Laser Console User`s Manual
Contents
1. NOTE 1 At 80MHz and 800MHZ the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people d 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 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 26 predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Vari Lase Laser Console is used exceeds the applicable RF compliance level above the Vari Lase Laser Console should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Vari Lase Laser Console Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the Vari Lase Laser Console The Vari Lase Laser Console is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Vari Lase Laser Console can help prevent electromag2. 1W to 150W Better than 20 Class IPXO Power connection 100 240V 50 60Hz North America use center tapped circuit when connecting the equipment to 240V single phase power 30 300 VA Green indicator 2 pcs T6 3 AL Typically O lt 100uA Typically 300A lt 500pA 300pA at 110V and at center tapped 240V Room temp 15 27 C 59 81 F Humidity 10 80 Air pressure gt 0 7 atm 1 type BF Not suited 51 5 x 30 0 x 15 0cm Approx 12kg EMC Regulations and Testing EMC specifications are tested under the following conditions e Air foot activator was used e Interlock function was connected to a 3m non shielded cable e Accessory connector was connected to a 3m non shielded cable e Connected optical fibre was found to be of no influence to the EMC test results The system is developed and tested in accordance with the following regulations covering electrical and laser safety EN 60601 1 A1 Electrical safety EN 60601 1 1 Medical electrical equipment EN 60601 1 4 Medical systems with software IEC 601 2 22 Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 825 1 Safety of laser products The following regulations and standards has been used to obtain the necessary EMC approvals IEC 601 1 2 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 24 Guidance and Manufacturer s Declaration EMC Topics Guidance and manufacturer s decl
3. In the event of a fault or breakdown which may be attributable to faulty production or materials Vascular Solutions Inc will make good all repairs within a period of one year from the date of purchase The warranty covers all repair costs including labor resulting from malfunction or fault arising from normal use of the equipment as described in the instruction manual issued by Vascular Solutions Inc and supplied with the equipment The warranty shall only entitle the buyer the right to request repair or replacement of defective parts of the goods Please note that this warranty does not extend to fibers consumables eyewear and other accessories which may be supplied with the equipment Furthermore Vascular Solutions Inc shall in no event be liable for operating loss loss of time or profits or any similar consequential or indirect losses Only if personal injury or damage to property is caused directly by a defect in the products supplied which defect may be ascribed to Vascular Solutions Inc shall Vascular Solutions Inc be liable for defects in components supplied by others to Vascular Solutions Inc The equipment should always be handled with care When returned for repair the equipment should therefore be shipped in the original packing material or alternative packaging supplied by Vascular Solutions Inc to avoid any damage during transportation Vari Lase Laser Console User s Guide Page 28 Appendix A TABL
4. 10 to enter the parameters One can also press the Ready key 12 to enter the parameters and bring the unit directly into Ready mode Pressing the C key 9 during setting of a parameter terminates the setting without changing the parameter Output power The output power level is shown in the display Fluence The fluence level is shown in the display Pulse width The pulse width is shown in the display Pulse repetition frequency Output can be set to single pulse or CW The frequency is shown in the display Please note Fluence is a physical property closely connected to output power and pulse width Hence changing one treatment parameter may unavoidably affect the others To ease operation the Vari Lase laser console automatically re computes and updates all affected parameters when power fluence or pulse width is set by the user Further due to the dependency between the parameters maximum value of fluence pulsewidth and frequency depends on the setting of the other parameters Standby mode and Ready mode When the Ready key is pressed the unit enters Ready mode In this mode laser radiation will be emitted when the foot switch is pressed Pressing the M C or P key or any selector key will return the system to Standby mode Ready When the Standby key is pressed the unit enters Standby mode For safety reasons the laser should always be brought into Standby mode whenever not treat
5. FAULT fault situation switch to recover P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 21 34 CONNECT FB SENSOR This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 35 EEPROM PAGE ERROR This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 36 VAUX MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 37 VAUX MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 38 PARAMETER ERROR Parameter s in the Code Plug or Laser output is disabled Resumes laser is out of range Pressing the normal operation when the Standby key will initialize the Standby key has been pressed parameters to default values 39 PULSE TIMING ERROR This is an internal laser system Laser shuts down Cycle key fault situation Switch to recover 40 SAFETY PARAMETER This is an internal laser system Laser shuts down Cycle key ERROR fault situation switch to recover 41 CENTRE DIODE TEMPERATURE STOP Laser diode temperature high The laser is shut down Normal operation will resume when temperature is reduced 42 ATTACHED SCANNER IS A scanner which is not compatible Check whether the scanner is a NOT COMPATIBLE with the laser is attached type intended to b
6. RETRY fault situation Cycle key switch to recover retry Note Do not repeatedly provoke an over current stop The laser diodes could be damaged Reduce power and retry 4 POWER HIGH FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 5 POWER LOW FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 6 VDIODE FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 7 5V MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 8 5V MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 9 10V MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 10 10V MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 11 10V SCAN MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 12 10V SCAN MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 13 12V MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 14 12V MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situati
7. material the relative humidity should be at least 30 RH Electrical fast transient burst 2kV for power supply lines 2kV for power supply lines Mains power quality should be 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 11 596 U gt 95 dip in U1 for 0 5 cycle 40 U 60 dip in U1 for 5 cycles 70 Ur 30 dip in U1 for 25 cycles 596 Us gt 95 dip in U1 for 5 sec lt 5 U4 gt 95 dip in U1 for 0 5 cycle 40 U 60 dip in U7 for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 U gt 95 dip in U1 for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Vari Lase Laser Console requires continued operation during power mains interruptions it is recommended that the system be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospi
8. 55369 USA Vari Lase REF946 000 P N 40 0411 Rev D Explanatory label and Laser Warning label must be affixed on the front of the system Visible and invisible laser radiation Avoid eye or skin exposure to direct or scattered radiation Class 4 laser product Wavelength 810nm Max output power 35W Wavelength 635nm Max output power 5mW Serial number plate is situated on the back panel of the console 12345 MADE IN MEDICO Iw S VINE Symbol on type plate indicates Type BF Applied Part o K P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 8 Description of Operating Console x N MS bu 10 12 15 N 13 7 8 9 14 17 le oj ais z d e 9 18 19 20 21 Or Ps CON SS Say te 02 ON O o P N 42 0472 01 Rev B 07 2007 16 17 22 23 Selector used for parameter selection Selector used for parameter selection Selector used for parameter selection Selector used for parameter selection Program key Provides the possibility of choosing any preprogrammed set of treatment parameters Menu key Provides access to the various menus Step Left key This key is used for menu browsing and operation Step Right key This key is used for menu browsing and operation Clear key Used for resetting Enter key Confirms the parameters currently displayed Jog Shuttle Turning the jog shuttle clockwise will
9. avoid any damage during transportation Technical Specifications for the Vari Lase Laser Console Laser Type Output Power Range Maximum Precision Mode of Operation Wavelength Target Indicator Fiber Connection Fiber Diameter Numerical Aperture of Fiber Start Stop Functions Emergency Stop Warning Signals for Laser Radiation P N 42 0472 01 Rev B 07 2007 Continuous Wave Diode Laser Laser Class 4 IEC825 1W to 30W in steps of 1W 35W depending on transmission in connected fiber Better than 10 at maximum output power Pulsed beam or continuous wave 810nm 10nm Red indicator light through fiber 635nm Quick Safe Connect 600um or 400um 0 37 or larger Foot switch Large button on front panel Flashing yellow indicator and intermittent sound Vari Lase Laser Console User s Guide Page 23 Laser Ready Warning Laser Ready Time Out Emission Frequency Range Pulse Width Nominal Ocular Hazard Distance Beam Divergence Output Power Meter Range Accuracy Protection Against Ingress of Water Power Supply Power Consumption Indication of Power Connection Fuses Patient Leakage Current Earth Leakage Current Operating Environment Safety Class Application in Presence of Flammable Anaesthetic Mixtures Size Weight Yellow indicator on front panel and target indicators 250 seconds Min 0 3Hz Max 100Hz 10 1000 msec Bare fiber 10m Bare fiber 0 7 rad
10. down Normal STOP situation The Power Factor operation will resume when Controller temperature is too high temperature is reduced This temperature can be preset in Service Setting mode 26 DRIVER TEMPERATURE This is an internal laser fault The laser is shut down Normal STOP situation The Laser Diode Driver operation will resume when temperature is too high This temperature is reduced temperature can be preset in Service Setting mode 27 CONNECT FIBER All laser controls are disabled until Resumes normal operation when a fiber is mounted the fiber is mounted 28 CONNECT INTERLOCK All laser controls are disabled until Resumes normal operation when an interlock connector switch is connected installed Pin 2 GND and 5 Interlock input must be shorted on the interlock connector 29 CONNECT CODEPLUG All laser controls are disabled until Resumes normal operation when a Code Plug has been installed connected but clears user settings to default values 30 CONNECT SENSOR This is an internal laser system Laser shuts down Cycle key BOARD fault situation Switch to recover 31 AIMING LASER FAULT The aiming laser draws an Laser shuts down Cycle key unusually high current and might switch to recover be damaged 32 SETTING WRITE ERROR This is an internal laser system Laser shuts down Cycle key fault situation Switch to recover 33 IC BUS RELEASE This is an internal laser system Laser shuts down Cycle key
11. socket for 220V power supply in North America the outlet must be of the center tapped type Vari Lase Laser Console User s Guide Page 18 Connection and Release of Foot Switch A connector 23 for the foot switch is provided on the front panel For connection simply plug in the foot switch connector For release push the release button 22 Trouble Shooting Symptom Possible Cause Recommendation No light in display when switched on e Defective power fuses e Low power supply e Change fuses e Wait at least 5 sec for power up Low output power e Defective fiber e Low pulse width combined with low frequency e Change fiber e Choose higher pulse width Fluence pulse duration or frequency cannot be set as high as it could be previously Fluence is a physical property closely connected to output power and pulse width Due to the dependency between the parameters maximum value of fluence pulse width and frequency depends on the setting of the other parameters Decrease the value of one or more of the other treatment parameters A temperature fault message is displayed and the Vari Lase laser console stops radiating e Overheated diode due to combination of high room temperature high power setting and high duty cycle e Internal laser cooling system ineffective e Wait a few seconds for the System to cool down If the problem remains try to reduce room temperature
12. E A 1 ROUTINE MAINTENANCE SCHEDULE Service Frequency Performed by Check the exterior of the unit Daily Clinic or hospital staff making certain that there are no loose electrical connections or damage Test of fiber Daily Clinic or hospital staff Verify output power see page 12 Daily Clinic or hospital staff Perform Power Meter and laser Every 24 months Vascular Solutions Inc authorized output Calibration Check that personnel only power meter has an accuracy of 2096 or better Check that laser output has an accuracy of 1096 or better Use an external calibrated power meter for both checks TABLE A 2 POWER METER CALIBRATION PROCEDURE Note This chapter highlights the instructions for the Verification of Calibration of the Vari Lase laser system These instructions are provided to comply with Federal Regulations These procedures should be performed only by a Vascular Solutions Inc authorized representative Calibration verification performed by any other individual will void any manufacturer s warranty stated or implied 1 Enter Service mode 2 Setthe Power Meter Gain setting 800 to 10096 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 head temperature is displayed at the end of the measurement cycle 4 Setthe l
13. Guidance and Manufacturer s Declaration EMC Topics eseeeeseeeeeeeeee eene enne nnn 25 Warranty Terms and Provisions uuueeeeeeeeeeeeeeeeeeeeeeeeeee e seien nnn nn nnnh nnn nnn nnn nnn nnn nana nana nn nenne ennnen enee 28 PADDONGIX PEE 29 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 2 Caution 1 The Vari Lase laser console is a Class 4 laser which emits invisible laser radiation 2 Avoid exposure to direct or scattered radiation 3 Patient operator and others in contact with the laser must wear suitable protective eyewear Protective eyewear must be of a quality corresponding to the standards IEC 825 and EN 207 4 The Vari Lase laser console should be used only with the Bright Tip laser fiber VARI LASE CONSOLE IMPORTANT NOTICE This Vari Lase console is sold for use solely with Vari Lase Bright Tip fibers and procedure kits Vari Lase Bright Tip fibers incorporate a ceramic distal protective tip which prevents the vessel wall from contacting the fiber transmission core Vascular Solutions does not sell bare tipped fibers for use with this console and Vascular Solutions instructs and recommends that only Vari Lase Bright Tip fibers be used with this console Please consult the Vari Lase console manual and Instructions for Use for complete information 5 Read the operating instructions thoroughly before connecting the unit to the powe
14. Reduce output power Reduce duty cycle shorter dwell time longer breaks e Return for repair Call Vascular Solutions Inc Customer Service Aiming beam has faded or is looking diffused As the aiming beam passes through the same optical system as the working beam it provides a good method of checking the unit If the aiming beam spot is not present at the distal end of the fiber its intensity is reduced or if it looks diffused the fiber might be damaged Check the unit by undertaking an output power verification as described in the paragraph Output Power Verification on page 12 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 19 Warnings and Stop Codes The table below provides a complete overview over the various warnings and fault messages that can be displayed by the Vari Lase laser console If one of the faults occurs repeatedly note the message and contact Vascular Solutions Error Error message Cause Recovery code 0 EMERGENCY STOP Emergency button has been Laser shuts down Cycle key pressed switch to recover 1 I O SYSTEM FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 2 DETECTOR STOP This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 3 OVER CURRENT STOP _ This is an internal laser system All laser circuits are shut down REDUCE POWER AND
15. VariszLase Laser Console User s Manual lll vascular Manufactured for Vascular Solutions Inc 6464 Sycamore Court Minneapolis MN 55369 763 656 4300 www vascularsolutions com Vari Lase Laser Console Instruction Manual Copyright 2007 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 1 Table of Contents IC EOdemlJicEeee 2 CI DII M M 3 Digestum 4 Intended Use iine uu dee eee Lei eise as 4 4 Clinical ProCere m 6 Installation and User Obligations lllleseeeeseeee eene enne nnne nn nnn nnn nnn nnn nen nn nnn nnne ennaa 6 Important Safety Information eeeseeeeeeeeeseeesee eene eene eene nenne nnne nnn nnn nnn nnns nna nnn n nnn nnn nnne nnne nnn nnns 7 IE TIEN DIAC 8 Description of Operating Console 1 e eas tat cu a uana na enda cta aa arenas Sana a Ela cstadavdeustestesdevessarsazesdandurds 9 lp icu me 11 Output Power Verification 2 eanan a eno ca ra Leda eaa va ga Do Les kae a n a anpa DAR Le a EG DE Re DRE anrai 13 Definition and Retrieval of Treatment P
16. arameter Sets sese 13 Remote Intetlocking 5 5 1re reri ee Lene terea k ee ene s aa E ee Lean E oae aa ep oo E cai en epos aaa uni Ta aa ea gabe eaae ae eaa ee aa sees ees e eainiie 14 System Set up and Status Display Controls eeeesessssesessseeeeee eene nennen nnne nennen nnns 15 Laser Setting 16 Service Adjustment Functions ccceseeseeeee eee eeeeeeeesneeeeeeeeeeeeeenesssaaeeeseeseeeeessessaaeeeeeseaeeeeeesseasaneaenennnegs 16 Cleaning and UCL eene n enhn nnn nn nnns ann naeh nennen nsns asse nnn Annan nnne 18 Power Connection and Replacement of Fuses eeseeseeeeeseeeee ee eene nnnn nnne nnn nnne nennen nnne nnn nnn 18 Connection and Release of Foot Switch eeeeesseseeesseeeeeeeennn nennen nennen nnn rnnt nnn nnns 19 TrOUBIE SHOOUING mE 19 Warnings and Stop Cod6s uiiiiiiciee icta iria a eva as cca sten ra as cacbaastundsacaswsdassnausaactessesugsaiebadaasccsedivaaasvaasecegenias 20 Protective EVeWedAL 5 1e een rei eee eben bo reae reus ea Pampa ere EROR E en oen aa Da aa eae eade A p essa eaa ETT 23 lini Meet ec cT NC SM 23 Storing and Transportatior 5 2 it cria rop rk es sao ecc ca ie so naa ga an pco ra sc seau PeKaO KTaO Lua Riga vba CR anise a dn 23 Technical Specifications for the Vari Lase Laser Console eese 23
17. aration electromagnetic emissions The Vari Lase Laser Console 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 Vari Lase Laser Console uses RF energy only for its internal CISPR 11 function 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 Vari Lase Laser Console is suitable for use in all Harmonic emissions Class A establishments including domestic establishments and those IEC 61000 3 2 directly connected to the public low voltage power supply Voltage fluctuations Complies network that supplies buildings used for domestic purposes flicker emissions Guidance and manufacturer s declaration electromagnetic immunity The Vari Lase Laser Console 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 Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8kV air 6kV contact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic
18. aser power to 30W using service setting 705 and measure the output power using an external calibrated power meter 5 Point the fiber into the internal power meter and measure the power using service setting 802 6 Setthe Power Meter Gain setting 800 to External Power Meter Reading Power Meter Gain 100 Internal Power Meter Reading Note The Power Meter Loss is as default set to 0 1 by the factory and should not be changed This value is based on the power meter head material properties P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 29
19. e compatible Check whether the scanner or the scanner cable is damaged Cycle key switch 43 SCANNER ERROR An error has occurred while Check whether the scanner or the interfacing to the scanner scanner cable is damaged Cycle key switch 44 DIODE TEMP HIGH A high diode temperature is All fans will be working at full FAULT measured speed to cool the system P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 22 Protective Eyewear Protective eyewear must be of a quality corresponding to the standards IEC 825 and EN 207 According to these specifications the protective eyewear must be marked with the following Type of laser D Continuous wave laser Wavelength 800 830nm Or larger wavelength interval Protective class L4 Or higher Service In the event of malfunction or fault please contact Vascular Solutions Inc Customer Service at 888 240 6001 or 763 656 4300 Storing and Transportation The system should be stored under temperature conditions in the range of 0 50 C 32 122 F air humidity below 80 and air pressure gt 0 7 atm If transporting the unit to other destinations for instance to another clinic or in connection with service the Vari Lase laser console should always be transported in the original packaging material When returned to Vascular Solutions for service or repair the equipment must be shipped in the original packing material to
20. e damage to the fiber the QSC SMA adapter or the laser console 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 fiber s lifespan 11 While the Vari Lase laser console is powering up laser emission is disabled all keys and selectors are disabled and parameters are set to default WARNING Do not place the QSC adapter into the laser console without a Bright Tip fiber connected or else the laser beam may be activated 12 Setthe treatment parameters see below 13 Bring the Vari Lase laser console into Ready mode by pressing the Ready key 12 After a required 3 seconds safety delay the unit will become ready and the Laser Ready indicator 15 will be lit Vari Lase Laser Console User s Guide Page 11 14 Start treatment using the foot switch Each time the foot switch is activated laser radiation will be emitted and the Laser Emission Indicator 16 will be lit Setting of treatment parameters Power fluence pulse width and pulse repetition rate can be set to prepare for the required treatment Operating the selectors 1 2 3 and 4 and the jog shuttle 11 does the setting The treatment parameter to be set is selected by pressing the associated selector 1 2 3 or 4 located below the display When a parameter is selected it can be modified by turning the jog shuttle When all parameters are properly set for treatment press
21. e protection must be worn by the patient and all operating personnel to protect from damage by direct or reflected laser energy Complications As with all medical procedures complications may occur For the endovenous laser treatment of varicose veins these may include e vessel perforation e thrombosis e pulmonary embolism e phlebitis e hematoma e infection e paresthesia e Skin burns Vari Lase Laser Console User s Guide Page 4 P N 42 0472 01 Rev B 07 2007 Precautions The Vari Lase procedure should be performed only by physicians who are thoroughly trained in percutaneous endovenous techniques and procedures and knowledgeable in the use of this laser console Inspect the laser fiber before use and avoid touching the laser lenses and Bright Tip fiber ends to avoid damage to the fiber and the instrument optics Exercise care in handling of the Bright Tip laser fiber during the procedure to reduce the possibility of accidental breakage bending or kinking Important Note Additional information concerning the Bright Tip fiber handling and use can be found in the instruction manual provided with the Bright Tip laser fiber Vari Lase Laser Console User s Guide Page 5 Clinical Procedure Follow the Instructions for Use accompanying the endovenous laser procedure kit and components being used and accepted medical practice The techniques procedures and equipment described do not represent ALL medically acceptab
22. ear to guard against ocular injury Never look directly into any laser beam Use surgical instruments with a dull and dark anodized finish whenever possible Shiny surfaces can reflect laser beams Take extreme care if shiny surgical instruments are used Fire and explosion precautions Combustible material can ignite if 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 minimize the danger of fire a Surround the surgical field with wet gauze or towels b If possible eliminate flammable materials from the surgical field c Have a fire extinguisher nearby Always place the laser in Standby mode whenever possible This will prevent accidental firing of the laser Vari Lase Laser Console User s Guide Page 7 Precautions against transfer of diseases The cleansing and sterilization instructions provided by this manual must always be followed to avoid transfer of diseases through patient contact with operation components WARNING Insufficient cleansing or sterilization of operation components that come into contact with the patient may result in transfer of diseases Labels and Symbols The type plate is situated at the rear of the laser system eo Manufactured for 100 240Vac 2xT6 3AL 250V Vascular Solutions Inc 50 60Hz 6464 Sycamore Court Minneapolis MN
23. ess Step Right or Step Left to select another digit Press the Save selector to store the new value The service settings are described in more detail in the following table Vari Lase Laser Console User s Guide Page 16 USER SETTINGS 100 Sound Level This setting changes the volume of the internal speaker The volume changes instantly but will not be saved until Save is pressed 101 Display Contrast This setting changes the contrast of both displays The contrast changes instantly but will not be saved until Save is pressed 102 Language This setting changes the language used for displayed text 103 Status Display 1 This setting features the selection of status reading 1 as described on page 14 to be displayed 104 Status Display 2 This setting features the selection of status reading 2 as described on page 14 to be displayed ACCESS CODES 200 Access Code This setting is to be used by authorized service personnel only UNIT IDs 300 Serial Number The unit serial number is displayed here 301 Type Number The unit type number is displayed here 304 SW Version The software version is displayed here CODEPLUG SETTINGS 418 Aiming Beam Level Brightness of the aiming beam The brightness changes instantly but will not be saved until Save is pressed 419 Aiming Beam Color Determines the color of the aiming beam TIME LOG 500 Power On Time Reports the to
24. increase any selected parameter turning it counter clockwise will decrease the parameter Ready key When activated the laser is ready to emit energy See Operation section on page 10 for more details Standby key When activated the Vari Lase laser console is placed in Standby mode Parameters can be modified but no laser output can be generated Emergency Stop key See Operation section on page 10 Laser Ready Indicator Lit when the Vari Lase laser console is placed in Ready mode and foot switch is not activated Laser Emission Indicator Lit when laser emission occurs Key switch Unit is disabled when the key is in off position or when the key is removed Lit when the unit is activated Vari Lase Laser Console User s Guide Page 9 P N 42 0472 01 Rev B 07 2007 18 19 20 21 22 23 24 25 26 27 Bright Tip Fiber Connection Laser pulses are delivered via a fiber assembly Not currently in use Slot for Code Plug connected to the fiber Laser Beam Input Port for verification purpose See paragraph Output Power Verification on page 12 Release button for air foot switch connector Connector for air foot switch Connector for Remote Interlock Power Switch Power Lead Connector Fuse Holder and Voltage Selector see paragraph Power Connection and Replacement of Fuses on page 17 0 Manufactured for 100 240Vac 2xT6 3AL 250V Vascular Solut
25. ing In Standby mode laser radiation cannot be emitted If the system remains idle in Ready mode for 250 seconds it will automatically return to Standby mode for the sake of operator and Standby patient safety P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 12 Start and stop of laser radiation CAUTION When the Laser Ready Indicator is on the Vari Lase laser console emits radiation immediately upon activation of the foot switch When the laser is active the yellow Laser Emission Indicator flashes and an audible tone signal will be heard Foot Switch Operation When the foot switch is pressed the Vari Lase laser console starts radiating Releasing the footswitch stops emission Emergency Stop Key When the Emergency Stop Key 14 is pressed the Vari Lase laser console stops emitting radiation and all functions are blocked The power switch 25 must be turned OFF for approximately 15 seconds and ON again for restart Output Power Verification The Vari Lase laser console provides advanced built in facilities for output power verification purpose 1 Press the M key 6 to enter the Function Menu 2 Press the Measure Power selector 1 3 Align the tip of the handpiece with the sensor opening 21 and keep it aligned during the entire measuring process 4 Activate the footswitch and keep the footswitch pressed during the whole measuring process Any meas
26. ions Inc LU He o N vascular 6464 Sycamore Court 300VA Minneapolis MN 55369 USA Vari Lase REF946 000 OLUTIONS P N 40 0411 Rev D 25 26 27 Vari Lase Laser Console User s Guide Page 10 Operation P N 42 0472 01 Rev B 07 2007 Preparing for use 1 Plug the foot switch tube into the socket 23 2 Switch on the power switch at the rear of the unit 25 3 Connect interlocking or insert dummy plug in the connector located at the rear of the unit 24 4 Enable the unit by inserting and turning the key in the switch 17 Check that the indicator above the switch is lit 5 Visually inspect the QSC adapter lens for contamination or damage 6 Insert code plug with QSC connector SMA to QSC 7 Remove the protection cap from adapter the Bright Tip laser fiber connector 8 Insert the Bright Tip laser fiber connector carefully in the SMA socket of the SMA to QSC adapter Tighten the screw carefully 9 Remove plug from the laser port 10 Insert the SMA to QSC adapter in the Vari Lase laser console The SMA to QSC adapter is marked with a plate showing an appropriate reference number 50xxx 400um fibers To facilitate the use of 400um fibers the QSC SMA adapter Ref 50600 must be used 600pm fibers To facilitate the use of 600um fibers the QSC SMA adapter Ref 50599 must be used Caution Always use the correct combination of fiber and QSC SMA adapter Incorrect use may lead to sever
27. le protocols nor are they intended as a substitute for the physicians experience and judgment in treating any specific patient Each Vari Lase Endovenous Laser Procedure will require the following components e Vari Lase 810nm Laser Console e Safety eyewear for patient and all operating personnel e Duplex ultrasound console and transducer for mapping and guidance e Procedure kit and sterile procedure pack Installation and User Obligations The Vari Lase laser console is designed to operate within normal room temperature 15 27 C 59 81 F and humidity conditions The unit must be allowed to acclimatize before use following exposure to extreme temperature or humidity Do not install the unit close to radiators or other sources of heat convection The unit may overheat due to excessive room temperature in combination with operation at high output power In case of overheating the system will automatically shut down for a short cooling period After a few seconds the system will be ready for continued treatment We advise against the use of lasers at a distance of less than 2 5 meters from short wave or microwave equipment since unstable laser irradiation may occur No attempt should be made by unauthorized persons to open the unit with a view to repair Failure to observe this caution may present a serious safety hazard and will void the warranty Vascular Solutions Inc cannot be held liable for events resulting from
28. ned this number will be overridden 6 For easy operation an optional textual name may be assigned too To do this press Selector key 2 to enter the Change name function use the Step Left 7 Step Right 8 and the Jog Shuttle 11 to spell out the textual name 7 Press Selector key 4 to save the parameter set together with the assigned number and name Or press the Selector key 3 to exit without saving the parameters Retrieving a parameter set Go through the following steps to retrieve a predefined set of parameters gt 1 Press the P key 5 2 Turn the Jog Shuttle 11 until the number or name of the desired set of parameters appears in the upper rightmost corner of the display 3 Press 10 or the P key 5 to select the parameters for treatment or press the Ready key 12 to select the parameters and bring the unit directly into ready mode Remote Interlocking P N 42 0472 01 Rev B 07 2007 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 interlocking dummy plug that must be inserted in the interlocking socket 24 in case no interlocking is required If remote interlocking is required If the interlocking feature is required to ensure a safe entry to the treatment area an appropriate micro switch may be mou
29. negligence abuse or incorrect operation of the unit Please acquaint yourself thoroughly with the instructions for use and in the event of doubt contact Vascular Solutions Inc P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 6 Important Safety Information ie D P N 42 0472 01 Rev B 07 2007 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 Electrical safety WARNING Only Vascular Solutions authorized personnel should attempt to inspect and or repair the Vari Lase laser console The system must be protectively connected to ground If used in North America at 220V the power circuit must be center tapped Avoid exposure to laser radiation in excess of the allowable limits listed in Title 21 U S Code of Federal Regulation parts 1040 10 and 1040 11 during the installation and operation of the Vari Lase laser console Optical safety WARNING Injury to the eyes and the epidermis can result from either direct or scattered 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 WARNING All personnel in the operating room must be protected from stray and scattered radiation by wearing the appropriate protective eyew
30. netic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Vari Lase Laser Console 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 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz d 124 P d 124P d 23 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 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 metres 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 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 27 Warranty Terms and Provisions P N 42 0472 01 Rev B 07 2007 This equipment has been manufactured by MedArt A S Asah Medico A S for Vascular Solutions Inc to rigorous standards of production and quality control based on international standards
31. nted on the doorframe in a way that ensures contact closure when the door is closed The jumper between pin 2 and 5 of the dummy plug must be removed and the micro switch must be wired to these pins instead Multiple doors can be wired in series if needed Vari Lase Laser Console User s Guide Page 14 System Set up and Status Display Controls P N 42 0472 01 Rev B 07 2007 A number of system features which may be set up by the user exist To do this please follow the below procedure 1 Make sure the unit is in Standby mode 2 Press the M key 6 to enter the Function Menu 3 Press Selector 2 to enter the User Setup function Four set up options will be displayed Press the Step Right or the M key to display two more These six options are described below Sound Level Turn the Jog Shuttle to change the volume of the internal speaker Press 10 when a satisfactory volume is found Display Contrast Turn the Jog Shuttle to change the display contrast Press 10 when a satisfactory display contrast is found Aiming Beam Turn the Jog Shuttle to adjust the brightness of the aiming beam Press 4 10 when the desired brightness is found The effect will be visible next time Ready mode is entered Choose Language Turn the Jog Shuttle to see the languages which can be used for display text Press 10 when the desired language is found Status Display 1 Status Display 2 The user can choose two selectable s
32. on switch to recover 15 32V MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 16 32V MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 20 17 5V MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 18 5V MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 19 5V UREG MIN FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 20 5V UREG MAX FAULT This is an internal laser system Laser shuts down Cycle key fault situation switch to recover 21 POWER DOWN Low power supply Saves data internally and shuts down system Check power 22 TEMPERATURE 1 STOP Laser diode temperature high The laser is shut down Normal operation will resume when temperature is reduced 23 TEMPERATURE HIGH Internal temperature is too high The laser is shut down Normal operation will resume when temperature is reduced 24 TEMPERATURE 2 STOP Laser diode temperature high The laser is shut down Normal operation will resume when temperature is reduced 25 PFC TEMPERATURE This is an internal laser fault The laser is shut
33. r and prior to use The unit must be set regulated and used in accordance with the instructions for use Failure to observe usual safety precautions may present a risk of hazardous exposure to laser radiation 6 When the laser is not in use ensure that it is rendered inaccessible to unauthorized personnel Remove the key to disable the unit Restrictions on use of Class 4 laser equipment Visible and invisible laser radiation Avoid eye or skin exposure to direct or scattered radiation Class 4 laser product Wavelength 810nm Max output power 35W Wavelength 635nm Max output power 5mW U S Federal Law restricts this device to sale by or on the order of a physician 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 P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 3 Introduction We congratulate you on the purchase of this Vari Lase laser console among the most advanced and user friendly diode lasers available It constitutes the fruition of many years of experience in the manufacturing and development of high technology medical lase
34. r equipment Rigorous quality control and factory testing ensure the very highest levels of quality and reliability The unit incorporates various fail safe systems and conforms to international standards for medical electrical equipment IEC 601 1 and those specifically for laser equipment IEC 601 2 22 and IEC 825 This manual is intended to provide you with an overview of the operation of this laser console Further instructions regarding its use in particular situations may be obtained in the Instructions for Use provided with the Vari Lase Endovenous Laser Procedure Kit Intended Use P N 42 0472 01 Rev B 07 2007 Indications The Vari Lase procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity Contraindications The Vari Lase procedure is contraindicated in patients with an aneurysmal section in the vein segment to be treated The Vari Lase procedure is contraindicated in patients with severe peripheral vascular disease as evidenced by an ankle brachial index of 0 5 The Vari Lase procedure is contraindicated in patients with thrombus in the vein segment to be treated Warnings Treatment of a vein located close to the skin surface may result in a skin burn Paresthesia may occur from thermal damage to adjacent sensory nerves Appropriate ey
35. t is in Standby mode Press the M key Press Step Right Press the Service Setup selector The unit is now brought into Service mode The following six groups of service settings are accessible to the user USER SETTINGS Standard user controls like display contrast sound level etc ACCESS CODES Access codes can be entered for service or maintenance purpose For safety reasons access is only granted to authorized personnel akwnns UNIT IDs Reports various IDs associated with each individual Vari Lase laser console CODEPLUG SETTINGS Standard user set up values which are stored in the Code Plug TIME LOG This group contains time logging and timing functions LOG FUNCTIONS Provides the possibility of copying the internal unit operation log to the Code Plug which can then be sent to the Vari Lase laser console manufacturer for inspection Service mode controls e Use the Jog Shuttle to browse the service settings e Use the Step Left or Step Right keys to change from one group of service settings to another e Use the Change selector to enable changing of a parameter please note the Change feature only exists for a subset of the parameters e There are two types of parameter input modes e Limited Range Parameters Operate the Jog Shuttle to change the parameters Press the Save selector to store the new value e Large Number Selection Operate the Jog Shuttle to change the value of the current digit Pr
36. tal environment NOTE Ur is the AC mains voltage prior to application of the test level P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 25 Guidance and manufacturer s declaration electromagnetic immunity The Vari Lase Laser Console 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 communications equipment should be used no closer to any part of the Vari Lase Laser Console including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 124P Conducted RF 3Vrms 3Vrms IEC 61000 4 6 150kHz to 80MHz d 1 2 P 80M to 800MHz Radiated RF 3V m 3V m IEC 61000 4 3 80MHz to 2 5GHz d 2 3VP 800M to 2 5GHz 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 metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol
37. tal 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 LOG FUNCTIONS 1101 Copy Log to Code Plug Press Selector key 4 to copy the entire contents of Internal Apparatus Log and all the internal laser settings to the inserted Code Plug Press Selector key 1 to confirm and wait for the copying to complete it may take some time The log is stored in a previously unused part of the Code Plug all previous Code Plug contents remains unchanged and the system can be used as normal P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 17 Cleaning and Maintenance The Vari Lase laser console requires no maintenance except for periodic calibration of the power meter Please refer to Appendix A for a routine maintenance schedule Do not expose the unit or accessories to moisture or extremes of temperature or humidity Do not attempt to sterilize any part of the equipment but the handpieces Calibration of Power Meter Every 24 months the power meter should be recalibrated Cleaning Visually inspect the QSC adapter lens before each use for contamination or damage Use only compressed air to clean the lens if contamination is present Replace the QSC adapter if the contamination cannot be removed with compressed air Clean the unit using a clo
38. tatus readings to be displayed during operation The two readings can be chosen from a group of four e None No status is displayed e Pulses The number of pulses generated e ActiveTime The amount of time laser has been radiated e Joules The amount of joules generated One reading is chosen by using menu entry Status Display 1 and the other by using menu entry Status Display 2 Use the Jog Shuttle to browse through the four options Press 10 when the desired status reading is found The reading will be displayed whenever the unit is in Standby or Ready mode The user may want to reset the readings e g before a patient treatment is initiated To do this please follow the below procedure 1 Make sure the unit is in Standby mode 2 Press the M key 6 to enter the Function Menu 3 Press Selector 3 to reset the status display readings Vari Lase Laser Console User s Guide Page 15 Laser Settings The Vari Lase laser console permits the user to change the fiber system and still gain the full benefit of the displayed operation parameters Service Adjustment Functions P N 42 0472 01 Rev B 07 2007 The Vari Lase laser console provides the user with various features for setting and reading of equipment parameters These adjustable parameters are organized into six service groups that can be accessed when the unit is in Service mode Follow the procedure below to enter Service mode Make sure the uni
39. th moistened in a mixture of 30 alcohol and 70 water Pure undiluted alcohol or detergents should not be used During cleaning the unit must be switched off and disconnected from the power supply Any dirt must be cleaned from the fiber lens The combination of high output power and a delicate fiber necessitates a clean fiber lens to avoid damage Even specks of dust may be sufficient to cause fatal contamination The touch of a finger rubbing of the tip against a piece of clothing or occurrence of airborne dust can contaminate the lens Power Connection and Replacement of Fuses Small slot P N 42 0472 01 Rev B 07 2007 The equipment is connected to the power via the power connector 26 on the back panel of the unit and the power switch 25 is switched ON The unit is equipped with 2 pcs glass fuses T6 3AL which protect the unit in case of electrical fault If the unit cannot be switched on try to replace the fuses before the unit is sent in for repair To replace the fuses 1 Remove the power cord 2 Referto the picture to the left Insert a screwdriver into the small slot as shown and release the fuse socket by wrenching the screwdriver 3 Pull out the fuse socket 27 4 Replace the fuses and re insert the fuse socket The fuse socket can be inserted in either of the two possible directions as the Vari Lase laser console automatically switches to the actual input voltage When inserting the fuse
40. urement interrupted by the release of the footswitch will be ignored 5 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 6 The measured output stated in terms of percentage of expected output is displayed 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 measurements are undertaken CAUTION All personnel in the operating room must be protected by protective eyewear during the measurement Definition and Retrieval of Treatment Parameter Sets The Vari Lase laser console features the possibility of defining 16 different sets of treatment parameters which can later be retrieved for fast unit set up The parameters are not affected by unit power off P N 42 0472 01 Rev B 07 2007 Vari Lase Laser Console User s Guide Page 13 Definition and storage of a parameter set Go through the following steps to define a set of treatment parameters for later retrieval 1 Make sure the unit is in laser Standby mode 2 Use the Selector keys 1 through 4 and the Jog Shuttle 11 to define a set of treatment parameters 3 Press the M key 6 to enter the Function Menu Press Selector 4 to enter the Save Program function 5 Turn the Jog Shuttle 11 to assign a unique number to the defined set of parameters Any set previously assig
Download Pdf Manuals
Related Search