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Cod. 111007EN Rev.E PULSAR ANTERIOR SEGMENT SURGERY SYSTEM INSTALLATION AND OPERATING MANUAL OPTIKON 2000 S.p.A. Via del Casale di Settebagni, 13 - 00138 Rome Italy Phone +39 06 8888355 - Fax. +39 06 8888440 e-mail sales@optikon.com - www.optikon.com...
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OPTIKON 2000 SpA is an ISO 9001 and ISO 13485 certified company which manufactures surgical and diagnostic devices for ophthalmology. Its products are manufactured to satisfy the requirements of 93/42/EEC Medical Devices Directive.
It is responsibility of the user to provide its personnel with a thorough understanding of the equipment operation before use. In no event shall OPTIKON 2000 S.p.A. be liable for any injury, incidental or consequential damages incurred by the purchaser, users or patients as a result of operation of the product.
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OPTIKON 2000 S.p.A. OPTIKON 2000 S.P.A. reserves the right to ascertain, in case of faults, whether or not the equipment and/or its accessories have been altered, tampered with, in any way, or have been damaged by improper use.
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PULSAR Installation and Operating Manual OPTIKON 2000 WARNINGS Care in the handling of PULSAR surgery system is one of the first principles in an operating-room, and no amount of warnings can take place of such care. The following warnings will aid the user to provide adequate safeguards to assure safe, trouble free performance.
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Connect the unit into an outlet on a circuit different from that to which the • other devices are connected. Consult your local distributor or OPTIKON 2000 technical assistance • Environmental • The system should never be used in the presence of flammable anaesthetics, disinfecting agents, cleaning agents, etc., due to possible fires or explosion.
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Renew electrode cables upon evidence of deterioration. • Use only original OPTIKON 2000 S.P.A. diathermy cable • Severe RF burns can result if the diathermy output current is diverted to the operator by careless handling.
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• Use only original OPTIKON 2000 S.P.A. tubing sets. • Do not prime or tune the handpiece while the tip is in the eye of the patient;...
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PULSAR Installation and Operating Manual OPTIKON 2000 • Check that the BSS bottle and the pressurized bag for forced irrigation are placed at or above the patient’s eye level. • Before starting an intervention, ensure that the volume of available irrigation solution is sufficient and monitor it throughout the intervention.
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PULSAR Installation and Operating Manual OPTIKON 2000 7. Connect the air tube to the “AIR” outlet located on the instrument. 8. Reopen the irrigation clamp. • Note: If air bubbles are observed in the infusion set’s line or in the irrigation line, ask the surgeon to activate just irrigation until the bubbles have been expelled, before reinserting the surgical instrument’s tip in the patient’s eye.
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PULSAR Installation and Operating Manual OPTIKON 2000 • All reusable accessories are supplied non sterile. They must be first cleaned, then sterilized in autoclave as indicated on the relevant instructions for use. They could be damaged by the use of other sterilization methods, like hot air or "chemclave"...
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PULSAR Installation and Operating Manual OPTIKON 2000 4 SYMBOLS Table shown below reports some symbols approved by I.E.C. and their meaning. When there is not enough room, they are frequently used on medical equipment to enable an easy and fast communication of information and warnings. Sometimes two or more symbols may be assembled to obtain a special meaning.
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2) Specifications are subject to change without notice. 5.3 CIRCUIT DIAGRAMS OPTIKON 2000 S.p.A. will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user's appropriately qualified technical personnel to repair those parts of equipment which are repairable.
PULSAR Installation and Operating Manual OPTIKON 2000 5.4 EMC TABLES 5.4.1 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Pulsar ESP is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsar ESP should assure that it is used in such an environment.
(>95% dip in U ) for interruptions, and voltage typical commercial or hospital environment. 0.5 cycle 0.5 cycle variations on power supply If the user of the Pulsar2 ESP requires • • 40% U (60% dip in U ) for 5 40% U...
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PULSAR Installation and Operating Manual OPTIKON 2000 NOTE: 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.
PULSAR Installation and Operating Manual OPTIKON 2000 5.5 DIATHERMY POWER CHARACTERISTICS DIATHERMY POWER vs LOAD PULSAR 100 150 200 250 300 350 400 450 500 550 600 650 700 750 Preset=100% Preset=50% Diathermy Power vs load DIATHERMY POWER vs PRESET...
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If external or internal shipping damage is discovered, notify the carrier (mail, railways or forwarding agents) and OPTIKON 2000 as soon as possible. Check the contents against the packing list and notify OPTIKON 2000 immediately of any discrepancies.
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PULSAR Installation and Operating Manual OPTIKON 2000 NOTE: It is the responsibility of the user to clean and sterilize the handpieces, tips, I/A tubing and other microsurgical reusable instruments. 4. Connect the "GAS FILTER" supplied with the unit (Fig.3, No.4) to the rear panel.
PULSAR Installation and Operating Manual OPTIKON 2000 6.4 IRRIGATION / ASPIRATION SYSTEM SET-UP For proper I/A lines setup, follow the procedure outlined below: 1) Insert the I/A cassette in its housing on the plate by aligning the reference line on the cassette with the corresponding line on the plate.
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PULSAR Installation and Operating Manual OPTIKON 2000 6) Rotate the I/A cassette counterclockwise until its reference line is aligned with the corresponding line on the plate. Remove the cassette. Always run the I/A priming procedure before using the ultrasound handpiece. This...
ASPIRATION SYSTEM OPTIKON 2000 S.P.A. PULSAR surgical system delivers aspiration through the action of its dual pump system. The Surgeon can choose between a Peristaltic pump and a Venturi pump depending on the surgery needs and to his preferences.
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PULSAR Installation and Operating Manual OPTIKON 2000 performed with a “closed system”: a sterile membrane in the ACS3 cassette completely separates the vacuum sensor from the sterile fluids. The pumps in the PULSAR are controlled by a powerful microprocessor. Vacuum level can be panel preset or controlled by the surgeon via the system footswitch (linear mode).
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The TIP vibrates longitudinally at high velocity thus enabling a fragmentation of tissue very locally, around tip's contact surface. The OPTIKON 2000 S.P.A. titanium alloy tips can be re-used and have a long life. The internal energy loss processes of the piezo ceramic element leads to a warm up of piezo transducer during high frequency vibration work, therefore the aspirated fluid from the eye is also used for heat dissipating.
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PULSAR Installation and Operating Manual OPTIKON 2000 Pulsed phaco power causes the power to be pulsed at predetermined intervals when the footswitch is in position 3. Within the Pulsed Mode settings the surgeon can also select: • Short Pulse is available in linear or panel power. It generates pulses of U/S power.
PULSAR Installation and Operating Manual OPTIKON 2000 7.2 EQUIPMENT LAYOUT This section contains information on the equipment layout. All operating controls and adjustments are identified and described further on. Sockets and other elements on the front panel are described in Fig. 1 Left side (pump side) of the equipment is described in Figure 2.
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PULSAR Installation and Operating Manual OPTIKON 2000 Left side view (Fig. 2) 1) IRRIGATION VALVE The irrigation line is run in front of this valve. The valve allows starting and stopping irrigation at surgeon’s demand. 2) REFLUX VALVE The Reflux/Venting pinch valve permits introduction of fresh BSS solution in the aspiration line, thus releasing the vacuum in the line and, eventually, reversing direction of flow.
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PULSAR Installation and Operating Manual OPTIKON 2000 Rear panel (fig. 3) 1) COOLING FAN Removes hot air from the unit. 2) CONNECTOR FOR VIDEO OVERLAY This connector makes it possible the connection to the "Eclipse" Video Overlay device, which allows you to superimpose the main parameters on the video shot during surgery.
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This is the discharge valve for the humidity condensed in the gas filter. Gently depress the valve to evacuate water from the filter glass container. 12) I.V. POLE CONNECTOR This connector provides a direct interface to the OPTIKON 2000 S.P.A. AUTOMATIC I.V. POLE. 13) POWER (ON/OFF MAINS SWITCH ASSEMBLY) The power switch is used to switch on/off the unit.
PULSAR Installation and Operating Manual OPTIKON 2000 NOTE: The abbreviations used on the unit and its user interface are defined as follows: CUT RATE = Vitrectomy cutting rate (cuts per minute) DIATH = Bipolar diathermy I/A = Irrigation/Aspiration IRR = Irrigation LINEAR = Linear control mode (Linear footswitch control).
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Installation and Operating Manual OPTIKON 2000 On the screen is permanently visible an Optikon round logo. When the software is running correctly the logo rotates. If it stops then the system is idle. The user should periodically look at the logo to check for the system status. For a better explanation of user interface glossary and layout see figures below.
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PULSAR Installation and Operating Manual OPTIKON 2000 Setup pop-up window Pop-up window for parameters setup When the equipment is switched on, the user interface software is loaded and the Program Screen is displayed (section 8, point 7). Once the appropriate program has been selected and the relevant parameters verified on the configuration table, the user can go to the main function screen by touching the <DONE>...
PULSAR Installation and Operating Manual OPTIKON 2000 7.4 VOICE PROMPTING In an operating room, the console of the unit is often positioned behind the surgeon's shoulders, therefore he cannot take advantage of the LCD monitor to check the status of the machine and to be warned in case of irregular conditions.
PULSAR Installation and Operating Manual OPTIKON 2000 8 EQUIPMENT OPERATION 8.1 BIPOLAR DIATHERMY User Interface • Parameter windows available - Irrigation - Diathermy • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Diathermy parameters - Power % (0–100%)
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PULSAR Installation and Operating Manual OPTIKON 2000 it is always advisable to begin with a low setting (such as 30%) increasing it in case gradually up to obtain desired surgical effect. The bipolar diathermy can operate both in fixed panel power control mode or linear surgeon power control mode.
PULSAR Installation and Operating Manual OPTIKON 2000 8.2 I/A (Irrigation/Aspiration) User Interface • Parameter windows available - Irrigation - Aspiration • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Aspiration parameters - Status (Venturi or Peristaltic) - Vacuum mmHg (5 – 500)
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PULSAR Installation and Operating Manual OPTIKON 2000 6) To change pump mode from Venturi to peristaltic or vice-versa, touch the status button at the top of the aspiration parameter window. NOTE: When changing pump mode, always check that the aspiration parameters are suitable for the type of pump selected before restarting aspiration.
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PULSAR Installation and Operating Manual OPTIKON 2000 The vacuum level is automatically reduced to zero and a simultaneous VENTING occurs whenever the footswitch is released. AUDIBLE ALARM An audible sound of varying frequency indicates vacuum level reached into the collection tank (lower frequency with low vacuum level and higher frequency with high vacuum level).
PULSAR Installation and Operating Manual OPTIKON 2000 8.3 PHACOEMULSIFICATION User Interface • Parameter windows available - Irrigation - Aspiration - Ultrasound • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Aspiration parameters - Status (Venturi or Peristaltic) - Vacuum mmHg (5 – 500)
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PULSAR Installation and Operating Manual OPTIKON 2000 Operation 1) Screw the desired titanium tip into the end of the phaco handpiece, using care to properly engage the threads. Finger tighten the tip. 2) Carefully advance the ring spanner aperture over the titanium tip (being careful not to touch the tip) so that the aperture fully engages the circular head at the base of the tip and positioned against the end of handpiece.
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PULSAR Installation and Operating Manual OPTIKON 2000 CAUTION: Always test the balance between irrigation and aspiration settings by using the test chamber: fill the test chamber with irrigating solution and fit it on the irrigation sleeve. Venturi pump: Place the test chamber to the same level of the patient’s eye and activate aspiration at the levels set for subsequent surgery.
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PULSAR Installation and Operating Manual OPTIKON 2000 A preliminary simple test named Tuning is required whenever a phaco handpiece is plugged in. Tuning ensures that the handpiece has suitable response for the equipment. Tuning is executed automatically executed by the equipment at the end of the priming procedure.
PULSAR Installation and Operating Manual OPTIKON 2000 8.3.1 PROGRAMMABLE EMISSION MODE (P.E.M.) The research in the field of cataract extraction surgery is aimed today to remove the human lens with a less invasive technique. This led to smaller incisions in the 90s and it is leading now to reduce the amount of ultrasound energy needed to emulsify the lens.
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PULSAR Installation and Operating Manual OPTIKON 2000 2) t OFF time off, interval between pulses (0-90 milliseconds). 3) Amplitude, height of the pulses (10-100% of preset power). i.e. leaving amplitude of modulation to “0”, Gate to “off” and defining only the...
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PULSAR Installation and Operating Manual OPTIKON 2000 The Edge defines the phase of the modulating waveform. In the previous example, choice is “RISING”, therefore, when the footswitch goes beyond position #3, the ultrasound starts from 0 amplitude and then rises up to 100% of preset.
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PULSAR Installation and Operating Manual OPTIKON 2000 3) HOLD When in hold state, the gate will allow through unchanged only the bursts in the first half period of modulation. Following bursts will be emitted all at the same amplitude as the end level of the first half period (see below).
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(i.e. U/S2). Each User Program may contain up to three different programmed emission modes (in U/S1, U/S2 and U/S3). Optikon does not suggest any specific ultrasound emission pattern or any specific surgical procedure. This matter falls under direct Surgeon responsibility. 8-14 Cod.
PULSAR Installation and Operating Manual OPTIKON 2000 8.4 VITRECTOMY User Interface • Parameter windows available - Irrigation - Aspiration - Cutter • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Aspiration parameters - Status (Venturi or Peristaltic) - Vacuum mmHg (5 –...
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PULSAR Installation and Operating Manual OPTIKON 2000 mode). Swapping between memories VIT1 and VIT2 can also be achieved by means of the footswitch. For footswitch operation please refer to the relevant section. 1) Attach the IRRIGATION tube from the I/A lines by pushing the end fitting male Luer lock into the corresponding fitting on the semi-disposable scleral guide tubing (female Luer lock).
PULSAR Installation and Operating Manual OPTIKON 2000 11) Depress footswitch beyond standby position to activate irrigation. Irrigation can also be activated by the "CONTINUOUS IRRIGATION" button located on the footswitch or by pressing the <IRR> soft key on the LCD screen.
PULSAR Installation and Operating Manual OPTIKON 2000 In Vitrectomy, Diathermy and Scissors mode (if available), a key in the control allows reaching the maximum bottle height with a single touch. This function is used to increase the intraocular pressure and stop bleeding in case of intraoperative haemorrhage in posterior segment procedures.
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PULSAR Installation and Operating Manual OPTIKON 2000 Single Linear05 NOTE: for correct operation of the equipment, please select a footswitch mode which is compatible to the footswich actually connected to the console. • 112103 Footswitch in “Double Linear05” mode memory...
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PULSAR Installation and Operating Manual OPTIKON 2000 When the main paddle is depressed beyond detent #1, pump is activated, causing aspiration and irrigation to occur simultaneously. Further depression of the paddle will increase aspiration level linearly, if linear control mode is selected on the console.
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PULSAR Installation and Operating Manual OPTIKON 2000 • 112103 Footswitch in “Single Linear05” mode memory only 1-2 or Aspiration 1-2-3 U/S->I/A Cont. Irrigation Vit->Diath Stand by Irrigation Lin. Aspiration Lin. U/S or Diath Reflux As shown in figure, the footswitch consists of a main paddle that can be moved...
PULSAR Installation and Operating Manual OPTIKON 2000 continuous irrigation is activated, aspiration (and, eventually, cutting) starts immediately, as the main paddle is slightly depressed, thus extending the available travel for linear control. In U/S mode, when the main paddle is depressed beyond detent #2 phaco handpiece is activated, further depression of the paddle will increase the phaco tip stroke (if linear control mode is on) or burst rate up to the preset level.
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PULSAR Installation and Operating Manual OPTIKON 2000 In order to create and store a new program or modify the active program, first adjust the various equipment parameters in the relevant Parameters Windows, then touch the Program mode key. The Program screen will appear. To reset all parameter modifications effected on the active program, touch the Undo Changes key on the main function screen.
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PULSAR Installation and Operating Manual OPTIKON 2000 <Ftswtch> Touching this button will cause a window to open, in which it is possible to select the type of footswitch to be used and its configuration. The available functions are indicated for each configuration. Use the arrows to scroll through the various footswitches;...
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PULSAR Installation and Operating Manual OPTIKON 2000 Program keys <Advanced> Touching this button will cause a window to open, in which it is possible to: • Select the language for the warnings, for the error messages, and for the other messages displayed by the PULSAR unit.
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PULSAR Installation and Operating Manual OPTIKON 2000 The virtual keyboard <Delete> Touch this key to permanently delete the program shown in the available programs window. The active program and the ‘Factory Default’ program cannot be deleted. Program select keys By means of the <UP>/<DOWN> keys the user can scroll the available stored programs.
PULSAR Installation and Operating Manual OPTIKON 2000 8.8 SHUT DOWN PROCEDURE NOTE: If the PULSAR surgery system is not being used for an extended period, the following procedure should be observed: 1) Depress "POWER" switch to switch off the control console.
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PULSAR Installation and Operating Manual OPTIKON 2000 9 CLEANING, STERILIZATION AND MAINTAINANCE The medical personnel must take the responsibility to keep existing instruments and equipment functioning properly. The following simple steps serve as practical guidelines in establishing your care and maintenance program.
To maintain optimal performance through the full life of the equipment, a yearly maintainance and calibration program should be established. Please, inquire with your local Optikon Distributor/Service Center. NOTE: To maintain system safety, the compliance to EN60601-1 leakage current limits should be tested at least once a year.
PULSAR Installation and Operating Manual OPTIKON 2000 9.3.2 ACCESSORIES 1) Avoid dropping or mishandling handpieces and accessories. It is critical that these components be handled with outmost care and inspected thoroughly after each use for any damage or wear. 2) Periodically lubricate all external "O" rings on handpieces, cannulas, I/A handpiece, and connectors etc..
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PULSAR Installation and Operating Manual OPTIKON 2000 10 TROUBLESHOOTING 10.1 WARNING AND ERROR MESSAGES The PULSAR console delivers warning and error messages on the LCD to inform the operator of situations which may require special attention. A window pops up in the middle of the LCD giving full explanation of the warning or error, if operation can continue, an OK button appears on the window.
MISCELLANEOUS PROBLEMS The following guide lists some malfunctions which may occur, the symptoms and the corrective actions. If the PULSAR surgery system remains inoperative even after performing the corrective actions indicated below, contact OPTIKON 2000 S.p.A. sales/service department. SYMPTOMS CORRECTIVE ACTION A.C.
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PULSAR Installation and Operating Manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION Irrigation System No irrigation flowing. a) Irrigation pinch valve closed. Check by pressing the footswitch and verify that the irrigation pinch valve opens and BSS solution is available. b) Irrigation tube is disconnected from the handpiece.
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PULSAR Installation and Operating Manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION Priming errors Err 11: Vac offset. Some vacuum is present although aspiration pump has not been activated. a) Priming has been restarted after an Err 13. Open the irrigation clamp and restart priming procedure.
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Defective titanium tip. Replace tip. d) Weak handpiece. Handpiece Piezoceramics normally deteriorate with use and sterilization cycles. Send handpiece to the OPTIKON 2000 S.P.A. Service centre. e) Aspiration level is too low. An insufficient aspiration level may not hold the nucleus fragments properly during emulsification.
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PULSAR Installation and Operating Manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION Footswitch Footswitch does not energise the active a) The PULSAR unit is off, Switch the unit on. equipment section. b) Footswitch is not connected. Connect the footswitch 10-6 Cod. 111007EN...
PULSAR Installation and Operating Manual OPTIKON 2000 11 INDEX ACS3 vacuum sensor Filter outlet Air input Fixed panel power control mode Air output Footswitch connector Aspiration system Footswitch selection 8-13 Audible beep Gas filter Bipolar diathermy Gas inlet BSS bottle 8-3;...
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PULSAR Installation and Operating Manual OPTIKON 2000 Priming procedure Program select keys 8-21 U/S (phaco) socket Pulsed phaco power U/S 1 screen U/S 2 screen UP/DOWN arrow keys 7-9; 8-1 Reflux valve 3-1; 5-1; 7-1; 7-9 User interface Rotating symbol Vacuum level 7-2;...