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- Page 1 Cod.111001EN 2012-02-16 Rev. J PULSAR MS ANTERIOR SEGMENT SURGERY SYSTEM INSTALLATION AND OPERATING MANUAL OPTIKON 2000 S.p.A. Via del Casale di Settebagni 13 - 00138 Rome – Italy Tel. +39 06 8888355 – Fax. +39 06 8888440 e-mail sales@optikon.com www.optikon.com...
- Page 2 OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company that manufactures 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.
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Page 3: Table Of Contents
TABLE OF CONTENTS Page DISCLAIMER ................1-1 LIMITED WARRANTY CONDITIONS ......... 2-1 WARNINGS ................. 3-1 SYMBOLS ................... 4-1 GENERAL INFORMATION ............5-1 SYSTEM DESCRIPTION ......................5-1 TECHNICAL SPECIFICATIONS ..................... 5-2 CIRCUIT DIAGRAMS ......................5-5 EMC TABLES .......................... 5-5 5.4.1 ELECTROMAGNETIC EMISSIONS................5-5 5.4.2 ELECTROMAGNETIC IMMUNITY ................. - Page 4 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...
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Page 5: Disclaimer
Fax. +39 06 8888440 e-mail sales@optikon.com 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. Cod. 111001EN 2012-02-16 Rev.J... - Page 6 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Cod. 111001EN 2012-02-16 Rev.J...
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Page 7: Limited Warranty Conditions
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. - Page 8 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Cod. 111001EN 2012-02-16 Rev.J...
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Page 9: Warnings
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 WARNINGS Care in the handling of PULSAR surgical system constitutes one of the basic operating room principles which should always be adhered to, and no list of warnings can replace such care. - Page 10 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 warnings • The system should never be used in the presence of flammable anaesthetics, disinfecting agents, cleaning agents, etc., due to possible fires or explosion.
- Page 11 Renew electrode cables upon evidence of deterioration. • Use only original OPTIKON 2000 S.p.A diathermy cables. • Severe RF burns can result if the diathermy output current is diverted to the operator by careless handling.
- Page 12 • Correct set-up of irrigation and aspiration lines is critical to ensure proper operation of the PULSAR unit. • 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;...
- Page 13 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 • Before starting an intervention, ensure that the volume of available irrigation solution is sufficient and monitor it throughout the intervention. • Make sure that the quantity of aspirated fluids does not exceed the maximum capacity of the collection bag, as this may result in an hazardous situation to the patient or the operators.
- Page 14 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 • Always use the lowest ultrasonic output power level which is compatible to the surgical application. • The phaco handpiece must be connected to the PULSAR irrigation/aspiration system and must not be used without it.
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Page 15: Symbols
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 SYMBOLS Table shown below reports some I.E.C. approved symbols and their meanings. In the absence of sufficient space, these symbols are often used on medical instruments to enable quick and simple communication of information and warnings. - Page 16 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Cod. 111001EN 2012-02-16 Rev.J...
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Page 17: General Information
All microsurgical handpieces are ergonomically designed for comfort in use and maximum manual dexterity. Custom option and variety of accessories allow tailoring “OPTIKON PULSAR” to your specific needs. Clear audio/visual alerts indicate situations requiring attention, plus ensuring patient safety. -
Page 18: Technical Specifications
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 5.2 TECHNICAL SPECIFICATIONS PARAMETER SPECIFICATIONS Manufacturer ......OPTIKON 2000 S.p.A. via del Casale di Settebagni, 13 00138 Rome - Italy Model: ........ PULSAR Minimal Stress Regulatory conformity: .... 93/42/EEC Directive on medical devices Technical standards: .... - Page 19 DIATHERMY power via system footswitch depression Handpiece type: ....Bipolar microforceps, slim stat pencil eraser, intraocular diathermy handpieces Diathermy cable: ....Two poles, 26 gauges, 75 ohm, steam autoclavable. Use only original OPTIKON 2000 SpA diathermy cable Control: ......System footswitch Cod. 111001EN 2012-02-16 Rev.J...
- Page 20 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 PARAMETER SPECIFICATIONS PHACOEMULSIFIER Handpiece type: ....piezoelectric Frequency ......Approx 40 KHz Tip stroke: ......From 0 to 100 µm Power: ....... Panel or linear control of the U/S power via system footswitch depression U/S Mode: ......
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Page 21: Circuit Diagrams
5.4.1 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Pulsar MS is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsar MS should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment –... -
Page 22: Electromagnetic Immunity
5.4.2 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Pulsar MS is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsar MS should assure that it is used in such an environment. Immunity test... - Page 23 5.4.3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND PULSAR MS Pulsar MS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Pulsar MS can help preventing...
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Page 24: Diathermy Power Characteristics
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 5.5 DIATHERMY POWER CHARACTERISTICS PULSAR DIATHERMY POWER vs LOAD Preset=100% Preset=50% Diathermy power vs load DIATHERMY POWER vs PRESET PULSAR Percent Load=450 Ohm -{}- Diathermy power vs preset Cod. 111001EN 2012-02-16 Rev.J... -
Page 25: Installation And Maintenance
If the package or contents are damaged, notify the carrier (post office, railway or shipping agent) and Optikon 2000 as soon as possible. Check that the contents correspond to those indicated on the attached shipping documents. -
Page 26: Irrigation/Aspiration System Set-Up
PULSAR Minimal Stress 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. Check that the mains voltage corresponds to the one indicated on the rear panel. - Page 27 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 2) Gently stretch the supplied irrigation tube and insert through the perpendicular intake port down into the side slot of the irrigation pinch valve. 3) Slightly flatten the reflux tube and insert it into reflux pinch valve.
- Page 28 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Always run the I/A priming procedure before using the ultrasound handpiece. This procedure will test correct installation and operation of the I/A tubing pack and it will prime the line with fluids, thus avoiding possible malfunctions and injury to the patient.
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Page 29: Equipment Operation
The PULSAR can control an automatic electric I.V. pole that provides adjustment of the irrigation source height. ASPIRATION SYSTEM The OPTIKON 2000 PULSAR surgery system delivers aspiration through the action of its peristaltic pump. Fluids and particulate materials are aspirated at the distal end of the tip and subsequently deposited in a collection bag of the disposable or reusable circuit. - Page 30 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 negative pressure is read with a "closed system": a sterile membrane in the ACS3 cassette completely separates the negative pressure sensor from the sterile fluids. The PULSAR unit's pump is controlled by a powerful microprocessor. The vacuum level can be preset from the control panel or checked by the surgeon by means of the footswitch (linear method).
- Page 31 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.
- Page 32 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Continuous phaco power provides continuous uninterrupted phaco power to the handpiece and requires no pulse rate settings. 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:.
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Page 33: Equipment Layout
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 7.2 EQUIPMENT LAYOUT This section contains information on the configuration of the apparatus. 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 fig. - Page 34 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 5) VITRECTOMY SOCKET The activation line of the vitrectomy handpiece cable plugs into this socket. Left side view (Fig. 2) 1) IRRIGATION PINCH VALVE The irrigation line is run through this valve. The valve allows starting and stopping irrigation at surgeon’s demand.
- Page 35 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 5) COLLECTION BAG SUPPORTS These two brackets support and hold in place the collection bag at the end of the aspiration path. Rear panel (fig. 3) 1) COOLING FAN Removes hot air from the unit.
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Page 36: User Interface
This is the system footswitch connector socket. Footswitch depression activates the PULSAR functions. 6) I.V. POLE CONNECTOR This connector provides a direct interface to the OPTIKON 2000 SpA automatic I.V. pole. 7) POWER (ON/OFF MAINS SWITCH GROUP) The main switch turns the unit on/off. The mains fuses and the mains power cord socket are located on this switch. - Page 37 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 screen in the appropriate areas. The seven-section display to the right of the front panel shows the height of the I.V. pole. If a sterile cloth is placed on the monitor, the unit can be activated by a sterile instrument nurse.
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Page 38: Voice Prompting
181004 is connected. The <UP> and <DOWN> arrow keys raise and lower the bottle. NOTE: The knob located under the front panel of the Pulsar MS can be used to adjust the brightness of the display. 7.4 VOICE PROMPTING... -
Page 39: Equipment Operation
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 8. EQUIPMENT OPERATION 8.1 BIPOLAR DIATHERMY User Interface Parameter windows available - Power • Irrigation parameters - Status IRR (ON/OFF) - I.V. Pole height • Diathermy parameters - Power % (0–100%) - Page 40 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 NOTE: Adjusting a parameter will not undo the default parameters. To recall the default parameters or to permanently store the new settings in the machine memory, see paragraph "8.7. TO RECALL OR STORE A PROGRAM".
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Page 41: I/A (Irrigation/Aspiration)
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 8.2 I/A (IRRIGATION/ASPIRATION) User Interface • Parameter windows available - FLOW (aspiration flow) - VAC (limit vacuum) • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Aspiration parameters - Vacuum mmHg (5 – 500) - Page 42 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 7) The set values of flow and vacuum level can be adjusted by means of the <UP> and <DOWN> arrow keys next to the corresponding windows; for both sizes it is possible to have the set control panel mode (PANEL) or the linear surgical control mode (LINEAR).
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Page 43: Phacoemulsification
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 8.3 PHACOEMULSIFICATION User Interface • Parameter windows available - FLOW (aspiration flow) - VAC (limit vacuum) - POWER (U/S energy) • Irrigation parameters - Status (ON/OFF) - I.V. Pole height •... - Page 44 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Operation When the <U/S> key is pressed to select the ultrasound mode, the voice synthesizer will announce "US 1." The ultrasound window will display the emission mode (continuous, burst, or pulse), the phacoemulsifier timer, the EPT time, and the timer reset (TIMER RESET).
- Page 45 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 10) Adjust the flow rate of the PULSAR unit in the FLOW window according to the operator needs. 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.
- Page 46 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 key <E> for the ultrasound power <POWER CONTROL>. To return to the standard U/S mode once the parameters have been set, you simply need to press the <DONE> key. 16) To reset the timer, touch the <A> key corresponding to the <TIMER RESET> field 17) Excessive diathermy for the level of power selected could indicate a fault.
- Page 47 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 CAUTION Although the PULSAR is equipped with the Minimal Stress circuitry to limit the amount of ultrasound energy delivered to the eye, still some care must be taken to avoid damages (corneal burns) to the endothelium of the eye.
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Page 48: Vitrectomy
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 8.4 VITRECTOMY User Interface • Parameter windows available - FLOW (aspiration flow) - VAC (limit vacuum) - Cut rate • Irrigation parameters - Status (ON/OFF) - I.V. Pole height • Aspiration parameters - Vacuum mmHg (5 –... - Page 49 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 6) If it is desired to operate in the closed tip mode, touch the <A> key until the message <CLOSE TIP> appears. Press <A> again to return to the open tip mode.
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Page 50: Automatic I.v. Pole
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 a. Semi-disposable vitrectome 123001 is reusable and autoclavable approximately 10 times. b. Changing a parameter will not undo the default parameters. To recall the default parameters or to permanently store the new settings in the machine memory, see paragraph "8.7. TO RECALL OR STORE A PROGRAM". -
Page 51: Footswitch
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 8.6 FOOTSWITCH A SPLASH-PROOF footswitch allows the surgeon to control various modes of instrument operation. The footswitch connects to the rear panel of the control console (Fig.3, No.5). The PULSAR unit can be programmed to use the footswitch 112101. The footswitch can be used in a single or double linear (for right-handed and left-handed people), MMP, and IVP modes. - Page 52 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 NOTE: For the correct functioning of the unit select the pedal control mode that is compatible with the pedal that is effectively attached to the control panel. • FOOTSWITCH 112101 USED IN DOUBLE LINEAR MODE (“DBLE. LIN.”)
- Page 53 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 When the main pedal is pressed beyond the second mechanical detent (MECH. DETENT 2), diathermy, if selected, will be activated. If the linear control mode was selected, a further press on the main pedal will increase the level of diathermy emission.
- Page 54 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 • FOOTSWITCH 112101 USED IN SINGLE LINEAR MODE (SING. LIN.) As can be seen in the figure, the pedal unit consists of a main pedal that can be moved vertically and/or horizontally and three separate controls that activate CONTINUOUS IRRIGATION, switching between "MMP 1-2"...
- Page 55 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 activated, ultrasound will be activated as soon as the pedal has been pressed beyond the first detent; this will extend the available travel for linear control. In the U/S mode, if both aspiration and phacoemulsifier have been set in the linear mode, the power level of aspiration and ultrasound will gradually increase by pressing the pedal until it is completely pressed down.
- Page 56 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 • FOOTSWITCH 112101 USED IN SINGLE LINEAR MODE (SING. LIN.) In the "IVP" mode (refer to section 8.7) the footswitch button located above and to the left raises the I.V. pole and the button located below and to the left lowers the I.V.
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Page 57: To Recall Or Store A Program
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 saline solution to enter the aspiration line. The unit will emit a low audible signal (800 Hz). Pressing the main pedal beyond stop 2 activates DIATHERMY, if it has been selected. - Page 58 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 program has been modified. Then touch the <PROG> Program mode button. The Programs screen will appear and will display the active program and the asterisk next to it which indicates that it has been modified.
- Page 59 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Exit without saving Next/previous cursor Character position selection SAVE AS box Set the name using the <UP> arrow keys next to the "CHAR" and "NEXT/PREV." windows. The "CHAR" key allows you to change the letter and the "NEXT/PREV." key allows you to advance to the next letter.
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Page 60: Shutdown Procedure
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 (below). An asterisk will appear in ACT. PROG. to indicate that the program has been modified. Press "SAVE" key <A> to permanently save the modification. 8.8 SHUTDOWN PROCEDURE NOTE: If the Pulsar surgical system is not used for an extended period, follow the procedure described below. -
Page 61: Cleaning, Sterilization And Maintenance
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 CLEANING, STERILIZATION AND MAINTENANCE The medical personnel are responsible for keeping the instruments and equipment in the best operating conditions. The simple steps described below constitute a practical guideline for defining a suitable care and maintenance program. -
Page 62: Reusable Accessories
To keep the system safe, check the unit’s conformity with electric current leakage limits according to standard EN60601-1 at least once a year. Contact the bioengineering division of your facility or your Optikon 2000 authorised distributor/service centre. 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. - Page 63 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 CAUTION 1) Do not use synthetic detergents or oil-based soaps 2) Be sure that the diathermy handpiece is completely dry before using it, as RF currents may find a path through wet surfaces.
- Page 64 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK Cod. 111001EN 2012-02-16 Rev.J...
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Page 65: Troubleshooting Guide
The troubleshooting guide lists some of the anomalies that may occur in the unit’s operation, the related symptoms and corrective actions. If the problems with the PULSAR surgical system persist even after having carried out the corrective actions below, contact an OPTIKON 2000 authorised service centre. SYMPTOMS CORRECTIVE ACTION... - Page 66 PULSAR Minimal Stress 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.
- Page 67 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 SYMPTOMS CORRECTIVE ACTION “MAJOR LEAKAGE” a) Test chamber is not installed on the sleeve. Ensure that the test chamber is properly installed on the sleeve. b) I/A lines are not connected to the handpiece.
- Page 68 The handpiece is weak and cannot deliver more than Weak handpiece. 50 µm. Give the handpiece to an OPTIKON 2000 “WEAK HANDPIECE” authorized service centre to repair. Footswitch Footswitch does not energise the active a) The PULSAR unit is off.
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Page 69: Index
PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 INDEX ACS3 Vacuum sensor ....7-6 I.V. POLE connector ....7-8 Act. Prog. window ....8-19 Irrigation pinch valve ....7-6 Acoustic signal ......3-1 Irrigation system .......7-1 Arrow keys <UP>/<DOWN> ..8-2; 8-5;... - Page 70 PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Reduction mode ....... 8-8 U/S screen ......8-6 Repetitive cutting mode ... 8-12 U/S (phaco) socket ....7-5 Rise Time ....... 8-8 UNDO key ......8-21 Unit’s ground connector ....7-8 User interface ......7-8 "Save"...
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