OPTIKON R-Evo Smart E Reference manual

1X10XXEN
Rev.E
R-Evo Smart E
R-Evo Smart S
R-Evo Smart CR
MEDICAL DEVICE FOR OCULAR SURGERY
MANUAL FOR INSTALLATION AND USE

Optikon 2000 S.p.A is the manufacturer of the R-Evo Smart, a medical
device for phacoemulsification and vitrectomy.
The product complies with the requirements of the Medical Device
Directive 93/42/EEC.

INDEX
1. EXCLUSION OF LIABILITY .......................................................1-1
2. LIMITED WARRANTY CONDITIONS .............................................2-2
3. GENERAL INFORMATION .......................................................... 3
3.1 LEGEND OF SYMBOLS .......................................................................3
3.2 TABLE OF SYMBOLS .........................................................................4
3.3 TARGET GROUP .............................................................................6
3.4 INTENDED USE ...............................................................................6
3.5 NOTES FOR THE OPERATOR ...............................................................7
3.6 GENERAL SPECIFICATIONS ............................................................... 27
3.7 EMC TABLES................................................................................ 31
3.8 POWER CHARACTERISTICS IN DIATHERMY APPLICATIONS ........................... 35
3.9 CIRCUIT DIAGRAMS........................................................................ 35
4. INSTALLATION AND OPERATION ................................................36
4.1 DESCRIPTION OF THE DEVICE............................................................ 39
4.2 MEDICAL DEVICE COMPONENTS ......................................................... 45
4.2.1 Overall view (optional trolley with tray and electric IV pole) ................................... 45
4.2.2 Front panel connectors and control elements (CR)................................................ 47
4.2.3 Front panel connectors and control elements (E and S) .......................................... 48
4.2.4 Back panel connectors and control elements....................................................... 49
4.2.5 Side view .................................................................................................. 50
4.2.6 System pedal ............................................................................................. 51
4.2.7 TACTILE SCREEN AND USER INTERFACE .............................................................. 53
4.3 INSTALLATION PROCEDURE .............................................................. 57
4.3.1 Installation of the equipment ......................................................................... 57
4.3.2 Installation of the I/A cassette........................................................................ 62
4.3.3 Installation of phaco accessories ..................................................................... 64
4.4 USER'S PROGRAMS......................................................................... 66
4.5 OPERATION................................................................................. 70
4.5.1 Irrigation/Aspiration .................................................................................... 70
4.5.2 Phacoemulsification ..................................................................................... 74
4.5.3 Bipolar endothermy for retinal surgery .............................................................. 77
4.5.4 Vitrectomy ................................................................................................ 79
4.5.5 Illumination ............................................................................................... 80
4.5.6 Tamponade ............................................................................................... 81
4.5.7 Pedal programming...................................................................................... 83
5. SYSTEM ALARM MESSAGES.......................................................85
6. CARE AND MAINTENANCE ........................................................94
6.1 MAINTENANCE OF THE DEVICE .......................................................... 94
6.2 MAINTENANCE OF ACCESSORIES ........................................................ 96
6.3CARE OF THE DEVICE ..................................................................... 97
7. ACCESSORIES.......................................................................98

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1. EXCLUSION OF LIABILITY
The user of this Medical Device must carefully read the specific warnings provided in
this manual. It is the responsibility of the operator to ensure that the personnel in
charge acquire a thorough knowledge of the operation of the instrument before use.
In no case the Manufacturer is responsible for accidental or indirect damages caused
to the purchaser, operators or patients following the use of the product.
Use of the Medical Device is subject to professional medical evaluation. The
Manufacturer is not responsible for any clinical problem resulting from improper use
of the appliance and does not provide any medical recommendation.
The Manufacturer declares to be responsible for safety, reliability and performance
only in the following cases:
•updates, calibrations and repairs carried out by personnel authorised by the
Manufacturer;
•the instrument is used in accordance with the instructions for the user;
•the electrical system to which the appliance is connected is in compliance with
the IEC safety standards.
IMPORTANT NOTE:
At the time of printing this manual, every effort has been made to ensure that all
illustrations and information accurately represent the product and its operation. It
is however possible that, during the duration of this manual, changes are made to
the product in order to continue to effectively meet the needs of users. Such
changes may be made without notice.
Manufacturer:
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13
00138 Rome - Italy
Tel. [phone]
Fax. [phone]
e-mail [email protected]
www.optikon.com
NOTE
The information contained in this manual is the exclusive property of OPTIKON
2000 S.p.A. The total reproduction of the manual is permitted only with the prior
written authorisation of OPTIKON 2000 S.p.A.

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2. LIMITED WARRANTY CONDITIONS
All equipment and accessories sold and installed in the European Union are
guaranteed by the Manufacturer against manufacturing and material defects, for ONE
YEAR from the date of invoice. The warranty of consumables is limited to the first use
of the appliance.
For warranty conditions applicable outside the European Union, contact your
authorised distributor.
All parts covered by the warranty will be repaired or replaced free of charge.
The warranty includes the search for the cause of the defect, the repair of the fault
and the final inspection of the unit or components.
The warranty does not cover problems resulting from misuse, accidents, misuse,
tampering or modifications by persons not belonging to the manufacturer's authorised
technical service.
The Manufacturer reserves the right to check, in case of failure, if the instrument
and/or its accessories have been modified or tampered with in any way, or if they
have been damaged due to improper use.
Similarly, the Manufacturer reserves the right to modify the instrument and/or its
accessories if operating techniques require such changes.
The warranty is void if the serial number of the included instrument and/or
accessories has been lost or has been tampered with and found to be illegible.
The warranty does not include the cost of sending the instrument and accessories: all
shipping costs, packaging, etc. will be borne by the customer.
In the event of an explicit request for intervention by the Manufacturer's technicians,
all travel and accommodation costs shall be borne by the customer.
OPTIKON 2000 S.p.A. is not liable for any damage incurred during transport. If this
situation should arise, the customer must immediately inform the carrier who carried
out the delivery.
Manufacturer:
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13
00138 Rome - Italy
Tel. [phone]
Fax. [phone]
e-mail [email protected]
www.optikon.com

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3. GENERAL INFORMATION
3.1 LEGEND OF SYMBOLS
All information about the safety aspects of using this Medical
Device is provided. This section contains a summary of the
most important safety information.
Hazard symbols
The following safety information has been included in the
user manual. Take note of this information and take special
care in the cases indicated.
WARNING Indicates a hazard that can cause damage resulting in
fatal or serious injury.
CAUTION Indicates a hazard that can cause accidents for which
medical care is required.
INFORMATION Indicates a hazard that can cause injuries for which
medical care is not required.

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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 symbols are placed on the label of the R-Evo Smart. Before using the appliance,
familiarize yourself with the symbols and the definitions shown in the table.
SYMBOLS PUBLISHED BY THE IEC
SYMBOL
DESCRIPTION
MANUFACTURER
DATE OF MANUFACTURE
ALTERNATING CURRENT
RF EMISSIONS
OFF (DISCONNECTED FROM THE
MAINS)
ON (CONNECTED TO MAINS)
TYPE B APPLIED PART
TYPE BF APPLIED PART
SEPARATED WASTE COLLECTION
FOR ELECTRICAL/ELECTRONIC
EQUIPMENT
EQUIPOTENTIALITY
CONSULT THE OPERATING
INSTRUCTIONS

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FUSE RATING
COMPRESSED AIR INLET
AIR INJECTION SOCKET
ILLUMINATION SOURCE SOCKET
SOCKET FOR DIATHERMY
PEDAL SWITCH SOCKET
OTHER SYMBOLS ON THE DEVICE
SILICONE OIL INJECTION SOCKET
PHACO SOCKET
VITRECTOMY SOCKET
KNOB FOR UNLOCKING CASSETTE
USB SOCKET
Irrigation solution
CONTROLLED IRRIGATION

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3.3 TARGET GROUP
This user manual is intended for physicians, nurses and other
medical and technical personnel involved in preparing,
operating or maintaining the device after appropriate training.
It is the duty of the customer or institution to instruct and train
all personnel who must use the Medical Device.
Additional service activities are not part of this user manual.
These activities will be carried out by staff specially trained in
this regard by OPTIKON 2000 S.p.A.
Scope of application
Purpose
The R-Evo Smart Surgical Medical Device has been designed to
be used in operating theatres by qualified medical personnel
(eye surgeon) for surgical procedures for the treatment of the
anterior ocular segment. The equipment was designed for
irrigation, irrigation/aspiration, crystalline phacoemulsification,
anterior vitrectomy, bipolar diathermy coagulation techniques.
The R-Evo Smart CR also features the functions of posterior
vitrectomy, air and silicone oil tamponade, endo-ocular
illumination. The Medical Device is intended for use in clinics,
hospitals and other institutions dealing with human medicine.
3.4 INTENDED USE
The R-Evo Smart is intended for use in surgical treatments such
as extracapsular extraction, phacoemulsification or glaucoma of
the anterior segment of the human eye, the R-Evo Smart CR
model also for surgical treatment of retinal detachment and
other pathologies of the vitreous body and the posterior
segment of the human eye. Any malfunctions occurring during
use are indicated by a message displayed on the display and by
alarm signals.
Any use other than the one stated above, is excluded as it
may cause unforeseeable risks. In particular, the use of this
system in brain or heart surgery is excluded.
WARNING Risk of injury to the patient!
•The diathermy section of the R-Evo Smart surgical
systems should not be used with patients with
pacemakers or other cardiac stimulators without
having previously consulted a cardiologist.

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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 with the contents of the user
manual before starting the 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 the instructions in this user
manual.
•Keep the user manual in a place that is easy to access
at any time by the staff using the Medical Device.
•The Medical Device must be used only by qualified
medical personnel, aware of the possible risks due
to the use of this device and who have received
complete and adequate training for the prevention
and management of any clinical complications.
•The Medical Device should only be used by a staff
who has received adequate training and
instructions. It is the duty of the customer or
institution to instruct and train all personnel who
will use it.
•It is essential to have adequate training to install and use
R-Evo Smart devices correctly, this training is offered by
OPTIKON 2000 S.p.A. Contact the OPTIKON 2000 S.p.A.
local service centre for more information.
Transport
CAUTION Risk of injury to the patient's eye!
The Medical Device has been packaged in such a way as to
minimize the risk of damage during transport.
•In case you should observe any damage due to

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transport, inform the carrier and do not use the
device.
•For long-distance transport (eg dismantling, return for
repair, etc.), the device must be placed in its original
packaging or in special packaging. For further
information, contact your dealer or the OPTIKON 2000
S.p.A. technical service.
Assembly and installation
INFORMATION Risk of damaging the Medical Device!
•Make sure that the installation and use conditions of
the device comply with the surgical requirements:
–Low vibration
–Clean environment
–Assess of excessive mechanical loads
INFORMATION Risk of interferences and malfunctions !
•This Medical Device requires special precautions
regarding EMC (Electomagnetic Compatibility), it must be
installed and commissioned according to the EMC
information and indications given in the accompanying
documents.
INFORMATION Risk of interferences and malfunctions !
• This Medical Device should not be used in proximity of
other devices. If it must be used close to other
equipment, it must be carefully observed to verify
normal operation in the actual configuration in which it
is used.
INFORMATION Risk of damaging the Medical Device!
The maximum height of the IV pole is 225 cm from the
ground.
•Do not install the R-EVO SMART systems in rooms with a
low ceiling.
INFORMATION Risk of damaging the Medical Device!
If the ventilation openings are closed and blocked, the
device may overheat.
•Install the R-EVO SMART so that the ventilation
openings are neither closed nor obstructed.
WARNING Risk of explosion or fire hazard!

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The Medical Device is not suitable for use in hazardous
areas.
• R-Evo Smart systems must not be used:
–in areas at 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 system in damp rooms. Do not
expose the system to water splashes, dripping water or
sprayed water.
•To ensure safe operation, do not install the Medical
Device in a location that may be exposed to heaters or
radiators, direct sunlight, or any other heat source at
excessive temperatures.
Operation
CAUTION Risk of injury to the patient or the user!
•Observe the maximum loads indicated for the following
components:
–Maximum load on the instrument tray, 1 kg.
–Maximum load of the bottle and irrigation solution, 0.5
kg.
CAUTION Risk of injury to the patient or the user!
Danger of overturning when crossing doorsteps.
•Push the medical device slowly and carefully using its
handles when crossing doorsteps up to 3 cm. If the
doorstep is higher than 3cm it must be moved by two
people.
INFORMATION Risk of minor injury to the patient!
A moving white dot logo at the bottom right of the
screen indicates that the device is working properly.
•If the dots around the logo stop moving, the
device is stopped, and you must stop using it.
•Before any use, carry out the installation, the surgical
configuration and the operating procedures described
here. If a malfunction occurs that is not corrected using
the "Correction of malfunctions" chapter, please put the

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"non-working" label on the device and contact the
OPTIKON 2000 S.p.A. technical service.

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•Carefully follow the instructions when installing and
using the unit in order to prevent harmful interference
by with other devices.
This Medical Device has been tested and found
compliant to the emission and immunity limits
established by the IEC60601-1-2:2014 standard for
electro-medical devices. These limits are conceived to
ensure proper protection from interferences in a typical
medical environment. However, interferences may still
exist in a specific installation. If the system 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 other devices.
▪Increase the distance between the devices.
▪Connect the unit to a power outlet other
than the one to which the other devices
are connected.
▪Contact your dealer or the technical service of
OPTIKON 2000 S.p.A.
•The sound emission capacity of the device is tested at
startup.
Verify that a beep sounds is emitted when initializing the
system.
•Any malfunctions occurring during use of the medical
device are indicated by a message on the display and by
alarm signals. Resolve the malfunction and confirm the
message by pressing the corresponding key in the
display. If the malfunction can not be eliminated, or if
the error occurs again, do not continue to use the
device, but put up signs indicating that it is "out of
order" and contact your dealer or the OPTIKON 2000
S.p.A. technical service.
•Do not pull on the power cables or other connecting
cables.
•When moving the Medical Device make sure that no
tubes are crushed or pulled out.
•Portable and mobile radio communication devices can
affect operation of the Medical Device

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•Never leave the Medical Device unattended when the
light source is switched on, to avoid causing damage to
the patient's retina due to excessive irradiation time.

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Maintenance
•The Medical Device is a sophisticated high-tech product.
To ensure optimal performance and safe operating
conditions, we recommend, as part of a normal
maintenance program, to have an annual inspection
performed by technical staff authorized by OPTIKON
2000 S.p.A.
•To avoid a decrease in the safety of the Medical Device,
due to ageing, wear, etc. the institution operating the
device must ensure, in compliance with the applicable
national regulations, that regular safety checks have
been carried out on the prescribed schedule and on the
stipulated exent. The technical safety checks must be
carried out exclusively by the manufacturer or by
qualified personnel. The scope of the security
engineering controls should include at least the
following items:
–Availability of the user manual
–Visual inspection of the device and its
accessories to verify the absence of damage
and the readability of the symbols and labels.
–Protective earthing impedance test
–Current leakage 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 may break during application and
cause device malfunctions.
•Do not change the shape of the handpiece for
vitrectomy or the tip used with the
R-EVO SMART systems (e.g. do not bend, cut or
scratch).
WARNING Risk of injury to the patient's eye!
Changes due to the application of manual force on the
upper part of the infusion pole could result in an
incorrect level of the bottle and injury to the patient.

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•The height level of the infusion pole must not be
changed by applying manual force.
•Modification and repair of the Medical Device or any
other system used together with it must only be
performed by the OPTIKON 2000 S.p.A. or other
appropriately authorized personnel.

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Disposal
CAUTION Environmental pollution!
Environmental pollution may occur if the waste is disposed
of incorrectly!
•Do not dispose of the Medical 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 items may contaminate the user or the
environment. Dispose of waste collection fluids in
accordance with local or government regulations and
laws on the disposal of organic material.

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Approved accessories
WARNING Risk of injury to the patient's eye!
•Use only items approved and recommended by OPTIKON
2000 S.p.A.
CAUTION Risk of injury to the patient's eye!
•Use only original accessories and consumables
manufactured by OPTIKON 2000 S.p.A. for use
with R-EVO SMART systems. Consult the
Instructions for Use of the accessories to check
their compatibility with the R-EVO SMART.
•The use of accessories and cables not included in the
packaging of the Medical Device could lead to an
increase in electromagnetic interference or reduce the
immunity of the device to such interference. For these
systems use only spare parts approved by OPTIKON 2000
S.p.A.
•Additional equipment connected to electrical medical
devices must comply with IEC or ISO standards (e.g. IEC
60950 for data processing equipment). In addition, all
configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or Clause
16 of the 3rd edition of IEC 60601-1). Any person who
connects additional equipment to a medical electrical
appliance is configuring a medical system and is
therefore responsible for compliance with the
regulations relating to medical electrical systems. Note
that local laws have priority over the aforementioned
regulations. If in doubt, consult your dealer or the
OPTIKON 2000 S.p.A. technical service.

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Electric system
INFORMATION Risk of equipment malfunction!
•Never connect a USB device to the medical device while
it is in use.
•Use only USB pendrives that are free from viruses.
•The Medical Device is set to be used with a line
voltage of 100 - 240 V (± 10%), 50-60Hz. Check that
the local line voltage matches 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. To replace the fuses, contact an
authorized technical service.
•Connect the R-EVO SMART to a mains power supply with
the features shown on the rear panel of the console. To
ensure safe operation, the medical device must have
adequate grounding.
•To avoid the risk of electric shock, the device must only
be connected to a power supply with adequate
grounding.
•Before connecting or disconnecting the unit to the
mains, ensure that the main switch is turned off.
•The main switch must be turned off when the device is
not in use.
•Before replacing the fuses, switch the device off and
let it cool down for a few minutes.
•If required by law and guidelines of the country in
which you are using, the Medical Device must be
connected to a UPS.
•Do not place containers containing liquids on the
Medical Device. Make sure that no cleaning products
are allowed into the device.
•Never try to connect electrical connectors by forcing
them (plugs, sockets). If a connector does not fit easily
into a socket, make sure it is not intended for another
socket. If a connector is damaged, contact your local
OPTIKON 2000 S.p.A. technical service.
•Do not use electric extension cords or multiple plugs.
•The systems must be grounded correctly to ensure safe