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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

[email protected]

www.optikon.com

Содержание PULSAR MS

Страница 1: ...ev 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 op...

Страница 2: ...O 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 9...

Страница 3: ...TEM SET UP 6 2 7 EQUIPMENT OPERATION 7 1 7 1 EQUIPMENT DESCRIPTION 7 1 7 2 EQUIPMENT LAYOUT 7 5 7 3 USER INTERFACE 7 8 7 4 VOICE PROMPTING 7 10 8 EQUIPMENT OPERATION 8 1 8 1 BIPOLAR DIATHERMY 8 1 8 2...

Страница 4: ...THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...

Страница 5: ...if updates calibrations and repairs are carried out by personnel which has been authorised by OPTIKON 2000 S p A the system is used in compliance with the user instructions the mains electric installa...

Страница 6: ...PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Cod 111001EN 2012 02 16 Rev J 1 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...

Страница 7: ...by persons who are not part of the authorised OPTIKON S p A technical service OPTIKON 2000 S p A reserves the right to verify in case of failures if the instrument and or its accessories have been mod...

Страница 8: ...PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Cod 111001EN 2012 02 16 Rev J 2 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...

Страница 9: ...ion and management of possible clinical complications Before each operation carry out the surgical configuration and operating procedures described herein Do not use the system if it does not work pro...

Страница 10: ...ly high temperatures Install the PULSAR system so that the ventilation openings are not obstructed Dispose waste collection fluids according to the local laws regulations on disposal of organic materi...

Страница 11: ...put current is diverted to the operator by careless handling When the bipolar diathermy handpiece and a monitoring system are used at the same time all the electrodes of the monitoring system that are...

Страница 12: ...ith other medical equipment when the bipolar diathermy handpiece is in use Handpieces Do not allow the tip of the vitrectomy probe diathermy or I A handpiece to touch metallic objects Do not attempt t...

Страница 13: ...y 4 Remove the infusion set s spike from the bottle being careful not to touch it with your hands and not to allow it to come into contact with any non sterile material 5 Insert the infusion set s spi...

Страница 14: ...un in a beaker of sterile solution Testing in air will cause irreparable damage to the tip Footswitch Never lift or move footswitch by the cable Damage may result The footswitch is not autoclaveable S...

Страница 15: ...ols are combined together in order to obtain special meanings These are the symbols used on the PULSAR label Before using the unit familiarize yourself with the symbols and definitions provided in the...

Страница 16: ...PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Cod 111001EN 2012 02 16 Rev J 4 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...

Страница 17: ...ay be executed in real time by simply depressing the footswitch The aspiration is equipped with a peristaltic pump system The anticollapse system eliminates pulsation and increase fluid suction precis...

Страница 18: ...CATIONS Storage temp range between 10 C and 70 C humidity 10 100 non condensing Operating temp range between 10 C and 40 C humidity 30 75 ELECTRICAL SPECIFICATIONS Input voltage selectable at 100 120...

Страница 19: ...uts per minute Single cut Single cut mode available Port size Adjustable from 0 2 to 0 7mm reusable cutters only Actuating medium Pressurized air from internal source Operating pressure 190 KPa 27 5 0...

Страница 20: ...00 minutes to 59 59 minutes equivalent Phaco Time display CLASSIFICATION OF THE INSTRUMENT ACCORDING TO IEC 60601 1 Type of protection against electric shocks Class 1 Degree of protection against ele...

Страница 21: ...tic 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 Guidance RF emissio...

Страница 22: ...in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If...

Страница 23: ...n 3 V m 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...

Страница 24: ...OWER CHARACTERISTICS DIATHERMY POWER vs LOAD 0 1 2 3 4 5 6 7 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 Ohm W a t t Preset 100 Preset 50 PULSAR Diathermy power vs load DIATHERMY POWER...

Страница 25: ...ave gained all the knowledge needed for successful operation of your PULSAR surgery system 6 2 UNPACKING AND INITIAL INSPECTION The unit has been packed to reduce the risk of damage during shipping to...

Страница 26: ...sts if the automatic I V pole is present when the unit is switched on therefore be sure that the pole is connected and powered 7 Check that the available A C supply voltage corresponds to the one sele...

Страница 27: ...tlet to the dot of LOCK marking Confirm that the cap of the ACS 3 is fully tightened 5 Insert the tube exiting the ACS3 system into the slot on the pump s right side guide the tube around the rotor do...

Страница 28: ...2012 02 16 Rev J 6 4 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 th...

Страница 29: ...allows sterile on off control of the irrigation via the system footswitch or via the IRR button on the user s graphic interface An orange LED on the IRR key indicates that the pinch valve is on Irrig...

Страница 30: ...simultaneously aspirated by the longitudinal reciprocating action of the inner tube generated by pneumatical impulses received from the control console The extremely close tolerances between the inne...

Страница 31: ...transducer during high frequency vibration work therefore the aspirated fluid from the eye is also used for heat dissipating The Minimal Stress logo indicates an exclusive patented feature of our phac...

Страница 32: ...Delivers a single burst of U S power of 120 ms duration The surgeon must return to footswitch position 2 pause for approx sec and then depress it back into position 3 to obtain an additional burst Mul...

Страница 33: ...ibed in Fig 1 Left side pump side of the equipment is described in fig 2 Rear panel connectors are identified in Fig 3 Front view Fig 1 1 LCD DISPLAY This display allows the operator to do the followi...

Страница 34: ...d stopping irrigation at surgeon s demand 2 VENTING AND REFLUX PINCH VALVE The Reflux Venting pinch valve permits introduction of fresh BSS solution in the aspiration line thus releasing the vacuum in...

Страница 35: ...of the aspiration path Rear panel fig 3 1 COOLING FAN Removes hot air from the unit 2 VOLUME CONTROL KNOB This control knob allows adjustment to the surgeon s taste of the loudness of voice and sound...

Страница 36: ...on the fuse carrier s cover must be set for the voltage that is available in the zone in which the unit is to be used NOTE The abbreviations used on the unit and its user interface are defined as fol...

Страница 37: ...ve values of the parameters are always visible in the foreground in dedicated windows To adjust increase or decrease a specific value the user must press the arrow keys UP and DOWN located at the bott...

Страница 38: ...of the Pulsar MS can be used to adjust the brightness of the display 7 4 VOICE PROMPTING In an operating room the console of the unit is often located behind the surgeon who as a consequence cannot u...

Страница 39: ...y mode The speech synthesizer announces DIATHERMY The window of the corresponding parameters will show the energy output middle value on the POWER window and the preset mode the value at the bottom 3...

Страница 40: ...5 When diathermy is activated by depressing footswitch diathermy power is delivered to the handpiece and an audible tone of continuous pitch is automatically generated to alert the operator 6 Excessi...

Страница 41: ...on 1 Touch the I A button on the LCD screen to select the Irrigation Aspiration mode When the I A button is pressed the voice synthesizer will announce I A one Two windows are displayed on the Irrigat...

Страница 42: ...ONTINUOUS IRRIGATION button IRR key 9 Depress footswitch beyond mechanical detent n 1 to activate IRRIGATION and ASPIRATION at the VACUUM and FLOW preset limit if in PANEL mode If in LINEAR mode the f...

Страница 43: ...0 Mode linear panel Ultrasound parameters Phaco tip stroke m 5 100 Mode linear panel U S Rate Continuous Short Pulse Single Burst Multi Burst Continuous Burst Pulse frequency 1 2 3 4 5 6 8 10 13 16 20...

Страница 44: ...sleeve threads Slowly tighten the sleeve onto the handpiece until the end of the sleeve leaves the amount of U S tip exposed as preferred by the surgeon Orient the irrigation portholes on the sleeve o...

Страница 45: ...row keys to adjust the level in relation to the travel of the tip phacoemulsifier power 13 Selecting the REDUCTION MODE field C key will cause you to enter a sub screen where it is possible to adjust...

Страница 46: ...or correct installation for proper functioning and completely filled with BSS solution I A priming procedure can be skipped in some special circumstances i e when it is necessary to replace the ultras...

Страница 47: ...endothelium of the eye Always use the minimum level of ultrasound energy which is suitable to remove the cataract The incision should not be too tight around the sleeve allow some irrigating solution...

Страница 48: ...ection 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 2 Attach th...

Страница 49: ...sition 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 front panel 12 Depress footswitch be...

Страница 50: ...er tip should always be test run in a beaker of sterile solution Testing in air will cause irreparable damage to the blade CAUTION Aspiration should always be tested in a beaker of sterile solution 8...

Страница 51: ...ople MMP and IVP modes The functions that can be activated in each mode are summarized in the following paragraphs To select a different pedal touch the PROGRAM MODE soft key on the function main scre...

Страница 52: ...hen the main pedal is pressed beyond the first mechanical detent MECH DETENT 1 the pump is activated thus allowing irrigation and aspiration to be active simultaneously Pressing on the pedal again wil...

Страница 53: ...e surgeon to switch between Memory 1 2 and 3 in U S and Memory 1 and 2 in DIATH I A and VIT The Change Function button makes it possible to change from U S to I A and vice versa or from VIT to DIATH a...

Страница 54: ...elected on the console further depression of the pedal will increase aspiration level linearly When the surgeon presses the main pedal beyond the first detent this also activates the vitrectomy scalpe...

Страница 55: ...and 3 in U S and Memories 1 and 2 in I A mode The switching control for changing the function makes it possible to switch from U S mode to I A mode and vice versa and from VIT mode to DIATH mode and...

Страница 56: ...ess on the footswitch will increase the aspiration level in a linear manner In the vitrectomy mode when the surgeon presses the main pedal beyond stop 1 this also activates the vitrectomy scalpel If t...

Страница 57: ...TSWITCHES AREA If you have footswitch 112102 it is advisable to save in the programs area a work program with footswitch 112102 selected so that it will not be necessary to reset the footswitch each t...

Страница 58: ...ams screen will appear and will display the active program and the asterisk next to it which indicates that it has been modified Programs Screen To permanently save the modifications to a program pres...

Страница 59: ...the programs area and press LOAD key C To undo all the modifications made to the active program s parameters press UNDO key D To permanently delete a program on the list first select it using the arro...

Страница 60: ...rocedure described below 1 Press the POWER switch to turn off the console 2 Disconnect the power cable from the rear panel of the console Grasp the plug not the cable 3 Disconnect the footswitch contr...

Страница 61: ...cleaning and drying of the instruments after use chemical agents or sterilizing solutions cleaning with tap water leftover residues of laundry detergent in the operating room cloths detergents with u...

Страница 62: ...ove I A tubing after each use 3 To maintain optimal performance for the entire life of the equipment an annual maintenance and calibration program must be defined Contact your Optikon 2000 authorised...

Страница 63: ...ynthetic 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 3 Vitrectomy handpieces should never...

Страница 64: ...PULSAR Minimal Stress Installation and operating Manual OPTIKON 2000 Cod 111001EN 2012 02 16 Rev J 9 4 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK...

Страница 65: ...la punta 4 Phaco ready Ultrasuoni pronti 5 Weak handpiece Manipolo poco efficiente 10 2MISCELLANEOUS PROBLEMS The troubleshooting guide lists some of the anomalies that may occur in the unit s operat...

Страница 66: ...Open the vent valve Aspiration System Poor or missing aspiration a I A tubing set not properly installed Double check tubing installation b I A tubing connectors not properly inserted into the corres...

Страница 67: ...gaged in the handpiece connectors Push connectors in b The tube or the test chamber is not correctly assembled Verify that the test chamber is fully engaged on the sleeve and that the sleeve is proper...

Страница 68: ...Inspect the tip and replace if necessary c Damaged U S handpiece Replace it Poor U S power a Insufficient U S power preset Increase U S power preset b Footswitch not fully depressed Depress the footsw...

Страница 69: ...uipment 3 2 E Emission mode 8 8 Environmental warnings 3 2 F Footswitch connector 7 8 Footswitch in double linear mode 8 15 FLOW CONTROL key 8 5 Fuse carrier 7 8 I I V POLE connector 7 8 Irrigation pi...

Страница 70: ...mber 8 8 Timer reset 8 7 To recall or store a program 8 19 To create and store a new program 8 19 To select a pedal 8 14 8 22 Tuning 8 9 U U S screen 8 6 U S phaco socket 7 5 UNDO key 8 21 Unit s grou...

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