1X1012EN Rev.

Digitally signed by Grabazei Alexandru

Date: 2019.07.30 10:50:11 EEST
Reason: MoldSign Signature
Location: Moldova

R-Evolution
R-Evolution CR
COMBINED EYE SURGERY MEDICAL DEVICE
MANUAL FOR INSTALLATION AND USE

OPTIKON 2000 S.p.A.

Via del Casale di Settebagni 13 - 00138 Rome – Italy
Tel. +39 06 8888355 – Fax. +39 06 8888440
e-mail: [email protected]
www.optikon.com
OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company
that produces surgical and diagnostic devices for ophthalmology.

All OPTIKON 2000 products are manufactured in compliance with the

requirements of Directive 93/42/EEC on medical devices.
 TABLE OF CONTENTS

1. DISCLAIMER ........................................................................ 1-1

2. LIMITED WARRANTY CONDITIONS ............................................. 2-2
3. GENERAL INFORMATION ........................................................... 3
3.1 KEY TO SYMBOLS ........................................................................... 3
3.2 TABLE OF SYMBOLS ........................................................................ 4
3.3 TARGET GROUP ............................................................................ 7
3.4 INTENDED USE .............................................................................. 7
3.5 NOTES FOR THE OPERATOR ........................................................... 8
4. TECHNICAL SPECIFICATIONS .................................................... 29
4.1 GENERAL SPECIFICATIONS .............................................................. 29
4.2 EMC TABLES ............................................................................... 33
4.3 DIATHERMY POWER CHARACTERISTICS ............................................... 38
4.4 WIRING DIAGRAMS ....................................................................... 38
5. INSTALLATION AND USE.......................................................... 39
5.1 DESCRIPTION OF THE APPARATUS ..................................................... 42
5.2 DEVICE COMPONENTS .................................................................. 49
5.2.1 Overall view .............................................................................................. 49
5.2.2 Front panel connectors and control elements ................................................ 51
5.2.3 Rear panel connectors and control elements.................................................. 53
5.2.4 Footswitch ................................................................................................ 54
5.3 TOUCHSCREEN AND USER INTERFACE .............................................. 57
5.4 INSTALLATION PROCEDURE ............................................................. 61
5.4.1 Installation of the equipment ......................................................................... 61
5.4.2 Installation of the Easysys I/A cassette ............................................................. 67
5.4.3 Installation of phaco accessories ................................................................. 69
5.5 USER PROGRAMS ......................................................................... 71
5.6 OPERATION ............................................................................... 75
5.6.1 Irrigation / Aspiration ................................................................................. 75
5.6.2 Phacoemulsification .................................................................................. 80
5.6.3 Bipolar endodiathermy for retinal surgery ....................................................... 84
5.6.4 Vitrectomy ................................................................................................ 85
5.6.5 Scissors .................................................................................................... 87
5.6.6 Illumination ............................................................................................... 88
5.6.7 Tamponade .............................................................................................. 89
5.6.8 Footswitch programming ............................................................................... 91
5.6.9 Mean Ocular Perfusion Pressure (CR only) .......................................................... 94
6. SYSTEM ALARM MESSAGES .................................................... 97
7. CARE AND MAINTENANCE .................................................... 106
7.1 EQUIPMENT MAINTENANCE .......................................................... 106
7.2 MAINTENANCE OF ACCESSORIES ................................................... 109
7.3 CARE OF THE DEVICE ................................................................. 110
8. ACCESSORIES ..................................................................... 111
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1. DISCLAIMER
The user of this Medical Device must carefully read the specific warnings provided in
this manual. It is the responsibility of the operator to guarantee the assigned
personnel a thorough knowledge of the instrument’s operation before use. In no case
is OPTIKON 2000 S.p.A. liable for any burns or accidental or consequential damage
caused to the buyer, operators or patients following the use of the product.
The use of the Medical Device is subject to professional medical evaluation.
OPTIKON 2000 S.p.A. is not liable for any clinical problem resulting from an
incorrect use of this apparatus and does not provide any medical recommendation.
OPTIKON 2000 S.p.A. declares to be responsible for the safety, reliability and
performance only if:
 updates, calibrations and repairs are carried out by personnel which has been
authorised by OPTIKON 2000 S.p.A.;
 the Medical Device is used in compliance with the user instructions;
 the electrical system to which the Medical Device is connected proves to be in
compliance with IEC safety regulations.

IMPORTANT NOTE:
Every effort has been made so that all the illustrations and information precisely
represent the product and its operation as they were at the time this manual was
printed. It is possible, however, that during the existence of this manual
modifications have been made in order to continue to effectively satisfy the
needs of the users. At times, such modifications are made without advance
notice.

OPTIKON 2000 S.p.A.

Via del Casale di Settebagni, 13
00138 Rome - Italy
Tel. +39 06 8888355
Fax. +39 06 8888440
e-mail [email protected]
www.optikon.com

NOTE
The information contained in this manual is the exclusive property of OPTIKON
2000 S.p.A. Partial or total reproduction of this manual is permitted only upon
written authorisation by OPTIKON 2000 S.p.A.

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2. LIMITED WARRANTY CONDITIONS

All the OPTIKON 2000 S.p.A. instruments and accessories sold and installed in the
European Union are guaranteed against manufacturing and material defects for ONE
YEAR from the invoicing date. The guarantee on the consumable material is limited
to the first use of the apparatus.
For the warranty conditions outside the European Union, contact your authorised
OPTIKON 2000 S.p.A. distributor.
All the parts covered by the warranty will be repaired or replaced free of charge .
The warranty includes the search for the defect’s cause, repair of the failure and
final inspection of the unit or components.
This warranty does not cover any problems which are the result of improper use,
accidents, incorrect use and tampering or modifications made by persons who are
not part of the authorised OPTIKON S.p.A. technical service.
OPTIKON 2000 S.p.A. reserves the right to verify, in case of failures, if the
instrument and/or its accessories have been modified or tampered with in any way,
or if they have been damaged by improper use.
OPTIKON 2000 S.p.A. also reserves the right to modify the instrument and/or its
accessories in the event operating techniques require such modifications.
The warranty is not valid if the serial number of the instrument and/or accessories
attributed by OPTIKON 2000 S.p.A. is missing, tampered with and/or unreadable.
The warranty does not include the expenses for returning the instrument and
accessories: all charges for shipping , packaging, etc. shall be borne by the buyer.
In the event of an explicit request for work by OPTIKON technicians, all travelling
and lodging expenses shall be charged to the customer.
OPTIKON 2000 S.p.A. is not liable for damages caused during transport. If this
occurs, the customer must immediately notify the carrier that handled the delivery.

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3. GENERAL INFORMATION
3.1 KEY TO SYMBOLS

We wish to furnish you with information on the safety

aspects involved in working with this Medical Device. This
section contains a summary of the most important
information on safety-related topics.

Hazard symbols

The following safety information has been incorporated into

the user manual. Please note this information and act with
particular care in these cases.

WARNING Indicates a hazard which can cause damage leading

to fatal or serious injuries.
CAUTION Indicates a hazard which can cause damage leading to
injuries in need of medical attention.
INFORMATION Indicates a hazard which can cause damage leading
to injuries with no need of medical attention.

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3.2 TABLE OF SYMBOLS

The table below shows some I.E.C. approved symbols and their meanings. These
symbols are often used on medical instruments to enable quick and simple
communication of information and warnings. At times two or more symbols are
combined together in order to obtain special meanings.
These are the symbols used on the R-Evolution label. Before using the unit,
familiarize yourself with the symbols and definitions provided in the table.

SYMBOLS PUBLISHED BY IEC

SYMBOL DESCRIPTION

MANUFACTURER

DATE OF MANUFACTURE

ALTERNATING CURRENT

RF EMISSION

OFF (DISCONNECTED FROM

MAINS)

ON (CONNECTED TO MAINS)

TYPE B APPLIED PART

TYPE BF APPLIED PART

SEPARATED WASTE COLLECTION

FOR ELECTRICAL/ELECTRONIC
EQUIPMENT

EQUIPOTENTIALITY

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SEE OPERATING INSTRUCTIONS

NOMINAL FUSE RATING

EXTERNAL COMPRESSED AIR

INLET

AIR INJECTION SOCKET

LIGHT SOURCE SOCKET

DIATHERMY SOCKET

FOOTSWITCH SOCKET

BATTERY CHECK

OTHER SYMBOLS ON THE EQUIPMENT

SCISSORS SOCKET

SILICONE OIL INJECTION SOCKET

PHACO SOCKET

VITRECTOMY SOCKET

KNOB FOR UNLOCKING CASSETTE

USB SOCKET

IRRIGATING SOLUTION

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INCREASE LEVEL

DECREASE LEVEL

CONTROLLED IRRIGATION

SPHYGMOMANOMETER ARM CUFF

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3.3 TARGET GROUP

This user manual is intended for physicians, nurses and other

medical and technical staff involved in the preparation,
operation or maintenance of the device after appropriate
training. It is the duty of the customer or institution operating
the Medical Device to train and instruct all staff in the use of
the system.
Additional service activities are not part of this user manual.
These activities will be performed by staff specially trained
for this purpose by Optikon 2000.

Range of applications

Purpose
The R-Evolution Surgical Medical Device has been designed to
be used in surgical theatres by qualified medical personnel
(eye surgeon) for surgical procedures for treatment of the
anterior segment of the eye. The equipment has been
designed for the implementation of irrigation, irrigation/
aspiration, phacoemulsification of crystalline lens, anterior
vitrectomy, bipolar diathermy coagulation techniques. The R-
Evolution CR also features posterior vitrectomy, air and
silicone oil tamponade, endo-ocular illumination. The Medical
Device is intended for use in clinics, hospitals, and other
institutions of human medicine.

3.4 INTENDED USE

The R-Evolution is intended for surgical treatments, such as

extra-capsular extraction, phacoemulsification or glaucoma in
the anterior segment of the human eye, the R-Evolution CR
also for surgical treatment of retinal detachment and other
pathologies of the vitreous body and the posterior segment of
the human eye. Malfunctions during the use of the Medical
Device are indicated by a message on the display and alarm
signals.
Any use other than the one stated above, is excluded as it
may cause unforeseeable risks. In particular, the use of
this Medical Device in brain or heart surgery is excluded.

WARNING Risk of injury to the patient!

• The diathermy section of the R-Evolution must not

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be used with patients with a pace maker or other
cardiac stimulators without consulting a
cardiologist in advance.

3.5 NOTES FOR THE OPERATOR

• Use the Medical Device only for the intended purpose

as described.
• Comply with the legal regulations regarding market
surveillance and obligatory reporting applicable in
the respective country, as well as any further
regulations and standards.

User qualification

• Please familiarize yourself thoroughly with the

contents of the user manual before starting up the
Medical Device. Please note the instructions for use
of the other equipment as well.
• Before using the device, all medical staff must have
read and understood all instructions included in the
present user manual.
• Keep the user manual in a place that is easily
accessible at any time to the staff charged with
operation of the Medical Device.
• The Medical Device may only be used by qualified
medical employees who understand the possible
risks associated with the use of this medical
device and completed adequate training in the
prevention and management of clinical
complications, if any.
• The Medical Device must be used exclusively by
staff who received adequate training and
instruction. It is the duty of the customer or
institution operating the system to train and
instruct all staff using the Medical Device.

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• Adequate training is essential for proper installation
and operation of the R-Evolution, training that is
provided by Optikon 2000. Contact your local Optikon
2000 Service for details.

Transportation

CAUTION Risk of injury to the patient’s eye!

This Medical Device has been packaged to minimize the
risk of damage in shipment.
• If you notice any shipping damage, notify the carrier
and do not use the device.
• For transports over extended distances (e.g.
dismantling, return for repair purposes, etc.), you
need to package the device in its original package or
special return shipment packages. For details, please
contact your dealer or Optikon 2000 Service.

Set-up and installation

INFORMATION Risk of damaging the Medical Device!

• Make sure that the installation conditions and the
use of the device meet surgical requirements:
– Low vibration
- Clean environment
– Avoidance of extreme mechanical loads

INFORMATION Risk of damaging the Medical Device!

The maximal height level of the infusion pole is 290 cm.
• Do not install the R-EVOLUTION under a low ceiling.

INFORMATION Risk of damaging the Medical Device!

Closed or obstructed ventilation openings may cause the
device to overheat.
• Install the R-EVOLUTION such that the ventilation
openings are not closed or obstructed.
WARNING Risk of fire or explosions!
The Medical Device is not design to work in

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hazardous areas.

• R-Evolution must not be used:

– in areas where there is a risk of explosion,
– if inflammable anesthetics or volatile solvents,
such as alcohol, benzene or similar chemicals,
are present at a distance of less than 25 cm.

• Do not use or store the Medical Device in damp

rooms. Do not expose the device to water splashes,
dripping water or sprayed water.

• To ensure safe operation, do not install the Medical

Device in a location where it may be exposed to
heating appliances or radiators, direct sunlight or
any other source of heat with extremely high
temperatures.

Operation

CAUTION Risk of injury to the patient or user!

• Please comply with the maximal loads on the following
components:
– Maximal load on instrument tray 1 kg.
– Maximal load of bottle and irrigation solution 1 kg.

CAUTION Risk of injury to patient or user!

Risk of tipping when crossing doorsteps.
• Push the device slowly and carefully by its handle
over doorsteps of up to 3 cm. If the doorstep is
higher than 3 cm, the equipment must be moved
over the doorstep by two people.

INFORMATION Risk of minor injury to the patient!

A logo with rotating white dots at the lower right
edge of the screen indicates that the system is
working properly.
• If the d o t s a r o u n d t h e l o g o cease to
move, the software is in idle and you have to
discontinue the use of the Medical Device.
• Before each use, carry out the installation, surgical

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configuration and operating procedures described
herein. If a malfunction occurs which cannot be
corrected using the chapter "Remedying
malfunctions", please label the device as non-
functional and contact the Optikon 2000 service.

• Carefully follow the instructions when installing and

using the unit in order to prevent harmful
interference by with other devices. If the Medical
Device causes harmful interference with the function
of other devices (can be detected by turning the
unit off and on again), the user is encouraged to try
to remedy the interference by one or more of the
following measures:
 Reorient or relocate the other devices.
 Increase the distance between the devices.
 Connect the unit to an outlet of a
circuit different from the one to which
the other devices are connected.
 Please contact your local dealer or the
Optikon 2000 Service.
• The sound emission capability of the equipment is
tested at start-up.
Verify that an acoustical signal is emitted during
initialization.
• Malfunctions during the use of the Medical Device are
indicated by a message on the display and alarm
signals Remedy the malfunction and confirm the
message by pressing the corresponding key on the
display. If the malfunction cannot be eliminated or
the error keeps recurring, do not continue using the
device, but rather attach a sign to it stating that it
is "out of order", and contact your local Optikon 2000
Service or local dealer.
• Do not pull on power cables or other connecting
cables.
• Moving the equipment make sure that no hoses get
pinched or pulled off.
• Never leave a Medical Device unattended while the
light source is turned on in order to prevent retinal

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damage on the eye of the patient from excessive
irradiation times.

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Maintenance

• This Medical Device is a sophisticated high-technology

product. To ensure optimal performance and safe
working order, we recommend, as part of regular
scheduled maintenance, having it checked yearly by
Service personnel authorized by Optikon 2000.

• To prevent any impairment of the system safety as a

result of aging, wear, etc., the institution operating
the device must ensure, in accordance with the
applicable national regulations, that the regular
technical safety checks prescribed for this Medical
Device are performed on schedule and to the
stipulated extent. The technical safety checks must
be performed by the manufacturer or qualified
persons only. The scope of the technical safety
checks should at least comprise the following items:
– Availability of the user manual
– Visual inspection of the equipment and
accessories for damage and legibility of the
symbols/labels
– Test of protective earthing impedance
– Leakage current test
– Functional test of all switches, buttons,
outlets, and indicator lamps of the Medical
Device.

Modifications

WARNING Risk of injury to the patient’s eye!

Modified products might break during application and
cause malfunction of the Medical Device.
• Do not change the shape of a vitrectomy handpiece
or phaco tip used with the R-EVOLUTION (i.e. do not
kink, cut or scratch).

WARNING Risk of injury to the patient’s eye!

Changes due to the application of manual force to the
height level of the infusion pole lead to an incorrect

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height level of the bottle and patient injury.
• The height level of the infusion pole must not be
modified or changed by the application of manual
force.
• Modifications and repairs of this Medical Device or any
system operated together with this device may only
be performed by the Optikon 2000 Service or other
suitably authorized persons.

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Disposal

CAUTION Pollution of the environment!

Inappropriate disposal may contaminate the
environment!
• Do not dispose of the device along with normal
domestic waste.
Separate disposal according to the local
laws/regulations governing the disposal of electrical
and electronic equipment is required
• Infected parts may contaminate user or the
environment. Dispose waste collection fluids
according to the local laws/regulations governing
the disposal of organic materials.

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Approved accessories

WARNING Risk of injury to the patient’s eye!

• Use only those sets that are approved and
recommended by Optikon 2000.

CAUTION Risk of injury to the patient’s eye!

• Use only original accessories and consumables
made by Optikon 2000 that are designed for
use with the R-EVOLUTION. Check the
Instructions for Use of the accessories for
compatibility with the R-EVOLUTION.

• The use of accessories and cables that are not

enclosed in the scope of delivery of the Medical
Device may lead to increased emission of
electromagnetic interference or reduced immunity
of the device to interference. Only use spare parts
approved by Optikon 2000 for this device.
• Additional equipment connected to medical
electrical devices must comply with the respective
IEC or ISO standards (e.g. IEC 60950 for data
processing equipment). In addition, all configurations
must meet the requirements for medical electrical
systems (see IEC 60601-1-1 or Clause 16 of the 3rd
edition of IEC 60601-1). Anybody connecting
additional equipment to medical electrical
equipment configures a medical system and is
therefore responsible for the compliance of the
system with the requirements for medical electrical
systems. Please note that that local laws take
priority over the above mentioned requirements. If
in doubt, consult your local Optikon 2000 service or
the local representative.

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Electrical system

INFORMATION Risk of equipment malfunctions!

• Use only USB pendrives that are free from viruses.

• Virus-free USB sticks must be used exclusively.

• The Medical Device is set for use with a line voltage

of 100 – 240 V (± 10 %), 50-60Hz . Please check
that the local line voltage corresponds to this
voltage.
• Always replace the fuse with one of the same type.
• To reduce the risk of electric shock, do not remove
the protective cover. Have an authorized service
technician replace the fuses.
• Connect the R-EVOLUTION to a mains supply having the
characteristics shown on the rear panel of the
console. To guarantee safe operation, the
e q u i p m e n t must be properly grounded.
• To avoid the risk of electrical shock, this device may
only be connected to a properly grounded supply
unit.
• Before connecting the unit to the power supply, or
disconnecting it, make sure that the main switch is
off.
• The main switch be kept turned off when the Medical
Device is not in use.
• Before replacing fuses, switch off the Medical Device
and let it cool down a few minutes.
• If required by the regulations and guidelines in the
country of use, the Medical Device must be
connected to an uninterruptible power supply.
• Do not place any fluid-filled containers on top of the
equipment. Make sure than no cleaning agents can
enter the device.
• Never attempt to connect any electrical connectors
by force (plugs, sockets). If a connector does not fit
into a socket, check whether it’s intended for
another one. If a connector is damaged, please

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contact your local Optikon 2000 Service.
• Do not use power strips.
• The Medical Device must be properly grounded to
ensure safe operation.
• Additional potential equalization: The Medical Device
must be incorporated into protective earth
connectors.

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Diathermy application

WARNING Risk of injury in patients with cardiac pacemakers!

There is a possible risk in patients with a cardiac
pacemaker or stimulation electrodes because the
diathermy generator may generate RF interference.
The pacemaker may fail.
• If you have concerns in this regard, please
contact a knowledgeable physician for advice.

WARNING Risk of injury to the patient’s eye!

• When the bipolar diathermy handpiece and a
monitoring system are used at the same time, all
electrodes of the monitoring system that are not
protected by resistors or high frequency inductors
must be placed as far away as possible from the
diathermy electrodes.
• Risk of burns or fire; do not use diathermy near
conductive materials such as metal bed parts, inner-
spring mattresses, and the like. Replace the
electrode cables as soon as there is any evidence of
wear.
• Use original diathermy cables from
Optikon 2000 only.
Risk of burns!
• The PATIENT should not come into contact with
metal parts which are earthed or which have an
appreciable capacitance to earth (for example
operating table supports, etc.).
• Skin-to-skin contact (for example between the
arms and body of the PATIENT) should be avoided,
for example by insertion of dry gauze
• The cable of the bipolar diathermy should not touch
the patient or other cables.
• Temporarily unused diathermy handpieces should be
stored in a location that is isolated from the PATIENT.
• Severe RF (radio frequency) burns can result if the
diathermy output current is diverted to the operator
by careless handling.

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• Always use the lowest output diathermy power level

which is compatible to the surgical application.
• failure of the diathermy generator could result in an
unintended increase of output power.
• Evidence of low output level or faulty operation of
the bipolar diathermy handpiece, even though the
equipment has been set for normal use, may indicate
a bad contact in the electrodes connections.
• Using the bipolar diathermy handpiece , do not use
flammable anesthetics, nitrogen monoxide or
oxygen, if sufficient ventilation by a suitable
aspiration system is not guaranteed.
• Flammable materials such as disinfecting agents
and cleaning agents should be evaporated before
using the bipolar diathermy handpiece.
There is a risk of pooling flammable solutions under
the patient or in body depressions, such as under
the neck or in the eye orbit. Any flammable fluid
deposited in these areas should be dried before
using diathermy. Some materials such as cotton
wool or gauze, if soaked with oxygen, can catch
fire because of the sparks caused by the
equipment in its normal use.

• Interference with other medical equipment due

to the use of the bipolar diathermy handpiece is
possible.
• R-evolution diathermy generator is designed for
bipolar coagulation applications only, therefore no
neutral electrode must be used.

Risk of injuries!
• Mainly due to the rectifying effect of arcs between the
electrodes and tissue , diathermy may cause
neuromuscular stimulation, with risk of injuries due to
muscular contraction.

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Irrigation/Aspiration application

WARNING Risk of injury to the patient’s eye!

Positioning the irrigation solution too low may cause
the pressure in the eye of the patient is too low.
• Make sure that the irrigation solution is always at or
above eye level of the patient.
• Please comply with the indications described in the
“Set-up of the irrigation/aspiration tubing” chapter
of this manual. Non-compliance with the indications
specified therein may lead to serious consequences.
• Correct set-up of irrigation and aspiration lines is
critical to ensure proper operation of the
R-EVOLUTION.
• Switching from peristaltic mode to Venturi mode may
cause anterior chamber collapse if a low impedance
phaco tip is used (i.e. large bore phaco tip) and if the
vacuum is set at a high level. To ensure patient safety,
always check that the vacuum setting is proper for
the desired type of pump before restarting
aspiration after switching pump types.
• Use only original Optikon 2000 tubing sets.
• Do not prime or fine-tune the handpiece while it is
situated in the eye of the patient as this could result
in patient injury.
• Before any intervention make sure that a sufficient
amount of balanced salt solution is available.
Monitor the amount of balanced salt solution during
the entire intervention.
• During the operation, keep monitoring the level of
balanced salt solution in the infusion bottle. If the
amount of balanced salt solution is deemed
insufficient for completing the operation,
immediately notify the surgeon and replace the
infusion bottle or infusion bag proceeding as follows:

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IRRIGATION BY GRAVITY
• Interrupt the surgical procedure and remove the
handpiece from the incision.
• Close the clamp on the infusion hose.
• Unhook the bottle from the infusion pole when the
bottle is almost empty.
• Remove the spike of the infusion set from the bottle,
being careful not to touch it with your hands or any
other non-sterile materials.
• Insert the infusion set’s spike in the cap of the new
bottle and hook it to the I.V. pole.
• If the drip chamber becomes completely empty,
squeeze it to fill it with balanced salt solution until it
is approximately 50% full.
• Re-open the infusion clamp.
• If air bubbles are observed in the irrigation tubing,
ask the surgeon to activate just irrigation until the
bubbles have been expelled, before reinserting the
handpiece in the patient’s eye.

CONTROLLED INFUSION
• Interrupt the surgical procedure and remove the
handpiece from the incision.
• Close the clamp on the infusion hose.
• Disconnect the air tube from the “CONTROLLED” outlet
located on the medical device console.
• Unhook the near-empty infusion container from its
support.
• Remove the spike of the infusion set from the infusion
container, being careful not to touch the needle with
your hands and not to allow it to come into contact
with any non-sterile material.
• Puncture the spike of the infusion set into the cap of
a fresh infusion container and suspend it on the
support.
• Connect the air tube to the “CONTROLLED” outlet of
the medical device console.
• Re-open the irrigation clamp.

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• If air bubbles are observed in the irrigation tubings,
ask the surgeon to activate just irrigation until the
bubbles have been expelled, before reinserting the
handpiece in the patient’s eye.

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Ultrasound application

WARNING Risk of injury to patient or user!

Prolonged exposure to or direct contact with the
vibrating phaco tip while testing the phaco tip for
vibrations may cause damage to healthy tissue.
• Never place your hand or finger on the phaco tip or
the silicone sleeve of the phaco handpiece while
testing the phaco handpiece.

CAUTION Risk of injury to the patient’s eye!

Burn injury caused by excessive ultrasound energy!
• Vibration noise should increase with ultrasound power
setting, a constant high noise at all power levels
indicates equipment malfunction.

CAUTION Risk of injury to the patient’s eye!

Moving the phaco tip/silicone sleeve in the incision
may cause corneal damage in the patient.
• Do not twist against and do not apply pressure to the
wound.

CAUTION Risk of injury to the patient’s eye!

Corneal burn injury caused by excessive ultrasound
energy.
• Always use the lowest ultrasonic output power level
which is compatible to the surgical application.
• Do not activate the phaco handpiece while the phaco
tip is surrounded by air. The ultrasonic power should
be applied to the phaco handpiece with the phaco
tip immersed in a sterile test chamber filled with
infusion fluid or in a beaker of sterile fluid at ambient
temperature. Non-compliance with these
instructions can lead to damage to the phaco tip
and/or phaco handpiece.
• Please make sure that the phaco handpiece is properly
connected to the irrigation/aspiration system of the
R-evolution and it is used together with the system
only.
• A loud buzz from the phaco handpiece at minimum

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power setting may indicate a malfunction of the
power regulation circuitry which may cause corneal
burns or endothelial damage. Please contact your
local dealer or the Optikon 2000 Service.
• Never press the phaco tip/silicone sleeve against
the wound in order to prevent the phaco tip from
over-heating.
• Undesirable increase of the output power may be
indicative of a malfunction of the R - E v o l u t i o .
Please contact your local dealer or the Optikon
2000 Service.

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Vitrectomy application

• Never activate the vitrectomy handpiece while the

cutting tube is surrounded by air. The cutting tube
should always be test run in a beaker of sterile
solution. Testing in air will cause irreparable damage
to the cutting tube.

Illumination

WARNING Risk of injury to the patient’s eye!

• Adapt the irradiation intensity and the

corresponding duration of exposure by selecting
suitable irradiation settings.

WARNING Risk of injury to the patient’s eye!

Retinal damage due to excessive power level.

• Although the fiber optic endo-ocular illumination
system is designed for no or minimal emission of
Infrared and Ultraviolet radiation, to avoid possible
damage to the retina, always use the minimum
power level which is compatible to the surgical
application.

INFORMATION Risk of minor injury to the user!

Light output ports that are turned on are hot.

• Turn off the light and wait several minutes before
you touch the light output ports!
• To reduce the risk of retinal damage, the edge of the
fiber optic illumination probe should not be situated in
the immediate vicinity of the retina.

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Air-silicone oil tamponade

WARNING Risk of injury due to excessive air pressure!

• An audible air leakage at power up may indicate
Silicone section malfunction. Please, consult your local
Optikon 2000 Service.

• To avoid possible eye infections, use only the original

Optikon 2000 air infusion hose for air tamponade
which is provided with an air sterilization filter.
• The use of non- standard air supply tubing kit
may compromise the accuracy of intra-ocular air
pressure and compromise sterility of air.
• During the injection of silicone oil, the intraocular
pressure is not controlled by the R-Evolution CR such
that the surgeon is in charge of controlling the
intraocular pressure (IOP). It is important to check
silicone flow at the preset injection pressure before
inserting the cannula in the eye.
• Release the foot switch to discontinue the injection
of silicone oil. In any case of emergency, you can
take the silicone oil infusion tubing off the silicone
supply unit.

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Digital Sphygmomanometer (MOPP)

CAUTION Do not apply the cuff to an arm with another medical

equipment attached. The equipment may not function
properly.
 Measurements may be distorted if the device is used close
to televisions, microwave ovens, cellular telephones, X-
ray or other devices with strong electrical field.

WARNING Risk of injury!

With people who have a severe circulatory deficit in the
arm, consult a specialist before using the device, to avoid
medical problems.
 Do not apply the cuff on an arm receiving an intravenous
drip or blood transfusion. It may cause injury or accidents.
 Do not apply the cuff on an arm with an unhealed wound.
 Do not apply the cuff on the arm on the side of a
mastectomy.
 The device is not intended for neonatal use, neither for
use on preeclamptic patients.

INFORMATION Risk of device malfunction.

 Do not modify the device. It may cause accidents or
damage to the device.
 Clean the arm cuff with a dry, soft cloth or a cloth
dampened with water and neutral detergent. Never use
alcohol, benzene, thinner or other harsh chemicals.
 Avoid tightly folding the cuff or storing the hose tightly
twisted for long periods, as such treatment may shorten
the life of the components.
 Verify that the cuff size is adequate for the arm of the
patient.
 Place the arm cuff directly against the skin, as clothing
may cause a faint pulse and result in a measurement
error.
 Constriction of the upper arm, caused by the tightly
rolling up a shirtsleeve, may prevent accurate readings.
 Proper functioning of the device has only be tested with
Optikon arm cuffs. Always use original spare parts.

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4. TECHNICAL SPECIFICATIONS
4.1 GENERAL SPECIFICATIONS

PARAMETER SPECIFICATION
Manufacturer: ...................... OPTIKON 2000 S.p.a.
via del Casale di Settebagni, 13
00138 Rome - Italy
Model: ............................... R-Evolution / R-Evolution CR
Regulatory compliance: ......... 93/42/EEC Medical Devices Directive (MDD)
Technical standards: ............. EN60601-1; EN60601-1-2 ; EN60601-2-2 ; EN80601-2-58 ;
EN60601-2-30

ENVIRONMENTAL SPECS
Storage and transport: ............ temp range –10°C to +70°C, humidity 10-100%
(non-condensing),
atmospheric pressure 500-1060hPa
Operation: .......................... temp range +10°C to +35°C, humidity 30-75%,
atmospheric pressure 940-1060hPA (for max aspiration
vacuum); 810-1060hPA (aspiration vac. up to 500mmHg)

ELECTRICAL SPECS
Input voltage: ...................... 100-240 Vac.
Frequency: ......................... 50/60 Hz
Power consumption: .............. 420 W
Line fuses: .......................... 100-240 Volt: T4AH 250V

COMPRESSED AIR SPECS (R-Evolution CR only)

Input air pressure:................. from 500 to 800 KPa (72 to 116 PSI)
Air consumption: .................. 32 normal litre/minute

IRRIGATION
Fluid delivery: ..................... gravity fed - eye pressure determined by the height of
irrigation source or Controlled
Valving element: .................. solenoid driven pinch valve
Control: ............................. system footswitch

ASPIRATION
Aspiration pump types: ........... R-Evolution: rotary vane and peristaltic
R-Evolution CR: Venturi and peristaltic
Actuating medium: ................ (Venturi pump) pressurized air from external source
pressure: 500÷800 KPa (72÷116 PSI)
Flow: ................................ at least 30 normal litre/minute @ 600mmHg
Default vacuum level: user programmable
Available vacuum range: 5 to 700 mmHg

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PARAMETER SPECIFICATION

Default flow rate: ................. user programmable

Available flow rate range: ....... 1 to 90cc/min (peristaltic only)
Available aspiration rise time: .. from 0.5s to 12s (25 levels)
Surgeon mode (linear aspiration): linear aspiration (vacuum and/or flow rate) from
minimum to maximum user programmable values,
linearly controlled via system footswitch
Safety device: ...................... vacuum sensor; monitors the vacuum in the aspiration
line
Control: ............................. system footswitch

POSTERIOR VITRECTOMY (R-Evolution CR only)

Handpiece type: ................... pneumatically powered guillotine cutter (VIT),
pneumatically powered microscissors (SCISS)
Cutting mode: ...................... reciprocating motion
Default cut rate: .................. user programmable
Available cutting rate: ............ from 60 to 10.000 cuts per minute (VIT)
from 120 to 20.000 cuts per minute (Twedge)
from 60 to 310 cuts per minute (SCISS)
Single cut mode: .................. Available for Scissors only
Port size: ........................... 0.5mm
Actuating medium: ................ pressurized air from external source
Operating pressure: ............... 2.3bar to 4.2bar
Surgeon mode (Linear cut): ...... linear cut rate from programmable start frequency to
programmable end frequency, controlled via system
footswitch
Control: ............................. system footswitch
ANTERIOR VITRECTOMY
Handpiece type: ................... pneumatically powered guillotine cutter
Cutting mode: ...................... reciprocating motion
Default cut rate: .................. user programmable
Available cutting rate: ............ from 60 to 4.200 cuts/min (CR 60 to 10.000cuts/min)
Port size: ........................... 0.5mm approx.
Actuating medium: ................ pressurized air from external source (CR) or from
internal oil less compressor (R-EVOLUTION)
Operating pressure: ............... 2.3bar
Surgeon mode (Linear cut): ...... linear cut rate from 0 to preset controlled via system
footswitch
Control: ............................. system footswitch
DIATH (DIATHERMY)
Type: ................................ bipolar generator - generator stops when RF power is not
needed

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PARAMETER SPECIFICATION

Operating frequency: ............. 2 MHz

Nominal power: .................... 9W (200 Ohm LOAD)
No load max. voltage: ............ 100 V
Default bipolar power: ........... user programmable
Available bipolar power: ......... 5 to 100% (percent)
Surgeon mode (linear power): .. allows linear control of the DIATHERMY power via system
footswitch depression
Handpiece type: ................... bipolar microforceps, slim stat pencil eraser, intraocular
diathermy pencils
Diathermy cable: .................. two poles, 26 gauges, 75 ohm, 200V max, steam
autoclavable. Use only original OPTIKON 2000 S.P.A.
diathermy cable
Control: ............................. system footswitch
ILLUMINATION (R-Evolution CR only)
Source type: ....................... Three independent LED lamps
Luminous flux: .................... 400+400+400lm
Intensity adjustment: ............ 20 levels + 4 protection and epiretinal membrane
visualization enhancement cut-off filters
AIR INJECTION SECTION (R-Evolution CR only)
Nominal pressure: ................. from 5 to 120 mmHg
Actual IOP: ......................... Nominal pressure ± 3 mmHg
Safety devices:..................... Air activation sound
SILICONE INJECTION SECTION (R-Evolution CR only)
Nominal pressure: ................ from 0,4 to 5 bar
Signals: ............................. Silicone injection activation sound, Low pressure at air
inlet

PHACOEMULSIFIER
Handpiece type: ................... piezoelectric, four crystals and six crystals models
Frequency: ......................... approx. 43KHz (39.5-44KHz)
Tip stroke: .......................... from 0 to 100µm
Power: .............................. panel or linear control of the U/S power from
programmable start value to programmable end value
via system footswitch depression.
U/S Mode: .......................... Linear or Panel; Continuous, Autolimit, Short Pulse, HD
Pulse, Single Burst, Multi-Burst, Continuous Burst,
Programmable Emission Mode
U/S Timer:.......................... from 0.00 minutes to 9.59 minutes – Equivalent Phaco
Time display

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PARAMETER SPECIFICATION

SPHYGMOMANOMETER (MOPP) (R-Evolution CR only)

Measurement method: ............ Oscillometric measurement
Device validation: ................. The Medical Device has been clinical investigated
according to the requirements of ISO 81060-2:2013
Measurement range: .............. Systolic: 25-280mmHg
Diastolic: 10-220mmHg
Pulses: 20-230 Beats per Minute
Overpressure limit:................ 300mmHg
Standard Arm Cuff size: .......... 27-35cm

EQUIPMENT CLASSIFICATION ACCORDING TO IEC 60601-1

Type of protection against
electric shock: ..................... class I
Degree of protection against electric shock:
Diathermy: ......................... Type BF, floating both at high and low frequencies
U/S: ................................. Type B
Vitrectomy:......................... Type BF
Illumination: ....................... Type BF
Air: .................................. Type BF
Silicone:............................. Type BF
Scissors: ............................. Type BF
Sphygmomanometer arm cuff: .. Type BF
Degree of protection against
harmful ingress of water (unit) : IPX0
Degree of protection against
harmful ingress of water
(footswitch): ....................... IPX8
Degree of safety of application
in the presence of a flammable
anaesthetic mixture: .............. not suitable

DIMENSIONS
Height: ........................... 165 cm
Width: ............................ 54 cm
Depth: ............................ 57 cm
Weight: ........................... 130 Kg

NOTE:
1) Weight and dimensions shown are approximate.
2) Specifications are subject to change without notice.

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4.2 EMC TABLES

The R-Evolution devices are suitable for use in the specified electromagnetic
environment. The purchaser or user of the R-Evolution should assure that it is used in an
electromagnetic environment as described below:
Emissions test Compliance Electromagnetic Environment
RF emissions Group 1 This R-Evolution CR uses RF energy only for its
internal function. Therefore, the RF emission is
CISPR 11 very low and not likely to cause any interference
in nearby electronic equipment.
RF emissions Class A This R-Evolution CR is suitable for use in all
establishments other than domestic and those
CISPR 11 directly connected to the public low-voltage
power supply network that supplies buildings
Harmonic emissions Not used for domestic purposes.
applicable
IEC 61000-3-2
Voltage fluctuations/ Not
flicker emissions applicable

IEC 61000-3-3

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The R-Evolution are intended for use in the electromagnetic environment specified
below. The customer or the user of the R-Evolution should assure that it is used in
such an environment.

The R-Evolution devices are suitable for use in the specified electromagnetic
environment. The purchaser or user of the R-Evolution should assure that it is used in an
electromagnetic environment as described below:
Immunity IEC 60601-1-2 Compliance Electromagnetic Environment
Test Test level level
Electrostatic 6 kV contact IEC 60601-1-2 Floors should be wood, concrete
discharge (ESD) 8 kV air Test level or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast 2 kV for power IEC 60601-1-2 Mains power quality should be
transient/burst supply lines Test level that of a typical commercial or
IEC 61000-4-4 hospital environment.
1 kV for input/output
lines > 3 m
Surge 1 kV differential mode IEC 60601-1-2 Mains power quality should be
IEC 61000-4-5 Test level that of a typical commercial or
2 kV common mode hospital environment.
Voltage dips, short 0% Un for 0.5 cycles IEC 60601-1-2 Mains power quality should be
interruptions 40 % Un for 5 cycles Test level that of a typical commercial or
and voltage 70 % Un for 25 cycles hospital environment. If the user
variations on 0 % Un for 5 s of the R-Evolution CR requires
power supply input continued operation during
lines power mains interruptions, it is
IEC 61000-4-11 recommended that the R-
Evolution CR be powered from
an uninterruptible power supply
or a battery.
Power frequency 3 A/m IEC 60601-1-2 Power frequency magnetic fields
(50/60 Hz) Test level should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.

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non-LIFE SUPPORTING EQUIPMENT

The R-Evolution devices are intended for use in the electromagnetic environment specified
below. The customer or the user of the R-Evolution should assure that it is used in such an
environment
Immunity IEC 60601-1-2 Compliance Electromagnetic Environment
Test Test level level
Portable and mobile RF communications
equipment should be used no closer to any
part of the R-Evolution CR, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter
Recommended separation distance

3 V/m d  1.2  P 80 MHz to 800MHz

Radiated RF 80 MHz to 2.5 3 V/m
EN 61000-4-3 GHz d  2.3  P 800 MHz to 2.5GHz

Conducted RF 3V
150 kHz to 80 3V d  1.2  P
EN 61000-4-6 MHz

Where P is the maximum output rating of the

transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths for fixed RF transmitter, as
determined by an electromagnetic site
survey, should be less then the compliance
level in each frequency range
Interference may occur in the vicinity of
equipment marked with the following symbol:

NOTE:
UT is the a.c. mains voltage prior to application of the test level
Note 1:At 80 MHz and 800 MHz, the higher frequency range applies.
Note2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To access 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 R-Evolution is used exceeds the applicable RF compliance
level above, the R-Evolution should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating the R-Evolution unit.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended Separation Distance for non-LIFE SUPPORTING EQUIPMENT

The R-Evolution devices are intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the R-
Evolution can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitter) and
the R-Evolution as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of
the transmitter (m)
(W) 150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d  1.2  P d  1.2  P d  2.3  P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at the maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated 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) at 80MHz and 800MHz, the separation distance for the higher frequency range applies
(2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people

For transmitters rates at maximum output power not listed above, the
recommended separation distance 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:
Note 1-At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2-These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

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4.3 DIATHERMY POWER CHARACTERISTICS

DIATHERMY POWER vs LOAD

4.4 WIRING DIAGRAMS

On request, OPTIKON 2000 S.p.A. provides wiring diagrams, component lists,

descriptions, calibration instructions or other information that may help the
operator’s trained technical personnel during repair of the repairable elements of
the apparatus.

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5. INSTALLATION AND USE

Before first start-up

CAUTION Risk of injury to the patient’s eye!

Optikon 2000 Service or an expert authorized by
Optikon 2000 will install the Medical Device. Please
make sure that the following requirements continue
to be met for further operation:
• The connecting parts must be seated properly.
Screw connections are tightened.
• All cables and plugs are in perfect condition, i.e. show
no signs of wear, kinks or other damage.
• The nominal voltage of the equipment corresponds
to the rated line voltage at the site of installation.
• The power plug may be connected only to a
socket provided with a faultless protective
earth conductor.
• The device is connected to the power cord supplied
for this purpose.

Before each use

CAUTION Injury to the patient’s eye!

 Make sure that all specified "Requirements for
operation" are fulfilled.
 Reattach covers or caps that were removed before.
Close any existing openings with the relevant caps.
 Take note of any and all symbols and signs attached
to the equipment.
 The ventilation openings must not be closed or
covered.
 Check whether the R-EVOLUTION offers enough room
for maneuvering to avoid damage to the cables and
ensure unrestricted movement of the device, and to
have an easy access to reach power switch to
disconnect electrical supply.

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 Connect equipotential connector on the rear of the

device to equipotential connector of Operating Room
by equipotential cable. It is necessary to have a
second ground reference in case of malfunction of
main plug earth.
 The power supply plug is used as a method for
simultaneous electrical insulation of all poles from
the mains. Do not position the device in a such way
that it would be difficult to disconnect the power
supply plug from the mains.
 Check the user settings of the selected user profile
to avoid unexpected behavior of the Medical
Device.

After each use

 At the end of the surgery session, disconnect all surgical
instruments from the console. Lower the electrical
mayo tray to its minimum level and store it in its
receptacle in the console.
 Use the main power switch to switch off the
equipment.
 The main power switch must always be off when the
Medical Device is not in use. And cable plug must be
removed from the main supply.
 (CR only) Disconnect the compressed air supply
hose from the operating theatre wall socket.

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Liability and warranty

Warranty and liability depend on the applicable
contractual stipulations.

INFORMATION Loss of warranty

No modifications to the Medical Device may be made.
The manufacturer shall not be liable for damage
caused by unauthorized persons tampering with the
device. Furthermore, this will forfeit any rights to
claim under warranty.

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5.1 DESCRIPTION OF THE APPARATUS

The R-EVOLUTION CR provides the surgical modules / functions described below:

Irrigation system
The R-EVOLUTION features both gravity irrigation and
controlled irrigation.

Gravity irrigation
When irrigation is gravity fed, the flow rate of the
liquid and the irrigation pressure are determined by
the height level at which the infusion source is placed.
The R-EVOLUTION control an automatic motorized
infusion pole that can be sued to adapt the height level
of the irrigation medium.

CAUTION Injury to the patient’s eye!

Use the higher hook to suspend balanced salt solution
bottle for anterior segment surgery.
Use the lower hook for posterior segment surgery.
Use the lower hook when performing Controlled
irrigation

Controlled irrigation
If the "Controlled irrigation" function is used, the
irrigation pressure for the infusion is automatically set by
the R-EVOLUTION. This system for controlling the
irrigation pressure provides a number of advantages as
compared to simple gravity-fed irrigation, such as
dynamic control of the intraocular pressure with
automatic compensation of fluctuations due to the
aspiration flow, this both in cataract and in retinal
surgery. In order to take advantage of the “controlled
irrigation” function, a controlled irrigation bag or a
controlled irrigation administration set must be used.
These devices are available through Optikon. A valve is
used for sterile control of the On/Off status of irrigation
by means of the foot switch or by means of a soft key in
the graphical user interface.
Always use the lower IVP hook when performing
Controlled irrigation.

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Aspiration system
The R-EVOLUTION features an aspiration function by
action of their two-pump system. Depending on surgical
needs or preference, the surgeon can select either a flow
pump (peristaltic) or a vacuum pump (Venturi or rotary
vane).
The purpose of the cassette receptacle is to secure the
I/A cassette.
Fluids and particulate materials are aspirated at the
distal end of the tip and subsequently deposited in the
collection tank of the disposable tubing set.
A safety vacuum sensor monitors the vacuum level in the
aspiration tubing and adapts the pump action according
to need. This vacuum reading is performed with a
"closed system": a sterile membrane in the I/A cassette
completely separates the vacuum sensor from the sterile
fluids.
The pumps in the R-EVOLUTION are controlled by a
microprocessor. The vacuum level can either be preset on
the touchscreen or controlled by the surgeon via the foot
switch (linear mode).

Vitrectomy
The vitrectomy handpiece connects to the vitrectomy
socket . Essentially, it consists of two parts:
– CUTTER TIP (blade) and
– BODY (containing the drive mechanism actuated by
compressed air)
The vitrectomy handpiece uses the single acting
actuator principle: air pressure effects the out-stroke
of the b l a d e (cutting port closes). Once the pressure is
no longer applied, the in-stroke is achieved by a built-in
spring.
The tip contains the cutting element which consists of an
outer (fixed) and an inner reciprocating tube acting in
longitudinal direction, which are matched to each
other.
Used for aspiration, the inner tube has a front end blade
with a sharpen outer edge. At the front end, the outer
tube has a lateral opening for cutting and aspiration.

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The tissues are cut and simultaneously aspirated by the
longitudinal reciprocating action of the inner tube,
generated by pneumatic pulses generated by the
device.

The extremely close distance between the inner and

outer tubes creates a slight constant tension that provides
a self-sharpening effect. It is evident that such precision
combines with the guillotine design to afford ideal cutting
properties. The cutting speed (from 60 to 10.000 cuts/min
if a standard cutter is used or 120-20.000 cuts/min using
Twedge cutter) and vacuum level (from 5 to 700 mmHg)
can be adjusted using the switching elements on the
touchscreen.

Bipolar Diathermy
Bipolar diathermy uses radio frequency (RF) currents to
produce heat in body tissues and thus cause coagulation.
The energy of a RF oscillator (inside the equipment) is
conducted to a pair of electrodes (diathermy forceps or
diathermy pen) that are touched against the biological
tissues to be treated. The application of bipolar high
frequency (RF) power contributes to the reduction of
undesired neuromuscular stimulation.
R-Evolution generates adjustable output power on
the diathermy socket (1) in the range from 0.1 to
approx. 9 Watt @ 200 Ω.

Illumination
The R-Evolution CR features three high-intensity LED
lamps (fiber optic illuminators) and, on two out of the
three, it features filters to protect retina from the blue
components of the light and for optimal viewing
conditions during retinal surgery procedures.

Each of the three independent illumination systems is

powered by a LED lamp focused on the head of the fiber
optic. LED lamps emit, virtually, only in the visible,
therefore, no IR or UV filter is necessary and maximum
patient safety is assured.
An electronic system allows the light level to be adjusted
on 20 levels without affecting the color of the light. There
are 3 different yellow filters (435nm, 475nm and 515nm)

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to emphasize the presence of membranes when

colorants are used and to protect the retina of the
patient from unnecessary exposure to blue radiations
and thus enables longer treatment times.
A green filter improves contrast, even with no
colorants, as it darkens the red eye structures making
white membranes and other ocular tissues more
visible.

Air tamponade
The air tamponade system utilizes a sophisticated
technology for automatic control of the ocular pressure.
This allows the surgeon to introduce sterile air at a
preset value (in mmHg), while the system automatically
balances variations due to possible losses from the
surgical incisions.
The air delivery module of the R-Evolution CR is designed
to supply sterile air at adjustable low pressure settings
over the entire range of 5-120 mmHg.
A disposable encapsulated membrane filter is fitted to
the air supply tubing connected to the air socket on the
front panel, such that virtually all types of particles are
removed, when the air passes through this filter.
Switching between BSS irrigation to air tamponade and
back to BSS is achieved by an automatic system,
controlled by touch screen or footswitch. No need to act
on any manual stopcock.

Silicone oil tamponade

The silicone oil injection device is a compact, self-
contained unit. It comprises a syringe, pre-filled with
silicone oil, coupled via high pressure tubing to the front
panel of the Medical Device.
The syringe is activated by compressed air that is
controlled in linear fashion by the footswitch.
Phacoemulsification
The piezoelectrical phaco handpiece made by Optikon
2000 can be connected to the phaco socket. The phaco
handpiece contains a piezo transducer that vibrates at a
frequency of approx. 43 KHz and end strokes of approx.
100 μm. The piezo transducer of the phaco handpiece
comprises three distinct components:

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– The PIEZOELECTRIC CERAMIC ELEMENT converts the

electrical energy supplied by the control console
directly into mechanical vibratory motions of approx.
43,000 cycles per second (43 kHz).
– The BODY amplifies and mechanically transmits the
motion of the piezoelectric ceramic element to the
phaco tip.
– The PHACO TIP vibrates longitudinally and thus
facilitates fragmentation of the tissue in a
circumscribed area about the contact surface of the
phaco tip to the cataract. The maximal re-use cycles of
the phaco tips are described in the Instructions for
Use enclosed with these units.
The internal energy loss processes of the piezo ceramic
element cause the piezo transducer to heat up while it
vibrates at high frequency such that the fluid aspirated
from the eye is also used to dissipate the heat.
The R-EVOLUTION features the patented Minimal Stress
circuit that facilitates measurement of the phaco tip
motion (stroke) in real-time. This information is used by
the microprocessor to stabilize the stroke of the phaco
tip.
The main advantages of this system are as follows:
– U/S power preset indicates the effective phaco tip
stroke and corresponds to microns of phaco tip
movement.
– Different phaco handpieces are equalized and
compensated with respect to the typical loss of
efficiency due to aging effects.
– The tip vibration is no longer affected by differences
in cataract hardness or temperature fluctuations in
the handpiece.
– The requisite average energy and peak energy are
lower compared to standard phacoemulsification.
– Reduction of bouncing of cataract fragments.
– Phaco handpieces can be tested by the equipment
to verify their efficiency, avoiding operation of the
device below the acceptable limits.
Ultrasonic power can be delivered in Continuous or
Pulsed mode

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– In Continuous mode, the phaco energy is supplied to

the handpiece continuously and without interruption if
the footswitch is depressed beyond mechanical feedback
point 2 (area C, see ”System footswitch” description).

- In Pulse mode, the power is emitted in the form of

pulses in preset intervals, if the footswitch is situated
in area C, after having passed position 2. The surgeon
can select between the following settings in pulse
mode:
– Pulsed power is made available in linear or panel
control mode. It generates periodic pulses of
ultrasound power. The user may select from a range
of 1-100 pulses/sec. At each repetition frequency, the
user can set the length of the active cycle (duty cycle)
choosing among three available levels (named as
“Standard”, “Cold”, “Ice Cold” and corresponding
approximately to an on time of 50%, 25% and 10%
respectively), thus limiting the ultrasonic energy
delivered to the minimum needed level.
- HD pulse automatically adjusts pulses duty cycle
according to the occlusion state of the surgical tip,
this allows fast removal of the cataract fragments
engaged by the tip and avoids unnecessary emission of
energy when the tip itself is free from occlusions.
– Single Burst delivers single bursts of ultrasound power
with a duration of 120 ms. The surgeon must return
the foot switch to area C, pause for approx. ½ sec
and then press it back into area C to obtain another
single burst.
– Multi Burst generates ultrasound pulses with a
duration of 80 ms, with additional bursts being
generated (approx. 1 burst per second) when the foot
switch has passed tactile position 2 and reaches area
C. As the foot switch is depressed further the limit
stop, the frequency of bursts increases up to a
maximal rate of 4 bursts per second.
– Cont Burst yields a pulse duration of 80 ms. Once the
foot switch has passed tactile position 2 and reaches
area C, the pulse are generated consecutively at an
increasing rate. At maximal depression of the foot
switch, the bursts blend together and the units

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delivers continuous ultrasound power.

- Programmable Emission Mode R-EVOLUTION features a

new sophisticated Programmable Emission Mode
(PEM). PEM. allows the surgeon to design his own
ultrasound emission pattern, the one which fits his
surgical techniques or cataract hardness best. This
function leads to a substantial reduction of the
ultrasound energy needed for cataract removal.

Measuring Ocular Perfusion Pressure

A digital blood pressure monitor allows
R-EVOLUTION CR to periodically measure patient
diastolic and systolic pressure and, also using
intraocular pressure, it calculates the Mean Ocular
Perfusion Pressure (MOPP). The equipment shows the
MOPP on the touch screen monitor and draws in the
irrigation preset dial colored areas. A green area
indicates irrigation pressures for which the MOPP is
greater than 35mmHg (safe area, according to medical
literature).
A yellow and a red area indicate, respectively,
irrigation pressures very close or above the said safety
limit.
If the irrigation pressure is kept in the red (MOPP
below 35mmHg) for more than 30 seconds, an
information message alerts the surgeon suggesting to
lower the irrigation pressure.
This system strongly reduces the probability of retinal
iatrogenic damages caused by irrigation pressure too
high for the specific patient.

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5.2 DEVICE COMPONENTS

5.2.1 Overall view

1 19" Touchscreen
The touchscreen allows the Operator to set parameters and to read their
actual value. The touch screen can be covered by a dedicated drape for
sterile operation.
2 Touchscreen hinge
The touchscreen can be swiveled to the left or right or somewhat up and
down to improve the visibility.
3 Instruments tray
The foldable instrument tray allows the Surgeon or nurse to place and
prepare the required surgical set and accessories. T h e t r a y i s

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attached to an articulated arm and it can be moved
u p / d o w n e l e c t r i c a l l y . For sterile use, a s i n g l e u s e s t e ri l e d ra p e
i s a va i l a b le . The instrument tray can be kept inside the housing if it is
not used.

4 I/A Cassette and cassette receptacle

5 Steerable casters with locking tabs
The Medical Device is equipped with four steerable casters which allow
easy positioning in the OR. The locking tabs prevent the device from
moving or rolling away.
At least two locking tabs must be pressed down to position the Medical
Device.
• Press locking tab down to block the caster.
• Press locking tab up to release the caster.

6 Infusion pole with bottle holders

The computer controlled electric pole allows moving to the
memorized height the balanced salt solution container during
procedures involving gravity irrigation. The higher hook is only used
for anterior segment surgery performed with gravity feed
irrigation. The lower hook is for posterior segment surgery and
also to suspend the proprietary pressurized irrigation bag during
any surgical procedure involving “controlled irrigation”.

7 Handgrip
It is used to mo ve and relocate the Medical Device within the O.R.

8 Cable holder(s)
The two couples of cable holders are used to reel up the power cable,
footswitch cable and gas hose.

9 Ventilation grids
These grids allow removing hot air from the device. Do not occlude the
grids to avoid overheating.

10 Footswitch flange
It is used to h an g the footswitch for storing, when not in use.

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5.2.2 Front panel connectors and control elements

1 US (Phaco) socket with pilot lamp

The connector of the phaco handpiece connects to this socket.

2 Vitrectomy socket with pilot lamp

The connector of the vitrectomy handpiece connects to this socket.

3 Diathermy socket with pilot lamp

The connector of the bipolar diathermy handpiece connects to this socket.

4 Air tamponade socket with pilot lamp

The connector of the air hose with filter connects to this socket.

5 Silicone oil injection socket with pilot lamp

The connector of the silicone oil tamponade system connects to this
socket.

6 Scissors socket with pilot lamp

The connector of the pneumatic scissors connects to this socket.

Each 1-6 ring-like pilot lamp illuminates when the relevant function is
selected.

7-8 LED Light source sockets, with filters

The connector of the fiber optics connects to this socket.

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9 LED Light source sockets, without filters
The connector of the fiber optics connects to this socket.
10 Mayo tray height adjustment push-buttons
These arrow keys are used to adjust the level of the motorized tray for
surgical instruments.

11 Power-ON push button, with pilot lamp

To turn the equipment on, switch to ON the power switch “1” on the
rear panel, push and hold pushed, until its pilot lamp goes on, this push
button.

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5.2.3 Rear panel connectors and control elements

1 Power switch
The power switch is used to turn the device on/off.
2 Fuse carrier and power plug
Only connect the Medical Device to an outlet which is provided with a
properly connected protective ground conductor.
3 IVP Rocker switch
This is used to control the infusion pole without using the touchscreen.
4 Footswitch connector
Footswitch connector is connected to this socket when used in wired mode
or for recharging internal batteries.
5 System ground connector
This connector can be used to connect the R-EVOLUTION CR to the
grounding of the device.
6 USB connectors
An USB memory device can be connected to these sockets for software
upgrades or import/export of user programs.
7 Air inlet plug
External compressed air inlet for Venturi pump, vitrectomy handpiece, and
silicone oil injection.
The air pressure must be in the range from 500 to 800kPa. The available
flow must be at least 32Nl/min.
8 Sphygmomanometer connection
The air hose of the sphygmomanometer arm cuff connects to this socket

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5.2.4 Footswitch

The foot switch for surgical equipment allows the surgeon

to activate the selected function on his device. The
functions "On/Off" are activated by means of the side
buttons, whereas the linear functions are activated by
means of the foot pedal.
The foot switch has the following functions:
– Nine commands of the "on/Off" type consistent with
the setting of the device to which it is connected.
– Simultaneous linear control over two functions
depending on how far the foot pedal is depressed or
swiveled to the side. For example: U/S power and
degree of aspiration or vitrectomy cutting rate and
degree of aspiration.

The foot switch may work wireless or it may connect

to the foot switch socket o n t h e r e a r p a n e l o f t h e
equipment.

CAUTION Risk of infection!

The foot switch cannot be autoclaved.
• For information about cleaning and/or disinfection of
the foot switch, please refer to the "Maintenance and
care" chapter in this manual.
The foot switch comprises the following components:
1 Main paddle
The paddle can be moved in horizontal and vertical
directions to trigger certain functions.
The vertical direction of the foot pedal is subdivided
into three areas with two tactile positions. Certain
functions are assigned to each area and can be
triggered by pressing the foot pedal (see image on left).
Resting position
Area A is situated between the resting position and
the first tactile C position.
Tactile position 1
Area B is situated between the first tactile position
and the second tactile position.
Tactile position 2

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Area C is situated between the second tactile position
and the limit stop.
2 Side buttons
3 Socket for connection cable
To connect the foot switch to the connector block of
the R-EVOLUTION for wired operation. Also used for
battery charger.
4 Carrier bracket
For storage and carrying the foot switch in the main
unit.
5 Rating label
6 Battery check pilot lamp
The wireless footswitch is energized by rechargeable
batteries, the Battery Check pilot lamp flashes
alternating between green and red while recharging and
became green, fixed when the charging has been
completed. The lamp is off when the pedal is not
connected to the battery charger or to the console.

1 6 3

2 2
4

5
2 2

The footswitch battery recharges automatically whenever the footswitch is wired to

the console. It can also be recharged using the dedicated battery charger supplied
with the device. A full charge allows using the footswitch for more than a surgery
session.
The battery level can be verified on the console during use (battery icon on the
lower right corner of the monitor). If the battery level becomes low, an alarm
message is generated.
Fully recharge the battery before first use or following a long period of inactivity.
The battery must be replaced by Technical Service personnel only.

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The multi-function footswitch is programmed through the R-EVOLUTION touch-
screen monitor. Refer to “5.6.8 Footswitch programming“ for further details.

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5.3 TOUCHSCREEN AND USER INTERFACE

The R-Evolution is equipped with an interactive touch-screen and LCD (Liquid Crystal
Display). The user interface consists of a graphic software, running under the
Windows platform, simulating the various keys and displays.

The user can select the equipment function and adjust the relevant parameters by
touching the screen in the appropriate areas. Actual and preset values for each
parameter are displayed. If a sterile drape is placed on the monitor the equipment
can be operated by a sterile scrub nurse.

In order to make the interface screen as much readable as possible, the R-Evolution
user interface has been designed so that function keys, preset and actual
parameters values are always visible on the screen, while setup keys for less
frequently used settings are hidden during equipment operation. Parameters are
logically grouped in parameter windows.

In the example on the left, maximum

pre-set limit for U/S power (30µm) is
shown both at the centre of the dial
wheel and by the larger radial finger
indicator. The thinner finger indicates
the power programmed at ultrasound
start (5 µm).

Ultrasounds are emitted in Pulsed

mode (13Hz), with a low duty cycle
(Cold)

Actual U/S power (20 µm) is indicated

by the green filled area from 5 to 20.

To adjust the parameter value, the

user touches the area of the dial
wheel close to the desired new pre-
set limit.

A fine adjustment can be achieved by touching the - and + keys immediately under
the dial wheel.

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To set the status or value of less
frequently changed parameters, such
us Linear/Panel control or Emission
mode, the user touches the
“Ultrasound” button at the top of the
window.

A new child window will open,

allowing control of all additional
parameters.

“DSR Settings” in this example refers

to the initial and final values for
ultrasound power emission when in
linear mode.

Touch a key to change the desired

parameter and then “OK” to close the
child window.

Some settings, e.g. P.E.M. and Pulsed, may require the system to present to the user
additional dial wheels, push buttons or other controls.

A bar at the top of the touch screen contains a series of buttons and indicators:

1. Active User Program Button/indicator.

To access the available program list, depress this button.

2. Footswitch Program Button/indicator.

Footswitch can be configured to operate according to Surgeon preferences.
To access the available footswitch program list, depress this button.

3. Undo Changes Button/indicator.

Allows undoing any change done by the user to the currently active program.

4. Save Button/indicator.
Allows updating current User Program with all changes done by the User
(current configuration). Default Programs cannot be modified and updated.

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5. Save as Button/indicator.
Allows saving the current configuration as a new User Program.

6. Alarm Button/indicator.
Pushing this button, the list of currently active alarms appears on the screen.

7. Help Button.
Pushing this button a context sensitive help appears on the screen.

A status bar, at the very bottom of the screen, indicates the actual status of the
equipment by expanding the relevant indicator for the active surgical function (in the
example above, Sculpt).

Touch the button indicator of any other surgical function to switch the equipment to
the desired operating mode.

An Optikon logo, circled by white flashing dots indicates that the system software is
operating normally.

INFORMATION Risk of minor injury to the patient!

• If the d o t s a r o u n d t h e l o g o cease to move, the
software is in idle and you have to discontinue the use
of the Medical Device.
The user should periodically look at the logo to check
for the system status.

Equipment error messages are categorized on three level of severity:

 Warnings have higher priority. Errors of this level are numbered 1xx
and indicated by a red symbol. An error of this priority requires to interrupt
the use of the equipment.

 Cautions have a lower priority. Errors of this level are numbered 2xx
and indicated by a yellow symbol. An error of this priority impedes the use of
a specific function only.

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 Information have the lowest priority. Errors of this level are numbered
3xx and indicated by a blue symbol. An error of this priority requires user
attention to perform a specific action.

Refer to the “System alarm messages” chapter in this manual for a detailed
description of all error messages, their causes and possible corrective actions.

Equipment warnings and error messages

pop-up on the screen. Once the user has
acknowledged the warning/error message,
the pop-up disappears, the error is
memorized into the warnings/errors
messages board.

As a reminder of the still active alarm

condition, the Alarm symbol (the bell at the
top right of the screen) will appears circled
in the colour of the higher priority active
alarm.

Touching the alarm symbol, causes the

software to display a list of all the
active alarms.

Press “OK” to close the alarm list and

to resume normal operation.

All errors are automatically logged in

the system memory and they are
accessible in Service mode to Optikon
Service Technicians.

For further details on the use of the Graphical User Interface, please refer to the
description of the use of the individual equipment functions.

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5.4 INSTALLATION PROCEDURE

5.4.1 Installation of the equipment

The unit has been packed such as to minimize the

risk of damage during shipping.
• Open the package and examine the components
for damage. When cutting the packing material,
be careful not to damage the contents.

The REF 111012 (CR 121012) R-Evolution is made up by the following

parts:
REF DESCRIPTION
Console
3M1854 Dust Cover
1X1012U0 Instructions for use.
IEC60601 Safety check Test Report (attached to the IFU)
565035 2 4AHT fuses
554138 Mains power supply cable
3M2093 IV Pole extension rod
374578 Compressed air supply hose (CR only)

The wireless footswitch REF 112104:

REF DESCRIPTION
Multifunction footswitch
3M0678 Footswitch-Console connection cable
3N0800 Battery charger

CAUTION Risk of injury caused by transport damage

• If the package or contents are damaged, please
notify the carrier (post office, railway or shipping
agent) and the Optikon 2000 Service without delay.
• Check that the contents correspond to those
indicated on the enclosed shipping documents.
Notify the Optikon 2000 Service of any
discrepancies without delay.

To install the Medical Device, proceed as described

below:
Adequate training is essential for proper installation

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and operation of the R-EVOLUTION and its accessories.
Training on the installation and use is provided by
Optikon 2000 for both systems. Contact your local
Optikon 2000 Service for details.
It is the responsibility of the user to clean and sterilize
the handpieces, tips, I/A tubing and any other
reusable microsurgical accessories.
• Open the package of the medical device and its
accessories.
• Take R-EVOLUTION out of its transport package.
• Comply with the corresponding Instructions for
Use when unpacking sterile and re-sterilizable
microsurgical accessories.
• Check if the pressure of the pressure supply is
consistent with the value indicated on the rear
panel (from 500 to 800 kPa - 72.5 to 116 psi).
• Take the compressed air supply hose and connect the
gas input port "GAS INLET" to the wall compressed air
supply line.

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INFORMATION Risk of crushing - mind your fingers!

There is a risk of crushing your fingers when you fold
up the i n s t r u m e n t t r a y i n i t s compartment.
• Move down the tray to its lower position, then push it in
its receptacle placing the fingers under the tray.
• Connect the foot switch cable to the socket
labeled "FOOTSWITCH CONTROL".
• Connect the alternating current power cable to the
AC power inlet.
• Connect the other end of the AC power cable to a
grounded wall socket.
Relocating the device

The Medical Device is provided with a handle that can

be used to safely and easily transport the device to a
different installation location. Please use the handle for
the purpose indicated. Four locking tabs on the base
allow you to conveniently select the installation
conditions.
– None of the locking tabs has been pressed:
The Medical Device can be positioned easily
and without effort and in all orientations in
the OR and at the operating table.
– All locking tabs have been pressed:
The Medical Device is fixed in place preventing it from
rolling away. After the device has been positioned as
desired at the operating table, you should press the
locking tabs down.

Installation of the Medical Device in the O.R.

To install the Medical Device in the OR, please proceed

as follows:
• Release all locking tabs.
• Hold the equipment by the handle and then push it
gently to the desired location.
• The Medical Device must be positioned on level

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ground.
• Press at least two locking tabs of casters and make
sure that the Medical Device cannot roll away on its
own accord.

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Preparing the Medical Device for sterile operation

CAUTION Risk of infection!

The patient or user may be infected if accessories loose
sterility.
• For sterile use of the touchscreen, use t he sterile
drape.
• If you use the REMOTE CONTROL and the instrument
tray, please use the corresponding drape.
• The Medical Device may be operated by suitably
instructed staff only.
Sterile single-use drapes can be used to cover the device
in sterile condition. The following drapes are available
for the R-EVOLUTION surgical equipment:

– SCREEN DRAPE R-EVOLUTION

– REMOTE CONTROL COVER
– TRAY COVER R-EVOLUTION
Please comply with the Instructions for Use of each drape
when placing the drapes.

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Powering the device up

Before switching the device on, verify that:

 The compressed air line has been connected.

 The power cable has been connected.
 The foot control panel has been connected (unless it
will be used in wireless mode).

WARNING Risk of injury to the patient’s eye!

• Audible hissing of air at power-up may indicate a
malfunction of the silicone section.
Please contact your local dealer or the Optikon 2000
Service.

CAUTION Functional test

• The software checks the validity of the calibration at
power-up. If there is any discrepancy, the safe default
calibration is stored and you are prompted to
calibrate the Medical Device (5 sounds).
Please contact your local dealer or the O ptikon 2000
Service.

To power the Medical Device up, proceed as follows:

• Press the power switch on the rear panel.
 The infusion pole drives a few centimeters up and
down.
 The Medical Device performs a self-test, during which
a start screen showing the Optikon logo is visible on
the display.
 Once the Medical Device is powered up, the
configuration menu is displayed on the screen.
 At first start-up, the Medical Device displays the
standard user profiles, "Factory Default", and the
operating interface in English. During subsequent log-
ins, it shows also the new users, if any, and the
interface in the language chosen.

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5.4.2 Installation of the Easysys I/A cassette

For proper cassette installation, proceed as follows:

• Connect the ma le plug of the administration set
into the corresponding connector on the short line at
the top of the I/A cassette.
• Insert the I/A cassette into the side panel by lining up
the reference line on the I/A cassette and the
corresponding dot on the side panel.
• Rotate the I/A cassette clockwise until it snaps into
place.

CAUTION Injury to the patient’s eye!

Use the higher hook to suspend balanced salt solution
bottle for anterior segment surgery.
Use the lower hook for posterior segment surgery.

CAUTION Risk of infection!

Exchanging the infusion bottle, pathogens may enter
into and contaminate the balanced salt solution.
• Never touch the drip chamber spike when
attaching, exchanging or removing the infusion
bottle.
• Puncture the drip chamber spike into the infusion
bottle or the infusion bag for controlled irrigation.
• Connect the end of the irrigation and aspiration
tubings to the corresponding connectors of the
respective handpiece.

CAUTION Risk of injury to the patient!

• Before you use the phaco handpiece, always subject
the irrigation/ aspiration tubing to a priming
procedure. During the priming procedure, the
irrigation/aspiration hose set is checked for proper
installation and operation and the hose is filled with
liquid. This prevents possible malfunction and injury
to the patient.
To remove the I/A cassette, proceed as follows:

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To take out the I/A cassette at the end of the surgery
press the “PUSH” button
Wait for the peristaltic pump to be fully retracted.
• Rotate the I/A cassette counterclockwise until its
reference line and the corresponding dot on the side
panel are lined up.
• Remove the I/A cassette

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5.4.3 Installation of phaco accessories

WARNING Risk of injury to the patient’s eye!

Priming while the p h a c o t i p is used in a patient may
cause serious damages to the eye structures.
• Never perform a priming procedure while the Medical
Device is in use on a patient.

Connecting the phaco tip to the phaco handpiece

1 2 • Screw the appropriate phaco tip (2) into the end of

the phaco handpiece (1) making sure that the
threads engage properly. Tighten the tip with your
fingers only.

• Carefully place the opening of the wrench (on the

flange side) over the phaco tip (2) without damaging
the tip such that the phaco tip wrench engages the
slits on the base of the tip.

• Carefully tighten the phaco tip with the phaco tip

wrench clockwise.
• Then remove the phaco tip wrench.

Connecting the silicone sleeve to the phaco tip

3 • Carefully slide the threaded silicone sleeve (3) over the
phaco tip until the threads engage.

• Slowly tighten the silicone sleeve on the phaco

handpiece until the end of the silicone sleeve leaves
just as much of the phaco tip exposed as desired by
the Surgeon.

• The phaco handpiece (1) is now ready to receive the

irrigation/aspiration hoses from the I/A cassette system.

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Connecting the irrigation/aspiration hoses
• In order to connect the aspiration hose of the
irrigation/aspiration hose set, slide the end
connector into the corresponding connector on the
phaco handpiece and tighten it by pushing while
slightly rotating.

• In order to connect the irrigation hose of the

irrigation/aspiration hose set, slide the end connector
of the male Luer lock into the corresponding female
connector on the phaco handpiece and tighten it by
pushing while slightly rotating.

Priming procedure

• Fill the test chamber (9) with balanced salt solution

and slide it onto the silicone sleeve.

• Place the test chamber at the eye level of the

patient.

9 • Connect the I/A cassette to the Medical Device, if this

has not already been done, and connect it to the
infusion bottle.

• Plug the electrical power plug of the phaco handpiece

into the U/S socket (1) on the front of the unit.

• Press the <Prime> key on the lower left corner of the

screen.

• After completion of the priming procedure, the

following display is shown "U/S Ready”

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5.5 USER PROGRAMS

Configuration of users programs

All default parameters of the R-EVOLUTION can be
adapted to suit the individual needs of the user. The
parameters thus set are saved for later re-use in
programs and assigned to the users.
The R-EVOLUTION can store up to 30 different users and
up to 40 programs per user.

CAUTION Risk of injury to the patient!

• Changes made to software settings during the
application may lead to patient injury.

Creating users and programs

Creating a new user or new program
• Prior to creating a new user or new program, set
the desired operating parameters in the cataract
(Anterior Segment) or retina (Posterior Segment)
mode.
• The "Undo" key is displayed when a parameter
has been modified. If you press the <Undo> key,
the previous settings are restored.
• Press the <Save as>
• A virtual keypad showing the current user name is
displayed.
• If the new program belongs to the current user,
enter the name of the new program and then press
the <Save> key . For a new program to be saved,
the name of the new programs must include at
least three characters and one letter.
• In order to create a new user, press the <New user>.
The cursor is then moved to the "User" field, in which
a name can be entered for the new user.
• Confirm the new user name by pressing the <Save>
key and then move the cursor to the "Program"
field.

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Save the program to an existing user
• Press the <Select user> key. The existing users are
then displayed in the pop-up window called "Select
user".
• Select one of these users and press the <OK> key.
• This closes the pop-up window and the cursor
moves into the "Program" field, in which the
name of the new program can be entered.

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Changing programs

• Adapt the various operating parameters in the

cataract or retina mode.
• The "Undo Changes" key is activated to indicate
that a program has been modified. If you press
the < Undo Changes > key, the previous settings
are restored.

• To permanently save the modifications made in the

same program, press the <Save> key
Modifications cannot be saved to the DEFAULT
programs. In order to save modifications into a new
program, you need to create a new program (Save
as).

Deleting a program

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• Select program the program you wish to delete.

• The key with the name of the active program is green-
active. Press the
<Delete> key, to delete the active program
(after confirmation).
• Subsequently, the previous program of the same
user, if any, is loaded.

If all programs of the active user have been deleted, the user is removed,
and the system loads the DEFAULT program. DEFAULT programs cannot be
deleted.

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5.6 OPERATION

5.6.1 Irrigation / Aspiration

Installation of the irrigation and aspiration hoses and

I/A cassette
• For information about the installation of the
irrigation and aspiration hoses and exchangeable
I/A cassette, please refer to the relevant chapter.

Connection of hoses and handpiece

• Select the I/A cannula needed and carefully insert it
into the coaxial I/A handpiece .
• Rotate the silicone sleeve onto the cap of the I/A
cannula .
The silicone cap should be pressed gently onto the
cap until the silicone sleeve has passed the aspiration
connector on the I/A cannula .
• Connect the irrigation/aspiration hoses of the
installed irrigation/ aspiration lines by sliding the
end connectors into the corresponding irrigation
and aspiration connectors on the handpiece line.
For information on the installation and application of
bimanual handpieces, please refer to the Instructions
for Use of the respective handpiece.

Select function
• Touch the <Cortex> button .

Aspiration settings
• The R-EVOLUTION is equipped with an I/A cassette such that
both a peristaltic pump and a Venturi or rotary vane pump are
available simultaneously. In order to switch between the two
aspiration modes, press the <Peristaltic> or the
<Venturi>/<Rotary vane> button in the "Aspiration" frame.

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CAUTION Risk of injury to the patient’s eye!

• Switching between peristaltic pump and Venturi
or rotary vane pump during the surgery without
changing the settings may lead to injury to the
patient.
INFORMATION: the flow rate and the vacuum limit can
be set independently for the peristaltic pump, whereas
only the vacuum can be set in case of the Venturi and
rotary vane pump. Using the Venturi or rotary vane
pumps, the actual flow rate increases with the vacuum
setting and size of the aspiration cannula.

WARNING Injury to the patient’s eye!

Changing the height level of the infusion pole by
manually forcing it can lead to a wrong indication of
the bottle height level and t o injury to the patient!
• Do not force the infusion pole modifying its
height.

CAUTION Injury to the patient’s eye!

Anterior chamber instability may be caused if the
height level of the infusion pole or the vacuum settings
are incorrect!

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• Start with low safe settings for the vacuum and
increase them in increments to determine the
correct settings for vacuum and height level of the
infusion pole while making sure that the anterior
chamber is stable.
The set values of flow (peristaltic pump only) and
vacuum level can be adjusted using the “+ -“
buttons or the slider.

Vacuum and flow rate can be controlled both in "fixed"

and in "linear" control mode.
In order to switch to "linear" mode, press the
<Lin.Flow> and/or <Lin.Vac> buttons, and in order
to switch to "fixed" mode, press the <Panel Flow>
and/or <Panel Vac> buttons

When a function is controlled in “fixed” mode, it reaches

automatically the User preset value as it is activated by
the footswitch.
When in “linear” mode, the Surgeon, by footswitch
depression or rotation, can linearly control the function
value from a start value to a final “stop” value previously
set in “DSR Settings” (Dynamic Setting Regulation).

Values set in “DRS Settings” are shown in the working

screen by two finger indexes delimitating the linear
regulation range.

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Irrigation settings
• In Anterior segment surgery, if gravity fed irrigation is
used, hang the irrigating solution bottle to the higher
hook on the IV pole. In retinal surgery and for
controlled irrigation use the lower hook on the IV pole.

INFORMATION if the higher hook is used to suspend

irrigating solution bottle, add 50cm to the bottle height
indication shown in the irrigation frame.

• Set the infusion pole height level to match the

vacuum settings and I/A tip that is connected, in
order to maintain proper fluid balance.
• Activate irrigation by pressing the foot switch beyond
its standby position.
Continuous irrigation (irrigation flows even after the
foot switch is released) can be activated by the slider
switch on the touchscreen or by pressing the
corresponding side button on the foot switch,
depending on the programming of the foot switch.

• In order to discontinue continuous irrigation, press the

<Off> button on the touchscreen or press the foot
switch button again.

WARNING Injury to the patient’s eye!

The patient may be injured if the waste container of the
I/A cassette is full.
• Make sure not to exceed the capacity of the

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I/A cassette or waste container.

WARNING Injury to the patient’s eye!

The intraocular pressure is reduced if the quantity of
balanced salt solution is insufficient.
• Keep an eye on the level of balanced salt solution
in the infusion bottle during the surgery. If the
level required for the surgery is no longer provided,
alert the physician and replace the infusion bottle
or infusion pouch.

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5.6.2 Phacoemulsification

Display of the message, "Connect handpiece", on the

screen indicates that the phaco handpiece is not
connected or not being recognized.

Priming

The "Please prime ..." message indicates that a priming

procedure is required. Press the <Priming> button to
activate the priming process; the irrigation/aspiration
lines are checked for correct connection and correct
function and filled completely with balanced salt solution.
The priming of irrigation/aspiration can be by-passed
under certain conditions, i.e. when the phaco handpiece
or phaco tip need to be replaced after successfully
running the priming procedure. To bypass the priming of
irrigation/aspiration, press the system foot switch beyond

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region C: a pop-up window opens to inquire if you really
wish to bypass the priming procedure.

Fine tuning

A simple, preliminary test called Tuning (fine tuning) is

needed each time a phaco handpiece is connected or
each time the phaco tip is changed. The purpose of fine
tuning is to match the response of the phaco handpiece to
the existing unit. At the end of the priming procedure or if
the priming procedure is bypassed, the unit automatically
runs a fine tuning. If the fine tuning is not successful, the
message, "Please check tip", is displayed for four seconds
and the user needs to repeat the priming procedure.

INFORMATION Damage to the phaco tip!

• Do not activate the phaco handpiece while the
phaco tip is surrounded by air. The ultrasound power
should be supplied to the phaco handpiece when the
phaco tip is immersed in a test chamber filled with
infusion fluid or a beaker filled with a sterile liquid at
room temperature. Non- compliance with these
instructions can lead to damage to the phaco tip
and/or phaco handpiece.

WARNING Injury to the patient’s eye!

Although the R-EVOLUTION is equipped with a
sophisticated power control circuitry to limit the
ultrasound power that is supplied to the eye, care is still
necessary to prevent damage to the endothelium of the
eye (corneal injury).
• Always use the lowest ultrasound power level
that is sufficient for cataract removal.
• The incision should not be too tight around the sleeve
and allow for some leakage of balanced salt
solution.
• Do not stress the incision by torsions while trying to
reach fragments of nucleus in the eye.

• If the phaco tip is situated fully in the nucleus, the

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aspiration flow stops and the tip is no longer correctly
cooled down. Do not activate ultrasound power for
extensive periods of time or at high levels if the
phaco tip is occluded.

In ultrasounds mode, besides irrigation aspiration parameters, which are adjusted as

described in the previous section, the Surgeon can set ultrasounds power level and
emission mode.

Ultrasounds can be emitted in “Continuous” mode, Pulsed mode (where three preset
levels of duty cycle, named as “STD”, “Cold” and “Ice Cold” respectively are
available), Single Burst, Multiple Burst, Continuous Burst or PEM (user Programmable
Emission Mode).

If peristaltic aspiration is chosen, “Autolimit” mode (maximum stroke limited to

50µm during tip occlusion) can be activated to limit possibility of corneal damages.

“HD Pulse” mode, also available with peristaltic aspiration only, automatically
adjusts pulses duty cycle according to the occlusion status of the phaco tip, thus
minimizing the time needed for phacoemulsification of the cataract, while
maintaining ultrasounds emitted power to the lowest level possible.

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If “Linear” control mode is chosen, Ultrasound emission can be linearly controlled

by system footswitch depression or rotation from a “Start” power to a final “Stop”
power (DSR mode). Note that “Start” power can be set either smaller or greater
than “Stop” power

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Basic settings for retina modes

5.6.3 Bipolar endodiathermy for retinal surgery

Connecting accessories
• Plug the desired endodiathermy handpiece, such as,
e.g., diathermy pin, into the bipolar diathermy cable.
• Plug the connector of the bipolar diathermy cable
into the diathermy socket of the device.

Diathermy settings
• Adjust the preset power level in the "Diathermy"
frame using the + - buttons or the slider. If you are
uncertain about the power to use, it is always

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advisable to begin with a low setting eventually
increasing it gradually to obtain the desired surgical
effect.

Bipolar diathermy can be carried out both in "fixed"

power control mode or "linear" power control mode. In
the latter case, the delivered power is linearly controlled
from 5% to the preset limit by pressing the foot switch.
• To switch between "linear" and "fixed" mode, press
the <linear> and <fixed> buttons.
Adjusting a parameter does not change the default
parameters. To recall the previous parameters press
“Undo”, to permanently save the new settings in the
memory of the device refer to “Creating an User
Program”.

5.6.4 Vitrectomy

WARNING Injury to the patient’s eye!

Non-sterile air might enter into the patient's eye if the
vitrectomy handpiece is connected incorrectly.
• The vitrectomy handpiece should always be tested
for proper function using a beaker with a sterile
solution, before placing the handpiece in the
patient's eye.

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Three vitrectomy sub-modes are
available: “Core1”, “Core2” and
“Shaving”.
These are independent memory
areas where the Surgeon can save
irrigation, aspiration and cutting
parameters optimized for the
various phases of the retinal
surgery.
User can switch between phases
either by touch screen or by
system footswitch.
A “Link” button in the irrigation
frame allow linking irrigation
pressure in all phases of the
vitrectomy.
If the “Link” button is not active, the irrigation pressure can be independently set
for the various phases.
The “Max” button in the irrigation frame, sets irrigating pressure to a value which is
higher than blood arteriosus pressure, to allow an immediate, momentary stop of
retinal hemorrhages.

WARNING Injury to the patient’s eye!

Maintaining the irrigating pressure at a value which is
greater than arteriosus pressure may cause permanent
damages to the retinal tissue.

• The “Max” button must be activated for the

shortest possible time. An alarm is automatically
triggered if irrigating pressure is kept over 70mmHg
for more than one minute.

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To set vitreous cutter parameters, hit the “Vitrectomy” button. The following
adjustments are possible:
Stand by position (footswitch not depressed) of the cutting port can be set on “Open
port” or “Closed port”.
Cutter duty cycle can be set on “Low”, “Medium” or High”. This affects, for a given
vacuum level and cutting frequency, the Material (vitreous) Removal Capability: the
higher is the duty cycle, the higher the removal capability.
The cutting frequency can be controlled either in “Panel” mode or in “Linear”
mode. If “Linear” control mode is chosen, cutting frequency can be linearly
controlled by system footswitch depression or rotation from a “Start” power to a
final “Stop” power (DSR mode). Note that “Start” frequency can be set either
smaller or greater than “Stop” frequency.

5.6.5 Scissors

WARNING Injury to the patient’s eye!

Non-sterile air might enter into the patient's eye if the
scissors are connected incorrectly.

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• The scissors should always be tested for proper
function using a beaker with a sterile solution,
before placing the scissors in the patient's eye.

INFORMATION Damage to the scissors!

Testing in air will cause irreparable damage to the
scissors.
• The scissors should always be test run in a beaker
of sterile solution. Aspiration is disabled during
the use of the scissors.
• Activate the <open> button to use mode with an
open tip. In order to return to the mode with a
closed tip, press <closed>.
• The cutting rate can be adjusted using the + -
buttons or sliders. The scissors can be operated in
"linear" mode and in "fixed" mode. In "linear" mode,
the cutting rate is linearly controlled by pressing the
foot switch.
• If you intend to work in "Single cut" mode, activate
the <Single cut> button. In order to return to
multiple cut mode, press the <Multiple cut> button.
In single cut mode, the motion of the scissors blade
is linearly controlled by pressing the foot switch.

5.6.6 Illumination

The R-Evolution is equipped with a LED light-

illumination system featuring three independent light
sources. Lamp 1 and lamp 2 are equipped with blue light
suppression filters and with a green filter.
• Connect the light guide fiber for endoillumination
to the desired light guide fiber socket on the front
panel of the device.

WARNING Injury to the patient’s eye!

• Although the fiber optic endo-ocular illumination
system does not emit infrared and ultraviolet
radiations, always use the minimal power level
sufficient for the surgical application to avoid
possible damage to the retina.

WARNING Injury to the patient’s eye!

• To reduce the risk of retinal damage, the edge of the
fiber optic illumination probe should not be situated

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in the immediate vicinity of the retina.

INFORMATION Longer surgery time

If the light guide socket is turned on and the fiber
is not connected, the R-EVOLUTION
automatically lowers the light emission, for better
Surgeon comfort.

• Select the light source that you want to adjust and use
the <on/off> key to turn it on or off.
• Adjust the light level of the selected lamp using the + -
buttons or the slider.
A set of four filters allows to emphasize the presence of
membranes.
Yellow filters also protects the eye of the patient from
unnecessary exposure to b l u e radiation and thus
enables longer treatment times

5.6.7 Tamponade

WARNING Injury to the patient’s eye!

• In order to prevent any possibility of infecting the
patient's eye, the original injection tube from
Optikon 2000, equipped with an air sterilization filter
should be used for air tamponade exclusively.

CAUTION Injury to the patient!

• The automatic intraocular pressure monitoring is
calibrated for exclusive use of accessories
manufactured or distributed by Optikon 2000
(membrane filters, tubing, scleral guide).

WARNING Injury to the patient’s eye!

• The silicone stop valve is checked during power-up.
Make sure that there is no hissing sound during
power-up of the Medical Device.

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CAUTION Injury to the patient’s eye!

• During the injection of silicone oil, the intraocular
pressure (IOP) is not controlled by the R-Evolution CR
such that the surgeon is in charge of controlling
the IOP. It is important to check the silicone oil
flow at set injection pressure before inserting the
cannula into the eye.

CAUTION Injury to the patient’s eye!

• Release the foot switch to discontinue the injection of
silicone oil. In any case of emergency close the
injection stop cock or take the silicone oil injection
tubing off the silicone supply unit.

INFORMATION Loss of silicone oil

• In order to prevent silicone oil from leaking into the
aspiration line of the I/A cassette, the silicone oil
collection tank should be kept in a vertical position
and be replaced as soon as it is completely filled with
silicone oil.
– In order to speed up the removal of high density
oil, the enclosed Y connector can be used to
connect two removal sets and use them
simultaneously.
– For further details, please refer to the
accompanying documents of the silicone oil removal
set.

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5.6.8 Footswitch programming

Push “System settings” button to access to the graphic footswitch programming

interface.
This interface allows customization of the footswitch behavior:

a. Touching any of the four round side buttons (1) or any of the side
pointing arrows (2) on screen causes a pop-up window to show. This
window allows chosing which function to link to the individual button
or side movement of the main paddle.

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Note that not all functions can be associated to all buttons or

movements. Disabled functions are grayed.

b. The label (3) indicates which function is linked to the vertical

movement of the main paddle (in the example, U/S, vit cut and
Aspiration).

c. Touching the up pointing arrow (4), a pop-up window will appear

allowing adjustment of the position of SW3 (U/S start point), thus
allowing the user to custom share the vertical travel of the paddle
between linear aspiration and linear adjustment of U/S power.

d. Touching the button (5), a pop-up window will allow adjustment of the
tactile feedback (vibration strenght) of SW3 (U/S start).

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Once a footswitch configuration has been programmed and saved, it can be recalled
and saved within User programs. It is possible to use the same configuration through
all the User program or to assign different footswitches to each stage of the
program, i.e. “Single linear” in “Sculpt” and “Dual Linear” in “Quad”.

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5.6.9 Mean Ocular Perfusion Pressure (CR only)

It is well known from medical literature that an elevated intra-ocular pressure

impairs proper blood circulation in the retinal vessels and that, if this condition is
maintained for an extended period of time, permanent retinal damages may occur.
The fact that some retinal surgeries, while properly executed from the technical
point of view, did not cause the anticipated functional improvements, is often
attributed to iatrogenic damage caused by the fact that an excessive irrigation
pressure (and, consequently, IOP) has been set during the intervention.
The limit to which the IOP can be set while keeping a proper retinal perfusion is a
function of the diastolic and systolic pressure of the specific patient. The lower are
these values, the lower the IOP must be kept.
The Mean Ocular Perfusion Pressure is a function of the difference between the
mean arterial pressure (computed from diastolic and systolic pressure) and the Intra
Ocular Pressure.
A MOPP equal or greater than 35mmHg, if considered to assure a proper perfusion of
retinal vessels. If it is lowered below this value, the blood circulation in the retina
gradually decreases, coming to a complete stop.
The digital blood pressure monitor allows R-EVOLUTION CR to periodically monitor
the patient diastolic and systolic pressure and, on the basis of the set irrigation
pressure, the IOP and the MOPP.
- Connect the arm cuff of the blood pressure monitor to the
dedicated connector located on the rear panel of the
R_EVOLUTION CR.
The Irrigation frame will appear as in the following image:

- Install the I/A cassette and position the sphygmomanometer cuff

on the patient arm, then press “Start”.
The blood pressure monitor will automatically measure the
patient arterial pressure and the R_EVOLUTION CR will compute
his MOPP.
The equipment screen will appear as in the following image:

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Around the dials to set BSS bottle height (or Controlled irrigating
pressure) and air tamponade pressure, colored sectors will
appear: settings of bottle height or infusion pressure in the green
area cause a MOPP (about 10mmHg) greater than 35mmHg, thus
allowing a proper blood circulation in the retinal vessels. Settings
in the red sector cause a MOPP equal or smaller than 35mmHg, if
they are mantained for a long period of time, a iatrogenic
damage may occur.
The MOPP calculated from the last arterial pressure measure and
from the current irrigating pressure is shown in the lower portion
of the irrigation frame. The time passed in the red area is shown
nearby, close to a red alert sign.
- An information message, suggesting to lower irrigation pressure as
soon as possible, will appear if the said pressure has been in the
red area for more than 30 seconds.

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- Whenever needed, touch the “Irrigation” button to display a pop-
up window showing the diastolic and systolic values acquired last
and, in percentage, the time spent in the green, yellow and red
colored areas respectively.

- Arterial pressure is measured periodically during the surgery.

Ay the end of the surgical case, before removing the
sphygmomanometer cuff from the patient arm, touch “Stop” in
the “Irrigation” frame.
- All MOPP counters are automatically reset when the I/A cassette
is replaced (new patient).

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6. System alarm messages

WARNING Error messages on the touchscreen

Error messages with a red warning sign indicate a serious
error that cannot be remedied by the user.
• In case of Warning error messages, please contact the
Optikon 2000 service team.

• Please note the explanations for each error message

on the next pages.

CAUTION Error messages on the touchscreen

Error messages with a yellow warning sign indicate a
moderate error that can be remedied by the user or our
service.
• Please note the explanations for each error message
on the next pages.

INFORMATION Error messages on the touchscreen

Error messages with a blue warning sign indicate a
minor error or an instruction that can be
remedied/followed by the user.
• Please note the explanations for each error message
on the next pages.
100 Error messages

Id Message Probable cause Corrective measure

100 "Air pressure error" visual message + sound Please contact the
Optikon 2000 service
Error in air tamponade team.
or Controlled irrigation
system (output pressure
much higher or lower
than preset)

101 "Pressure level error" visual message + sound Please contact the
Incorrect pressure at Optikon 2000 service
output of proportional team.
valve

102 "Vacuum level error" Vacuum exceeds preset Please contact the
value in Venturi mode Optikon 2000 service

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team

103 “Diathermy power Error in diathermy system Please contact the

mismatch” (output power much Optikon 2000 service
higher or smaller than
preset)

104 “U/S enable failure” Error in ultrasound Please contact the

system (power output Optikon 2000 service
not turned on despite
prompting due to error
in activation gate or wire
contacting problem)

200 Error messages

Id Message Probable cause Corrective measure

200 "Air enable failure" Error in air tamponade Please contact the
and Controlled Optikon 2000 service
irrigation systems (safety team.
switch Off secondary
transistor, is checked at
start-up)

201 "Watchdog failure" Error in monitoring circuit Please contact the

(checked at start-up) Optikon 2000 service
team.

202 "Serial communication Communication error Please contact the

fault" between graphical user Optikon 2000 service
interface and control team.
board

203 "Diathermy enable / Error in diathermy system Please contact the

Diathermy reading (power output turned on Optikon 2000 service
mismatch" due to error in activation team.
gate)

205 "Diathermy enable Error in diathermy system Please contact the

failure" (power output not Optikon 2000 service
turned on despite team.
prompting due to error
in activation gate or wire
contacting problem)

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Id Message Probable cause Corrective measure

206 "Power supply / Incorrect voltage Please contact the

reference voltage reference at A/D Optikon 2000 service
mismatch" transducer or incorrect team.
+5V power value
(checked at start-up)

207 "US enable / US Error in ultrasound Please contact the

reading mismatch" system (power output Optikon 2000 service
turned on due to error team.
in activation gate)

209 "Vacuum offset error" Priming error: vacuum a) Priming procedure

sensor offset excessive was restarted after
Err 210. Open the
infusion clamp on
the infusion set,
briefly open
continuous
irrigation, and
restart priming
procedure.

b) Vacuum sensor
needs calibration
Please contact the
Optikon 2000 service
team for calibration
of the unit.

210 "No irrigation" Priming error: Vacuum Open the infusion

does not decrease after clamp on the
the pinch valve is infusion set, briefly
opened. open continuous
irrigation, and
restart priming
procedure.

211 "Too high infusion The infusion pole is Lower the infusion
pressure" situated at too high a pole as far as
level possible

212 "IVPole failure" Error on the infusion pole Please contact the
Optikon 2000 service
team.

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Id Message Probable cause Corrective measure

213 “Light 1 overheating” The LED endoillumination Verify that the rear
system 1, 2 or 3 has panel ventilation
reached an excessive grids are free from
temperature. obstructions.
216 “Light 2 overheating” Switch off the
overheated LED and
use one of the other
217 “Light 3 overheating” two sources.
If the problem
persists, contact the
Optikon 2000 service
team.

214 “Battery discharged” The battery of the Immediately wire

wireless footswitch is the footswitch to
discharged the console to
continue.

215 “Footpedal Pedal is switched off or Press paddle or

communication fault” batteries are completely connect by cable.
dry.

300 Error messages

Id Message Probable cause Corrective measure

300 "Install I/A cassette" The I/A cassette is not Connect I/A cassette
connected

301 "I/A cassette full, The waste collection Replace I/A cassette
aspiration halted" container of the I/A
cassette is full

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Id Message Probable cause Corrective measure

302 "Low input pressure Pressure of the external a) Device is not

air supply is too low or connected to
zero compressed air
supply or stopcock is
closed. Connect the
device to
compressed air
source or open the
stopcock.
b) Pressure of the
compressed air
supply of the device
is less than 450 kPa
(65 psi).
Check the pressure
of the compressed
air circuit.

303 "Major leakage" Priming error: Peristaltic a) Test chamber is

pump cannot establish a not installed on the
vacuum of 100 mmHg sleeve. Make sure
within 30 sec. that the test
chamber is properly
installed on the
sleeve.
b)
Irrigation/aspiration
tubing is not
connected to
handpiece. Connect
the
irrigation/aspiration
tubing from the
cassette to the
phaco
handpiece.
c) The I/A cassette is
defective.
Replace I/A cassette
d) The pump system
needs calibration.
Please, contact the
Optikon 2000 service
team.

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Id Message Probable cause Corrective measure

304 "Aspiration line Priming error: Vacuum a) Handpiece and tip

occluded" level may not have been
when priming the tubing properly cleaned
exceeds 300 mmHg before sterilization.
Replace tip and/or
handpiece.
b) The I/A cassette is
defective.
Replace I/A cassette

305 "Minor leakage" Priming error: Peristaltic a)

pump cannot establish a Irrigation/aspiration
vacuum of 300 mmHg connectors are not
fully engaged in the
handpiece
connectors. Connect
the connectors
properly.
b) The sleeve or the
test chamber is not
correctly assembled.
Verify that the test
chamber is fully
engaged on the
sleeve and that the
sleeve is properly
positioned on the
handpiece.

306 "Check tip" Priming error: Phaco a) Phaco tip is loose.

handpiece cannot be Screw the phaco tip
adjusted properly into the
handpiece using the
phaco tip wrench.
b) Phaco tip is
damaged.
Inspect the phaco tip
and replace
according to need.
c) Phaco handpiece
is
damaged. Replace
phaco handpiece

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Id Message Probable cause Corrective measure

307 "Weak handpiece" Phaco handpiece cannot a) Check if the phaco

deliver more than 50 tip is loose and, if
micrometers. this is the case,
tighten it properly
using the phaco tip
wrench.
b) It is common that
the piezoceramic
element deteriorates
with use and number
of sterilization
cycles. Please submit
the handpiece to the
Optikon service
team.

308 Install Controlled Controlled irrigation air Connect Controlled

irrigation line is not connected to irrigation system
the equipment output correctly or use
gravity feed
irrigation instead.

310 "Low Stroke" Ultrasound handpiece a) Check if the phaco

cannot deliver set stroke tip is loose and, if
this is the case,
tighten it properly
using the phaco tip
wrench.
b) It is common that
the piezoceramic
element deteriorates
with use and number
of sterilization
cycles. Please
return the handpiece
to the Optikon
service team.

311 “Plug U/S handpiece” The U/S handpiece is not Plug the U/S
connected to the console handpiece into the
appropriate
connector on the
console. If the
problem persist,
replace the

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Id Message Probable cause Corrective measure

handpiece.

312 “Please, prime” Phaco handpiece is See “5.4.3

connected but not Installation of phaco
primed. accessories”

313 “Please, prime” Vitrectomy handpiece is Follow on-screen

connected but not instructions to prime
primed. and test the
vitrectomy cutter.

314 “Please, prime” I/A cassette is connected Follow on-screen

but not primed. instructions to prime
and test the I/A
cassette.

315 “Battery low” The wireless footswitch Recharge the battery

battery is low. as soon as possible or
wire the footswitch
to the console.

316 “Battery temperature Wireless footswitch The battery should

fail” battery is overheating be replaced, contact
during recharge Optikon service dept.

317 “Battery fail” Wireless footswitch The battery should

battery is defective. be replaced, contact
Optikon service dept.

318 “For aspiration select In “Fluids” mode, while Select peristaltic

peristaltic” injecting silicone oil pump to aspirate
Venturi pump cannot be while injecting
used. silicone oil

323 “Warning! Low Irrigating pressure has Lower the irrigating

perfusion pressure for been set in the “red pressure in the
more than 30 area” for more than 30 “green area” as soon
seconds. Cosider consecutive seconds. as possible.
lowering irrigating
pressure until
perfusion normalizes
into the green area”

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400 Other messages

Id Message Probable cause Corrective measure

400 "Skip I/A Priming?" One of the foot switch a) if footswitch has
switches is being pressed. been pressed
involuntarily,
remove your foot
and press "NO" on
the screen
b) Defective foot
switch.
Replace foot switch

401 “Stop priming?” Footswitch has been If the footswitch has

pressed during priming been pressed
procedure. involuntarily, press
“no”.

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7. Care and maintenance

7.1 EQUIPMENT MAINTENANCE

Changing fuses

The fuses for the control unit are located in the power
inlet at the back of the unit. To change the fuses,
proceed as follows:

CAUTION Risk of injury to the user!

Hot fuses can cause s k i n burns.
• Before changing the fuses turn off the device and
allow it too cool down for a few minutes.
• Turn off the Medical Device using the power switch.
1
• Pull the power chord.
• Press lock lever (1) and remove the fuse holder.
• Remove the defective fuses and install new fuses.

INFORMATION Risk of damaging the Medical Device!

Incorrect fuses may damage the device.
• Use fuses with the correct ratings only! Please refer
to the rear panel label for details.
• Re-install the fuse holder. Lock lever (1) must audibly
snap in.
• Plug the power cord back in.
• Turn the unit on at the power switch.

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Maintenance of the Medical Device

CAUTION Risk of injury to the patient’s eye!

Malfunction of the Medical Device may injure the
patient!
• Have your authorized service partner perform a
safety check on the equipment in accordance
with IEC 62353 that includes the following items:
– during the installation of the Medical Device,
– in regular intervals (every 12 months),
– during maintenance work,
– after repairs, upgrades, calibration, and soft- and
firmware updates

INFORMATION Risk of damaging the Medical Device!

• To keep the Medical Device safe, check the unit
conformity with electric current leakage limits
according to standard EN 60601-1 at least once a
year. Contact the technical division of your facility
or your authorized distributor or the Optikon 2000
Service.
• Store the R-EVOLUTION in a clean dry location.
 Remove I/A tubing after each u se.
• To prevent any impairment of the Medical Device
safety as a result of aging, wear, etc., the user must
ensure, in accordance with the applicable national
regulations, that the regular technical safety checks
defined for this device are performed on schedule
and to the stipulated extent. The technical safety
checks may be performed by the manufacturer or
qualified persons only. The scope of the technical
safety checks should at least comprise the following
items:
– Availability of the user manual
– Visual inspection of the Medical Device and
accessories for damage and legibility of the
labels
– Test of protective earthing
– Leakage current test

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– Function test of all switches, buttons, sockets and
indicator lamps on the Medical Device

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7.2 MAINTENANCE OF ACCESSORIES

CAUTION Risk of injury to patient or user!

Wet surfaces may cause electrical shock as RF currents
may find a path through wet surfaces.
• Make sure that the diathermy handpiece is completely
dry before using it.
• Avoid dropping or mishandling handpieces and
accessories. It is critical to handle these components
with utmost care and inspect them thoroughly for
any damage or wear after each use.
• Periodically inspect the fluid lines, fittings,
external O-rings and handpieces for any
damage or wear.
• Reassemble all parts before storing.
• Place tip protective caps over handpieces
(where provided) before wrapping and storing.

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7.3 CARE OF THE DEVICE

Cleaning

The medical staff is responsible for keeping the medical device and further
equipment in optimal operating condition. The simple steps described below
constitute a practical guideline for defining a suitable care and maintenance
program.

CAUTION Risk of infection!

• Clean the front panel with a soft cloth dampened
with distilled water.
If necessary, use neutral detergent only.
• It is not permissible to use media that damage the
device.
• For cleaning please refer to the indications
given in the relevant instructions for use.

Sterilization

WARNING Injury to patient or user!

The console, foot switch and I.V. pole cannot be
sterilized.
• For reprocessing accessories, like phaco tips, please
refer to the indications given in the relevant
instructions for use.

Disinfection

INFORMATION Surface damage on the device!

• Use a disinfectant based on aldehyde and/or alcohol.
The addition of quaternary compounds is acceptable.
To prevent damaging surfaces, disinfecting components
other than those listed below must not be used.
The maximum concentrations are:
– For alcohol (tested with 2 propanol): 60%
– For aldehyde (tested with glutaraldehyde): 2%
– For quaternary compounds (tested with DDAC): 0.2%

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8. ACCESSORIES
This chapters lists accessories, spare parts and consumables designed by Optikon for
the R-Evolution.
For detailed information, inquire with your local Optikon dealer or visit the
www.optikon.com website.

CAUTION Risk of injury to patient’s eye!

• Use only original accessories and consumables made
by Optikon 2000 that are designed for use with the
R-EVOLUTION. Check the Instructions for Use of the
accessories for compatibility with the
R-EVOLUTION CR-EVOLUTION.

General use accessories

REF Description
112104 Multifunction footswitch(pedal+ battery charger + connection cable)
122007 Remote Control
111008 Eclipse HD - Video Overlay system

Posterior segment surgical accessories (CR only)

Posterior Vitrectomy
“Optivit” 20, 23, 25G Vitrectomy cutters
“Twedge” Vitrectomy cutters (dual cut) 23, 25, 27G
Endoillumination
“Standard” 20, 23, 25, 27G Endoillumination probes
“Wide angle” 20, 23, 25G Endoillumination probes
“Chandelier” 20, 23, 25, 27G Endoilluminator
Irrigation / Aspiration
“Minimal IOP” Controlled irrigation kit
Drip chamber for Controlled irrigation
“Easysys” I/A cassette
20G Infusion cannula
Fluids removal cannulas, 20, 23, 25G
Valved trocars 23, 25, 27G
Non valved trocars 23, 25G
Active and passive “Charles” aspiration handpieces
Fluids exchange
Automatic stopcock air injection tube, with filter
Injection/removal kit for silicone oil

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Diathermy
Endodiathermy handpieces 20, 23, 25G
Diathermy forceps
Pencil Esodiathermy handpiece
Diathermy cable
Phacoemulsification
“Slim 4” phacoemulsification handpiece (anterior and posterior segment)
“Six” phacoemulsification handpiece (anterior and posterior segment)
“Low friction” Pars Plana phacoemulsification tip

Anterior segment surgical accessories

Phacoemulsification
“Slim 4” phacoemulsification handpiece (anterior and posterior segment)
“Six” phacoemulsification handpiece (anterior and posterior segment)
1,8 to 3,2mm incision phacoemulsification tips
1,8 to 2,9mm incision “flared” phacoemulsification tips
“Sleeveless” 1mm incision phacoemulsification tips
Silicone sleeves for 1,8 to 3,2mm incision phacoemulsification techniques
Irrigation / Aspiration
I/A handpiece for quick insertion tips
Straight I/A tips, with silicone sleeve for incisions from 1,8 to 3,2mm
Angled I/A tips, with silicone sleeve for incisions from 1,8 to 3,2mm
I/A tips with metal sleeve
Diathermy
Pencil Esodiathermy handpiece
Diathermy forceps
Diathermy cable
Anterior Vitrectomy
20G Vitrectomy cutter, with irrigation sleeve
20, 23, 25G Vitrectomy cutters, without coaxial irrigation

R-Evolution procedure packs

Optikon 2000 supplies custom tailored procedure packs for both vitrectomy and
phacoemulsification.
Procedure packs contains a selection of the accessories listed above.
For detailed information, inquire with your local Optikon dealer.

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