1470nm Laser Console User`s Manual
Contents
1. ase 1470nm Laser Console User s Manual Vari Lase N vascular OLUTIONS VarizzLase Endovenous Laser Console 1470nm Laser User s Manual Distributed by Vascular Solutions Inc 6464 Sycamore Court Minneapolis MN 55369 US A Manufactured by 888 240 6001 USA MedArt A S 763 656 4300 Industriholmen 15A 763 656 4250 DK2650 Hvidovre Denmark Page 1 of 32 42 0835 01 Rev A 4 13 Vari Lase Laser Console Instructions for Use Copyright 2013 MedArt A S Industriholmen 15A DK 2650 Hvidovre Denmark Reproduction of any part of this manual is not permitted without the ex press permission of MedArt A S Date March 6 2013 MedArt A S Phone 45 3634 2300 Industriholmen 15A Fax 45 3634 2323 DK 2650 Hvidovre Mail info medart dk Denmark Web www medart dk MedArt Page 2 of 32 42 0835 01 Rev A 4 13 Table of Contents Table Of ieee an aeaaea a e a a raea eaaa Kem aaee Aaea paH Ee Enae Enan aHa 3 E Le EE 4 Handling PRECAUTIONS essre EEEE ENESE A EEKE EA 4 Iptroeueten sornes EE ENEE EENS AEEEEEAEE ENEE 5 Intended Use amp Indications for USe nrsrrnnnnnnvnnnnnnnvnnnnnnnvnnnnnnnvnnnnnnnvnnnnnnnvennnnnnvennnnnnnennnnnnnennnnnnnennnnnnnnnnnnnnnnennn 6 Endovenous Procedure it seeest esteetesgeteheesgeeEeeeEE ENEE 7 7 Sal 8 Labels and Sy Mol Sui vc 0 10 Description of Operating Console 12 14 OQutput Power Verificatlon2. cally for laser equipment IEC 60601 2 22 and IEC 60825 The Vari Lase laser unit conforms to the EU Medical Device Directive 93 42 EEC This product is marked with a unique serial number SN that identifies the product The SN is placed on the rear panel of the MedArt 715 laser unit The product type number is located on the rear panel of the product The Vari Lase laser console is marked with 6 0459 MedArt A S Page 5 of 32 42 0835 01 Rev A 4 13 Intended Use amp Indications for Use The Vari Lase laser console is indicated for endovascular medical therapy of vascular conditions It transmits through an optical fiber and the power density reaches 12kW cm enabling the laser to coagulate evaporate and carbonize tissue The Vari Lase laser console operates with a wavelength of 1470nm The 1470nm wavelength is absorbed in melanin hemoglobin dark tissue and in water This ena bles a fast heat increase in the irradiated area leading to effective heating of tissue at low output power Indications for the Vari Lase laser console The Vari Lase laser console is indicated for the medical treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein Contraindications for the Vari Lase laser console The Vari Lase laser console procedure is contraindicated in patients with an aneuris mal section in the vein segment to be treated The Vari Lase laser console procedure is contrai
3. smmmssissisnmssenmenvkvsnen sender ra oean aeea Eae Ea aa Ea aae aae e cxncesennsedcnueexsetreenessedeasdoeees 16 Definition and Retrieval 7 17 Remote Interlockng vasse 18 BatrekbbertzonneettOot geess SES 18 Connection 18 System Setup and Status Display Controls nunnan anneanne nnana 19 Service Adjustment FunctionS rrsswrnnavnnnnnvnnnnnnnnnvnnnnnvnnnnnnnnnnnnnnnvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnr 20 Cleaning and Mammtename e egseeresabdeRCEEENE EENS EES SEENEN NEES 22 Mains Power Connection and 22 Troubleshooting E 23 Warnings and Stop Code i seess NEESS EENS EE 24 NOHD Nominal Optical Hazard Distance and MPE cccsseeeeeeeseceeeseeeeeseseseeeseseseeeseseseeneeseseenens 25 Protective Eye Weal egkeEEEgeEEEEENESEN EENS 25 25 Service ANG GISPOSAl E 26 Product Life TIME ee 26 Storing and Transportation ee EES EEN 26 Technical Specifications for the Vari Lase laser CONSOle rrssrrrxvrnnnnvnnnnnnnnnnnnnnnvennnnnnnnnnnnnnvnnnnnnnnnnnnnnnnnnnnn 27 Guidance and manufacturer s declaration EMC topics nnmnnn 29 Appendix 0 0 32 MedArt Page 3 of 32 42 0835 01 Rev A 4 13 Caution 1 Read the operating instructions thoroughly before connecting the laser unit to mains power and prior to use The laser unit must be set regu lated and used in accordance with these in
4. 2 Pulses Displays number of pulses generated 3 Active Time Display time the laser has been active 4 Joules Displays the joules generated Use the jog wheel 11 to browse the four options Press the Enter key 10 to select when the desired display is found The reading will be displayed when the unit is in either STANDBY or READY mode Choose Language Turn the jog wheel 11 to browse the languages and select by pressing the Enter key 10 to select when the desired language is found Reset Counters The user may want to reset the readings e g before a patient treatment is initiated To do this please follow the steps below 1 Make sure the unit is in STANDBY mode 2 Press the Menu key 6 to enter FUNCTION MENU 1 3 Press Selector key 2 to reset the status display readings MedArt Page 19 of 32 42 0835 01 Rev A 4 13 Service Adjustment Functions The Vari Lase laser console provides the user with various features for setting and reading equipment parameters These adjustable parameters are organized into six service groups that can be accessed when the unit is in SERVICE mode Follow the steps below to enter Service mode Make sure the unit is in STANDBY mode Press the Menu key 6 to enter FUNCTION MENU 1 Press the Right key 8 to enter FUNCTION MENU 2 Press Selector key 1 to enter SERVICE mode 5 gt lt The following five groups of service settings are accessible to the user USER SETTING
5. Provides access to the various menus features by the Vari Lase laser console Used for menu browsing and operation Used for menu browsing and operation Used for stepping upwards in the menu hierarchy and leaving the selected menu item without saving changed parameters Confirms saves the parameters currently displayed accompanying LED lit when active 65 Co When activated the Vari Lase laser con sole is set into Ready Mode See para graph Operation on page 14 for more details When activated the Vari Lase laser con sole is set into Standby Mode Parame ters can be modified but no laser output can be generated See paragraph Operation on page 14 42 0835 01 Rev A 4 13 15 16 17 18 19 20 21 22 23 24 25 26 27 28 MedArt Use Laser ready indicator Laser emis sion indicator Key switch 2 Fiber con nector Laser beam W input port Ss Display gt Foot switch inlet Gu Remote inter TAY locking A Service con nector B Service con nector Mains power switch Fuse holder Mains power cable inlet Follow In structions for Page 13 of 32 Lit whenever the Vari Lase laser console is emitting aiming light Flashing when laser emission occurs The laser unit is disabled when the key is in off position or when the key is re moved Text TURN KEY and a key symbol is displayed when the key is turned in off position Laser
6. acteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the AC mains power voltage prior to application of the test level Med Page 29 of 32 42 0835 01 Rev A 4 13 Guidance and manufacturer s declaration electromagnetic immunity MedArt 715 is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF com munications equipment should be used no closer to any part of the MedArt 715 including ca bles than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Vrms 3Vrms IEC 61000 4 6 150kHs to 80MHs d LP Radiated RF 3V m 3V m d 1 24 80M to 800MHs IEC 61000 4 3 80MHs to 2 5GHs d 2 3VP 800M to 2 5GHs where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compli ance level in each frequency range Interference may occur in the vicinity of equipment marked with the following
7. button Page 18 of 32 42 0835 01 Rev A 4 13 System Setup and Status Display Controls A number of system features can be setup by the user by following the steps be low Make sure the unit is in STANDBY mode 2 Press the M key 6 to enter FUNCTION MENU 1 3 Press Selector key 1 to enter the menu USER SETUP 1 where four setup options are displayed 4 Press the Right key 8 or the Menu key 6 to display a further three setup options in USER SETUP 2 All seven setup options are listed below Sound Level Turn the jog wheel 11 to change the volume of the internal speaker Press the Enter key 10 to select when the desired volume is found For safety reasons the level cannot be set to values lower than 30 Display Contrast Turn the jog wheel 11 to change the display contrast Press Enter key 10 to select when the desired display brightness level is reached Aiming Beam Turn the jog wheel 11 to adjust the brightness of the aiming beam Press the En ter key 10 to select when the desired brightness is found The selected aiming beam level will be visible on the fiber output during adjustment Energy Mark Turn the jog wheel 11 to change the energy mark level Press Enter key 10 to select when the desired display brightness level is reached Status Display 1 Status Display 2 The user can select two status display options for use during operation from the following 1 None No status is displayed
8. identified lithium battery CR2032PCB BATTERY LI ION The battery is not changeable by the operator The battery is expected to have a lifetime that exceeds the life of the system The unit must be calibrated and safety checked by appropriately trained and au thorized personnel once every two years Separate collection for disposal of waste electrical and electronic equipment For information on correct disposal of your MedArt equipment please contact your Ld Vari Lase dealer Details on the nearest dealer can be obtained from MedArt A S Phone 45 3634 2300 Industriholmen 15A Fax 45 3634 2323 DK 2650 Hvidovre Mail info medart dk Denmark Web www medart dk Vascular Solutions Inc Phone 1 763 656 4300 6464 Sycamore Court Fax 1 763 656 4250 Minneapolis MN 55369 Web www vasc com USA Product Life Time The laser system is designed for a lifetime of 10 years In order to maintain the prod uct performance the recommended service intervals and activities should be followe throughout the entire service life of the product Storing and Transportation The laser unit must be stored between 10 C and 50 14 122 F Air humidity must be below 80 and air pressure within the range of 70kPa 150kPa MedArt Page 26 of 32 42 0835 01 Rev A 4 13 Always transport the Vari Lase laser console in the original packaging Technical Specifications for the Vari Lase laser console Type no Laser type Output
9. power Range Maximum Precision Mode of operation Wavelength Target indicator Fiber connection Fiber diameter Numerical aperture of fiber Start stop functions Emergency stop Warning signal for aiming light radiation Warning signals for laser radia tion Laser Ready warning Laser Ready timeout Emission Frequency range Pulse width Nominal Ocular Hazard Dis tance Beam divergence Acoustical mark Output power meter Range Accuracy Protection against ingress of water Power supply Power consumption Indication of mains power ON Fuses Patient leakage current Earth leakage current Operating environment Safety class Application in presence of flam mable anesthetic mixtures MedArt MedArt 715 Continuous Wave Diode Laser Laser Class 4 IEC 60825 1 15W in steps of 1W 15W depending on transmission in connected fiber Better than 10 at maximum output power Continuous wave or pulsed beam 1470nm 10nm Red indicator light through fiber 635nm Can be enabled when the laser is in Standby mode SMA 905 MedArt Quick Safe Connect QSC 400um 600um amp 1000um 0 22 or higher Foot switch Large button on front panel Yellow indicator on the front panel Flashing yellow indicator and intermittent sound Text READY in display Yellow indicator on front panel and target indi cators 250 seconds 0 3 100Hz 10 3000msec 0 22NA fiber gt NOHD 0 3m 0 37NA
10. the unit and will enter a controlled shut down procedure The shut down procedure can be initiated in any mode of operation Page 15 of 32 42 0835 01 Rev A 4 13 Output Power Verification Med The Vari Lase laser console provides advanced built in facilities for output power verification purpose RON 6 7 Press the M key 6 to enter the Function Menu Press the Right key 8 to enter the second Function Menu Press Measure Power selector 2 Align the output tip of the fiber with the sensor opening 19 and keep it aligned during the entire measuring process Activate the foot switch and keep the foot switch pressed during the entire measuring process Any measurement interrupted by the release of the foot switch will be ignored The Vari Lase laser console automatically tests the laser output by measuring the power level of a number of pulses wait for this to complete The measured optical output is displayed in watts Repeated measurements may cause the built in power meter to heat up If so a message will appear urging the user to wait 5 minutes before further measure ments are taken Caution All personnel in the operating room must wear protective eye wear during the measurement Page 16 of 32 42 0835 01 Rev A 4 13 Definition and Retrieval of Treatment Parameter Sets Med The Vari Lase laser console features predefined sets of treatment parameters These parameter sets can be re
11. 2 If remote interlocking is required If the interlocking feature is required to ensure a safe entry to the treatment area an appropriate switch may be mounted on the doorframe in a way that ensures contact closure when the door is closed Multiple doors can be wired in series if needed A special cable giving access to the interlocking socket 22 can be supplied at request by Vascular Solutions Bare Fiber Connection Warning Follow the recommendations below or this could result in damage to the fiber and or delivery system and consequently harm to the patient or user Connecting bare fibers To facilitate endovenous laser treatment a bare fiber equipped with a standard SMA 905 connector as specified by International Electro technical Commission IEC document 86B 1903 CDV connector plug F SMA I may be connected to the Vari Lase laser console using a SMA to QSC adapter Remove the protection cap from the fiber SMA 905 connector While the QSC adapter is installed in the laser insert the SMA 905 into the QSC adapter and carefully tighten the nut Caution Keep the fiber cap on when the fiber system is not connected Do not touch the fiber connector tip as this will reduce the lifetime of the fiber Connection and Release of Foot Switch A connector 21 for the foot switch is provided on the rear panel For connection simply plug in the foot switch connector Release the foot switch by pressing the adjacent
12. Cause Recovery 0 EMERGENCY STOP Emergency button has been Laser shuts down Cycle mains pressed power switch to recover 1 UO SYSTEM STOP This is an internal laser system Laser shuts down Cycle key situation switch to recover 3 OVER CURRENT STOP This is an internal laser system All laser circuits are shut down situation Cycle key switch to recover retry Note Do not repeatedly provoke an over current stop the laser diodes could be damaged Re duce power and retry 4 POWER HIGH STOP This is an internal laser system Laser shuts down Cycle key situation switch to recover 5 POWER LOW STOP This is an internal laser system Laser shuts down Cycle key situation switch to recover 6 VDIODE STOP This is an internal laser system Laser shuts down Cycle key situation switch to recover 7 POWER DOWN Power supply output voltage low Saves data internally and shuts down system Check mains power 8 DIODE TEMPERATURE Laser diode temperature is too The laser is shut down Normal STOP high operation will resume when tem perature is reduced 12 CONNECT FIBER All laser controls are disabled until Resumes normal operation when a fiber is inserted the fiber is inserted 13 CONNECT INTERLOCK All laser controls are disabled until Resumes normal operation when an interlock connector switch is connected installed Pin 1 GND and 2 In terlock input must be shorted on the interlock connector 16 CONNECT FB SENSOR This is an internal laser system Las
13. S Standard user controls like display contrast sound level etc ACCESS CODES Access codes can be entered for user service or maintenance purposes only For safety reasons full service access is only granted to MedArt authorized personnel UNIT IDs Reports various IDs associated with each Vari Lase laser console TIME LOG This group contains time logging and timing functions LASER SETUP ADJ Setup of aiming beam and laser energy mark functionality behavior SERVICE mode controls All available User Settings are in English regardless of the language selected e Use the jog wheel 11 to browse the service settings e Use the Left Right keys 7 8 to change from one group of service settings to another e Use selector key 4 Change to modify a parameter Note the change feature only exists for a subset of the parameters There are two types of parameter input modes e Limited range parameters Operate the jog wheel 11 to change the parame ters Press the Selector key 4 to save the set value e Large number selection Operate the jog wheel 11 to change the value of the current digit Press the Right Left keys 7 8 to select another digit Press the Selector key 4 to save the set value Available service settings are described in more detail by the following table MedArt Page 20 of 32 42 0835 01 Rev A 4 13 USER SETTINGS 100 Sound Level This setting changes the volume of the internal speaker T
14. arge ESD 8kV air 8KV air crete or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 RH Electrical fast transi 2kV for power supply 2kV for power supply Mains power quality should be ent burst lines lines that of a typical commercial or IEC 61000 4 4 1kV for input output 1kV for input output hospital environment lines lines Surge 1kV differential mode 1kV differential mode Mains power quality should be IEC 61000 4 5 2kV common mode 2kV common mode that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur lt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur lt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of MedArt 715 requires contin ued operation during mains power interruptions it is rec ommended that the system be powered from an uninterruptible power supply Power frequency 50 60Hs magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels char
15. ated twice per second When pulse length is longer than 50msec an audible tone will be generated when laser is emit ted Pressing the M Back or P key or any selector key will return the system to STANDBY mode Page 14 of 32 42 0835 01 Rev A 4 13 If the system is idle in READY mode for 250 seconds it will automatically return to STANDBY mode for operator and patient safety When the Standby key is pressed the unit enters STANDBY mode and laser ra Standby diation cannot be emitted For safety reasons the laser should always be in STANDBY when not in use Start and stop of laser radiation When the laser is active the yellow Laser emission indicator flashes and an audi ble tone will be heard Caution When the Laser ready indicator is on the Vari Lase laser console emits laser radiation READY When the display shows READY the Vari Lase laser console emits laser radiation immediately upon activation of the foot switch Foot switch operation When the foot switch is pressed the Vari Lase laser console emits radiation Re leasing the foot switch stops emission Emergency STOP key When the emergency stop key 14 is pressed the Vari Lase laser console stops emitting laser radiation and will not function The mains power switch 25 must be switched OFF for approximately 15 seconds and ON again to restart Shut down procedure The Vari Lase laser console is shut down by pressing the mains power switch 25 on the rear of
16. disconnected from the main power supply Mains Power Connection and Replacement of Fuses The laser unit is connected to mains power via the mains power cable inlet 27 on the back panel of the laser unit The mains power switch 25 is used to switch the laser unit ON or OFF The unit is equipped with 2 glass fuses T1 6AL which protect the la ser unit in case of electrical fault If the unit cannot be switched ON try to replace the fuses before the unit is handed in for repair To replace the fuses 1 Remove the mains power cord 2 Pull out the fuse box 26 3 Replace the fuses and re insert the fuses fuse box 4 Close the fuse box Use only 5x20mm T1 6AL fuses NOTE The Vari Lase laser console must always be grounded MedArt Page 22 of 32 42 0835 01 Rev A 4 13 Troubleshooting Symptom Possible Cause Recommendation No light in display when switched on e Defective mains power fuses e Low mains power supply Change fuses Wait min 5sec for power up Low output power Defective fiber Defective QSC e Low pulse width combined with low frequency Change fiber Change QSC Choose higher pulse width Fluence pulse duration or fre quency cannot be set as high as it could be previously A temperature fault message is displayed and the Vari Lase laser console stops radiating Fluence is a physical property closely connected to output power and pulse width Due to th
17. e Vari Lase laser console into READY mode by pressing the Ready key 12 After a 3 seconds safety delay the unit will be ready and the text in dis play will show READY 10 Start treatment by pressing the foot switch to emit laser radiation When laser radiation is emitted the laser emission indicator 16 will be lit ARON Setting treatment parameters Power pulse width and pulse repetition rate can be set to prepare for the required treatment Treatment parameter is selected by pressing the associated selector 1 2 3 or 4 Modify the selected parameter by turning the jog wheel When all parameters are correct press Enter 10 to save Alternatively press the Ready key to save and bring the unit directly into READY mode Pressing the Back key 9 terminates the selection without changing the parameter Output power Power can be set in the range 0 15W in 1W increments The output power level is shown in the display Pulse width Pulse width can be set in the range 10 3000msec The pulse width is shown in the display Pulse repetition frequency Frequency can be set in the range 0 3 100Hs Further output can be set to single pulse and continuous wave CW The frequency is shown in the display Standby Mode and Ready Mode When the Ready key is pressed the unit enters READY mode and laser radiation will be emitted when the foot switch is pressed When pulse length is shorter than 50msec a steady audible tone will be gener
18. e de pendency between the parame ters maximum value of fluence pulse width and frequency de pends on the setting of the other parameters e Overheated diode due to combination of high room temperature high power set ting and high duty cycle e Internal laser cooling system ineffective Decrease the value of one or more of the other treatment parameters e Wait a few seconds for the system to cool down If the problem remains try to reduce room temperature Reduce output power Reduce duty cycle shorter dwell time longer breaks e If this fails return to MedArt for repair Aiming beam has faded or diffused As the aiming beam passes through the same optical sys tem as the working beam it provides a good method of checking the unit If the aim ing beam spot is not present at the distal end of the fiber its intensity is reduced or it looks diffused the fiber might be damaged e Check the unit by undertaking output power verification as described in the paragraph Output Power Verification on page 17 Med Page 23 of 32 42 0835 01 Rev A 4 13 Warnings and Stop Codes The table below provides a complete overview over the various warnings and stop messages that can be displayed by the Vari Lase laser console If one of the messages appears repeatedly note the message and call your Vari Lase laser console dealer e Error message
19. eck that laser output has an accuracy of 10 or better Use an external calibrated power meter for both checks Every 24 months Table A 2 Power Meter Calibration Procedure Performed by Clinic or hospital staff Clinic or hospital staff Clinic or hospital staff Vari Lase laser console manufac turer authorized personnel only Note This chapter highlights the instructions for the Verification of Calibration of the Vari Lase laser console These instructions are provided to comply with Federal Regulations These procedures should be performed only by the Vari Lase laser console manufacturer or a duly author ized representative trained by the Vari Lase laser console manufacturer Calibration verification performed by any other individual will void any manufacturer s warranty stated or implied 1 Enter SERVICE mode 2 Setthe PowerMeter Gain setting 800 to 100 3 Check that the power meter temperature is close to ambient temperature 3 C The power meter temperature can be read from service setting 802 Set the measurement power to OW and start the power measurement by pressing Ready The power meter temperature is displayed at the end of the measurement cycle 4 Set the laser power to 15W using service setting 705 and measure the output power using an exter nal calibrated power meter 5 Point the fiber at the internal power meter and measure the power using service setting 802 6 Set the PowerMe
20. edArt Page 28 of 32 42 0835 01 Rev A 4 13 Guidance and manufacturer s declaration EMC topics Guidance and manufacturer s declaration electromagnetic emissions MedArt 715 is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 MedArt 715 uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 MedArt 715 is suitable for use in all establishments including Harmonic emissions Class A domestic establishments and those directly connected to the IEC 61000 3 2 public low voltage power supply network that supplies build Voltage fluctuations Complies ings used for domestic purposes flicker emissions Guidance and manufacturer s declaration electromagnetic immunity MedArt 715 is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Immunity test Electrostatic dis IEC 60601 test level 6kV contact Compliance level 6kV contact Electromagnetic environment guidance Floors should be wood con ch
21. ents of IEC 60825 and EN 207 According to these specifications the protective eye wear must be marked with the following Type of laser D continuous wave laser Wavelength 1450 1500 nm_ or larger wavelength interval Protective class gt L1 or higher Accessories The list below provides a complete overview over accessories available for the Vari Lase laser console Description Vascular Solu Medart Part No tions Part No Instruction for use 1470nm 15W 42 0835 01 98359 Mains power cord US 10 0431 01 70107 Mains Power cord Europe 10 0431 02 70101 Mains power cord UK 10 0431 03 70104 Inter lock dummy plug 10 0691 01 50413 MedArt Quick Safe Connect OSC for 1470nm 10 0690 01 50655 Key for key switch 10 0442 YP1555 Foot switch with protective cover 10 0432 80115 Protective Eyewear for 1470nm 7577 50185 Fuses 5x20mm T1 6AL 10 0435 FSR20T1 6 MedArt Page 25 of 32 42 0835 01 Rev A 4 13 Service and disposal In the event of malfunction or fault please contact your MedArt dealer The laser unit contains no user serviceable parts Service must be performed only by the Vari Lase laser console manufacturer or authorized representative appropriately trained by MedArt A S No attempt should be made by unauthorized personnel to open the Vari Lase laser console Failure to observe this caution may present a serious safety hazard and will void all warranties The Vari Lase laser console contains a clearly
22. er shuts down Cycle key situation switch to recover 17 PARAMETER STOP Parameter s in the internal code Laser output is disabled Resumes plug or laser is out of range normal operation when standby Pressing the Standby key 13 will has been pressed initialise the parameters to default values 18 SAFETY PARAMETER This is an internal laser system Laser shuts down Cycle key STOP situation switch to recover 22 LASER TEMPERATURE Internal system temperature too Switch off the system and let reach room temperature before powering it up MedArt Page 24 of 32 42 0835 01 Rev A 4 13 NOHD Nominal Optical Hazard Distance and MPE The Nominal Optical Hazard for the system is calculated The basis for this calculation is the wavelength of the system the max power and the parameters of the delivery system The MPE Maximum permissible exposure is also calculated 600um 0 37 600um 0 22 400um 0 22 N A Numerical aperture 0 37 0 22 0 22 Divergence d 0 76rad 0 45rad 0 45rad Optics 0 6mm 0 6mm 0 4mm NOHD 0 18m 0 30m 0 3m Spot area in 10cm 43cm 15cm 15cm Eiocm Irradiance in a distance of 3 5kW m 10kW m 10kW m 10cm measured in 7mm aperture MPE Empe 995 W m 995 W m 995 Wim Required damping KE 0 5 1 0 1 0 Min protective eye wear L1 Li 1 Protective Eye Wear Protective eye wear must be worn at all times when the laser is in operation Eye wear must meet the requirem
23. fiber gt NOHD 0 18 m QSC output 0 45rad Unique beep sequence after emission of 10 500J Volume level increase 0 70 Acoustical mark can be enabled or disabled 1W to 150W Better than 20 Class 0 Main power connection 100 240VAC 50 60Hs 30 150VA Display is lit 2 pcs T1 6AL 5x20mm Typically OWA lt 100A Typically 150uA lt 300A gt 300uA at 110V and at center tapped 240V Room temp 15 27 C 59 81 F Humidity 10 80 Air pressure 70 kPa 150 kPa type BF Not suited Page 27 of 32 42 0835 01 Rev A 4 13 Sise 30 x 27 x 17cm Weight Approx 4 5kg EMC regulations and testing EMC specifications are tested under the following conditions e Air foot activator was used e Interlock function were connected to 3m twisted pair shielded cable e Connected optical fiber had no influence on the EMC test re sults The system is developed and tested in accordance with the following regulations covering software elec trical and laser safety EN 60601 1 1 Electrical safety EN 60601 1 1 Medical electrical equipment EN 60601 1 4 2 edition Medical systems with software IEC 60601 2 Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60825 1 Ed 2 Safety of laser products IEC 62304 3 edition Medical device software The following regulations and standards has been used to obtain the necessary EMC approvals IEC 60601 1 2 EMC standards M
24. he volume changes in stantly but will not be saved until Save is pressed 101 Display Brightness This setting changes the brightness the display The brightness changes instantly but will not be saved until Save is pressed 102 Language This setting changes the language used for displayed text The selected language is not saved until Save is pressed 103 Status Display 1 This setting features the selection of status reading 1 as described on page 19 to be displayed 104 Status Display 2 This setting features the selection of status reading 2 as described on page 19 to be displayed ACCESS CODES 200 Access Code To be used by authorized service personnel only UNIT IDs 300 Serial Number The laser unit serial number is displayed 301 Type Number The laser unit type number is displayed 304 SW Version The laser unit software version is displayed TIME LOG 500 Power On Time Reports the total power on time of the laser in minutes 501 Laser Active Total Time Reports the total Laser Active time at any power level in minutes 509 Total Joules Reports the total number of joules emitted from the laser LASER SETUP ADJUST 709 Aiming Beam Level Brightness of the aiming beam The aiming beam output changes instantly but will not be saved until Save is pressed 711 Aiming Beam in STANDBY mode Defines whether or not the aiming beam is on in STANDBY mode The aiming beam outp
25. nd must be disposed of Never autoclave sterilize or use any other method to clean any part of the endovenous procedure kit If the endovenous procedure kit s due date is exceeded the entire kit must be disposed of Vascular Solutions carries no responsibility and cannot be held liable for any injury or transfer of diseases caused by reuse or misuse of any part of the single use endovenous procedure kit Installation and User Obligations Med The Vari Lase laser console is designed to operate within normal humidity and tem perature conditions 15 27 C 59 81 F The unit must be allowed to acclimatise before use following exposure to extreme temperature or humidity Do not install the unit close to radiators or other sources of heat convection The Vari Lase laser console may overheat due to excessive room temperature in combination with operation at high output power In case of overheating the laser unit will automatically shut down for a short cooling period Hereafter the laser unit will be ready for continued treatment We advise against the use of lasers at a distance of less than 2 5m from short wave or microwave equipment since unstable laser irradiation may occur No attempt should be made by unauthorized persons to open the Vari Lase laser console with a view to repair Failure to observe this caution may present a serious safety hazard and will void warranty MedArt cannot be held liable for any events
26. ndicated in patients with severe pe ripheral vascular disease as evidenced by an ankle brachial index of lt 0 5 The Vari Lase laser console procedure is contraindicated in patients with thrombus in the vein segment to be treated The Vari Lase laser console is contraindicated in patients with a history of deep vein thrombosis Warning Caution should be used in advancing the sheath in case of extremely tortuous anatomy of the great saphenous vein to minimize damage to the vessel Warning Improper endovenous laser treatment can pose a major risk to the patient s health Endovenous laser treatment shall only be carried out by appropriately trained physicians Caution Caution should be exercised with patients who have a history of peripheral vascular disease to ensure that this is accounted for during treatment Caution Caution should be used when localizing the fiber tip during the procedure The aiming light can be used as a guide but an ultrasonic Doppler is required in order to ensure correct and precise fiber tip positioning gt lt lt lt 1 Max Power density in a 600um fiber MedArt Page 6 of 32 42 0835 01 Rev A 4 13 Endovenous Procedure Kit Warning The endovenous procedure kit is single use and must never be reused Endovenous procedure kits are supplied sterile and are only sterile when the seal is intact If the seal is broken or the packaging is damaged the en tire kit must not be used a
27. not properly certified bio compatible must never be used for endovenous laser treatment to prevent toxic effects Precautions against embolic hazard Warning The Vari Lase Procedure Kit is designed for single use only Reuse of the fiber may result in hot spots causing combustion fragmented fibers and embolization Precautions against hazardous radiation exposure To ensure a safe and efficient treatment the user must always follow the procedures in this manual Warning Use of controls or adjustments to performance of procedures other than those specified herein may result in hazardous radiation exposure Page 9 of 32 42 0835 01 Rev A 4 13 Labels and Symbols hl Vascular DISTRIBUTED BY 12345 MedArt A S DK 2650 Hvidovre 9 8 A B MedArt Vari Lase 1470nm Endovenous Laser Console Label on rear of laser system An MedArt A S A DISTRIBUTED BY Vascuter S dutona inc 6484 Syama e Cart Mineespol MN 54340 USA Customer Service 1 888 240 6001 Glass IV Laser Output 1470nm 15W 635nm SmW Vari Lase PN 41 1931 02 Rov A Specifies the name and address of the manufacturer of the equipment Specifies the main power supply rating Specifies the fuse rating Specifies type BF applied part Body Floating European Directive 2002 96 EC requires that equipment bearing this symbol must not be disposed of with unsorted m
28. nto any laser beam WARNING Use surgical instruments with a dull and dark anodised finish whenever possible Shiny surfaces can reflect laser beams Take extreme care if shiny surgical instru ments are used Fire and explosion precautions Avoid exposure to combustible materials as they can ignite when exposed to certain wavelengths of laser radiation WARNING Do not operate the laser in the presence of explosive gases and liquids as well as highly concentrated oxygen The following precautions can minimise the risk of fire a Surround the surgical field with wet gauze or towels b If possible eliminate flammable materials from the surgical field Ka Page 8 of 32 42 0835 01 Rev A 4 13 gt EE gt Med C Have a fire extinguisher nearby Always place the laser unit in STANDBY when not it in use to prevent accidental firing of the laser Precautions against transfer of diseases The cleansing and sterilization instructions provided by this manual shall always be followed to avoid transfer of diseases through patient contact with operation compo nents WARNING Insufficient cleansing or sterilization of surgical components that come into contact with the patient may cause the transfer of diseases Precautions against toxic effects When undertaking endovenous treatments it is of utmost importance that all materials introduced into the veins of the patient are fully bio compatible WARNING Material that is
29. pulses are delivered via a fiber assembly Laser input port for verification purpose See paragraph Output Power Verifica tion on page 16 Display used for displaying visual infor mation to the user Air foot switch inlet and release button situated on rear panel Interlocking socket situated under the front panel See paragraph Remote Interlocking on page 18 Service connector A Intended for service use only Service connector B Intended for service use only Instructions to follow the information in the Instructions for Use See Mains Power Connection and Re placement of Fuses page 22 42 0835 01 Rev A 4 13 Operation Preparing for use 1 Carefully insert the fiber in the fiber connector located at the front of the laser unit 18 Plug the foot switch tube into the socket at the rear of the laser unit 21 Insert the mains power cord at the rear of the laser unit 27 Switch on the mains power switch at the rear of the laser unit 25 Connect interlock or insert dummy plug in the connector 22 cf Remote In terlocking 6 Enable the laser unit by inserting and turning the key in the switch 17 The aiming light will be activated and the indicator 15 will be lit 7 While the Vari Lase laser console is powering up laser emissions all keys and selectors are disabled Vari Lase laser console is by default set into STANDBY mode 8 Set the treatment parameters 9 Set th
30. r set Only the name of the pa rameter set will be changed the setting will remain unchanged Retrieving a preset parameter 1 Make sure the laser unit is in STANDBY mode 2 Press the Program key 5 and program names are displayed 3 Pressing the Program key 5 again the program parameters are displayed and added 4 Press the Left Right keys 7 8 to access the remaining program locations 5 Press the Selector key 1 4 corresponding to the parameter set to be used 6 The previously saved parameter set is recalled and the laser unit is ready to be set into READY mode Page 17 of 32 42 0835 01 Rev A 4 13 Changing the name of a program 1 Make sure the laser unit is in STANDBY mode 2 Press the Program key 5 4 times 3 Press the Selector key 1 4 corresponding to the program whose name you wish to change Use the Left Right keys 7 8 to access other program loca tions 4 Use the Left Right keys 7 8 and jog wheel 11 to change the name 5 Press Enter 10 to return to STANDBY mode Note The name of program 16 is overwritten by system defaults at the next sys tem power up Remote Interlocking The Vari Lase laser console provides an interlocking feature that can be employed for deactivation of laser emission when doors are opened to the treatment area If remote interlocking is not required The unit is supplied with a special inter locking dummy plug that has to be inserted in the interlocking socket 2
31. resulting from negligence abuse or incor rect operation of the unit Please acquaint yourself thoroughly with the instructions for use and in the event of any doubt contact your Vari Lase dealer Page 7 of 32 42 0835 01 Rev A 4 13 Safety Med The Vari Lase laser console is designed and tested for maximum safety for both the user and patient It is however ultimately the operator s responsibility to introduce safe practices which ensure the safety of personnel and equipment WARNING The Vari Lase laser console contains no user serviceable parts and only appropriately trained MedArt personnel should attempt to inspect and or repair the Vari Lase laser console Do not open the Vari Lase laser console This is dangerous and will void the manufac turer s warranty Electrical safety The system must be grounded Optical safety Avoid exposure to laser radiation during installation and operation of the Vari Lase laser console in excess of allowable limits in CFR Title 21 parts 1040 10 and 1040 11 WARNING Injury to the eyes and the epidermis can result from either direct or scat tered radiation The power density of the light emitted from lasers can be high enough to cause severe burns to the skin when directly exposed to the beam All personnel in the operating room must be protected from stray and scattered radiation by wearing the appropriate protective eye wear to guard against ocular injury Never look directly i
32. stance between portable and mobile RF communications equipment transmitters and MedArt 715 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter W 150kHs to 80MHs 80MHs to 800MHs 800MHs to 2 5GHs d 1 2VP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 23 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80MHs and 800MHs the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures objects and people MedArt Page 31 of 32 42 0835 01 Rev A 4 13 Appendix A Table A 1 Routine Maintenance Schedule Service Frequency Check the exterior of the unit mak Daily ing certain that there are no loose electrical connections or damage Test fiber Daily Verify output power Daily see page 17 Perform power meter and laser output Calibration Check that pow er meter has an accuracy of 20 or better Ch
33. structions Failure to ob serve usual safety precautions may present a risk of hazardous expo sure to laser radiation 2 The Vari Lase laser console is a Class 4 laser which emits invisible laser radiation 3 Avoid exposure to direct or scattered radiation 4 Suitable protective eyewear must be worn by patient operator and all persons in contact with the laser Protective eye wear must meet IEC 60825 and EN 207 standards 5 The fiber systems for the Vari Lase laser console must be used only with a suitable hand piece or as a delivery system in connection with endovenous treatments 6 When the laser unit is not in use ensure it is rendered inaccessible to unauthorized personnel by removing the key to disable the laser unit Warning labels on laser unit Restrictions on use of Class 4 laser equipment The Vari Lase laser system is intended solely for physicians trained in the use of these instruments The safety precautions for Class 4 laser equipment must be followed The physician is responsible for evaluating each patient s suitability to undergo laser surgery and furthermore to inform the patient about any risks involved the actual treatment pre and postoperative care and any other relevant information All use of the equipment is based on the doctors knowledge and experience The doctor is responsible for correct diagnosis and for all treatment results MedArt undertakes no liability whatsoever for an
34. symbol NOTE 1 At 80MHs and 800MHs the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be pre dicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF trans mitters an electromagnetic site survey should be considered If the measured field strength in the lo cation in which the MedArt 715 is used exceeds the applicable RF compliance level above the MedArt 715 should be observed to verify normal operation If abnormal performance i is observed additional measures may be necessary such as reorienting or relocating the MedArt 715 system Over the frequency range 150kHs to 80MHs field strengths should be less than 3V m MedArt Page 30 of 32 42 0835 01 Rev A 4 13 Recommended separation distances between portable and mobile RF communications equipment and the MedArt 715 laser system The MedArt 715 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MedArt 715 system can help prevent electromagnetic inter ference by maintaining a minimum di
35. ter Gain setting 800 to External Power meter reading PowerMeterGain Internal Power meter reading x 100 Note The PowerMeter Loss is set to 0 1 as factory default and should not be changed This value is based on the material properties of the power meter MedArt Page 32 of 32 42 0835 01 Rev A 4 13 Var 1470nm Laser Console User s Manual vascular Vascular Solutions Inc Manufacturer 6464 Sycamore Court North MedArt A S Minneapolis Minnesota 55369 USA Industriholmen 15A USA Customer Service 888 240 6001 DK 2650 Hvidovre Denmark www vasc com www treatveins com 42 0835 01 Rev A 04 13
36. trieved for faster unit setup Treatment parameter features Storage for 16 parameter sets programs Stored parameter sets can be quickly retrieved by pressing the button twice Each parameter set can have a 16 character definition After power off parameter sets are saved Power up defaults When powering up the Vari Lase laser console the parameters in program 16 are always retrieved The parameters in program 16 can be changed and stored by the user if different values are preferred Note If you change the preset DEFAULT program parameters the new default settings will be active on next power up Factory defaults are 1W CW Continuous Wave Aiming light level 100 Aiming light ON in STANDBY mode Laser Energy Emission Every 70J Laser Energy Emission Mark ON Laser Energy Beep inc 30 Program function modes The program function has 4 modes that can be selected by pressing the Program key 5 First press Shows simple parameter screen with parameter set names only Press one of the 4 Selector keys 1 4 to recall the intended program or press the Left or Right keys 7 8 to scroll between blocks of 4 parameters Second press Show detailed information about each program Again the Selector keys 1 4 recall a program and the Left or Right keys 7 8 scroll Third press Press a Selector key 1 4 to save the current set of parameters Fourth press Press a Selector key 1 4 to rename the paramete
37. unicipal waste For further details please see appropriate section in this manual Indicates the foot switch inlet Specifies the name and address of the corporation which distributes the equipment within Europe Please notice this corporation is not the same as the manufacturer Serial number label is situated at the rear panel of the laser Interlock label under front panel of the laser system Service connector A Service use only Display programming Service connector B Service use only Main CPU programming Page 10 of 32 42 0835 01 Rev A 4 13 Interlocking socket See paragraph Remote Inter locking on page 18 ComMonitor Explanatory label is affixed visibly on the left side of the system Laser Warning label is affixed visibly on the left side of the system Complies with facturing date R 1040 10 and 1040 GE ent aor Month Yes Label showing date of manufacture on rear of system asi dated June 24 2007 MedArt Page 11 of 32 42 0835 01 Rev A 4 13 Description of Operating Console Vari Lase MedArt Vari Lase laser console 1 4 10 11 12 13 14 Selector Q Program M Menu lt lt Left lt lt Right e lt gt Back lt Enter Jog wheel Emergency Stop Page 12 of 32 Parameter selection accompanying LED lit when active Provides the possibility of choosing any pre programmed set of treatment param eters accompanying LED lit when active
38. ut changes instantly but will not be saved until Save is pressed 712 Laser Energy Mark Interval Defines the amount of energy that must be emitted between each laser emission mark 713 Laser Energy Mark Beep inc Defines whether or not the laser emission mark is played with an increased sound level compared to the standard laser warning beep The increased level can never exceed the 100 system maximum 714 Laser Emission Mark Defines whether or not the audible laser emission mark enabled or not If enabled a laser emission mark is heard every time a certain amount of laser energy has been emitted corresponding to the value set in 712 MedArt Page 21 of 32 42 0835 01 Rev A 4 13 Cleaning and Maintenance Maintenance The Vari Lase laser console requires periodic calibration of the power meter No other user maintenance is required Do not expose the laser unit and accessories to moisture or extremes of tempera ture humidity Do not attempt to sterilize any part of the equipment For a routine maintenance schedule please refer to appendix A Power Meter Calibration Every 24 months the power meter must be calibrated by authorized personnel Contact your Vari Lase dealer for information Cleaning Clean the laser unit using a cloth moistened in a mixture of 30 alcohol and 70 water Pure undiluted alcohol or detergents must not be used During cleaning the laser unit must be switched off and
39. y damage or injury as a result of an application of a product which is not in strict accordance with intended use and the instructions provided with the product This waiver also includes liability for any damage and injury arising as a result of the product user s lack of qualification to evaluate the treatment applied in the actual individual circumstances or as a result of errors or mistakes com mitted by such user who would otherwise be considered as having the necessary professional skills to apply such treatment Handling Precautions Do not bend the fiber excessively Minimum bending diameter 120mm Avoid touching the fiber ends Med at Page 4 of 32 42 0835 01 Rev A 4 13 Introduction Med We congratulate you on your purchase of the Vari Lase laser system among the most advanced and user friendly diode lasers on the market It constitutes a fruition of years of experience in the field of manufacture and development of high end technology medical laser equipment The Vari Lase unit is fed by a diode laser module that can provide a continuous or pulsed wave laser beam It boasts a highly intelligent and compact user friendly interface Rigorous control amp testing techniques are employed to ensure the highest level of quality and reliability The laser system incorporates various fail safe systems and conforms to interna tional standards for medical electrical equipment IEC 60601 1 and those specifi
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