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CRYO-LINE

Manual for installation and use

OPTIKON 2000

Code 131002 EN

2014-02-06 Rev.F

4-2

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Summary of Contents for CRYO-LINE

Page 1: ... F CRYO LINE SYSTEM FOR CRYOSURGERY IN OPHTHALMOLOGY MANUAL FOR INSTALLATION AND USE 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: ... ISO 9001 and ISO 13485 certified company that produces 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 ...

Page 3: ... 7 1 7 1 3 INITIAL TEST OF THE SYSTEM 7 1 7 1 4 STANDARD OPERATION 7 1 7 1 5 TEMPERATURE CONTROL 7 1 7 1 6 APPLICATION TIME CONTROL 7 2 7 1 7 APPLICATION TIME AND APPLIED TEMPERATURE CONTROL 7 2 7 2 CONFIGURATION OF THE UNIT 7 3 7 3 USER INTERFACE 7 5 7 4 SOUND MESSAGES 7 6 8 USER INTERFACE 8 1 8 1 LANGUAGE SELECTION 8 1 8 2 STANDARD OPERATION 8 1 8 3 APPLICATION TIME CONTROL 8 2 8 4 APPLICATION T...

Page 4: ...11 1 RECOMMENDED ACCESSORIES 11 1 11 2 AVAILABLE CRYOSURGICAL PROBES 11 2 11 3 SPARE PARTS 11 3 12 INDEX 12 1 ...

Page 5: ... 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 electrical system to which the system is connected proves to be in compliance with IEC safety regulations IMPORTANT NOTE Every effort has been made so that all the illustrations and information precisely represent the product and its...

Page 6: ...CRYO LINE Manual for installation and use OPTIKON 2000 Code 131002 EN 2014 02 06 Rev F 1 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK ...

Page 7: ...s made 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 modified or tampered with in any way or if they have been damaged by improper use OPTIKON 2000 S p A also reserves the right to modify the instrument and or its accessories in the event operating ...

Page 8: ...CRYO LINE Manual for installation and use OPTIKON 2000 Code 131002 EN 2014 02 06 Rev F 2 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK ...

Page 9: ...arbon Dioxide or N2O Nitrogen Protoxide gas for medical use with a minimum content of 99 and maximum allowable content of impurities including humidity of 1 The cylinder must be charged to a pressure not exceeding 70 bar 1015 PSI Do not use cylinders with a siphon in order to prevent the gas from leaking from the cylinder in the liquid state Position the cylinder vertically with the valve facing u...

Page 10: ...not bend it but wind it up in the sterilization box with a minimum radius of 5 cm If you notice gas leaking from the probe do not use the probe send the defective probe to the Optikon service centre Use of accessories and cables other than those provided with the unit may result in an increase of the emissions or in decreased immunity of the system Portable and mobile communications equipment can ...

Page 11: ...er supply voltage of 220V Check that the local voltage is the same as that predetermined on the unit Otherwise prepare the unit for the local power supply voltage In the countries where the local voltage is 100 120 V replace the fuses of the unit with the appropriate fuses supplied These operations must be carried out exclusively by appropriately trained personnel To reduce the risk of electric sh...

Page 12: ...CRYO LINE Manual for installation and use OPTIKON 2000 Code 131002 EN 2014 02 06 Rev F 3 4 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK ...

Page 13: ...ed together in order to obtain special meanings These are the symbols used on the CRYO LINE label Before using the unit familiarize yourself with the symbols and definitions provided in the table SYMBOLS PUBLISHED BY IEC SYMBOL DESCRIPTION MANUFACTURER AND DATE OF MANUFACTURE WHERE APPLICABLE ALTERNATING CURRENT WARNING OPEN DISCONNECTED FROM MAINS CLOSED CONNECTED TO MAINS TYPE BF APPLIED PART SE...

Page 14: ...CRYO LINE Manual for installation and use OPTIKON 2000 Code 131002 EN 2014 02 06 Rev F 4 2 THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK ...

Page 15: ...on CRYO LINE medical device has been designed to be used in ophthalmic surgery by trained personnel In particular the surgical procedures in which the device can be used are listed below Cataract Glaucoma Detachment of the retina Vitrectomy The OPTIKON CRYO LINE medical device uses medical type Nitrogen Protoxide N2O or Carbon Dioxide CO2 from cylinders without a siphon in order to obtain freezing...

Page 16: ...mp range between 10 C and 40 C humidity 30 75 ELECTRICAL SPECIFICATIONS Input voltage selectable at 100 120 220 240 Vac Frequency 50 60 Hz Current consumption 80 VA Fuses 220 240 V 1 A T 100 120 V 2 A T PNEUMATIC CIRCUIT Supply gas medical N20 or CO2 in cylinder without siphon Maximum input pressure 70 bar 1015 PSI CLASSIFICATION OF THE INSTRUMENT ACCORDING TO IEC 60601 1 Type of protection agains...

Page 17: ...the Cryo Line should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Cryo Line uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Cryo Line is suitable for use ...

Page 18: ...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 the user of the Cryo Line requires continued operation during power mains interruptions it is recommended that the Cryo Line be powered from an uninterruptible power supply or a battery Power frequency 50...

Page 19: ...ECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND CRYO LINE Cryo Line is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Cryo Line can help preventing electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitt...

Page 20: ... 06 Rev F 5 6 5 5 WIRING DIAGRAMS On request OPTIKON 2000 S p A provides wiring diagrams component lists descriptions calibration instructions or other information that may help the operator s trained technical personnel during repair of the repairable elements of the apparatus ...

Page 21: ...en the package and examine the components When opening the package handle all the components with care When cutting the packing material be careful not to damage the contents 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 Imm...

Page 22: ...3 Lower at the same time the control footswitch and the safety pin interlock to expel the dust particles from the CRYO LINE system CAUTION NITROGEN PROTOXIDE IS TOXIC NOTE This operation is necessary only if the instrument is used for the first time or after it has been left unused for a long period 14 Remove the protective cap from the connector of the cryosurgical probe Insert the connector of t...

Page 23: ... is in an idle state Freezing probe tip freezing phase Defrosting probe tip defrosting phase Venting evacuation phase of the residual gas inside the pneumatic circuit Purge purification phase of particulates and humidity present in the pneumatic circuit of the probe and instrument 7 1 3 INITIAL TEST OF THE SYSTEM In this phase the CRYO LINE automatically tests the electrovalves 7 1 4 STANDARD OPER...

Page 24: ...urs when the relative procedure COUNT DOWN is activated by pressing the key next to the symbol on the display In this state pressing the footswitch activates the freezing procedure of the cryosurgical probe which lasts until the end of the time period set by the operator The expiration of the application time is accompanied by a sound signal At the expiration of the application time the cryosurgic...

Page 25: ...iew 1 BACKLIT LCD DISPLAY This display allows the operator to do the following See which functions are activated Read all the effective and preset values Read the warnings and error messages 2 BUTTONS Silicone keys with which it is possible to select the different functions of the unit 3 CONTRAST CONTROL Contrast adjustment roller for the Display 4 PROBE CONNECTOR The pneumatic line of the cryosur...

Page 26: ...mains voltage selector and power cord socket are located near this switch 5 FOOTSWITCH CONNECTOR This is the port for the connector of the footswitch that when pressed activates the functions of the CRYO LINE unit 6 SERIAL CONNECTOR This connector allows to connect the CRYO LINE unit to a PC through a serial connection This connector is used for technical servicing of the instrument 7 EQUIPOTENTIA...

Page 27: ...on time or time remaining before defrosting 3 Temperature of the cryosurgical probe 4 Pressure within the pneumatic circuit User interaction with the system 5 Activation of the Venting state or interruption of the probe cleaning 6 Adjustment of the application time 7 Activation of the application time control function 8 Display of the temperature in Celsius C or Fahrenheit F 9 Adjustment of the ap...

Page 28: ...es are associated with 1 Confirmation of the pressing of one of the console buttons 2 Counting of the application time 3 End of the application time 4 End of the probe cleaning time 5 As an alarm sound signal i Gas pressure too high in the pneumatic circuit of the instrument ii Gas pressure too low for proper freezing of the probe iii Failure of one of the system tests iv Accidental disconnection ...

Page 29: ...ust then press the Save key Your choice will be saved also for subsequent use of the device 8 2 STANDARD OPERATION The important parameters are the application time probe temperature pneumatic circuit pressure and system state Operation 1 Select a cryosurgical probe 2 Insert the probe connector into the relative connection on the console If the probe is equipped with a thermocouple insert the rela...

Page 30: ...phase Venting 6 After a few minutes of inactivity the system performs a new probe cleaning cycle Purge in order to remove the latent humidity inside the pneumatic line of the cryosurgical probe To exit from this state the operator can press the relative Stop key on the console To begin the freezing phase of the probe Freezing just press the footswitch connected to the instrument 8 3 APPLICATION TI...

Page 31: ...on the display in the part regarding the time The end of the application time is signalled by an intermittent sound signal with a duration of about 2s 7 The end of the freezing phase can occur either by depletion of the preset application time or by simply releasing the footswitch connected to the console At the end of this phase the system performs the defrosting of the probe Defrosting and the d...

Page 32: ...ion temperature using the buttons located next to the on the right side of the instrument display 6 To start the freezing phase of the probe Freezing press the footswitch connected to the instrument The attainment of the preset temperature is accompanied by a sound signal with a duration of about 1s If the probe does not reach the preset temperature within 5s the system automatically enters the de...

Page 33: ...as explained in the installation procedure 2 Switch on the instrument 3 A sound will be heard a few seconds after the start up as an assessment test of the audio circuit 4 If the gas pressure at the inlet is too low or too high a message will appear on the display Adjust the reducer located on the cylinder or in the case of pressure that is too low replace the cylinder The attainment of the ideal ...

Page 34: ... turn off the console 2 Close the valve on the cylinder or the centralized system outlet 3 Detach the power cord and the gas supply hose from the centralized system outlet or high pressure gas cylinder and from the rear panel of the console Grip the plug not the cable 4 Disconnect the footswitch control from the rear panel of the console 5 Disconnect the connectors of the probe and thermocouple Se...

Page 35: ... not subject the surgical instruments to hot air sterilization or liquid sterilization c The Cryosurgical probes must dry for at least 20 minutes before being used 9 1 CLEANING 9 1 1 UNIT 1 Periodically clean the LCD display with a soft cloth dampened with distilled water If necessary use neutral detergent only 2 Do not use alcohol solvents or abrasives on the console 9 1 2 ACCESSORIES The most co...

Page 36: ...ife of the equipment an annual maintenance and calibration program must be defined Contact your Optikon 2000 authorised distributor service centre NOTE 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 c...

Page 37: ...o not use synthetic detergents or oil based soaps 2 Make certain that the probe s console connector is completely dry before using it any humidity present may compromise the freezing efficiency 3 Make certain that the thermocouple connector is completely dry in order to avoid false temperature readings ...

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Page 39: ...tive meaning of the error appear in the top centre part of the LCD display These warnings and error messages are summarized in the table below ENGLISH WARNING ERROR MESSAGE X Err 01 Test E1 EV4 failed X Err 02 Test Loading failed X Err 03 Test EV3 failed X Err 04 Test EV3b failed X Err 05 Test EV2 failed X Err 06 High pressure X Err 07 Low pressure X Err 08 Footswitch pushed without the probe X Er...

Page 40: ...e SYMPTOMS CORRECTIVE ACTION Mains power supply CRYO LINE completely inactive a The power cord is not connected Connect the cord to the console and the mains b The fuse has blown Replace it Gas leak Leak that can be heard from the adapter a Adapter not tightened enough Tighten it firmly b Defective gasket Replace the gasket Leak from the console a Pressure too high Pressure which is too high cause...

Page 41: ... or authorised personnel Err 06 High pressure Do not use the instrument in this condition Check the type of gas used or the operating pressure of the system to which the OPTIKON Cryo Line is connected Err 07 Low pressure Do not use the instrument in this condition Replace the cylinder or check the operating pressure of the system to which the instrument is connected Err 08 The footswitch has been ...

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Page 43: ...RYO LINE Manual for installation and use OPTIKON 2000 Code 131002 EN 2014 02 06 Rev F 11 1 11 ACCESSORIES 11 1 RECOMMENDED ACCESSORIES CODE DESCRIPTION PICTURE 183001 Instrument cart with cylinder holder ...

Page 44: ... 2 11 2 AVAILABLE CRYOSURGICAL PROBES CODE DESCRIPTION PICTURE 133001 Cataract cryosurgical probe 133002 Retina cryosurgical probe spherical 133003 Retina cryosurgical probe spatula 133004 Retina cryosurgical probe T 133005 Retina cryosurgical probe Bonnet 133006 Glaucoma cryosurgical probe ...

Page 45: ...he user must be limited to the replacement of the parts listed below The warranty will not be considered valid if work is carried out on any other part CODE DESCRIPTION PICTURE 132005 Spare cartridge for gas filter 132006 CO2 fitting for cylinder CHINA 132008 Fitting for N20 cylinder ISO5145 132009 CO2 fitting for cylinder ISO5145 132010 N2O fitting for cylinder FRANCE ...

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Page 47: ...ustment 7 3 Disposal of electrical and electronic equipment 3 3 E Electrovalve test 8 5 Environmental warnings 3 2 F Flammable anaesthetic mixtures 3 3 Fuses 5 2 M Maximum cylinder pressure 3 1 N Nitrogen Protoxide evacuation 3 2 P Probe cable winding 3 2 Purification of the probe 6 2 S Safety switch 7 3 Sound messages 7 6 System states 7 1 V Vent button 3 2 Volume control knob 7 4 W Warranty cond...

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