Vectra Genisys User Manual
Contents
1. Energy Measured in Joules energy equals the treatment time multiplied by the power More importantly Energy Density equals the power output multiplied by the treatment time and divided by the spot size cm2 This gives a more specific measurement of energy delivered Frequency Pulsed frequencies are selectable from 8 to 10 000 Hz Laser Head The clear lens face of the applicator that contacts the patient s skin It consists of laser diodes with or without LED s or SL Dis depending on the applicator Power Measured in Watts W power wattage is directly proportional to the treatment time and penetration of the laser light energy High powered diodes will reduce patients treatment time and give a higher amount of energy at a deeper depth Power output can be either continuous or pulsed Power Density Ratio of power divided by treatment time Pulsed Mode This is the ratio of the On time to Total time of the cycle expressed as a percentage The lower the percentage the lower temporal average intensity 100 is continuous laser light Pulsed Mode is 90 on and 10 off NOTE Pulsed Mode is also equivalent to Duty Cycle Spot Size Area of the LED SLD or laser beam when it leaves the face of the lens Treatment Area Area of tissue affected by LED SLD or laser when wavelength divergence angles and depth of penetration are factored This is the area used to calculate dosage Treatment Time Measure2. chattanooga Chattanooga Group is an ISO 13485 Certified Company Manual Model 2784 Vectra Genisys Laser TABLE OF CONTENTS FOREWORD EE B Product Description 2 cece ABOUT LASER LIGHT THERAPY B gt Precautionary Instructions 2 2 0 0 c ccc eee eee e eee 3 aE ETETE E EE N 3 4 B gt Wang 4 5 B gt Dangers onua caaea 6 B gt Overview of Laser Light Theranpm 7 9 B gt Overview Common Terms ccc eeeeeeeeeeeeeeeeeeees 8 9 lee EE 10 B gt Adjunctive se 10 B gt Contraindications 0 cece cece ene 10 11 B gt Additional Precautions 00 e eee eee eee 11 B Preventing Adverse Effects 00 c uieii 11 SEENEN ANS ENNEN ENEE e 11 KEE EE EE EEN 11 B Factors that Affect Treatment 0 000s 12 NOMENCLATURE s es ssesesososeesesososeesssee 13 19 Belle Ve LEE 20 B gt Unit Specifications 00 cece eee rrr 20 B Laser Light Technical Specifications 0 e eee 21 B gt Description of Device Markings 0 cee eee eee 21 B gt Laser Applicator Specifications 0 naaa 22 23 B gt Laser Protective Eyewear Specifications 0000 24 fe Toc 211 25 31 B gt Installing the Laser Interlock Ierger EEN 25 B Mounting the Unit on the Wall 26 28 B gt Installing the Battery Dach 29 30 CHARGING amp USING THE BATTERY PACK 6 31 MP OPERATION scccccsesivssssaeusisaceciseinaanoenas 32 60 B Entering amp Changing the pn 32 34 B
3. Clinical Resources Select this button to access the following functions e Clinical Indications e Utilities e Retrieve User Protocols e Save User Protocols Use the Up and Down arrow buttons to navigate through the available options STOP Select this button to stop a treatment session TOC 15 P N OM E N C LATU RE i Vectra Genisys Laser Frequency Back Use this button to return to the previous window and toggle between 12 preset frequencies Down Arrow When the window displays a list of options press the Down Arrow button to scroll down the list PAUSE Use this button to pause the treatment session When pressed the P icon displays To restart therapy press the PAUSE button Accessory Panel The Accessory Panel serves as a port of connection for the various accessories Laser Interlock Door Interrupt Switch Connection This option allows you to set up a switch similar to the laser stop switch that interrupts treatment when the door of the treatment room is opened during a therapy session Laser Stop Switch Connection As a Safety measure and to minimize any apprehension it is recommended that you always allow the patient to hold the Laser Stop Switch during laser light therapy When the red button on the end of the switch is pressed a beeper sounds and the treatment is paused Parameters can then be verified and changed if necessary and therapy can be resumed The Laser Stop Switch is very sensitive E
4. To select an indication for a patient do the following 1 Press the Clinical Resources button The Clinical Library window displays S Using the Up Arrow and Down Arrow buttons highlight Clinical Indications and press the DISPLAY Enter button The Clinical Indications menu displays 39 OPERATION USING CLINICAL INDICATIONS CONTINUED 3 Using the Up Arrow and Down Arrow buttons highlight the appropriate indication The indications displayed depend upon the applicator used Vectra Genisys Laser 4 Press the DISPLAY Enter button to accept the highlighted selection 5 If available highlight the appropriate laser light tissue depth with the indication you selected using the Up Arrow and Down Arrow buttons 40 A P E RAT l O N Vectra Genisys Laser USING CLINICAL INDICATIONS CONTINUED 6 Press the DISPLAY Enter button to accept the highlighted selection You are returned to the main window with the settings from the indication you selected displayed d Review the final indication parameters for the laser light treatment Make any necessary modifications or corrections 8 Press the DOSAGE button either the up or down arrow to adjust the output to the prescribed dosage NOTE The Dosage and the Treatment Time are directly correlated Whenever Dosage is changed the Treatment Time is automatically changed and reflected on the window 41 a te o P E RAT
5. and where the practitioner would normally avoid the use of any other analgesia in order to retain the beneficial aspects of pain e for direct aim into the eyes of humans or animals e over areas injected with steroids in the past 2 3 weeks e over areas that are suspicious or contain potentially cancerous tissue e over areas of active hemorrhage e over a pregnant uterus e over the neck thyroid or carotid sinus region or chest vagus nerve or cardiac region of the thorax e directly over areas with open wounds unless covered with a clear protective barrier e treatment over sympathetic ganglia e for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed e on patients suspected of carrying serious infectious disease and or disease where it is advisable for general medical purposes to suppress heat or fevers e over or near bone growth centers until bone growth is complete 10 wa ley e over the thoracic area if the patient is using a cardiac pacemaker e over or applied to the eye e on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result Additional Precautions Additional precaution should be used when the laser light is used on patients with the following conditions e Over an area of the spinal cord following a laminectomy i e w
6. 20 of nominal Vectra Genisys Laser DESCRIPTION OF DEVICE MARKINGS The markings on the unit are assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility One or more of the following markings may appear on the device Standards lk Classified by Intertek Testing Services NA Inc lla Complies with 21CFR 1040 10 amp 1040 11 9700675 IEC UL EN 60601 1 60601 1 2 and 60601 2 22 CAN CSA C2242 NO 601 EMIO EN Refer to ACCOMPANYING DOCUMENTS Equipment capable of delivering output values in excess of 10 mA r m s or 10V ms averaged over any period of 5 s A Grom ae EE This unit is considered to be a Class 3B laser product and thus emits visible and invisible laser radiation IR Avoid direct eye exposure to the laser light beam The symbol to the right is located on the back of the applicator and indicates the active radiant surface the area on the applicator that emits infrared laser energy and the direction of the beam of obt SPECI FICATIONS A Vectra Genisys Laser LASER APPLICATOR SPECIFICATIONS For all single diode and cluster laser and LED applicators the expected increase in the measured quantities after manufacture added to the values measured at the time of manufacture is 20 The new software incorporates a cooling function that forces the user to cool the laser clusters prior to the next treatment The software will calculat
7. 489 Hixson TN 37343 us a 800 592 7329 u s A 423 870 2281 423 875 5497 Fax chattgroup com Chattanooga Group is an ISO 13485 Certified Company 2009 Encore Medical L P
8. 92 Laser Safety in Health Care Facilities or ANSI Z 136 3 1996 American National Standard for the Safe Use of Lasers in the Health Care Environment Product Description The Vectra Genisys Laser designed and manufactured by Chattanooga Group offers a new dimension in clinical laser light therapy made possible by advanced software design and digital signal processing Effectiveness of this treatment is dependent upon correct use If treatment times are exceeded the therapy may not result in positive clinical outcomes 2009 Encore Medical L P and its affiliates Austin Texas USA Any use of editorial pictorial or layout composition of this publication without express written consent from Chattanooga Group of Encore Medical L P is strictly prohibited This publication was written illustrated and prepared for print by Chattanooga Group of Encore Medical L P NOVUS is a registered trademark of TCG International Inc Virex II 256 is a registered trademark of Johnson Wax Professional PDI Sani Cloth Plus Hb are registered trademarks of Professional Disposables Inc PDI the Healthcare Division of Nice Pak Products Inc f TOC a they FOREWORD Vectra Genisys Laser The following features are available on the Vectra Genisys Laser Clinical Portable Battery Powered Option The Vectra Genisys Laser is a truly portable laser unit that does not confine you to a wall socket to operate Clinical Indications An efficient a
9. Genisys Laser 3 Press the DISPLAY Enter button to accept the highlighted selection 4 Press the Up Arrow and Down Arrow buttons to highlight the appropriate language 5 Press the DISPLAY Enter button to accept the highlighted selection Your unit now displays the language you selected 57 OPERATION SYSTEM UTILITIES CONTINUED Viewing Unit Version Information Vectra Genisys Laser Use this utility to verify that the unit is using the latest software available To do this do the following 1 Press the Clinical Resources button The Clinical Library window displays S Use the Up Arrow and Down Arrow buttons to highlight the View Unit Version Info option 58 Vectra Genisys Laser Press the Display button to accept the highlighted selection The Unit Version Information window displays 4 Press any key to return to the Clinical Library window 59 O H E RAT l d N Vectra Genisys Laser TREATMENT TIPS Contact To obtain the most effective results the applicator should be in contact with the patient s skin Applicator Position Due to the characteristics of laser light the angle at which the light enters the patient s skin is very important Therefore the applicator lens should always be parallel to the treatment area Treating Joints If you are applying laser light therapy to a patient s joint it is more effective to apply the laser light en
10. Genisys Laser INSTALLING THE BATTERY PACK CONTINUED 3 Connect the battery pack cable to the unit s battery connector in the bottom of the battery recess 4 Put the battery pack into the unit making sure to orient it as shown 5 Replace the battery access door and re tighten the screw using the screwdriver 6 Reverse the steps in this section in order to remove the battery pack 30 S ET U P Vectra Genisys Laser CHARGING amp USING THE BATTERY PACK CHARGING THE BATTERY PACK The battery pack is automatically charged by the unit whenever there is mains power connected Charging may be interrupted during operation of the unit by the control circuitry to limit total power consumption A fully charged battery will provide 2 5 hours of treatment depending on the power pulsed mode and frequency used NOTE Even when the battery pack is connected the unit will default to mains power USING THE BATTERY PACK To save battery power the Vectra Genisys Laser is equipped with a power off function This function is activated when the unit is powered on and has been left idle for approximately 5 minutes at which time the unit powers off To restore power press the Power On Off button TOC 31 O P E RAT O N Vectra Genisys Laser ENTERING AND CHANGING THE PIN To gain access to any part of the Vectra Genisys Laser unit you must enter a Personal Identification Number PIN The unit is shipped
11. OPERATION Vectra Genisys Laser RESTORING FACTORY SETTINGS Certain default utility settings on the unit may be changed to suit your requirements These settings consist of the unit s language and power up settings However you may want to return the unit to its original settings To restore the original power up default settings on the unit do the following 1 On the main window press the Clinical Resources button The Clinical Library window displays 2 Press the Up Arrow or Down Arrow buttons to highlight the Restore Factory Settings option 45 OPERATION RESTORING FACTORY SETTINGS CONTINUED S Press the DISPLAY Enter button to accept the highlighted selection The Restore Factory Settings Confirmation window displays Vectra Genisys Laser 4 Press any button on the Operator Interface The default power up settings are restored and you are returned to the Clinical Library window 46 OPERATION RESTORING FACTORY PROTOCOLS Vectra Genisys Laser If necessary you can choose to restore the user defined protocols to the unit s original parameters when it was shipped to you To do this do the following 1 Press the Clinical Resources button The Clinical Library window displays 2 Press the Up Arrow or Down Arrow buttons to highlight the Restore Factory Protocols option 47 OPERATION RESTORING FACTORY PROTOCOLS CONTINUED Vectra Genisys Laser of Pre
12. button and the LCD remains blank longer than a few seconds the contrast may require adjusting To adjust it turn the contrast control dial clockwise until the display contrast is optimal ERROR CODES AND DESCRIPTIONS Description Error Description Code Code 100 entered an invata pin number 201 aseroutput too high O O O O O O O OOO ei aset an appticator but noneisptuggeain 202 Iesse a2 _ appliatorbecameunpluggedduringtrentment aos ueDowtputistoonigh 103 attempted to savea protocol withnoapplicatorpluggedin 204 _ urDewputistoolow SSCS ios pressed START buttreatmenttimeiezero zos _ laser intemattreatment tine error occurred laser treatment has been terminated 105 rewrieved a user protocoi but no applicator ptugoedin Jam _ some type of eriticattaser board error has occured T06 retrieved a user protocoinot previously saved and no applicator pluggedin 301 nolaserboardisdetectedinunit 107 remrieved auser protocol foran applicator diferent from the applicator pluggedin 302 erorreadinghomlaserboard user selected clinical indication but no applicator is plugged in 303 error reading from laser board sO user selected clinical indication but there are not clinical indications for the error writing to laser board probe plugged in laser stop switch is unplugged Plug in the laser stop switch before starting a error calibrating applicator laser treatment Press any key to continue error accessing th
13. from the selling dealer or Chattanooga Group Service Department The Service Manual contains safety precautions nomenclature specifications troubleshooting removal and replacement instructions general maintenance calibration instructions parts lists schematics warranty and other information which would assist a certified service technician to repair the unit Council Directive 2002 96 EC concerning Waste Electrical and Electronic Equipment WEEE Indicates a requirement not to dispose of WEEE as municipal waste Contact your local distributor for information regarding disposal of the unit and accessories 64 wa ley WARRANTY Vectra Genisys Laser Chattanooga Group a division of Encore Medical L P Company warrants that the Vectra Genisys Laser Product is free of defects in material and workmanship This warranty shall remain in effect for two years 24 months from the date of original consumer purchase If this Product fails to function during the two year warranty period due to a defect in material or workmanship at the Company s option Company or the selling dealer will repair or replace this Product without charge within a period of thirty 30 days from the date on which the Product is returned to the Company or the dealer All repairs to the Product must be performed by a service center certified by the Company Any modifications or repairs performed by unauthorized centers or groups will void this warranty The warra
14. gt Preparing the Patient s Skin for Therapy 0 00 eee 35 B gt Starting Stopping amp Interrupting Therapy 36 38 B Using Clinical Indications 0 cece cece cece ee eeeeeee 39 42 B Creating a User Protocol uuau eee e cece eee raaa 43 44 B gt Restoring Factory Settings ccc cece eee arraina 45 46 B Restoring Factory Protocols 0 00 cece cece eee 47 48 B Selecting a User Defined Protocol 0 0 cece ee eee 49 50 B gt System Utilities 00 cece reran rann 51 59 PUM ONE ere 51 Changing Power Up reese SE Brightening or Dimming the tch 53 Viewing Applicator Information 0 00 54 55 Changing Languages ccc ccc ence nee ees 56 57 Viewing Unit Version Information 58 59 TABLE OF CONTENTS TREATMENT TIPS cccccecccccccccceccevccecs 60 ACCESSORIES ccc cceccccccccceccccecccecceees 61 B Standard Accessories 0 ccc cc ccc cece ec een eeeeuneeees 61 B Optional Accessories 0 0 00 ccc cece cee PONTAS id rir E IENE 61 TROUBLESHOOTING ccccccccccccceccceecces 62 B gt Troubleshooting the Display 62 B gt Error Codes and Description 62 MAINTENANCE oeoo o essens oesnoessoessossseee 63 64 B gt Maintaining the Un 63 B gt Cleaning aaa aaaea EEEE 63 B gt Service ooo ccc bbb bbb bbb bbb bbb bbb bbb been 64 B gt Warranty Repair Out of Warranty Repair 0 cece 64 WARRANTY ccccceccccccccccccccccceecceee
15. procedures outlined in the section entitled Preparing the Patient s Skin for Laser light Therapy on page 35 Then continue with step 4 of the section entitled Starting Stopping and Interrupting Therapy on page 37 50 wd tbe OPERATION SYSTEM UTILITIES Audible Tones Audible tones will be heard in the following conditions e The laser is arming e Any button is pressed e The rechargeable battery s power is low in which case the Low Battery icon will display e Any error message is displayed e The therapy time reaches 0 00 e The treatment session is paused or resumed Changing Power Up Presets The following power up presets can be changed and stored as new presets e Frequency e Treatment Time e Dosage To change the power up presets do the following 51 4 Vectra Genisys Laser OPERATION Vectra Genisys Laser SYSTEM UTILITIES CONTINUED 1 Make the desired changes 2 Press the Clinical Resources button The Clinical Library window displays 3 Press the Up Arrow and Down Arrow buttons to highlight Save Protocol and press the DISPLAY Enter button to accept the highlighted selection The Save Protocol menu displays 4 Press the Up Arrow or Down Arrow buttons to highlight Default Protocol 52 aa be OPERATION Vectra Genisys Laser SYSTEM UTILITIES CONTINUED 5 Press the DISPLAY Enter button to accept the highlighted selection The User Defa
16. restricts this device to sale by or on the order of a physician or licensed practitioner e This unit generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation Harmful interference to other devices can be determined by turning this unit on and off Try to correct the interference using one or more of the following reorient or relocate the receiving device increase the separation between the equipment connect the equipment to an outlet on a different circuit from that which the other device s are connected and consult the Chattanooga Group Service Department for help e Use of parts or materials other than Chattanooga Group s can degrade minimum safety A WARNING Before each use clean the plastic lens with NOVUS Polish System www novuspolish com Apply with a clean cloth Failure to clean the lens between patient therapy sessions could cause beam fragmentation Be sure to read all instructions for operation before treating a patient Do not drop the applicator or unit on hard surfaces Do not submerge the applicator or unit in water All of these conditions will damage the applicator and unit Damage resulting from these conditions is not covered under the warranty Use of controls or adjustments or performance of procedure
17. screen Press any button to clear the message 2 Press the Frequency button to select one of the 12 preset frequencies Press the Up Arrow button to increase the frequency in 1 Hz increments Hold the button down to quickly display higher frequencies Press the Down Arrow button to decrease the frequency in 1 Hz increments Hold the button down to quickly display lower frequencies An audible tone will be heard when changes are made 3 Press the TIME button and raise or lower treatment time using the up and down arrows NOTE The Treatment Time and the Dosage are directly correlated Whenever Treatment Time is changed the Dosage is automatically changed and reflected on the window 36 wa hey O P E RAT O N Vectra Genisys Laser STARTING STOPPING AND INTERRUPTING THERAPY CONTINUED 4 Press the DOSAGE button and raise or lower the unit s output using the up and down arrows NOTE The Dosage and the Treatment Time are directly correlated Whenever Dosage is changed the Treatment Time is automatically changed and reflected on the window oF Press the START button A message displays to alert you to the fact that the laser is armed The unit will beep two times to count down the number of seconds left until the applicator is ready and an orange light will blink two times on the back of the applicator Press the Pause Resume button to begin the treatment After you press the Pause Resume button the orange
18. 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 compliance level in each frequency range tel Interference may occur in the vicinity of equipment marked with the following symbol i NOTE 1 At 80 MHz and 800 MHz 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 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 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 Vectra Genisys Laser is used exceeds the applicable RF compliance level above the Vectra Genisys Laser should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Vectra Genisys Laser b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m TOC j qaau seep APPENDIX A EMC TABLES Vectra
19. 1000 4 11 70 U 70 U 30 dip in U for 25 cycles 30 dip in U for 25 cycles lt 5 U lt 5 U gt 95 dip in U for 5 sec gt 95 dip in U for 5 sec Power frequency 50 60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical magnetic field commercial or hospital environment IEC 61000 4 8 NOTE U is the a c mains voltage prior to application of the test level fh Toc 7 den ve APPENDIX A E EMC TABLES Vectra Genisys Laser TABLE 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY CONTINUED The Vectra Genisys Laser is intended for use in the electromagnetic environment specified in the table below The user of the Vectra Genisys Laser unit should assure that it is used in such an environment Immunity IEC 60601 Test Test Level Portable and mobile RF communications equipment should be used no closer to any part of the Vectra Genisys Laser including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance a RF 3 Vrms 3V d 3 5 VP IEC 61000 4 6 150 kHz to 80 MHz V Radiated RF 3 V m 1 kV differential mode d 3 5 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 2 kV common mode E d DND 800 MHz to 2 5 GHz E 1 Compliance Level Electromagnetic Environment Guidance where P is the maximum output power rating of
20. CH The Laser Interlock is an optional safety device designed to interrupt Laser Light Therapy anytime the door to the the therapy room is opened Contact only qualified electricians to install the Laser Interlock kit and have them refer to the wiring diagram below The Laser Interlock kit consists of a switch resistor and a jack You must supply the necessary cable that complies with local and international codes AA DANGER The Laser Interlock must be installed by a professional or qualified electrician Serious eye injury can result if the device is not properly installed Also when installing the device for multiple doors the resistance total may not exceed 4800 ohm Diagram for Therapy Room with One Door Diagram for Therapy Room with Multiple Doors Laser Interlock ras RT 47hmay Series Connected RT 4 8k max RT 434K Chained w ww o e Interlock Resistor 40 43 single P2 SSS Phonepl Wei Resistor Wei 24K singe Open Circuit o To J2 Ta P2 To J2 Phoneplug2 Toc Vectra Genisys Laser MOUNTING THE UNIT ON THE WALL The Vectra Genisys Laser can be operated while the unit is resting on a flat surface or mounted on a wall To mount the unit on a wall do the following dy Remove the repositional base from the bottom of the unit 2 Using the repositional base as a guide mark the 4 wa
21. Genisys Laser TABLE 3 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE VECTRA GENISYS LASER The Vectra Genisys Laser unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Vectra Genisys Laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Vectra Genisys Laser as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter Rated Maximum Output Power of m Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 800 MHz d 3 5 vP d 3 5 vP d DP 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 80 MHz and 800 MHz 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 f Toc j aa pg 28050D e Chattanooga Group 4717 Adams Road P O Box
22. LED Five 850 nm 100 mW Laser 6 2218 0 097 0 54334 0 06 9 Diode Cluster Laser 1040 mW 1040 GaAlAs SLD Four 670 nm 10 mW LED y a LED V Five 850 nm 200 mW Laser 12 4438 0 097 0 54334 13 Diode Cluster Laser 415 mW 0 055 GaAlAs SLD Seven 670 nm 10 mW LED LED Three 850 nm 100 mW Laser a Three 950 nm 15 mW SLD 6 2218 0 097 0 54334 0 48 13 Diode Cluster Laser 715 mW 0 095 GaAlAs SLD Seven 670 nm 10 mW LED 1 12 LED V Three 850 nm 200 mW Laser 0 1128 Three 950 nm 15 mW SLD 12 4438 0 097 0 54334 4 33 Diode Cluster Laser 1440 mW 1440 0 046 GaAlAs SLD Twelve 670 nm 10 mW LED LED Eight 880 nm 25 mW SLD Eight 950 nm 15 mW SLD Five 850 nm 200 mW Laser 12 4438 0 097 0 54334 23 TOC SPECIFICATIONS LASER PROTECTIVE EYEWEAR SPECIFICATIONS OPTICAL DENSITY vs WAVELENGTH Vectra Genisys Laser 8 7 D 6 N 5 Si A 4 F Dp 3 2 O 2 i O 200 300 400 500 600 ZOO 800 900 1000 1100 Wavelength Useful Range Optical Density 5 es sssesssessseesseesssesseesseesseesseeoneeoseroneeoseeoseee 190 400 nm Optical Density 3 s sssesssessseesseesseesseesseesseesseesseeoseeoseeoseessees 625 830 nm Optical Density E 815 1050 nm d Each unit is shipped with Laser Protective Eyewear The eyewear is L3 rated and approved and EN207 compliant 24 fe Toc 0413 a hey D 5 ET U H 7 Vectra Genisys Laser INSTALLING THE LASER INTERLOCK DOOR INTERRUPT SWIT
23. Laser applicators must be recalibrated annually It is recommended that all Chattanooga Group laser products be returned to the factory or an authorized servicing dealer for repairs or recalibration Recalibration is also recommended after the replacement or repair of any major component Should the Vectra Genisys Laser unit require service contact the selling dealer or Chattanooga Group Service Department NOTE The Vectra Genisys Laser unit was calibrated during the manufacturing process The unit is ready to be placed into service upon delivery All units returned to the factory for service must include the following WARRANTY REPAIR OUT OF WARRANTY REPAIR 1 Written statement containing the following information e Return Authorization RA Number Obtain from Factory e Unit Model Number e Unit Serial Number e Contact person with Phone and Fax Numbers e Billing Address for Out of Warranty Repair e Shipping Address Where to Ship Unit after Repair e Detailed Description of Problem or Symptoms 2 Copy of original invoice issued at purchase of the unit 3 Ship the unit to address specified by an authorized service technician Service to these units should be performed only by Service Technicians certified by Chattanooga Group Laser requires annual calibration from the date placed in service by a Service Technician certified by Chattanooga Group The Vectra Genisys Laser Service Manual is available for purchase and can be requested
24. O N Vectra Genisys Laser USING CLINICAL INDICATIONS CONTINUED d To begin therapy continue with the instructions outlined in the section entitled Preparing the Patient s Skin for Laser light Therapy on page 35 Then proceed to step 4 on page 37 42 OPERATION CREATING A USER PROTOCOL This is a library you create You may store up to 10 protocols in the User Protocol Library To create User Protocols do the following 1 Make the desired parameter changes Vectra Genisys Laser 2 Press the Clinical Resources button The Clinical Library window displays 3 Press the Down Arrow or Up Arrow buttons to highlight the Save Protocol option 4 Press the DISPLAY Enter button to accept the Save Protocol selection The Save Protocol menu displays 43 A P E RAT O N Vectra Genisys Laser CREATING A USER PROTOCOL CONTINUED 5 Use the Up Arrow and Down Arrow buttons to highlight any unused user protocol If you select Unit Default Protocol this will become the protocol displayed when the unit powers up 6 Press the DISPLAY Enter button to accept the highlighted selection and save your custom protocol The User Protocol Confirmation window displays to indicate that the protocol is now saved as the number you specified re Press any button on the Operator Interface The Clinical Library window displays and your new user defined protocol is now saved 44 wd tbe
25. Vectra Genisys Laser PREPARING THE PATIENT S SKIN FOR LASER LIGHT THERAPY Before applying laser light therapy to the patient you must first prepare the patient s skin By properly preparing the patient s skin for laser light therapy you will allow more laser light energy to reach the targeted areas and reduce the risk of skin irritation To prepare the patient s skin for laser light therapy do the following 1 Thoroughly wash the skin on which you intend to place the laser head with mild soap and water or alcohol wipe 2 Dry the skin thoroughly A WARNING Before each use clean the plastic lens with NOVUS Polish System www novuspolish com Make certain to apply with a clean cloth Failure to clean the lens between patient therapy sessions could cause beam fragmentation which may reduce the effectiveness of the treatment Toc 35 OPERATION 8 Vectra Genisys Laser STARTING STOPPING AND INTERRUPTING THERAPY The LCD will provide continuous information during the treatments concerning dosage and elapsed time Parameters are adjusted using Operator Interface buttons on the front of the unit The laser light output can be stopped by pressing the PAUSE or STOP buttons located on the Operator Interface To apply laser light therapy do the following 1 Plug the Laser Stop Switch into the connection of the unit If the switch is depressed the treatment will be paused and a message will appear on the
26. d in seconds it is the suggested time per laser point that therapy is given fh toc demm mb ABOUT LASER LIGHT THERAPY WectraGenisys Laser OVERVIEW OF LASER LIGHT THERAPY COMMON TERMS CONTINUED Wavelength Measured in nanometers nm wavelength is the key component in obtaining effective therapy as different wavelengths bring about different physiological effects Superficial skin disorders have been found to be most effectively treated at wavelengths 600 700 nm while deeper muscular or ligament lesions and joint conditions are better treated at higher wavelengths of 700 1000 nm ABOUT LASER LIGHT THERAPY a Vectra Genisys Laser Indications for Laser Light The Vectra Genisys Laser is indicated to provide topical heating for the following e temporary increase of local blood circulation e temporary relief of minor muscle and joint aches pains and stiffness e temporary relaxation of muscles e temporary relief of muscle spasms e temporary relief of minor pain and stiffness associated with arthritis Adjunctive Use The Vectra Genisys Laser may be used adjunctively for the following e symptomatic relief of minor pain e minor muscle and joint pain e minor muscle spasms e relief of associated minor stiffness and pain associated with arthritis e promoting relaxation of muscles A Toc Contraindications The Vectra Genisys Laser should NOT be used e where analgesia may mask progressive pathology
27. e Power On Off button Applicator Symbols These symbols denote the status of the Laser Applicator Ce This symbol indicates that therapy is in progress output is being distributed to the patient and the applicator is functioning w normally Ce This symbol indicates that although the applicator is plugged in no laser light energy is being emitted from the applicator Ce This symbol indicates that the Pause button has been pressed and no output is being emitted from the applicator D ow this symbol indicates that the applicator has been unplugged from the unit Lens This clear lens acts as a shield to protect the patient s skin Laser Head This aluminum housing located on the end of the applicator accommodates the lens laser diodes LED s SLD s and their associated electronics Pause Resume Use this button to begin or pause the treatment session To restart therapy press the PAUSE button NOM ENCLATU RE Vectra Genisys Laser A LED s SLD s These Light Emitting Diodes generate different wavelengths of light that allow the user to treat topical or surface symptoms Laser Diode This mechanism generates different wavelengths of light that allow the user to treat various deeper penetrating symptoms LED Indicator Output Power This orange light illuminates when laser light energy is being distributed by the applicator 19 UNIT SPECIFICATIONS DIMENSIONS Height With base ss
28. e beam of light e When the unit is on not all wavelengths are visible to the naked eye Therefore when performing any operational or functional check always wear Chattanooga Group laser protective eyewear ABOUT LASER LIGHT THERAPY WectraGenisys Laser OVERVIEW OF LASER LIGHT THERAPY In short the light energy absorbed into the patient s tissue triggers biological changes at a cellular level to provide topical heating for the temporary increase in local blood circulation temporary relief of minor muscle and joint aches pains and stiffness relaxation of muscles and relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis The dose and frequency of treatment can be adjusted to produce the desired effect Low Level Laser Light differs from ordinary light in four ways Briefly it is much more intense directional monochromatic and coherent Most lasers consist of a column of active material with a partly reflecting mirror at one end and a fully reflecting mirror at the other The active material can be solid ruby crystal liquid or gas HeNe CO etc Low Level Laser Light has unique physical properties that no ordinary light has This is the key to why laser light is so effective compared to other kinds of light in healing There are more than 100 double blind positive studies confirming the clinical effect of LLLT Low Level Laser Therapy More than 2500 research reports are
29. e internal EPROM used to store system configuration settings and protocols 62 B se MAI NTE NANC E Vectra Genisys Laser Maintaining the Vectra Genisys Laser The following items should be checked at least monthly to ensure proper operation of this unit e Power cord and plug Check to make sure the cord is not frayed kinked and does not have torn or cut insulation e Applicator cable Check to make sure the cable is flexible free of kinks not frayed and the insulation is intact e Applicator lens Check to see that there is no build up of oil or foreign material on or behind the applicator lens 44 WARNING Before each use clean the plastic lens with NOVUS Polish System www novuspolish com Make certain to apply with a clean cloth Failure to clean the lens between patient therapy sessions could cause beam fragmentation which may reduce the effectiveness of the treatment Cleaning To clean the accessories use only soap and water The Vectra Genisys Laser s case may be cleaned by wiping with a damp cloth or mild cleaning solution Avoid abrasive cleansers The Laser Head must be cleaned with a disinfectant cleaner i e Virex II 256 ora germicidal disposable cloth i e PDI Sani Cloth Plus Hb between each therapy session Do not use any chlorine based cleaners on the laser head fe Toc dem veab MAI NTE NANC E P Vectra Genisys Laser Service The Vectra Genisys
30. e the cooling time needed when treatment times exceed 3 minutes per application For a 3 minute treatment it will force a 15 second cool down period before the next treatment can begin For a 4 minute treatment it will force a 2 minute cool down period before the next treatment can begin The software extrapolates for times between 3 and 4 minutes A message will display on the screen informing the user that the probe is cooling down and the time period required After 5 seconds this message will disappear If the user attempts to use the probe before the cool down period is completed the message will re display to signify that the applicator is still in cool down mode After the cool down period is complete a message displays that informs the user that the unit is ready for use Single Diode Applicators Applicator Wavelength Output Power Treatment Diode Nominal Ocular Hazard Divergance Bleid Spot Size nm Power Density Area Type Hie al a2 cm mW W cm cm NOHD in meters for road rte AEL lt 0175 W cm 22 SPECI FICATIONS Vectra Genisys Laser LASER APPLICATOR SPECIFICATIONS CONTINUED Cluster Diode Applicators Applicator Output Power Contact Diode Diode Specifications Nominal Ocular Hazard Divergance Divergance Spot Size Power Density Area Type Distance e ER cm mW W cm C NOHD in meters for rad AEL lt 0175 W cm 9 Diode Cluster Laser 540 mW 0 072 GaAlAs SLD Four 670 nm 10 mW LED 0 64
31. each use This unit should be operated in temperatures between 59 to 85 F 15 to 40 C and transported and stored in temperatures between 20 to 110 F 7 to 43 C with relative humidity ranging from 30 60 Where the integrity of the external protective earth conductor arrangement is in doubt equipment shall be operated from its internal electrical power source DO NOT disassemble modify or remodel the unit or accessories This may cause unit damage malfunction electrical shock fire or personal injury Failure to use and maintain the Vectra Genisys Laser and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty ABOUT LASER LIGHT THERAPY Genisys Laser A CAUTION e DO NOT remove the cover This may cause unit damage malfunction electrical shock fire or personal injury There are no user serviceable parts inside the unit If a malfunction occurs discontinue use immediately and consult the dealer for repair service e DO NOT permit any foreign materials or liquids to enter the unit Take care to prevent any foreign materials including but not limited to inflammables water and metallic objects from entering the unit These may cause unit damage malfunction electrical shock fire or personal injury e If you have difficulty operating the unit after carefully reviewing this user manual contact your Chattanooga Group dealer for assistance e US federal law
32. ergy into the joint by positioning the joint in an open position e g knee in flexion However do not attempt this method if it is uncomfortable to the patient Applicator Selection If the injury you intend to treat is very small pinpoint you should only need to treat the area with a single diode applicator If the area surrounding the treatment area is sensitive it is recommended that you apply therapy with a single diode applicator first then use the cluster applicator for the surrounding area Cold and Heat If you intend to apply cold or heat in conjunction with laser light therapy use the following guidelines e Use cold before laser light therapy This slows the flow of red blood cells and reduces the amount of energy removed from the area e Use heat after the treatment This speeds the flow of red blood cells so that more energy can be removed from the area fh Toc Zen mee ACC E S S O RI E S Vectra Genisys Laser Standard Accessories Optional Accessories Description Ref Description 27525 Single Diode 850 nm Laser 100 mW Applicator 26 AWG 68 89 in 174 143 cm Shielded 27470 Laser Stop Switch 26 AWG 68 89 in 174 143 cm Shielded 27811 9 Diode Applicator 540 mW 26 AWG 68 89 in 174 143 cm Shielded 27812 9 Diode Applicator 1040 mW 26 AWG 68 89 in 174 143 cm Shielded 61 TROU B LES HOOTI NG Vectra Genisys Laser ERRORS Troubleshooting the Display If you press the Power On Off
33. hen major covering tissues have been removed e Over anesthetic areas e On patients with hemorrhagic diatheses 11 ABOUT LASER LIGHT THERAPY Vectra Genisys Laser 44 DANGER Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy microwave diathermy therapeutic laser diathermy or laser diathermy anywhere on their body Energy from diathermy shortwave microwave ultrasound and laser can be transferred through the implanted neurostimulation system can cause tissue damage and can result in severe injury or death Injury damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned off Preventing Adverse Effects Perform the following procedures to avoid the negative effects of laser light therapy Patient Susceptibility A WARNING Some patients are more sensitive to laser output i e patients taking medications that increase sensitivity to light and may experience a reaction similar to a heat rash Be sure to inspect the treatment area during and following treatment and discontinue if an adverse reaction does occur Output Power Higher output levels have a greater potential for patient waa they ABOUT LASER LIGHT THERAPY tege Genisys Laser discomfort Choose a lower dosage to reduce output or select a pulsed duty cycle to decrease patient discomfort Factors
34. light will illuminate on the back of the applicator to indicate that laser light output is being distributed NOTE When treatment time has expired a tone will sound The therapy can be interrupted at any time by pressing the Pause Resume button on the back of the applicator the STOP button on the Operator Interface or the PAUSE button on the Operator Interface When the STOP button is pressed the applicator stops emitting laser light energy and the unit returns to the default settings To resume therapy press the Start button During treatment the following occurs whenever the PAUSE button on the Operator Interface or the Pause Resume button on the back of the applicator are pressed 37 wd ley OPERATION Vectra Genisys Laser STARTING STOPPING AND INTERRUPTING THERAPY CONTINUED e the timer pauses e the unit beeps once e the S icon displays e the laser applicator stops emitting laser light energy e the orange light goes out To resume therapy press the PAUSE button on the Operator Interface the Pause Resume button on the back of the laser applicator or the START button 6 To finish the laser light therapy press the STOP button 38 A P E RAT l O N Vectra Genisys Laser USING CLINICAL INDICATIONS The indications contained in this section are to be used only as guidelines Each patient should be individually assessed to determine the appropriateness of the parameter setting prior to use
35. ll holes with a pencil or pen 26 S ET U P Vectra Genisys Laser MOUNTING THE UNIT ON THE WALL CONTINUED 3 Using a 9 64 3 6 mm or 0 357 cm drill bit drill four holes you marked in the previous step 4 Press 4 appropriately sized sheetrock anchors into the wall so that the sheetrock anchor is flush with the wall 5 Screw four 8 flathead wood screws 1 inch or 2 54 cm into the wall anchors Make sure you leave 1 4 of an inch 0 635 cm between the wall and the head of the screw 27 Vectra Genisys Laser MOUNTING THE UNIT ON THE WALL CONTINUED 6 Replace the repositional base on the bottom of the unit fi Line up the screw heads with the holes on the repositional base and slide the unit down slightly until the screw heads are securely fastened to the repositional base 28 S ET U P Vectra Genisys Laser INSTALLING THE BATTERY PACK The Vectra Genisys Laser accommodates both AC mains power and an optional battery pack The pack contains 20 Nickel Metal Hydride NiMH drycell batteries The unit can operate with the rechargeable power supply for approximately five hours of continuous use To install the battery pack in the Vectra Genisys Laser do the following 1 Locate the battery access door at the bottom of the unit and loosen the screw with a regular screwdriver 2 Remove the battery access door and retain this cover 29 S ET U H Vectra
36. n or liability in connection with the sale of the Product Any representation or agreement not contained in the warranty shall be void and of no effect THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE A Toc j APPENDIX A EMC TABLES Vectra Genisys Laser TABLE 1 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Vectra Genisys Laser unit is intended for use in the electromagnetic environment specified in the table below The user of the Vectra Genisys Laser unit should assure that it is used in such an environment Emission Tests Compliance Electromagnetic Environment Guidance RF emissions ST The Vectra Genisys Laser uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any CISPR 11 p interference in nearby electronic equipment RF emissions F Steeg KC EEN The Vectra Genisys Laser is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations Flicker Emissions Complies IEC 61000 3 3 Toc APPENDIX A EMC TABLES Vectra Genisys Laser TABLE 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Vectra Genisys Laser is intended for u
37. ng products manufactured by other companies The use of other accessories or cables may result in increased emissions or decreased immunity of this unit Use of other accessories other than those specified may result in increased emissions and decreased immunity If laser is not in use power off unit or remove applicator Laser equipment not in use should be protected against unqualified use Remove battery pack if unit is not to be used for an extended period Some patients are more sensitive to laser output i e patients taking medications that increase sensitivity to light and may experience a reaction similar to a heat rash Do not treat through clothing Stop treatment immediately if patient experiences discomfort or pain Do not apply laser on an area of skin that has lotion or ointments applied as burns may occur Do not use on or over a tattoo Inspect the plastic lens of the laser head for blemishes deformation pitting scratches discoloration and cleanliness before each use The laser head must be cleaned with a disinfectant cleaner i e Virex II 256 or germicidal cloth i e PDI Sani Cloth Plus Hb between each therapy session Ensure that no liquids enter into the laser head while cleaning Do not use any chlorine based cleaners on the laser head The following factors may affect laser treatment color of skin age of lesion depth of lesion sensitivity of the patient tissue type and medications that increase sensitivi
38. nty period for applicators is one year 12 months This Warranty Does Not Cover e ANY MALFUNCTION OR FAILURE IN THE PRODUCT CAUSED BY PRODUCT MISUSE INCLUDING BUT NOT LIMITED TO DROPPING THE UNIT OR APPLICATOR AND FAILURE TO PROVIDE REASONABLE AND NECESSARY MAINTENANCE OR ANY USE THAT IS INCONSISTENT WITH THE PRODUCT USER MANUAL e Replacement parts or labor furnished by anyone other than the Company the selling dealer or a certified Company service technician e Defects or damage caused by labor furnished by someone other than Company the selling dealer or a certified Company service technician COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you To Obtain Service From Company or the selling dealer under this warranty 1 A written claim must be made within the warranty period to the Company or the selling dealer Written claims made to the Company should be sent to Telephone 800 592 7329 USA 423 870 2281 866 864 0598 Service FAX 423 875 5497 and 2 The Product must be returned to the Company or the selling dealer by the owner This warranty gives you specific legal rights and you may also have other rights which vary from state to state or location to location The Company does not authorize any person or representative to create for it any other obligatio
39. pproach for setting up a treatment using preset parameters Real Time Feedback This feature provides a measured and monitored output system that adjusts the dosage delivered to the patient Electronic Signature Automatically calibrate the system to any Vectra Genisys Laser applicator Ergonomic Applicators A new ergonomic design that offers a 20 degree contour in the applicator hand grip This ergonomic extra will help deliver uniform laser light therapy with greater clinician comfort Clear LCD Guide the operator through the setup process providing continuous feedback about treatment settings Gives you optimal visibility during attended procedures User Protocols User protocols allow you to set save and change the parameters of each program protocol in order to tailor it to meet your patients specific needs Ten storage slots are available for user protocols ABOUT LASER LIGHT THERAPY Precautionary Instructions The precautionary instructions found in this section and throughout this manual are indicated by specific symbols Understand these symbols and their definitions before operating this equipment The definition of these symbols are as follows JN lt auTION A WARNING d DANGER Text with a CAUTION indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment Text with a WARNING indicator will explain po
40. published The book Laser Therapy clinical practice and scientific background by Jan Tun r and Lars Hode is a good reference guide for literary documentation There is no exact limit with respect to the penetration of the light The light gets weaker the further from the surface it penetrates There is however a limit at which the light intensity is so low that no biological effect of the light can be registered This limit where the effect ceases is called the greatest active depth In addition to the factors mentioned above this depth is also contingent on tissue type pigmentation and dirt on the skin Fat tissue is more transparent than muscle tissue Some laser applicators may cause a noticeable heat sensation particularly in hairy areas and on sensitive tissues such as lips Common Terms Applicator The hand held assembly used to deliver laser light energy The applicator includes the laser head diode and related electronics Collimating The shape of the laser light beam While neither focused nor dispersed this laser light beam resembles a column when applied from the unit through the applicator fe Toc dem sop ABOUT LASER LIGHT THERAPY WectraGenisys Laser OVERVIEW OF LASER LIGHT THERAPY CONTINUED Continuous Mode The output of the laser light is not interrupted during the treatment time Dosage A measure of the intensity of the laser light energy over the treatment area The unit of measure is Joules or Joules cm
41. s 65 APPENDIX A EMCTABLES cceceeeeee 66 69 B Table 1 Guidance and Manufacturer s Declaration Electromagnetic EMISSIONS 0cccee cence 66 B gt Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity eeaessnnersannne 67 68 B gt Table 3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Vectra Genisys Laser 69 fh Toc Vectra Genisys Laser FOREWORD Vectra Genisys Laser This manual has been written for the operators of the Vectra Genisys Laser It contains general instructions for operation precautionary instructions and maintenance recommendations In order to obtain maximum life and efficiency from your Vectra Genisys Laser and to assist in the proper operation of the unit read and understand this manual thoroughly The specifications put forth in this manual were in effect at the time of publication However owing to Chattanooga Groups policy of continuous improvement changes to these specifications may be made at any time without obligation on the part of Chattanooga Group Before administering any treatment to a patient you should become acquainted with the operating procedures as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of therapeutic laser light Users of this device should refer to CAN CSA Z386
42. s other than those specified herein may result in hazardous exposure to laser light energy Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes e This device should be kept out of the reach of children e This device should be used only under the continued supervision of a licensed practitioner ABOUT LASER LIGHT THERAPY eeneg Laser A WARNING Dispose of all products in accordance with local and national regulations and codes This equipment is not designed to prevent the ingress of water or liquids Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous conditions causing damage to the unit and applicator Care must be taken when operating this unit adjacent to or stacked with other equipment Potential electromagnetic or other interference could occur to this or other equipment Try to minimize this interference by not using other equipment i e cell phones etc in conjunction with it Use only accessories that are specially designed for this unit Do not use accessories manufactured by other companies on this table unit device etc Chattanooga Group is not responsible for any consequence resulting from usi
43. se in the electromagnetic environment specified in the table below The user of the Vectra Genisys Laser should assure that it is used in such an environment IEC 60601 Immunity Test Compliance Level Electromagnetic Environment Guidance Test Level Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the IEC 61000 4 2 8 kV air 8 kV air relative humidity should be at least 30 Electrical fast transient burst kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a typical commercial or hospital environment If the user interruptions and voltage gt 95 dip in U for 0 5 cycle gt 95 dip in U for 0 5 cycle of the Vectra Genisys Laser requires continued operation during power mains interruptions it is variations on power supply 40 U 40 U recommended that the Vectra Genisys Laser be powered from an uninterrupted power supply or a input lines 60 dip in U for 5 cycles 60 dip in U for 5 cycles 1 battery IEC 6
44. sesssesssesssersseesseesseesseesseesseessees 6 4 in 16 3 cm Width with applicator sacssesisssscsessessesssoavavsasaassoorsives 11 3 in 28 8 cm Width without applicator eessen 9 4 in 23 9 cm Depth front tO rear ee 12 9 in 32 8 cm WEIGHT Standard Weight with applicator and base een 5 07 Ib E E E ere eet 2 3 kg DEE e 1 87 Ib 0 85 kg POWER gle T h a PE EE E E 120 240 V 50 60 Hz 75 VA Electrical e IAGS sesersacestcccssscasicssesratosstaasenentensnetnencnesesntinenier CLASS 1 Electrical Type ssssssssssssssrssssrssssressesrssseressstrssseresssrsssstnsssns TYPEB J R in eier Infrared Lamp laser PEAS ee 3B Battery Type s esssesssesssesssessseessersserssersss Nickel Metal Hydride NiMH ee 1 2 V x 20 size AA SPECIFICATIONS Vectra Genisys Laser Complies with 21CFR 1040 10 amp 1040 11 IEC UL EN 60601 1 60601 1 2 and 60601 2 22 IEC 60825 1 2001 CAN CSA C22 2 No 601 1 M90 w A2 Each unit is shipped with repositional base laser protective eyewear laser stop switch and this manual For a complete list of standard and optional accessories see page 61 CE 0413 20 SPECIFICATIONS LASER TECHNICAL SPECIFICATIONS Duty Cycles PTS e D 90 nd e E 100 Pulse Freouenches ee 8 Hz 10000 Hz EE and continuous Wavelengthe 670 950 nm dependent on applicator Output 100 1440 mW dependent on applicator Output accuracy uu cecssessssestesesesseseeseseeseees
45. ss the DISPLAY Enter button to accept the highlighted selection The Restore Factory Protocols Confirmation window displays 4 Press any button on the Operator Interface Lhini al Library The user defined protocols are erased and restored to the original parameters You are estored returned to the Clinical Library window 48 OPERATION SELECTING A USER DEFINED PROTOCOL To select a predefined laser light therapy program do the following Vectra Genisys Laser 1 Press the Clinical Resources button The Clinical Library window displays 2 Use the Up Arrow and Down Arrow buttons to highlight the Retrieve User Protocol option 3 Press the Display Enter button to accept the highlighted selection A list of user defined protocols displays 49 O P E RAT O N Vectra Genisys Laser SELECTING A USER DEFINED PROTOCOL CONTINUED 4 Use the Down Arrow button to highlight the appropriate protocol As you highlight each protocol a description of the protocol s parameters displays to the right 5 Press the Display Enter button to select the highlighted protocol The main window displays with the parameters of the protocol you selected 6 Verify the parameters of this program and use the appropriate buttons on the Operator Interface to adjust any setting if necessary For example to adjust the time press the up and down arrows on the TIME button 7 To begin therapy perform all the
46. ssible safety infractions that will potentially cause serious injury and equipment damage Text with a DANGER indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury NOTE Throughout this manual NOTE may be found These Notes are helpful information to aid in the particular area or function being described Vectra Genisys Laser A CAUTION Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with using any laser light device Observe the precautionary and operational decals placed on the unit Do not operate this unit when connected to any unit other than Chattanooga Group devices Do not operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner Portable and mobile RF communications equipment can affect Medical Electrical Equipment DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel as damage may result Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to laser light energy Handle the applicator with care Inappropriate handling of the applicator may adversely affect its characteristics Inspect applicator cables and associated connectors before
47. that Affect Treatment The following factors may affect laser light treatment e Color of skin light or dark e Age of lesion e Depth of lesion e Sensitivity of patient e Type of tissue e Medications that increase sensitivity to light 12 NOMENCLATU RE Vectra Genisys Laser UNIT LCD Intensity Power Contrast Dial a On Off e B ss e LCD r N Pause Resume f Laser Head TIME d A D Se 4 Up Arrow Clinical E fa Resources LED Indicator STOP Output Power Frequency Applicator see page 14 Down Arrow xN as A aS DOSAGE PAUSE START Intensity spl Geh Gei Laser Stop Switch Applicator Accessory Connection Required Connection Panel Laser Interlock Bee Door Interrupt Switch Connection US Market N OM E N C LATU RE Vectra Genisys Laser APPLICATOR LED Indicator Output Power Laser Head Pause Resume Button gt Se Laser Head aw LED s SLD s NOM ENCLATU RE Vectra Genisys Laser OO Power On Off a The Power On Off button controls the flow of electricity to the unit LCD The LCD Liquid Crystal Display allows the user to view and monitor the information displayed during laser light therapy The following information is displayed on the LCD e Frequency e Duty Cycle e Dosage e Treatment Time e Clinical Indications Time Press the Up or Down arrow buttons to set total treatment time of therapy
48. ty to light ABOUT LASER LIGHT THERAPY Vectra Genisys Laser 4 DANGER e Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide e The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the unit is used e DO NOT connect the unit to an electrical supply without first verifying that the power supply is the correct voltage Incorrect voltage may cause unit damage malfunction electrical shock fire or personal injury Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number Plate Contact your Chattanooga Group dealer if the unit is not properly rated e Laser protective eyewear should be worn by the operator and patient to block infrared light energy from the eyes during treatment e DO NOT point the laser light beam directly into human or animal eyes The lens of the eye does not detect the invisible coherent laser light beams potentially resulting in permanent retinal damage e This unit is considered to be a Class 3B laser light product and thus emits visible and invisible laser light radiation IR Avoid direct eye exposure to the laser light beam The symbol to the left is located on the back of the applicator and indicates the active radiant surface the area on the applicator that emits infrared laser light energy and the direction of th
49. ult Protocol confirmation window displays 6 Press any key to confirm the settings You are returned to the Clinical Library window Brightening or Dimming the LCD To brighten or dim the LCD turn the contrast control dial until the display contrast is optimal 53 OPERATION SYSTEM UTILITIES CONTINUED Viewing Applicator Information Vectra Genisys Laser Use this utility to verify applicator specifications To do this do the following 1 Press the Clinical Resources button The Clinical Library window displays 2 Press Up Arrow and Down Arrow buttons to highlight the View Applicator Info option 54 OPERATION SYSTEM UTILITIES CONTINUED 3 Press the DISPLAY Enter button to accept the highlighted selection The Laser Applicator Information window displays Vectra Genisys Laser 4 Verify the information on the window and press the Back button to return to the Clinical Library window 55 OPERATION SYSTEM UTILITIES CONTINUED Changing Languages Vectra Genisys Laser You may change the language displayed by the Vectra Genisys Laser to either English or Spanish To change the language displayed on the LCD do the following 1 Press the Clinical Resources button The Clinical Library window displays 2 Use the Up Arrow and Down Arrow buttons to highlight the Language option 56 OPERATION SYSTEM UTILITIES CONTINUED Vectra
50. with a default PIN that allows you initial access but you may change the number anytime To enter and change the PIN do the following 1 Turn the system power ON by pressing the Power On Off button The unit displays the message Initializing System Then the Enter PIN window displays 2 111 1 isthe default PIN Press the button representing the number 1 four times so that x x x displays briefly The main window displays If you enter the wrong PIN the message Incorrect PIN was entered Please try again Press any key to continue displays Press any key on the Operator Interface NOTE If you lose or forget your PIN contact Chattanooga Group Service Department at 866 864 0598 or 423 870 2281 32 wd tbe OPERATION SE ENTERING AND CHANGING THE PIN CONTINUED 3 Press the Clinical Resources button The Clinical Library window displays 4 Using the Up Arrow and Down Arrow buttons highlight Change PIN 5 Press the Display Enter button to select the highlighted selection The Change PIN window displays 33 OPERATION ENTERING AND CHANGING THE PIN CONTINUED 6 Press the buttons that represent the numbers to which you want to change the PIN Vectra Genisys Laser Once you enter four numbers a message displays to inform you of the new PIN A Press any key on the Operator Interface You are returned to the Clinical Library window 34 OPERATION
51. xplain this to the patient when using it in order to prevent unnecessary interruptions in treatment NOM ENCLATU RE i Vectra Genisys Laser Applicator Connection This port serves as the connection point between the unit and the applicator START Select Start to begin a treatment session Intensity Display Enter Select this button to change display from J cm to Joules Also this button is used to accept the highlighted selection Dosage Use the Up or Down arrow to increase or decrease output power dosage Applicator The hand held assembly used to deliver laser light energy The applicator includes the laser head diode and related electronics Up Arrow When the window displays a list of options press the Up Arrow button to scroll up the list Battery Indicator When displayed on the LCD this symbol indicates the battery pack option is present on the Vectra Genisys Laser This symbol also displays the charge status of the battery LCD Intensity Contrast Dial If the intensity of the LCD display diminishes turn the dial until the display contrast is optimal Toc 7 N OM E N C LATU RE Vectra Genisys Laser M Charge Indicator This symbol displays when the unit is connected to mains power and the battery pack is charging NOTE During battery operation if the unit is left on but not active for more than five minutes it will power off to conserve battery power To restore power press th
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