OPTIKON R-Evo Smart E Manual For Installation And Use
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OPTIKON R-Evo Smart E Manual For Installation And Use

Medical device for ocular surgery
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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

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February 9, 2025

Ideal machine setting for grade 2-3 cataract and hard cataract peristaltic pump, gravity

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Summary of Contents for OPTIKON R-Evo Smart E

  • Page 1 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...
  • Page 2 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.

  • Page 3: Table Of Contents

    INDEX EXCLUSION OF LIABILITY ............1-1 LIMITED WARRANTY CONDITIONS ..........2-2 GENERAL INFORMATION ............3 LEGEND OF SYMBOLS ............... 3 TABLE OF SYMBOLS ................. 4 TARGET GROUP ................6 INTENDED USE ................6 NOTES FOR THE OPERATOR ............... 7 GENERAL SPECIFICATIONS ............... 27 EMC TABLES ................

  • Page 4: Exclusion Of Liability

    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. Cod. 1X10XXEN 2020-09-14 Rev.E...

  • Page 5: Limited Warranty Conditions

    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.

  • Page 6: General Information

    R-evo Smart E/S/CR Installation and use manual 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.

  • Page 7: Table Of Symbols

    R-evo Smart E/S/CR Installation and use manual 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.
  • Page 8 R-evo Smart E/S/CR Installation and use manual 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...

  • Page 9: Target Group

    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...

  • Page 10: Notes For The Operator

    • 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...
  • Page 11 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: –...
  • Page 12 R-evo Smart E/S/CR Installation and use manual 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.
  • Page 13 R-evo Smart E/S/CR Installation and use manual "non-working" label on the device and contact the OPTIKON 2000 S.p.A. technical service. Cod. 1X10XXEN 2020-09-14 Rev.E...
  • Page 14 "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.
  • Page 15 R-evo Smart E/S/CR Installation and use manual • 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. Cod. 1X10XXEN 2020-09-14 Rev.E...
  • Page 16 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.
  • Page 17 • 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. Cod. 1X10XXEN 2020-09-14 Rev.E...
  • Page 18 R-evo Smart E/S/CR Installation and use manual 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.
  • Page 19 Installation and use manual 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.
  • Page 20 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 Cod.
  • Page 21 R-evo Smart E/S/CR Installation and use manual operation. • Equalization of additional potential: The Medical Device must be provided with connectors with earth protection. Cod. 1X10XXEN 2020-09-14 Rev.E...
  • Page 22 Replace the electrode cables as soon as there is any evidence of wear. • Use only OPTIKON 2000 S.p.A. original diathermy cables. • Serious burns from RF (radio frequencies) may occur if the output current of the diathermy system is diverted to the operator due to careless use.
  • Page 23 R-evo Smart E/S/CR Installation and use manual coming out of the appliance during normal use. • Interference may occur with other medical devices due to use of the bipolar diathermy handpiece. Cod. 1X10XXEN 2020-09-14 Rev.E...
  • Page 24 • Use only original OPTIKON 2000 S.p.A. tubing sets. • Do not initialise the handpiece (Priming) when it is in use on the patient's eye, as this could result in patient injury.
  • Page 25 R-evo Smart E/S/CR Installation and use manual • Remove the spike of the infusion set from the bottle, taking care not to touch it with your hands or any other unsterile material. • Insert the spike of the infusion set into the cap of the new bottle and hook it onto the IV pole.
  • Page 26 R-evo Smart E/S/CR Installation and use manual Ultrasound application WARNING Risk of injury to the patient's eye! Do not check the operation or the vibration of the phaco tip by touching it with the fingers: Prolonged exposure or direct contact with the vibrating tip may cause tissue damage.
  • Page 27 R-evo Smart E/S/CR Installation and use manual endothelial damage. Contact your dealer or the technical service of OPTIKON 2000 S.p.A. • Never press the tip or silicone sleeve against the wound to prevent the phaco tip from overheating. • Unwanted increases in output power may indicate a malfunction of the R-Evo Smart Surgical Medical Device.
  • Page 28 R-evo Smart E/S/CR Installation and use manual Vitrectomy applications • Never activate the vitrectomy handpiece with the blade in the air. The vitrectome must always be tested with the blade in a sterile solution container. The test carried out in the air will cause irreparable damage to the cutting system.
  • Page 29 Consult the OPTIKON 2000 S.p.A. Technical Service. • To avoid possible eye infections, only use original OPTIKON 2000 S.p.A. air tamponade tubes with an air sterilisation filter. • The use of a non-standard air-tamponade tubing kit could compromise the accuracy of intraocular pressure and alter the sterility of the injected air.

  • Page 30: General Specifications

    SPECIFICATION Manufacturer: ...... OPTIKON 2000 S.p.A. via del Casale di Settebagni, 13 00138 Rome - Italy Model:........ R-Evo Smart E/R-Evo Smart S/R-Evo Smart CR Compliance with regulations: ... 93/42/EEC Medical Device Directive (MDD) Technical standards: ..... EN60601-1; EN60601-1-2; EN60601-2-2 EN80601-2-58 ENVIRONMENTAL SPECIFICATIONS Storage and transport: ....
  • Page 31 Port size: ......0.5mm Operating Modes: ....pressurized air from an external source (R-Evo Smart S and CR) or integrated dry compressor (R-Evo Smart E) Operating pressure: ....from 2.6 bar Linear cutting mode: ....linear cut rate from 0 to preset controlled via system pedal Control: ......
  • Page 32 R-evo Smart E/S/CR Installation and use manual PARAMETERS SPECIFICATION Operating frequency: ..... 2 MHz Rated power: ....... 9W (200 Ohm LOAD) Maximum voltage without load: . 100 V Default power: ..... user programmable Available power: ....from 5 to 100% (percent) Linear mode: .......
  • Page 33 R-evo Smart E/S/CR Installation and use manual PARAMETERS SPECIFICATION CLASSIFICATION OF THE EQUIPMENT ACCORDING TO THE IEC 60601-1 STANDARD Type of protection against electric shock: ...... Class I Degree of protection against electric shock: Diathermy: ......Type BF, floating at high and low frequencies U/S: ........

  • Page 34: Emc Tables

    R-evo Smart E/S/CR Installation and use manual 3.7 EMC TABLES ELECTROMAGNETIC EMISSIONS The emissions of this device make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If used in a residential environment (for which CISPR 11 Class B is normally required) this device may not provide adequate protection for radio-frequency communication services.
  • Page 35 R-evo Smart E/S/CR Installation and use manual ELECTROMAGNETIC IMMUNITY GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The R-Evo Smart systems are intended for use in the electromagnetic environments specified below. The customer or the user of the R-Evo Smart must ensure that it is used in such an environment.
  • Page 36 R-evo Smart E/S/CR Installation and use manual GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The R-Evo Smart systems are intended for use in the electromagnetic environment specified below. The customer or the user of the R-Evo Smart should assure that it is used in such an environment.
  • Page 37 R-evo Smart E/S/CR Installation and use manual The R-Evo Smart intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the R-Evo Smart can help prevent electromagnetic interference by maintaining a minimum distance between...

  • Page 38: Power Characteristics In Diathermy Applications

    3.8 POWER CHARACTERISTICS IN DIATHERMY APPLICATIONS DIATHERMY POWER vs LOAD 3.9 CIRCUIT DIAGRAMS On request, OPTIKON 2000 S.p.A. provides wiring diagrams, parts lists, descriptions, calibration instructions or other information to help the operator's trained technical personnel repair the repairable parts of the equipment.

  • Page 39: Installation And Operation

    Risk of injury to the patient's eye! The Medical Device must be installed by the technical service of OPTIKON 2000 S.p.A. or by an expert authorized by it. Ensure that the following requirements are met for the entire duration of operation: •...
  • Page 40 R-evo Smart E/S/CR Installation and use manual the instrument to the equipotential connector of the operating room using an equipotential bonding cable. If necessary, have a second ground reference in the event of a malfunction of the main earth plug.
  • Page 41 R-evo Smart E/S/CR Installation and use manual Responsibility and guarantee The warranty and the liability depend on the applicable contractual stipulations. INFORMATION Loss of warranty rights No changes must be made to the Medical Device. The manufacturer is not responsible for damage caused by tampering with the device by unauthorized persons.

  • Page 42: Description Of The Device

    These optional accessories are provided by OPTIKON 2000 S.p.A. 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.
  • Page 43 Depending on the surgical needs or preferences, the surgeon can select a flow pump (peristaltic) or a vacuum pump (Venturi). The R-Evo Smart E has only a peristaltic pump. The I/A cassette is housed on the pump plate on the side of the machine.
  • Page 44 R-evo Smart E/S/CR Installation and use manual The tissues are cut and aspirated simultaneously, thanks to the reciprocal longitudinal action of the inner tube, generated by pneumatic impulses coming from the surgical system. The extremely close distance between the outer and inner tubes creates a slight constant tension that provides a self- sharpening effect.
  • Page 45 The syringe is activated by compressed air which is controlled linearly by the foot switch. Phacoemulsification The piezoelectric handpiece made by OPTIKON 2000 S.p.A. can be connected to the phaco socket. The handpiece contains a piezo transducer that oscillates at a frequency of 40 KHz (+4.5 kHz/-1 kHz) with an amplitude of about...
  • Page 46 R-evo Smart E/S/CR Installation and use manual – The PHACO TIP that vibrates longitudinally and therefore facilitates the fragmentation of the tissue in a circumscribed area about the contact surface between the tip and the cataract. The maximum number of re- uses of the tips are described in the Instructions for Use enclosed with the tips.
  • Page 47 R-evo Smart E/S/CR Installation and use manual passing position 2. The surgeon can select the following settings in pulse mode: – "Pulsed" mode: ultrasound is available both in panel mode and in linear mode. Ultrasonic pulses are generated, the pulse repetition rate can be adjusted between 1 and 100Hz.

  • Page 48: Medical Device Components

    The instrument tray allows the surgeon or nurse to prepare the surgical set and the necessary accessories. The tray is connected to an articulated arm. For a sterile use, OPTIKON 2000 S.p.A. provides a disposable cover sheet. If the instrument tray is not used, it can be stored in its housing.
  • Page 49 R-evo Smart E/S/CR Installation and use manual • Press the locking tab down to lock the wheel. • Turn the locking tab upward to unlock the wheel. 5 Irrigation pole with bottle holder The computer controlled electric pole allows moving to the memorized height the balanced salt solution container during procedures involving gravity irrigation.

  • Page 50: Front Panel Connectors And Control Elements (Cr)

    R-evo Smart E/S/CR Installation and use manual 4.2.2 Front panel connectors and control elements (CR) 1 US socket (Phaco) The connector of the phaco handpiece connects to this socket 2 Vitrectomy socket The connector of the vitrectomy handpiece connects to this socket.

  • Page 51: Front Panel Connectors And Control Elements (E And S)

    R-evo Smart E/S/CR Installation and use manual 4.2.3 Front panel connectors and control elements (E and S) 1 US socket (Phaco) The connector of the phaco handpiece connects to this socket 2 Vitrectomy socket The connector of the vitrectomy handpiece connects to this socket.

  • Page 52: Back Panel Connectors And Control Elements

    R-evo Smart E/S/CR Installation and use manual 4.2.4 Back panel connectors and control elements USB connectors A USB pendrive for updating software or for importing/exporting user programs can be connected to these sockets. Ventilation grid Air inlet of the internal ventilation system of the instrument. When placing the instrument in the operating room, be careful not to obstruct the ventilation grid.

  • Page 53: Side View

    R-evo Smart E/S/CR Installation and use manual Air inlet socket Input for the external compressed air for the Venturi pump, the vitrectomy handpiece and the silicone oil injection (only R-Evo Smart). The air pressure must be 500 to 800kPa. The available flow must be at least 32Nl/min.

  • Page 54: System Pedal

    R-evo Smart E/S/CR Installation and use manual 4.2.6 System pedal The pedal for surgical equipment allows the surgeon to activate the selected function on the device he is using. The "On/Off" functions are activated with the side buttons, while the linear functions are activated with the central paddle.
  • Page 55 R-evo Smart E/S/CR Installation and use manual Tactile position 1 Zone B is located between the first tactile position and the second tactile position. Tactile position 2 Zone C is located between the second tactile position and the stop limit.

  • Page 56: Tactile Screen And User Interface

    R-evo Smart E/S/CR Installation and use manual 4.2.7 TACTILE SCREEN AND USER INTERFACE R-Evo Smart systems are equipped with an interactive touch screen and LCD (liquid crystal display). The user interface consist of a graphic software that works on the Linux platform and simulates the various keys and displays.
  • Page 57 R-evo Smart E/S/CR Installation and use manual To set the status or value of parameters that are changed less frequently, such as linear or panel control (fixed) or emission mode, the user touches the "Ultrasound" button located at the top of the window.
  • Page 58 R-evo Smart E/S/CR Installation and use manual 6. Save as button... It allows to save the current configuration as a new user program. 7. Alarm button/indicator. Pressing this button displays a list of currently active alarms on the screen. The...
  • Page 59 All 1xx and 2xx errors are automatically inserted into the system memory and are accessible via the Service mode by OPTIKON 2000 S.p.A. technical service personnel. For more information on using the graphical user interface, refer to the description of the use of individual device functions.

  • Page 60: Installation Procedure

    • Open the packaging and examine the components for damage. When cutting the packaging material, be careful not to damage the contents. The R-Evo Smart E REF 111009 (S 111010) (CR 121012) consists of the following parts: Code DESCRIPTION 111009 Console R-Evo Smart E;...
  • Page 61 R-evo Smart E/S/CR Installation and use manual systems. Training is provided by OPTIKON 2000 S.p.A. Consult your OPTIKON 2000 S.p.A. technical service for more detailed information. It is the user's responsibility to clean and sterilize the handpieces, tips and any other reusable microsurgical accessory.
  • Page 62 R-evo Smart E/S/CR Installation and use manual – If one of the locking tabs is pressed: The trolley can be placed easily and effortlessly, in any orientation, in the surgical room near the operating table. All– Locking tabs have been pressed in: The tool carrier is secured in place and avoids any movement.
  • Page 63 R-evo Smart E/S/CR Installation and use manual Preparation for sterile operations CAUTION Risk of infection! The patient or user may become infected if the accessories lose their sterility. • Place sterile accessories on the instrument tray covered by the sterile drape supplied or, however, on a secure surface to prevent accidental drops.
  • Page 64 WARNING Risk of injury to the patient's eye! • An audible air leak at start-up may indicate a malfunction of the silicone section. Contact your dealer or the technical service of OPTIKON 2000 S.p.A. CAUTION Functional test • The software checks the validity of the calibration at power on.

  • Page 65: Installation Of The I/A Cassette

    R-evo Smart E/S/CR Installation and use manual During subsequent accesses, the system also shows any new user and program added, the interface will be in the chosen language. Installation of the I/A cassette 4.3.2 For a correct installation of the cassette, proceed as follows: •...
  • Page 66 R-evo Smart E/S/CR Installation and use manual • Rotate the I/A cassette counter-clockwise until its reference line and the corresponding point on the pump panel are aligned. • Remove the I/A cassette. Cod. 1X10XXEN 2020-09-14 Rev.E...

  • Page 67: Installation Of Phaco Accessories

    R-evo Smart E/S/CR Installation and use manual 4.3.3 Installation of phaco accessories CAUTION Risk of injury to the patient's eye! If the "priming" is done while the tip is used on the patient, this could cause serious damage to the patient's ocular structure.
  • Page 68 R-evo Smart E/S/CR Installation and use manual Connection of irrigation/aspiration tubings • To connect the aspiration tube of the irrigation/aspiration tube assembly, insert the end of the female connector into the corresponding male connector of the phaco handpiece and tighten while pressing and turning slightly.

  • Page 69: User's Programs

    R-evo Smart E/S/CR Installation and use manual 4.4 USER'S PROGRAMS Configuring programs for users All predefined parameters of the R-EVO SMART can be adapted to the user's individual needs. The parameters thus set are saved to be reused later in programs and assigned to users.
  • Page 70 R-evo Smart E/S/CR Installation and use manual Save the program for an existing user • Press the "Select user" button. Existing users are displayed in a call pop-up window. • Select one of these users and press the "OK" button.
  • Page 71 R-evo Smart E/S/CR Installation and use manual Program editing • Adjust the different parameters of the medical device in cataract or retina mode. • The "Cancel" button is activated to indicate that a program has been changed. If you press the "Cancel"...
  • Page 72 R-evo Smart E/S/CR Installation and use manual Cancellation of a program • Select the program you want to delete. • The button with the name of the active program is in green. Press the "Delete" button to delete the active program (after confirmation).

  • Page 73: Operation

    R-evo Smart E/S/CR Installation and use manual 4.5 OPERATION 4.5.1 Irrigation/Aspiration Installation of irrigation and aspiration tubings and I/A cassette • For information on installing the irrigation and aspiration tubings and the I/A cassette, refer to the relevant chapter. Connection of tubings and handpiece •...
  • Page 74 R-evo Smart E/S/CR Installation and use manual CAUTION Risk of injury to the patient's eye! • When switching from the peristaltic pump to the Venturi or rotary pump during surgery without changing settings, there is a Risk of injury to the patient.
  • Page 75 R-evo Smart E/S/CR Installation and use manual • Start with low vacuum safety settings and gradually increase them to determine the correct vacuum and height settings for the IV pole, making sure the anterior chamber is stable. The set flow values (only for the peristaltic pump) and the vacuum level can be adjusted using the + - keys or the cursor.
  • Page 76 R-evo Smart E/S/CR Installation and use manual Irrigation settings • Set the height of the IV pole according to the vacuum settings and the connected tip, in order to maintain an adequate balance of the liquids. • Activate irrigation by pressing the foot switch beyond its standby position.

  • Page 77: Phacoemulsification

    R-evo Smart E/S/CR Installation and use manual 4.5.2 Phacoemulsification If the message "Connect handpiece" is displayed on the screen, this means that the handpiece is not connected or is not recognized by the machine. Preparation and test ("Priming") The message "Please, prime" indicates that the "Priming"...
  • Page 78 R-evo Smart E/S/CR Installation and use manual Ultrasound Test (Ultrasound adjustment and verification) Every time a handpiece is connected or replaced, it is necessary to perform a simple preliminary ultrasound test. The purpose of this procedure is to tune the...
  • Page 79 R-evo Smart E/S/CR Installation and use manual In Ultrasound mode, in addition to the irrigation and aspiration parameters described in the previous section, it is possible to adjust the ultrasound mode and emission level. Ultrasound can be emitted in Continuous, Pulsed modes (with three duty cycle levels, called "STD,"Cold"and "Ice cold "), Single Burst, Multiple Burst, Continuous...

  • Page 80: Bipolar Endothermy For Retinal Surgery

    R-evo Smart E/S/CR Installation and use manual Basic settings for retina modes 4.5.3 Bipolar endothermy for retinal surgery Connection of accessories • Connect the desired endothermy handpiece, such as, for example, the diathermy pencil eraser, to the bipolar diathermy cord.
  • Page 81 R-evo Smart E/S/CR Installation and use manual Bipolar diathermy can be activated in both "Panel" and "Linear" control modes. In the last case, the output power is linearly controlled from 5% to the preset limit, by pressing the pedal. • To switch between "linear" and "panel" modes, touch the "Linear"...

  • Page 82: Vitrectomy

    R-evo Smart E/S/CR Installation and use manual 4.5.4 Vitrectomy Risk of injury to the patient's eye! WARNING If the vitrectomy handpiece is not connected properly, non-sterile air may enter the patient's eye. • Before placing it in the patient's eye, the vitrectomy handpiece must always be tested for proper functioning in a sterile solution container.

  • Page 83: Illumination

    R-evo Smart E/S/CR Installation and use manual Touching the "Vitrectomy" button accesses the vitrectome settings. It is possible to choose the rest position (pedal not pressed) of the cutting port between "port open" and "port closed". The duty cycle of the vitrectome can be set to one of three levels ("Low", "Medium", "High").

  • Page 84: Tamponade

    4.5.6 Tamponade WARNING Risk of injury to the patient's eye! • To avoid possible infection of the patient's eye, only use the original OPTIKON 2000 S.p.A. injection tube equipped with an air sterilisation filter for air tamponade. CAUTION Risk of injury to the patient! •...
  • Page 85 R-evo Smart E/S/CR Installation and use manual • The silicone stop valve is checked during power on test. Make sure there is no hissing when turning the device on. CAUTION Risk of injury to the patient's eye! • During the injection of silicone oil, the intraocular...

  • Page 86: Pedal Programming

    R-evo Smart E/S/CR Installation and use manual 4.5.7 Pedal programming Press "Maintenance" to access the pedal programming graphical interface. Through this interface the user can customise the various pedal functions. a. If the user presses one of the four side buttons (1) or one of the side...
  • Page 87 R-evo Smart E/S/CR Installation and use manual Please note that not all functions can be associated with every button or movement of the paddle. The disabled functions are greyed out. b. The label (3) shows the functions associated with the vertical movement of the main paddle (in the example, U/S, cutting and aspiration).

  • Page 88: System Alarm Messages

    • In case of error messages indicated by a warning signal, contact the OPTIKON 2000 S.p.A. technical service. • Take note of the explanations offered for each of the error messages on the following pages.
  • Page 89 R-evo Smart E/S/CR Installation and use manual "Vacuum level error" The vacuum exceeds the Contact the technical preset value in Venturi service of OPTIKON mode 2000 S.p.A. "Invalid diathermy Fault in the diathermy Contact the technical power" system (the output power...
  • Page 90 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement "Diathermy enabling Fault in the diathermy Contact the error" system (the output power technical service of is not activated even OPTIKON 2000 S.p.A. though the opposite is shown, due to an error in...
  • Page 91 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement "No irrigation" Error during preparation: Open the infusion The vacuum does not clamp on the decrease after opening infusion unit, briefly the venting valve. open the continuous irrigation and restart the preparation procedure.
  • Page 92 R-evo Smart E/S/CR Installation and use manual 300 Error messages Message Possible cause Correction measurement "Install the I/A The I/A cassette is not Connect the I/A cassette" connected cassette "I/A cassette full, The I/A cassette Replace the I/A aspiration stopped"...
  • Page 93 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement d) The pump system must be recalibrated, contact the OPTIKON 2000 S.p.A. technical service. "Aspiration line Error during preparation a) The handpiece and occluded" (Priming): the vacuum tip have not been...
  • Page 94 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement c) the phaco handpiece is damaged. Replace the phaco handpiece "Weak phaco The phaco handpiece can a) Check to see if the handpiece" not oscillate to more than phaco tip is loose, and 50 micrometres.
  • Page 95 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement cycles. Return the handpiece to the OPTIKON 2000 S.p.A. technical service. Insert U/S handpiece The U/S handpiece is not Connect the U/S connected to the unit handpiece to the unit.
  • Page 96 R-evo Smart E/S/CR Installation and use manual Message Possible cause Correction measurement Stop priming During the priming See "5.4.3 Installing procedure the user the phaco presses the pedal accessories". Cod. 1X10XXEN 2020-09-14 Rev.E...

  • Page 97: Care And Maintenance

    R-evo Smart E/S/CR Installation and use manual 6. Care and maintenance 6.1 MAINTENANCE OF THE DEVICE Replacing fuses The fuses of the control unit are located in the mains socket on the back of the unit. To replace the fuse,...
  • Page 98 EN 60601-1 standard at least once a year. Contact the medtech division of your installation, your authorized distributor or the OPTIKON 2000 S.p.A. technical service. • Store the R-EVO SMART in a dry and clean place.

  • Page 99: Maintenance Of Accessories

    R-evo Smart E/S/CR Installation and use manual 6.2 MAINTENANCE OF ACCESSORIES CAUTION Risk of injury to the patient or the user! Wet surfaces may cause electric shocks, as they are conductive to RF currents. • Make sure that the diathermy handpiece is completely dry before using it.

  • Page 100: Care Of The Device

    R-evo Smart E/S/CR Installation and use manual 6.3 CARE OF THE DEVICE Cleaning The medical staff is responsible for the maintenance of the medical device and all the equipment in optimal operating conditions. The simple steps described below are a practical guideline to define a suitable maintenance and care program.

  • Page 101: Accessories

    R-evo Smart E/S/CR Installation and use manual 7. ACCESSORIES This section lists accessories, spare parts and consumables for the R-Evo Smart provided by the OPTIKON 2000 S.p.A. Consult the zone distribution and site www.optikon.com for detailed information on the individual products.
  • Page 102 20G Vitrectomy probe, with irrigation sleeve 20, 23, 25G Vitrectomy probes, without irrigation sleeve Procedural packages for R-Evo Smart OPTIKON 2000 S.p.A. provides customizable procedural packages for Vitrectomy and for Phacoemulsification. The procedural packages consist of accessory assemblies that appear in the previous tables.

This manual is also suitable for:

R-evo smart sR-evo smart cr

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