new surgical microscope.
For valuable information about Leica Microsystems products and services, and the
address of your nearest Leica representative, please visit our website:

www.leica-microsystems.com

Thank you for choosing our products. We hope that you will enjoy the quality and
performance of your Leica Microsystems surgical microscope.

Leica Microsystems (Schweiz) AG Medical Division

Max-Schmidheiny-Strasse 201
CH-9435 Heerbrugg
Phone: +41 71 726 3333

Legal disclaimer
All specifications are subject to change without notice.
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.
You should never use a medical product of Leica Microsystems without the full
understanding of the use and the performance of the product.

Liability
For our liability, please see our standard sales terms and conditions. Nothing in this
disclaimer will limit any of our liabilities in any way that is not permitted under
applicable law, or exclude any of our liabilities that may not be excluded under
applicable law.

II PROVEO 8 / Ref. 10 733 910 / Version 03

 

Contents
1 Introduction 3 8.1 Switching the microscope on 39
1.1 About this user manual 3 8.2 Surgeon panel 40
1.2 Symbols in this user manual 3 8.3 Positioning the optics carrier 41
1.3 Optional product features 3 8.4 Adjusting the optics carrier 42
8.5 Integrated slit illumination 44
2 Product identification 3
8.6 Transport position (F42) 44
3 Safety notes 4 8.7 Shutting down the surgical microscope 45
3.1 Intended use 4
9 Control unit with touch panel function 45
3.2 Directions for the person responsible for the
9.1 Menu structure 45
instrument 4
9.2 Selecting users 46
3.3 Directions for the operator of the instrument 5
9.3 Menu – User Settings 47
3.4 Dangers of use 6
3.5 Signs and labels 9 10 Menu 59
10.1 Menu – "Maintenance" 59
4 Design 13
10.2 Menu – "How to..." 60
4.1 F42 floor stand 13
10.3 Menu – "Service" 60
4.2 CT42 telescope mount 14
4.3 PROVEO 8 Optics carrier modules 15 11 Accessories 61
11.1 Devices and accessories manufactured by Leica
5 Functions 16
Microsystems (Schweiz) AG 61
5.1 Balancing system 16
11.2 Accessories list for advanced configurations 62
5.2 Brakes 17
11.3 Drapes 62
5.3 Illumination 19
5.4 Fusion Optics 19 12 Care and maintenance 63
12.1 Maintenance instructions 63
6 Controls 20
12.2 Cleaning the touch panel 63
6.1 PROVEO 8 optics carrier including focus, tilt and XY
12.3 Maintenance 63
with IVC 20
12.4 Changing fuses 64
6.2 PROVEO 8 optics carrier including focus, tilt and XY
12.5 Notes on reprocessing of resterilizable products 64
with IVA 21
6.3 Surgeon panel 22 13 Disposal 67
6.4 Balancing 22
14 What to do if ...? 68
6.5 Control unit 22
14.1 Malfunctions 68
6.6 F42 stand 22
14.2 Malfunctions documentation accessories 68
6.7 F42 Terminals 23
14.2 Error messages on the control unit 69
6.8 CT42 Terminals on the rack controller 24
6.9 CT42 horizontal arm 25 15 Specifications 71
6.10 Footswitch and handles 26 15.1 PROVEO 8 71
15.2 F42 floor stand 72
7 Preparation before surgery 28
15.3 CT42 telescope mount 72
7.1 Transportation (F42) 28
15.4 CT42 rack controller 73
7.2 Installing a binocular tube 29
15.5 Ambient conditions 73
7.3 Setting the binocular tube 30
15.6 Standards fulfilled 73
7.4 Adjusting the eyepiece 30
15.7 Limitations of use (only F42) 73
7.5 Change the 0° assistant to another position 31
15.8 Dimensional drawings 75
7.6 Changing the camera 32
7.7 Balancing and locking the parallelogram 33 16 Manufacturer's declaration of electromagnetic
7.8 Positioning on the operating table 35 compatibility (EMC) 78
7.9 Attaching sterile controls and drape 37 16.1 Table 1 from EN 60601-1-2 78
7.10 Function check 38 16.2 Table 2 from EN 60601-1-2 79
16.3 Table 4 from EN 60601-1-2 80
8 Operation 39

PROVEO 8 / Ref. 10 733 910 / Version 03 1



17 Annex 82
17.1 Checklist before the operation 82

2 PROVEO 8 / Ref. 10 733 910 / Version 03

 Introduction

1 Introduction 1.3 Optional product features

Different product features and accessories are optionally available.
1.1 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 microscope PROVEO 8 is described.
representative 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 2 Product identification

user manual gives important safety information (see The model and serial numbers of your product are located on the
chapter "Safety notes"). identification label on the stand system closed to the power plug.
X Enter this data in your user manual and always refer to it when
you contact us or the service workshop regarding any questions
X Read this user manual carefully before operating the you may have.
product.
Type Serial no.

The full name of this operation microscope is PROVEO 8. ... ...

1.2 Symbols in this user manual

The symbols used in this user manual have the following meaning:

Symbol Warning Meaning

word
Warning Indicates a potentially hazardous situation
or improper use that could result in serious
personal injuries or death.
Caution Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in minor or moderate injury.
Note Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in appreciable material, financial
and environmental damage
Information about use that helps the user
to employ the product in a technically
correct and efficient way.
X Action required; this symbol indicates that
you need to perform a specific action or
series of actions.
MD Medical Device

PROVEO 8 / Ref. 10 733 910 / Version 03 3

Safety notes

3 Safety notes X When instructing new users, do so thoroughly and explain the
meanings of the warning signs and messages.
The PROVEO 8 surgical microscope is state-of-the-art technology. X Allocate responsibilities for commissioning, operation and
Nevertheless, hazards can arise during operation. maintenance. Monitor compliance with this.
X Always follow the instructions in this user manual, and in X The PROVEO 8 is intended for professional use only.
particular the safety notes.
WARNING
3.1 Intended use
Risk of electric shock!
• The PROVEO 8 surgical microscope is an optical instrument for X Connect this equipment only to a supply mains with
improving the visibility of objects through magnification and protective earth.
illumination. It can be applied for observation and
documentation and for human and veterinary medical X Only use the PROVEO 8 surgical microscope if it is free of defects.
treatment. X Inform your Leica representative or Leica Microsystems
• The major field of use is Ophtalmology.
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
• The microscope device is not for use in microsurgery (Neuro,
immediately about any product defect that could potentially
Plastic/Reconstructive, Ear, Nose and Throat surgeries). cause injury or harm.
• The PROVEO 8 surgical microscope may be used only in closed X If you use accessories from other manufacturers with the
rooms and must be placed on a solid floor or mounted to the PROVEO 8 surgical microscope, make sure that these
ceiling. manufacturers confirm that the combination is safe to use.
• It is available on the floor stand F42 and on the telescope mount
Follow the instructions in the user manual for those accessories.
CT42. • Modifications, installations to or service on the PROVEO 8
The F42 is a floor stand for three-dimensional positioning of the surgical microscope may be carried out only by technicians who
PROVEO 8 in the room. are explicitly authorized by Leica to do so.
The CT42 is a ceiling mounted electrical linear actuator for For further details refer to the installation manual.
lifting and lowering the PROVEO 8. It is operated by a hand • Only original Leica replacement parts may be used in servicing
switch. the product.
• The PROVEO 8 surgical microscope is subject to special • After service work or technical modifications, the device must
precautionary measures for electromagnetic compatibility. It be readjusted in accordance with our technical specifications.
must be installed and commissioned in accordance with the • If the instrument is modified or serviced by unauthorized
guidelines and manufacturer's declarations and recommended persons, is improperly maintained (as long as maintenance was
safety distances (according to EMC tables based on not carried out by a qualified trained service engineer), or is
EN60601‑1‑2). handled improperly, Leica Microsystems will not accept any
• Portable and mobile as well as stationary RF communications
liability.
equipment can have a negative effect on the reliability of the • The effect of the surgical microscope on other instruments has
PROVEO 8 surgical microscope's functionality. been tested as specified in EN 60601-1-2. The system passed the
• Always release the brakes to move or relocate the PROVEO 8
emission and immunity test. Comply with the usual pre­
surgical microscope. cautionary and safety measures relating to electromagnetic and
• The essential performance of the PROVEO 8 is to provide
other forms of radiation.
illumination and mechanical stability of the optics carrier in any • The electric installation in the building must conform to the
position. national standard, e.g., current-operated ground leakage
protection (fault-current protection) is suggested.
3.2 Directions for the person • Like any other instrument in the operating theater, this system
responsible for the instrument may fail. Leica Microsystems (Schweiz) AG therefore
X Ensure that the PROVEO 8 surgical microscope is used only by recommends that a backup system be kept available during the
persons qualified to do so. operation.
X Ensure that this user manual is always available at the place
where the PROVEO 8 surgical microscope is in use.
X Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.

4 PROVEO 8 / Ref. 10 733 910 / Version 03

 Safety notes

3.3 Directions for the operator of the Sources:

1) DIN EN ISO 15004-2; Ophthalmic instruments - Fundamental
instrument requirements and test methods - Part 2: Light hazard
X Follow the instructions described here. protection.
X Follow the instructions given by your employer regarding the If both illuminations are used, the lower of the two values
organization of work and safety at work. for the permitted exposure time must be used according to
Phototoxic damage to the retina during eye surgery the configured light output. The two hazards do not have to
be set off against each other, as their reflections on the
WARNING retina are not superimposed. This also applies to the use of
Damage to the retina due to prolonged exposure! the Slit Illumination "Phototoxic damage to the retina
The light of the instrument may be harmful. Risk of retina during eye surgery" on page 5.
damage increases with the duration of exposure.
X During exposure to the light from this instrument, do Slit illumination
not exceed the hazard reference values. The following table shows the allowed surgery durations and their
If the exposure time exceeds the value in the table on possible extension when reducing the slit width:
page 5 with this instrument at maximum output Slit width [mm] Time [min.]
power, the hazard reference value will be exceeded. >6 1
5 1.2
The following table is intended to serve as a guideline and make the 4 1.5
surgeon aware of the potential hazard. The data have been 3 2
calculated for the worst-case scenario: 2 3
• Eye with aphakia
• Completely unmoving eye (continuous irradiation of the same Protect the patient with the following safeguards:
region) • Short exposure times
• Uninterrupted light exposure, e.g. no surgical instruments in the • Low brightness settings
eye • Switching off the illumination during breaks in the operation
• Pupils dilated to 7 mm
The calculations are based on the corresponding ISO standard1) and It is recommended to adjust the brightness to the minimum
the exposure limit values recommended in that standard. . necessary for the surgery. Infants, patients with aphakia (whose eye
Main light
lens has not been replaced by an artificial lens with a UV protection
screen), small children and persons with diseases of the eye are at
Light setting Recommended maximum exposure time according to 1) [min.]
greater risk. The risk is also increased if the person being treated or
25% 6.5 operated on has, within the last 24 hours, already been exposed to
50 % 2.5 illumination from the same or any other ophthalmological
75% 1.5 instrument that uses a bright visible light source. This applies
100 % 1 especially to patients that have been examined via retinal
Retina Protection photography.
16.5
Function Activated

Coaxial Red Reflex illumination Decisions about brightness must be made case by case. In any
event, the surgeon must evaluate the risks and benefits of the used
Light setting Recommended maximum exposure time according to 1) [min.]
light intensity. Despite all efforts to minimize the risk of retinal
25% 10
injury by surgical microscopes, damage may still occur.
50 % 4.5
Photochemical retinal damage is a possible complication of the
75% 3 necessity to use bright light to make eye structures visible during
100 % 2 difficult ophthalmological processes.
Retina Protection
14
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 03 5

Safety notes

3.4 Dangers of use WARNING

Risk of injury due to downward movement of the surgical
WARNING microscope!
Risk of electric shock! X Complete all preparations and adjustments to the stand
X Connect this equipment only to a supply mains with before the operation.
protective earth. X Never change the accessories or attempt to rebalance
the microscope while it is above the field of operation.
X Before changing accessories, always lock the
WARNING
parallelogram (see chapter 7.7.2).
Damage to the retina due to prolonged exposure! X Balance the PROVEO 8 after re-equipping it.
The light of the instrument may be harmful. Risk of retina X Do not release the brakes when the instrument is in an
damage increases with the duration of exposure. unbalanced state.
X During exposure to the light from this instrument, do
X Before re-equipping during the operation, first swing
not exceed the hazard reference values. the microscope away from the operating field.
If the exposure time exceeds the value in the table on
page 5 with this instrument at maximum output
power, the hazard reference value will be exceeded. WARNING
Risk of injury due to downward movement of the surgical
microscope!
WARNING
X Never change the accessories or attempt to rebalance
Risk of human errors due to scaring noises during surgery! the microscope while it is above the field of operation.
X Don't plug/unplug external devices at the "Line In" input
X After re-equipping, always rebalance the microscope on
during surgery. the parallelogram.
X Make sure that the volume level on audio device is set to
the minimum before connecting to the "Line In" input.
WARNING
Risk of injury from downward movement of surgical
WARNING
microscope!
Danger of injury due to: X Complete all preparations and adjustments to the stand
• uncontrolled lateral movement of the parallelogram
before the operation.
• tilting of the stand
X If settings need to be altered during the operation, first
• feet in lightweight shoes could become trapped beneath
swing the microscope away from the operating field.
the casing of the base
X If the microscope needs to be re-equipped, do this
X For transportation, always move the PROVEO 8 surgical
before the operation.
microscope into the transport position. X Before re-equipping, always lock the parallelogram.
X Never move the stand while the unit is extended.
X Do not use the handles or remote brake release when
X Never roll over cables lying on the floor.
the instrument is in an unbalanced state.
X Always push the PROVEO 8 surgical microscope; never
pull it.
WARNING
WARNING Risk of injury due to downward movement of the surgical
Danger to the patient due to failure of the integrated slit microscope!
illumination! X Always lock the parallelogram:

If the integrated slit illumination motor fails, the slit • when transporting the microscope
illumination can be manually activated/deactivated using • when re-equipping
the rotary knob (2).

6 PROVEO 8 / Ref. 10 733 910 / Version 03

 Safety notes

WARNING CAUTION
Risk of injury from parts falling down! Damage of the touch panel!
X Before the operation, make sure that the optical X Operate the touch panel using your fingers only.
components and accessories are sufficiently secured and Never use hard, sharp or pointed objects made out of
cannot move. wood, metal or plastic.
X Never clean the touch panel using cleaners that contain
WARNING abrasive substances. These substances can scratch the
Risk of infection! surface and cause it to be become dull.
X Always use the PROVEO 8 surgical with sterile controls
and knobs. CAUTION
Surgical microscope can move without warning!
WARNING X Always lock the footbrake when you are not moving the
Danger of fatal electrical shock! system.
X Operate the system only with all equipment in its proper
position (all covers fitted, doors closed).
CAUTION
Damage to the PROVEO 8 surgical microscope due to
WARNING uncontrolled tilting!
Danger of fatal electrical shock! X Hold the handle when releasing the brake.
X The PROVEO 8 surgical microscope may be connected to
a grounded socket only (F42).
CAUTION
Damage to the PROVEO 8 surgical microscope during
WARNING transportation!
Motors return to their park position! X Never move the stand in the extended condition.
X Before switching on the microscope, ensure that the X Never roll over cables lying on the floor.
travel paths of XY-unit and focus are free of X Do not transport or store the system in areas with an
obstructions. elevation angle bigger than 10°.

WARNING CAUTION
Light that is too intense can damage the retina! Damage to the housing of the stand or to the touch panel of
X Observe the warning messages in the chapter on "Safety the control unit!
notes". If the optics carrier is moved into the transport position or
from the transport position to the operating position:
X Ensure that the transport lock must be locked.
WARNING
Danger to the patient due to failure of the magnification
motor! CAUTION
If the magnification motor fails, the magnification can be There is a risk of damage to the surgical microscope from
manually adjusted using the rotary knob. uncontrolled tilting!
X Firmly hold the handles before triggering the "All

WARNING Brakes" function.

Danger to the patient due to downward movement of the
CT42 telescope mount! CAUTION
X Do not use the up/down movement when the Danger of damage!
microscope is over the patient. X 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 03 7

Safety notes

CAUTION
Risk of infection!
X Leave sufficient space around the stand to ensure that
the sterile drape does not come into contact with non-
sterile components.

CAUTION
Risk of overheating of the system!
Covering the air inlet can result in a controlled shutdown of
the system due to overheating.
X Make sure that there is always some space between the
air inlet and the drape.

CAUTION
Damage of the magnification motor!
X Only adjust the magnification manually if the
magnification motor is defective.

CAUTION
Danger to the patient due to changes in the user settings!
X Never change the configuration settings or edit the user
list during an operation.

CAUTION
Risk of injury!
X Pay special attention to the required safety distances if
you use the Combination Mode function together with
accessories from other manufacturers that can reduce
the working distance to less than 140 mm (non-contact
wide-angle observation systems), since focus together
with Combination Mode is a semi-automated function.

CAUTION
Danger of collision!
The surgical microscope can collide with surrounding
components, the ceiling or lamps.
X Check the danger area before moving the swing arm.
X Carefully move the ceiling mount upwards, and observe
ceiling and lamps.

8 PROVEO 8 / Ref. 10 733 910 / Version 03

 Safety notes

3.5 Signs and labels

3.5.1 F42 floor stand

13

11
12
13

13

14

10

11 12

13
9 8 8

2 15 3 4 5 4 6 6

PROVEO 8 / Ref. 10 733 910 / Version 03 9

Safety notes

1 Leica Microsystems (Schweiz) AG Type label 6 Light risk label

Max Schmidheiny-Strasse 201 MD
CH-9435 Heerbrugg
MODEL PROVEO 8
STAND F42
(OCT Ready)
100 – 240 V 50 - 60 Hz
600 VA

MD Medical device

2 Fabrication label
7 System weight label


 
   8 Only to be operated
 Trained personnel
by trained personnel


 Utilisation réservée à
 
 un personnel formé

a Prefix number
b Leica system article no. 9 Equipotential bonding
c Serial number
d Incremental number
starting at 1 for each batch
e JJ = year (2 ditis) 10 Max. load for Optics
max. 8.0 kg (17.64 lb)
f MM = month (2 digits) Carrier
g TT = day (2 digits)
h Production starting date 11 Open
3 Follow the User Manual

12 Closed
4 Grounding reliability can only Grounding label
be achieved when EQUIPMENT is
connected to equivalent
receptacle marked "Hospital
only" or "Hospital Grade".
13 Crushing hazard label
For US and Canada only

La fiabilité de la mise à la
terre n'est assurée que si
l'équipement est connecté à une 14 Monitor weight label
max. 16 kg (35.27 lb)
prise équivalente, marquée
"Hôpital seulement" ou "Qualité
hôpital".

15 UDI Label
5 MET label
 Device Identifier (DI)
 GS1 Data Matrix Code

Production Identifier (PI)
Serial number
Date of manufacturing

10 PROVEO 8 / Ref. 10 733 910 / Version 03

 Safety notes

CT42 telescope mount

 A 

 




 B

 

PROVEO 8 / Ref. 10 733 910 / Version 03 11

Safety notes

1 Leica Microsystems (Schweiz) AG Type label 6 INMETRO label

Max Schmidheiny-Strasse 201
CH-9435 Heerbrugg MD
MODEL PROVEO 8
STAND C42/CT42
MODULE Rack Controller

100 –240 V 50 - 60 Hz
500 VA

PRIM 2x T6.3 AH 250 V

7 Equipotential
2 Fabrication label bonding


  8 Max. load for optics
Max. 8.0 kg (17.64 lb)
   carrier


 9 Open

 

10 Closed
a Prefix number
b Leica system article no.
c Serial number 11 Crushing hazard label
d Incremental number starting at
1 for each batch
e JJ = year (2 digits)
f MM = month (2 digits) 12 Monitor weight label
g TT = day (2 digits) max. 16 kg (35.27 lb)

h Production starting date

3 Follow the User 13 SKF type label
Manual

4 Grounding reliability can only Grounding label

be achieved when EQUIPMENT is
connected to equivalent
receptacle marked "Hospital
only" or "Hospital Grade".
For US and Canada only

La fiabilité de la mise à la
terre n'est assurée que si 14 MODEL PROVEO 8 Type label
l'équipement est connecté à une STAND C42 / CT42
prise équivalente, marquée
"Hôpital seulement" ou "Qualité MODULE Swing Arm
hôpital".
15 UDI Label
5 MET label
 Device Identifier (DI)
 GS1 Data Matrix Code

Production Identifier (PI)
Serial number
Date of manufacturing

12 PROVEO 8 / Ref. 10 733 910 / Version 03

 Design

4 Design
4.1 F42 floor stand

1 PROVEO 8 optics carrier

2 Parallelogram
3 Video monitor (optional)
4 Control unit with touch panel
5 Camera and video control units (optional))
6 Footbrake
7 Base
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 03 13

Design

4.2 CT42 telescope mount

1 PROVEO 8 optics carrier

2 Parallelogram 
3 Monitor arm (optional)
4 Video monitor (optional)
5 CT42 telescope mount
6 Horizontal arm 
7 Remote control telescope
8 Up
9 Down  

 




14 PROVEO 8 / Ref. 10 733 910 / Version 03

 Design

4.2.1 CT42 rack controller 4.3 PROVEO 8 Optics carrier

modules
4.3.1 PROVEO 8 with IVC module
 




 

1 Mains • Optics carrier with integrated camera and integrated inverters

2 Holder for footswitch
3 Video control units and recording systems (optional) 4.3.2 PROVEO 8 with IVC module without
4 Control unit with touch panel inverter
5 Wireless foot switch
6 Wall plate

• Optics carrier with integrated camera, without integrated

inverters

7 Terminals (electical, video etc.)

8 Rack Compartment Set (optional)

PROVEO 8 / Ref. 10 733 910 / Version 03 15

Functions

4.3.3 PROVEO 8 with IVA module 5 Functions

5.1 Balancing system
With a balanced surgical microscope PROVEO 8 you can move the
optics carrier to any position without tilting or moving down.
After balancing all movements during operation only need a minor
force.
The parallelogramm balances the up/down movement.
Balancing the parallelogram see chapter 7.7.1.

Balancing the optics carrier at the F42 floor stand

• Optics carrier with C-mount interface, without integrated

inverters

16 PROVEO 8 / Ref. 10 733 910 / Version 03

 Functions

Balancing the optics carrier at the CT42 telescope mount 5.2 Brakes
The PROVEO 8 surgical microscope has 4 electromagnetic brakes
which stop the movements of the stand, the ceiling mount and the
surgical microscope:
The electromagnetic brakes can be released via handle or nurse
switch.

5.2.1 Brakes at the F42 floor stand

1 Rotation of the tower

2 Rotation of parallelogram
3 Up/Down movement of parallelogram
4 Rotation of microscope carrier

PROVEO 8 / Ref. 10 733 910 / Version 03 17

Functions

5.2.2 Selected brakes at the F42 floor stand 5.2.3 Brakes at the CT42 telescope mount
With the function "Selected brakes" the user can release any

individual brake. 

This function can be activated by a qualified person only.

1 Rotation of horizontal arm

2 Rotation of parallelogram
3 Up/Down movement of parallelogram
4 Rotation of microscope carrier

1 Rotation of tower
2 Rotation of parallelogram
3 Up/Down movement of parallelogram
4 Rotation of microscope carrier

Don't move the system without released brakes.

18 PROVEO 8 / Ref. 10 733 910 / Version 03

 Functions

5.2.4 Selected Brakes at the CT42 telescope mount

With the function "Selected brakes" the user can release any
individual brake.

These function can be activated by a qualified person only.

 

1 Rotation of horizontal arm

2 Rotation of parallelogram
3 Up/Down movement of parallelogram
4 Rotation of microscope carrier

5.3 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.

5.4 Fusion Optics

This feature provides an augmentation in resolution and depth of
field for an ideal 3-D optical image.
Fusion Optics operates with two separate beam paths with
different information: the left beam path is optimized for high
resolution, the right beam path for optimum depth of field.
The human brain merges these two very different images to a
single, optimal spatial image.

PROVEO 8 / Ref. 10 733 910 / Version 03 19

Controls

6 Controls
6.1 PROVEO 8 optics carrier including focus, tilt and XY with IVC

19
18 17

1 XY Coupling 11 Fine focus for assistant

2 Rotary knob for changing the 0° assistant position 12 Rotary knob "Inverter" assistant (emergency operation only,
3 Rotary knob "Inverter" (emergency operation only, with version with version see chapter 4.3.1)
see chapter 4.3.1) 13 0° assistant
4 Fine focus for integrated camera 14 Surgeon panel
5 Rotary knob "Magnification" (emergency operation only) 15 2× CAN sockets - only for Leica accessories
6 Rotary knob "Slit illumination" (emergency operation only) 16 Cooling slots
7 Slot for filter slide 17 Objective
8 Handle 18 Mounting threads for accessories
9 Rotary knob for Red Reflex illumination diameter 19 Socket for BIOM
10 PROVEO 8 optics carrier

20 PROVEO 8 / Ref. 10 733 910 / Version 03

 Controls

6.2 PROVEO 8 optics carrier including focus, tilt and XY with IVA










 









 



 


1 XY Coupling 11 0° assistant
2 Rotary knob for changing the 0° assistant position 12 Surgeon panel
3 Fine focus for external camera 13 2× CAN sockets - only for Leica accessories
4 Rotary knob "Magnification" (emergency operation only) 14 C-mount adapter
5 Rotary knob "Slit illumination" (emergency operation only) 15 Cooling slots
6 Slot for filter slide 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 03 21

Controls

6.3 Surgeon panel 6.5 Control unit

1 Touchpanel (graphical user interface)

6.6 F42 stand

6

1 Surgeon panel
2 Infrared receiver for remote control (Recorder)
5
3 Touchpanel
1
6.4 Balancing
4
2
3

1 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).
2 Power input
3 Thermal Magnetic Circuit Breaker
4 Main switch for PROVEO 8 surgical microscope
1 Transport lock (block parallelogram) 5 Power LED Indicator
2 Balancing knob 6 Remote control holder
7 Nurse switch holder
Balancing the parallelogram see chapter 7.7.1.

22 PROVEO 8 / Ref. 10 733 910 / Version 03

 Controls

6.7 F42 Terminals

LAN* to connect to Dicom

Line In** for external music player/mobile phone
ADF 1/2 Additional Function
XGA in 1*** to connect an external video source (for optional
DI C800)
OCT ext.*** to connect external OCT devices
DVI Out to connect an external monitor
DVI in*** external input for stand monitor
FS for second wireless footswitch only (footswitch 2)
C-VIDEO out*** to connect external monitor
HD SDI out*** to connect external monitor
Brake release for nurse switch only

* may not be used during surgery

** note the warning below
*** connect medical equipment only

WARNING
Risk of human errors due to loud disturbing noises during
surgery!
X Don't plug/unplug external devices at the "Line In" input
during surgery.
X 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 03 23

Controls

6.8 CT42 Terminals on the rack

controller
The CT42 rack controller is mounted on the wall.

LAN* to connect to Dicom

Line In not in use
ADF 1/2 Additional Function
XGA in 1** to connect an external video source (for optional
DI C800)
CAN ext.** to connect external CAN devices
DVI Out to connect an external monitor
DVI in** external input for stand monitor
FS for second wireless footswitch only (footswitch 2)
C-VIDEO out** to connect external monitor
HD SDI out** to connect external monitor

* may not be used during surgery

** connect medical equipment only

1 Mains switch
2 Mains fuses
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).

24 PROVEO 8 / Ref. 10 733 910 / Version 03

 Controls

6.9 CT42 horizontal arm

1 Nurse switch holder (can be pasted in individual location)

2 Nurse switch port

PROVEO 8 / Ref. 10 733 910 / Version 03 25

Controls

6.10 Footswitch and handles 6.10.2 Standard configuration "Retina"

See also User manual Wireless Footswitch, 14 functions. Footswitches and handles can be assigned individually for
each user in the configuration menu.

6.10.1 Standard configuration "Cataract"

Footswitch and handles can be assigned individually for

each user in the configuration menu.

Focus− Focus+

VR Synchronized Focus− VR Synchronized Focus+

Magnification− Magnification+
Main light+ Red Reflex+
All Lights On/Off VR Mode On/Off
Main light− Ref Reflex−

Focus− Focus+

Magnification− Magnification+
Handles
All Lights On/Off

Selected Brake: Selected Brake:

Handles

Selected Brake: Selected Brake:

All Brakes All Brakes

All Brakes All Brakes

26 PROVEO 8 / Ref. 10 733 910 / Version 03

 Controls

6.10.3 Standard configuration "OCT" 6.10.4 Standard configuration "OCT VR"

Footswitches and handles can be assigned individually for Footswitches and handles can be assigned individually for
each user in the configuration menu. each user in the configuration menu.

OCT Up OCT Up

OCT Left OCT Right OCT Left OCT Right

OCT Save OCT Change Joystick State OCT Save OCT Change Joystick State

OCT Scan OCT Next Procedure OCT Scan OCT Next Procedure

OCT Z – OCT Z+ OCT Z – OCT Z+

OCT Optimize Image OCT Auto Locate OCT Optimize Image OCT Auto Locate

OCT Live Mode/Stop OCT Mode On/Off OCT Live Mode/Stop OCT Mode On/Off

OCT Down OCT Down

Handles Handles

Change View OCT Frame Forward Change View OCT Frame Forward

All Brakes OCT Frame Backward All Brakes OCT Frame Backward

PROVEO 8 / Ref. 10 733 910 / Version 03 27

Preparation before surgery

7 Preparation before surgery X Ensure that the PROVEO 8 is in the transport position.

7.1 Transportation (F42)

WARNING
Danger of injury due to:
• uncontrolled lateral movement of the parallelogram
• tilting of the stand
• feet in lightweight shoes could become trapped beneath
the casing of the base
X For transportation, always move the PROVEO 8 surgical
microscope into the transport position.
X Never move the stand while the unit is extended.
X Never roll over cables lying on the floor.
X Always push the PROVEO 8 surgical microscope; never
pull it.

CAUTION
Surgical microscope can move without warning!
X Always lock the footbrake when you are not moving the
system.

CAUTION
Damage to the PROVEO 8 surgical microscope due to
uncontrolled tilting! In case the PROVEO 8 is not in transport position, refer to
X Hold the handle when releasing the brake. section 8.6.

X Press the footbrake padel on the right (1) to unlock the castor
CAUTION wheels lock.
Damage to the PROVEO 8 surgical microscope during X Move the microscope using the handle.
transportation! X Press the footbrake padel on the left (2) to lock the castor
X Never move the stand in the extended condition. wheels lock.
X Never roll over cables lying on the floor.
X Do not transport or store the system in areas with an
elevation angle bigger than 10°.

CAUTION
Damage to the housing of the stand or to the touch panel of
the control unit!
If the optics carrier is moved into the transport position or 2
from the transport position to the operating position:
X Ensure that the transport lock must be locked.

28 PROVEO 8 / Ref. 10 733 910 / Version 03

 Preparation before surgery

7.2 Installing a binocular tube

WARNING
Risk of injury due to downward movement of the surgical 1
microscope!
X Complete all preparations and adjustments to the stand
before the operation.
X Never change the accessories or attempt to rebalance
the microscope while it is above the field of operation.
X Before changing accessories, always lock the
parallelogram (see chapter 7.7.2).
X Balance the PROVEO 8 after re-equipping it.
X Do not release the brakes when the instrument is in an
unbalanced state.
X Before re-equipping during the operation, first swing
the microscope away from the operating field.
X Make sure that the optical accessories are clean and free of dust
and dirt.
X Loosen clamping screw (1).
X Insert the accessories into the dovetail ring.
X Tighten the clamping screw (1).

WARNING
Risk of injury from parts falling down!
X Before the operation, make sure that the optical
components and accessories are sufficiently secured and
cannot move.

7.2.1 Installing the eyepieces

X Make sure that the optical accessories are clean and free of dust
and dirt.
X Screw the knurled nut (1) of the eyepieces on the binocular tube
as far as end stop.

PROVEO 8 / Ref. 10 733 910 / Version 03 29

Preparation before surgery

7.3 Setting the binocular tube 7.4 Adjusting the eyepiece

7.3.1 Setting the interpupillary distance 7.4.1 Determining/adjusting diopter settings for
X Adjust the interpupillary distance to a value between 55 mm users
and 75 mm, see on the scale (1). The individual diopters can be adjusted continuously for each
X Using the adjusting wheel (2), set the interpupillary distance eyepiece from +5 to –5. The diopters must be set exactly and
such that a circular image field can be seen. separately for both eyes. Only this method will ensure that the
image will stay in focus within the entire magnification range =
parfocal. The surgical microscope ensures a high degree of fatigue
1 resistance when the diopter setting is correct for both eyes.

A parfocally adjusted microscope ensures that assistant's

view and monitor image will always remain sharp,
regardless of the selected magnification.
X Select the minimum magnification.
X Place a flat test object with sharp contours under the lens at
working distance.
2 X Focus the microscope.
X Set the maximum magnification.
X Focus the microscope.
7.3.2 Adjusting the tilt X Set the minimum magnification.
X Hold the binocular tubes with both hands.
X Tilt the binocular tube upwards or downwards until a
comfortable position for viewing is reached.

X Without looking into the eyepieces, turn both eye lenses to

+5 diopters.
X Slowly turn the eyepieces towards –5 individually for each eye
until the test object appears in sharp focus.
X Select the highest magnification and check the sharpness.

30 PROVEO 8 / Ref. 10 733 910 / Version 03

 Preparation before surgery

7.4.2 Adjusting the pupillary distance The top (2) is lifted.

X Rotate the eyecups up or down until the desired distance is set.

7.4.3 Checking parfocality

X Place a flat test object with sharp contours under the objective
at working distance. X Change the 0° assistant position (3).
X Zoom to the highest magnification.
X Focus on the test object.
X Zoom through the whole magnification range, observing the
test object.

The image sharpness must remain constant at all

magnifications. If this is not the case, check diopter settings
of the eyepieces.

7.5 Change the 0° assistant to another

position
The 0° assistant can be positioned on the left and on the right side.
X Unlock knob (1).
X When the desired position is reached, push the top down and
lock the knob (1) again.

PROVEO 8 / Ref. 10 733 910 / Version 03 31

Preparation before surgery

7.6 Changing the camera 7.6.2 Laserfilter for IVC

X Unlock knob (1).
7.6.1 Integrated video adapter (IVA)
X Insert the camera (1) into the C-mount adapter of the optics
carrier.

The top (2) is lifted.

X Tighten the allen screw (2).

X Remove the laserfilter dummy (3) .

X Connect preinstalled camera cable to camera (1). 

32 PROVEO 8 / Ref. 10 733 910 / Version 03

 Preparation before surgery

X Insert the laserfilter IVC (4) into the laserfilter slot of the optics 7.7 Balancing and locking the
carrier.
parallelogram
 7.7.1 Balancing the parallelogram

WARNING
Risk of injury due to downward movement of the surgical
microscope!
X Never change the accessories or attempt to rebalance
the microscope while it is above the field of operation.
X After re-equipping, always rebalance the microscope on
the parallelogram.

7.6.3 Slot for color and special filters

There is a slot in the optics carrier housing into which filter slides
can be inserted.
X Remove the cover (1).
There are two slots for filters.
• Left filter slot: Color temperature filter for main LED
• Right filter slot: Special filters or diaphragms

X Release the parallelogram (see chapter 7.7.3).

X Hold the microscope by the handles.
X Turn one handle to release the brakes (All Brakes).
X Check whether the microscope drifts up or down.
Microscope drifts downwards:
X Turn balancing knob (2) clockwise.
Microscope drifts upwards:
X Turn balancing rotary knob (2) counterclockwise.

7.7.2 Locking the parallelogram

The plane of filter is sharply imaged in the same plane as the object. WARNING
The GG420 UV protection filter is built-in. In addition, the "GG475 Risk of injury due to downward movement of the surgical
UV protection filter" and the "Protection Filter 5×" are available. microscope!
X Remove the filter cover. X Always lock the parallelogram:
X Push in the filter slide, inclined slightly upwards, until it • when transporting the microscope
engages. • when re-equipping

CAUTION
There is a risk of damage to the surgical microscope from
uncontrolled tilting!
X Firmly hold the handles before triggering the
"All Brakes" function.

PROVEO 8 / Ref. 10 733 910 / Version 03 33

Preparation before surgery

X Pull the transport lock (1) and bring it into a horizontal position. 7.7.4 Releasing the brakes

WARNING
Risk of injury from downward movement of surgical
microscope!
X Complete all preparations and adjustments to the stand
before the operation.
X If settings need to be altered during the operation, first
swing the microscope away from the operating field.
X If the microscope needs to be re-equipped, do this
before the operation.
X Before re-equipping, always lock the parallelogram.
X Do not use the handles or remote brake release when
the instrument is in an unbalanced state.

X Hold and turn one or both handles to release the brakes

(All Brakes).
X Move the parallelogram up and down until the transport lock
engages.
The parallelogram is now locked.

7.7.3 Releasing the parallelogram

CAUTION
There is a risk of damage to the surgical microscope from Forwards
uncontrolled tilting!
X Firmly hold the handles before triggering the
"All Brakes" function.
X Grip and turn one handle to release the brakes. Backwards
X At the same time, pull the transport lock (1) and bring it into a
vertical position.
Unless they are individually configured for the current user, the
brakes are released by turning the handles as follows:
X Turn backwards and hold: Selected brakes are released
X 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.

The parallelogram is now released.

If necessary, rebalance the parallelogram.

34 PROVEO 8 / Ref. 10 733 910 / Version 03

 Preparation before surgery

7.8 Positioning on the operating table X Press the footbrake padel on the left (2) to lock the castor
wheels lock.
7.8.1 F42 floor stand

WARNING
Risk of injury due to downward movement of the surgical
microscope!
X Complete all preparations and adjustments to the stand
before the operation.
X Never change the accessories or attempt to rebalance
the microscope while it is above the field of operation. 2
X Before changing accessories, always lock the
parallelogram (see chapter 7.7.2).
X Balance the PROVEO 8 after re-equipping it.
X Do not release the brakes when the instrument is in an
1
unbalanced state.
X Before re-equipping during the operation, first swing
the microscope away from the operating field.
X Position the footswitch below the operating table.
CAUTION X Plug the power cable into the power outlet.
Danger of damage! X Connect the equipotential bonding to the stand.
X Before lifting the optics carrier make sure that the area X Start the system.
above the parallelogram is clear to avoid collisions with X Release the brakes (see chapter 7.7.4) and bring the system to a
OR lamps, ceiling etc. possible position (see picture below).
Maximum swing arm extension is at 135° angle.
X Using the handrail, carefully push the surgical microscope to the
operating table and position it as desired.
• All positions are also possible as the mirror image max. 135°
angle
position.
• The instrument must be positioned such that the range
of movement is large enough for the expected tasks.

PROVEO 8 / Ref. 10 733 910 / Version 03 35

Preparation before surgery

7.8.2 CT42 telescope mount Raising and lowering the CT42 telescope mount
The CT42 telescope mount can be raised and lowered electrically.
CT42 telescope mount These functions can be controlled via buttons on the remote control
unit.

Move telescopic arm to the desired height:

• "Up" key (1): Raise telescopic arm.
1 • "Down" key (2): Lower telescopic arm.

 

Under permanent-load conditions, the telescope may not be

operated for more than 1 minute in a 10 minute period.
After 2 minutes of uninterrupted operation, the built-in
temperature switch deactivates the motor of the Leica CT42
telescope mount.
AS N
To test the emergency stop function move down and press
the down and the up switch at the same time to stop the
S movement.

CT42 telescope mount park position

1 CT42 rack controller CAUTION

A Assistant Danger of collision!
AS Surgeon assistant The surgical microscope can collide with surrounding
S Surgeon components, the ceiling or lamps.
N Nurse X Check the danger area before moving the swing arm.
X Carefully move the ceiling mount upwards, and observe

WARNING ceiling and lamps.

Danger to the patient due to downward movement of the X Swing the microscope away.
CT42 telescope mount! X Remove the sterile components.
X Do not use the up/down movement when the X Lock the swing arm.
microscope is over the patient. X Switch off the power switch on the swing arm.
X Press the "Up" key on the remote control and raise the stand.

36 PROVEO 8 / Ref. 10 733 910 / Version 03

 Preparation before surgery

7.9 Attaching sterile controls and 7.9.2 Sterile drape for optics carrier
drape • Only use the sterile tested drapes specified in the
WARNING Accessories section.
• Drape only as far as indicated (see picture below).
Risk of infection!
X Always use the PROVEO 8 surgical with sterile controls
and knobs. CAUTION
Risk of infection!
7.9.1 Covers for rotary buttons X Leave sufficient space around the stand to ensure that
the sterile drape does not come into contact with non-
Use the covers also when you use sterile disposable drapes. sterile components.
The controls will be easier to grasp. X Activate the "All Brakes" function on the handle and extend the
X Fit steam-sterilizable covers on the magnification, working parallelogram.
distance and Red Reflex illumination manual override knobs.
Maximum swing arm extension is at 135° angle.

X Put on sterile gloves.

X Attach all the sterile controls.
X Unpack the sterile drape carefully and drape it over the
PROVEO 8 surgical microscope as far as the parallelogram.
X Clamp the protective glass (optional) onto the objective.
X Do not attach the sterile drape too tightly with the provided
ribbons. It must still be easy to move the instrument.
X Check the ease of movement of the instrument.
• Follow the instructions provided by the manufacturer of
the sterile drape.
• Always use the drape with a protective glass.
• Do not drape further than to position (1).

F42 floor stand

X Attach steam-sterilizable covers to accessories as well (if 

present).

PROVEO 8 / Ref. 10 733 910 / Version 03 37

Preparation before surgery

CT42 telescope mount 7.10 Function check

Refer to the checklist before operation (see chapter 17.1).

CAUTION
Risk of overheating of the system!
Covering the air inlet (1) can result in a controlled shutdown
of the system due to overheating.
X Make sure that there is always some space between the
air inlet (1) and the drape.

38 PROVEO 8 / Ref. 10 733 910 / Version 03

 Operation

8 Operation 8.1.1 F42 floor stand

WARNING
8.1 Switching the microscope on Danger of fatal electrical shock!
X The PROVEO 8 surgical microscope may be connected to
WARNING
a grounded socket only (F42).
Danger of fatal electrical shock!
X Operate the system only with all equipment in its proper X Switch on the microscope using the power switch (1) on the
position (all covers fitted, doors closed). stand.
The system is starting an initialization procedure.
WARNING
Motors return to their park position! 1
X Before switching on the microscope, ensure that the
travel paths of XY-unit and focus are free of
obstructions.

When built-in Enfocus module is available, please wait for

1–2 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 startup and shutdown especially if
OCT is connected.

PROVEO 8 / Ref. 10 733 910 / Version 03 39

Operation

8.1.2 CT42 telescope mount 8.2 Surgeon panel

On the surgeon panel, the following screen is displayed:
The fixed installation of the PROVEO 8 Control Unit has to be
carried out by a licensed electrican.
X Switch on the microscope using the power switch (1) on the rack
controller (2).
The system is starting an initialization procedure.

Retina
Protect

The icons have the following meaning (only for information):

1 Status of XY-Unit

2 Status of OCT
3 Status of Inverter
4 IOL Mode/Retina Protect
Check basic functions of the system: 5 Status of Recorder
• Check the Main and Red Reflex illumination. 6 Status of VR Mode
• Check the footswitch functions. 7 Value of main illumination
• Check the rotary handles.
8 Value of Red Reflex illumination
• Check if the brakes work reliable.
9 Value of magnification
The main screen is displayed on the control unit.
Keys with touch function:
10 Adjusting the tilt angle
11 Reset button for focus (line shows position of focus)

40 PROVEO 8 / Ref. 10 733 910 / Version 03

 Operation

8.3 Positioning the optics carrier 8.3.2 Fine positioning

X Position the optics carrier with the XY drive using the joystick (1)
8.3.1 Initial positioning
on the footswitch.

Return to middle position by pressing the "Reset" key (2) or

the "Reset" buttons on the control unit.

You can change the speed at which the XY motors move on

the "Speed" menu screen.
X Grasp the optics carrier by both handles (1). This value can be saved individually for each user.
X Turn one handle to release the brakes (All Brakes).
X Position the optics carrier and release the handle.

Also refer to the chapter 7.7.4.

CAUTION
Damage to the PROVEO 8 surgical microscope due to
uncontrolled movement!
X Hold the handle when releasing the brake.

8.3.3 Adjusting the tilt

X Pressing the tilt + button or – button on the surgeon panel for
tilt adjustment in the desired direction and hold it there (see
chapter 8.2).
The microscope tilts in the desired direction.
The microscope can be tilted 15° forwards and 105° backwards.
Pressing the "Reset" button on the control unit returns the
microscope to home position (0°).

PROVEO 8 / Ref. 10 733 910 / Version 03 41

Operation

8.4 Adjusting the optics carrier 8.4.2 Adjusting the Red Reflex illumination
diameter
8.4.1 Adjusting the brightness
You can adjust the Red Reflex illumination diameter using the
rotary knob (1) or the footswitch/handle.
WARNING
X Turn rotary knob (1) and set the Red Reflex illumination
Light that is too intense can damage the retina! diameter as required.
X Observe the warning messages in the chapter on "Safety
notes".
You can make the illumination brighter or darker for the Main Light
and the Red Reflex Light using either the touch panel monitor, a
footswitch, or handle.
On the touch panel monitor in the "Main" menu screen 

8.4.3 Exposure time

For further information (see Phototoxic damage to the retina during
eye surgery, page 5).

8.4.4 Retina Protection

The user can activate the Retina Protection function during the
surgery via the footswitch or the touch panel of the control unit.
When Retina Protection function is activated, the main light
X Press the or button on the bar for adjusting the intensity is reduced to 10% and the Red Reflex intensity is reduced
brightness of the Main Light and the Red Reflex Light. to 20%. The user can still adjust the light intensity below the
– or – threshold. When the user deactivates the Retina Protection
X Press the brightness adjustment bar directly.
function, the light intensity will go back to previous intensity.
The brightness of the active illumination changes.

• Clicking the or button changes the brightness

value in increments of 1. Holding down the button with
your finger changes the value in increments of 5.
• The start setting can be saved individually for each user
(see chapter 9.3.2).

On the footswitch/handle
Depending on the assignment (see chapters 9.3.4 and 9.3.5), you
can also increase and decrease the brightness of the illumination
use the correspondingly assigned buttons on the footswitch/
handle.

42 PROVEO 8 / Ref. 10 733 910 / Version 03

 Operation

8.4.5 Adjusting the magnification (zoom) Manually adjusting the magnification (zoom)
You can adjust the magnification using a footswitch/handle or the WARNING
"Magnification" adjustment bar on the "Main" menu screen of the
Danger to the patient due to failure of the magnification
control unit.
motor!
On the touch panel monitor in the "Main" menu screen If the magnification motor fails, the magnification can be
manually adjusted using the rotary knob (1).

CAUTION
Damage to the magnification motor!
X Only adjust the magnification manually if the
magnification motor is defective.

X Press the or button on the bar for adjusting the

magnification.
– or –
X Press the magnification adjustment bar directly.
The magnification changes.

• Clicking the or button changes the X Push in rotary button (1).

magnification value in increments of 1. Holding down X Set the desired magnification by turning the knob.
the button with your finger changes the value in
increments of 5.
• You can adjust the magnification motor speed in the 8.4.6 Adjusting the focus
"Speed" menu.
• These values can be saved individually for each user (see • If the focus motor fails, adjust the focus manually
chapter 9.3.3). releasing the brakes.
• Grasp the optics carrier (see chapter 8.3.1).
You can focus the microscope using the focus keys on the
footswitch.
• You can change the speed at which the zoom motor
moves in the "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 03 43

Operation

8.5 Integrated slit illumination 8.6 Transport position (F42)

You can extend and retract the slit illumination via footswitch or
handle knob. CAUTION
The slit illumination width can be continuously changed from 2 mm Damage to the housing of the stand or to the touch panel of
to 6 mm, and move from left to right via footswitch. the control unit!
If the optics carrier is moved into the transport position or
from the transport position to the operating position:
X Ensure that the transport lock must be locked.

X Locking the parallelogram (see chapter 7.7.2).

X Unplug all storage devices from the documention/recording
system.
X Press the "All Brakes" button or the nurse switch and move the
PROVEO 8 into the transport position.


WARNING
Danger to the patient due to failure of the integrated slit
illumination!
If the integrated slit illumination motor fails, the slit
illumination can be manually activated/deactivated using
the rotary knob (2).

NOTE
X Make sure that the video monitor does not collide with the
parallelogram of the stand.

44 PROVEO 8 / Ref. 10 733 910 / Version 03

 Control unit with touch panel function

8.7 Shutting down the surgical 9 Control unit with touch

microscope panel function
NOTE
CAUTION
When built-in Enfocus module is available, wait for 1–2 minute for
Damage of the touch panel!
the system to shutdown completely and do not unplug the power
X Operate the touch panel using your fingers only.
cable before the system is completely shutdown.
Never use hard, sharp or pointed objects made out of
X Bring the surgical microscope into the transport position (F42). wood, metal or plastic.
X If present, turn off the TrueVision recording system according to X Never clean the touch panel using cleaners that contain
the manufacturer's instructions. abrasive substances. These substances can scratch the
X Shut down the system by switching off the surgical microscope surface and cause it to be become dull.
at the power switch (see section 8.1).
Unplug and secure the power cable (F42).
X
X Store the footswitch on the stand (F42) or under the rack (CT42).
9.1 Menu structure
1

1 Quick access line to the screens "Main", "Speed", "Menu", "DIC"

and "Recording"
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 03 45

Control unit with touch panel function

1 2 3 4 5 6 7

The quick access line is displayed at the top of each screen to enable
access to the following menus at any time.
1 Main menu
2 Speed menu (see chapter 9.3.3)
3 Menu (see chapter 9.3)
4 DIC menu
5 Warning messages
6 Change Monitor Display View (activated when OCT is enabled in
the accessory list)
7 Display recording in progress (green blinking), no recording (no
color)
9.2.1 Presets
9.2 Selecting users You can find a list of default users preset by Leica for the most
In the "Main" and "Speed" menu screens, the three buttons common types of operation under "Presets".
"Presets", "User List" and "Show Settings" appear in the dynamic
button bar at all times.

X Click one of the default users, then click "Select".

The PROVEO 8 surgical microscope is ready to use.

• You can adapt and save the settings of these default

users as required (see chapter 9.3.13).
• You can click the "Show Settings" button at any time to
see an overview of the user settings of the current user.

46 PROVEO 8 / Ref. 10 733 910 / Version 03

 Control unit with touch panel function

9.2.2 User list 9.2.3 Show Settings

The "User List" opens a two-page user list from which you can X Press the "Show Settings" button in the dynamic button bar to
select one of up to thirty users that can be saved. see an overview of the user settings of the current user.

Click the "1-15" or "16-30" button to switch between screens.

X Select a user. 9.3 Menu – User Settings
The "Select" button is shown. You can configure user settings in this menu.
X Click "Select".
The user settings are loaded. X Click the "Menu" button and select "USER SETTINGS".
• When the user list is open, it can be edited at any time.
• Before each operation, make sure that your desired user
is selected and familiarize yourself with the assignment
of the handles and the optional footswitch (if used).
User Settings can be protected via a password. To change the user
settings, please refer to chapter 9.3.

The following screen is displayed:

PROVEO 8 / Ref. 10 733 910 / Version 03 47

Control unit with touch panel function

"Load" Loads the settings of an existing user from the X Select the user.
user list for modifying. The available functions are displayed in the dynamic button
"Create New User" Opens a new user with "blank" settings. line:
"New (Preset)" Opens the "Preset" screen for selecting a default
user in order to create a new user with the "Cancel" Cancel the action.
settings of the desired preset and to load or "Move" Moves the selected user to another
modify the user's settings. available location of your choosing.
"Edit User List" Allows to rename, to move or to delete users. "Delete" Deletes the selected user.
"Rename" Renames an existing user. The user's
• You can also add a user from the operational menu. settings are not changed.
• If you want to keep the current settings, you can save "Change password" Changes the password.
them by clicking the "Save" button (which appears as
soon as the basic settings of the current users have been CAUTION
changed), either for the current user ("Save") or under a
Danger to the patient due to changes in the user settings!
new username ("Save as New").
X Never change the configuration settings or edit the user
list during an operation.
Editing the user list
Various functions are available in the user list depending on the
situation.

48 PROVEO 8 / Ref. 10 733 910 / Version 03

 Control unit with touch panel function

9.3.1 User Setting Protection

To avoid unauthorized or accidental changes of user settings, each
user setting can be protected by a password/PIN. This keeps the
working parameters identical each time you load a protected user
setting. Changes can be done during the application, but will not be
stored unless “Saved as “current” or “Saved as new” with entering
the correct password/PIN.

Saving and protecting the user settings is done in two ways:

As a current user setting
You will receive a prompt for the password/PIN.
X If a password/PIN was defined save the changes of the user
settings with entering the correct password/PIN.
If it is incorrect the system will go back to “Start values main”.
X Choose “Save as current” and enter the password/PIN again.
If no password/PIN was defined, you can define a password/PIN
(4-10 characters).
X Press “OK” for re-entering and confirmation.
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”.

As a new user setting

You will receive a screen message and a prompt for the password/
PIN after entering the name of the user setting. If the settings
should be protected:
X Enter a password/PIN (4-10 characters) and press “OK” for
re-entering and confirmation. The password characters can be
letters, numbers or special characters.
If no password/PIN should be defined you can exit the procedure by The user can also reset the password by pressing "Change
pressing “Skip” or before re-entering with “Cancel”. Password" button and enter a new password.
If the re-entered password/PIN does not match the enter/re-enter
process has to be repeated.

PROVEO 8 / Ref. 10 733 910 / Version 03 49

Control unit with touch panel function

9.3.2 Setting the "Main" start values

For the selected user you can set the start values for the main light,
Red Reflex light and magnification on this screen.

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
by a lock icon in front of the user setting name in the Select User
page. X Clicking the or key changes the values in increments of
one. Holding down the button with your finger changes the
value in increments of five.
X You can also set the desired value by directly clicking the bars.

9.3.3 Setting the "Speed" start values

For the selected user you can set the start values for the travel
speed of the magnification, focus, XY motors and slitlamp on this
screen.

X Clicking the or key changes the values in increments of

one. Holding down the button with your finger changes the
value in increments of five.
X You can also set the desired value by directly clicking the bars.

50 PROVEO 8 / Ref. 10 733 910 / Version 03

 Control unit with touch panel function

Fast Slitlamp When activated, the slitlamp moves with Configuring individual keys
fast travel speed. X In the left selection field, select the function group with the
Focus Linked to Zoom When activated, the focus speed depends desired functions.
on the magnification: X You can scroll forwards or backwards in the list by clicking the
• low magnifaction – fast focus speed arrowheads.
• high magnification – slow focus speed X Select the desired function.
X Click the caption of the desired key to assign the selected
XY Linked to Zoom When activated, the XY speed depends on
function to it.
the magnification:
• low magnifaction – fast XY speed
• high magnification – slow XY speed Overview of function groups
The possible configuration is divided into the following function
9.3.4 Footswitch assignment groups:
(Footswitch 1 and Footswitch 2) XY
Here the user can configure individual settings for the footswitch. • X+
• X–
• Y+
• Y–
• XY Reverse
Drive
• Magnification +
• Magnification –
• Focus +
• Focus –
• VR Lens Focus +
• VR Lens Focus –
• Tilt +
• Tilt –
• Slitwidth +
• Slitwidth –
• Slitlamp left
The built-in footswitch wireless receiver is Footswitch 1, the
• Slitlamp right
inserted optional footswitch is Footswitch 2.
• Main Inverters In/Out
• All Inverters In/Out
X First select a footswitch 14 or 12 functions. • VR Synchronized Focus+
X Click the left or right arrow to select Normal Mode, VR • VR Synchronized Focus–
Mode, IOL Mode, OCT Mode, or OCT VR Mode.
X Click the button "Cataract", "Retina", "IOL" or "OCT". Light
The default settings are assigned to the footswitch. • Mainlight On/Off
X You can then modify these settings as you like. • Red Reflex On/Off
Clicking the "Clear All" button clears the assignments for all • All Lights On/Off
keys. • Mainlight +
• Mainlight –
• Red Reflex +
• Red Reflex –
• Red Reflex Diameter +
• Red Reflex Diameter –
• Slitlamp In/Out
• Retina Protection On/OFF

PROVEO 8 / Ref. 10 733 910 / Version 03 51

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Reset • OCT Auto Sharpen

• Reset Magnification • OCT Auto Brighten
• Reset Focus • OCT Focus+
• Reset Tilt • OCT Focus-
• Reset XY • OCT Z+
• Reset All • OCT Z-
• OCT Next Workflow
DI C800 • OCT Live Mode/Stop
• DIC: Image On/Off • OCT Continuous Scan
• DIC: Brightness + • OCT Scan
• DIC: Brightness – • OCT Save
IOL • OCT Crosshair On/Off
• OCT Reset DSC
• IOL Back
• OCT Frame Backward
• IOL Next
• OCT Frame Foward
• IOL Templates On/Off
• OCT First Frame
• IOL Topography On/Off
• OCT Last Frame
• IOL Rotate CCW (Left)
• OCT Next Procedure
• IOL Rotate CW (Right)
• OCT Previous Scan
• IOL Toggle Fullscreen
• OCT Toggle Image Lock
• IOL Change Transparency
• OCT Toggle Image Contrast
Extra
• Docu: Start/Stop Record X You can change the status of a function with the "Toggle"
• Docu: Start/Stop Playback function (e.g. on/off or next). The "Pulse" function continuously
• Docu: Still Capture changes a status (such as increasing the brightness).
• Combination Mode Toggle X To delete an assignment which you do not want, select the "No
• IOL Mode On/Off Function" element - which can be found in all function groups -
• VR mode On/Off and assign it to the key in question.
• OCT Mode On/Off X If you are creating only one footswitch configuration for one
• Keratoscope On/Off user, we recommend duplicating it to the second footswitch
• Fixation Light On/Off input by pressing the "Duplicate" button.
• Quick Focus This ensures that your footswitch functions the way you want it
• Quick Tilt to, regardless of which input it is plugged into.
• Quick Focus & Quick Tilt
• HDMI Toggle (assistant)
• HDMI Toggle (output)
• XGA Out Toggle
• Change View
• ADF 1 Toggle
• ADF 1 Pulse
• ADF 2 Toggle
• ADF 2 Pulse
OCT
• OCT Up
• OCT Down
• OCT Left
• OCT Right
• OCT Change Joystick State
• OCT Optimize Image
• OCT Auto Locate

52 PROVEO 8 / Ref. 10 733 910 / Version 03

 Control unit with touch panel function

9.3.5 Handle assignment • All Inverters In/Out

You can assign up to three functions of your choosing to the handle. Light
The fourth function must always be "All Brakes". • Mainlight On/Off
However, you can assign this function to any position you like. • Red Reflex On/Off
• All Lights On/Off
• Mainlight +
• Mainlight –
• Red Reflex +
• Red Reflex –
• Red Reflex Diameter +
• Red Reflex Diameter –
• Slitlamp In/Out
• Retina Protection On/OFF
Reset
• Reset Magnification
• Reset Focus
• Reset Tilt
• Reset XY
• Reset All
X Select the handle in the right selection field.
X You can scroll forwards or backwards in the list by clicking the DI C800
arrowheads. • DIC: Image On/Off
X In the left selection field, select the function group that • DIC: Brightness +
contains the desired function. • DIC: Brightness –
You can scroll forwards or backwards in the list by clicking the IOL
arrowheads.
X Select the desired function.
• IOL Back
• IOL Next
Click the caption of the desired key to assign the selected function
• IOL Templates On/Off
to it.
• IOL Topography On/Off
Overview of function groups • IOL Rotate CCW (Left)
The possible configuration is divided into the following function • IOL Rotate CW (Right)
groups: • IOL Toggle Fullscreen
• IOL Change Transparency
XY
• XY Reverse Extra
• Docu: Start/Stop Recording
Drive
• Docu: Start/Stop Playback
• Magnification + • Docu: Still Capture
• Magnification – • Combination Mode Toggle
• Focus + • IOL Mode On/Off
• Focus – • VR mode On/Off
• VR Lens Focus + • OCT Mode On/Off
• VR Lens Focus – • Keratoscope On/Off
• Tilt + • Fixation Light On/Off
• Tilt – • Quick Focus
• Slitwidth + • Quick Tilt
• Slitwidth – • Quick Focus & Quick Tilt
• Slitlamp left • XGA Out Toggle
• Slitlamp right • HDMI Toggle (assistant)
• Main Inverters In/Out

PROVEO 8 / Ref. 10 733 910 / Version 03 53

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• HDMI Toggle (output)

• Selected Brakes
• All Brakes
• Change view
• ADF 1 Toggle
• ADF 1 Pulse
• ADF 2 Toggle
• ADF 2 Pulse
OCT
• OCT Up
• OCT Down
• OCT Left
• OCT Right
• OCT Change Joystick Stage
• OCT Optimize Image
• OCT Auto Locate In this screen, the user can enable or disable the desired
• OCT Auto Sharpen Combination Mode parameters for the individual users.
• OCT Auto Brighten
• OCT Focus +
When switching through the Combination Mode function,
• OCT Focus –
only the actively set parameters for the individual user are
• OCT Z +
activated.
• OCT Z –
• OCT Next Workflow
• OCT Live Mode/Stop X Enter the total number of steps by clicking the or key in
• OCT Continuous Scan "Number of Steps".
• OCT Scan X Select the appropriate parameters for each step in "Step".
• OCT Save X Set the valid focus mode "Relative" or "Absolute" for all
• OCT Crosshair On/Off parameters.
• OCT Reset DSC • Relative range: –75 mm … +75 mm
• OCT Frame Backward • Absolute range: –37.5 mm … +37.5 mm
• OCT Frame Forward Combination Mode parameters
• OCT First Frame • Magnification for activating (on) and deactivating (off). When
• OCT Last Frame set to "off" the magnification stays at the actual value.
• OCT Next Procedure • Inverter signal; e.g. for triggering internal or external inverter
• OCT Previous Scan from SDI Oculus
• OCT Toggle Image Lock • ADF1, ADF2 pulse signal for triggering external systems, e.g.
• OCT Toggle Image Contrast Room Light on/off, external slit lamp …
The focus can take on two states:
9.3.6 Combination Mode • "Absolute": the learned, absolute position is accurately
approached.
With the Combination Mode you can create an individual procedure
Range: –37.5 mm … +37.5 mm
for each user. You can save the following parameters for various
• "Relative": the learned distance between 2 dots, e.g. for defined
frequently recurring phases (max. 5 steps) of the operation:
• Main Light brightness contact lenses for retina operations.
• Red Reflex brightness Range: –75 mm … +75 mm
• Magnification
• Focus Mode
• Inverter
• ADF1 (Additional function 1)
• ADF2 (Additional function 2)

54 PROVEO 8 / Ref. 10 733 910 / Version 03

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CAUTION The setting of "Electronic inverter active" depends on the connected

inverter:
Risk of injury!
• Oculus SDI 4c with BIOM: Electronic Inverter active = inactive
X Pay special attention to the required safety distances if
• all others: Electronic Inverter active = active
you use the Combination Mode function together with
accessories from other manufacturers that can reduce Footswitch assignment VR
the working distance to less than 140 mm (non-contact You can store a special footswitch assignment for VR (vitreoretinal)
wide-angle observation systems), since focus together mode here.
with Combination Mode is a semi-automated function.

For the Combination Mode function to be available, you

must first assign it to a key on your footswitch.
Running Combination Mode
X 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.
9.3.7 VR Mode
On this page , you can store user-specific settings for the VR mode
(vitreoretinal mode).

So that you can switch between the "normal" assignment and

assignment in VR mode, the following conditions must be met:
• In the "VR Mode" tab, "footswitch for VR mode active" must be
activated.
• In each of the two footswitch assignments, "VR Mode on/off"
must be assigned.
The adjustment is the same as for the footswitch
assignment (see chapter 9.3.4).
Using VR mode
X Press the button with the "VR Mode on/off" assignment.
VR mode is activated. The actions activated in the user settings are
carried out once.
The settings (ON/OFF) of the following functions can be stored
An active VR mode is highlighted in green on the "Main" menu
specifically for VR mode:
page.
XY Reverse – reverse X and Y
Mainlight Off – switch off main light If VR mode is activated, no user settings can be configured.
RedReflex Off – switch off Red Reflex illuminaton To do so, first deactivate VR mode.
Roomlight off – switch off additional function (ADF1 / ADF2)
Electronic inverter active – activate inverter Ending VR mode
Footswitch for VR mode active – activate separate assignment of X Press the button with the "VR Mode on/off" assignment again.
the footswitch The microscope undoes all actions again.
Quick Focus Active – activate the quick focus (see chapter 9.3.11)
When an electrical BIOM is in use the VR mode is
Integrated inverters synchronized – on: both inverters active,
automatically activated/deactivated.
off: only inverter of the main surgeon active

These functions are activated at the factory.

You can deactivate the functions using the "ON" key.

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9.3.8 OCT mode Footswitch assignment OCT VR

The OCT functions can be controlled by the footswitch by assigning
OCT functions in the OCT mode.
Footswitch assignment OCT

The user can switch from VR footswitch mode to OCT VR footswitch

mode. To switch between “VR mode” to OCT on the footswitch, the
following conditions must be met:
• In the “Footswitch 1 VR Mode” tab, “OCT Mode On/Off” must be
The user can switch from normal footswitch mode to OCT mode. To assigned on the footswitch.
switch between “normal” assignment to OCT on the footswitch, the • In the “Footswitch 1 OCT VR Mode” tab, “OCT Mode On/Off”
following conditions must be met: must be assigned on the footswitch.
• In the “Footswitch 1” tab, “OCT Mode On/Off” function must be Where an electrical BIOM is in use the VR mode is automatically
assigned on the footswitch. activated/deactivated. The user can press “OCT mode On/Off” to go
• In the “Footswitch 1 OCT Mode” tab, “OCT Mode On/Off” must from VR mode to OCT VR mode; capture and review OCT images,
be assigned on the footswitch. and go back to VR mode by pressing “OCT mode On/Off” on the
The recommended workflow is to go from normal mode to OCT footswitch.
mode, capture and review OCT images, and back to normal mode. If a mechanical BIOM or contact lens is used, the “VR mode On/Off”
The user can also program OCT functions in the “Handles OCT” and must be programmed on the normal footswitch to activate the VR
control OCT functions with the handles when OCT mode is activated mode. To go from VR mode into OCT VR mode, the user can press
(ex. play frame forward). “OCT mode On/Off”, and press again to go back to VR mode.
Using OCT mode The user can also program OCT functions in the “Handles OCT VR”
and control OCT functions with the handles when OCT mode is
X Press the button with the "OCT Mode on/off" assignment.
activated (ex. play frame forward).
OCT mode is activated. The actions activated in the user settings are
carried out once. Using OCT VR mode
An active OCT mode is highlighted in green on the "Main" menu X Press the button with the "OCT Mode on/off" assignment.
page. OCT mode is activated. The actions activated in the user settings are
Ending OCT mode carried out once.
An active OCT mode is highlighted in green on the "Main" menu
X Press the button with the "OCT Mode on/off" assignment again.
page.
The microscope undoes all actions again.
Ending OCT VR mode
X 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.

56 PROVEO 8 / Ref. 10 733 910 / Version 03

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9.3.9 BIOM synchronized focus 9.3.10 DI C800

In this screen, the user can modify the data reflection settings of
the connected 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.
• VR Synchronized focus: Synchronized focusing of the optics
carrier and BIOM front lens ensuring that the BIOM front lens no
9.3.11 Quick tilt/focus
longer needs to move vertically in relation to the eye
• Focus: Narrow view and wider view at the same magnification
and focus just by pressing an assigned button on the footswitch
• VR Lens Focus: Independent focusing of the BIOM front lens for
faster focusing of the retina prior to the vitreoretinal procedure

Footswitch Automatic Change to VR Mode: When

working on the posterior segment, the BIOM can be swing
into the beam path and the footswitch will change the
settings automatically to VR mode including the
synchronized focus if programmed.

The user can set desired values for quick focus and quick tilt
according to his preferences.
X Activate the footswitch button assigned to the quick focus or
quick tilt function by clicking it.
Distance for quick Distance to move upwards from current
focus position after activating the assigned key.

PROVEO 8 / Ref. 10 733 910 / Version 03 57

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Quick focus timeout 1 to 10 minutes or off. 9.3.13 Saving user settings

Return to start position within the presetted
time frame of the timeout only after Protect your settings with a password (see chapter 9.3.1).
activating the assigned key.
If timeout has expired and the assigned key is X Click the "Save" button in the main menu.
pressed the optics carrier will not move. X Select an available location in the user list at which you want to
Note store your user.
In case the user releases the electromagnetic
brakes by the handles, the quick focus
function will be deactivated. If you like, you can edit the user list first.
Default off
Angle for quick tilt Angle at which the optics carrrier moves after
pressing the assigned key for the quick tilt.
Default 35°

The tilt function is disabled when electrical BIOM is

connected.

9.3.12 Auto Reset

If the user move the parallelogram up to its end position after the
operation, you trigger the auto Reset function:
• all of the motors (zoom, focus and XY) move to their reset
position.
• The recorder stops.
• The tilt motor is not resetted.
• The current user settings are reloaded.
• The illumination is switched off.
If the user move the PROVEO 8 back downwards across the
X Enter the desired username using the keyboard.
operating field, the illumination switches on and the PROVEO 8 is
ready to operate immediately.

NOTE
X This function can be deactivated by your Leica Microsystems
service technician.

X Click the "OK" button to save the user at the desired location
under the name you have entered.

58 PROVEO 8 / Ref. 10 733 910 / Version 03

 Menu

10 Menu 10.1.2 Maintenance –> Check Switches

On this screen, you can test the switches on the handles, the
10.1 Menu – "Maintenance" footswitches, the remote control or the hard keys.
X Press the Menu button and select "MAINTENANCE" (1).
1

Top right selection field

In this field you can select the connection you are using or the
desired switches.
X Scroll forwards or backwards in the list by clicking the
The Maintenance menu offers the following screens:
• Lamp History arrowheads to select the connection.
• Check Switches 10.1.3 Maintenance –> Microscope Settings
• Microscope Settings
On this screen you can configure the accessories you are using.
This ensures that the correct magnification is shown on the "Main"
10.1.1 Maintenance –> Lamp History menu page.
On this screen, you can view and reset the operating hours of Main
Light and Red Reflex Light.

Select Surgeon Tube

In this field you can enter the binocular tube currently being used
by the surgeon.
X Scroll forwards or backwards in the list by clicking the
arrowheads.

PROVEO 8 / Ref. 10 733 910 / Version 03 59

Menu

Select Eyepiece
In this field you can select the type of the eyepieces being used by
the surgeon.
X Scroll forwards or backwards in the list by clicking the
arrowheads.

If you do not make a selection, the magnification is

calculated for the standard equipment:
binocular tube 30°–150° and eyepiece with 10
magnification.

Select Objective
In this field you can enter the objective currently being used by the
surgeon.
X Scroll forwards or backwards in the list by clicking the
arrowheads. X Press the button for the topic desired.
Detailed information "How to ..." is displayed.
10.2 Menu – "How to..."
X Press the Menu button and select "HOW TO" (1). 10.3 Menu – "Service"
X Press the Menu button and select "SERVICE MENU" (1).

This screen displays, in short form, user instructions for operating 1

your surgical microscope. This area is password-protected.

Before starting the service menu, end the recording

procedure on the documentation system. Otherwise data
could be lost.

60 PROVEO 8 / Ref. 10 733 910 / Version 03

 Accessories

11 Accessories Picture Devices and accessories

A broad range of accessories enables the PROVEO 8 surgical DI C800

microscope to be matched to the requirements of the user. Your
Leica representative will be pleased to help you select the
appropriate accessories.
10× eyepiece
11.1 Devices and accessories 8.33× eyepiece
12.5× eyepiece
manufactured by Leica
ToricEyePiece
Microsystems (Schweiz) AG
11.1.1 Observer side
Ophthalmology Bridge
Picture Devices and accessories
Oculus SDI - can bus Laserfilter 532/810 nm for IVC

Binocular tube, inclinable

5° to 25° with PD

Laserfilter 532/810 nm for IVA

Binocular tube, 10° to 50° with PD

11.1.2 Patient-side
Binocular tube, 30° to 150°, Picture Devices and accessories
T, Typ II L
Objective APO WD175 OCT ready
Objective APO WD200 OCT ready
Objective APO WD225 OCT ready
RUV800 WD175
Binocular tube, 10° to 50°, Typ II,
RUV800 WD200
UltraLow ™III

Binocular tube, inclined, T, Typ II

Slit Illumination

Binocular tube, 0° to 180°

Holder for protective glass

PROVEO 8 / Ref. 10 733 910 / Version 03 61

Accessories

Picture Devices and accessories 11.3 Drapes

Protective glass Supplier Article No. Main Back Assistant Assistant
Front assistant left right
Oculus BIOM 5 Microtec 8033650EU
8033651EU
✓ ✓ ✓ ✓
8033652EU
8033654EU
Pharma- 9228H
✓ – ✓ ✓
Sept 9420H
Fuji System 0823155 ✓ – ✓ ✓
11.2 Accessories list for advanced 0823154 ✓ ✓ – ✓
configurations Spiggle &
250013OH ✓ – ✓ ✓
Theis
Enfocus OCT system
Advance
09-GL800 ✓ – ✓ ✓
HD Recording Systems Medical
• HDR
• Evolution 4K recorder The use of the Protective glass 10446058 is recommended.
• IOLcompass
Camera Systems
• Camera System HD C100
• Camera System HD C300
Monitors
• 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.

62 PROVEO 8 / Ref. 10 733 910 / Version 03

 Care and maintenance

12 Care and maintenance CAUTION

Damage of the touch panel!
12.1 Maintenance instructions X Operate the touch panel using your fingers only.
Never use hard, sharp or pointed objects made out of
• Put a dust cover over the instrument while the breaks are in
wood, metal or plastic.
work. X Never clean the touch panel using cleaners that contain
• Keep accessories in a dust-free place when not in use.
abrasive substances. These substances can scratch the
• Remove dust with a pneumatic rubber pump and a soft brush.
surface and cause it to be become dull.
• Clean the objectives and eyepieces with special optics cleaning
cloths and pure alcohol.
• Protect the surgical microscope from damp, vapors, acids, 12.3 Maintenance
alkalis, and corrosive substances. The PROVEO 8 surgical microscope generally requires no
Do not keep chemicals near the instrument. maintenance. To ensure that it always operates safely and reliably,
• Protect the surgical microscope from improper handling. we recommend that you take the precaution of contacting the
Install other device sockets or unscrew optical systems and responsible service organization.
mechanical parts only when explicitly instructed to do so in this You can arrange for periodic inspections or, if appropriate, conclude
user manual. a maintenance contract with them.
• Protect the surgical microscope from oil and grease.
Never oil or grease the guide surfaces or mechanical parts. • It is recommended to conclude a service contract with
• Remove coarse debris with a moistened disposable cloth.
Leica Service.
• To disinfect the surgical microscope, use compounds from the • Use only original spare parts for servicing.
surface disinfectant group based on the following active • After 18 months you will be reminded that the
ingredients: inspection is due when you switch on the microscope.
• aldehydes,
• alcohols,
• quaternary ammonium compounds.

Due to potential damage to the materials, never use

products based on
• halogen-splitting compounds,
• strong organic acids,
• oxygen-splitting compounds.
X Follow the disinfectant manufacturer's instructions.

It is recommended to conclude a service contract with Leica

Service.

12.2 Cleaning the touch panel

X Before cleaning the touch panel, switch off your PROVEO 8 and X Press the "CONFIRM" button.
disconnect it from the power supply. The dialog window is closed.
X Use a soft, lint-free cloth to clean the touch panel.
X Do not apply cleaning agent directly to the touch panel; rather,
apply it to the cleaning cloth.
X Use a commercially available glass/eyeglass cleaner or plastic
cleaner to clean the touch panel.
X Do not apply pressure to the touch panel while cleaning it.

It is recommended to conclude a service contract with Leica

Service.

PROVEO 8 / Ref. 10 733 910 / Version 03 63

Care and maintenance

12.4 Changing fuses 12.5.2 Instructions

12.4.1 CT42 telescope mount Workplace

Required fuse type: T6.3 AH 250 V X Remove surface contamination with a disposable cloth/paper
cloth.
X Unscrew the fuse holder (2) on the rack controller. Storage and transport
• No special requirements.
• It is recommended to perform the reprocessing of a product
immediately following its use.
Preparation for cleaning
  X Remove the product from the PROVEO 8 surgical microscope.
Cleaning: manually
• Equipment: water, detergent, alcohols, microfiber cloth
Procedure
X R inse surface contamination off of the product (temp. < 40 °C).
X Remove the fuse (1) from their receptacles and replace them.
Use some rinsing agent depending upon degree of
12.5 Notes on reprocessing of contamination.
X Alcohol may also be used to clean the optics if heavy
resterilizable products contamination such as fingerprints, grease streaks etc. is
12.5.1 General present.
X Dry off products, except for optical components, with a
Products disposable cloth/paper cloth. Dry off optical surfaces with a
micro-fiber cloth.
Reusable products supplied by Leica Microsystems (Schweiz) AG
such as rotary knobs, objective protective glasses and capping Cleaning: automatically
pieces. • Equipment: cleaning/disinfecting device
Limitation of reprocessing: It is not recommended to clean products with optical components
in a cleaning/disinfecting device. In addition, optical components
For the medical devices used on patients suffering from Creutzfeldt
must not be cleaned in ultrasonic baths in order to prevent damage.
Jacob Disease (CJD) or suspected of having CJD or variant CJD, the
local statutory requirements have to be met. Normally resterilizable Disinfection
products used on this group of patients are to be eliminated The alcohol disinfection solution "Mikrozid, Liquid" may be used in
without risk by incineration. accordance with the instructions on the label.
Occupational safety and health protection Please note that after disinfection, the optical surfaces must be
rinsed thoroughly with fresh drinking water, followed by fresh
Particular attention must be paid to the occupational safety and
demineralized water. The products must be dried thoroughly before
health protection of the persons responsible for preparing
the subsequent sterilization.
contaminated products. Current regulations of hospital hygiene and
prevention of infection must be observed in the preparation, Maintenance
cleaning and disinfection of the products. No special requirements.
Limitation of reprocessing Control and functional test
Frequent reprocessing has little effects on these products. The end Check the snap-on behavior of rotary knobs and handles.
of the product life cycle is usually determined by wear and tear and
damage through use. Packaging
Individual: A standard PE bag may be used. The bag must be large
enough for the product so that the closure is not under tension.
Sterilization
See Sterilization table on chapter 12.5.3.

64 PROVEO 8 / Ref. 10 733 910 / Version 03

 Care and maintenance

Storage
No special requirements.
Additional information
None
Contact information of manufacturer
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. In general, this
requires validations and routine monitoring of the process. Every
deviation from the supplied instructions should also be examined
carefully by the processing person to determine effectiveness and
possible detrimental consequences.

PROVEO 8 / Ref. 10 733 910 / Version 03 65

Care and maintenance

12.5.3 Sterilization table

The following table gives an overview of the available sterilizable components to the surgical microscopes of
Leica Microsystems (Schweiz) AG, Medical Division.

Permissible sterilization methods Products

Article Designation Steam autoclave Ethylene STERRAD® 1) M320 M220 M620 PROVEO 8 M525 M530 M720
No. 134 °C, oxide max. M844
t > 10 min. 60 °C M822
M820
10180591 Clip-on handle  –  – –   – – –
10428328 Rotary knob, binocular tubes T  – – –  –    
10384656 Rotary knob, transparent  –  –   – – – –
10443792 Lever extension  – – – –   – – –
10446058 Protective glass, multifocal –   – – – –   –
lense
10448439 Protective glass   – – – –  – – 
10448440 Cover, sterilizable  – –  – – – – – –
10448431 Protective objective glass     – – – – – –
10448296 Protective objective glass,   – – – –  – – 
spare part (package of 10)
10448280 Protective objective glass,   – – – –  – – 
complete, sterilizable
10448581 Cover, sterilizable for RUV800  – – – – –  – – –
10731702 Cover, sterilizable  –   – –  – – –
10429792 Sleeve for slit illumination  –  – – –  – – –

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.

66 PROVEO 8 / Ref. 10 733 910 / Version 03

 Disposal

13 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.

PROVEO 8 / Ref. 10 733 910 / Version 03 67

What to do if ...?

14 What to do if ...?
If your instrument has a malfunction that is not described
here, please contact your Leica representative.

14.1 Malfunctions
Malfunction Cause Remedy
The image remains unfocussed. Eyepieces are not mounted correctly. X Screw the eyepieces all the way on.
Diopters not set correctly. X Perform dioptric correction exactly according to the
instructions (see chapter 7.4.1).
Magnification cannot be adjusted Failure of magnification motor. X Press the magnification rotary knob.
electrically. X Set magnification by turning (see chapter 8.4.5).
Parallelogram cannot be moved. Parallelogram locked in position. X Release the locking mechanism (see chapter 7.7.3).

PROVEO 8 is not correctly balanced. Position of accessory was changed after X Balance out PROVEO 8 (see chapter 7.7.1).
balancing.
The image appears shaded through the Accessories not installed properly. X Install the accessories exactly in the holders (see
microscope at the edges and the chapter 7.2).
illumination field is outside the field of
vision.
Functions cannot be activated using the Incorrect assignment entered at control X Change the assignment using the control unit.
foot switch. unit.

14.1.1 F42 floorstand

Malfunction Cause Remedy

The stand of the PROVEO 8 moves. Footbrakes not applied. X Fix footbrakes in place (see chapter 7.1)

14.1.2 CT42 telescope mount

Malfunction Cause Remedy

The Leica CT42 cannot be moved up or The Leica CT42 is protected by a X 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. X Check the clamping terminal.

14.2 Malfunctions documentation accessories

Malfunction Cause Remedy
Video pictures unfocussed. Microscope or fine focus not precisely focussed. X Focus precisely, use graticule if necessary.
X Perform diopter correction exactly
according to the instructions.

68 PROVEO 8 / Ref. 10 733 910 / Version 03

 What to do if ...?

14.2 Error messages on the control unit

When the control unit detects an error, the yellow "Check" button lights up.
X Press the "Check" button.
The list with error messages is displayed.
X To acknowledge a message, select the message and press the "Confirm" button.
When there is no error message pending, the yello "Check" button disappears.

Error code Source Visible for user Meaning Possible cause of error
0112h PROVEO 8 Optics yes Main LED overtemperature • Main LED too hot.
• No air flow possible.
• Opitcs Carrier might be covered.
0116h PROVEO 8 Optics yes RedReflex LED overtemperature • RedReflex LED too hot.
• No air flow possible.
• Opitcs Carrier might be covered.
0402h Slitlamp adapter yes Lamp defective Lamp defective
FE01h MDC yes Optics carrier not found • CAN connection loose.
• Cable damaged.
• Controller defective.
FE02h MDC yes XY controller not found • CAN connection loose.
• Cable damaged.
• Controller defective.
FE03h MDC yes F42 controller not found • CAN connection loose.
• Cable damaged.
• Controller defective.
FE04h MDC yes Slitlamp adapter not found • CAN connection loose.
• Cable damaged.
• Controller defective.
• No slitlamp adapter installed (Device list not correctly
configured).
FE06h MDC yes DIC800 not found • CAN connection loose.
• Cable damaged.
• Controller defective.
• No DIC800 installed (Device list not correctly
configured)
FE07h MDC yes HDR not found • RS232 connection loose.
• Cable damaged.
• Controller defective.
• No IVR850 installed (Device list not correctly
configured).
FE08h MDC yes External inverter (SDI) not found • CAN connection loose.
• Cable damaged.
• Controller defective.
• No SDI module installed (Device list not correctly
configured).

PROVEO 8 / Ref. 10 733 910 / Version 03 69

What to do if ...?

Error code Source Visible for user Meaning Possible cause of error
FE09h MDC yes Camera control unit not found • RS232 connection loose.
• Cable damaged.
• Controller defective.
• No CCU module installed (Device list not correctly
configured).

70 PROVEO 8 / Ref. 10 733 910 / Version 03

 Specifications

15 Specifications 15.1.2 Optical data

With UltraLow™ II binocular tube

15.1 PROVEO 8
Objective
15.1.1 Microscope features OptiChrome™
Eyepiece WD = 175 mm/f = 200 mm
Magnification 6:1 zoom, motorized
Total magnification Field of view (mm)
Objective / OptiChrome™
working distance WD 175 mm/f = 200 mm 8.33× 3.4× – 20.4× 53.9 – 9.0
WD 200 mm/f = 225 mm 10× 4.1× – 24.5× 51.4 – 8.6
WD 225 mm/f = 250 mm
WD: Working distance 12.5× 5.1× – 30.7× 41.6 – 6.9
f: Focal length
Eyepieces Wide-field eyepieces for persons wearing glasses
8.3×, 10× and 12.5× dioptric adjustment Objective
±5 diopter settings; OptiChrome™
Eyepiece WD = 200 mm/f = 225 mm
adjustable eyecup
Illumination Main light: Total magnification Field of view (mm)
lntegrated LED illumination system for intensive,
8.33× 3.0× – 18.2× 60.6 – 10.1
uniform illumination of the field of view.
Continuously adjustable brightness with halogen 10× 3.6× – 21.8× 57.8 – 9.6
like color temperature.
12.5× 4.5× – 27.3× 46.8 – 7.8
Coaxial illumination:
llumination unit for generating a clear and stable
Red Reflex, decreasing stray light through the Objective
sclera and increasing the image contrast. OptiChrome™
Integrated LED illumination system for intensive, Eyepiece WD = 225 mm/f = 250 mm
uniform illumination of the field of view.
Continuously adjustable brightness with halogen Total magnification Field of view (mm)
like color temperature. 8.33× 2.7× – 16.3× 67.3 – 11.2
Adjustable Iris Diameter of Coaxial Illumination can be adjusted 10× 3.3× – 19.6× 64.3 – 10.7
from 4 mm to 23 mm WD.
12.5× 4.1× – 24.5× 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 03 71

Specifications

15.1.3 Microscope carrier Integrated Prepared for integration of video camera system
documentation and digital recording system.
Rotation of optics 380° Open architecture
Inclination tilt –15° / +105° Connectors Numerous built-in connectors for Video and control
data transfer. Internal power supply 12 VDC,
XY speed Zoom linked XY speed
19 VDC, 24 VDC and AC terminals
Indicator LED for Video record status
Carrier for monitor 860 mm long and flexible arm with 4 axis for
IR sensor for remote control of the HDR rotation and inclination to carry optional video
monitor.
XY range 62 × 62 mm Max. monitor weight: 15.5 kg
Focus range 75 mm Materials Use of RoHS conform materials

Camera image size with respect to the field of view Surface coating The microscope is coated with a paint which is
system designed to provide an antimicrobial effect on
• Camera for surfaces.
visible light Field of view
Maximum height In park position: 1950 mm
Range Cantilever Max. 1925 mm
Camera image size Load Max. 8.0 kg from microscope dovetail ring interface
Maximum weight Approx. 345 kg without load

Field of view
15.3 CT42 telescope mount
• TLC 12ZWDN-100 (230 V)
15.2 F42 floor stand • TLC 12ZWDN2-100 (120 V)
Electrical data Electrical data
Power connection 600 VA Power connection 100–120 V~ 50-60 Hz 1200 W
100–240 V~ 50-60 Hz 220–230 V~ 50 Hz 890 W
Protection class Class 1 Protection class Class 1

Type Floor stand with 4 electromagnetic brakes. Ceiling attachment Max. distance from concrete ceiling to
intermediate ceiling: 1500 mm
Base 760 × 760 mm with four 360° rotating castors with Attachment to concrete shell construction ceiling:
a diameter of 150 mm each, one parking brake 440 mm hole circle
4 x M12 HSLB M12/15
Balancing Adjustable gas spring via balancing knob
Weight Swing arm 70 kg
Floor stand control The latest electronics control for the continuous
Monitor arm 15.5 kg
unit governing of all motor functions and the light
Ceiling bracket 60 kg
intensity.
Telescope 50 kg
Menu selection based on unique software for user-
specific configuration, with built-in electronic Total weight Approx. 200 kg
auto-diagnosis and user support
Brakes Swing arm:
Control unit stand Open architecture for future software 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

72 PROVEO 8 / Ref. 10 733 910 / Version 03

 Specifications

Range Extension: 1492 mm 15.5 Ambient conditions

Swing arm extension: 1492 mm
In use +10 °C to +30 °C
Travel Range Telescopic unit: 500 mm +50 °F to +86 °F
Swing arm: +390 mm / -350 mm 30 % to 95 % rel. humidity
Balancing Adjustable gas spring via balancing knob 800 mbar to 1060 mbar atmospheric pressure

Turning range Axis 1 (ceiling mount): ±110° Storage –30 °C to +70 °C

Axis 2 (in the middle): ±150° –22 °F to +158 °F
Axis 3 (over XY unit): ±190° 10 % to 100 % rel. humidity
500 mbar to 1060 mbar atmospheric pressure
Duty cycle 120 V AC: 0.8 min/37 min
(intermittent 230 V AC: 1 min/37 min Transport –30 °C to +70 °C
operation) –22 °F to +158 °F
10 % to 100 % rel. humidity
Duty cycle (short- 120 V AC: 1.2 min 500 mbar to 1060 mbar atmospheric pressure
time operation) 230 V AC: 2 min

15.6 Standards fulfilled

15.4 CT42 rack controller
CE conformity
Electrical data • Medical Devices Directive 93/42/EEC including amendments.
Power connection 500 VA • Classification: Class I, in compliance with Annex IX, Rule 1 and
100–240 V~ 50-60 Hz Rule 12 of the Medical Devices Directive.
2 × T6.3 AH 250 V • Medical electrical equipment, Part 1: Generally defined for the
Protection class Class 1 safety in IEC 60601-1; EN 60601-1; UL 60601-1;
CAN/CSA-C22.2 NO. 601.1-M90.
The PROVEO 8 rack controller is internally fused with two T6.3 AH
• Electromagnetic compatibility
fuses. The building installation has to be secured with a fuse higher
IEC 60601-1-2; EN 60601-1-2; EN 61000-3-2; IEC 61000-3-2.
than 6.3 A in the line conductor. The neutral conductor of the
• Further applied harmonized standards: IEC 62366, EN 15004-2,
building installation may not be fused.
EN 10936-2, EN 62471, EN 980.
To ensure that the device is disconnected from the mains, remove
• The Medical Division, within Leica Microsystems (Schweiz) AG,
the fuse of the building installation.
holds the management system certificate for the international
Please also respect the installation manual.
standard ISO 13485 relating to quality management and quality
assurance.
Dimensions 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
Wall attachment Brick wall on a solid floor.
Metal stud 406 mm (plasterboard) The PROVEO 8 is not suitable for crossing thresholds higher than
Metal stud 625 mm (plasterboard) 20 mm.
Table stand possible
To move the surgical microscope over thresholds of 20 mm, the
wedge (1) included in the packaging can be used.
X Loosen the screws (2) on one side of the hinge in order to
remove the wedge (1).

PROVEO 8 / Ref. 10 733 910 / Version 03 73

Specifications




X Place the wedge (1) in front of the threshold.

X 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.

74 PROVEO 8 / Ref. 10 733 910 / Version 03

 Specifications

15.8 Dimensional drawings

15.8.1 F42 floor stand

max. 1571

(380)
max. 1231

PROVEO 8 / Ref. 10 733 910 / Version 03 75

Specifications

max. 1
50°

°
. 190
max

no
nde
sto
p
max
. 190
°

max.
180°

76 PROVEO 8 / Ref. 10 733 910 / Version 03

 Specifications

15.8.2 CT42 telescope mount

L* (min 300 / max 1500)

380x380

Ø400-Ø530

170
40
H* (standard = 1140 / max. 1640)

±190°
500 (stroke)

600
2900* (max 3600)

390**
350**

1600 (recommended)
1720 (max. 2320)

350° ±150°
1420 (max. 1920)

1205**

415 985 90

1490

* variable, depending on OR height

**up/down movement of Parallelogram, w/o Tilt-Focus

PROVEO 8 / Ref. 10 733 910 / Version 03 77

Manufacturer's declaration of electromagnetic compatibility (EMC)

16 Manufacturer's declaration of electromagnetic compatibility

(EMC)
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residental environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.

This "Guidance and manufacturer's declaration" document is based on EN 60601-1-2.

16.1 Table 1 from EN 60601-1-2

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 – guidance

RF emissions in accordance with CISPR 11 Group 1 The PROVEO 8 surgical microscope uses RF energy only for
its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.

conducted emissions in accordance with CISPR 11 Class A The PROVEO 8 is suitable for use in establishments other
than domestic and those directly connected to the public
Harmonic emissions according to IEC 61000-3-2 Class A low-voltage power supply network that supplies buildings
used for residential purposes.
Emission of voltage fluctuations/flicker according to IEC 61000-3-3 Complies

78 PROVEO 8 / Ref. 10 733 910 / Version 03

 Manufacturer's declaration of electromagnetic compatibility (EMC)

16.2 Table 2 from EN 60601-1-2

Guidance and manufacturer's declaration – electromagnetic immunitiy

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.
When the PROVEO 8 surgical microscope is exposed to any of the disturbances below, you might notice one of the following effects:
• flickering/noise on the HD Monitor
• 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.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Discharge of static ± 8 kV contact discharge ± 8 kV contact discharge Floors should be of wood, concrete or ceramic
electricity (ESD) according tile. If floors are covered with synthetic
to IEC 61000-4-2 ± 15 kV air discharge ± 15 kV air discharge material, the relative humidity should be at
least 30 %.

Electrical fast transient/ ± 2 kV for power supply line ± 2 kV for power supply line Mains power quality should be that of a typical
burst immunity according commercial or hospital environment.
to IEC 61000‑4-4 ± 1 kV for input and output ± 1 kV for input and output
lines lines

Surges according to ± 1 kV differential mode ± 1 kV differential mode Mains power quality should be that of a typical
IEC 61000-4-5 commercial or hospital environment.
± 2 kV common mode ± 2 kV common mode

Voltage dips, short <5 % UT (>95 % dip in UT) 70% UT 25/30 cycles Mains power quality should be that of a typical
interruptions and power for ½ cycle commercial or hospital environment.
supply voltage fluctuations 40% UT 10/12 cycles When short interruptions of 5 % UT for
IEC 61000-4-11 40 % UT (60 % dip in UT) 5 seconds occur, the PROVEO 8 surgical
for 5 cycles 40% UT 5/6 cycles microscope will cease operation and restart
automatically. It can be brought back to the
70 % UT (30 % dip in UT) 0% UT 0.5/0.5 cycles state it was before with user intervention.
for 25 cycles If the user of the PROVEO 8 surgical microscope
0% UT 1/1 cycles requires that the instrument remain functional
<5 % UT (>95 % dip in UT) even after power interruptions, it is
for 5 sec 0% UT 250/300 cycles recommended that the PROVEO 8 surgical
microscope be provided with an auxiliary power
source such as an uninterruptible power supply
(UPS) or battery back-up.

Magnetic fields at mains 3 A/m 30 A/m

frequency (50/60 Hz)
according to IEC 61000-4-8

Note UT is the AC voltage prior to application of the test level.

PROVEO 8 / Ref. 10 733 910 / Version 03 79

Manufacturer's declaration of electromagnetic compatibility (EMC)

16.3 Table 4 from EN 60601-1-2

Guidance and manufacturer's declaration – electromagnetic immunity

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.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Portable and mobile RF communications should be used no closer to

any part of the PROVEO 8 surgical microscope, including cables, than
the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF - Disturbance 3/6 Veff 10 Veff d = 0.35 √P for 150 kHz to 80 MHz
variables according to 150 kHz to 80 MHz d = 0.35 √P for 80 MHz to 800 MHz
IEC 61000-4-6 d = 0.7 √P for 800 MHz to 2.7 GHz

Radiated RF - Disturbance 3 V/m 10 V/m Where P is the maximum output power rating of the transmitter in
variables according to 80 MHz to 2.7 GHz 80 MHz to 3 GHz watts (W) according to the transmitter manufacturer and d is the
IEC 61000-4-3 recommended separation distance in meters (m). Field strengths
from fixed RF transmitters, as determined by an electromagnetic site
Proximity fields survey, should be less than the compliance level in each frequency
range. Interference may occur in the vicinity of equipment marked
with the following symbol:

Note 1 At 80 MHz, the higher frequency range applies.

Note 2 These guidelines may not apply in all situations. Electromagnetic propagation amount is affected by absorption and reflection from
structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the PROVEO 8.

80 PROVEO 8 / Ref. 10 733 910 / Version 03

 Manufacturer's declaration of electromagnetic compatibility (EMC)

Recommend separation distances between portable and mobile RF telecommunications equipment and the PROVEO 8 surgical
microscope

The PROVEO 8 surgical microscope is intended for operation in an electromagnetic environment in which radiated RF interference is controlled. The
customer or user of the PROVEO 8 surgical microscope can help prevent electromagnetic interference by maintaining the minimum distance between
portable/mobile RF communication equipment (transmitters) and the PROVEO 8 surgical microscope, depending on the output power of the
communication equipment, as stated below.

Separation distance according to frequency of transmitter in m

Rated maximum output 150 kHz up to 80 MHz 80 MHz up to 800 MHz 800 MHz up to 2.5 GHz
power of transmitter in W d = 0.35 √P d = 0.35 √P d = 0.7 √P

0.01 0.04 0.04 0.07

0.1 0.11 0.11 0.22

1 0.35 0.35 0.70

10 1.11 1.11 2,21

100 3.50 3.50 7.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

Note 1 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

If use is made of accessories or cables other than those specified in this user manual or approved by the manufacturer of the
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.

PROVEO 8 / Ref. 10 733 910 / Version 03 81

Annex

17 Annex
17.1 Checklist before the operation

Patient ........................................................................................................................................................................................

Surgeon ........................................................................................................................................................................................

Date ........................................................................................................................................................................................

Step Procedure Details Checked / Signature

1 Cleaning the optical accessories X Check the tubes, eyepieces and the documentation
accessories (if used) for cleanliness.
X Remove dust and dirt.
2 Installing the accessories X Lock the PROVEO 8 in place and install all accessories on
the microscope so it is ready for use (see chapter 7.2).
X Position the handles as desired.
X Connect the mouthswitch and/or footswitch, if used.
X Check the camera image on the monitor and realign if
necessary.
X Check that all equipment is in its proper position (all
covers fitted, doors closed).
3 Checking the tube settings X Check the tube and eyepiece setting for the selected user.
4 Function check X Connect the power cable (only F42).
X Switch on the microscope.
X Test all functions on the handles and the footswitch.
X Check the user settings on the control unit for the selected
user.
5 Balancing X Balance the PROVEO 8 (see chapter 7.7.1).
X Press the "All Brakes" button on the handle and check the
balancing.
6 Sterility X Fit sterile components and sterile drape if used (see
chapter 7.9.2).
X Repeat balancing.
7 Positioning at the OP table X Position the PROVEO 8 on the OP table as required and lock
the footbrake (see chapter 7.1) (only F42).

82 PROVEO 8 / Ref. 10 733 910 / Version 03

 

PROVEO 8 / Ref. 10 733 910 / Version 03 83

 CONNECT
10 733 910en/Version 03• Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2023 • Printed – 02.2023 – Subject to
modifications. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH.
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