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Vectra Genisys® Laser Module

WARRANTY

Chattanooga Group, a division of Encore Medical, L.P. ("Company"), warrants that the Vectra Genisys® Laser Module ("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, the Company or the selling dealer will repair or replace this Product
without charge within a period of thirty 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 warranty period for applicators is one year (12 months).

This Warranty Does Not Cover:

• 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.

• Replacement parts or labor furnished by anyone other than the Company, the selling dealer or a certified Company service technician.
• 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:
4717

Adams Road

P.O.

Box

489

Hixson,

TN

37343 U.S.A.

Telephone:

1-423-870-2281

U.S.A.

1-800-592-7329

U.S.A.

1-800-366-6661

CANADA

1-423-875-5497

U.S.A.

FAX

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 obligation 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.

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Содержание Vectra Genisys 2758

Страница 1: ...A Vectra Genisys Laser Module TABLE OF CONTENTS Moving Rehabilitation Forward User Manual ISO 13485 Certified Model 2758 Vectra Genisys Laser Module ...

Страница 2: ...ications 17 Description of Device Markings 17 Laser Applicator Specifications 18 19 Single Diode Specifications 18 Cluster Diode Specifications 19 Laser Protective Eyewear Specifications 20 SETUP 21 28 Installing the Laser Interlock Door Interrupt Switch 21 Attaching the Module to the Unit 22 27 Removing the Module from the Unit 28 OPERATION 29 47 Preparing the Patient s Skin 29 Starting Stopping ...

Страница 3: ... Laser Module TABLE OF CONTENTS TABLE OF CONTENTS Vectra Genisys Laser Module MAINTENANCE 52 53 Maintaining the Vectra Genisys Laser Module 52 Cleaning 52 Service 52 Warranty Repair Out of Warranty Repair 53 WARRANTY 54 ...

Страница 4: ...ding the application of therapeutic laser Users of this device should refer to CAN CSA Z386 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 Module designed and manufactured by Chattanooga Group offers a new dimension in clinical laser light therapy made p...

Страница 5: ...cators 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...

Страница 6: ...nary 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...

Страница 7: ... difficulty operating the unit after carefully reviewing this users manual contact your Chattanooga Group dealer for assistance U S Federal law restricts this device to sale by or on the order of a physician or licensed practitioner Use of parts or materials other than Chattanooga Group s can degrade minimum safety Before each use clean the plastic lens with NOVUS Polish System Contact Novus at ww...

Страница 8: ...evices 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 equipment 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...

Страница 9: ...t properly rated Laser protective eyewear should be worn by the operator and patient to block infrared light energy from the eyes during treatment 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 This unit is considered to be a Class 3B laser product an...

Страница 10: ...aser 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 Light Therapy More than 2500 research reports are published The book Laser Therapy clinical practice and scientific background by Jan Tunér and Lars Hode is a good reference guide for literary documentation There is no e...

Страница 11: ...ent 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 with...

Страница 12: ...aves 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 Measured in seconds it is the suggested time per laser point that therapy is given Wavelength Measured in nanometers nm wavelength is the key component in obtaining effective therapy as ...

Страница 13: ...enisys Laser Module should NOT be used where analgesia may mask progressive pathology and where the practitioner would normally avoid the use of any other analgesia in order to retain the beneficial aspects of pain for direct aim into the eyes of humans or animals over areas injected with steroids in the past 2 3 weeks over areas that are suspicious or contain potentially cancerous tissue over are...

Страница 14: ... Patient Susceptibility 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 discomfort Choose a lower dosage to reduce output or select a pulsed duty cycle to decrease patient discomfort DANGER Patients with an implanted neurostimulation device must not be treat...

Страница 15: ...ASER LIGHT THERAPY Factors that Affect Treatment The following factors may affect laser treatment Color of skin light or dark Age of lesion Depth of lesion Sensitivity of patient Type of tissue Medications that increase sensitivity to light ...

Страница 16: ...t Interrupt Switch Connection Applicator Connection Ribbon Cable Connection Pause Resume Button Feet Indentions LED Indicator Output Power Laser Head Laser Interlock Door Interrupt Switch Connection Power Cord Routing Area MODULE APPLICATOR Lens LED s SLD s Laser Diode Not Applicable in US Market ...

Страница 17: ...n be verified and changed if necessary and therapy can be resumed Use of the Patient Interrupt Switch should always be explained to the patient before starting treatment Patients will feel safer knowing they can stop the treatment if necessary The Patient Interrupt Switch is very sensitive Explain this to the patient when using it in order to prevent unnecessary interruptions in treatment Laser In...

Страница 18: ... Diode This mechanism generates different wavelengths of light that allow the user to treat various deeper penetrating symptoms 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 LED Indicat...

Страница 19: ...R 1040 10 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 module is shipped with four screws laser protective eyewear a Patient Interrupt Switch this manual and an extended front access panel For a complete list of standard and optional accessories see page 48 MODULE SPECIFICATIONS DIMENSIONS Length 10 95 in 27 8 cm Height 8 35 in 21 2 cm Wi...

Страница 20: ...ng markings may appear on the device Standards Classified by Intertek Testing Services NA Inc Complies with 21CFR 1040 10 1040 11 IEC UL EN 60601 1 60601 1 2 and 60601 2 22 CAN CSA C22 2 No 601 1 M90 w A2 Refer to ACCOMPANYING DOCUMENTS Equipment capable of delivering output values in excess of 10mA r m s or 10V r m s averaged over any period of 5s Type B Equipment This unit is considered to be a ...

Страница 21: ...he 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 calculate 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 for...

Страница 22: ...218 0 097 0 54334 0 64 0 06 9DiodeClusterlaser1040mW 1040 0 138 7 55 GaAlAs SLD LED Four 670 nm 10 mW LED Five 850 nm 200 mW Laser 12 4438 0 097 0 54334 0 64 0 188 13DiodeClusterlaser415mW 415 0 055 7 55 GaAlAs SLD LED Seven 670 nm 10 mW LED Three 850 nm 100 mW Laser Three 950 nm 15 mW SLD 6 2218 0 097 0 54334 1 12 0 136 0 48 13DiodeClusterlaser715mW 715 0 095 7 55 GaAlAs SLD LED Seven 670 nm 10 m...

Страница 23: ...ptical Density 5 190 400 nm Optical Density 3 625 830 nm Optical Density 3 815 1050 nm Each unit is shipped with Laser Protective Eyewear The eyewear is L3 rated and approved and EN207 compliant 0 1 2 3 4 5 6 7 8 200 300 400 500 600 700 800 900 1000 1100 OPTICAL DENSITY vs WAVELENGTH Wavelength Optical Density ...

Страница 24: ...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 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...

Страница 25: ...urface 4 Remove the front access panel and disconnect all cables and wires ATTACHING THE MODULE TO THE UNIT Disconnect the unit from the power source electrical outlet or battery module before attempting any maintenance removal or replacement procedures to prevent possible electrical shock and equipment damage However if you are disconnecting another module e g battery make certain you leave the r...

Страница 26: ...he warning label covering the ribbon cable and unroll the ribbon cable If the warning label has previously been removed continue with the next step If you are disconnecting another module make certain you leave the ribbon cable plugged into the main unit NOTE If the unit is equipped with an sEMG Module leave it in place to maintain sEMG functions for Channels 1 and 2 The sEMG Module will not inter...

Страница 27: ...WIST THE RIBBON CABLE Before proceeding with the next step make certain the ribbon cable is not twisted If the ribbon cable is twisted the pins will not properly align If the power is turned on with misalignment of pins or a twisted ribbon cable the controlling electronics in the module will be destroyed and possible damage to the internal components will occur CAUTION Be careful when fitting the ...

Страница 28: ...ibbon cable is positioned exactly as shown in the picture on the left 13 Turn the unit upside down and lay it flat on your lap or a covered surface so as not to scratch the plastic display lens Using a 1 Phillips Head screwdriver secure the module to the unit with the four screws shipped with the module NOTE Tighten the screws only enough to prevent the unit from shifting on the unit Do not over t...

Страница 29: ...ended front access panel to the lanyard NOTE When securing the front access panel make certain the lanyard does not become kinked 16 Feed the female end of the power cord through the power cord routing area and plug it into the unit 17 Replace the rear access panel 18 Plug the male end of the power cord into an approved electrical outlet ...

Страница 30: ...le and display a configuration change message 22 Read and carefully follow the instructions on the screen WARNING Verify that the module installed is the module displayed in the message BEFORE pressing the START button If it is not DO NOT press the START button Turn the system Off and back On If the problem persists call the dealer or Chattanooga Group Technical Support immediately DO NOT USE THE ...

Страница 31: ...ed front access panel and disconnect all cables and wires 4 Route the Power Cord through the Power cord routing area on the Module to the unit 5 Replace the Rear Panel 6 Using a 1 screwdriver remove the four screws that are securing the module Retain the screws for future use 7 Remove the module from the unit 8 Using only your fingers gently remove the female end of the ribbon cable from the conne...

Страница 32: ...tion 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 PREPARING THE PATIENT S SKIN Before each use clean the plastic lens with NOVUS Polish System Contact Novus at novuspolish com Make certain to apply with a clean cloth Failure to clean th...

Страница 33: ...d elapsed time Parameters are adjusted using Operator Interface buttons on the front of the unit The output can be stopped by pressing the PAUSE or STOP buttons located on the Operator Interface To administer laser light therapy to a patient make certain you have performed the necessary steps listed in Preparing the Patient s Skin on page 29 Then continue with the following procedures 1 On the Mai...

Страница 34: ...to enter the wrong PIN you can press the button next to Clear PIN to try again For information on changing the PIN see pages 44 46 NOTE If you lose or forget your PIN contact Chattanooga Group Service Department at 866 864 0598 or 423 870 2281 3 Press the button next to Laser Therapy The message Reading Protocol Please Wait displays The next Laser Therapy window displays STARTING STOPPING AND INTE...

Страница 35: ...ncrease the treatment time NOTE The Treatment Time and the Calculated Dosage are directly correlated Whenever Treatment Time is changed the Calculated Dosage is automatically changed and reflected on the Laser Parameters window 6 Press the button next to the icon to decrease the number of seconds for the treatment time Hold the button down to quickly decrease the treatment time STARTING STOPPING A...

Страница 36: ...PTING LASER LIGHT THERAPY CONTINUED 7 Press the button next to the icon to accept the treatment time you selected You are returned to the Laser Parameters window Notice that if you changed the Treatment Time the Calculated Dosage automatically changed 8 Press the button next to Frequency The Frequency window displays ...

Страница 37: ...splay higher frequencies 11 Press the button next to the icon to decrease the frequency in 1 Hz increments Hold the button down to quickly display lower frequencies 12 Press the button next to the icon to accept the frequency you selected You are returned to the Laser Parameter window with the new Frequency displayed 13 Press the button next to Calculated Dosage The Calculated Dosage window displa...

Страница 38: ... 15 Press the button next to the icon to decrease the dosage Hold the button down to quickly decrease the dosage 16 Press the button next to the icon to accept the dosage you selected You are returned to the Laser Parameters window Notice that if you changed the Calculated Dosage the Treatment Time automatically changed 17 Press the button next to Display to change the displayed unit of measure fr...

Страница 39: ... laser 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 Completed Treatment Revi...

Страница 40: ...timer pauses the unit beeps once Paused is displayed on the laser status indicator the laser applicator stops emitting laser energy the orange light goes out To resume therapy press the PAUSE button on the Operator Interface the Pause button on the back of the laser applicator or the START button When the treatment timer reaches zero the Treatment Review Laser window displays 19 To resume the same...

Страница 41: ... Press the button next to Start New Treatment to begin a new therapy session refer to step 2 on page 31 Or press Save to Patient Card to transmit the parameters of the treatment to the patient card For more information on the Save to Patient Card option see the unit s user manual NOTE Between therapy sessions touch the laser head to see if it is warm If it is warm allow it to cool before the next ...

Страница 42: ...t should be individually assessed to determine the appropriateness of the parameter setting prior to use To select an indication for a patient do the following 1 On the Laser Therapy window press the button next to Laser Indication The Laser Indications window displays 2 On the Laser Indications window press the button next to the tissue you intend to treat The next Laser Indications window displa...

Страница 43: ... next to the symptom you intend to treat The next Laser Indications window displays 4 If the indication you require has an available severity select either Acute or Chronic If the indication you require does not have a severity continue with the next step The next Laser Indications window displays ...

Страница 44: ...aser Therapy window displays The parameters of the indication are displayed on the window 6 If necessary make any parameter changes or adjustments 7 To begin therapy continue with the instructions outlined in the section entitled Preparing the Patient s Skin on page 29 8 To save these parameters as a new user protocol continue with the next section entitled Creating a User Protocol ...

Страница 45: ...tion do the following 1 Complete steps 1 through 6 of the previous section entitled Using Clinical Indications 2 While the Laser Therapy window is displayed press the button Clinical Resources Library button on the user interface The Create a User Protocol window displays 3 Use the buttons on the first three rows to enter a name for the indication pressing the button after each letter or number ...

Страница 46: ...ave finished entering the name of the protocol press the button next to The message Saving Protocol Please Wait displays You are returned to the Laser Therapy window with the parameters of the indication you just saved displayed as well as the name of the indication CREATING A USER PROTOCOL CONTINUED ...

Страница 47: ...1 On the Main window press the button next to Laser Therapy The Laser PIN window displays 2 1 1 1 1 is the default PIN Press the button next to the number 1 four times so that displays briefly If you begin to enter the wrong PIN you can press the button next to Clear PIN to try again The Laser Therapy window displays ...

Страница 48: ...dule OPERATION 3 Press the button next to Change Laser PIN The Change Laser PIN window displays 4 Press the buttons next to the numbers to which you want to change the PIN Once you enter four numbers a message displays to inform you of the new PIN SYSTEM UTILITIES CONTINUED ...

Страница 49: ...46 Vectra Genisys Laser Module OPERATION SYSTEM UTILITIES CONTINUED 5 Press any button to continue You are returned to the Laser Therapy window ...

Страница 50: ...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 laser light therapy with a single diode applicator first then use the cl...

Страница 51: ...4 143 cm Shielded 27841 Single Diode 850 nm Laser 200 mW Applicator 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 27814 13 Diode Applicator 415 mW 26 AWG 68 89 in 174 143 cm Shielded 27816 13 Diode Applicator 715 mW 26 AWG 68 89 in 174 143 cm Shielded 27808 33 Diode cluste...

Страница 52: ...ed A Make certain Treatment Room Door is completely closed B Make certain the Laser Interlock cable is connected to the system C Replace Laser Interlock to System cable with a known good cable D Contact department responsible for installation of the Treatment Room Door Laser Interlock Kit for maintenance or repair E Send Laser Module to Factory for Service 132 Warning Attempted to start a laser tr...

Страница 53: ...IN Enter correct Laser PIN number 139 Warning Laser Board Software upgrade warning Contact Chattanooga Group Service Department 142 Warning A User Protocol was selected but no Laser Module is installed on system Install Laser Module to Therapy System Refer to Laser User Manual pages 21 27 for installation Instructions 143 Warning A User Protocol was selected but no Laser Applicator connected to sy...

Страница 54: ...Applicator D Send Laser Module to Factory for Service 214 Error General Laser PC Board Error Send Laser Module to Factory for Service 215 Error Laser Applicator out of calibration due to laser output being too high Send Laser Applicator to Factory for Service 216 Error Laser Applicator out of calibration due to laser output being too low Send Laser Applicator to Factory for Service 217 Error Laser...

Страница 55: ...nly soap and water The Vectra Genisys Laser Module s case may be cleaned by wiping with a damp cloth or mild cleaning solution Avoid abrasive cleansers Service The Vectra Genisys Laser Applicator must be recalibrated annually Chattanooga Group laser products must be returned to the factory or an authorized servicing dealer for repairs or recalibration Should the Vectra Genisys Laser unit require s...

Страница 56: ...ce 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 Through the purchase of a Service Manual Chattanooga Group has made available circuit diagrams component part lists descriptors or other information which will assist authorized tech...

Страница 57: ...any the selling dealer or a certified Company service technician 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 ...

Страница 58: ...ox 489 Hixson TN 37343 U S A Telephone 1 423 870 2281 U S A 1 800 592 7329 U S A 1 800 366 6661 CANADA 1 423 875 5497 U S A FAX chattgroup com Moving Rehabilitation Forward 2008 Encore Medical L P ISO 13485 Certified 28049D ...

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